View ValuationNervGen Pharma 将来の成長Future 基準チェック /06NervGen Pharmaは、71.3%と76.8%でそれぞれ年率71.3%で利益と収益が成長すると予測される一方、EPSはgrowで66.6%年率。主要情報71.3%収益成長率66.63%EPS成長率Pharmaceuticals 収益成長14.4%収益成長率76.8%将来の株主資本利益率n/aアナリストカバレッジGood最終更新日19 May 2026今後の成長に関する最新情報Breakeven Date Change • Jan 08Forecast to breakeven in 2028The 2 analysts covering NervGen Pharma expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of CA$1.09m in 2028. Average annual earnings growth of 71% is required to achieve expected profit on schedule.すべての更新を表示Recent updatesお知らせ • Apr 29Nervgen Pharma Corp. Announces Appointment of Keith Vendola as Chief Financial Officer, Effective April 27, 2026NervGen Pharma Corp. announced the appointment of Keith Vendola, MD, MBA, as Chief Financial Officer, effective April 27, 2026. Dr. Vendola will lead the Company’s financial strategy and operations, including capital markets activity, financial planning, corporate development and supporting strategic initiatives. With more than two decades of experience spanning financial and strategic roles at clinical-stage biopharmaceutical companies, healthcare investment banking, corporate strategy, and scientific research, Dr. Vendola brings a distinctive combination of capital markets, operational, and medical expertise to NervGen. Dr. Vendola joins NervGen from Wugen, a clinical-stage cell therapy company, where he served as CFO. Prior to Wugen, he was CFO of IO Biotech, leading the company through its IPO. Earlier in his career, he served as CFO and Chief Strategy Officer of Rezolute, where he led the company through financial transformation and its Nasdaq listing, as well as Chief of Staff to the CEO and Vice President of Competitive Strategy and Investor Relations at Coherus BioSciences, where his responsibilities spanned corporate development, strategy, and operations. Dr. Vendola began his corporate finance career as a healthcare investment banker at BofA Securities and JPMorgan Chase. Dr. Vendola earned his MBA in finance from Northwestern's Kellogg School of Management, MD from Dartmouth Medical School, and BA in psychology, with honors, from the College of the Holy Cross. He completed an executive education program in strategic negotiations at Harvard Business School and was a research fellow at the National Institutes of Health.お知らせ • Apr 08NervGen Pharma Corp Announces Successful End-Of-Phase 2 Meeting And FDA Alignment On RESTORE, A Phase 3 Registrational Study Of NVG-291 For Chronic TetraplegiaNervGen Pharma Corp. completed a successful End-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA) and alignment on RESTORE, the Company’s Phase 3 registrational study designed to evaluate NVG-291 for the treatment of chronic tetraplegia. Alignment with the FDA across proposed study parameters of RESTORE, a 16-week registrational study evaluating NVG-291 in chronic tetraplegia. Primary endpoint will be the change from baseline in GRASSP Quantitative Prehension at Week 12, a validated functional endpoint designed to capture improvement in fine-motor hand use, the highest priority domain in tetraplegia. Key secondary endpoints include Patient and Clinician Global Impression of Change (PGIC/CGIC), and blinded qualitative interviews designed to contextualize the clinical meaningfulness of NVG-291. RESTORE initiation remains on-track for mid-2026, with study initiation activities underway. Overview of the RESTORE Phase 3 Registrational Study Design: Study Design: Randomized, double-blind, placebo-controlled; approximately 150 subjects. Population Characteristics: Adults aged 18-75 with chronic tetraplegia due to traumatic SCI (=C7; ASIA Impairment Scale C or D), 1-10 years post-injury. Study Sites: Up to 60 sites across the United States and Canada. Dosing Regimen: Daily subcutaneous injections of NVG-291 for 12 weeks, followed by a 4-week observational period. Primary Endpoint: Change from baseline to Week 12 in GRASSP Quantitative Prehension (QtP), a validated measure of functional hand use. Key Secondary Endpoints: PGIC, CGIC, Spinal Cord Independence Measure, Version-III (SCIM-III), and lower extremity spasticity, as measured by the Modified Ashworth Scale. Qualitative Assessments: Blinded qualitative interviews will be conducted when exiting the 16-week study period to contextualize the clinical meaningfulness and real-world impact of NVG-291. Open-Label Extension (OLE): An optional 12-week OLE will follow the main study, providing access to NVG-291 for all placebo-randomized subjects. The RESTORE registrational study remains on-track for initiation in mid-2026, with study initiation activities underway. Phase 1b/2a CONNECT SCI Chronic Tetraplegia Data Supports the RESTORE Phase 3 Registrational Study Design. Data from the randomized, placebo-controlled Phase 1b/2a CONNECT SCI study in chronic tetraplegia supports the RESTORE registrational study design, including endpoint selection, timing of assessments, and dosing regimen. Primary Endpoint Selection (GRASSP QtP): A mean improvement of +3.7 points at Week 12 in NVG-291-treated subjects versus +0.4 points for placebo-treated subjects (+3.3-point treatment difference), exceeding the 2.0-point minimally important difference. Sustained Treatment Effect at Week 16: Continued improvement in GRASSP QtP to +4.4 points for NVG-291-treated subjects versus +1.2 points for placebo-treated subjects, demonstrating a sustained treatment effect at Week 16, four weeks after treatment cessation. Clinical Meaningfulness (PGIC): 75% (6/8) of NVG-291-treated subjects reported being “much” or “very much” improved (=6/7 PGIC score) versus 33% (3/9) of placebo-treated subjects, reinforcing the relevance of observed functional gains. Real-World Impact: Blinded qualitative interviews conducted up to 364 days post-study contextualized systemic improvements, including 67% (6/9) of NVG-291-treated subjects reporting improved bladder control and 56% (5/9) reporting reduced muscle spasticity. Dosing Regimen and Safety: Favorable safety and tolerability across 12 weeks of daily subcutaneous dosing of NVG-291, with no treatment-related serious adverse events or treatment discontinuations. Phase 1b/2a CONNECT SCI Subacute Tetraplegia Update. Following a successful EOP2 meeting and FDA alignment across the proposed study parameters of RESTORE, NervGen has elected to conclude enrollment in the Phase 1b/2a CONNECT SCI study in subacute tetraplegia and unblind available data. FDA alignment on the RESTORE registrational study design emphasizes clinical endpoints that capture how individuals with chronic tetraplegia function, feel, and succeed in everyday life. The Company intends to apply this regulatory alignment and endpoint framework to inform a future registrational-quality study in subacute tetraplegia.お知らせ • Mar 06NervGen Pharma Corp. Announces Executive ChangesNervGen Pharma Corp. appointed Shamim Ruff as Chief Regulatory Affairs Officer and Christine McSherry as Senior Vice President (SVP), Patient Advocacy and Clinical Affairs. Shamim Ruff brings more than 30 years of strategic leadership in regulatory affairs to NervGen, where she will oversee the company’s regulatory strategy and work closely with the executive team to support the realization of NervGen’s mission to transform the lives of individuals living with SCI. Most recently, Ms. Ruff served as Chief Regulatory Affairs Officer and SVP, Head of Quality Assurance at Stoke Therapeutics, leading regulatory strategy for the company's RNA medicine platform. Prior to Stoke, Ms. Ruff served as Chief Regulatory Affairs Officer at Sarepta Therapeutics, where she built the company's regulatory affairs and quality organizations and led regulatory strategy for its rare and infectious disease pipelines. She also served as Chair of the Development Advisory Board and Strategic Regulatory Advisor to the CEO and NDA Submissions Team at Soleno Therapeutics and on the Board of Directors of Reata Pharmaceuticals until its acquisition by Biogen. Her earlier career included leadership roles at Sanofi-Genzyme, Amgen, Abbott, and AstraZeneca. Ms. Ruff holds a master's degree in analytical chemistry from the University of Loughborough, U.K., and a bachelor's degree in chemistry and biology from the University of Leicester, U.K. Christine McSherry brings more than 30 years of experience bridging patient advocacy and clinical development. She will play a pivotal role in ensuring the voice of the SCI community is central to NervGen’s clinical strategy. Previously, Ms. McSherry co-founded Casimir, a clinical research organization that worked across more than 20 rare diseases, capturing and quantifying patient and caregiver perception of treatment benefit. Casimir's work pioneered the development of outcome measures to advance the FDA's patient-focused drug development initiative. Ms. McSherry served as CEO of Casimir until its acquisition by Emmes. In 2001, she founded the Jett Foundation, after the diagnosis of her son, Jett, with Duchenne muscular dystrophy (DMD). The Foundation became a leading voice for affected families and played a central role in the advocacy efforts that contributed to the FDA's approval of Exondys 51, the first approved therapy for DMD. Ms. McSherry continues to serve as a Director of the Jett Foundation and previously served on the Board of Directors of the Duchenne Alliance. She holds a BSN from Northeastern University and is a registered nurse.Recent Insider Transactions • Mar 03Insider recently sold US$80k worth of stockOn the 2nd of March, Krista McKerracher sold around 20k shares on-market at roughly US$3.98 per share. This transaction amounted to 30% of their direct individual holding at the time of the trade. In the last 3 months, they made an even bigger sale worth US$115k. Insiders have been net sellers, collectively disposing of US$235k more than they bought in the last 12 months.New Risk • Feb 24New minor risk - Insider sellingThere has been significant insider selling in the company's shares over the past 3 months. Total value of shares sold: US$155k This is considered a minor risk. There are several reasons why an insider may be selling, including to cover a tax obligation or pay for some other expense. However, we generally consider it a negative if insiders have been selling, especially if they do so below the current price. It implies that they considered a lower price to be reasonable. This is a weak signal, but if there is a pattern of unexplained selling, it can be a sign the insider believes the company's stock is overpriced. Note: We only include open market transactions and private dispositions of directly owned stock by individuals, not by corporations or trusts. Currently, the following risks have been identified for the company: Major Risks Negative equity (-CA$2.9m). Revenue is less than US$1m. Minor Risks Share price has been volatile over the past 3 months (12% average weekly change). Significant insider selling over the past 3 months (US$155k sold).Recent Insider Transactions • Feb 24Insider recently sold US$115k worth of stockOn the 20th of February, Krista McKerracher sold around 30k shares on-market at roughly US$3.83 per share. This transaction amounted to 31% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. Insiders have been net sellers, collectively disposing of US$155k more than they bought in the last 12 months.Recent Insider Transactions • Feb 19Insider recently sold US$40k worth of stockOn the 12th of February, Krista McKerracher sold around 10k shares on-market at roughly US$4.00 per share. This transaction amounted to 9.3% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. This was the only on-market transaction from insiders over the last 12 months.お知らせ • Feb 17NervGen Pharma Corp., Annual General Meeting, Apr 23, 2026NervGen Pharma Corp., Annual General Meeting, Apr 23, 2026. Location: ontario, toronto Canadaお知らせ • Feb 14NervGen Pharma Corp. Announces Executive Changes, Effective March 15, 2026NervGen Pharma Corp. announced that William J. Adams tendered his resignation as Secretary and Principal Financial and Accounting Officer of the Company, due to his retirement. Mr. Adams' resignation is effective as of March 15, 2026. Mr. Adams' resignation was not the result of any disagreements with the Company, its management or the Company's Board of Directors. On February 12, 2026, the Board approved the appointment of Dr. Adam Rogers as the Company's Principal Financial and Accounting Officer, effective as of March 15, 2026.お知らせ • Feb 13NervGen Pharma Corp. Announces CFO Changes, Effective March 15, 2026NervGen Pharma Corp. announced that Bill Adams will retire as Chief Financial Officer, effective March 15, 2026. The Company has engaged a leading executive search firm to identify a successor, and Mr. Adams will continue in an advisory capacity following his retirement date to support the transition. On February 12, 2026, the Board approved the appointment of Dr. Adam Rogers as the Company’s interim Chief Financial Officer and the Company’s Principal Financial and Accounting Officer, effective as of March 15, 2026.お知らせ • Feb 10+ 1 more updateNervGen Pharma Corp. Appoints Adam Rogers as President, Effective February 9, 2026NervGen Pharma Corp. announced its Board of Directors has unanimously appointed Adam Rogers, MD, as President, effective immediately on February 9, 2026. Dr. Rogers will continue leading the Company’s growth and execution of its mission to transform the lives of individuals living with spinal cord injury. Adam Rogers, MD, has served on NervGen’s Board of Directors since July 2022 and was appointed Chairman and Interim Chief Executive Officer in July 2025 as part of a leadership transition supporting the Company’s next stage of growth. Dr. Rogers is a Principal of Boston-based PFP Biosciences Holdings and a board-certified ophthalmologist specializing in diseases and surgery of the retina and vitreous. Dr. Rogers previously co-founded Hemera Biosciences, a clinical-stage biotechnology company developing a one-time investigational gene therapy administered as an outpatient intravitreal injection to preserve vision in patients with geographic atrophy. Dr. Rogers served as Chief Executive Officer from 2017 until December 2020, when the rights to its lead program were acquired by Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson. Earlier in his career, Dr. Rogers served as an Assistant Professor of Ophthalmology at the New England Eye Center of Tufts Medical Center. He has authored numerous peer-reviewed publications and holds an M.D. from Emory University School of Medicine.Breakeven Date Change • Jan 08Forecast to breakeven in 2028The 2 analysts covering NervGen Pharma expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of CA$1.09m in 2028. Average annual earnings growth of 71% is required to achieve expected profit on schedule.お知らせ • Nov 20+ 1 more updateNervGen Pharma Corp. announced that it expects to receive $10.050002 million in funding from Sci Ventures, PFP Biosciences Holdings, The Paul And Phyllis Fireman Charitable Foundation and other investors.NervGen Pharma Corp. announced a non-brokered private placement to issue 4,785,715 units at an issue price of $2.10 for the proceeds of $10,050,001.5 on November 18, 2025. The financing will include participation from new and existing investors, including SCI Ventures and the Paul and Phylis Fireman Charitable Foundation. Each Unit will consist of one common share and one-half of one Common Share purchase warrant. The Warrants will be valid for 36 months following the closing of the Non-Brokered Unit Offering and each Warrant will be exercisable for one Common Share at an exercise price of $2.65. Officers and members of the Company's board of directors, including NervGen's Chairman and Interim Chief Executive Officer (the "Related Parties"), are expected to participate in the Non-Brokered Unit Offering. Transaction is subject to the approval of the TSX Venture Exchange and is expected to close on or about November 19, 2025. Al of the Securities issued pursuant to the Non-Brokered Unit Offering will be subject to a four month and one day hold period in accordance with applicable Canadian securities laws.お知らせ • Jul 17+ 1 more updateNervGen Pharma Corp. Announces Stepping Down of Mike Kelly as a DirectorNervGen Pharma Corp. announced a leadership transition as the company enters the next phase of development for its candidate, NVG-291. President and Chief Executive Officer Mike Kelly has stepped down as a director.お知らせ • Jul 02NervGen Pharma Corp. Announces Resignation of Daniel Mikol, MD, Ph.D as Chief Medical OfficerNervGen Pharma Corp. announced resignation of Daniel Mikol, MD, Ph.D as Chief Medical Officer in order to pursue new opportunities. Randall Kaye, MD, who was recently appointed Chief Medical Advisor, will increase the scope of his role as the company initiates a search for Dr. Mikol's replacement.お知らせ • Jun 19+ 1 more updateNervgen Pharma Corp. Appoints Randall Kaye as Chief Medical AdvisorNervGen Pharma Corp. announced the appointment of Randall Kaye, MD, to the role of Chief Medical Advisor. Dr. Kaye, a current member of NervGen's Board of Directors and Chair of the Science Committee since 2020, brings highly relevant and extensive experience in central nervous system (CNS) therapeutic development, regulatory strategy, and medical affairs to the NervGen team. The expanded engagement follows the company's announcement of positive topline results in the chronic cohort of the Phase 1b/2a clinical trial evaluating NVG-291 in individuals with cervical spinal cord injury. As a NervGen Board member and Science Committee Chair, Dr. Kaye has served as an advisor to the NVG-291 program since its early clinical development. He previously served as chief medical officer of multiple biopharmaceutical companies, including most recently at Longboard Pharmaceuticals Inc., where he helped guide CNS development programs through a $2.6 billion acquisition by H. Lundbeck A/S. His expertise spans the areas of neurology, psychiatry, immunology, and infectious disease, and includes oversight of clinical operations, regulatory affairs, and medical strategy. Dr. Kaye earned his MD, MPH, and BS degrees from George Washington University and completed a Research Fellowship at Harvard Medical School.お知らせ • Jun 02NervGen Pharma Corp. Reports Positive Topline Data from the Chronic Cohort of its Phase 1b/2a Clinical Trial Evaluating NVG-291 in Spinal Cord InjuryNervGen Pharma Corp. announced positive Topline results from the chronic cohort (1-10 years post injury) of its Phase 1b/2a clinical trial evaluating its lead drug candidate, NVG-291, as a potential treatment for spinal cord injury. The double-blind, placebo-controlled proof-of-concept Phase 1b/2a Clinical trial (NCT05965700) evaluates the safety and efficacy of NVG-291 in two separate cohorts of individuals with cervical motor incomplete spinal cord injury: chronic (1-10 years post-in injury) and subacute (20-90 days post-in injury), given demonstrated efficacy in preclinical models of both chronic and acute spinal cord injury. The trial is being partially funded by a grant from Wings for Life, which is being provided in several milestone-based payments and will offset a portion of the direct costs of this clinical trial. NervGen has received Fast Track designation from the FDA for NVG-291 in individuals with spinal cord injury. The company is testing the clinical efficacy of its lead candidate, NVG-291. in a Phase 1b/2 a clinical trial in spinal cord injury and has initiated preclinical test of concept evaluation of pipeline candidate, NVG-300, in models of neurotrauma and spinal cord injury. As the first pharmaceutical candidate to show improved motor recovery based on increased motor evoked potential amplitude, these study results represent a significant scientific advance and step forward in the potential to treat SCI, where there remains no approved pharmaceuticals to enable sustained functional recovery. Topline safety and efficacy results reinforce the potential of NVG-291 to promote nervous system repair in individuals living with traumatic cervical SCI, the expected benefits of changes in upper extremity motor function for individuals living with SCI and the potential to otherwise treat SCI.お知らせ • Mar 05NervGen Pharma Corp., Annual General Meeting, May 06, 2025NervGen Pharma Corp., Annual General Meeting, May 06, 2025. Location: ontario, toronto Canadaお知らせ • Feb 08NervGen Pharma Corp. Completes Dosing of First Subject in Subacute Cohort of its Phase 1b/2a Clinical Trial of NVG-291 in Spinal Cord InjuryNervGen Pharma Corp. announced that the first subject has been enrolled and dosed in the subacute cohort of its Phase 1b/2a proof-of-concept, double-blind, randomized placebo-controlled clinical trial (NCT05965700) evaluating its lead candidate, NVG-291, in individuals with spinal cord injury (SCI). The company previously reported the completion of enrollment of the chronic cohort and announced that results for the chronic cohort are expected in Second Quarter 2025. Recently, the company received IRB approval for an amendment focused on the subacute cohort of the Phase 1b/2a clinical trial. Key changes to the protocol were implemented to facilitate enrollment, for example, revising the timing of subacute SCI to 20 to 90 days post-injury, and to decrease the burden on study participants by reducing the number of visits and assessments. About Phase 1b/2a Trial. The double-blind, placebo-controlled proof-of-concept Phase 1b/2aclinical trial (NCT05965 700) evaluates the safety and efficacy of NVG-291 in two separate cohorts of individuals with cervical spinal cord injury: chronic (1-10 years post-injury) and subacute (20-90 days post-injury), given demonstrated efficacy in preclinical models of both chronic and acute spinal cord injury. The trial is designed to evaluate the efficacy of a fixed dose of NVG-291 using multiple clinical outcome measures as well as objective electrophysiological and MRI imaging measures and blood biomarkers that together will provide comprehensive information about the extent of recovery of function, with a focus on improvements in motor function. The trial is being partially funded by a grant from Wings for Life, which is being provided in several milestone-based payments and will offset a portion of the direct costs of this clinical trial. NVG-291 has received Fast Track designation in spinal cord injury from the U.S. Food and Drug Administration.お知らせ • Jan 02NervGen Pharma Corp. Completes Enrollment in Chronic Cohort of its Phase 1b/2a Clinical Trial of NVG-291 in Spinal Cord InjuryNervGen Pharma Corp. announced that it has enrolled the 20th and final subject in the chronic cohort of its Phase 1b/2a proof-of-concept, double-blind, randomized placebo-controlled clinical trial (NCT05965700) evaluating its lead candidate, NVG-291, in individuals with spinal cord injury (SCI). Furthermore, the company has received IRB approval for an amendment to its Phase 1b/2 a clinical trial and has initiated the screening of subjects for the subacute cohort of the study. The double-blind, placebo-controlled proof-of-concept Phase 1b/2a clinical trial (NCT059 65700) evaluates the safety and efficacy of NVG-291 in two separate cohorts of individuals with cervical spinal cord injury: chronic (1-10 years post-injury) and subacute (20-90 days post-injury), given demonstrated efficacy in preclinical models of both chronic and acute spinal cord injury. The trial is designed to evaluate the efficacy of a fixed dose of NVG-291 using multiple clinical outcome measures as well as objective electrophysiological and MRI imaging measures and blood biomarkers that together will provide comprehensive information about the extent of recovery of function, with a focus on improvements in motor function. Specifically, the primary objective is to assess the change in corticospinal connectivity of defined upper and lower extremity muscle groups following treatment based on changes in motor evoked potential amplitudes. Secondary objectives are to evaluate changes in a number of clinical outcome assessments focusing on motor function and strength, as well as changes in additional electrophysiological measurements. The cohorts will be comprised of approximately 20 subjects each and will be evaluated independently as the data becomes available. The trial is being partially funded by a grant from Wings for Life, which is being provided in several milestone-based payments and will offset a portion of the direct costs of this clinical trial.お知らせ • Dec 20NervGen Pharma Corp. has filed a Follow-on Equity Offering in the amount of CAD 30 million.NervGen Pharma Corp. has filed a Follow-on Equity Offering in the amount of CAD 30 million. Security Name: Common Shares Security Type: Common Stock Transaction Features: At the Market Offeringお知らせ • Jul 25NervGen Pharma Corp. Appoints Neil Klompas to Board of DirectorsNervGen Pharma Corp. announced the appointment of Mr. Neil Klompas to the company's Board of Directors. Mr. Klompas is an experienced life sciences and healthcare sector executive and board member, who recently served as President and Chief Operating Officer of Zymeworks Inc. During his time with the company, he oversaw finance and operations executing the company's initial public offering on the NYSE and TSX. Prior to Zymeworks, Mr. Klompas worked with KPMG LLP as part of the Pharmaceutical, Biotech Medical Devices MA Transaction Services practice in Princeton, NJ, and with KPMG LLP in the life sciences assurance practice based in Vancouver. Mr. Klompas has served as Board Chair for Ovensa Inc., and as the Chair of the Audit Committee and Special Committee of Liminal Biosciences Inc. until its acquisition in 2023. He holds his BSc in Microbiology Immunology from the University of British Columbia and is a Chartered Professional Accountant. The company also announced that it has granted 150,000 incentive stock options to Mr. Klompas exercisable at a price of $2.85 per share for a period of five years and that vest equally every three months over a one-year period. All options have been granted in accordance with the policies of the TSX Venture Exchange and the conditions of the company's stock option plan.お知らせ • Jun 06NervGen Pharma Corp. Approves Board and Audit Committee ElectionsNervGen Pharma Corp. at the AGM held on June 4, 2024, approved to appoint John Ruffolo as the new Chair of Audit Committee. As the Founder and Managing Partner of Maverix Private Equity, founder of OMERS Ventures and a Fellow of the Chartered Professional Accountants, John's experience is a great fit to support NervGen's growth. Glenn Ives was elected by his fellow Board members as Chair of the Board following the AGM. As a past Chair of Deloitte Canada and the Deloitte Global Risk Committee, Glenn's experience is well suited to lead NervGen's board as they advance their programs into later-stage clinical development.お知らせ • Mar 29+ 1 more updateNervGen Pharma Corp., Annual General Meeting, Jun 04, 2024NervGen Pharma Corp., Annual General Meeting, Jun 04, 2024.お知らせ • Oct 26NervGen Pharma Corp. Receives Fast Track Designation for NVG-291 for the Treatment of Individuals with Spinal Cord InjuryNervGen Pharma Corp. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for its proprietary lead compound, NVG-291, in individuals with spinal cord injury (SCI). FDA's Fast Track program is designed to facilitate the development of drugs intended to treat serious conditions and fill unmet medical needs as part of the FDA's goal to get important new drugs to patients earlier. Fast Track also provides eligibility for both Priority Review, which can shorten the New Drug Development (NDA) review process, and for Accelerated Approval, which can allow for an earlier or faster approval based on a surrogate or intermediate clinical endpoint.お知らせ • Oct 18Nervgen Pharma Appoints John Ruffolo to Board of DirectorsNervGen Pharma appointed John Ruffolo to Board of Directors . He has Extensive experience in private equity, venture capital and advising high growth, innovative companies, Brings personal experience and knowledge of spinal cord injury to NervGen's board, Important board addition joins as Company advances clinical milestone with Phase 1b/2a study of NVG-291 underway. John Ruffolo is the Founder and Managing Partner of Maverix Private Equity, a private equity firm focused on innovation-enabled growth and disruption investment strategies. Previously he founded OMERS Ventures, the venture capital arm of the large Ontario pension fund where he led early investments in startup success stories such as Shopify Inc. He has also championed Canada's technology industry as a co-founder of the Council of Canadian Innovators, along with former Research in Motion co-CEO Jim Balsillie. As an active board member in the profit and not-for-profit sectors, John currently works with many leading innovative organizations includingAI Partnerships Corp., engineering.com, OneEleven, the Rick Hansen Foundation, the CIBC Foundation, Caldwell's Top 40 Under 40, the Investigative Journalism Foundation, and the Dean's Global Council for the Schulich School of Business. The Company also announced that it has granted 150,000 incentive stock options to Mr. Ruffolo exercisable at a price of $1.75 per share for a period of five years and that vest equally every three months over a one-year period.お知らせ • Sep 26NervGen Pharma Corp. Announces First Subject Dosed in Landmark Phase 1b/2a Clinical Trial for NVG-291 in Spinal Cord InjuryNervGen Pharma Corp. announced the first subject has been dosed in the Company's landmark Phase 1b/2a proof-of-concept placebo-controlled clinical trial for its proprietary lead compound, NVG-291, in individuals with spinal cord injury (SCI). Given there are approximately 300,000 people with SCI living in the United States alone, the limited number of clinical trials in this area and the tremendous anticipation for this trial within the SCI community, recruitment for the chronic cohort (1-10 years post injury) is anticipated to happen relatively quickly with results expected by mid-2024. Results from the subacute cohort (10-49 days post-injury) are expected in late 2024/early 2025. The trial is being conducted at Shirley Ryan AbilityLab in Chicago.お知らせ • Feb 16NervGen Pharma Announces Completion of Dosing of All Subjects in Phase 1 Clinical Trial of Proprietary Drug Candidate NVG-291NervGen Pharma Corp. announced that all subjects (male, premenopausal and post-menopausal females) in the Phase 1 clinical trial of the Company's proprietary lead compound, NVG-291, have completed dosing. The Company now plans to initiate a Phase 1b/2a clinical trial of NVG-291 in individuals with spinal cord injury in Third Quarter 2023. Based on the encouraging results from preclinical studies, the Company plans to evaluate the efficacy of NVG- 291 versus placebo in two cohorts: individuals with a chronic injury (1-10 years post-injury) and individuals with a subacute injury (10-49 days post-injury). In preclinical studies of spinal cord injury, NervGen's NVG-291 has been demonstrated to promote neural repair mechanisms, including axonal regeneration, remyelination and plasticity.業績と収益の成長予測NasdaqCM:NGEN - アナリストの将来予測と過去の財務データ ( )CAD Millions日付収益収益フリー・キャッシュフロー営業活動によるキャッシュ平均アナリスト数12/31/20287-27N/A506412/31/2027N/A-39N/A-39512/31/2026N/A-25N/A-2463/31/2026N/A-42-24-24N/A12/31/2025N/A-44-19-19N/A9/30/2025N/A-26-17-17N/A6/30/2025N/A-27-17-17N/A3/31/2025N/A-26-18-18N/A12/31/2024N/A-24-17-17N/A9/30/2024N/A-24-16-16N/A6/30/2024N/A-23-12-12N/A3/31/2024N/A-20-10-10N/A12/31/2023N/A-22-11-11N/A9/30/2023N/A-20-13-13N/A6/30/2023N/A-19-17-17N/A3/31/2023N/A-20-18-18N/A12/31/2022N/A-21-18-18N/A9/30/2022N/A-19-16-16N/A6/30/2022N/A-19-13-13N/A3/31/2022N/A-15-11-11N/A12/31/2021N/A-13-8-8N/A9/30/2021N/A-13-7-7N/A6/30/2021N/A-12-7-6N/A3/31/2021N/A-12-6-6N/A12/31/2020N/A-11-6-6N/A9/30/2020N/A-10-6-6N/A6/30/2020N/A-10-7-7N/A3/31/2020N/A-9-7-7N/A12/31/2019N/A-10N/A-8N/A9/30/2019N/A-8N/A-7N/A6/30/2019N/A-6N/A-5N/A3/31/2019N/A-4N/A-4N/A12/31/2018N/A-1N/A-1N/A9/30/2018N/A-1N/A0N/A6/30/2018N/A0N/A0N/Aもっと見るアナリストによる今後の成長予測収入対貯蓄率: NGEN今後 3 年間、利益が出ない状態が続くと予測されています。収益対市場: NGEN今後 3 年間、利益が出ない状態が続くと予測されています。高成長収益: NGEN今後 3 年間、利益が出ない状態が続くと予測されています。収益対市場: NGEN来年は収益がないと予測されています。高い収益成長: NGEN来年は収益がないと予測されています。一株当たり利益成長率予想将来の株主資本利益率将来のROE: NGENの 自己資本利益率 が 3 年後に高くなると予測されるかどうかを判断するにはデータが不十分です成長企業の発掘7D1Y7D1Y7D1YPharmaceuticals-biotech 業界の高成長企業。View Past Performance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2026/05/20 12:39終値2026/05/20 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NervGen Pharma Corp. 6 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。7 アナリスト機関Raghuram SelvarajuH.C. Wainwright & Co.Elemer PirosLucid Capital MarketsMichael OkunewitchMaxim Group4 その他のアナリストを表示
Breakeven Date Change • Jan 08Forecast to breakeven in 2028The 2 analysts covering NervGen Pharma expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of CA$1.09m in 2028. Average annual earnings growth of 71% is required to achieve expected profit on schedule.
お知らせ • Apr 29Nervgen Pharma Corp. Announces Appointment of Keith Vendola as Chief Financial Officer, Effective April 27, 2026NervGen Pharma Corp. announced the appointment of Keith Vendola, MD, MBA, as Chief Financial Officer, effective April 27, 2026. Dr. Vendola will lead the Company’s financial strategy and operations, including capital markets activity, financial planning, corporate development and supporting strategic initiatives. With more than two decades of experience spanning financial and strategic roles at clinical-stage biopharmaceutical companies, healthcare investment banking, corporate strategy, and scientific research, Dr. Vendola brings a distinctive combination of capital markets, operational, and medical expertise to NervGen. Dr. Vendola joins NervGen from Wugen, a clinical-stage cell therapy company, where he served as CFO. Prior to Wugen, he was CFO of IO Biotech, leading the company through its IPO. Earlier in his career, he served as CFO and Chief Strategy Officer of Rezolute, where he led the company through financial transformation and its Nasdaq listing, as well as Chief of Staff to the CEO and Vice President of Competitive Strategy and Investor Relations at Coherus BioSciences, where his responsibilities spanned corporate development, strategy, and operations. Dr. Vendola began his corporate finance career as a healthcare investment banker at BofA Securities and JPMorgan Chase. Dr. Vendola earned his MBA in finance from Northwestern's Kellogg School of Management, MD from Dartmouth Medical School, and BA in psychology, with honors, from the College of the Holy Cross. He completed an executive education program in strategic negotiations at Harvard Business School and was a research fellow at the National Institutes of Health.
お知らせ • Apr 08NervGen Pharma Corp Announces Successful End-Of-Phase 2 Meeting And FDA Alignment On RESTORE, A Phase 3 Registrational Study Of NVG-291 For Chronic TetraplegiaNervGen Pharma Corp. completed a successful End-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA) and alignment on RESTORE, the Company’s Phase 3 registrational study designed to evaluate NVG-291 for the treatment of chronic tetraplegia. Alignment with the FDA across proposed study parameters of RESTORE, a 16-week registrational study evaluating NVG-291 in chronic tetraplegia. Primary endpoint will be the change from baseline in GRASSP Quantitative Prehension at Week 12, a validated functional endpoint designed to capture improvement in fine-motor hand use, the highest priority domain in tetraplegia. Key secondary endpoints include Patient and Clinician Global Impression of Change (PGIC/CGIC), and blinded qualitative interviews designed to contextualize the clinical meaningfulness of NVG-291. RESTORE initiation remains on-track for mid-2026, with study initiation activities underway. Overview of the RESTORE Phase 3 Registrational Study Design: Study Design: Randomized, double-blind, placebo-controlled; approximately 150 subjects. Population Characteristics: Adults aged 18-75 with chronic tetraplegia due to traumatic SCI (=C7; ASIA Impairment Scale C or D), 1-10 years post-injury. Study Sites: Up to 60 sites across the United States and Canada. Dosing Regimen: Daily subcutaneous injections of NVG-291 for 12 weeks, followed by a 4-week observational period. Primary Endpoint: Change from baseline to Week 12 in GRASSP Quantitative Prehension (QtP), a validated measure of functional hand use. Key Secondary Endpoints: PGIC, CGIC, Spinal Cord Independence Measure, Version-III (SCIM-III), and lower extremity spasticity, as measured by the Modified Ashworth Scale. Qualitative Assessments: Blinded qualitative interviews will be conducted when exiting the 16-week study period to contextualize the clinical meaningfulness and real-world impact of NVG-291. Open-Label Extension (OLE): An optional 12-week OLE will follow the main study, providing access to NVG-291 for all placebo-randomized subjects. The RESTORE registrational study remains on-track for initiation in mid-2026, with study initiation activities underway. Phase 1b/2a CONNECT SCI Chronic Tetraplegia Data Supports the RESTORE Phase 3 Registrational Study Design. Data from the randomized, placebo-controlled Phase 1b/2a CONNECT SCI study in chronic tetraplegia supports the RESTORE registrational study design, including endpoint selection, timing of assessments, and dosing regimen. Primary Endpoint Selection (GRASSP QtP): A mean improvement of +3.7 points at Week 12 in NVG-291-treated subjects versus +0.4 points for placebo-treated subjects (+3.3-point treatment difference), exceeding the 2.0-point minimally important difference. Sustained Treatment Effect at Week 16: Continued improvement in GRASSP QtP to +4.4 points for NVG-291-treated subjects versus +1.2 points for placebo-treated subjects, demonstrating a sustained treatment effect at Week 16, four weeks after treatment cessation. Clinical Meaningfulness (PGIC): 75% (6/8) of NVG-291-treated subjects reported being “much” or “very much” improved (=6/7 PGIC score) versus 33% (3/9) of placebo-treated subjects, reinforcing the relevance of observed functional gains. Real-World Impact: Blinded qualitative interviews conducted up to 364 days post-study contextualized systemic improvements, including 67% (6/9) of NVG-291-treated subjects reporting improved bladder control and 56% (5/9) reporting reduced muscle spasticity. Dosing Regimen and Safety: Favorable safety and tolerability across 12 weeks of daily subcutaneous dosing of NVG-291, with no treatment-related serious adverse events or treatment discontinuations. Phase 1b/2a CONNECT SCI Subacute Tetraplegia Update. Following a successful EOP2 meeting and FDA alignment across the proposed study parameters of RESTORE, NervGen has elected to conclude enrollment in the Phase 1b/2a CONNECT SCI study in subacute tetraplegia and unblind available data. FDA alignment on the RESTORE registrational study design emphasizes clinical endpoints that capture how individuals with chronic tetraplegia function, feel, and succeed in everyday life. The Company intends to apply this regulatory alignment and endpoint framework to inform a future registrational-quality study in subacute tetraplegia.
お知らせ • Mar 06NervGen Pharma Corp. Announces Executive ChangesNervGen Pharma Corp. appointed Shamim Ruff as Chief Regulatory Affairs Officer and Christine McSherry as Senior Vice President (SVP), Patient Advocacy and Clinical Affairs. Shamim Ruff brings more than 30 years of strategic leadership in regulatory affairs to NervGen, where she will oversee the company’s regulatory strategy and work closely with the executive team to support the realization of NervGen’s mission to transform the lives of individuals living with SCI. Most recently, Ms. Ruff served as Chief Regulatory Affairs Officer and SVP, Head of Quality Assurance at Stoke Therapeutics, leading regulatory strategy for the company's RNA medicine platform. Prior to Stoke, Ms. Ruff served as Chief Regulatory Affairs Officer at Sarepta Therapeutics, where she built the company's regulatory affairs and quality organizations and led regulatory strategy for its rare and infectious disease pipelines. She also served as Chair of the Development Advisory Board and Strategic Regulatory Advisor to the CEO and NDA Submissions Team at Soleno Therapeutics and on the Board of Directors of Reata Pharmaceuticals until its acquisition by Biogen. Her earlier career included leadership roles at Sanofi-Genzyme, Amgen, Abbott, and AstraZeneca. Ms. Ruff holds a master's degree in analytical chemistry from the University of Loughborough, U.K., and a bachelor's degree in chemistry and biology from the University of Leicester, U.K. Christine McSherry brings more than 30 years of experience bridging patient advocacy and clinical development. She will play a pivotal role in ensuring the voice of the SCI community is central to NervGen’s clinical strategy. Previously, Ms. McSherry co-founded Casimir, a clinical research organization that worked across more than 20 rare diseases, capturing and quantifying patient and caregiver perception of treatment benefit. Casimir's work pioneered the development of outcome measures to advance the FDA's patient-focused drug development initiative. Ms. McSherry served as CEO of Casimir until its acquisition by Emmes. In 2001, she founded the Jett Foundation, after the diagnosis of her son, Jett, with Duchenne muscular dystrophy (DMD). The Foundation became a leading voice for affected families and played a central role in the advocacy efforts that contributed to the FDA's approval of Exondys 51, the first approved therapy for DMD. Ms. McSherry continues to serve as a Director of the Jett Foundation and previously served on the Board of Directors of the Duchenne Alliance. She holds a BSN from Northeastern University and is a registered nurse.
Recent Insider Transactions • Mar 03Insider recently sold US$80k worth of stockOn the 2nd of March, Krista McKerracher sold around 20k shares on-market at roughly US$3.98 per share. This transaction amounted to 30% of their direct individual holding at the time of the trade. In the last 3 months, they made an even bigger sale worth US$115k. Insiders have been net sellers, collectively disposing of US$235k more than they bought in the last 12 months.
New Risk • Feb 24New minor risk - Insider sellingThere has been significant insider selling in the company's shares over the past 3 months. Total value of shares sold: US$155k This is considered a minor risk. There are several reasons why an insider may be selling, including to cover a tax obligation or pay for some other expense. However, we generally consider it a negative if insiders have been selling, especially if they do so below the current price. It implies that they considered a lower price to be reasonable. This is a weak signal, but if there is a pattern of unexplained selling, it can be a sign the insider believes the company's stock is overpriced. Note: We only include open market transactions and private dispositions of directly owned stock by individuals, not by corporations or trusts. Currently, the following risks have been identified for the company: Major Risks Negative equity (-CA$2.9m). Revenue is less than US$1m. Minor Risks Share price has been volatile over the past 3 months (12% average weekly change). Significant insider selling over the past 3 months (US$155k sold).
Recent Insider Transactions • Feb 24Insider recently sold US$115k worth of stockOn the 20th of February, Krista McKerracher sold around 30k shares on-market at roughly US$3.83 per share. This transaction amounted to 31% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. Insiders have been net sellers, collectively disposing of US$155k more than they bought in the last 12 months.
Recent Insider Transactions • Feb 19Insider recently sold US$40k worth of stockOn the 12th of February, Krista McKerracher sold around 10k shares on-market at roughly US$4.00 per share. This transaction amounted to 9.3% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. This was the only on-market transaction from insiders over the last 12 months.
お知らせ • Feb 17NervGen Pharma Corp., Annual General Meeting, Apr 23, 2026NervGen Pharma Corp., Annual General Meeting, Apr 23, 2026. Location: ontario, toronto Canada
お知らせ • Feb 14NervGen Pharma Corp. Announces Executive Changes, Effective March 15, 2026NervGen Pharma Corp. announced that William J. Adams tendered his resignation as Secretary and Principal Financial and Accounting Officer of the Company, due to his retirement. Mr. Adams' resignation is effective as of March 15, 2026. Mr. Adams' resignation was not the result of any disagreements with the Company, its management or the Company's Board of Directors. On February 12, 2026, the Board approved the appointment of Dr. Adam Rogers as the Company's Principal Financial and Accounting Officer, effective as of March 15, 2026.
お知らせ • Feb 13NervGen Pharma Corp. Announces CFO Changes, Effective March 15, 2026NervGen Pharma Corp. announced that Bill Adams will retire as Chief Financial Officer, effective March 15, 2026. The Company has engaged a leading executive search firm to identify a successor, and Mr. Adams will continue in an advisory capacity following his retirement date to support the transition. On February 12, 2026, the Board approved the appointment of Dr. Adam Rogers as the Company’s interim Chief Financial Officer and the Company’s Principal Financial and Accounting Officer, effective as of March 15, 2026.
お知らせ • Feb 10+ 1 more updateNervGen Pharma Corp. Appoints Adam Rogers as President, Effective February 9, 2026NervGen Pharma Corp. announced its Board of Directors has unanimously appointed Adam Rogers, MD, as President, effective immediately on February 9, 2026. Dr. Rogers will continue leading the Company’s growth and execution of its mission to transform the lives of individuals living with spinal cord injury. Adam Rogers, MD, has served on NervGen’s Board of Directors since July 2022 and was appointed Chairman and Interim Chief Executive Officer in July 2025 as part of a leadership transition supporting the Company’s next stage of growth. Dr. Rogers is a Principal of Boston-based PFP Biosciences Holdings and a board-certified ophthalmologist specializing in diseases and surgery of the retina and vitreous. Dr. Rogers previously co-founded Hemera Biosciences, a clinical-stage biotechnology company developing a one-time investigational gene therapy administered as an outpatient intravitreal injection to preserve vision in patients with geographic atrophy. Dr. Rogers served as Chief Executive Officer from 2017 until December 2020, when the rights to its lead program were acquired by Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson. Earlier in his career, Dr. Rogers served as an Assistant Professor of Ophthalmology at the New England Eye Center of Tufts Medical Center. He has authored numerous peer-reviewed publications and holds an M.D. from Emory University School of Medicine.
Breakeven Date Change • Jan 08Forecast to breakeven in 2028The 2 analysts covering NervGen Pharma expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of CA$1.09m in 2028. Average annual earnings growth of 71% is required to achieve expected profit on schedule.
お知らせ • Nov 20+ 1 more updateNervGen Pharma Corp. announced that it expects to receive $10.050002 million in funding from Sci Ventures, PFP Biosciences Holdings, The Paul And Phyllis Fireman Charitable Foundation and other investors.NervGen Pharma Corp. announced a non-brokered private placement to issue 4,785,715 units at an issue price of $2.10 for the proceeds of $10,050,001.5 on November 18, 2025. The financing will include participation from new and existing investors, including SCI Ventures and the Paul and Phylis Fireman Charitable Foundation. Each Unit will consist of one common share and one-half of one Common Share purchase warrant. The Warrants will be valid for 36 months following the closing of the Non-Brokered Unit Offering and each Warrant will be exercisable for one Common Share at an exercise price of $2.65. Officers and members of the Company's board of directors, including NervGen's Chairman and Interim Chief Executive Officer (the "Related Parties"), are expected to participate in the Non-Brokered Unit Offering. Transaction is subject to the approval of the TSX Venture Exchange and is expected to close on or about November 19, 2025. Al of the Securities issued pursuant to the Non-Brokered Unit Offering will be subject to a four month and one day hold period in accordance with applicable Canadian securities laws.
お知らせ • Jul 17+ 1 more updateNervGen Pharma Corp. Announces Stepping Down of Mike Kelly as a DirectorNervGen Pharma Corp. announced a leadership transition as the company enters the next phase of development for its candidate, NVG-291. President and Chief Executive Officer Mike Kelly has stepped down as a director.
お知らせ • Jul 02NervGen Pharma Corp. Announces Resignation of Daniel Mikol, MD, Ph.D as Chief Medical OfficerNervGen Pharma Corp. announced resignation of Daniel Mikol, MD, Ph.D as Chief Medical Officer in order to pursue new opportunities. Randall Kaye, MD, who was recently appointed Chief Medical Advisor, will increase the scope of his role as the company initiates a search for Dr. Mikol's replacement.
お知らせ • Jun 19+ 1 more updateNervgen Pharma Corp. Appoints Randall Kaye as Chief Medical AdvisorNervGen Pharma Corp. announced the appointment of Randall Kaye, MD, to the role of Chief Medical Advisor. Dr. Kaye, a current member of NervGen's Board of Directors and Chair of the Science Committee since 2020, brings highly relevant and extensive experience in central nervous system (CNS) therapeutic development, regulatory strategy, and medical affairs to the NervGen team. The expanded engagement follows the company's announcement of positive topline results in the chronic cohort of the Phase 1b/2a clinical trial evaluating NVG-291 in individuals with cervical spinal cord injury. As a NervGen Board member and Science Committee Chair, Dr. Kaye has served as an advisor to the NVG-291 program since its early clinical development. He previously served as chief medical officer of multiple biopharmaceutical companies, including most recently at Longboard Pharmaceuticals Inc., where he helped guide CNS development programs through a $2.6 billion acquisition by H. Lundbeck A/S. His expertise spans the areas of neurology, psychiatry, immunology, and infectious disease, and includes oversight of clinical operations, regulatory affairs, and medical strategy. Dr. Kaye earned his MD, MPH, and BS degrees from George Washington University and completed a Research Fellowship at Harvard Medical School.
お知らせ • Jun 02NervGen Pharma Corp. Reports Positive Topline Data from the Chronic Cohort of its Phase 1b/2a Clinical Trial Evaluating NVG-291 in Spinal Cord InjuryNervGen Pharma Corp. announced positive Topline results from the chronic cohort (1-10 years post injury) of its Phase 1b/2a clinical trial evaluating its lead drug candidate, NVG-291, as a potential treatment for spinal cord injury. The double-blind, placebo-controlled proof-of-concept Phase 1b/2a Clinical trial (NCT05965700) evaluates the safety and efficacy of NVG-291 in two separate cohorts of individuals with cervical motor incomplete spinal cord injury: chronic (1-10 years post-in injury) and subacute (20-90 days post-in injury), given demonstrated efficacy in preclinical models of both chronic and acute spinal cord injury. The trial is being partially funded by a grant from Wings for Life, which is being provided in several milestone-based payments and will offset a portion of the direct costs of this clinical trial. NervGen has received Fast Track designation from the FDA for NVG-291 in individuals with spinal cord injury. The company is testing the clinical efficacy of its lead candidate, NVG-291. in a Phase 1b/2 a clinical trial in spinal cord injury and has initiated preclinical test of concept evaluation of pipeline candidate, NVG-300, in models of neurotrauma and spinal cord injury. As the first pharmaceutical candidate to show improved motor recovery based on increased motor evoked potential amplitude, these study results represent a significant scientific advance and step forward in the potential to treat SCI, where there remains no approved pharmaceuticals to enable sustained functional recovery. Topline safety and efficacy results reinforce the potential of NVG-291 to promote nervous system repair in individuals living with traumatic cervical SCI, the expected benefits of changes in upper extremity motor function for individuals living with SCI and the potential to otherwise treat SCI.
お知らせ • Mar 05NervGen Pharma Corp., Annual General Meeting, May 06, 2025NervGen Pharma Corp., Annual General Meeting, May 06, 2025. Location: ontario, toronto Canada
お知らせ • Feb 08NervGen Pharma Corp. Completes Dosing of First Subject in Subacute Cohort of its Phase 1b/2a Clinical Trial of NVG-291 in Spinal Cord InjuryNervGen Pharma Corp. announced that the first subject has been enrolled and dosed in the subacute cohort of its Phase 1b/2a proof-of-concept, double-blind, randomized placebo-controlled clinical trial (NCT05965700) evaluating its lead candidate, NVG-291, in individuals with spinal cord injury (SCI). The company previously reported the completion of enrollment of the chronic cohort and announced that results for the chronic cohort are expected in Second Quarter 2025. Recently, the company received IRB approval for an amendment focused on the subacute cohort of the Phase 1b/2a clinical trial. Key changes to the protocol were implemented to facilitate enrollment, for example, revising the timing of subacute SCI to 20 to 90 days post-injury, and to decrease the burden on study participants by reducing the number of visits and assessments. About Phase 1b/2a Trial. The double-blind, placebo-controlled proof-of-concept Phase 1b/2aclinical trial (NCT05965 700) evaluates the safety and efficacy of NVG-291 in two separate cohorts of individuals with cervical spinal cord injury: chronic (1-10 years post-injury) and subacute (20-90 days post-injury), given demonstrated efficacy in preclinical models of both chronic and acute spinal cord injury. The trial is designed to evaluate the efficacy of a fixed dose of NVG-291 using multiple clinical outcome measures as well as objective electrophysiological and MRI imaging measures and blood biomarkers that together will provide comprehensive information about the extent of recovery of function, with a focus on improvements in motor function. The trial is being partially funded by a grant from Wings for Life, which is being provided in several milestone-based payments and will offset a portion of the direct costs of this clinical trial. NVG-291 has received Fast Track designation in spinal cord injury from the U.S. Food and Drug Administration.
お知らせ • Jan 02NervGen Pharma Corp. Completes Enrollment in Chronic Cohort of its Phase 1b/2a Clinical Trial of NVG-291 in Spinal Cord InjuryNervGen Pharma Corp. announced that it has enrolled the 20th and final subject in the chronic cohort of its Phase 1b/2a proof-of-concept, double-blind, randomized placebo-controlled clinical trial (NCT05965700) evaluating its lead candidate, NVG-291, in individuals with spinal cord injury (SCI). Furthermore, the company has received IRB approval for an amendment to its Phase 1b/2 a clinical trial and has initiated the screening of subjects for the subacute cohort of the study. The double-blind, placebo-controlled proof-of-concept Phase 1b/2a clinical trial (NCT059 65700) evaluates the safety and efficacy of NVG-291 in two separate cohorts of individuals with cervical spinal cord injury: chronic (1-10 years post-injury) and subacute (20-90 days post-injury), given demonstrated efficacy in preclinical models of both chronic and acute spinal cord injury. The trial is designed to evaluate the efficacy of a fixed dose of NVG-291 using multiple clinical outcome measures as well as objective electrophysiological and MRI imaging measures and blood biomarkers that together will provide comprehensive information about the extent of recovery of function, with a focus on improvements in motor function. Specifically, the primary objective is to assess the change in corticospinal connectivity of defined upper and lower extremity muscle groups following treatment based on changes in motor evoked potential amplitudes. Secondary objectives are to evaluate changes in a number of clinical outcome assessments focusing on motor function and strength, as well as changes in additional electrophysiological measurements. The cohorts will be comprised of approximately 20 subjects each and will be evaluated independently as the data becomes available. The trial is being partially funded by a grant from Wings for Life, which is being provided in several milestone-based payments and will offset a portion of the direct costs of this clinical trial.
お知らせ • Dec 20NervGen Pharma Corp. has filed a Follow-on Equity Offering in the amount of CAD 30 million.NervGen Pharma Corp. has filed a Follow-on Equity Offering in the amount of CAD 30 million. Security Name: Common Shares Security Type: Common Stock Transaction Features: At the Market Offering
お知らせ • Jul 25NervGen Pharma Corp. Appoints Neil Klompas to Board of DirectorsNervGen Pharma Corp. announced the appointment of Mr. Neil Klompas to the company's Board of Directors. Mr. Klompas is an experienced life sciences and healthcare sector executive and board member, who recently served as President and Chief Operating Officer of Zymeworks Inc. During his time with the company, he oversaw finance and operations executing the company's initial public offering on the NYSE and TSX. Prior to Zymeworks, Mr. Klompas worked with KPMG LLP as part of the Pharmaceutical, Biotech Medical Devices MA Transaction Services practice in Princeton, NJ, and with KPMG LLP in the life sciences assurance practice based in Vancouver. Mr. Klompas has served as Board Chair for Ovensa Inc., and as the Chair of the Audit Committee and Special Committee of Liminal Biosciences Inc. until its acquisition in 2023. He holds his BSc in Microbiology Immunology from the University of British Columbia and is a Chartered Professional Accountant. The company also announced that it has granted 150,000 incentive stock options to Mr. Klompas exercisable at a price of $2.85 per share for a period of five years and that vest equally every three months over a one-year period. All options have been granted in accordance with the policies of the TSX Venture Exchange and the conditions of the company's stock option plan.
お知らせ • Jun 06NervGen Pharma Corp. Approves Board and Audit Committee ElectionsNervGen Pharma Corp. at the AGM held on June 4, 2024, approved to appoint John Ruffolo as the new Chair of Audit Committee. As the Founder and Managing Partner of Maverix Private Equity, founder of OMERS Ventures and a Fellow of the Chartered Professional Accountants, John's experience is a great fit to support NervGen's growth. Glenn Ives was elected by his fellow Board members as Chair of the Board following the AGM. As a past Chair of Deloitte Canada and the Deloitte Global Risk Committee, Glenn's experience is well suited to lead NervGen's board as they advance their programs into later-stage clinical development.
お知らせ • Mar 29+ 1 more updateNervGen Pharma Corp., Annual General Meeting, Jun 04, 2024NervGen Pharma Corp., Annual General Meeting, Jun 04, 2024.
お知らせ • Oct 26NervGen Pharma Corp. Receives Fast Track Designation for NVG-291 for the Treatment of Individuals with Spinal Cord InjuryNervGen Pharma Corp. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for its proprietary lead compound, NVG-291, in individuals with spinal cord injury (SCI). FDA's Fast Track program is designed to facilitate the development of drugs intended to treat serious conditions and fill unmet medical needs as part of the FDA's goal to get important new drugs to patients earlier. Fast Track also provides eligibility for both Priority Review, which can shorten the New Drug Development (NDA) review process, and for Accelerated Approval, which can allow for an earlier or faster approval based on a surrogate or intermediate clinical endpoint.
お知らせ • Oct 18Nervgen Pharma Appoints John Ruffolo to Board of DirectorsNervGen Pharma appointed John Ruffolo to Board of Directors . He has Extensive experience in private equity, venture capital and advising high growth, innovative companies, Brings personal experience and knowledge of spinal cord injury to NervGen's board, Important board addition joins as Company advances clinical milestone with Phase 1b/2a study of NVG-291 underway. John Ruffolo is the Founder and Managing Partner of Maverix Private Equity, a private equity firm focused on innovation-enabled growth and disruption investment strategies. Previously he founded OMERS Ventures, the venture capital arm of the large Ontario pension fund where he led early investments in startup success stories such as Shopify Inc. He has also championed Canada's technology industry as a co-founder of the Council of Canadian Innovators, along with former Research in Motion co-CEO Jim Balsillie. As an active board member in the profit and not-for-profit sectors, John currently works with many leading innovative organizations includingAI Partnerships Corp., engineering.com, OneEleven, the Rick Hansen Foundation, the CIBC Foundation, Caldwell's Top 40 Under 40, the Investigative Journalism Foundation, and the Dean's Global Council for the Schulich School of Business. The Company also announced that it has granted 150,000 incentive stock options to Mr. Ruffolo exercisable at a price of $1.75 per share for a period of five years and that vest equally every three months over a one-year period.
お知らせ • Sep 26NervGen Pharma Corp. Announces First Subject Dosed in Landmark Phase 1b/2a Clinical Trial for NVG-291 in Spinal Cord InjuryNervGen Pharma Corp. announced the first subject has been dosed in the Company's landmark Phase 1b/2a proof-of-concept placebo-controlled clinical trial for its proprietary lead compound, NVG-291, in individuals with spinal cord injury (SCI). Given there are approximately 300,000 people with SCI living in the United States alone, the limited number of clinical trials in this area and the tremendous anticipation for this trial within the SCI community, recruitment for the chronic cohort (1-10 years post injury) is anticipated to happen relatively quickly with results expected by mid-2024. Results from the subacute cohort (10-49 days post-injury) are expected in late 2024/early 2025. The trial is being conducted at Shirley Ryan AbilityLab in Chicago.
お知らせ • Feb 16NervGen Pharma Announces Completion of Dosing of All Subjects in Phase 1 Clinical Trial of Proprietary Drug Candidate NVG-291NervGen Pharma Corp. announced that all subjects (male, premenopausal and post-menopausal females) in the Phase 1 clinical trial of the Company's proprietary lead compound, NVG-291, have completed dosing. The Company now plans to initiate a Phase 1b/2a clinical trial of NVG-291 in individuals with spinal cord injury in Third Quarter 2023. Based on the encouraging results from preclinical studies, the Company plans to evaluate the efficacy of NVG- 291 versus placebo in two cohorts: individuals with a chronic injury (1-10 years post-injury) and individuals with a subacute injury (10-49 days post-injury). In preclinical studies of spinal cord injury, NervGen's NVG-291 has been demonstrated to promote neural repair mechanisms, including axonal regeneration, remyelination and plasticity.