CAMBRIDGE, Mass., Dec. 10, 2025 /PRNewswire/ -- Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced the appointment of Ron Squarer to its Board of Directors. "We welcome Ron to our Board of Directors, where his personal dedication to advancing oncology therapeutics, demonstrated success in...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...Read more
Phase 1 dose escalation trial of monotherapy IDE574 expected to begin in 1Q 2026 Targeting to present preclinical data detailing pharmacologic profile and evidence of anti-tumor activity in solid tumor models at a medical conference in 1H 2026 SOUTH SAN FRANCISCO, Calif., Dec. 10, 2025 /PRNewswire/ -- IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a leading precision medicine oncology company, announced the submission of an...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...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...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...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...Read more
Prospective clinical data show NexoBrid® removes embedded particles in friction and blast wounds, reducing pigmented wound surface by >90% Traumatic tattoos form when dirt, metal, or explosive residue becomes permanently embedded in the skin; findings support further evaluation in acute trauma settings YAVNE, Israel, December 10, 2025 -- MediWound Ltd. (Nasdaq: MDWD), a global leader in next-generation enzymatic therapeutics for...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...Read more
SAN MATEO, Calif., Dec. 10, 2025 (GLOBE NEWSWIRE) -- Sagimet Biosciences Inc. (Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing novel therapeutics targeting dysfunctional metabolic and fibrotic pathways, today announced that Ascletis Pharma Inc. issued a December 10 statement that China’s National Medical Products Administration (NMPA) has accepted its New Drug Application (NDA) for denifanstat for the treatment of...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,...Read more
First patient from TNBC trial demonstrated 76% tumor volume shrinkage with corresponding reductions in circulating tumor cells (CTC) and clusters Reinvigoration of immune system + turning cold tumors hot Preliminary ex-vivo data in HER2+ patients demonstrates immune reinvigoration and reductions in CTC and clusters SYDNEY, Dec. 10, 2025 /PRNewswire/ -- Kazia Therapeutics Limited ("Kazia" or the "Company") (NASDAQ: KZIA) today...Read more
MDNA11 demonstrates durable anti-tumor activity in phase-2 eligible expansion cohorts, enriched for immune checkpoint resistant melanoma, MSS endometrial cancer, MSI-H and TMB-H cancers, in each case exceeding objective response rate (ORR) benchmarks in these difficult to treat populations In the monotherapy expansion cohorts, irrespective of tumor type, patients treated with MDNA11, as the next treatment following progression on...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...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")...Read more
Test-Controls & Reference Materials for Labs & Test-Makers MISSISSAUGA, Ontario, Dec. 10, 2025 (GLOBE NEWSWIRE) -- Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF, Microbix®), a life sciences innovator, manufacturer, and exporter, announces the commercial launch of QAPs™ quality assessment products and availability of QUANTDx™ reference materials to support antigen or molecular tests for H3N2 strains of seasonal Influenza A...Read more
VTP-1000, an antigen-specific immunotherapy to treat celiac disease, showed a dose-dependent pharmacological effect in the SAD portion of the trial VTP-1000 was well-tolerated with no treatment-related SAEs The MAD portion of the trial, which includes a gluten challenge, is ongoing GERMANTOWN, Md., Dec. 10, 2025 (GLOBE NEWSWIRE) -- Barinthus Biotherapeutics plc (NASDAQ: BRNS) (“Barinthus Bio,” or the “Company”), an immunology and...Read more
Developed and evaluated specifically for women, DARE to PLAY™ Sildenafil Cream is a first-of-its-kind female arousal cream, a non-hormonal topical cream shown in clinical studies to increase genital blood flow in 10–15 minutes, and improve arousal sensations based on clinically-validated endpoints. Market introduction of DARE to PLAY™ is expected to mark a breakthrough in women’s sexual health and represents important progress toward...Read more
BriaCell presents positive clinical data in three posters at the San Antonio Breast Cancer Symposium (SABCS®) Phase 3 study of Bria-IMT™ plus immune check point inhibitor (CPI) continues to support biomarkers to identify patients who benefit from treatment with BriaCell’s regimen Maturing Phase 2 study data continues to support meaningful clinical benefit of the Bria-IMT regimen with outstanding long-term survival No toxicity...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...Read more
Results support the potential of PMN310 to improve outcomes by selectively targeting oligomers and avoiding binding to monomer and plaque ProMIS on track to complete enrollment in PRECISE-AD trial in Alzheimer’s disease by end of 2025 with planned Q2 2026 interim readout Cambridge, Massachusetts, Dec. 10, 2025 (GLOBE NEWSWIRE) -- ProMIS Neurosciences Inc. (Nasdaq: PMN), a clinical-stage biotechnology company focused on the...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...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...Read more
Data Presented at ESMO IO 2025 include Partial Responses, Durable Disease Control, and No New Safety Signals, Reinforcing Earlier Findings EDINBURGH, United Kingdom, Dec. 10, 2025 (GLOBE NEWSWIRE) -- NuCana plc (NASDAQ: NCNA) (“NuCana” or the “Company”) presented the latest clinical data at the annual European Society for Medical Oncology (“ESMO”) Immuno-Oncology Congress, December 10-12, 2025, in London. The data from patients with...Read more
WINNIPEG, Manitoba, Dec. 10, 2025 (GLOBE NEWSWIRE) -- Kane Biotech Inc. (TSX-V:KNE) (“Kane Biotech”, “Kane” or the “Company”) today announces that Health Canada has approved its revyve® Antimicrobial Wound Gel Spray for use in Canada. Health Canada approved revyve Antimicrobial Wound Gel Spray revyve Antimicrobial Wound Gel Spray has been previously cleared under the FDA 510(k) process. This Health Canada approval represents another...Read more
Conditional approval extended through December 2026 for the treatment of CID in dogs CID confirmatory effectiveness trial expected to conclude in February 2026, ahead of FDA's June deadline - 51 dogs enrolled to date; ~49 more expected SAN FRANCISCO, CA / ACCESS Newswire / December 10, 2025 / Jaguar Health, Inc.(NASDAQ:JAGX) today announced that the U.S. Food and Drug Administration (FDA) has granted renewal of the...Read more
From Handshake to Breakthrough: How Rakovina & Variational AI Are Cracking the Code on CNS-Penetrant Cancer Therapies VANCOUVER, British Columbia, Dec. 10, 2025 (GLOBE NEWSWIRE) -- Rakovina Therapeutics Inc. (TSX-V: RKV) (FSE: 7JO0) (“Rakovina” or the “Company”), a biopharmaceutical company advancing innovative cancer therapies through artificial intelligence (AI)-powered drug discovery, is pleased to announce that the Company...Read more
CRANFORD, N.J., Dec. 10, 2025 /PRNewswire/ -- Citius Oncology, Inc. ("Citius Oncology" or the "Company") (Nasdaq: CTOR), the oncology-focused subsidiary of Citius Pharmaceuticals, Inc. ("Citius Pharma") (Nasdaq: CTXR), today announced the closing of its previously announced registered direct offering with a single healthcare-focused investor, priced at-the-market under Nasdaq rules, for the purchase and sale of 1,284,404 shares of its...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...Read more
Global interim Phase 2 data in locally advanced/metastatic triple-negative breast cancer (”TNBC”) show encouraging antitumor activity for investigational therapy pumitamig (BNT327/BMS986545) plus chemotherapy in first- and second-line patients Pumitamig plus chemotherapy achieved confirmed objective response rate (cORR) of 61.5%, unconfirmed ORR (uORR) of 71.8% and disease control rate (DCR) of 92.3% irrespective of PD-L1 expression...Read more
Combines chemiluminescence detection with dual-channel fluorescence in the near-infrared and infrared (NIR and IR) ranges for expanded multiplexing Enables up to 24 targets per sample and supports complex assay configurations Strengthens Bio-Techne's leadership in proteomic analytical instruments and supports 21 CFR Part 11 compliance MINNEAPOLIS, Dec. 9, 2025 /PRNewswire/ -- Bio-Techne Corporation (NASDAQ: TECH), a global provider...Read more
Clear recognition of high unmet need and urgency for the SCN2A community and plausibility of the mechanism of elsunersen FDA agreed to proposed changes to the EMBRAVE3 trial design to be a single-arm, baseline-controlled study Enrollment in EMBRAVE3 is quickly accelerating and topline results expected in 2026 Topline results from ongoing EMBRAVE study (Part A, n=9) expected in 1H 2026 BOSTON, Dec. 09, 2025 (GLOBE NEWSWIRE)...Read more
FOSTER CITY, Calif., Dec. 09, 2025 (GLOBE NEWSWIRE) -- Terns Pharmaceuticals, Inc. (“Terns” or the “Company”) (Nasdaq: TERN), a clinical-stage oncology company, today announced that it has commenced a proposed underwritten public offering of $400 million of shares of its common stock and, in lieu of common stock to certain investors, pre-funded warrants to purchase shares of its common stock. In addition, Terns expects to grant the...Read more
SOUTH SAN FRANCISCO, Calif., Dec. 09, 2025 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ: DNLI) today announced that it intends to offer and sell $200 million of shares of its common stock and, in lieu of common stock to certain investors, pre-funded warrants to purchase shares of its common stock in an underwritten public offering. In addition, Denali Therapeutics intends to grant the underwriters a 30-day option to purchase up to...Read more
No advanced therapies approved to treat ColdU and SD—diseases of misery that dramatically impact all aspects of patient life Barzolvolimab is the only drug in development to demonstrate clinical benefit in patients in ColdU and SD in a large, randomized, placebo-controlled study--all primary and secondary endpoints met with high statistical significance at 12 weeks and sustained through end of treatment period (20 weeks) in Phase 2...Read more
Royalty term on Ultomiris® sales in the United States anticipated to continue into year-end 2028, extending term by three years Additional $100 million to $120 million in potential royalty revenue estimated to be received by Xencor, based on consensus sales forecasts PASADENA, Calif. / Dec 09, 2025 / Business Wire / Xencor, Inc. (NASDAQ:XNCR), a clinical-stage biopharmaceutical company developing engineered antibodies for...Read more
BOSTON, Dec. 9, 2025 /PRNewswire/ -- Ginkgo Bioworks (NYSE: DNA) today announced its partnership with Deep Origin on a 4.5-year project funded by the Advanced Research Projects Agency for Health (ARPA-H) Computational ADME-Tox and Physiology Analysis for Safer Therapeutics (CATALYST) program. CATALYST is led by ARPA-H Health Science Futures Mission Office Acting Deputy Director Andy Kilianski, Ph.D. The collaboration,...Read more
First patient in the world treated with Alpha DaRT® in the brain According to the National Brain Tumor Society, glioblastoma is one of the most complex, deadly, and treatment-resistant cancers, with an estimated average survival rate of only 8 months This pilot study is a key part of Alpha Tau’s broader strategy to bring Alpha DaRT to cancer patients with some of the highest unmet needs JERUSALEM, Dec. 09, 2025...Read more
City of Hope to Evaluate PEDMARK® for Reducing Ototoxicity in Adult Men with Stage II-III Metastatic Testicular Germ Cell Tumors Initiation of Study Reflects Growing Clinical Interest in Addressing the Burden of Hearing Loss Among Patients Receiving Cisplatin-Based Chemotherapy RESEARCH TRIANGLE PARK, N.C., Dec. 09, 2025 (GLOBE NEWSWIRE) -- Fennec Pharmaceuticals Inc. (NASDAQ:FENC; TSX: FRX), a specialty pharmaceutical...Read more
Financing includes leading U.S. biotechnology institutional investors and mutual funds LOS ANGELES, CA, Dec. 09, 2025 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. (“ImmixBio”, “Company”, “We” or “Us” or ”IMMX”), a global leader in relapsed/refractory AL Amyloidosis, today announced the closing of its previously announced underwritten registered offering of 19,117,646 shares of its common stock at a price to the public of $5.10 per...Read more
Placebo-controlled Phase 2 study will evaluate SAT-3247 treatment over three months among ambulatory children with Duchenne Study endpoints include safety and tolerability, effect on muscle force and function, and impact on muscle quality and regeneration Enrollment of first study participant anticipated by end of 2025 TORONTO / Dec 09, 2025 / Business Wire / Satellos Bioscience Inc. (TSX: MSCL, OTCQB: MSCLF) (“Satellos” or the...Read more
The ALSTARS Trial is a Phase 2, multi-center, randomized, double-blind, placebo-controlled study to assess the safety and efficacy of COYA 302 in patients with amyotrophic lateral sclerosis (ALS) being conducted at clinical sites in the United States and Canada Dosing of ALS patients has commenced in the ALSTARS Trial and signifies a key milestone for the Company. COYA 302, a combination of proprietary low-dose IL-2 and CTLA-4 Ig, is...Read more
TORONTO and HOUSTON, Dec. 09, 2025 (GLOBE NEWSWIRE) -- Medicenna Therapeutics Corp. (“Medicenna” or the “Company”) (TSX: MDNA, OTCQX: MDNAF), a clinical-stage immunotherapy company focused on the development of Superkines for the treatment of cancer as well as autoimmune and inflammatory diseases is pleased to announce that it will host a live webinar on December 10, 2025 at 08:30 AM Eastern Time. As previously announced,...Read more
New patent further strengthens global intellectual property estate supporting Atossa's lead program across the breast cancer spectrum and other hormone-driven conditions SEATTLE, Dec. 9, 2025 /PRNewswire/ -- Atossa Therapeutics, Inc. (Nasdaq: ATOS) ("Atossa" or the "Company"), a clinical-stage biopharmaceutical company developing innovative therapies in areas of significant unmet need in breast cancer, today announced that the United...Read more
Key Opinion Leader, Dr. Ralph DeFronzo presents the “Future of Menin Inhibitors” and discusses icovamenib and its clinical results shared during WCIRDC 2025 in online interview SAN CARLOS, Calif., Dec. 09, 2025 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (Nasdaq: BMEA), a clinical stage diabetes and obesity company, today announced the release of a KOL interview during the 23rd World Congress on Insulin Resistance, Diabetes &...Read more
Alignment achieved on all key points surrounding non-clinical, CMC and post-market authorization confirmatory study design Biomarker data advanced as key pre-specified surrogate clinical efficacy endpoint, with pending analysis awaiting alignment with US FDA on biomarker statistical analysis plan to be discussed at upcoming December 11, 2025 FDA Type C Meeting Company reiterates end of January 2026 timeline for MAA submission New...Read more
New Patent Grants Broad Composition Claims for PDS0101 Previously Granted Patent Protections and Anticipated Market Exclusivity Provide Protection for PDS0101 in the United States into the 2040s PRINCETON, N.J., Dec. 09, 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,...Read more
PHILADELPHIA, Dec. 09, 2025 (GLOBE NEWSWIRE) -- Century Therapeutics, Inc. (‘Century’, NASDAQ: IPSC), a biotechnology company developing induced pluripotent stem cell (iPSC)-derived cell therapies for autoimmune diseases and cancer, today announced the appointments of Han Lee, Ph.D., M.B.A., and Martin Murphy, Ph.D., to its Board of Directors. As part of their appointments, Dr. Lee will serve as a member of the Audit and the Compensation...Read more
RMAT designation indicates that SENTI-202 has the potential to address unmet medical needs for patients with Relapsed/Refractory (R/R) Acute Myeloid Leukemia (AML) based on preliminary clinical evidence, and offers benefits of FDA working closely with Senti Bio to provide guidance and advice on generating the data needed to support approval of the product in an efficient manner Second FDA designation for SENTI-202 this year, after...Read more
ASH 2025 oral presentation on SENTI-202 in 20 Relapsed/Refractory Acute Myeloid Leukemia (R/R AML) patients (18 response evaluable) shows high efficacy: 50% ORR and 42% CR/CRh (100% of CRs and 83% of all responses were MRD negative) at RP2D, 7.6 months median duration of composite Complete Remission across all patients, and a favorable safety profile Pharmacodynamic data from these patients validate SENTI-202’s novel OR/NOT Logic Gate...Read more
POTOMAC, MARYLAND / ACCESS Newswire / December 9, 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 it has reached a key enrollment milestone of 65% for its ongoing Phase 2 CALMA clinical trial evaluating IGC-AD1 for the treatment of agitation in Alzheimer's...Read more
Weinstein brings a global track record of transforming companies through value unlocking, and participation in over 20 M&A transactions and more than $5 billion in exits across healthcare, biotechnology, and nutrition. Weinstein’s ownership is expected to increase to approximately 30% on an issued and outstanding basis, reflecting his conviction in Pluri’s asset base, its valuation potential, and its long term strategy. HAIFA,...Read more
Over 230 patients screened and over 160 patients enrolled in BriaCell’s pivotal Phase 3 study in metastatic breast cancer (MBC) Enrollment exceeding expectations with strong clinical site and patient interest Topline interim data readout expected in 1H2026 Phase 3 combination regimen continues under FDA Fast Track designation PHILADELPHIA and VANCOUVER, British Columbia, Dec. 09, 2025 (GLOBE NEWSWIRE) -- BriaCell...Read more
100% of patients in Cohorts 1-3 remain free of cytokine release syndrome CRIS-7-derived CD3 design underpins a controlled T-cell response, supporting the differentiated safety profile, combinability with standard of care SEATTLE, WA / ACCESS Newswire / December 9, 2025 / Aptevo Therapeutics Inc. (NASDAQ:APVO), a clinical-stage biotechnology company focused on developing novel immune-oncology therapeutics based on its proprietary...Read more
5 of 8 patients (62.5%) achieved Undetectable MRD (uMRD) LEXINGTON, Mass., Dec. 9, 2025 /PRNewswire/ -- Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of emavusertib (CA-4948), an orally available, small molecule IRAK4 and FLT3 inhibitor, yesterday provided updated clinical data from the ongoing frontline Acute Myeloid Leukemia (AML) triplet study (CA-4948-104) in a poster presentation at the 67th ASH...Read more
Data highlights the ability of Akari’s Trop2 ADC, AKTX-101, to kill K-Ras G12V mutated cancer cell lines in preclinical models, potentially addressing one of the most lethal cancers with the lowest survival rates The K-Ras G12V mutation is the oncogenic driver for 1/3 of all pancreatic ductal adenocarcinoma (PDAC), the most common form of pancreatic cancer Significant unmet need in pancreatic cancer where median overall survival...Read more
Continues to drive enrollment with increase to 78% now consentedBlinded response activity tracking within expected range Consented subjects now across seven countries supporting the expansion of the MIRACLE trial HOUSTON, Dec. 09, 2025 (GLOBE NEWSWIRE) -- Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), today provided an update on enrollment from its November report with an increase to 78% of the target number...Read more
Once issued, this new U.S. Patent will expand the scope of Enveric’s EVM301 patent portfolio of potential neuroplastogenic molecules for treatment of neuropsychiatric conditions. CAMBRIDGE, Mass. / Dec 09, 2025 / Business Wire / Enveric Biosciences (NASDAQ: ENVB) (“Enveric” or the “Company”), a biotechnology company advancing novel neuroplastogenic small-molecule therapeutics to address psychiatric and neurological disorders, today...Read more
Financing from new and existing healthcare focused investors The proceeds are expected to extend the Company’s cash runway into Q1 2027, with potential inflection points anticipated in its clinical programs during that period DOYLESTOWN, Pa., Dec. 09, 2025 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc. (Nasdaq: APRE) (“Aprea”, or the “Company”), a clinical-stage biopharmaceutical company developing innovative treatments that exploit...Read more
Engineered to Deliver Potent Pain Relief with Unique, Built-In, Abuse Protection SAN DIEGO, CA / ACCESS Newswire / December 9, 2025 / Ensysce Biosciences, Inc. (NASDAQ:ENSC) ("Ensysce" or the "Company"), a clinical-stage pharmaceutical company pioneering novel solutions for severe pain with built-in abuse and overdose protection, today announced that the first patient has been enrolled in the Company's pivotal Phase 3 clinical...Read more
Findings support advancement into Phase 2 to explore a first-in-class pathway aimed at stress-related neuropsychiatric conditions NEW YORK CITY, NEW YORK / ACCESS Newswire / December 9, 2025 / Protagenic Therapeutics Inc. (NASDAQ:PTIX), a biopharmaceutical company developing therapeutics that target the biology of chronic stress and its downstream psychiatric and neurologic effects, today reported positive topline safety results from its...Read more
Proceeds strengthen cash position and support commercial launch of LYMPHIR™, a novel cancer immunotherapy for cutaneous T-cell lymphoma (CTCL) CRANFORD, N.J., Dec. 9, 2025 /PRNewswire/ -- Citius Oncology, Inc. ("Citius Oncology" or the "Company") (Nasdaq: CTOR), the oncology-focused subsidiary of Citius Pharmaceuticals, Inc. ("Citius Pharma") (Nasdaq: CTXR), today announced that it has entered into a definitive agreement with a...Read more
Two-year epcoritamab monotherapy data demonstrate high complete response and encouraging survival rates in patients with Richter transformation (RT), highlighting its potential as a treatment option for those unsuitable for chemotherapy Additional early data show promising efficacy of epcoritamab combination regimens in patients with RT Results underscore the potential of epcoritamab as a versatile therapy for a broad range of B-cell...Read more
Nearly all (90%) of essential thrombocythemia (ET) patients treated with INCA033989 at the higher dose achieved a hematologic response (HR) with 83.3% achieving a complete HR Molecular responses were frequent, rapid, durable and correlated with hematologic responses; a reduction in mutCALR variant allele frequency (VAF) from baseline occurred in 96.2% of patients with ≥1 post-baseline VAF measurement Exploratory analyses from the...Read more
Dramatically improved disease control with 21.2 months vs. 2.9 months median event-free survival (EFS) Favorable safety profile with 7% vascular occlusion rate Broad patient benefit with proven effectiveness even in patients without T315I mutation (11.9 vs. 3.1 months event-free survival) ROCKVILLE, Md. and SUZHOU, China, Dec. 08, 2025 (GLOBE NEWSWIRE) -- Ascentage Pharma Group International (NASDAQ: AAPG; HKEX: 6855), a global,...Read more
By the end of 3 induction cycles, the best minimal residual disease (MRD) negativity rate and the MRD-negative complete response (CR) rate were 66.0% and 64.2%, respectively High-risk IKZF1plus patients showed 90% molecular response rate Low-intensity chemotherapy combination achieved deep responses with favorable safety profile ROCKVILLE, Md. and SUZHOU, China, Dec. 08, 2025 (GLOBE NEWSWIRE) -- Ascentage Pharma Group...Read more
76.7% complete cytogenetic response rate achieved in patients who failed second-generation TKI first-line therapy Molecular responses continue to deepen with extended treatment duration, reaching 60% major molecular response at 21 cycles Strong efficacy data support potential advancement to earlier treatment lines for a broader patient population ROCKVILLE, Md. and SUZHOU, China, Dec. 08, 2025 (GLOBE NEWSWIRE) -- Ascentage...Read more
ARO-MAPT utilizes the Targeted RNAi Molecule (TRiM™) platform designed for subcutaneous administration and systemic delivery to the CNS by crossing the blood-brain-barrier Study initiation further highlights Arrowhead’s innovation and leadership in the delivery of siRNA PASADENA, Calif. / Dec 08, 2025 / Business Wire / Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that it has dosed the first subjects in a Phase 1/2a...Read more
SAN DIEGO, Dec. 8, 2025 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme") today announced the election of Jim Lang to its Board of Directors. Mr. Lang brings more than 30 years of executive leadership experience in healthcare, life sciences, business services and data analytics. "Jim brings extensive experience in building and scaling innovative healthcare businesses, and we are delighted to welcome him to...Read more
WATERTOWN, Mass., Dec. 08, 2025 (GLOBE NEWSWIRE) -- Kymera Therapeutics, Inc. (NASDAQ: KYMR), a clinical-stage biopharmaceutical company advancing a new class of oral small molecule degrader medicines for immunological diseases, today announced that it has commenced an underwritten public offering of $500.0 million of shares of its common stock. All of the shares of common stock to be sold in this offering are being offered by Kymera. In...Read more
KT-621 achieved deep STAT6 degradation across both the 100 mg and 200 mg dose groups tested, with median reductions of 94% and 98% in skin and blood, respectively, demonstrating strong translation from healthy volunteers to atopic dermatitis (AD) patients KT-621 achieved strong reductions in disease-relevant Type 2 biomarkers in blood, including TARC (median reduction of 74% in patients with baseline TARC levels comparable to dupilumab...Read more
Bezuclastinib demonstrated rapid and deep clinical benefit in AdvSM patients resulting in an objective response rate (CR+CRh+PR+CI) of 57% per mIWG criteria and 80% per PPR criteria Bezuclastinib demonstrated a powerful effect on mast cell burden with 89% of patients achieving ≥50% reduction in bone marrow mast cells or clearance of aggregates Bezuclastinib was very well tolerated with only 14.8% of patients requiring dose...Read more
Trial Design Finalized in Consultation and Alignment with U.S. Food and Drug Administration Study Designed to Establish a New Standard for Adult Pneumococcal Conjugate Vaccines Through Head-to-Head Safety, Tolerability and Immunogenicity Comparisons of VAX-31 with Capvaxive (PCV21) and Prevnar 20 (PCV20), the Current Standards of Care Company Expects to Report Topline Safety, Tolerability and Immunogenicity Data for OPUS Phase...Read more
SAN FRANCISCO, Dec. 08, 2025 (GLOBE NEWSWIRE) -- Structure Therapeutics Inc. (NASDAQ: GPCR), a clinical-stage global biopharmaceutical company developing novel oral small molecule therapeutics for metabolic diseases, with a focus on obesity, today announced the commencement of a proposed underwritten public offering, subject to market and other conditions, to issue and sell $500 million of American depositary shares (ADSs), each...Read more
Placebo-adjusted mean weight loss of 11.3% (27.3 lbs) with 120 mg dose in the 36-week Phase 2b ACCESS study with a 10.4% adverse event-related treatment discontinuation Placebo-adjusted mean weight loss up to 15.3% (35.5 lbs) observed with 240 mg dose in the exploratory ACCESS II study at 36 weeks No adverse event-related treatment discontinuations observed when starting at lower 2.5 mg dose in ACCESS Open Label Extension and...Read more
64% MMR achievement by 24 weeks across all efficacy evaluable patients 75% MMR achievement by 24 weeks in efficacy evaluable patients at doses >320mg QD Encouraging safety/tolerability profile maintained with longer duration of treatment Company to host investor update call today at 4:30pm ET FOSTER CITY, Calif., Dec. 08, 2025 (GLOBE NEWSWIRE) -- Terns Pharmaceuticals, Inc. (Terns or the Company) (Nasdaq: TERN), a...Read more
WESTLAKE VILLAGE, Calif., Dec. 08, 2025 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced that Amit Munshi has been appointed to the Arcutis Board of Directors effective December 4, 2025, and announced the retirement of founder and long-serving Board member Bhaskar Chaudhuri, PhD. Dr. Chaudhuri...Read more
CAMBRIDGE, Mass., Dec. 08, 2025 (GLOBE NEWSWIRE) -- Wave Life Sciences Ltd. (Nasdaq: WVE), a clinical-stage biotechnology company focused on unlocking the broad potential of RNA medicines to transform human health (“Wave” or “Wave Life Sciences”), announced today that it has commenced an underwritten public offering of $250 million in aggregate of its ordinary shares, and, to certain investors that so choose in lieu of ordinary shares,...Read more
Following a single subcutaneous 240 mg dose, WVE-007 (INHBE GalNAc-siRNA) improved body composition at three months compared to baseline, with a 9.4% reduction in visceral fat (p=0.02), a 4.5% reduction in total body fat (3.5 lbs; p=0.07), and a 3.2% increase in lean mass (4.0 lbs; p=0.01), with no statistically significant changes in the placebo group Sustained and robust suppression of serum Activin E supports expectations for...Read more
Planned acquisition of brelovitug for chronic hepatitis delta virus (HDV) with Breakthrough Therapy and PRIME designations Anticipated to be highly synergistic with Mirum’s liver expertise and proven global commercial capabilities HDV: Large, high unmet-need rare liver disease with no FDA-approved therapies Top-line Phase 3 results expected in 2H 2026 Conference call today, December 8, 2025 at 8:30 am ET/5:30 am PT FOSTER CITY,...Read more
Ocular intends to submit AXPAXLI New Drug Application (NDA) for wet AMD shortly after year one data from SOL-1, if positive SOL-1 topline data remain on track for 1Q 2026 Ocular plans to leverage the 505(b)(2) regulatory pathway for new drug approvals which has the potential to shorten the review timeline for AXPAXLI If approved, AXPAXLI could be the first TKI to be commercialized in wet AMD, with a potential superiority label and...Read more
BRISBANE, Calif., Dec. 08, 2025 (GLOBE NEWSWIRE) -- Vera Therapeutics, Inc. (“Vera Therapeutics”), a late clinical-stage biotechnology company focused on developing and commercializing transformative treatments for patients with serious immunologic diseases, today announced its plans to commence a public offering, subject to market and other conditions, to issue and sell $200.0 million of shares of its Class A common stock. All of the...Read more
Registrational Expansion Cohort (REC) met primary endpoint, demonstrating statistically significant increase in dystrophin to 5.46% at 6 months (muscle content-adjusted; p<0.0001), replicating the same 7-fold change from baseline previously observed at the registrational dose Functional improvement was observed across multiple clinical endpoints at 6 months in REC; lung function was preserved at 6 months New positive...Read more
WALTHAM, Mass., Dec. 08, 2025 (GLOBE NEWSWIRE) -- Dyne Therapeutics, Inc. (Nasdaq: DYN), a clinical-stage company focused on delivering functional improvement for people living with genetically driven neuromuscular diseases, today announced that it has commenced an underwritten public offering of $300,000,000 of shares of its common stock. Dyne also intends to grant the underwriters a 30-day option to purchase up to an additional...Read more
REC-4881 (4 mg QD) achieved rapid clinical activity, with 75% of evaluable patients showing reductions in total polyp burden and a 43% median reduction after 12 weeks of treatment (n=12) After 12 weeks off therapy (week 25 of the study), 82% of evaluable patients (9 of 11) maintained a durable reduction in total polyp burden, with a 53% median reduction observed from baseline Natural history analysis showed that 87% of untreated FAP...Read more
Data presented at the 2025 American Epilepsy Society Annual Meeting PLYMOUTH MEETING, Pa. / Dec 08, 2025 / Business Wire / Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY), today announced the presentation of initial open-label extension (OLE) data from the company’s ongoing Phase 3 ARGUS trial investigating EPX-100 (clemizole hydrochloride) for the treatment of Dravet syndrome (DS), which showed clinically meaningful reductions in...Read more
ZL-1503, a promising treatment for moderate-to-severe atopic dermatitis and other Type 2 helper T-cell (Th2)-driven diseases, strengthens Zai Lab’s growing global pipeline ZL-1503 originated from Zai Lab’s in-house discovery and development engine SHANGHAI & CAMBRIDGE, Mass. / Dec 08, 2025 / Business Wire / Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced the dosing of the first participant in a global Phase 1/1b...Read more
Objective response rate (ORR) of 75.0% including three very good partial responses (VGPR) in heavily pre-treated Waldenström macroglobulinemia patients With a median follow up of 8.1 months, median duration of response (DOR) and median progression-free survival (PFS) have not been reached Encouraging efficacy and favorable tolerability support continued development of bexobrutideg in Waldenström macroglobulinemia Nurix will host a...Read more
First real-world evidence for a menin inhibitor shows 77% ORR (10/13), 31% (4/13) CR/CRh, 75% (9/12) MRD negativity, and favorable tolerability among primarily R/R NPM1m, KMT2Ar, and NUP98r acute leukemia pts Retrospective review shows revumenib was well tolerated as post-HSCT maintenance in children with KMT2Ar and NUP98r; all pts were alive and 90% (9/10) were relapse free at median follow-up of 19 months Ph 2 SAVE...Read more
CAMBRIDGE, Mass., Dec. 08, 2025 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a commercial-stage biopharmaceutical company focused on delivering innovative medicines for patients with rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has not yet issued a regulatory decision on the supplemental New Drug Application (sNDA) for mitapivat for the treatment of adult patients with...Read more
| Company | Change | Last Trade |
|---|---|---|
| Regeneron Pharmaceuticals | 33.63 4.86 | $726.21 |
| United Therapeutics | 8.50 1.78 | $484.86 |
| Vertex Pharmaceuticals | 7.63 1.75 | $444.64 |
| Bright Minds Biosciences | 6.99 9.03 | $84.39 |
| Bolt Biotherapeutics | 5.24 935.71 | $5.80 |
| Krystal Biotech | 5.08 2.17 | $239.72 |
| Ascendis Pharma | 4.54 2.31 | $201.24 |
| Abivax | 4.48 3.64 | $127.52 |
| Enveric Biosciences | 4.34 73.31 | $10.26 |
| Olema Oncology | 4.10 15.43 | $30.68 |
| Rhythm Pharmaceuticals | 4.06 4.03 | $104.77 |
| Axsome Therapeutics | 4.04 2.78 | $149.26 |
| Stoke Therapeutics | 3.68 12.08 | $34.15 |
| Praxis Precision Medicines | 3.63 1.41 | $261.58 |
| Kymera Therapeutics | 3.01 3.46 | $89.89 |
ClearPoint Neuro is a global therapy-enabling platform company providing stereotactic navigation and delivery to the brain. Applications of our ClearPoint Neuro Navigation System include electrode lead placement, placement of catheters, and biopsy. The platform has FDA clearance and is...
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Cue Biopharma is developing the first-ever class of therapeutics for the treatment of cancer that mimic the natural signals, or “Cues”, of the immune system. This novel class of injectable biologics selectively engages and modulates tumor-specific T cells directly within the patient’s body to transform...
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