CAMBRIDGE, Mass. / Dec 11, 2025 / Business Wire /
Enveric Biosciences, Inc. (NASDAQ: ENVB) (“Enveric” or the “Company”), a biotechnology company advancing next-generation neuroplastogenic small molecules to address psychiatric and neurological disorders, today announced the entry into definitive agreements for the immediate exercise of certain outstanding warrants to purchase up to an aggregate of 426,390 shares originally issued in February 2025 and September 2025,... Read more
FREMONT, Calif. / Dec 11, 2025 / Business Wire / Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, today announced the publication of one of the largest and most comprehensive patient cohorts to date from the landmark TRACERx study, in the journal Cell. The study, titled "Longitudinal ultrasensitive ctDNA monitoring for high-resolution lung cancer risk prediction," demonstrates the clinical importance of ultrasensitive, tumor-informed... Read more
Key milestone achieved as Company advances clinical program to full approval trial of ateganosine sequenced with a checkpoint inhibitor in comparison to chemotherapy CHICAGO, Dec. 11, 2025 (GLOBE NEWSWIRE) -- MAIA Biotechnology, Inc. (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, today announced that the first patient has been dosed in the Company’s THIO-104... Read more
Patients treated with 0.05% urcosimod demonstrated directionally favorable improvements in nerve fiber count and fiber length, trends not observed in the placebo group
These findings suggest that urcosimod may have a positive impact on corneal nerve health in patients with neuropathic corneal pain
Corneal nerve imaging data from the Phase 2 NCP trial were analyzed using in vivo confocal microscopy LONDON and NEW YORK, Dec. 11, 2025 (GLOBE NEWSWIRE) -- OKYO Pharma... Read more
The Accepted Abstract Provides Supportive Evidence for the TAMP™ Therapy Platform’s Novel, Localized Approach to Targeted Chemotherapeutic Delivery via Additional Pharmacokinetic and Pharmacodynamic Data MOUNTAIN VIEW, Calif., Dec. 11, 2025 (GLOBE NEWSWIRE) -- RenovoRx, Inc. (“RenovoRx” or “the Company”) (Nasdaq: RNXT), a life-sciences company developing innovative targeted oncology therapies and commercializing RenovoCath®, a patented, FDA-cleared dr... Read more
Ra’anana, Israel, Dec. 11, 2025 (GLOBE NEWSWIRE) -- Polyrizon Ltd. (Nasdaq: PLRZ) (“Polyrizon” or the “Company”), a biotechnology company focusing on the development of intranasal products, today announced new results from its ongoing preclinical evaluation of its proprietary intranasal naloxone hydrogel formulation, demonstrating promising permeation kinetics that complement the Company’s previously reported stability and mucoadhesion successes.
Following... Read more
BOSTON, Dec. 11, 2025 /PRNewswire/ -- TransCode Therapeutics, Inc. (NASDAQ: RNAZ) and Quantum Leap Healthcare Collaborative ("Quantum Leap") today announce a new collaboration to evaluate TransCode's lead therapeutic candidate TTX-MC138 as part of the Quantum Leap PRE-I-SPY clinical trial platform.
The PRE-I-SPY program will incorporate TTX-MC138 in a Phase 2a dose-expansion clinical trial enrolling up to 45 patients with colorectal cancer who have completed... Read more
Once Granted, the Patent Will Provide Protection for MOLBREEVI in Europe Until March 2041
Savara Was Also Recently Granted a European Patent Covering the Investigational Drug-Device Combination of MOLBREEVI Delivered Via PARI’s Proprietary eFlow® Nebulizer System LANGHORNE, Pa. / Dec 11, 2025 / Business Wire / Savara Inc. (Nasdaq: SVRA) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, today announced the... Read more
Novel first-in-class therapeutic targeting a key immune signaling pathway and the underlying cause of HIT
It is the first and only potent, highly selective inhibitor of human 12-LOX in clinical testing, distinguishing it from related compounds.
Orphan Drug and Fast Track designations from the FDA PONTE VEDRA, Fla., Dec. 11, 2025 (GLOBE NEWSWIRE) -- Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a biopharmaceutical company developing transformative therapeutics... Read more
Designation expands (Z)-Endoxifen program into rare pediatric neuromuscular disease and may qualify Atossa for a future Priority Review Voucher upon approval SEATTLE, Dec. 11, 2025 /PRNewswire/ -- Atossa Therapeutics, Inc. (Nasdaq: ATOS) ("Atossa" or the "Company"), a clinical-stage biopharmaceutical company developing novel therapies in oncology and other areas of high unmet clinical need, today announced that the U.S. Food and Drug Administration ("FDA") has... Read more
Oral presentation of ALG-055009 in vivo nonclinical data showcases synergistic fat mass loss in combination with incretin receptor agonists SOUTH SAN FRANCISCO, Calif., Dec. 11, 2025 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (Nasdaq: ALGS), a clinical stage biopharmaceutical company focused on improving patient outcomes through best-in-class therapies for liver and viral diseases, today announced positive data from four presentations, including two oral presentations,... Read more
6-month commercial pilot demonstrated increasing demand among prescribers
Expansion plan includes doubling the number of sales reps, a new GoodRx partnership, and enhanced digital marketing campaign
Additional clinical sites in ongoing babesiosis treatment trials will be initiated in light of FDA feedback regarding Company’s breakthrough therapy designation request WASHINGTON, Dec. 11, 2025 (GLOBE NEWSWIRE) -- 60 Degrees Pharmaceuticals, Inc. (NASDAQ: SXTP; SXTPW)... Read more
Antigen spreading was evaluated in a subset of Phase 2 patients to assess the ability of ELI-002 7P to broaden immune responses to personalized tumor neoantigens not present in the targeted immunotherapy
87% (13/15) of evaluated patients demonstrated induction of T cell responses to tumor neoantigens beyond mKRAS following ELI-002 7P therapy
The induction of non-mKRAS antigen-specific T cell responses supports the potential for ELI-002 7P to generate a broader, more... Read more
EMBOLD data to serve as basis of efficacy and safety following discussion with the FDA BOSTON, Dec. 11, 2025 (GLOBE NEWSWIRE) -- Praxis Precision Medicines, Inc. (NASDAQ: PRAX), a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system (CNS) disorders characterized by neuronal excitation-inhibition imbalance, today announced the successful completion of the planned discussion with the FDA leading... Read more
Inhibiting prolactin receptor (PRLR) signaling with the ABS-201 anti-PRLR antibody promotes human hair follicle growth ex vivo
Human ex vivo data validate ABS-201’s potential to reverse follicular miniaturization and drive vellus-to-terminal hair regeneration by demonstrating that it prolongs anagen, stimulates keratin synthesis, and modulates the stem cell niche
Full dataset will be presented during today’s ABS-201 Key Opinion Leader (KOL) seminar VANCOUVER,... Read more
Poster PS5-08-16 Reports Early Observations from the INVINCIBLE-4 Study, an Ongoing Randomized, Presurgical Phase 2 Clinical Trial for Triple Negative Breast Cancer continue to show favorable safety 50% fewer grade 3 or higher Adverse Events were observed in the INT230-6 cohort compared to the Standard of Care ("SOC") neoadjuvant chemotherapy alone cohort. Poster PS4-10-15 Describes An Overview of a Potential Phase 3 Clinical Study Design with INT230-6 plus standard... Read more
CNSide Diagnostics now licensed in 48 U.S. States covering over 90% of the U.S. population HOUSTON, Dec. 11, 2025 (GLOBE NEWSWIRE) -- CNSide Diagnostics, LLC, a wholly-owned subsidiary of Plus Therapeutics, Inc. (Nasdaq: PSTV) (“Plus” or the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers, announces that it has been granted lab licenses... Read more
Roivant enters new phase of corporate journey with 3+ launches, 4+ NDA/BLA filings, 8+ pivotal and 3+ proof-of-concept study readouts expected over the next three years
Highlighting clinical execution, Roivant announces positive updates to timing guidance across four key programs: Brepocitinib NDA filing in dermatomyositis (DM) now expected in early calendar year 2026; commercial preparation underway with launch expected early in calendar year 2027
Brepocitinib Phase... Read more
CLEVELAND, Dec. 11, 2025 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced activation of The University of Texas Medical Branch (UTMB) in Galveston, Texas, as the newest Qualified Treatment Center (QTC) for the administration of ZEVASKYN (prademagene zamikeracel) gene-modified cellular sheets. ZEVASKYN, a first-of-its-kind, FDA-approved autologous, gene therapy is indicated for the treatment of wounds in adult and pediatric patients with recessive... Read more
BMI and hyperphagia reductions have been observed in patients with PWS treated with setmelanotide at Month 3 (n=8) and Month 6 (n=5); 17 of 18 enrolled patients remain on therapy
Promising results supportive of Phase 3, registrational trial of setmelanotide in PWS
Company initiated Phase 1, Part D study to evaluate weekly MC4R agonist RM-718 in patients with PWS
Company to hold conference call on Thursday, December 11 at 8:00 a.m. BOSTON,... Read more
JENA, Germany, Dec. 11, 2025 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company pioneering anti-inflammatory therapeutics by targeting the complement system, today announced that the World Health Organization (WHO) has granted the international nonproprietary (generic) name (INN) of “izicopan” to the Company for its orally available C5aR inhibitor, formerly known as INF904, in accordance with the WHO's Procedure for the Selection of Recommended... Read more
In DUBLIN-3 non-squamous EGFR WT NSCLC patients who progressed after anti-PD-(L)1, Plinabulin + docetaxel showed consistent and clinically meaningful improvements in OS, PFS, and ORR, reinforcing Plinabulin as a late-stage therapy with consistent survival benefit in anti-PD-(L)1-progressed NSCLC patients.
Supported by anti-cancer efficacy and safety in significant reduction exposure-adjusted grade 3/4 adverse events in DUBLIN-3, BeyondSpring will conduct DUBLIN-4, a... Read more
Publication in key market advances NewcelX's global IP strategy across Asia and supports the Company's expanding position in neurology and metabolic diseases ZURICH, Dec. 11, 2025 /PRNewswire/ -- NewcelX Ltd. (Nasdaq: NCEL), a next-generation biotechnology company developing advanced cell-therapy and neuroscience-driven therapeutics, today announced the publication of a major international patent application in China covering a new class of quinazoline, benzothiazine,... Read more
In a pretreated population of participants with advanced/metastatic cancer and the majority with prior PD-(L)1 treatment, BHV-1510 2.5 mg/kg Q3W plus cemiplimab resulted in confirmed objective response rates 3/5 (60%) in NSCLC, 4/4 (100%) in endometrial cancer, and 1/2 (50%) in urothelial cancer
There were low rates of adverse events attributed to unconjugated payload such as hematological toxicities and diarrhea, and there were no cases of interstitial lung... Read more
Results show, for the first time, that targeting underlying a-syn pathology with an active immunotherapy could slow the rate of progression of Parkinson’s disease
Clear safety profile with no clinically relevant safety issues reported
Targets met for immunogenicity (100% responder rate), pharmacodynamic effect, target engagement and clinical assessments
Underlines potential and importance of active immunotherapies in precision medicine for neurodegenerative diseases
AC... Read more
IMA203CD8 is a second-generation PRAME cell therapy with enhanced pharmacology in ongoing Phase 1a dose escalation
Manageable tolerability across all dose levels
Encouraging early clinical anti-tumor activity in advanced solid tumors after one-time infusion of IMA203CD8 at a low median dose during ongoing dose escalation, including deep and durable responses
Promising dose-dependent clinical signal in ovarian carcinoma supports the strategy to position IMA203CD8 in... Read more
CRB-913 was safe and well-tolerated across all doses studied
Daily neuropsychiatric assessments using CSSRS, PHQ-9, and GAD-7 were negative for all participants
A placebo-adjusted mean weight loss of 2.9% was observed at Day 14 in a dedicated cohort of people with obesity (n=12)
A 12-week dose-finding study in people with obesity initiated with completion expected in summer 2026
Company to host conference call and live webcast today at 8:00 am ET NORWOOD, Mass.,... Read more
Fast Track designation supported by positive results from the KT-621 BroADen Phase 1b atopic dermatitis (AD) patient trial
KT-621 BROADEN2 Phase 2b AD trial ongoing, with data expected to be reported by mid-2027 and BREADTH Phase 2b trial in asthma on track to initiate in 1Q26 WATERTOWN, Mass., Dec. 11, 2025 (GLOBE NEWSWIRE) -- Kymera Therapeutics, Inc. (NASDAQ: KYMR), a clinical-stage biopharmaceutical company advancing a new class of oral small molecule... Read more
Study did not meet the primary or key secondary endpoint
45% reduction in hypoglycemia events observed at top ersodetug dose (10 mg/kg) compared to 40% improvement in placebo arm
Management to host conference call today at 8:30am ET REDWOOD CITY, Calif., Dec. 11, 2025 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT) (“Rezolute” or the “Company”), a late-stage rare disease company focused on treating hypoglycemia caused by hyperinsulinism, today announced... Read more
Data demonstrates the significant and sustained tumor regression achieved by the CAPTN-3 platform across two distinct tri-specific antibodies, IM1240 and IM1305, targeting different tumor antigens
Transcriptomic analysis across ~11,000 TCGA samples shows NKG2A expression is strongly associated with tumor expression of 5T4 or TROP2, supporting inclusion of the NKG2A arm in CAPTN-3 designs
NKG2A arm significantly contributes to IM1240 anti-cancer immune activity in P... Read more
NEW YORK and AMSTERDAM, Dec. 11, 2025 (GLOBE NEWSWIRE) -- Atai Beckley N.V. (NASDAQ: ATAI) (“AtaiBeckley” or the “Company”), a clinical-stage biopharmaceutical company on a mission to transform patient outcomes by developing effective, rapid-acting and convenient mental health treatments, today announced that the United States Patent and Trademark Office has granted a new patent covering EMP-01 (oral R-MDMA), further strengthening the company’s intellectual property... Read more
Collaboration aims to automate RNA and protein detection in 3D tissue specimens, reducing complexity and technical barriers.
Innovation has the potential to improve preclinical research by reducing reliance on animal testing through New Approach Methodologies (NAMs) such as organoids and predictive modeling, enabling new directions and scale in advanced biomedical studies.
Partnership underscores Bio-Techne's commitment to drive innovation and accelerate the broad adoption... Read more
Targeted enrollment of 435 patients to enable potential full approval filing has been completed in OptimUM-02 trial
Topline data, including median PFS, are expected in 1Q 2026 to support a potential accelerated approval filing in the United States SOUTH SAN FRANCISCO, Calif., Dec. 11, 2025 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a leading precision medicine oncology company, today announced it has completed its targeted full enrollment of 435 patients... Read more
Investment to Fund Phase 1 Study in Renal Allograft Antibody-Mediated Rejection (AMR) in China SOUTH SAN FRANCISCO, CALIFORNIA / ACCESS Newswire / December 11, 2025 / CASI Pharmaceuticals, Inc. (NASDAQ:CASI, the "Company"), a clinical-stage biopharmaceutical company developing CID-103, an anti-CD38 monoclonal antibody, for patients with organ transplant rejection and autoimmune diseases, today announced that the Company has entered into a convertible note purchase... Read more
Rick Fair, a seasoned executive with deep experience developing and commercializing hematology products, joins Enliven as Chief Executive Officer
Co-Founder Sam Kintz will assume a new position as Head of Pipeline BOULDER, Colo., Dec. 11, 2025 /PRNewswire/ -- Enliven Therapeutics, Inc. (Enliven or the Company) (Nasdaq: ELVN), a clinical-stage biopharmaceutical company focused on the discovery and development of small molecule therapeutics, today announced the appointment... Read more
Mario Alberto Accardi PhD, President and founder of Centessa’s Orexin Program, appointed Chief Executive Officer and member of the Board of Directors BOSTON and LONDON, Dec. 11, 2025 (GLOBE NEWSWIRE) -- Centessa Pharmaceuticals plc (Nasdaq: CNTA), a clinical-stage pharmaceutical company, today announced that its Board of Directors has appointed Mario Alberto Accardi PhD, President and founder of Centessa’s Orexin Program, as Chief Executive Officer (CEO) and member... Read more
MISSISSAUGA, Ontario / Dec 11, 2025 / Business Wire / Covalon Technologies Ltd. (the "Company" or "Covalon") (TSXV: COV; OTCQX: CVALF), an advanced medical technologies company, today announced its fiscal 2025 fourth quarter and full 2025 fiscal year results for the period ended September 30, 2025, along with a number of important recent achievements and highlights.
Brent Ashton, Covalon’s Chief Executive Officer, commented, “Covalon has made significant progress as... Read more
Ragistomig is a 4-1BB X PD-L1 bispecific antibody, designed to treat patients with advanced or metastatic solid tumors, including those who have relapsed or are refractory to checkpoint inhibitors, a multi-billion dollar pillar of cancer care, hampered by widespread resistance
The study achieved its objective, as the new Q6W extended dosing interval produced encouraging anti-tumor efficacy and immunological data in prior immune-oncology refractory or relapsed patients... Read more
Company addresses FDA requests regarding formulation excipient
Global site start-up activities continue, with first-patient-in for registrational Phase 1b study targeted for Q1 2026, subject to FDA feedback HUNTSVILLE, Dec. 10, 2025 (GLOBE NEWSWIRE) -- Serina Therapeutics, Inc. (“Serina” or the "Company") (NYSE American: SER), a clinical-stage biotechnology company advancing its lead Investigational New Drug ("IND") candidate, SER-252, for advanced... Read more
CONCORD, Calif. / Dec 10, 2025 / Business Wire / Cerus Corporation (Nasdaq: CERS) announced today that it has entered into a group purchasing agreement with Blood Centers of America (BCA), the largest blood supply cooperative in the U.S. BCA member blood centers produce approximately half of the U.S. platelet and cryoprecipitate supply. The agreement covers Cerus’ entire INTERCEPT product line. Under this agreement, Cerus will partner with BCA to drive expanded access to... Read more
SOUTH SAN FRANCISCO, Calif. / Dec 10, 2025 / Business Wire / Quince Therapeutics, Inc. (Nasdaq: QNCX), a late-stage biotechnology company dedicated to unlocking the power of a patient’s own biology for the treatment of rare diseases, announced the publication of a summary of early-stage clinical studies of its Phase 3 lead asset, eDSP (dexamethasone sodium phosphate [DSP] encapsulated in a patient’s own red blood cells), in pulmonary and inflammatory bowel disorders (IBD)... Read more
Multiple active sites and strong US enrollment continue to support Q3 2026 timing for topline data readout
Clinical trial sites in Canada and the United Kingdom have received regulatory clearance to enroll
All patients who have completed HERO trial to date have successfully enrolled and remain in the Open Label Extension trial SAN DIEGO, Dec. 10, 2025 (GLOBE NEWSWIRE) -- Aardvark Therapeutics, Inc. (Aardvark) (Nasdaq: AARD), a clinical-stage biopharmaceutical company... Read more
BOSTON, Dec. 10, 2025 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a global commercial-stage biopharmaceutical company focused on transforming the lives of patients living with rare neuroendocrine diseases, today announced that it will host a live conference call and webcast on Thursday, December 11 at 8:00 a.m. ET to disclose preliminary data from its exploratory Phase 2 trial of setmelanotide in patients with Prader-Willi syndrome (PWS).
Conference... Read more
Company will host conference call and live webcast to review and discuss the data at 8:00 am ET NORWOOD, Mass., Dec. 10, 2025 (GLOBE NEWSWIRE) -- Corbus Pharmaceuticals Holdings Inc. (NASDAQ: CRBP), a clinical stage company focused on oncology and obesity, announced the Company’s plan to release results of its Phase 1a single ascending dose (SAD) and multiple ascending dose (MAD) study of CRB-913 prior to the market open on Thursday, December 11, 2025. Corbus will... Read more
CHICAGO, Dec. 10, 2025 (GLOBE NEWSWIRE) -- MAIA Biotechnology (NYSE American: MAIA) – The treatment paradigm for advanced non-small cell lung cancer (NSCLC) is undergoing another shift. After a decade of targeted therapies and checkpoint inhibitors (CPIs) dominating headlines, MAIA believes that a new therapeutic class—telomere-targeting agents—is emerging for the population with substantial unmet medical need: patients without actionable mutations and who no longer... Read more
Calgary, Alberta--(Newsfile Corp. - December 10, 2025) - Hemostemix Inc. (TSXV: HEM) (OTCQB: HMTXF) (FSE: 2VF0) ("Hemostemix" or the "Company"), the leading autologous (patient's own) stem cell therapy company offering VesCell™ (ACP-01) to individuals suffering from vascular dementia, angina, ischemic cardiomyopathy, congestive heart failure, non-ischemic dilated cardiomyopathy, pain, total body ischemia, peripheral arterial disease and chronic limb threatening ischemia,... Read more
MALVERN, Pa., Dec. 10, 2025 (GLOBE NEWSWIRE) -- Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today announced that Dr. Shankar Musunuri, Chairman, CEO, and Co-founder, will present at the Oppenheimer Movers in Rare Disease Summit taking place at the Sofitel New York on Thursday, December 11, 2025.“For the second year in a row, we will join leaders advancing groundbreaking discoveries for... Read more
THE WOODLANDS, Texas, Dec. 10, 2025 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced the publication of preclinical data validating Acyl-CoA Synthetase 5 (ACSL5) as a target for obesity and chronic weight management. The paper, titled “Acyl-CoA Synthetase 5 knockout and inhibitors protect against diet-induced obesity in mice by activating the ileal brake,” was published online in the Journal of the Endocrine Society.
ACSL5 is an... Read more
TORONTO, Dec. 10, 2025 (GLOBE NEWSWIRE) -- PharmAla Biotech Holdings Inc. (“PharmAla” or the “Company”) (CSE: MDMA) (OTC:MDXXF), a biotechnology company focused on the research, development, and manufacturing of novel MDXX class molecules (including its LaNeo™ MDMA), is excited to announce that it has completed release testing of its first Australian-made batch of LaNeo™ MDMA 40mg capsules.
“PharmAla is pleased to have completed this first batch of material... Read more
Platform Poised to Expand into Joint and Cartilage Repair HOUSTON, Dec. 10, 2025 (GLOBE NEWSWIRE) -- FibroBiologics, Inc. (Nasdaq: FBLG) (“FibroBiologics” or the “Company”), a clinical-stage biotechnology company with 270+ patents issued and pending with a focus on the development of therapeutics and potential cures for chronic diseases using fibroblasts and fibroblast-derived materials, today announced that it has submitted a new patent application with the... Read more
