SAN DIEGO, Dec. 01, 2025 (GLOBE NEWSWIRE) -- Belite Bio, Inc (NASDAQ: BLTE) (“Belite Bio” or the “Company”), a clinical-stage drug development company focused on advancing novel therapeutics targeting degenerative retinal diseases that have significant unmet medical needs, today announced that it has priced an underwritten public offering of 2,272,727 American Depositary Shares (“ADSs”), each representing one of its ordinary shares, at a public offering price... 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
Presentation to include new data in triple-negative disease, a breast cancer subtype with poor outcomes and limited viable treatment options
ATNM-400 overcomes HER2 therapy resistance and represents a novel targeted radiotherapy with the potential to avoid off-target toxicities including ILD that constrains other therapeutic modalities such as antibody drug conjugates
ATNM-400 has demonstrated the potential to overcome resistance to first-line tamoxifen endocrine... Read more
SHELTON, CONNECTICUT / ACCESS Newswire / December 1, 2025 / NanoViricides, Inc., a publicly traded company (NYSE Amer.:NNVC) (the "Company"), and a clinical stage, leading global pioneer in the development of broad-spectrum antivirals based on host-mimetic nanomedicine technology that viruses cannot escape, announced today that it has signed a Master Services Agreement (MSA) with Only Orphans Cote, LLC, ("OOC") a regulatory consultant firm founded by Dr. Timothy Cote. Dr.... Read more
SEATTLE / Dec 01, 2025 / Business Wire / Omeros Corporation (Nasdaq: OMER) today announced the closing of the asset sale and licensing transaction between Omeros and Novo Nordisk for the candidate drug zaltenibart (formerly OMS906). Zaltenibart is a first-in-class, late-stage clinical humanized monoclonal antibody targeting MASP-3 – the most upstream and key activator of the alternative pathway of the complement system – and has shown multiple potential advantages over... Read more
Biodexa Announces Enrolment of First European Patients into Pivotal Phase 3 Serenta Trial in FAP December 1, 2025 - Biodexa Pharmaceuticals PLC (“Biodexa” or “the Company”), (Nasdaq: BDRX), a clinical stage biopharmaceutical company developing a pipeline of innovative products for the treatment of diseases with unmet medical needs, is pleased to announce the enrolment of the first three patients by the University of Bonn, Germany into its pivotal Phase... Read more
MOUNTAIN VIEW, Calif., Dec. 01, 2025 (GLOBE NEWSWIRE) -- RenovoRx, Inc. (Nasdaq: RNXT) (“RenovoRx” or “the Company”), a life sciences company developing innovative targeted oncology therapies and commercializing RenovoCath®, a novel, FDA-cleared drug-delivery device, today announced that Chief Executive Officer Shaun Bagai will present at the iAccess Alpha Virtual Best Ideas Winter Investment Conference 2025, held on December 9-10, 2025. Mr. Bagai’s presentation... Read more
Submission of NDA in South Korea by Lotus Pharmaceutical results in the second ex-U.S. regulatory submission for VIZZ SAN DIEGO and TAIPEI, Taiwan, Dec. 01, 2025 (GLOBE NEWSWIRE) -- LENZ Therapeutics, Inc. (Nasdaq: LENZ) and Lotus Pharmaceutical Co., Ltd. (“Lotus”, TWSW Stock Code: 1795) today announced that Lotus has submitted a New Drug Application (NDA) to the Ministry of Food and Drug Safety (MFDS) for the review and approval of VIZZTM, for the treatment of... Read more
SUNNYVALE, Calif., Dec. 01, 2025 (GLOBE NEWSWIRE) -- BioCardia, Inc. [NASDAQ: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announces it will participate at the CSI Focus Devices in Heart Failure this week in Frankfurt, Germany. BioCardia’s President and Chief Executive Officer, Peter Altman, PhD, will make an invited presentation entitled, “Intramyocardial Cell Therapy for Ischemic... Read more
Salt Lake City, Dec. 01, 2025 (GLOBE NEWSWIRE) -- Recursion (Nasdaq: RXRX) a leading clinical stage TechBio company decoding biology to radically improve lives, announced today that it will present a new clinical readout from the ongoing TUPELO Phase 1b/2 trial of REC-4881 in FAP at an upcoming company webinar. The webinar will be held on December 8, 2025 at 8:00 am ET / 6:00 am MT / 1:00 pm GMT, and will be streamed live on Recursion’s X, LinkedIn, and YouTube... Read more
Proof-of-concept study underway for investigational oral therapy in Fragile X syndrome; top-line data from Phase 2 expected in 2027 FOSTER CITY, Calif. / Dec 01, 2025 / Business Wire / Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM), a leading rare disease company, today announced that the first participant has been enrolled in the BLOOM Phase 2 clinical study evaluating MRM-3379 in Fragile X syndrome (FXS).
Caused by a mutation of the FMR1 gene, FXS is the most common inherited... Read more
If approved, ReadyFlow Autoinjector would deliver an IV-equivalent diuretic dose (subcutaneous furosemide injection 80 mg/ml) in under 10 seconds
Would potentially provide a cost-effective and convenient option to address episodes of fluid buildup at home, benefiting patients, providers and payors
PDUFA target action date of July 26, 2026 WESTLAKE VILLAGE, Calif. and BURLINGTON, Mass., Dec. 01, 2025 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD) today announced... Read more
NobleCon is the preeminent showcase of small and microcap companies NEW YORK, Dec. 1, 2025 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ: HOTH), a patient focused biopharmaceutical company, today announced that Robb Knie, Chief Executive Officer, is scheduled to present at the Noble Capital Markets 21st Annual Emerging Growth Equity Conference in Boca Raton, FL.
To learn more about NobleCon and registration to attend or scheduling a one-on-one meeting... Read more
SGT-212 has been granted FDA Rare Pediatric Disease and Fast Track designations
SGT-212 is the only dual route gene therapy in development to treat Friedreich’s ataxia
FALCON Phase 1b clinical trial participant screening underway CHARLESTOWN, Mass., Dec. 01, 2025 (GLOBE NEWSWIRE) -- Solid Biosciences Inc. (Nasdaq: SLDB) (the “Company” or “Solid”), a life sciences company developing precision genetic medicines for neuromuscular and cardiac... Read more
Boca Raton, FL, Dec. 01, 2025 (GLOBE NEWSWIRE) -- INmune Bio, Inc. (NASDAQ: INMB), a clinical-stage biotechnology company developing inflammation and immunology therapies targeting innate immune dysfunction, announces new neuroimaging data from its Phase 2 MINDFuL trial of XPro1595 in patients with early Alzheimer’s disease (AD) and elevated neuroinflammation. The results will be presented at the 18th Clinical Trials on Alzheimer’s Disease conference (CTAD), being held... Read more
SAN DIEGO, Dec. 01, 2025 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a purpose-driven health biotech company solely focused on closing the gap in women’s health between promising science and real-world solutions, today announced that all rights to Ovaprene®, the company’s first-in-category, investigational, hormone-free monthly intravaginal contraceptive, will be returned to Daré by Bayer HealthCare LLC as a result of Bayer electing to terminate... Read more
Salarius subsidiary Decoy Therapeutics’ influenza fusion inhibitors, designed using its proprietary IMP3ACT™ platform, show excellent in silico free energy binding to the viral target entry protein, supporting potential for anti-flu activity
IMP3ACT’s demonstrated capability to create a single antiviral therapeutic against influenza, COVID and RSV has potential to position Salarius to address large existing global commercial opportunity CAMBRIDGE, Mass. and... Read more
ROCKVILLE, Md. and SUZHOU, China, Dec. 01, 2025 (GLOBE NEWSWIRE) -- Ascentage Pharma Group International (NASDAQ: AAPG; HKEX: 6855) (“Ascentage Pharma” or the “Company”), a global, commercial stage, integrated biopharmaceutical company engaged in the discovery, development and commercialization of novel, differentiated therapies to address unmet medical needs in cancer, announced today that Chairman & CEO, Dr. Dajun Yang, and others from the management team... Read more
Company to host a conference call and webcast on Saturday, December 6, 2025, at 8:00 pm ET SOUTH SAN FRANCISCO, Calif. and SAN DIEGO, Dec. 01, 2025 (GLOBE NEWSWIRE) -- ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, today announced a poster presentation highlighting data from a Phase 1b trial of enozertinib (ORIC-114) at the ESMO Asia Congress 2025 taking... Read more
New analyses from the ongoing open label extension (OLE) studies and findings from electroencephalogram (EEG) assessments in patients with Dravet syndrome treated with zorevunersen support the potential for disease modification BEDFORD, Mass. & CAMBRIDGE, Mass. / Dec 01, 2025 / Business Wire / Stoke Therapeutics, Inc. (Nasdaq: STOK), a biotechnology company dedicated to restoring protein expression by harnessing the body’s potential with RNA medicine, and... Read more
Study findings to be featured in a poster spotlight presentation HOUSTON, Dec. 01, 2025 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers, announces the acceptance of an abstract for poster spotlight (with oral) presentation at the upcoming San Antonio Breast Cancer Symposium (SABCS),... Read more
Seeking Alignment with European Medicines Agency (EMA) at February 2026 Meeting
Actively Evaluating Strategy Across DLB and Alzheimer’s Disease PURCHASE, N.Y., Dec. 01, 2025 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc., (the Company or Cognition) (NASDAQ: CGTX), a clinical-stage company developing drugs that treat neurodegenerative disorders, presented plans for a registrational program for zervimesine in mild-to-moderate Alzheimer's disease during the... Read more
Cross-trial analysis supports plasma pTau as a potential early predictor of clinical benefit, reinforcing the biomarker-driven design of ProMIS’ PRECISE-AD trial
ProMIS on track to leverage new plasma pTau insights with planned Q2 2026 interim readout Cambridge, Massachusetts, Dec. 01, 2025 (GLOBE NEWSWIRE) -- ProMIS Neurosciences Inc. (Nasdaq: PMN), a clinical-stage biotechnology company focused on the generation and development of antibody therapeutics and vaccines... Read more
JUPITER, Fla. and WAGENINGEN, Netherlands, Dec. 01, 2025 (GLOBE NEWSWIRE) -- Dyadic Applied BioSolutions (“Dyadic”), a global biotechnology company producing precision-engineered, animal-free proteins and enzymes across life science, food & nutrition, and bioindustrial markets, and BRIG BIO (official legal entity The Protein Collective B.V.), a Netherlands-based developer of next-generation recombinant dairy ingredients, today announced the signing of a Development... Read more
EMERYVILLE, Calif., Dec. 01, 2025 (GLOBE NEWSWIRE) -- Metagenomi, Inc. (Nasdaq: MGX) (the “Company”), an in vivo genome editing company capitalizing on its proprietary technologies to create curative genetic medicines for patients, today announced that the Company will present new preclinical data supporting the third target, APOC3, in its collaboration with Ionis Pharmaceuticals at the Nature Conference “Cracking the Code: Nucleic Acid Medicines Coming of Age”... Read more
On track to submit supplemental new drug application by end of year CARLSBAD, Calif. / Dec 01, 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 olezarsen as an adjunct to diet to reduce triglyceride (TG) levels in adults with severe hypertriglyceridemia (sHTG) (TG greater than or equal to 500 mg/dL). Breakthrough Therapy designation... Read more
CHICAGO / Dec 01, 2025 / Business Wire / Xeris Biopharma Holdings, Inc. (Nasdaq: XERS), a fast-growing biopharmaceutical company committed to improving patient lives by developing and commercializing innovative products across a range of therapies, today announced that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for its subsidiary Xeris Pharmaceuticals Inc.’s U.S. patent application covering XP-8121, one of its novel product candidates.... Read more
Promising efficacy and favorable safety data from the Phase 1 study in heavily pre-treated patients show potential of CLN-049 to address a broad population of AML patients CAMBRIDGE, Mass., Dec. 01, 2025 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (Nasdaq: CGEM), a clinical-stage biopharmaceutical company accelerating potential first- or best-in-class, high-impact therapies in autoimmune diseases and cancer, today announced that the U.S. Food and Drug Administration... Read more
Large-scale GWAS across ~1,600 samples shows how peptide-level mass spectrometry distinguishes true protein changes from potential binding artifacts resulting from affinity-based approaches, establishing accuracy as the foundation for downstream discovery REDWOOD CITY, Calif., Dec. 01, 2025 (GLOBE NEWSWIRE) -- Seer, Inc. (Nasdaq: SEER), the pioneer and trusted partner for deep, unbiased proteomic insights, today announced the publication in Nature Genetics of... Read more
Ficerafusp alfa 750mg QW in combination with pembrolizumab demonstrates overall response rate and safety profile consistent with the 1500mg QW dose
Data inform and advance progress toward dose selection for ongoing pivotal FORTIFI-HN01 clinical trial of ficerafusp alfa in combination with pembrolizumab in 1L HPV-negative R/M HNSCC
Company to host conference call and webcast on Saturday, December 6, 2025 at 9:00 a.m. ET BOSTON, Dec. 01, 2025 (GLOBE NEWSWIRE) -- Bicara... Read more
TSRA-196 is a potential one-time treatment to precisely correct the genetic mutation underlying AATD, with Investigational New Drug filing expected by the end of the year
Tessera to receive $150 million, inclusive of a cash upfront and equity investment from Regeneron; companies to share worldwide development costs and future profits 50:50
Collaboration combines Regeneron’s long-standing expertise in genetics, genetic medicines and clinical development with Tessera’s... Read more
SAN FRANCISCO, Dec. 01, 2025 (GLOBE NEWSWIRE) -- Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted protein degradation medicines in oncology and autoimmune diseases, today announced that the company will host a live webcast on Monday, December 8, 2025, at 8:15 p.m. ET, to review new and updated clinical data from the ongoing Phase 1a/1b clinical trial of its Bruton’s... Read more
Encinitas, California--(Newsfile Corp. - December 1, 2025) - Kiora Pharmaceuticals, Inc. (NASDAQ: KPRX) today announced that the U.S. Patent and Trademark Office issued a new patent (US-12,472,263) on additional and novel formulations of the KIO-100 family of compounds, This patent allows for additional delivery options, expanding the potential therapeutic utility of the active pharmaceutical ingredient (API) in KIO-104.
This newly issued patent specifically covers a novel... Read more
B7H3 and PTK7 is co-expressed in multiple solid tumor types, including lung, colorectal, and head and neck cancers, at approximately 30%, 46%, and 27%, respectively
Deep and durable regressions observed with IDE034 monotherapy in multiple preclinical in-vivo models with B7H3 and PTK7 co-expression
Enhanced durability with IDE034 and IDE161 PARG inhibitor combination in preclinical in vivo models; targeting to share additional preclinical data supporting mechanistic... Read more
Tinlarebant is the first therapeutic candidate to demonstrate clinical efficacy in a global Phase 3 trial for Stargardt disease, achieving a statistically significant p-value of 0.0033
Tinlarebant met the primary efficacy endpoint, demonstrating clinical benefit by significantly reducing the lesion growth rate by 36% compared to placebo, as measured by retinal imaging
Tinlarebant was well tolerated throughout the trial
Stargardt disease impacts more than 50,000 patients... Read more
Investment to support the continued evaluation and redevelopment of KALA’s product candidates and patent portfolio, and provide working capital and funding for a potential future strategic transaction ARLINGTON, Mass., Dec. 01, 2025 (GLOBE NEWSWIRE) -- KALA BIO, Inc. (NASDAQ:KALA), a clinical-stage biopharmaceutical company dedicated to the research, development and commercialization of innovative therapies for rare and severe diseases of the eye, announces it has... Read more
SAN DIEGO, Dec. 01, 2025 (GLOBE NEWSWIRE) -- Belite Bio, Inc (NASDAQ: BLTE) (“Belite Bio” or the “Company”), a clinical-stage drug development company focused on advancing novel therapeutics targeting degenerative retinal diseases that have significant unmet medical needs, today announced that it has commenced an underwritten public offering of American Depositary Shares (“ADSs”), each representing one of its ordinary shares. All of the securities in the... Read more
LONDON and GAITHERSBURG, Md., Dec. 01, 2025 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), an early commercial stage biopharmaceutical company developing, manufacturing and delivering next-generation programmed T cell therapies, today announced the appointment of Ryan Richardson to the Company’s Board of Directors. Mr. Richardson brings more than 20 years of strategy and corporate development experience and in the healthcare and investment banking industries... Read more
Jerry Durso, accomplished industry leader, to succeed Vipin Garg, Ph.D. as Chief Executive Officer
Transition follows seven years of strong leadership by Dr. Garg GAITHERSBURG, Md., Dec. 01, 2025 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a late clinical-stage biopharmaceutical company developing novel peptide-based therapeutics for liver and metabolic diseases, today announced a CEO succession plan under which Vipin Garg, Ph.D. will step down as the Company’s... Read more
CARLSBAD, Calif., Dec. 1, 2025 /PRNewswire/ -- Tyra Biosciences, Inc. (Nasdaq: TYRA), a clinical-stage biotechnology company focused on developing next-generation precision medicines that target large opportunities in Fibroblast Growth Factor Receptor (FGFR) biology, announced today the appointment of two key members of its leadership team: Bhavesh Ashar as Chief Operating Officer and Heather Faulds as Chief Regulatory Officer. Together, Mr. Ashar and Ms. Faulds will... Read more
PONTE VEDRA, Fla., Dec. 01, 2025 (GLOBE NEWSWIRE) -- Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a biopharmaceutical company developing transformative therapeutics to overcome current gaps in anticoagulation therapy, today announced the appointment of Lee Scott Golden, M.D., to its Board of Directors, effective immediately. Dr. Golden will serve as an independent director.
Dr. Golden currently serves as Executive Vice President and Chief Medical Officer at PTC Therapeutics,... Read more
WILMINGTON, Del. / Dec 01, 2025 / Business Wire / Incyte (Nasdaq:INCY) announces the appointment of Richard Hoffman as Executive Vice President and General Counsel effective today, December 1, 2025. In his new role, Mr. Hoffman will serve as a key member of the Executive Leadership Team and be responsible for the Company’s legal and compliance teams.
“Richard joins us with a distinguished background, including many years of experience as a partner at a premier law firm,... Read more
