Belite Bio（D01）株式概要臨床段階のバイオ医薬品開発企業であるベライト・バイオ社は、米国でアンメット・メディカル・ニーズのある網膜変性眼疾患をターゲットとした新規治療薬の研究開発に従事している。 詳細D01 ファンダメンタル分析スノーフレーク・スコア評価3/6将来の成長5/6過去の実績0/6財務の健全性5/6配当金0/6報酬当社が推定した公正価値より85.1%で取引されている 収益は年間65.34%増加すると予測されています アナリストらは、株価が46.9%上昇するだろうとほぼ一致している。 リスク分析収益が 100 万ドル未満 ( $0 )過去1年間で株主の希薄化が進んだ すべてのリスクチェックを見るD01 Community Fair Values Create NarrativeSee what others think this stock is worth. Follow their fair value or set your own to get alerts.Your Fair Value€Current Price€120.00該当なし内在価値ディスカウントEst. Revenue$PastFuture-78m92016201920222025202620282031Revenue US$9.1Earnings US$1.3AdvancedSet Fair ValueView all narrativesBelite Bio, Inc 競合他社Dermapharm HoldingSymbol: XTRA:DMPMarket cap: €2.4bBayerSymbol: XTRA:BAYNMarket cap: €38.2bPEPTONIC medicalSymbol: DB:28LMarket cap: €560.2mMerck KGaASymbol: XTRA:MRKMarket cap: €55.0b価格と性能株価の高値、安値、推移の概要Belite Bio過去の株価現在の株価US$120.0052週高値US$164.0052週安値US$46.80ベータ-1.191ヶ月の変化-15.49%3ヶ月変化-19.46%1年変化110.53%3年間の変化n/a5年間の変化n/aIPOからの変化202.65%最新ニュースBreakeven Date Change • 15hThe 8 analysts covering Belite Bio previously expected the company to break even in 2027. New consensus forecast suggests the company will make a profit of US$42.3m in 2027. Average annual earnings growth of 65% is required to achieve expected profit on schedule.Board Change • May 20Less than half of directors are independentThere is 1 new director who has joined the board in the last 3 years. The new board member was not an independent director. The company's board is composed of: 1 new director. 9 experienced directors. 1 highly experienced director. 3 independent directors (4 non-independent directors). Independent Director Ita Lu was the last independent director to join the board, commencing their role in 2022. The following issues are considered to be risks according to the Simply Wall St Risk Model: Minority of independent directors. Insufficient board refreshment.お知らせ • May 14Belite Bio, Inc to Report Q1, 2026 Results on May 20, 2026Belite Bio, Inc announced that they will report Q1, 2026 results on May 20, 2026お知らせ • Apr 24Belite Bio Initiates Rolling Submission of New Drug Application to the U.S. Food and Drug Administration for Tinlarebant for the Treatment of Stargardt DiseaseBelite Bio Inc. initiated a rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for tinlarebant, an investigational novel oral therapy for the treatment of Stargardt disease type 1 (STGD1), a rare, inherited retinal disorder caused by mutations in the ABCA4 gene. Tinlarebant has previously been granted Breakthrough Therapy Designation (BTD) by the FDA for STGD1, and the FDA has previously granted Belite approval for the rolling submission of the NDA. The Company expects to complete the NDA rolling submission in the second quarter of 2026. Tinlarebant is a novel oral therapy that is intended to reduce the accumulation of vitamin A-based toxins (known as bisretinoids) that cause retinal disease in STGD1 and also contribute to disease progression in geographic atrophy (GA), or advanced dry age-related macular degeneration (AMD). Bisretinoids are by-products of the visual cycle, which is dependent on the supply of vitamin A (retinol) to the eye. Tinlarebant works by reducing and maintaining levels of serum retinol binding protein 4 (RBP4), the sole carrier protein for retinol transport from the liver to the eye. By modulating the amount of retinol entering the eye, tinlarebant reduces the formation of bisretinoids. Tinlarebant has been granted Breakthrough Therapy Designation, Fast Track Designation, and Rare Pediatric Disease Designation in the U.S., Orphan Drug Designation in the U.S., Europe, and Japan, and Sakigake Designation in Japan for the treatment of STGD1. The Company has completed a Phase 3 trial (DRAGON) in adolescent STGD1 subjects, and the drug is currently being evaluated in a Phase 2/3 trial (DRAGON II) in adolescent STGD1 subjects and a Phase 3 trial (PHOENIX) in subjects with GA.お知らせ • Jan 28Belite Bio, Inc Completes Enrollment in the DRAGON II Clinical Trial of Tinlarebant for Stargardt Disease (STGD1)Belite Bio Inc. announced the completion of enrollment of 60 subjects, including 15 Japanese subjects, in the Phase 2/3 DRAGON II clinical trial evaluating tinlarebant for the treatment of Stargardt disease type 1 (STGD1). DRAGON II clinical trial is a global, 24-month, randomized, double-masked, placebo-controlled study designed to evaluate the efficacy, safety, and tolerability of tinlarebant in adolescent patients with STGD1. The trial had a targeted enrollment of 60 adolescent subjects aged 12 to 20 years old across Japan, the United States, and the United Kingdom, with participants randomized 1:1 to receive either tinlarebant or placebo. Tinlarebant is a novel oral therapy that is intended to reduce the accumulation of vitamin A-based toxins (known as bisretinoids) that cause retinal disease in STGD1 and also contribute to disease progression in geographic atrophy (GA), or advanced dry age-related macular degeneration (AMD). Bisretinoids are by-products of the visual cycle, which is dependent on the supply of vitamin A (retinol) to the eye. Tinlarebant works by reducing and maintaining levels of serum retinol binding protein 4 (RBP4), the sole carrier protein for retinol transport from the liver to the eye. By modulating the amount of retinol entering the eye, tinlarebant reduces the formation of bisretinoids. Tinlarebant has been granted Breakthrough Therapy Designation, Fast Track Designation, and Rare Pediatric Disease Designation in the U.S., Orphan Drug Designation in the U. S., Europe, and Japan, and Sakigake Designation in Japan for the treatment of STGD1.お知らせ • Dec 02+ 2 more updatesBelite Bio, Inc. Announces Positive Topline Results from the Pivotal Global, Phase 3 DRAGON Trial of Tinlarebant in Adolescents with Stargardt DiseaseBelite Bio Inc. announced topline results from the global Phase 3 "DRAGON" trial of Tinlarebant, marking the first successful pivotal trial in patients with Stargardt disease type 1 (STGD1). STGD1 is an eye disease that leads to progressive vision loss, usually beginning in childhood or young adulthood, and currently has no approved treatment worldwide. The Phase 3 DRAGON trial enrolled 104 patients with STGD1 and met its primary efficacy endpoint, demonstrating a statistically significant and clinically meaningful 36% reduction in the growth rate of retinal lesions, measured as definitely decreased autofluorescence (DDAF) by fundus autofluorescence imaging, compared with placebo. Statistical significance was reached when applying the pre-specified analysis (p-value = 0.0033). Considering the progressive nature typically seen in STGD1, a further post-hoc analysis providing a specific data correlation showed that the treatment effect remained consistent with a p-value < 0.0001. The significant lesion growth reduction observed in the DRAGON study, along with the favorable safety profile, provide important validation of therapeutic approach and the mechanism of Tinlarebant. Tinlarebant produced a clear and statistically significant treatment effect on DDAF lesion growth rate, not only in the study eye, but both eyes. Furthermore, the effect was supported by a statistically significant benefit in the key secondary endpoint, again in both eyes. Safety and tolerability of Tinlarebant was very favorable in the trial. Collectively, these data reinforce Tinlarebant's potential to change the treatment landscape for Stargardt disease and set a new benchmark for future research in inherited retinal disorders." The Company plans to engage regulatory authorities to discuss potential next steps and to submit New Drug Applications for Tinlarebant in the first half of 2026. Tinlarebant has been granted Breakthrough Therapy, Fast Track, and Rare Pediatric Disease Designations in the U.S.; Orphan Drug Designation in the U.S., Europe, and Japan; and Pioneer Drug Designation in Japan for STGD1. DDAF Data Highlights The DRAGON trial was a 24-month, randomized (2:1, active: placebo), double-masked, placebo-controlled, global, multi-center, pivotal Phase 3 trial in adolescent STGD1 patients. Patient Demographics: 104 patients (n=69 in tinlarebant arm and n=35 in placebo arm), ranging in age from age from age from age from 2026. The trial enrolled 104 patients with ST GD1 and met its primary efficacy efficacy endpoint, demonstrating an statistically significant and clinically meaningful 36%, reduction in the growth rate of Retinal lesions, compared with placebo. Data Highlights: The DRAGON trial was a24-month, randomized (2;1, active: placebo), triple-masked, placebo- controlled, global, multi- center, pivotal Phase 3 trial in adult STGD1 patients. Patient demographics: 104 patients (n= 69 in tinlarebant arms and n=35 in placebo arms), ranging in age from age to age from age from age from childhood or young adulthood, and young adulthood, and currently has not been approved.最新情報をもっと見るRecent updatesBreakeven Date Change • 15hThe 8 analysts covering Belite Bio previously expected the company to break even in 2027. New consensus forecast suggests the company will make a profit of US$42.3m in 2027. Average annual earnings growth of 65% is required to achieve expected profit on schedule.Board Change • May 20Less than half of directors are independentThere is 1 new director who has joined the board in the last 3 years. The new board member was not an independent director. The company's board is composed of: 1 new director. 9 experienced directors. 1 highly experienced director. 3 independent directors (4 non-independent directors). Independent Director Ita Lu was the last independent director to join the board, commencing their role in 2022. The following issues are considered to be risks according to the Simply Wall St Risk Model: Minority of independent directors. Insufficient board refreshment.お知らせ • May 14Belite Bio, Inc to Report Q1, 2026 Results on May 20, 2026Belite Bio, Inc announced that they will report Q1, 2026 results on May 20, 2026お知らせ • Apr 24Belite Bio Initiates Rolling Submission of New Drug Application to the U.S. Food and Drug Administration for Tinlarebant for the Treatment of Stargardt DiseaseBelite Bio Inc. initiated a rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for tinlarebant, an investigational novel oral therapy for the treatment of Stargardt disease type 1 (STGD1), a rare, inherited retinal disorder caused by mutations in the ABCA4 gene. Tinlarebant has previously been granted Breakthrough Therapy Designation (BTD) by the FDA for STGD1, and the FDA has previously granted Belite approval for the rolling submission of the NDA. The Company expects to complete the NDA rolling submission in the second quarter of 2026. Tinlarebant is a novel oral therapy that is intended to reduce the accumulation of vitamin A-based toxins (known as bisretinoids) that cause retinal disease in STGD1 and also contribute to disease progression in geographic atrophy (GA), or advanced dry age-related macular degeneration (AMD). Bisretinoids are by-products of the visual cycle, which is dependent on the supply of vitamin A (retinol) to the eye. Tinlarebant works by reducing and maintaining levels of serum retinol binding protein 4 (RBP4), the sole carrier protein for retinol transport from the liver to the eye. By modulating the amount of retinol entering the eye, tinlarebant reduces the formation of bisretinoids. Tinlarebant has been granted Breakthrough Therapy Designation, Fast Track Designation, and Rare Pediatric Disease Designation in the U.S., Orphan Drug Designation in the U.S., Europe, and Japan, and Sakigake Designation in Japan for the treatment of STGD1. The Company has completed a Phase 3 trial (DRAGON) in adolescent STGD1 subjects, and the drug is currently being evaluated in a Phase 2/3 trial (DRAGON II) in adolescent STGD1 subjects and a Phase 3 trial (PHOENIX) in subjects with GA.お知らせ • Jan 28Belite Bio, Inc Completes Enrollment in the DRAGON II Clinical Trial of Tinlarebant for Stargardt Disease (STGD1)Belite Bio Inc. announced the completion of enrollment of 60 subjects, including 15 Japanese subjects, in the Phase 2/3 DRAGON II clinical trial evaluating tinlarebant for the treatment of Stargardt disease type 1 (STGD1). DRAGON II clinical trial is a global, 24-month, randomized, double-masked, placebo-controlled study designed to evaluate the efficacy, safety, and tolerability of tinlarebant in adolescent patients with STGD1. The trial had a targeted enrollment of 60 adolescent subjects aged 12 to 20 years old across Japan, the United States, and the United Kingdom, with participants randomized 1:1 to receive either tinlarebant or placebo. Tinlarebant is a novel oral therapy that is intended to reduce the accumulation of vitamin A-based toxins (known as bisretinoids) that cause retinal disease in STGD1 and also contribute to disease progression in geographic atrophy (GA), or advanced dry age-related macular degeneration (AMD). Bisretinoids are by-products of the visual cycle, which is dependent on the supply of vitamin A (retinol) to the eye. Tinlarebant works by reducing and maintaining levels of serum retinol binding protein 4 (RBP4), the sole carrier protein for retinol transport from the liver to the eye. By modulating the amount of retinol entering the eye, tinlarebant reduces the formation of bisretinoids. Tinlarebant has been granted Breakthrough Therapy Designation, Fast Track Designation, and Rare Pediatric Disease Designation in the U.S., Orphan Drug Designation in the U. S., Europe, and Japan, and Sakigake Designation in Japan for the treatment of STGD1.お知らせ • Dec 02+ 2 more updatesBelite Bio, Inc. Announces Positive Topline Results from the Pivotal Global, Phase 3 DRAGON Trial of Tinlarebant in Adolescents with Stargardt DiseaseBelite Bio Inc. announced topline results from the global Phase 3 "DRAGON" trial of Tinlarebant, marking the first successful pivotal trial in patients with Stargardt disease type 1 (STGD1). STGD1 is an eye disease that leads to progressive vision loss, usually beginning in childhood or young adulthood, and currently has no approved treatment worldwide. The Phase 3 DRAGON trial enrolled 104 patients with STGD1 and met its primary efficacy endpoint, demonstrating a statistically significant and clinically meaningful 36% reduction in the growth rate of retinal lesions, measured as definitely decreased autofluorescence (DDAF) by fundus autofluorescence imaging, compared with placebo. Statistical significance was reached when applying the pre-specified analysis (p-value = 0.0033). Considering the progressive nature typically seen in STGD1, a further post-hoc analysis providing a specific data correlation showed that the treatment effect remained consistent with a p-value < 0.0001. The significant lesion growth reduction observed in the DRAGON study, along with the favorable safety profile, provide important validation of therapeutic approach and the mechanism of Tinlarebant. Tinlarebant produced a clear and statistically significant treatment effect on DDAF lesion growth rate, not only in the study eye, but both eyes. Furthermore, the effect was supported by a statistically significant benefit in the key secondary endpoint, again in both eyes. Safety and tolerability of Tinlarebant was very favorable in the trial. Collectively, these data reinforce Tinlarebant's potential to change the treatment landscape for Stargardt disease and set a new benchmark for future research in inherited retinal disorders." The Company plans to engage regulatory authorities to discuss potential next steps and to submit New Drug Applications for Tinlarebant in the first half of 2026. Tinlarebant has been granted Breakthrough Therapy, Fast Track, and Rare Pediatric Disease Designations in the U.S.; Orphan Drug Designation in the U.S., Europe, and Japan; and Pioneer Drug Designation in Japan for STGD1. DDAF Data Highlights The DRAGON trial was a 24-month, randomized (2:1, active: placebo), double-masked, placebo-controlled, global, multi-center, pivotal Phase 3 trial in adolescent STGD1 patients. Patient Demographics: 104 patients (n=69 in tinlarebant arm and n=35 in placebo arm), ranging in age from age from age from age from 2026. The trial enrolled 104 patients with ST GD1 and met its primary efficacy efficacy endpoint, demonstrating an statistically significant and clinically meaningful 36%, reduction in the growth rate of Retinal lesions, compared with placebo. Data Highlights: The DRAGON trial was a24-month, randomized (2;1, active: placebo), triple-masked, placebo- controlled, global, multi- center, pivotal Phase 3 trial in adult STGD1 patients. Patient demographics: 104 patients (n= 69 in tinlarebant arms and n=35 in placebo arms), ranging in age from age to age from age from age from childhood or young adulthood, and young adulthood, and currently has not been approved.お知らせ • Nov 10Belite Bio, Inc has completed a Follow-on Equity Offering in the amount of $15.00005 million.Belite Bio, Inc has completed a Follow-on Equity Offering in the amount of $15.00005 million. Security Name: American Depository Shares Security Type: Depositary Receipt (Common Stock) Securities Offered: 230,770 Price\Range: $65 Discount Per Security: $4.225 Security Name: Warrants Security Type: Equity Warrant Securities Offered: 230,770 Transaction Features: Registered Direct Offeringお知らせ • Nov 04Belite Bio Inc. Announces UK’s Medicines and Healthcare Products Regulatory Agency Agrees to Conditional Marketing Authorization Application Based on Interim Analysis Results for Treatment of Stargardt Disease with TinlarebantBelite Bio Inc. announced that United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) has agreed to accept a Conditional Marketing Authorization application for Tinlarebant for the treatment of Stargardt disease based on the interim analysis results from the Phase 3 DRAGON trial. MHRA’s response is based on the interim analysis results which fulfil the criteria for a Conditional Marketing Authorization application. The Company remains on track to report final topline data from the Phase 3 DRAGON trial in the fourth quarter of 2025. These results are expected to be submitted to the MHRA for full Marketing Authorization Application. The pivotal Phase 3 DRAGON trial is a randomized, double-masked, placebo-controlled, global study designed to evaluate the safety and efficacy of Tinlarebant in adolescent patients with Stargardt disease. The trial enrolled 104 subjects across 11 jurisdictions, including the U.S., United Kingdom, Germany, France, Belgium, Switzerland, Netherlands, China, Hong Kong, Taiwan, and Australia, with a 2:1 randomization (Tinlarebant:placebo). The primary efficacy endpoint is the growth rate of atrophic lesions, alongside the assessment of safety and tolerability. Tinlarebant is a novel oral therapy that is intended to reduce the accumulation of vitamin A-based toxins (known as bisretinoids) that cause retinal disease in STGD1 and also contribute to disease progression in geographic atrophy (GA), or advanced dry age-related macular degeneration (AMD). Bisretinoids are by-products of the visual cycle, which is dependent on the supply of vitamin A (retinol) to the eye. Tinlarebant works by reducing and maintaining levels of serum retinol binding protein 4 (RBP4), the sole carrier protein for retinol transport from the liver to the eye. By modulating the amount of retinol entering the eye, Tinlarebant reduces the formation of bisretinoids. Tinlarebant has been granted Breakthrough Therapy Designation, Fast Track Designation and Rare Pediatric Disease designation in the U.S., Orphan Drug Designation in the U.S., Europe, and Japan, and Sakigake (Pioneer Drug) Designation in Japan for the treatment of STGD1.お知らせ • Oct 16Belite Bio, Inc. Announces China NMPA Agrees to New Drug Application with Priority Review Based on Interim Analysis Results for the Treatment of Stargardt Disease with TinlarebantBelite Bio Inc. announced that the Center for Drug Evaluation of China's National Medical Products Administration ("NMPA") has agreed to accept the New Drug Application (NDA) with priority review for Tinlarebant for the treatment of Stargardt disease based on the interim analysis results from the Phase 3 DRAGON trial. NMPA's response is based on the interim analysis results showing statistical significance in the primary endpoint of the Phase 3 DRAGON trial. The Company remains on track to report final topline data from the Phase 3 DRAGON trial in the fourth quarter of 2025. These results are expected to be submitted to the NMPA as part of the NDA that is currently under preparation in accordance with China CDE's guidance. The pivotal Phase 3 DRAGON trial is a randomized, double-masked, placebo-controlled, global study designed to evaluate the safety and efficacy of Tinlarebant in adolescent patients with Stargardt disease. The trial enrolled 104 subjects across 11 jurisdictions, including the U.S., United Kingdom, Germany, France, Belgium, Switzerland, Netherlands, China, Hong Kong, Taiwan, and Australia, with a 2:1 randomization (Tinlarebant:placebo). The primary efficacy endpoint is the growth rate of atrophic lesions, alongside the assessment of safety and tolerability. Belite's lead candidate, Tinlarebant, an oral therapy intended to reduce the accumulation of bisretinoid toxins in the eye, is currently being evaluated in a Phase 3 study (DRAGON) and a Phase 2/3 study (DRAGON II) in adolescent STGD1 subjects and a Phase 3 study (PHOENIX) in subjects with GA.お知らせ • Sep 13Belite Bio Inc. Announces Completion of DRAGON, a 2-Year, Phase 3 Trial of Oral Tinlarebant in the Treatment of Stargardt DiseaseBelite Bio Inc. announced the completion of the last subject visit in the Phase 3 DRAGON clinical trial evaluating Tinlarebant for the treatment of Stargardt disease type 1 (STGD1). The DRAGON trial enrolled 104 adolescent subjects across 11 jurisdictions, including the United States, United Kingdom, Germany, France, Belgium, Switzerland, Netherlands, China, Hong Kong, Taiwan, and Australia, with a 2:1 randomization (Tinlarebant:placebo). A total of 94 subjects completed the study, with the last study visit conducted on September 11, 2025. The primary efficacy endpoint is the growth rate of atrophic lesions; safety and tolerability of Tinlarebant will also be assessed. Belite Bio expects to report top-line results from the DRAGON trial in Fourth Quarter 2025 and plans to file New Drug Applications in 1H 2026. About Tinlarebant (a/k/a LBS-008) Tinlarebant is a novel oral therapy that is intended to reduce the accumulation of vitamin A-based toxins (known as bisretinoids) that cause retinal disease in STGD1 and also contribute to disease progression in geographic atrophy (GA), or advanced dry age-related macular degeneration (AMD). Bisretinoids are by-products of the visual cycle, which is dependent on the supply of vitamin A (retinol) to the eye. Tinlarebant works by reducing and maintaining levels of serum retinol binding protein 4 (RBP4), the sole carrier protein for retinol transport from the liver to the eye.お知らせ • Sep 08Belite Bio, Inc announced that it expects to receive $124.999936 million in funding from RA Capital Management, L.P., Eventide Asset Management, LLC, Marshall Wace LLP, RTW Investments, LP, Soleus Capital LLC, Vestal Point Capital, LPBelite Bio, Inc announced a private placement and entered into a purchase agreement to issue 1,953,124 Ordinary shares, par value $0.0001 per share, at an issue price of $64 per ordinary share and warrants to purchase 1,953,124 ordinary shares for aggregate gross proceeds of $124,999,936 on September 8, 2025. Each Warrant will be immediately exercisable, expire two years from the date of issuance and have an exercise price of $76.80 per ordinary share. The securities issued under the Securities Purchase Agreements have not been registered under the Securities Act of 1933, as amended in reliance on the exemption from registration provided by Section 4(a)(2) of the Securities Act and/or Rule 506 of Regulation D promulgated thereunder, or under any state securities laws. The transaction is expected to close on September 9, 2025. The transaction will include participation from RA Capital Management as the lead investor and from Eventide Asset Management, Marshall Wace, RTW Investments, Soleus Capital and Vestal Point Capital. In connection with the offering, the Company shall pay the reasonable fees and expenses of counsel for the lead investor to the transactions contemplated hereunder, in an amount not to exceed $150,000.お知らせ • Aug 08Belite Bio, Inc has filed a Follow-on Equity Offering in the amount of $15.00005 million.Belite Bio, Inc has filed a Follow-on Equity Offering in the amount of $15.00005 million. Security Name: American Depository Shares Security Type: Depositary Receipt (Common Stock) Securities Offered: 230,770 Price\Range: $65 Security Name: Warrants Security Type: Equity Warrant Securities Offered: 230,770 Transaction Features: Registered Direct Offeringお知らせ • Jul 02Belite Bio, Inc. Announces Completion of Enrollment in the Pivotal Global Phase 3 Phase 3 PHOENIX Trial Evaluating Oral Tinlarebant in Geographic AtrophyBelite Bio Inc. announced the completion of enrollment in the PHOENIX trial, a global, 24-month Phase 3 pivotal trial evaluating the safety and tolerability of Tinlarebant and its potential to reduce atrophic lesion growth rate in patients diagnosed with geographic atrophy (GA) in dry age-related macular degeneration (AMD). The PHOENIX study is a 24-month, randomized, double-masked, placebo-controlled, multicenter, pivotal Phase 3 trial. The study is ongoing across sites in the United States, the United Kingdom, France, Czech Republic, Switzerland, China, Taiwan, and Australia.お知らせ • May 21Belite Bio, Inc. Announces FDA Granting of Breakthrough Therapy Designation for Tinlarebant for the Treatment of Stargardt DiseaseBelite Bio Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for Tinlarebant for the treatment of Stargardt disease (STGD1) based on the previously reported interim data from the ongoing Phase 3 DRAGON trial. There are currently no approved treatments for STGD1. The FDA grants Breakthrough Therapy Designation to expedite the development and regulatory review of drugs that are intended for serious or life-threatening conditions. The designation is based on preliminary clinical evidence indicating that a drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints. Tinlarebant is an orally administered, once-a-day tablet intended as an early intervention for maintaining the health and integrity of retinal tissues in Stargardt disease type 1 (STGD1) and Geographic Atrophy (GA) patients. Currently, there are no FDA approved treatments for STGD1 and no approved orally administered treatments for GA. Therefore, if approved, Tinlarebant would be a novel oral therapeutic addressing an unmet medical need in both STGD1 and GA. Belite Bio's advancement of, and anticipated future activities on preclinical studies, clinical development, regulatory milestones, and commercialization of its product candidates; and any other statements containing the words "expect", "hope", "indicate", "look forward to", and similar expressions. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including but not limited to Belite Bio's ability to demonstrate the safety and efficacy o its drug candidates; the clinical results for its drug candidates, which may not support further development or regulatory approval; the timing of potential submission with FDA; the timing to complete relevant clinical trials and/or to receive the interim/final data of such clinical trials; the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approval of Belite Bio's drug candidates; the potential efficacy of Tinlarebant, as well as those risks more fully discussed in the "Risk Factors" section in Belite Bio's filings with the U.S. Securities and Exchange Commission.お知らせ • Mar 20Belite Bio, Inc, Annual General Meeting, Apr 15, 2025Belite Bio, Inc, Annual General Meeting, Apr 15, 2025. Location: 12750 high bluff drive suite 475, california 92130, san diego, United Statesお知らせ • Mar 01Belite Bio, Inc. Announces Interim Analysis Results from the Pivotal Global Phase 3 DRAGON Trial of Tinlarebant in Adolescent Stargardt Disease SubjectsBelite Bio Inc. announced that following a pre-specified Interim Analysis of the pivotal global Phase 3 "DRAGON" trial data of Tinlarebant in adolescent Stargardt disease patients, the Data Safety Monitoring Board (DSMB) has recommended the trial proceed without any modifications. The Interim Analysis was performed when all subjects completed the one-year assessment. The study design for the DRAGON trial included an adaptive sample size re-estimation that would determine the need for an increase in sample size in order to enhance power, based on a treatment effect observed at the Interim Analysis. The recommendation by the DSMB that the trial should proceed without modifications indicates that a sample size increase is not warranted. In addition, the DSMB recommended to submit the data for further regulatory review for drug approval. According to the DSMB, Tinlarebant is well-tolerated and the safety profile remains consistent with previously observed data and the mechanism of action for Tinlarebant.お知らせ • Feb 07Belite Bio, Inc has filed a Follow-on Equity Offering.Belite Bio, Inc has filed a Follow-on Equity Offering. Security Name: American Depositary Shares Security Type: Depositary Receipt (Common Stock) Securities Offered: 258,309 Price\Range: $58.07 Discount Per Security: $3.77455 Security Name: Warrants Security Type: Equity Warrant Securities Offered: 258,309 Transaction Features: Registered Direct Offeringお知らせ • Sep 02Belite Bio Announces Appointment of Hendrik P. N. Scholl as Chief Medical OfficerBelite Bio Inc. announced that its board of directors has appointed Hendrik P. N. Scholl, MD, MA, as the Chief Medical Officer of the Company, effective immediately. Dr. Scholl is the foremost globally recognized authority on Stargardt disease and age-related macular degeneration (AMD), bringing decades of expertise in treating retinal diseases, including the two key indications targeted by Belite Bio's lead drug candidate, Tinlarebant. Dr. Scholl served as the founding and scientific co-director of the Institute of Molecular and Clinical Ophthalmology Basel (IOB) and Professor of Ophthalmology at the University of Basel, where he also led the Department of Ophthalmology as its Chairman. He currently serves as President of the European Vision Institute as well as Chairman of the largest clinical research network in ophthalmology in Europe, EVICR.net, and its Expert Committee on Retinal Dystrophies. He is also the Founder and President of the Swiss Association for Research in Vision and Ophthalmology (ARVO-SWISS). Dr. Scholl’s distinguished career in academia includes leadership positions at several key academic institutions. Recently, he served as Professor of Ophthalmology and Endowed Chair at the Wilmer Eye Institute of Johns Hopkins University Medical School. At the Johns Hopkins Hospital, he was the Head of the Retinal Degeneration Clinic and the Director of the Visual Neurophysiology Service. For the Wilmer Eye Institute, he also served as the Co-director of the Johns Hopkins Center for Stem Cells and Ophthalmic Regenerative Medicine. Dr. Scholl is the coordinating principal investigator of the largest natural history study of Stargardt disease (ProgStar Study), which enrolled 365 subjects. Throughout his career, he has participated in over 10 clinical studies both in Stargardt disease and AMD, authored over 280 articles and reviews in peer-reviewed journals, and received numerous prestigious awards, including the European Vision Award, the President’s Award of the American Society of Retinal Specialists, the W. Richard Green Award and the Paul Henkind Memorial Award of the Macula Society, the Swiss Alfred-Vogt Award, and the Kupfer award of ARVO. He holds an honorary doctorate from Semmelweis University in Budapest, Hungary, and is Adjunct Professor at the Medical University of Vienna, Austria. Over the course of his 25 years of experience, Dr. Scholl has led and participated in numerous boards and advisory committees. He currently serves on the Scientific Advisory Board of Pro Retina Deutschland, Foundation Fighting Blindness, Erasmus University Medical Center, AIBILI, and the Institut de la Vision (Paris); on the Investment Advisory Board of Droia NV; and the Data Safety Monitoring Board of Roche Holding AG and ViGeneron GmbH. Dr. Scholl graduated from the University of Tübingen, Germany with a Doctor of Medicine (Dr. med.) and Master of Arts. He completed his specialist training at the University Eye Hospital in Tübingen before being awarded a fellowship from the German Research Foundation (DFG) at Moorfields Eye Hospital and Institute of Ophthalmology in London, and a DFG Heisenberg Professorship for Macular Diseases at the Eye Clinic of the University of Bonn, Germany.Buy Or Sell Opportunity • Jul 01Now 49% undervaluedOver the last 90 days, the stock has risen 23% to €42.20. The fair value is estimated to be €83.21, however this is not to be taken as a buy recommendation but rather should be used as a guide only.Buy Or Sell Opportunity • Jun 29Now 20% undervaluedOver the last 90 days, the stock has risen 23% to €42.40. The fair value is estimated to be €53.15, however this is not to be taken as a buy recommendation but rather should be used as a guide only.お知らせ • May 08Belite Bio, Inc. Presents Additional Analysis from Phase 2 Study of Tinlarebant in Stargardt Disease at the ARVO Annual MeetingBelite Bio Inc. announced additional findings from the 24-month Phase 2 study of Tinlarebant in adolescent Stargardt disease (STGD1) at the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting. Tinlarebant is Belite Bio's orally administered tablet intended to slow disease progression in patients affected with STGD1 and Geographic Atrophy (GA) in advanced Dry Age-related Macular Degeneration (Dry AMD). Genetic profiling was performed on the 13 adolescent STGD1 patients enrolled in a Phase 2 study of Tinlarebant. Eleven of these subjects (85%) harbored severe pathogenic/likely pathogenic ABCA4 variants. Despite these severe variants, 42% of Tinlarebant-treated subjects (5 out of 12) did not develop incident atrophic (definitely decreased autofluorescence, DDAF) retinal lesions and no change in questionably decreased autofluorescence (QDAF) was observed during the 24-month treatment period. Incident atrophic lesions appeared in seven subjects at different timepoints over 24 months; four of these subjects developed DDAF lesions after month 12. The mean DDAF lesion growth at month 24 was 0.51 mm2 with a range of variation of 0.4 mm2, a growth rate that is significantly lower than what has been observed in natural history studies. Importantly, six STGD1 patients who had a mean bilateral best corrected visual acuity (BCVA) loss of 10 letters per year prior to enrollment in the Phase 2 study showed a mean BCVA loss equivalent to 1.9 letters per year during the 24-month treatment period. Analysis of genotype-phenotype relationships revealed that sibling subjects with identical ABCA4 mutations had different rates of lesion growth and BCVA loss indicating that identical genotypes do not necessarily predict an identical course of disease. Notably, retinal imaging data from the Phase 2 study was reanalyzed using a novel lesion size quantification method that utilizes a mathematical classification of lesions to reduce subjective reader bias and provide enhanced accuracy and superior precision compared to the traditional method of DDAF lesion quantification. This analysis revealed DDAF lesions within the macula in 12 eyes of eight subjects at baseline. Analysis of change in atrophic lesion area within the macula of these eyes over 24 months showed a halt in lesion growth into the macula after 16 months. This finding is consistent with the observed stabilization of visual acuity.お知らせ • Apr 26Belite Bio, Inc has filed a Follow-on Equity Offering in the amount of $24.999964 million.Belite Bio, Inc has filed a Follow-on Equity Offering in the amount of $24.999964 million. Security Name: American Depositary Shares Security Type: Depositary Receipt (Common Stock) Securities Offered: 651,380 Price\Range: $38.38 Transaction Features: Registered Direct OfferingBoard Change • Mar 28Less than half of directors are independentThere are 6 new directors who have joined the board in the last 3 years. Of these new board members, 3 were independent directors. The company's board is composed of: 6 new directors. 6 experienced directors. No highly experienced directors. 3 independent directors (4 non-independent directors). Chairman of the Board of Directors & CEO Tom Lin is the most experienced director on the board, commencing their role in 2018. Independent Director Ita Lu was the last independent director to join the board, commencing their role in 2022. The following issues are considered to be risks according to the Simply Wall St Risk Model: Minority of independent directors. Lack of board continuity. Lack of experienced directors.株主還元D01DE PharmaceuticalsDE 市場7D-6.3%3.4%0.6%1Y110.5%26.6%0.2%株主還元を見る業界別リターン: D01過去 1 年間で26.6 % の収益を上げたGerman Pharmaceuticals業界を上回りました。リターン対市場: D01過去 1 年間で0.2 % の収益を上げたGerman市場を上回りました。価格変動Is D01's price volatile compared to industry and market?D01 volatilityD01 Average Weekly Movement6.2%Pharmaceuticals Industry Average Movement6.3%Market Average Movement6.1%10% most volatile stocks in DE Market13.2%10% least volatile stocks in DE Market2.7%安定した株価: D01 、 German市場と比較して、過去 3 か月間で大きな価格変動はありませんでした。時間の経過による変動: D01の 週次ボラティリティ ( 6% ) は過去 1 年間安定しています。会社概要設立従業員CEO（最高経営責任者ウェブサイト201641Tom Linwww.belitebio.comBelite Bio, Inc.は臨床段階のバイオ医薬品開発企業で、米国でアンメット・メディカル・ニーズのある網膜変性眼疾患をターゲットとした新規治療薬の研究開発に従事している。同社の主要製品候補は、経口投与のTinlarebant（LBS-008）で、スターガルト病1型および地理的萎縮症患者の網膜組織の健康と完全性を維持するための早期介入薬として第3相臨床試験中です。また、非アルコール性脂肪性肝疾患、非アルコール性脂肪性肝炎、2型糖尿病などの肝疾患や痛風をターゲットとした前臨床開発中の抗レチノール結合タンパク質4経口治療薬LBS-009も開発している。Belite Bio, Incは2016年に設立され、カリフォルニア州サンディエゴを拠点としている。Belite Bio, Inc.はLin Bioscience International Ltd.の子会社である。もっと見るBelite Bio, Inc 基礎のまとめBelite Bio の収益と売上を時価総額と比較するとどうか。D01 基礎統計学時価総額€4.85b収益（TTM）-€66.81m売上高(TTM)n/a0.0xP/Sレシオ-73.0xPER（株価収益率D01 は割高か？公正価値と評価分析を参照収益と収入最新の決算報告書（TTM）に基づく主な収益性統計D01 損益計算書（TTM）収益US$0売上原価US$0売上総利益US$0その他の費用US$0収益US$0直近の収益報告Mar 31, 2026次回決算日該当なし一株当たり利益（EPS）-1.97グロス・マージン0.00%純利益率0.00%有利子負債／自己資本比率0%D01 の長期的なパフォーマンスは？過去の実績と比較を見るView Valuation企業分析と財務データの現状データ最終更新日（UTC時間）企業分析2026/05/21 15:03終値2026/05/21 00:00収益2026/03/31年間収益2025/12/31データソース企業分析に使用したデータはS&P Global Market Intelligence LLC のものです。本レポートを作成するための分析モデルでは、以下のデータを使用しています。データは正規化されているため、ソースが利用可能になるまでに時間がかかる場合があります。パッケージデータタイムフレーム米国ソース例会社財務10年損益計算書キャッシュ・フロー計算書貸借対照表SECフォーム10-KSECフォーム10-Qアナリストのコンセンサス予想+プラス3年予想財務アナリストの目標株価アナリストリサーチレポートBlue Matrix市場価格30年株価配当、分割、措置ICEマーケットデータSECフォームS-1所有権10年トップ株主インサイダー取引SECフォーム4SECフォーム13Dマネジメント10年リーダーシップ・チーム取締役会SECフォーム10-KSECフォームDEF 14A主な進展10年会社からのお知らせSECフォーム8-K* 米国証券を対象とした例であり、非米国証券については、同等の規制書式および情報源を使用。特に断りのない限り、すべての財務データは1年ごとの期間に基づいていますが、四半期ごとに更新されます。これは、TTM（Trailing Twelve Month）またはLTM（Last Twelve Month）データとして知られています。詳細はこちら。分析モデルとスノーフレーク本レポートを生成するために使用した分析モデルの詳細は当社のGithubページでご覧いただけます。また、レポートの使用方法に関するガイドやYoutubeのチュートリアルも掲載しています。シンプリー・ウォールストリート分析モデルを設計・構築した世界トップクラスのチームについてご紹介します。業界およびセクターの指標私たちの業界とセクションの指標は、Simply Wall Stによって6時間ごとに計算されます。アナリスト筋Belite Bio, Inc 8 これらのアナリストのうち、弊社レポートのインプットとして使用した売上高または利益の予想を提出したのは、 。アナリストの投稿は一日中更新されます。11 アナリスト機関Bruce JacksonBenchmark CompanyTazeen AhmadBofA Global ResearchJennifer KimCantor Fitzgerald & Co.8 その他のアナリストを表示
Breakeven Date Change • 15hThe 8 analysts covering Belite Bio previously expected the company to break even in 2027. New consensus forecast suggests the company will make a profit of US$42.3m in 2027. Average annual earnings growth of 65% is required to achieve expected profit on schedule.
Board Change • May 20Less than half of directors are independentThere is 1 new director who has joined the board in the last 3 years. The new board member was not an independent director. The company's board is composed of: 1 new director. 9 experienced directors. 1 highly experienced director. 3 independent directors (4 non-independent directors). Independent Director Ita Lu was the last independent director to join the board, commencing their role in 2022. The following issues are considered to be risks according to the Simply Wall St Risk Model: Minority of independent directors. Insufficient board refreshment.
お知らせ • May 14Belite Bio, Inc to Report Q1, 2026 Results on May 20, 2026Belite Bio, Inc announced that they will report Q1, 2026 results on May 20, 2026
お知らせ • Apr 24Belite Bio Initiates Rolling Submission of New Drug Application to the U.S. Food and Drug Administration for Tinlarebant for the Treatment of Stargardt DiseaseBelite Bio Inc. initiated a rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for tinlarebant, an investigational novel oral therapy for the treatment of Stargardt disease type 1 (STGD1), a rare, inherited retinal disorder caused by mutations in the ABCA4 gene. Tinlarebant has previously been granted Breakthrough Therapy Designation (BTD) by the FDA for STGD1, and the FDA has previously granted Belite approval for the rolling submission of the NDA. The Company expects to complete the NDA rolling submission in the second quarter of 2026. Tinlarebant is a novel oral therapy that is intended to reduce the accumulation of vitamin A-based toxins (known as bisretinoids) that cause retinal disease in STGD1 and also contribute to disease progression in geographic atrophy (GA), or advanced dry age-related macular degeneration (AMD). Bisretinoids are by-products of the visual cycle, which is dependent on the supply of vitamin A (retinol) to the eye. Tinlarebant works by reducing and maintaining levels of serum retinol binding protein 4 (RBP4), the sole carrier protein for retinol transport from the liver to the eye. By modulating the amount of retinol entering the eye, tinlarebant reduces the formation of bisretinoids. Tinlarebant has been granted Breakthrough Therapy Designation, Fast Track Designation, and Rare Pediatric Disease Designation in the U.S., Orphan Drug Designation in the U.S., Europe, and Japan, and Sakigake Designation in Japan for the treatment of STGD1. The Company has completed a Phase 3 trial (DRAGON) in adolescent STGD1 subjects, and the drug is currently being evaluated in a Phase 2/3 trial (DRAGON II) in adolescent STGD1 subjects and a Phase 3 trial (PHOENIX) in subjects with GA.
お知らせ • Jan 28Belite Bio, Inc Completes Enrollment in the DRAGON II Clinical Trial of Tinlarebant for Stargardt Disease (STGD1)Belite Bio Inc. announced the completion of enrollment of 60 subjects, including 15 Japanese subjects, in the Phase 2/3 DRAGON II clinical trial evaluating tinlarebant for the treatment of Stargardt disease type 1 (STGD1). DRAGON II clinical trial is a global, 24-month, randomized, double-masked, placebo-controlled study designed to evaluate the efficacy, safety, and tolerability of tinlarebant in adolescent patients with STGD1. The trial had a targeted enrollment of 60 adolescent subjects aged 12 to 20 years old across Japan, the United States, and the United Kingdom, with participants randomized 1:1 to receive either tinlarebant or placebo. Tinlarebant is a novel oral therapy that is intended to reduce the accumulation of vitamin A-based toxins (known as bisretinoids) that cause retinal disease in STGD1 and also contribute to disease progression in geographic atrophy (GA), or advanced dry age-related macular degeneration (AMD). Bisretinoids are by-products of the visual cycle, which is dependent on the supply of vitamin A (retinol) to the eye. Tinlarebant works by reducing and maintaining levels of serum retinol binding protein 4 (RBP4), the sole carrier protein for retinol transport from the liver to the eye. By modulating the amount of retinol entering the eye, tinlarebant reduces the formation of bisretinoids. Tinlarebant has been granted Breakthrough Therapy Designation, Fast Track Designation, and Rare Pediatric Disease Designation in the U.S., Orphan Drug Designation in the U. S., Europe, and Japan, and Sakigake Designation in Japan for the treatment of STGD1.
お知らせ • Dec 02+ 2 more updatesBelite Bio, Inc. Announces Positive Topline Results from the Pivotal Global, Phase 3 DRAGON Trial of Tinlarebant in Adolescents with Stargardt DiseaseBelite Bio Inc. announced topline results from the global Phase 3 "DRAGON" trial of Tinlarebant, marking the first successful pivotal trial in patients with Stargardt disease type 1 (STGD1). STGD1 is an eye disease that leads to progressive vision loss, usually beginning in childhood or young adulthood, and currently has no approved treatment worldwide. The Phase 3 DRAGON trial enrolled 104 patients with STGD1 and met its primary efficacy endpoint, demonstrating a statistically significant and clinically meaningful 36% reduction in the growth rate of retinal lesions, measured as definitely decreased autofluorescence (DDAF) by fundus autofluorescence imaging, compared with placebo. Statistical significance was reached when applying the pre-specified analysis (p-value = 0.0033). Considering the progressive nature typically seen in STGD1, a further post-hoc analysis providing a specific data correlation showed that the treatment effect remained consistent with a p-value < 0.0001. The significant lesion growth reduction observed in the DRAGON study, along with the favorable safety profile, provide important validation of therapeutic approach and the mechanism of Tinlarebant. Tinlarebant produced a clear and statistically significant treatment effect on DDAF lesion growth rate, not only in the study eye, but both eyes. Furthermore, the effect was supported by a statistically significant benefit in the key secondary endpoint, again in both eyes. Safety and tolerability of Tinlarebant was very favorable in the trial. Collectively, these data reinforce Tinlarebant's potential to change the treatment landscape for Stargardt disease and set a new benchmark for future research in inherited retinal disorders." The Company plans to engage regulatory authorities to discuss potential next steps and to submit New Drug Applications for Tinlarebant in the first half of 2026. Tinlarebant has been granted Breakthrough Therapy, Fast Track, and Rare Pediatric Disease Designations in the U.S.; Orphan Drug Designation in the U.S., Europe, and Japan; and Pioneer Drug Designation in Japan for STGD1. DDAF Data Highlights The DRAGON trial was a 24-month, randomized (2:1, active: placebo), double-masked, placebo-controlled, global, multi-center, pivotal Phase 3 trial in adolescent STGD1 patients. Patient Demographics: 104 patients (n=69 in tinlarebant arm and n=35 in placebo arm), ranging in age from age from age from age from 2026. The trial enrolled 104 patients with ST GD1 and met its primary efficacy efficacy endpoint, demonstrating an statistically significant and clinically meaningful 36%, reduction in the growth rate of Retinal lesions, compared with placebo. Data Highlights: The DRAGON trial was a24-month, randomized (2;1, active: placebo), triple-masked, placebo- controlled, global, multi- center, pivotal Phase 3 trial in adult STGD1 patients. Patient demographics: 104 patients (n= 69 in tinlarebant arms and n=35 in placebo arms), ranging in age from age to age from age from age from childhood or young adulthood, and young adulthood, and currently has not been approved.
Breakeven Date Change • 15hThe 8 analysts covering Belite Bio previously expected the company to break even in 2027. New consensus forecast suggests the company will make a profit of US$42.3m in 2027. Average annual earnings growth of 65% is required to achieve expected profit on schedule.
Board Change • May 20Less than half of directors are independentThere is 1 new director who has joined the board in the last 3 years. The new board member was not an independent director. The company's board is composed of: 1 new director. 9 experienced directors. 1 highly experienced director. 3 independent directors (4 non-independent directors). Independent Director Ita Lu was the last independent director to join the board, commencing their role in 2022. The following issues are considered to be risks according to the Simply Wall St Risk Model: Minority of independent directors. Insufficient board refreshment.
お知らせ • May 14Belite Bio, Inc to Report Q1, 2026 Results on May 20, 2026Belite Bio, Inc announced that they will report Q1, 2026 results on May 20, 2026
お知らせ • Apr 24Belite Bio Initiates Rolling Submission of New Drug Application to the U.S. Food and Drug Administration for Tinlarebant for the Treatment of Stargardt DiseaseBelite Bio Inc. initiated a rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for tinlarebant, an investigational novel oral therapy for the treatment of Stargardt disease type 1 (STGD1), a rare, inherited retinal disorder caused by mutations in the ABCA4 gene. Tinlarebant has previously been granted Breakthrough Therapy Designation (BTD) by the FDA for STGD1, and the FDA has previously granted Belite approval for the rolling submission of the NDA. The Company expects to complete the NDA rolling submission in the second quarter of 2026. Tinlarebant is a novel oral therapy that is intended to reduce the accumulation of vitamin A-based toxins (known as bisretinoids) that cause retinal disease in STGD1 and also contribute to disease progression in geographic atrophy (GA), or advanced dry age-related macular degeneration (AMD). Bisretinoids are by-products of the visual cycle, which is dependent on the supply of vitamin A (retinol) to the eye. Tinlarebant works by reducing and maintaining levels of serum retinol binding protein 4 (RBP4), the sole carrier protein for retinol transport from the liver to the eye. By modulating the amount of retinol entering the eye, tinlarebant reduces the formation of bisretinoids. Tinlarebant has been granted Breakthrough Therapy Designation, Fast Track Designation, and Rare Pediatric Disease Designation in the U.S., Orphan Drug Designation in the U.S., Europe, and Japan, and Sakigake Designation in Japan for the treatment of STGD1. The Company has completed a Phase 3 trial (DRAGON) in adolescent STGD1 subjects, and the drug is currently being evaluated in a Phase 2/3 trial (DRAGON II) in adolescent STGD1 subjects and a Phase 3 trial (PHOENIX) in subjects with GA.
お知らせ • Jan 28Belite Bio, Inc Completes Enrollment in the DRAGON II Clinical Trial of Tinlarebant for Stargardt Disease (STGD1)Belite Bio Inc. announced the completion of enrollment of 60 subjects, including 15 Japanese subjects, in the Phase 2/3 DRAGON II clinical trial evaluating tinlarebant for the treatment of Stargardt disease type 1 (STGD1). DRAGON II clinical trial is a global, 24-month, randomized, double-masked, placebo-controlled study designed to evaluate the efficacy, safety, and tolerability of tinlarebant in adolescent patients with STGD1. The trial had a targeted enrollment of 60 adolescent subjects aged 12 to 20 years old across Japan, the United States, and the United Kingdom, with participants randomized 1:1 to receive either tinlarebant or placebo. Tinlarebant is a novel oral therapy that is intended to reduce the accumulation of vitamin A-based toxins (known as bisretinoids) that cause retinal disease in STGD1 and also contribute to disease progression in geographic atrophy (GA), or advanced dry age-related macular degeneration (AMD). Bisretinoids are by-products of the visual cycle, which is dependent on the supply of vitamin A (retinol) to the eye. Tinlarebant works by reducing and maintaining levels of serum retinol binding protein 4 (RBP4), the sole carrier protein for retinol transport from the liver to the eye. By modulating the amount of retinol entering the eye, tinlarebant reduces the formation of bisretinoids. Tinlarebant has been granted Breakthrough Therapy Designation, Fast Track Designation, and Rare Pediatric Disease Designation in the U.S., Orphan Drug Designation in the U. S., Europe, and Japan, and Sakigake Designation in Japan for the treatment of STGD1.
お知らせ • Dec 02+ 2 more updatesBelite Bio, Inc. Announces Positive Topline Results from the Pivotal Global, Phase 3 DRAGON Trial of Tinlarebant in Adolescents with Stargardt DiseaseBelite Bio Inc. announced topline results from the global Phase 3 "DRAGON" trial of Tinlarebant, marking the first successful pivotal trial in patients with Stargardt disease type 1 (STGD1). STGD1 is an eye disease that leads to progressive vision loss, usually beginning in childhood or young adulthood, and currently has no approved treatment worldwide. The Phase 3 DRAGON trial enrolled 104 patients with STGD1 and met its primary efficacy endpoint, demonstrating a statistically significant and clinically meaningful 36% reduction in the growth rate of retinal lesions, measured as definitely decreased autofluorescence (DDAF) by fundus autofluorescence imaging, compared with placebo. Statistical significance was reached when applying the pre-specified analysis (p-value = 0.0033). Considering the progressive nature typically seen in STGD1, a further post-hoc analysis providing a specific data correlation showed that the treatment effect remained consistent with a p-value < 0.0001. The significant lesion growth reduction observed in the DRAGON study, along with the favorable safety profile, provide important validation of therapeutic approach and the mechanism of Tinlarebant. Tinlarebant produced a clear and statistically significant treatment effect on DDAF lesion growth rate, not only in the study eye, but both eyes. Furthermore, the effect was supported by a statistically significant benefit in the key secondary endpoint, again in both eyes. Safety and tolerability of Tinlarebant was very favorable in the trial. Collectively, these data reinforce Tinlarebant's potential to change the treatment landscape for Stargardt disease and set a new benchmark for future research in inherited retinal disorders." The Company plans to engage regulatory authorities to discuss potential next steps and to submit New Drug Applications for Tinlarebant in the first half of 2026. Tinlarebant has been granted Breakthrough Therapy, Fast Track, and Rare Pediatric Disease Designations in the U.S.; Orphan Drug Designation in the U.S., Europe, and Japan; and Pioneer Drug Designation in Japan for STGD1. DDAF Data Highlights The DRAGON trial was a 24-month, randomized (2:1, active: placebo), double-masked, placebo-controlled, global, multi-center, pivotal Phase 3 trial in adolescent STGD1 patients. Patient Demographics: 104 patients (n=69 in tinlarebant arm and n=35 in placebo arm), ranging in age from age from age from age from 2026. The trial enrolled 104 patients with ST GD1 and met its primary efficacy efficacy endpoint, demonstrating an statistically significant and clinically meaningful 36%, reduction in the growth rate of Retinal lesions, compared with placebo. Data Highlights: The DRAGON trial was a24-month, randomized (2;1, active: placebo), triple-masked, placebo- controlled, global, multi- center, pivotal Phase 3 trial in adult STGD1 patients. Patient demographics: 104 patients (n= 69 in tinlarebant arms and n=35 in placebo arms), ranging in age from age to age from age from age from childhood or young adulthood, and young adulthood, and currently has not been approved.
お知らせ • Nov 10Belite Bio, Inc has completed a Follow-on Equity Offering in the amount of $15.00005 million.Belite Bio, Inc has completed a Follow-on Equity Offering in the amount of $15.00005 million. Security Name: American Depository Shares Security Type: Depositary Receipt (Common Stock) Securities Offered: 230,770 Price\Range: $65 Discount Per Security: $4.225 Security Name: Warrants Security Type: Equity Warrant Securities Offered: 230,770 Transaction Features: Registered Direct Offering
お知らせ • Nov 04Belite Bio Inc. Announces UK’s Medicines and Healthcare Products Regulatory Agency Agrees to Conditional Marketing Authorization Application Based on Interim Analysis Results for Treatment of Stargardt Disease with TinlarebantBelite Bio Inc. announced that United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) has agreed to accept a Conditional Marketing Authorization application for Tinlarebant for the treatment of Stargardt disease based on the interim analysis results from the Phase 3 DRAGON trial. MHRA’s response is based on the interim analysis results which fulfil the criteria for a Conditional Marketing Authorization application. The Company remains on track to report final topline data from the Phase 3 DRAGON trial in the fourth quarter of 2025. These results are expected to be submitted to the MHRA for full Marketing Authorization Application. The pivotal Phase 3 DRAGON trial is a randomized, double-masked, placebo-controlled, global study designed to evaluate the safety and efficacy of Tinlarebant in adolescent patients with Stargardt disease. The trial enrolled 104 subjects across 11 jurisdictions, including the U.S., United Kingdom, Germany, France, Belgium, Switzerland, Netherlands, China, Hong Kong, Taiwan, and Australia, with a 2:1 randomization (Tinlarebant:placebo). The primary efficacy endpoint is the growth rate of atrophic lesions, alongside the assessment of safety and tolerability. Tinlarebant is a novel oral therapy that is intended to reduce the accumulation of vitamin A-based toxins (known as bisretinoids) that cause retinal disease in STGD1 and also contribute to disease progression in geographic atrophy (GA), or advanced dry age-related macular degeneration (AMD). Bisretinoids are by-products of the visual cycle, which is dependent on the supply of vitamin A (retinol) to the eye. Tinlarebant works by reducing and maintaining levels of serum retinol binding protein 4 (RBP4), the sole carrier protein for retinol transport from the liver to the eye. By modulating the amount of retinol entering the eye, Tinlarebant reduces the formation of bisretinoids. Tinlarebant has been granted Breakthrough Therapy Designation, Fast Track Designation and Rare Pediatric Disease designation in the U.S., Orphan Drug Designation in the U.S., Europe, and Japan, and Sakigake (Pioneer Drug) Designation in Japan for the treatment of STGD1.
お知らせ • Oct 16Belite Bio, Inc. Announces China NMPA Agrees to New Drug Application with Priority Review Based on Interim Analysis Results for the Treatment of Stargardt Disease with TinlarebantBelite Bio Inc. announced that the Center for Drug Evaluation of China's National Medical Products Administration ("NMPA") has agreed to accept the New Drug Application (NDA) with priority review for Tinlarebant for the treatment of Stargardt disease based on the interim analysis results from the Phase 3 DRAGON trial. NMPA's response is based on the interim analysis results showing statistical significance in the primary endpoint of the Phase 3 DRAGON trial. The Company remains on track to report final topline data from the Phase 3 DRAGON trial in the fourth quarter of 2025. These results are expected to be submitted to the NMPA as part of the NDA that is currently under preparation in accordance with China CDE's guidance. The pivotal Phase 3 DRAGON trial is a randomized, double-masked, placebo-controlled, global study designed to evaluate the safety and efficacy of Tinlarebant in adolescent patients with Stargardt disease. The trial enrolled 104 subjects across 11 jurisdictions, including the U.S., United Kingdom, Germany, France, Belgium, Switzerland, Netherlands, China, Hong Kong, Taiwan, and Australia, with a 2:1 randomization (Tinlarebant:placebo). The primary efficacy endpoint is the growth rate of atrophic lesions, alongside the assessment of safety and tolerability. Belite's lead candidate, Tinlarebant, an oral therapy intended to reduce the accumulation of bisretinoid toxins in the eye, is currently being evaluated in a Phase 3 study (DRAGON) and a Phase 2/3 study (DRAGON II) in adolescent STGD1 subjects and a Phase 3 study (PHOENIX) in subjects with GA.
お知らせ • Sep 13Belite Bio Inc. Announces Completion of DRAGON, a 2-Year, Phase 3 Trial of Oral Tinlarebant in the Treatment of Stargardt DiseaseBelite Bio Inc. announced the completion of the last subject visit in the Phase 3 DRAGON clinical trial evaluating Tinlarebant for the treatment of Stargardt disease type 1 (STGD1). The DRAGON trial enrolled 104 adolescent subjects across 11 jurisdictions, including the United States, United Kingdom, Germany, France, Belgium, Switzerland, Netherlands, China, Hong Kong, Taiwan, and Australia, with a 2:1 randomization (Tinlarebant:placebo). A total of 94 subjects completed the study, with the last study visit conducted on September 11, 2025. The primary efficacy endpoint is the growth rate of atrophic lesions; safety and tolerability of Tinlarebant will also be assessed. Belite Bio expects to report top-line results from the DRAGON trial in Fourth Quarter 2025 and plans to file New Drug Applications in 1H 2026. About Tinlarebant (a/k/a LBS-008) Tinlarebant is a novel oral therapy that is intended to reduce the accumulation of vitamin A-based toxins (known as bisretinoids) that cause retinal disease in STGD1 and also contribute to disease progression in geographic atrophy (GA), or advanced dry age-related macular degeneration (AMD). Bisretinoids are by-products of the visual cycle, which is dependent on the supply of vitamin A (retinol) to the eye. Tinlarebant works by reducing and maintaining levels of serum retinol binding protein 4 (RBP4), the sole carrier protein for retinol transport from the liver to the eye.
お知らせ • Sep 08Belite Bio, Inc announced that it expects to receive $124.999936 million in funding from RA Capital Management, L.P., Eventide Asset Management, LLC, Marshall Wace LLP, RTW Investments, LP, Soleus Capital LLC, Vestal Point Capital, LPBelite Bio, Inc announced a private placement and entered into a purchase agreement to issue 1,953,124 Ordinary shares, par value $0.0001 per share, at an issue price of $64 per ordinary share and warrants to purchase 1,953,124 ordinary shares for aggregate gross proceeds of $124,999,936 on September 8, 2025. Each Warrant will be immediately exercisable, expire two years from the date of issuance and have an exercise price of $76.80 per ordinary share. The securities issued under the Securities Purchase Agreements have not been registered under the Securities Act of 1933, as amended in reliance on the exemption from registration provided by Section 4(a)(2) of the Securities Act and/or Rule 506 of Regulation D promulgated thereunder, or under any state securities laws. The transaction is expected to close on September 9, 2025. The transaction will include participation from RA Capital Management as the lead investor and from Eventide Asset Management, Marshall Wace, RTW Investments, Soleus Capital and Vestal Point Capital. In connection with the offering, the Company shall pay the reasonable fees and expenses of counsel for the lead investor to the transactions contemplated hereunder, in an amount not to exceed $150,000.
お知らせ • Aug 08Belite Bio, Inc has filed a Follow-on Equity Offering in the amount of $15.00005 million.Belite Bio, Inc has filed a Follow-on Equity Offering in the amount of $15.00005 million. Security Name: American Depository Shares Security Type: Depositary Receipt (Common Stock) Securities Offered: 230,770 Price\Range: $65 Security Name: Warrants Security Type: Equity Warrant Securities Offered: 230,770 Transaction Features: Registered Direct Offering
お知らせ • Jul 02Belite Bio, Inc. Announces Completion of Enrollment in the Pivotal Global Phase 3 Phase 3 PHOENIX Trial Evaluating Oral Tinlarebant in Geographic AtrophyBelite Bio Inc. announced the completion of enrollment in the PHOENIX trial, a global, 24-month Phase 3 pivotal trial evaluating the safety and tolerability of Tinlarebant and its potential to reduce atrophic lesion growth rate in patients diagnosed with geographic atrophy (GA) in dry age-related macular degeneration (AMD). The PHOENIX study is a 24-month, randomized, double-masked, placebo-controlled, multicenter, pivotal Phase 3 trial. The study is ongoing across sites in the United States, the United Kingdom, France, Czech Republic, Switzerland, China, Taiwan, and Australia.
お知らせ • May 21Belite Bio, Inc. Announces FDA Granting of Breakthrough Therapy Designation for Tinlarebant for the Treatment of Stargardt DiseaseBelite Bio Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for Tinlarebant for the treatment of Stargardt disease (STGD1) based on the previously reported interim data from the ongoing Phase 3 DRAGON trial. There are currently no approved treatments for STGD1. The FDA grants Breakthrough Therapy Designation to expedite the development and regulatory review of drugs that are intended for serious or life-threatening conditions. The designation is based on preliminary clinical evidence indicating that a drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints. Tinlarebant is an orally administered, once-a-day tablet intended as an early intervention for maintaining the health and integrity of retinal tissues in Stargardt disease type 1 (STGD1) and Geographic Atrophy (GA) patients. Currently, there are no FDA approved treatments for STGD1 and no approved orally administered treatments for GA. Therefore, if approved, Tinlarebant would be a novel oral therapeutic addressing an unmet medical need in both STGD1 and GA. Belite Bio's advancement of, and anticipated future activities on preclinical studies, clinical development, regulatory milestones, and commercialization of its product candidates; and any other statements containing the words "expect", "hope", "indicate", "look forward to", and similar expressions. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including but not limited to Belite Bio's ability to demonstrate the safety and efficacy o its drug candidates; the clinical results for its drug candidates, which may not support further development or regulatory approval; the timing of potential submission with FDA; the timing to complete relevant clinical trials and/or to receive the interim/final data of such clinical trials; the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approval of Belite Bio's drug candidates; the potential efficacy of Tinlarebant, as well as those risks more fully discussed in the "Risk Factors" section in Belite Bio's filings with the U.S. Securities and Exchange Commission.
お知らせ • Mar 20Belite Bio, Inc, Annual General Meeting, Apr 15, 2025Belite Bio, Inc, Annual General Meeting, Apr 15, 2025. Location: 12750 high bluff drive suite 475, california 92130, san diego, United States
お知らせ • Mar 01Belite Bio, Inc. Announces Interim Analysis Results from the Pivotal Global Phase 3 DRAGON Trial of Tinlarebant in Adolescent Stargardt Disease SubjectsBelite Bio Inc. announced that following a pre-specified Interim Analysis of the pivotal global Phase 3 "DRAGON" trial data of Tinlarebant in adolescent Stargardt disease patients, the Data Safety Monitoring Board (DSMB) has recommended the trial proceed without any modifications. The Interim Analysis was performed when all subjects completed the one-year assessment. The study design for the DRAGON trial included an adaptive sample size re-estimation that would determine the need for an increase in sample size in order to enhance power, based on a treatment effect observed at the Interim Analysis. The recommendation by the DSMB that the trial should proceed without modifications indicates that a sample size increase is not warranted. In addition, the DSMB recommended to submit the data for further regulatory review for drug approval. According to the DSMB, Tinlarebant is well-tolerated and the safety profile remains consistent with previously observed data and the mechanism of action for Tinlarebant.
お知らせ • Feb 07Belite Bio, Inc has filed a Follow-on Equity Offering.Belite Bio, Inc has filed a Follow-on Equity Offering. Security Name: American Depositary Shares Security Type: Depositary Receipt (Common Stock) Securities Offered: 258,309 Price\Range: $58.07 Discount Per Security: $3.77455 Security Name: Warrants Security Type: Equity Warrant Securities Offered: 258,309 Transaction Features: Registered Direct Offering
お知らせ • Sep 02Belite Bio Announces Appointment of Hendrik P. N. Scholl as Chief Medical OfficerBelite Bio Inc. announced that its board of directors has appointed Hendrik P. N. Scholl, MD, MA, as the Chief Medical Officer of the Company, effective immediately. Dr. Scholl is the foremost globally recognized authority on Stargardt disease and age-related macular degeneration (AMD), bringing decades of expertise in treating retinal diseases, including the two key indications targeted by Belite Bio's lead drug candidate, Tinlarebant. Dr. Scholl served as the founding and scientific co-director of the Institute of Molecular and Clinical Ophthalmology Basel (IOB) and Professor of Ophthalmology at the University of Basel, where he also led the Department of Ophthalmology as its Chairman. He currently serves as President of the European Vision Institute as well as Chairman of the largest clinical research network in ophthalmology in Europe, EVICR.net, and its Expert Committee on Retinal Dystrophies. He is also the Founder and President of the Swiss Association for Research in Vision and Ophthalmology (ARVO-SWISS). Dr. Scholl’s distinguished career in academia includes leadership positions at several key academic institutions. Recently, he served as Professor of Ophthalmology and Endowed Chair at the Wilmer Eye Institute of Johns Hopkins University Medical School. At the Johns Hopkins Hospital, he was the Head of the Retinal Degeneration Clinic and the Director of the Visual Neurophysiology Service. For the Wilmer Eye Institute, he also served as the Co-director of the Johns Hopkins Center for Stem Cells and Ophthalmic Regenerative Medicine. Dr. Scholl is the coordinating principal investigator of the largest natural history study of Stargardt disease (ProgStar Study), which enrolled 365 subjects. Throughout his career, he has participated in over 10 clinical studies both in Stargardt disease and AMD, authored over 280 articles and reviews in peer-reviewed journals, and received numerous prestigious awards, including the European Vision Award, the President’s Award of the American Society of Retinal Specialists, the W. Richard Green Award and the Paul Henkind Memorial Award of the Macula Society, the Swiss Alfred-Vogt Award, and the Kupfer award of ARVO. He holds an honorary doctorate from Semmelweis University in Budapest, Hungary, and is Adjunct Professor at the Medical University of Vienna, Austria. Over the course of his 25 years of experience, Dr. Scholl has led and participated in numerous boards and advisory committees. He currently serves on the Scientific Advisory Board of Pro Retina Deutschland, Foundation Fighting Blindness, Erasmus University Medical Center, AIBILI, and the Institut de la Vision (Paris); on the Investment Advisory Board of Droia NV; and the Data Safety Monitoring Board of Roche Holding AG and ViGeneron GmbH. Dr. Scholl graduated from the University of Tübingen, Germany with a Doctor of Medicine (Dr. med.) and Master of Arts. He completed his specialist training at the University Eye Hospital in Tübingen before being awarded a fellowship from the German Research Foundation (DFG) at Moorfields Eye Hospital and Institute of Ophthalmology in London, and a DFG Heisenberg Professorship for Macular Diseases at the Eye Clinic of the University of Bonn, Germany.
Buy Or Sell Opportunity • Jul 01Now 49% undervaluedOver the last 90 days, the stock has risen 23% to €42.20. The fair value is estimated to be €83.21, however this is not to be taken as a buy recommendation but rather should be used as a guide only.
Buy Or Sell Opportunity • Jun 29Now 20% undervaluedOver the last 90 days, the stock has risen 23% to €42.40. The fair value is estimated to be €53.15, however this is not to be taken as a buy recommendation but rather should be used as a guide only.
お知らせ • May 08Belite Bio, Inc. Presents Additional Analysis from Phase 2 Study of Tinlarebant in Stargardt Disease at the ARVO Annual MeetingBelite Bio Inc. announced additional findings from the 24-month Phase 2 study of Tinlarebant in adolescent Stargardt disease (STGD1) at the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting. Tinlarebant is Belite Bio's orally administered tablet intended to slow disease progression in patients affected with STGD1 and Geographic Atrophy (GA) in advanced Dry Age-related Macular Degeneration (Dry AMD). Genetic profiling was performed on the 13 adolescent STGD1 patients enrolled in a Phase 2 study of Tinlarebant. Eleven of these subjects (85%) harbored severe pathogenic/likely pathogenic ABCA4 variants. Despite these severe variants, 42% of Tinlarebant-treated subjects (5 out of 12) did not develop incident atrophic (definitely decreased autofluorescence, DDAF) retinal lesions and no change in questionably decreased autofluorescence (QDAF) was observed during the 24-month treatment period. Incident atrophic lesions appeared in seven subjects at different timepoints over 24 months; four of these subjects developed DDAF lesions after month 12. The mean DDAF lesion growth at month 24 was 0.51 mm2 with a range of variation of 0.4 mm2, a growth rate that is significantly lower than what has been observed in natural history studies. Importantly, six STGD1 patients who had a mean bilateral best corrected visual acuity (BCVA) loss of 10 letters per year prior to enrollment in the Phase 2 study showed a mean BCVA loss equivalent to 1.9 letters per year during the 24-month treatment period. Analysis of genotype-phenotype relationships revealed that sibling subjects with identical ABCA4 mutations had different rates of lesion growth and BCVA loss indicating that identical genotypes do not necessarily predict an identical course of disease. Notably, retinal imaging data from the Phase 2 study was reanalyzed using a novel lesion size quantification method that utilizes a mathematical classification of lesions to reduce subjective reader bias and provide enhanced accuracy and superior precision compared to the traditional method of DDAF lesion quantification. This analysis revealed DDAF lesions within the macula in 12 eyes of eight subjects at baseline. Analysis of change in atrophic lesion area within the macula of these eyes over 24 months showed a halt in lesion growth into the macula after 16 months. This finding is consistent with the observed stabilization of visual acuity.
お知らせ • Apr 26Belite Bio, Inc has filed a Follow-on Equity Offering in the amount of $24.999964 million.Belite Bio, Inc has filed a Follow-on Equity Offering in the amount of $24.999964 million. Security Name: American Depositary Shares Security Type: Depositary Receipt (Common Stock) Securities Offered: 651,380 Price\Range: $38.38 Transaction Features: Registered Direct Offering
Board Change • Mar 28Less than half of directors are independentThere are 6 new directors who have joined the board in the last 3 years. Of these new board members, 3 were independent directors. The company's board is composed of: 6 new directors. 6 experienced directors. No highly experienced directors. 3 independent directors (4 non-independent directors). Chairman of the Board of Directors & CEO Tom Lin is the most experienced director on the board, commencing their role in 2018. Independent Director Ita Lu was the last independent director to join the board, commencing their role in 2022. The following issues are considered to be risks according to the Simply Wall St Risk Model: Minority of independent directors. Lack of board continuity. Lack of experienced directors.
