Fast Track Designation underscores the promise of Werewolf’s INDUKINE™ platform WATERTOWN, Mass., Oct. 08, 2025 (GLOBE NEWSWIRE) -- Werewolf Therapeutics, Inc. (the “Company” or “Werewolf”) (Nasdaq: HOWL), pioneering the development of therapeutics engineered to stimulate the body’s immune system for the treatment of cancer and other immune-mediated conditions, today announced that the Company has received Fast Track Designation for the use of WTX-124 for the potential treatment of patients with locally adv ...

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]

Core Insights - The FDA has granted Fast Track designation to PMN310, a therapeutic candidate by ProMIS Neurosciences for Alzheimer's disease, highlighting its potential to address an unmet medical need [1][2][3] - PMN310 is designed to selectively target toxic oligomers of amyloid-beta, potentially reducing side effects associated with current treatments [3][5] - The ongoing PRECISE-AD Phase 1b trial is evaluating PMN310's safety, tolerability, and pharmacokinetics, with interim results expected in Q2 2026 [3][6] Company Overview - ProMIS Neurosciences is a clinical-stage biotechnology company focused on developing therapeutic antibodies for neurodegenerative diseases, including Alzheimer's, ALS, and Parkinson's [1][7] - The company utilizes its proprietary EpiSelect™ technology to identify Disease Specific Epitopes (DSEs) on misfolded proteins [7][8] Industry 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, indicating a significant need for effective treatments [4] - The Fast Track program by the FDA aims to expedite the development of therapies for serious conditions, which is crucial for addressing the urgent need for safer and more targeted Alzheimer's treatments [2][4]

Core Insights - The FDA has granted Fast Track Designation for RAD101, a novel imaging small molecule developed by Radiopharm Theranostics, aimed at distinguishing between recurrent disease and treatment effects in brain metastases from solid tumors [1][3] - RAD101 targets fatty acid synthase (FASN), which is overexpressed in many solid tumors, including cerebral metastases, potentially improving diagnostic precision for over 300,000 patients diagnosed annually in the U.S. [2][3] Company Overview - Radiopharm Theranostics is a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for high unmet medical needs, listed on ASX (RAD) and NASDAQ (RADX) [6] - The company has a pipeline that includes one Phase 2 and three Phase 1 trials targeting various solid tumor cancers, including lung, breast, and brain metastases [6] Clinical Trial Details - The Phase 2b clinical trial of RAD101 is a multicenter, open-label study evaluating the diagnostic performance of 18F-RAD101 in 30 individuals with confirmed recurrent brain metastases [4] - The primary objective is to assess the concordance between 18F-RAD101 positive lesions and those identified through conventional imaging (MRI with gadolinium) [4] - Secondary endpoints include the accuracy, sensitivity, and specificity of RAD101 in differentiating tumor recurrence from radiation necrosis in previously treated brain metastases [4] Product Information - RAD101 is designed to allow for more accurate detection of cancer cells by targeting FASN activity, representing a clinically relevant method for imaging brain metastases [5] - Positive data from a Phase 2a imaging trial indicated significant tumor uptake independent of the tumor's origin, suggesting potential for non-invasive prediction of overall survival [5]

Company Overview - Tempest Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing first-in-class targeted and immune-mediated therapeutics for cancer treatment [1][8] - The company is headquartered in Brisbane, California, and has a diverse portfolio of small molecule product candidates [8] Drug Development and Designations - The European Medicines Agency (EMA) has granted Orphan Drug Designation (ODD) to amezalpat (TPST-1120), an oral, small molecule, selective PPAR⍺ antagonist for hepatocellular carcinoma (HCC) [1][6] - Earlier in the year, the FDA also granted ODD and Fast Track Designation (FTD) to amezalpat for the same indication, highlighting the urgent need for new treatment options [2][6] - Amezalpat has shown positive outcomes in a global randomized Phase 1b/2 clinical study, demonstrating a six-month improvement in median overall survival (OS) with a hazard ratio (HR) of 0.65 when combined with standard-of-care therapies [2][4] Disease Context - Hepatocellular carcinoma (HCC) is an aggressive cancer with over 900,000 new diagnoses globally each year, projected to become the third leading cause of cancer death by 2030 [3] - The majority of HCC cases are linked to chronic liver diseases, with a high recurrence rate of 70-80% even after early-stage diagnosis [3][4] Mechanism of Action - Amezalpat is designed to target tumor cells directly while also modulating immune suppressive cells and angiogenesis within the tumor microenvironment [4] - The drug has shown clinical superiority across multiple study endpoints, including overall survival in both the entire population and key subpopulations compared to standard care [4][6] Regulatory Benefits - The EMA's ODD provides benefits such as potential 10 years of market exclusivity following regulatory approval in the EU, reduced regulatory fees, and a centralized EU approval process [7]

Core Viewpoint - Innovent Biologics has presented promising Phase 1 study results for IBI343, a novel anti-CLDN18.2 ADC, for advanced pancreatic cancer, indicating its potential as a breakthrough therapy in a challenging-to-treat malignancy [2][4]. Company Overview - Innovent Biologics is a leading biopharmaceutical company founded in 2011, focused on developing high-quality medicines for various diseases, including oncology, cardiovascular, and autoimmune disorders [10]. - The company has launched 15 products and has multiple assets in various stages of clinical trials, partnering with over 30 global healthcare companies [10]. Clinical Study Results - The Phase 1 study of IBI343 showed a confirmed overall objective response rate (cORR) of 22.7% and a disease control rate (DCR) of 81.8% in patients with CLDN18.2 expression treated at a 6mg/kg dose [6]. - The median progression-free survival (mPFS) was reported at 5.4 months, and the median overall survival (mOS) was 9.1 months, with variations based on prior treatments [6]. - The safety profile of IBI343 was favorable, with a low rate of gastrointestinal toxicity and no new safety signals reported [6]. Market Context - Pancreatic cancer is one of the most aggressive cancers, with a global 5-year survival rate of less than 10% and approximately 510,000 new cases and 467,000 deaths annually [3][4]. - The clinical options for second-line treatment of advanced pancreatic cancer are limited, highlighting the urgent need for effective therapies [4]. Regulatory Designations - IBI343 has received Breakthrough Therapy Designation (BTD) from China's National Medical Products Administration (NMPA) and Fast Track Designation (FTD) from the U.S. Food and Drug Administration (FDA) [2][9].

Core Viewpoint - Teva Pharmaceutical Industries has received Fast Track designation from the FDA for its investigational anti-IL-15 antibody, TEV-53408, aimed at treating celiac disease, highlighting the urgent need for effective treatments in this area [1][3][7]. Company Overview - Teva Pharmaceutical Industries Ltd. is a global biopharmaceutical leader with over 120 years of experience, focusing on innovation and the development of medicines, including generics and biologics, to improve health outcomes [6]. Product Development - TEV-53408 is currently undergoing a Phase 2a trial to evaluate its efficacy and safety in adults with celiac disease, which affects approximately 1% of the global population [1][4][5]. - The drug works by inhibiting interleukin-15 (IL-15), which is responsible for the immune response to gluten, thereby aiming to reduce intestinal inflammation and damage in celiac disease patients [3][4]. Market Need - Celiac disease is a chronic autoimmune disorder that significantly impacts quality of life, with the only current treatment being a strict gluten-free diet, which many patients struggle to adhere to [5]. - There is a significant unmet medical need for new treatment options, as many patients continue to experience debilitating symptoms even on a gluten-free diet [3][5].