공고 • Aug 13

Rigel Pharmaceuticals Announces Availability Of VEPPANU (Vepdegestrant) For Patients With ER+/HER2-, ESR1-Mutated Advanced Or Metastatic Breast Cancer

Rigel Pharmaceuticals, Inc. announced VEPPANU (vepdegestrant) is now available by prescription in the United States for the treatment of adults with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-), estrogen receptor 1 (ESR1)-mutated advanced or metastatic breast cancer (mBC), as detected by a U.S. Food and Drug Administration (FDA)-authorized test, with disease progression following at least one line of endocrine therapy. VEPPANU is the first and only FDA-approved PROteolysis TArgeting Chimera (PROTAC). PROTACs are a new class of heterobifunctional protein degraders designed to harness the body's natural machinery to selectively degrade, rather than inhibit, disease-causing proteins. The recommended dosage of VEPPANU is 200 mg taken orally once daily. VEPPANU is immediately available through Rigel's network of specialty distributors and specialty pharmacies in the United States and Puerto Rico at $29,400 per 30-day supply. In a pivotal trial, VEPPANU was generally well tolerated and demonstrated statistically significant and clinically meaningful improvement in progression-free survival versus fulvestrant in this patient population. VEPPANU is indicated for the treatment of adults with estrogen receptor (ER)–positive, human epidermal growth factor receptor 2 (HER2)–negative, estrogen receptor–1 (ESR1)–mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test, with disease progression following at least one line of endocrine therapy. VEPPANU can cause QT (QTc) interval prolongation. Correct electrolyte abnormalities, including hypokalemia and hypomagnesemia, prior to and during treatment with VEPPANU. Perform an ECG prior to initiation of treatment with VEPPANU and do not initiate VEPPANU in patients with QTc >470 msec. Repeat ECG approximately 4 weeks after initiating treatment and as clinically indicated. Avoid concomitant use of VEPPANU with strong CYP3A inhibitors or drugs known to prolong the QTc interval. Based on findings from animal studies and its mechanism of action, VEPPANU can cause fetal harm when administered to a pregnant woman. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with VEPPANU and for 2 weeks after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with VEPPANU and for 2 weeks after the last dose. Serious adverse reactions occurred in 9% of patients who received VEPPANU. The serious adverse reactions included any fracture (1.3%), fall, hypercalcemia, hepatic injury, pneumonia, musculoskeletal pain (0.6% each), and QTc prolonged (0.3%). Fatal adverse reactions occurred in 1.0% of patients who received VEPPANU, including dyspnea, cerebral ischemia, and unknown cause (one patient each). Permanent discontinuation of VEPPANU due to an adverse reaction occurred in 2.9% of patients, dosage interruptions of VEPPANU due to an adverse reaction occurred in 14% of patients, and dosage reductions of VEPPANU due to an adverse reaction occurred in 1.9% of patients. The most common (=10%) adverse reactions, including laboratory abnormalities, were decreased white blood cells, increased AST, musculoskeletal pain, fatigue, decreased hemoglobin, decreased neutrophils, increased ALT, increased alkaline phosphatase, nausea, decreased blood potassium, increased bilirubin, decreased appetite, electrocardiogram QT prolonged, decreased platelets, and constipation. Avoid concomitant use with strong CYP3A inducers in patients receiving VEPPANU. If concomitant use cannot be avoided, increase VEPPANU dosage. Avoid concomitant use with certain P-gp substrates where minimal increases in concentration may lead to serious adverse reactions. Refer to the Prescribing Information for UGT1A9 substrates where minimal increases in the concentration may lead to serious adverse reactions. Avoid concomitant use of VEPPANU with other drugs with a known potential to prolong the QTc interval. Advise lactating women not to breastfeed during treatment with VEPPANU and for 2 weeks after the last dose. In May 2026, Rigel announced it entered into an exclusive, global license agreement with Arvinas, Inc. and Pfizer Inc. to develop, manufacture and commercialize VEPPANU.

공고 • Mar 31

Rigel Pharmaceuticals, Inc. Publishes Final ARROW Clinical Trial Data On GAVRETO (Pralsetinib) In Patients With RET+ NSCLC In Journal Of Clinical Oncology

Rigel Pharmaceuticals, Inc. announced publication of the final data from the Phase 1/2 ARROW study evaluating pralsetinib for the treatment of metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) in the Journal of Clinical Oncology. The final data includes an additional 42 months of follow-up from previously published data. Pralsetinib is the only once daily, oral RET-inhibitor therapy that is designed to selectively target RET in metastatic NSCLC and advanced or metastatic thyroid carcinoma. Additional key points from the paper include: Consistent with previous reports from the ARROW study NSCLC cohort, pralsetinib was generally well tolerated with a manageable toxicity profile. Three treatment-related deaths occurred in treatment-naive patients in Asia (pneumonia, n=2; interstitial lung disease and rhabdomyolysis, n=1 each), no new safety signals were observed and no hypersensitivity reactions were reported in patients receiving prior immunotherapies. Among patients with measurable disease (n=259), the overall response rate (ORR) was 70%, including 7% complete responses and 63% partial responses. ORR was 78% among treatment-naïve patients and 63% among patients receiving prior platinum-based chemotherapy. At final data lock, median treatment duration was 15.0 months. Median overall survival (OS) was 44.3 months in the overall measurable disease patient population, 50.1 months in treatment-naïve patients, and 39.7 months in prior-platinum patients, with median follow-ups of 47.6, 43.7, and 49.7 months, respectively. Longer median OS in the overall measurable disease patient population was seen in patients treated in the United States (62.4 months) vs. Asia (44.5 months) or Europe (29.6 months). Median overall progression-free survival (PFS) was 13.1 months in the overall measurable disease patient population, but was longer in patients in the United States (25.9 months) vs. Asia (12.6 months) or Europe (12.8 months). ORR remained high in subgroups bearing the RET fusion partners KI5FB and CCDC6 among both treatment-naive and prior platinum-based chemotherapy patients. Among all patients, median duration of response (DOR) was longer in patients with CCDC6 (47.9 months) vs. KIF5B (13.1 months). Fifteen patients had measurable central nervous system (CNS) metastases at baseline. The intracranial response rate (CNS ORR) among these patients was 53%. In the 11 response-evaluable patients with CNS metastases, CNS ORR was 73%. GAVRETO (pralsetinib) is indicated for the treatment of: Adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA-approved test; Adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate). This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). GAVRETO may increase the risk for serious infections, including bacterial, fungal, viral and opportunistic infections, which can lead to hospitalization or death. Withhold, reduce the dose or permanently discontinue GAVRETO based on severity. Serious Infections, Including Opportunistic Infections: GAVRETO may increase the risk for serious infections, including fatal and opportunistic infections. In the AcceleRET-Lung trial, infections occurred in 72% of patients who received GAVRETO, including 18% with Grade 3 and 3.7% with Grade 4 and 7% with fatal outcomes. Among the patients who received chemotherapy/immunotherapy, infections occurred in 52%, including 10% with Grade 3. Infections in the GAVRETO arm included pneumonia, urinary tract infection, opportunistic infections (such as pneumocystis jirovecii pneumonia and fungal infections) and others. Monitor patients for signs and symptoms of infection and treat appropriately. Withhold, reduce the dose, or permanently discontinue GAVRETO based on severity. Interstitial Lung Disease (ILD)/Pneumonitis: Severe, life-threatening, and fatal ILD/pneumonitis can occur in patients treated with GAVRETO. Pneumonitis occurred in 12% of patients who received GAVRETO, including 3.3% with Grade 3-4, and 0.2% with fatal reactions. Monitor for pulmonary symptoms indicative of ILD/pneumonitis. Withhold GAVRETO and promptly investigate for ILD in any patient who presents with acute or worsening of respiratory symptoms (e.g., dyspnea, cough, and fever). Withhold, reduce dose or permanently discontinue GAVRETO based on severity of confirmed ILD. Hypertension: Occurred in 35% of patients, including Grade 3 hypertension in 18% of patients. Overall, 8% had their dose interrupted and 4.8% had their dose reduced for hypertension. Treatment-emergent hypertension was most commonly managed with anti-hypertension medications. Do not initiate GAVRETO in patients with uncontrolled hypertension. Optimize blood pressure prior to initiating GAVRETO. Monitor blood pressure after 1 week, at least monthly thereafter and as clinically indicated. Initiate or adjust anti-hypertensive therapy as appropriate. Withhold, reduce dose, or permanently discontinue GAVRETO based on the severity. Hepatotoxicity: Serious hepatic adverse reactions occurred in 1.5% of patients treated with GAVRETO. Increased aspartate aminotransferase (AST) occurred in 49% of patients, including Grade 3 or 4 in 7% and increased alanine aminotransferase (ALT) occurred in 37% of patients, including Grade 3 or 4 in 4.8%. The median time to first onset for increased AST was 15 days (range: 5 days to 2.5 years) and increased ALT was 24 days (range: 7 days to 3.7 years). Monitor AST and ALT prior to initiating GAVRETO, every 2 weeks during the first 3 months, then monthly thereafter and as clinically indicated. Withhold, reduce dose or permanently discontinue GAVRETO based on severity. Hemorrhagic Events: Serious, including fatal, hemorrhagic events can occur with GAVRETO. Grade =3 events occurred in 4.1% of patients treated with GAVRETO including one patient with a fatal hemorrhagic event. Permanently discontinue GAVRETO in patients with severe or life-threatening hemorrhage. Tumor Lysis Syndrome (TLS): Cases of TLS have been reported in patients with medullary thyroid carcinoma receiving GAVRETO.

이자보상배율	59.1x
현금	US$95.33m
자본	US$425.42m
총부채	US$95.64m
총자산	US$521.07m

데이터	최종 업데이트 (UTC 시간)
기업 분석	2026/09/09 07:27
종가	2026/09/09 00:00
수익	2026/06/30
연간 수익	2025/12/31

패키지	데이터	기간	미국 소스 예시 ^*
기업 재무제표	10년	손익계산서 현금흐름표 대차대조표	SEC 양식 10-K SEC 양식 10-Q
분석가 컨센서스 추정치	+3년	재무 예측 분석가 목표주가	분석가 리서치 보고서 Blue Matrix
시장 가격	30년	주가 배당, 분할 및 기타 조치	ICE 시장 데이터 SEC 양식 S-1
지분 구조	10년	주요 주주 내부자 거래	SEC 양식 4 SEC 양식 13D
경영진	10년	리더십 팀 이사회	SEC 양식 10-K SEC 양식 DEF 14A
주요 개발	10년	회사 공시	SEC 양식 8-K

분석가	기관
James Birchenough	Barclays
James Birchenough	BMO Capital Markets Equity Research
Clarence Powell	BMO Capital Markets Equity Research

Rigel Pharmaceuticals 대차대조표 건전성

재무 건전성 기준 점검 6/6

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Is Rigel Pharmaceuticals (NASDAQ:RIGL) Using Too Much Debt?

Does Rigel Pharmaceuticals (NASDAQ:RIGL) Have A Healthy Balance Sheet?

Recent updates

RIGL: Breast Cancer Launch Will Raise Execution Risk For Future Returns

RIGL: Future Returns Will Reflect New Breast Cancer Franchise Expansion

Price target increased by 11% to US$61.20

Rigel Pharmaceuticals Announces Availability Of VEPPANU (Vepdegestrant) For Patients With ER+/HER2-, ESR1-Mutated Advanced Or Metastatic Breast Cancer

Consensus EPS estimates fall by 13%, revenue upgraded

Second quarter 2026 earnings: Revenues exceed analysts expectations while EPS lags behind

Rigel Pharmaceuticals: The Easy Money Has Been Made (Rating Downgrade)

Rigel Pharmaceuticals, Inc. to Report Q2, 2026 Results on Aug 04, 2026

Rigel Pharmaceuticals, Inc. Announces Board Changes

Rigel Pharmaceuticals Names Alison L. Hannah M.D. as Chief Medical Officer to Lead R289 Program

RIGL: Veppanu In Licensing And Ex U.S. Breast Cancer Expansion Will Drive Repricing

Rigel Pharmaceuticals, Inc.(NasdaqGS:RIGL) dropped from Russell Small Cap Comp Growth Benchmark

RIGL: Breast Cancer Launch Will Drive Future Upside Potential

RIGL: Breast Cancer Launch And Ex U S Expansion Will Shape Future Upside

Independent Director notifies of intention to sell stock

Rigel Pharmaceuticals Acquires Global Rights to FDA-Approved Oral Breast Cancer Therapy VEPPANU

RIGL: Execution On Breast Cancer Franchise Will Shape Future Upside Potential

Statutory Earnings May Not Be The Best Way To Understand Rigel Pharmaceuticals' (NASDAQ:RIGL) True Position

Rigel Pharmaceuticals, Inc. Reaffirms Earnings Guidance for the Year Ending December 31, 2026

First quarter 2026 earnings: EPS and revenues miss analyst expectations

RIGL: Higher Future P/E And RIPK1 Rights Will Drive Bullish Repricing

Rigel Pharmaceuticals, Inc. to Report Q1, 2026 Results on May 05, 2026

RIGL: Margin And Revenue Execution Will Shape Future Upside Potential

Rigel Pharmaceuticals, Inc., Annual General Meeting, May 14, 2026

Rigel Pharmaceuticals, Inc. Publishes Final ARROW Clinical Trial Data On GAVRETO (Pralsetinib) In Patients With RET+ NSCLC In Journal Of Clinical Oncology

RIGL: Higher Future P/E Assumptions Will Support Bullish Repricing

RIGL: Margin Improvement Execution Will Shape Future Upside Potential

Full year 2025 earnings: EPS exceeds analyst expectations

RIGL: Future Returns Will Reflect Elevated 2026 Guidance And Lower Risk Profile

Rigel Pharmaceuticals, Inc. to Report Q4, 2025 Results on Mar 03, 2026

Independent Director notifies of intention to sell stock

RIGL: Updated Earnings Outlook And P/E Assumptions Will Drive Bullish Repricing

President exercised options and sold US$379k worth of stock

Rigel Pharmaceuticals, Inc. Appoints Michael P. Miller to Its Board of Directors

RIGL: Higher 2025 Sales Guidance And Execution Will Shape Future Upside And Risks

RIGL: Future Returns Will Reflect Raised 2025 Sales Guidance And Positive Cash Flow

Investor sentiment deteriorates as stock falls 17%

Rigel Pharmaceuticals, Inc. Provides Earnings Guidance for the Full Year 2026

Is Rigel Pharmaceuticals (NASDAQ:RIGL) Using Too Much Debt?

RIGL: Future Returns Will Reflect Stronger Execution And Raised 2025 Sales Guidance

Executive VP & CFO exercised options to buy US$278k worth of stock.

RIGL Q3 Execution And 2025 Guidance Will Drive Bullish Repricing

Investor sentiment deteriorates as stock falls 17%

Rigel Pharmaceuticals, Inc. Presents Updated Data from the Ongoing Phase 1B Study Evaluating R289 in Patients with Lower-Risk Mds At the 67Th Ash Annual Meeting and Exposition

RIGL: Future Results Will Reflect Sustained Execution Amid Emerging Commercial And Pipeline Milestones

Now 24% undervalued

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RIGL: Future Results Will Reflect Continued Strong Commercial Execution Performance

Rigel Pharmaceuticals, Inc. Announces Publication of Final 5-Year Data on REZLIDHIA (Olutasidenib) in Patients with R/R mIDH1 AML in Journal of Hematology & Oncology

Rigel Pharmaceuticals, Inc.'s (NASDAQ:RIGL) Price Is Right But Growth Is Lacking After Shares Rocket 35%

Investor sentiment improves as stock rises 22%

RIGL: Strong Commercial Execution Will Drive Momentum As Upside Is Forecast

Third quarter 2025 earnings: EPS and revenues exceed analyst expectations

Rigel Pharmaceuticals, Inc. Revises Revenue Guidance for the Year 2025

Rigel Pharmaceuticals, Inc. Announces One Oral and Four Poster Presentations at the 67th American Society of Hematology Annual Meeting and Exposition

Rigel Pharmaceuticals, Inc. to Report Q3, 2025 Results on Nov 04, 2025

Now 23% undervalued

Rigel Pharmaceuticals, Inc. Announces First Patient Enrolled in the Dose Expansion Phase of its Phase 1b Study of R289 in Patients with Lower-Risk MDS

Investor sentiment deteriorates as stock falls 18%

Is Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL) Trading At A 23% Discount?

Benign Growth For Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL) Underpins Stock's 26% Plummet

Now 23% undervalued

Does Rigel Pharmaceuticals (NASDAQ:RIGL) Have A Healthy Balance Sheet?

Consensus revenue estimates increase by 26%

Expansion And Clinical Pipeline Will Drive Future Opportunities Despite Risks

New major risk - Revenue and earnings growth

Second quarter 2025 earnings: EPS and revenues exceed analyst expectations

Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL) Held Back By Insufficient Growth Even After Shares Climb 28%

Rigel Pharmaceuticals, Inc. Updates Earnings Guidance for the Year 2025

Investor sentiment improves as stock rises 22%

Consensus EPS estimates increase by 19%

Rigel Pharmaceuticals, Inc. to Report Q2, 2025 Results on Aug 05, 2025

Rigel Pharmaceuticals, Inc.(NasdaqGS:RIGL) dropped from Russell Small Cap Comp Value Index