Webcast set for 8:30 a.m. ET on December 3rd SALT LAKE CITY, Dec. 02, 2025 (GLOBE NEWSWIRE) -- Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries, “Clene”) and its wholly owned subsidiary Clene Nanomedicine Inc., a late clinical-stage biopharmaceutical company focused on revolutionizing the treatment of neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS), today announced it plans provide an update on its CNM-Au8... Read more
Company to host corporate webcast to share updated data on December 3, 2025 LAUSANNE, Switzerland, Dec. 2, 2025 /PRNewswire/ -- ADC Therapeutics SA (NYSE: ADCT), a commercial-stage global leader and pioneer in the field of antibody drug conjugates (ADCs), today announced that it will host a conference call and live webcast on Wednesday, December 3, 2025, at 8:00 a.m. EST to provide an update on the LOTIS-7 Phase 1b open-label clinical trial evaluating the safety and... Read more
Late-breaking HERIZON-GEA-01 presentation highlights the expanding clinical profile of Ziihera across HER2-driven gastrointestinal cancers
Jazz to host investor webcast on Friday, January 9, 2026, to review data DUBLIN, Dec. 2, 2025 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced two abstracts featuring key data for Ziihera® (zanidatamab-hrii) have been accepted for presentation at the American Society of Clinical Oncology... Read more
SAN FRANCISCO, Dec. 02, 2025 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) today announced that the Company will be attending and presenting at the Oppenheimer Movers in Rare Disease Summit being held on December 11, 2025, in New York, NY.
Thane Wettig, Chief Executive Officer of FibroGen, will participate in a panel titled Elevator Pitches from Rare Disease Companies with Key Near-Term, Potentially Stock-Moving Catalysts on Thursday, December 11 at 12:15... Read more
Webcast to be held Wednesday, December 3, at 8:00am ET CAMBRIDGE, Mass., Dec. 02, 2025 (GLOBE NEWSWIRE) -- Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage oncology company developing MasterKey therapies that target families of oncogenic mutations in patients with cancer, will host a webcast to present results from its Phase 2 clinical trial of silevertinib and provide a program update on Wednesday, December 3, 2025, at 8:00am ET.
Webcast information
The... Read more
Toronto, Ontario--(Newsfile Corp. - December 2, 2025) - PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) (the "Company" or "PharmaTher"), a specialty life sciences company focused on unlocking the therapeutic potential of ketamine for neuropsychiatric disorders, today announced it has closed the previously announced sale of its Abbreviated New Drug Application (ANDA #217858) for Ketamine Hydrochloride Injection USP to a leading sterile-injectables pharmaceutical company.
At... Read more
Global assignment of this unique name enhances international clarity, strengthens regulatory positioning, and supports olastrocel’s advancement across large unmet-need global markets PHOENIX, Dec. 02, 2025 (GLOBE NEWSWIRE) -- Creative Medical Technology Holdings, Inc. (NASDAQ: CELZ) (“Creative Medical” or the “Company”), a clinical-stage biotechnology company developing next-generation regenerative and immune cell therapies, today announced that the World... Read more
The patent relates to methods of administering therapeutically effective amounts of isolated allogeneic mesenchymal stem cells (MSCs) to patients with aging-related frailty with inflammaging and also to treat patients with non-ischemic dilated cardiomyopathy
Non-ischemic dilated cardiomyopathy is a progressive disorder with no current cure, often leading to heart transplantation
No approved treatments for aging-related frailty, a syndrome affecting older individuals... Read more
Calgary, Alberta--(Newsfile Corp. - December 2, 2025) - Hemostemix (TSXV: HEM) (OTCQB: HMTXF) (FSE: 2VF0) is proud to announce its participation in DFCon 2025, hosted by the American Limb Preservation Society in San Antonio, Texas - the global epicentre for innovation in diabetic foot care, vascular medicine, and limb preservation. With more than 500 delegates expected, DFCon gathers the widest spectrum of professionals shaping the future of diabetic limb salvage: podiatrists,... Read more
New Caregiver Resource Showcases Expert Contributions and Reinforces IGC Pharma's Leadership in Alzheimer's Innovation POTOMAC, MD / ACCESS Newswire / December 2, 2025 / IGC Pharma, Inc. (NYSE American:IGC) ("IGC" or the "Company"), a clinical-stage biotechnology company leveraging Artificial Intelligence (AI) to develop innovative treatments for Alzheimer's disease, today announced the publication of "Caring for a Loved One with Alzheimer's Disease: First Hand Ex... Read more
Jaguar's requesting advice from EMA on EU approval pathway for general diarrhea of FDA conditionally approved Canalevia®
A novel non-antibiotic approach to diarrhea treatment is important because there are no FDA-approved drugs to treat general diarrhea in dogs, the second most common reason for visits to veterinary emergency hospitals SAN FRANCISCO, CA / ACCESS Newswire / December 2, 2025 / Jaguar Health, Inc. (NASDAQ:JAGX) (Jaguar), today announced that its Italian... Read more
FDA approval marks Alpha Tau’s fifth simultaneous active U.S. IDE as the Company expands Alpha DaRT’s reach into recurrent prostate cancer JERUSALEM, Dec. 02, 2025 (GLOBE NEWSWIRE) -- Alpha Tau Medical Ltd. (NASDAQ: DRTS, DRTSW), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT®, today announced that the FDA has approved an Investigational Device Exemption (IDE) application to initiate a pilot study for the treatment of patients with... Read more
Company to Discuss Proposed Amendment to Phase 3 VERSATILE-003 Trial Enabling Potential Accelerated Approval Pathway PRINCETON, N.J., Dec. 02, 2025 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB) (“PDS Biotech” or the “Company”), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers, today announced that its request for a Type C Meeting with the FDA has been accepted by the agency, and the... Read more
FDA has determined that NRx’s Abbreviated New Drug Application (ANDA) is “substantially complete” and received for review. Assigned GDUFA goal date is July 29, 2026.
NRx has applied to FDA for use of KETAFREE™ as a proprietary product name, which is subject to review. KETAFREE™ is the first preservative-free ketamine formulation that does not include potentially toxic preservatives used in current multidose presentations of ketamine.
Current worldwide generic... Read more
CAMBRIDGE, Mass., Dec. 02, 2025 (GLOBE NEWSWIRE) -- Fulcrum Therapeutics, Inc.® (Nasdaq: FULC), a clinical-stage biopharmaceutical company focused on developing small molecules to improve the lives of patients with genetically defined rare diseases, will host an investor event on Sunday, December 7, 2025 at 7:00 a.m. ET to review new clinical data from the Phase 1b PIONEER trial of pociredir in sickle cell disease (SCD). These data will also be presented at the 67th American... Read more
LANGHORNE, Pa. / Dec 02, 2025 / Business Wire / Savara Inc. (Nasdaq: SVRA) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, announced the European Patent Office (EPO) has issued patent No. 4 496 611 titled, “Drug-Device Combination Comprising a Liquid Solution and a Nebulizer for Aerosolization of the Liquid Solution.” The patent is jointly held by Savara and PARI and covers the combination of Savara’s investigational therapy,... Read more
New U.S. Patent Extends Protection Through 2042
Patent Allowance Secures Highest Level of Intellectual Property Protection for MPAR® SAN DIEGO, CA / ACCESS Newswire / December 2, 2025 / Ensysce Biosciences, Inc. (NASDAQ:ENSC) ("Ensysce" or the "Company"), a clinical-stage pharmaceutical company pioneering next-generation pain and central nervous system therapeutics designed to minimize abuse and overdose risk, today announced that the U.S. Patent and... Read more
PLYMOUTH MEETING, Pa. / Dec 02, 2025 / Business Wire / Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY), today announced that it will highlight new open-label extension data from the company’s investigation of EPX-100 (clemizole hydrochloride) in the ongoing Phase 3 ARGUS trial for the treatment of Dravet syndrome at the 2025 American Epilepsy Society (AES) Annual Meeting being held December 5 – December 9, 2025, in Atlanta, GA.
The ARGUS trial is currently enrolling,... Read more
RICHMOND, Calif., Dec. 02, 2025 (GLOBE NEWSWIRE) -- Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicine company, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to ST-503, an investigational epigenetic regulator for the treatment of intractable pain due to small fiber neuropathy (SFN), a type of chronic neuropathic pain.
Fast Track Designation aims to facilitate the development and expedite the review of new... Read more
CAMBRIDGE, Mass., Dec. 2, 2025 /PRNewswire/ -- Insilico Medicine ("Insilico"), a global leader in AI-powered drug discovery, and Atossa Therapeutics ("Atossa") (Nasdaq: ATOS), a clinical-stage biopharmaceutical company developing novel treatments for breast cancer and other serious conditions, announce the publication of a joint study evaluating the potential of (Z)-endoxifen for glioblastoma multiforme (GBM). The peer-reviewed article, now published in Nature's Scientific... Read more
New Peer-Reviewed Publication Highlights Phase 2 SPRING Trial Data Supporting the Disease Modifying Potential of Nebokitug in PSC and Supports Advancement to a Phase 3 Registration Trial TEL AVIV, Israel, Dec. 02, 2025 (GLOBE NEWSWIRE) -- Chemomab Therapeutics Ltd. (Nasdaq: CMMB), (Chemomab), a clinical stage biotechnology company developing innovative therapeutics for fibro-inflammatory diseases with high unmet need, today announced that the results of its Phase 2... Read more
AGOURA HILLS, Calif., Dec. 02, 2025 (GLOBE NEWSWIRE) -- Oncotelic Therapeutics, Inc. (OTCQB: OTLC) 45% owned Joint Venture, Sapu Nano, a clinical-stage nanomedicine company, today announced new data demonstrating that its proprietary Deciparticle™ platform enables broad and consistent formulation of structurally diverse hydrophobic therapeutics—including macrolide mTOR inhibitors, cyclic peptides, linear peptides, ascomycin macrolactams, and polyketides—while... Read more
SAN DIEGO, Dec. 02, 2025 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (Nasdaq: KURA, “Kura”), a biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, today announced the first U.S. commercial sale of KOMZIFTI™ (ziftomenib) has been completed. Under Kura’s collaboration and license agreement with Kyowa Kirin Co. Ltd. and Kyowa Kirin, Inc. (collectively, “Kyowa Kirin”), this milestone triggers a $135 million... Read more
Positive feedback reinforces Silexion’s trajectory toward its planned Phase 2/3 trial initiation in Q2 2026
Company plans to complete regulatory submissions to the Israeli Ministry of Health by the end of Q4 2025 and in Germany during Q1 2026 GRAND CAYMAN, Cayman Islands, Dec. 02, 2025 (GLOBE NEWSWIRE) -- Silexion Therapeutics Corp. (NASDAQ: SLXN) (“Silexion” or the “Company”), a clinical-stage biotechnology company developing RNA interference (RNAi) therapies... Read more
NEWTON, Mass., Dec. 02, 2025 (GLOBE NEWSWIRE) -- Acumen Pharmaceuticals, Inc. (NASDAQ: ABOS), a clinical-stage biopharmaceutical company developing a novel therapeutic that targets soluble amyloid beta oligomers (AβOs) for the treatment of Alzheimer’s disease (AD), today announced new research at the 18th Annual Clinical Trials on Alzheimer’s Disease (CTAD) conference, taking place December 1-4, 2025, in San Diego and online. Results from a collaborative study... Read more
Immunotherapy-chemotherapy combination of eftilagimod alfa (efti) and paclitaxel led to strong objective response rates and immune activation in heavily pretreated metastatic breast cancer patients
AIPAC-003 has resulted in successful completion of FDA’s Project Optimus requirements and selection of 30 mg as efti’s optimal biological dose SYDNEY, AUSTRALIA, Dec. 02, 2025 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) (“Immutep” or “the Company”),... Read more
Vancouver, Canada, Dec. 02, 2025 (GLOBE NEWSWIRE) -- Clearmind Medicine Inc. (Nasdaq: CMND), (FSE: CWY0) (“Clearmind” or the "Company"), a clinical-stage biotech company focused on discovery and development of novel neuroplastogen-derived therapeutics to solve major under-treated health problems, today announced another key milestone in its Phase I/IIa clinical trial for the treatment of Alcohol Use Disorder (AUD): the first participant has been enrolled and dosed with... Read more
Ra’anana, Israel, Dec. 02, 2025 (GLOBE NEWSWIRE) -- Polyrizon Ltd. (Nasdaq: PLRZ) (“Polyrizon” or the “Company”), a biotechnology company developing intranasal products based on its proprietary Capture & Contain (C&C) platform, today announced the successful completion of a major manufacturing upscaling milestone for its proprietary nasal-spray product platform. This achievement marks a critical step toward supporting upcoming clinical and regulatory... Read more
PASADENA, Calif. / Dec 02, 2025 / Business Wire / Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that the United States Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to investigational plozasiran as an adjunct to diet to reduce triglyceride (TG) levels in adults with severe hypertriglyceridemia (SHTG) (TG levels greater than or equal to 500 mg/dL). There are currently limited and inadequate treatment options for the millions... Read more
Three poster presentations at the San Antonio Breast Cancer Symposium (SABCS), now available and to be presented on December 10, 2025, highlight robust survival and clinical benefit data in Phase 2, plus positive key biomarker data from the pivotal Phase 3
The pivotal Phase 3 study of Bria-IMT+CPI in advanced metastatic breast cancer is ongoing with an interim analysis expected in 1H2026 PHILADELPHIA and VANCOUVER, British Columbia, Dec. 02, 2025 (GLOBE NEWSWIRE)... Read more
Strengthening our Advisory Board with addition of Mark McKenna as Strategic Advisor and Peter Libby, MD as a Clinical Advisor
Expanding the Phase 2 recurrent pericarditis study into Canada, EU and the UK to evaluate QD dose ranging in preparation for the global Phase 3 development plan
Interim analysis for the ongoing Phase 2 recurrent pericarditis study to now be presented as part of Ventyx’s R&D Day planned for Q1 2026 SAN DIEGO, Dec. 02, 2025 (GLOBE NEWSWIRE)... Read more
Study, Which Enrolled 27 Patients, Met Primary Endpoint with a Significant Reduction in Hearing Loss in 3-18 Year Old Patients who Received PEDMARK® when Compared with Historically Reported Rates of Hearing Loss in Patients Receiving Cisplatin Alone (16-24% versus 56-63%, Respectively)
PEDMARK® Showed No Interference with Cisplatin Antitumor Activity as Evidenced by an Approximate 95% Clinical Response Rate
The Company Plans to Pursue Registration and... Read more
First and only investigational medicine for this rare, often fatal neurological condition
On track to submit new drug application (NDA) in Q1 2026 CARLSBAD, Calif. / Dec 02, 2025 / Business Wire / Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to zilganersen for the treatment of Alexander disease (AxD), a rare, progressive and often fatal neurological... Read more
1st of two presentations with results from Phase 2b study of neflamapimod at the 18th Clinical Trials on Alzheimer's Disease (CTAD) Conference
Data demonstrates neflamapimod treatment led to significant reductions in plasma glial fibrillary acidic protein (GFAP), a key marker of neuroinflammation-associated neurodegeneration, and increased beta amyloid (A) 42/40 ratio in DLB
Correlation of the effects of neflamapimod on plasma GFAP with positive treatment response,... Read more
Participants who lost 24% total body weight (>50 lbs.) on GLP-1 drugs maintained stable weight 6 months after GLP-1 discontinuation and single Revita treatment
1.5% mean weight change observed with Revita (n=17); published third-party studies after GLP-1 withdrawal alone have shown ~10% weight regain at similar time points
Upcoming randomized 6-month REMAIN-1 Midpoint Cohort data expected in January 2026; topline 6-month Pivotal Cohort data and potential PMA filing... Read more
Reductions in airway hyperresponsiveness and suppressed eosinophilic response at both 6 weeks and 12 weeks observed after a single 180mg dose of Briquilimab in the ETESIAN Study
Preliminary data from ETESIAN study supports further development of briquilimab in asthma
Jasper also announces completion of internal BEACON study investigation noting no deviations or issues with drug product utilized
Jasper to host conference call and webinar today at 8:00 a.m. ET REDWOOD... Read more
BOSTON, Dec. 02, 2025 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies, today announced that it intends to develop its fully human anti-IL-6 receptor (IL-6R) monoclonal antibody, TZLS-501, and related assets (together “TZLS-501”) via a spinout into a separate publicly traded company, to enhance the strategic focus of each company and to... Read more
Extends cash runway through at least the first half of 2028
Led by healthcare-dedicated investors, including Vivo Capital, Janus Henderson Investors, Coastlands Capital, Columbia Threadneedle Investments, Adage Capital Partners and Squadron Capital Management MIAMI, Dec. 02, 2025 (GLOBE NEWSWIRE) -- Pasithea Therapeutics Corp. (“Pasithea” or the “Company”) (Nasdaq: KTTA; KTTAW), a clinical-stage biotechnology company developing PAS-004, a next-generation... Read more
CELEBRATION, Fla., Dec. 02, 2025 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company), a commercial-stage company focused on providing therapies for people living with rare disease, today announced the appointment of Alicia Secor to the Company’s Board of Directors (Board). The Company also announced the retirement of director Wendy Dixon, PhD, effective today.
"We are pleased to welcome Alicia to our Board at this important juncture,... Read more
Veteran gastroenterologist and clinical development leader with deep expertise driving global Phase 2/3 programs across immunology, neurology, and gastrointestinal disease Carlsbad, CA, Dec. 02, 2025 (GLOBE NEWSWIRE) -- Palisade Bio, Inc. (Nasdaq: PALI) (“Palisade” or the “Company”), a clinical-stage biopharmaceutical company advancing next-generation, once daily, oral PDE4 inhibitor prodrugs for patients with inflammatory and fibrotic diseases, today... Read more
JERUSALEM, Dec. 2, 2025 /PRNewswire/ -- Scinai Immunotherapeutics Ltd. (Nasdaq: SCNI) ("Scinai", or the "Company"), a biopharmaceutical company developing innovative inflammation and immunology (I&I) therapeutics and operating a growing boutique CDMO business unit, today reported its financial results and corporate highlights for the nine months ended September 30, 2025.
First Nine Months 2025 Financial Summary Revenues for the nine months ended September 30, 2025... Read more
TORONTO, ONTARIO, Dec. 01, 2025 (GLOBE NEWSWIRE) -- COSCIENS Biopharma Inc. (TSX: CSCI) (FINRA: CSCIF) (“COSCIENS” or the “Company”), a life sciences company focused on pharmaceutical therapies, diagnostic products, and natural ingredients solutions, today announced that its wholly-owned subsidiary, Aeterna Zentaris GmbH, has entered into an exclusive distribution agreement with Wuzhou Drug International Trading Limited (“Wuzhou”) for the commercialization... Read more
Webinar to be held Tuesday, December 2nd, at 8:00 am ET REDWOOD CITY, Calif., Dec. 01, 2025 (GLOBE NEWSWIRE) -- Jasper Therapeutics, Inc. (Nasdaq: JSPR) (Jasper or the Company), a clinical stage biotechnology company focused on development of briquilimab, a novel antibody therapy targeting c-Kit (CD117) to address mast cell driven diseases such as chronic spontaneous urticaria (CSU), chronic inducible urticaria (CIndU) and asthma, today announced that the Company will... Read more
NEW YORK, Dec. 01, 2025 (GLOBE NEWSWIRE) -- Protara Therapeutics, Inc. (Nasdaq: TARA), a clinical-stage company developing transformative therapies for the treatment of cancer and rare diseases, today announced that it will host a conference call and live webcast at 8:30 am ET on Wednesday, December 3, 2025, to review new data from an interim analysis of the ongoing Phase 2 open-label ADVANCED-2 trial of TARA-002 in BCG-Naïve patients with non-muscle invasive bladder cancer... Read more
SAN CARLOS, Calif., Dec. 01, 2025 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea” or “Biomea Fusion” or “the Company”) (Nasdaq: BMEA), a clinical-stage diabetes and obesity company, today announced that it has been selected for an oral presentation of its long-term icovamenib follow up data at the 23rd World Congress on Insulin Resistance, Diabetes & Cardiovascular Disease (WCIRDC) taking place in Los Angeles, California on December 3-6, 2025. The Congress... Read more
Phase 1 data demonstrates durable responses and rPFS coupled with a manageable safety profile rPFS of 7.9-8.9 months in heavily pre-treated mCRPC patients
Preliminary results are encouraging with deep PSA reductions and a promising CRS profile in taxane-naïve Phase 1b expansion study
Initial results support a patient-friendly Q2W dosing schedule Janux to host virtual investor event today at 4:30 PM Eastern Time SAN DIEGO / Dec 01, 2025 / Business Wire / Janux... Read more
KOL panel to discuss how vispa-cel, an anti-CD19 allogeneic CAR-T cell therapy, can broaden access for patients with second-line large B cell lymphoma including through use in the community setting BERKELEY, Calif., Dec. 01, 2025 (GLOBE NEWSWIRE) -- Caribou Biosciences, Inc. (Nasdaq: CRBU), a leading clinical-stage CRISPR genome-editing biopharmaceutical company, today announced that it will host an expert physician panel discussion during an ancillary event at the... Read more
LYMPHIR now available nationwide CRANFORD, N.J., Dec. 1, 2025 /PRNewswire/ -- Citius Oncology, Inc. ("Citius Oncology") (Nasdaq: CTOR), the oncology-focused subsidiary of Citius Pharmaceuticals, Inc. ("Citius Pharma") (Nasdaq: CTXR), today announced the commercial launch of LYMPHIR™ (denileukin diftitox-cxdl). LYMPHIR is a novel IL-2 receptor-directed fusion protein approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with relapsed... Read more
Results obtained in the Phase 2 placebo-controlled CLEAR-MIND clinical trial showed that treatment with stem cell therapy laromestrocel was associated with a reduction in MRI measured neuroinflammation compared to placebo across multiple key brain regions, including key Alzheimer’s disease-associated regions, most notably in the hippocampus
Reduction in hippocampal neuroinflammation, measured using MRI assessed free water, correlated strongly with preservation of... Read more
Vancouver, Canada, Dec. 01, 2025 (GLOBE NEWSWIRE) -- Clearmind Medicine Inc. (Nasdaq: CMND), (FSE: CWY0) (“Clearmind” or the "Company"), a clinical-stage biotech company focused on discovery and development of novel neuroplastogen-derived therapeutics to solve major under-treated health problems, recently announced three transformative milestones in its FDA-approved Phase I/IIa clinical trial for CMND-100—the Company's proprietary, non-hallucinogenic, MEAI-based oral... Read more
