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
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 announced new data from two presentations... 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 inflammation (“I&I”)... 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 PD-1 inhibitor-resistant... 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 closing one of medicine’s... 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 related discontinuations in Phase... 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 immune checkpoint inhibitors (ICI),... 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 generation and development of antibody... 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 regulatory milestone for... 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 moderate to severe acne. Sagimet... 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 tissue repair, today announced... 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 (a.k.a., the “Flu”).
H3N2,... 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 investigational new drug (IND) application... 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 will host a 60-minute webinar... 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 conditional approval for Canalevia-CA1... 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 & Cardiovascular Disease (WCIRDC 2025)... 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 share, and to certain... 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, Medicenna will present updated... 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) -- Praxis Precision Medicines, Inc.... 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 disease.
This milestone marks a significant... 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 (GLOBE NEWSWIRE) -- Alpha Tau Medical... 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 Phase 1 Multiple Dose (MD) study... 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 (OS) is 1.4 years1 TAMPA,... 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 of subjects for the first... 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 trial of PF614, its lead product... 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 ADAPTIR™ and ADAPTIR-FLEX™ platform... 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 Annual Meeting (ASH).
The AML triplet... 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, Pharmacological Research and Evaluation through... 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 States Patent and Trademark Office... 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 designed to enhance the number and... 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 study
Initiation of EMBARQ-ColdU... 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 announced that it has received... 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, today announced that the Japan... 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 York, New York--(Newsfile Corp. -... 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 Therapeutics Corp. (Nasdaq: BCTX, BCTXW)... 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 company, today announced the planned... 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 mechanism of action for selectively... 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 the treatment of cancer and autoimmune... 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 “Company”), a clinical-stage... 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 levels
Data highlight the potential... 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 Orphan Drug Designation, is supported... 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 of life science tools, reagents,... 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 underwriters a 30-day option to... 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 an additional $30 million of shares... 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 single healthcare-focused investor... 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 specific cancer cell v... Read more
