Pivotal Phase III liver cancer study enrolling in Europe and Israel RAMAT GAN, Israel, Nov. 18, 2025 (GLOBE NEWSWIRE) -- Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs targeting oncological and inflammatory diseases, announced today that a patient treated with Namodenoson has reached an overall survival of 9 years to date with complete response to treatment. The patient, who suffered from advanced liver cancer, was ...

NRx has refiled its Abbreviated New Drug Application for KETAFREE™ (preservative free ketamine), received supportive correspondence from FDA, and expects Q2 2026 GDUFA date.HOPE Therapeutics is now operating three revenue-generating facilities in Florida and expects six or more by year-end providing neuroplastic drugs, transcranial magnetic stimulation, hyperbaric therapy, and digital therapeutics to treat suicidal depression and PTSD.NRx has secured operating capital anticipated to be sufficient for drug d ...

MELVILLE, N.Y., Nov. 17, 2025 (GLOBE NEWSWIRE) -- BioRestorative Therapies, Inc. (“BioRestorative”, “BRTX” or the “Company”) (NASDAQ:BRTX), a regenerative medicine innovator focused on stem cell-based therapies and products, today announced that it has been granted a Type B meeting with the U.S. Food and Drug Administration (“FDA”) to discuss a potential accelerated Biologics License Application (“BLA”) approval pathway for the Fast-Track-Designated BRTX-100 program for the treatment of chronic lumbar disc ...

Core Insights - Altimmune, Inc. is approaching significant milestones in the development of pemvidutide for metabolic dysfunction-associated steatohepatitis (MASH) and alcohol use disorder (AUD) [2][12] - The company has strengthened its executive leadership team with key appointments to support its growth strategy [2][9] - Financial results indicate a robust cash position and a reduction in research and development expenses compared to the previous year [7][19] MASH Program Updates - The 48-week data from the Phase 2b IMPACT trial of pemvidutide is expected to be released before the end of 2025 [2][12] - An End-of-Phase 2 meeting with the FDA is scheduled for the fourth quarter of 2025 to discuss the proposed design of the Phase 3 trial [5][12] - The trial design may include flexibility to adapt based on regulatory discussions regarding non-invasive tests and AI-based biopsy readings [2] AUD and ALD Trials - The RECLAIM trial for pemvidutide in AUD has completed patient recruitment ahead of schedule, indicating strong interest in new therapies for this condition [9][12] - The RESTORE trial for pemvidutide in alcohol-associated liver disease (ALD) has also been initiated, with a focus on safety and efficacy [9][12] Executive Leadership Changes - Recent appointments include Dr. Christophe Arbet-Engels as Chief Medical Officer, Linda Richardson as Chief Commercial Officer, and Robin Abrams as Chief Legal Officer [2][9] - These leaders bring extensive experience in clinical development, commercial strategy, and legal compliance to the company [9] Financial Performance - As of September 30, 2025, the company reported cash, cash equivalents, and short-term investments totaling approximately $211 million, a 60% increase from $131.9 million at the end of 2024 [7][19] - Research and development expenses decreased to $15 million from $19.8 million year-over-year, reflecting a strategic focus on cost management [19] - The net loss for the quarter was $19 million, or $0.21 per share, an improvement from a net loss of $22.8 million, or $0.32 per share, in the same period in 2024 [19]

Core Insights - Esperion Therapeutics (ESPR) has nominated ESP-2001, a specific allosteric ATP citrate lyase (ACLY) inhibitor, as a new preclinical development candidate for treating primary sclerosing cholangitis (PSC), a rare autoimmune liver disease with no approved treatments [1][7] - The company plans to initiate IND-enabling studies for ESP-2001 and submit an IND application to the FDA, aiming to start clinical studies in 2026 [2] - ESP-2001 has shown potential in reducing liver and bile duct injury, inflammation, and fibrosis in preclinical studies, indicating its ability to impact PSC progression [3] Company Developments - Esperion's stock rose by 5.2% following the announcement of ESP-2001 [2] - The collaboration with Evotec (EVO) was crucial in discovering ESP-2001, combining Esperion's expertise in ACLY therapy with Evotec's drug discovery platform [2][3] - The nomination of ESP-2001 triggered an undisclosed payment to Evotec [3] Financial Performance - Esperion's net product sales of Nexletol and Nexlizet in the U.S. grew by 42% in the first half of 2025, reaching $75.2 million, driven by increased prescription volumes [10] - Esperion aims to diversify its portfolio beyond cardiovascular diseases into the liver disorder market, targeting a potential market opportunity exceeding $1 billion annually with ESP-2001 [10] Market Position - Esperion currently holds a Zacks Rank of 3 (Hold) [11] - The company has two FDA-approved drugs, Nexletol and Nexlizet, which are marketed under different names in ex-U.S. markets [8][9]

Core Insights - Werewolf Therapeutics has received Fast Track Designation from the FDA for WTX-124, aimed at treating locally advanced or metastatic cutaneous melanoma after standard immunotherapy [1][3] - WTX-124 is a conditionally activated interleukin 2 (IL-2) therapy designed to enhance anti-tumor immune responses while minimizing systemic toxicities [2][4] - The Fast Track Designation allows for expedited development and frequent interactions with the FDA, potentially leading to priority review and accelerated approval [3] Company Overview - Werewolf Therapeutics is focused on developing therapeutics that stimulate the immune system for cancer and immune-mediated conditions, leveraging its proprietary PREDATOR® platform [4] - The company is advancing WTX-124 and WTX-330, both conditionally activated IL-2 and IL-12 INDUKINE molecules, for the treatment of solid tumors [4] - WTX-124 is currently being evaluated in a Phase 1/1b clinical trial, including both single-agent and combination arms with pembrolizumab [2][3]

Core Insights - Corbus Pharmaceuticals has received Fast Track designation from the FDA for CRB-701, aimed at treating recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) previously treated with platinum-based chemotherapy and anti-PD(L)-1 therapy [1][2] - CRB-701 is a next-generation antibody drug conjugate (ADC) targeting Nectin-4, featuring a site-specific, cleavable linker and a drug antibody ratio of 2, utilizing MMAE as the payload [2] - An ongoing Phase 1/2 clinical trial is assessing the safety, pharmacokinetics, and efficacy of CRB-701 in patients with advanced solid tumors with high Nectin-4 expression, with data to be presented at ESMO 2025 [3][9] Company Overview - Corbus Pharmaceuticals is a clinical stage oncology and obesity company focused on innovative scientific approaches to serious illnesses, with a pipeline that includes CRB-701, CRB-601, and CRB-913 [4] - CRB-601 is an anti-integrin monoclonal antibody targeting TGFβ activation on cancer cells, while CRB-913 is a CB1 receptor inverse agonist for obesity treatment [4]

Core Insights - NRx Pharmaceuticals has received an expanded Fast Track Designation from the FDA for NRX-100, allowing it to address an unmet medical need for treating suicidal depression in over 13 million Americans annually, significantly increasing its market potential [4][11][7] - The company is advancing its drug development pipeline, including NRX-100 and NRX-101, with various regulatory filings and applications aimed at accelerating approval processes [8][15][28] - HOPE Therapeutics, a subsidiary of NRx, is establishing a network of interventional psychiatry clinics to provide comprehensive care for mental health conditions, aiming to address a significant public health crisis [20][18][19] Drug Development and Regulatory Activities - NRX-100 is being developed through two paths: a generic approval via an Abbreviated New Drug Application (ANDA) and an innovative drug path via a New Drug Application (NDA) [8][28] - The ANDA market for ketamine is estimated at $750 million, with expectations to enter this market in early 2026 [8] - NRX-101 has received Breakthrough Therapy Designation and is being prepared for a New Drug Application, with over 80,000 pages of supporting material submitted [15][16] Financial Overview - For Q2 2025, the company reported a net loss of $17.6 million, compared to a net loss of $7.9 million in Q2 2024, primarily due to non-cash fair value accounting measurements [24] - The company had approximately $2.9 million in cash and cash equivalents as of June 30, 2025, which is expected to support operations into 2026 [25] HOPE Therapeutics and Market Strategy - HOPE Therapeutics aims to create a national network of clinics to provide integrated care for patients with suicidal depression and related conditions, addressing fragmented mental health treatment [20][18] - The company is negotiating to acquire additional facilities, targeting $100 million in total forward pro-forma revenue by the end of 2025 [23] Toxicology and Safety Considerations - A Citizen's Petition has been filed to remove Benzethonium Chloride from intravenous ketamine products, citing safety concerns and lack of GRAS status [9][10] - The proprietary formulation of NRX-100 is preservative-free, which is expected to be well-received by both physicians and patients, potentially capturing a larger market share [10][9]

Core Viewpoint - NRx Pharmaceuticals has received Fast Track designation from the FDA for NRX-100, a treatment for suicidal ideation in patients with depression, significantly expanding its addressable population to 13 million Americans who consider suicide each year [1][6]. Group 1: Fast Track Designation - The FDA granted Fast Track designation to NRX-100, indicating its potential to address an unmet medical need based on preliminary data [2][6]. - This designation represents a 10-fold increase in the addressable population compared to the previous designation in 2017, which was limited to bipolar depression [1][6]. Group 2: Clinical Evidence - Controlled trials submitted to the FDA showed a statistically significant reduction in suicidal ideation, with a Columbia University study reporting a 55% response rate for patients treated with intravenous ketamine compared to 30% for the active comparator [3]. - A trial sponsored by the Government of France indicated that 63% of patients achieved full remission from suicidal ideation within three days, compared to 31% for placebo [3]. Group 3: Market Potential - NRX-100 is positioned to address the over $3 billion market for suicidal depression in the U.S. [10]. - The company aims to make this potentially life-saving therapy accessible to all Americans, not just those who can afford it [7]. Group 4: Regulatory and Development Plans - NRx Pharmaceuticals plans to submit patient-level data from clinical trials to support the application for the Commissioner's National Priority Voucher (CNPV) program, which could expedite the review process [2][12]. - The company has filed for an Abbreviated New Drug Application (ANDA) and is working on draft labeling for NRX-100 to comply with CNPV requirements [8][12]. Group 5: Product Differentiation - NRX-100 is the first preservative-free formulation of ketamine submitted to the FDA, addressing safety concerns associated with existing products that contain toxic preservatives [9]. - The company has demonstrated long-term stability and sterility with its patented formulation, which is manufactured in the U.S. [9].

Core Insights - ProMIS Neurosciences Inc. has received Fast Track designation from the FDA for its lead therapeutic candidate PMN310, aimed at treating Alzheimer's disease [1][2][3] - The Fast Track designation is intended to expedite the development of therapies addressing serious conditions and unmet medical needs, allowing for enhanced engagement with the FDA [2] - PMN310 is designed to selectively target toxic forms of amyloid-beta, potentially reducing serious side effects associated with current Alzheimer's treatments [3][5] Company Overview - ProMIS Neurosciences is a clinical-stage biotechnology company focused on developing therapeutic antibodies for neurodegenerative diseases, including Alzheimer's disease, ALS, and Parkinson's disease [7] - The company utilizes its proprietary EpiSelect™ technology to identify Disease Specific Epitopes (DSEs) on misfolded proteins, which are implicated in neurodegenerative diseases [7] Clinical Trials - The ongoing PRECISE-AD Phase 1b trial is evaluating PMN310 in early Alzheimer's patients, focusing on safety, tolerability, pharmacokinetics, and biomarkers [3][6] - Interim biomarker and safety data from the trial are expected to be reported in Q2 2026, with final results anticipated in Q4 2026 [3][6] - The trial is designed to provide insights into the effects of PMN310 on biomarkers and clinical outcomes, with a particular emphasis on assessing the risk of ARIA [6] Market Context - Alzheimer's disease affects over 6 million people in the U.S. and is a leading cause of death and disability among older adults, highlighting the urgent need for safer and more effective treatment options [4] - PMN310 aims to offer a differentiated approach by selectively targeting toxic oligomers, potentially leading to improved efficacy and reduced side effects compared to existing therapies [5]