Pittsburgh, Pennsylvania and Toronto, Ontario--(Newsfile Corp. - December 19, 2025) - Sharp Therapeutics Corp. (TSXV: SHRX) (OTCQB: SHRXF) ("Sharp" or the "Company"), is pleased to announce that the non-brokered private placement to raise gross proceeds of not less than US$10,000,000 (the "Offering") previously announced on October 14, 2025 has been updated. The placement will consist of common shares in the capital of the Company priced at not less than US$2.50 per share.... Read more
MYQORZO, a Cardiac Myosin Inhibitor, Directly Addresses Underlying Hypercontractility Associated with Obstructive HCM
FDA Approval Based on Results of SEQUOIA-HCM
MYQORZO is Company’s First FDA-Approved Medicine
Company to Host Investor Conference Call Today at 4:30 PM Eastern Time SOUTH SAN FRANCISCO, Calif., Dec. 19, 2025 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that the U.S. Food and Drug Administration (FDA) has approved... Read more
Reducing inflammation helps create a regenerative environment in the Central Nervous System TORONTO and HAIFA, Israel, Dec. 19, 2025 (GLOBE NEWSWIRE) -- NurExone Biologic Inc. (TSXV: NRX) (OTCQB: NRXBF) (FSE: J90) (“NurExone” or the “Company”) today announced new laboratory data demonstrating that its proprietary exosomes can significantly reduce inflammatory activity compared to untreated cells and cells treated with a commercially available exosome produ... Read more
New Patent Expands IGC Pharma's Pharmaceutical Cannabinoid Portfolio Beyond Alzheimer's Disease POTOMAC, MD / ACCESS Newswire / December 19, 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 that the United States Patent and Trademark Office (USPTO) has officially issued U.S. Patent No. 12,491,200,... Read more
IRVING, Texas, Dec. 19, 2025 /PRNewswire/ -- Caris Life Sciences® (NASDAQ: CAI), a leading, patient-centric, next-generation AI TechBio company and precision medicine pioneer, today announced that Providence Swedish Cancer Institute and the institute's focused translational research extension, the Paul G. Allen Research Center, have joined the Caris Precision Oncology Alliance™ (Caris POA).
The Providence Swedish Cancer Institute, located in Seattle, Washington,... Read more
FOSTER CITY, Calif. / Dec 19, 2025 / Business Wire / Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM), a leading rare disease company, today announced that it has entered into a subscription agreement with entities associated with TCGX, an institutional investor, for a private placement of 1,000,000 shares of its common stock (the “Common Stock”). The Common Stock issued to the private placement investors at closing will be priced at $68.48 per share for approximately $68.5... Read more
The PL-16 Viral Blocker has shown over 90% success in protection of cells against viruses Raanana, Israel, Dec. 19, 2025 (GLOBE NEWSWIRE) -- Polyrizon Ltd., a pre-clinical-stage biotechnology company developing intranasal protective solutions, announced today that it has submitted a Pre-Request for Designation (Pre-RFD) to the U.S. Food and Drug Administration (FDA) for its PL-16 Viral Blocker, a non-pharmacological intranasal product designed to reduce exposure to... Read more
ISELIN, N.J., Dec. 19, 2025 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on enhancing the standard of care for bevacizumab for the treatment of retina diseases, today announced financial results for fiscal year 2025.
Financial Highlights for the Fiscal Year Ended September 30, 2025
For the fiscal year ended September 30, 2025, Outlook Therapeutics reported net loss attributable to common stockholders of $62.4 million,... Read more
CAMBRIDGE, Mass., Dec. 19, 2025 (GLOBE NEWSWIRE) -- Spero Therapeutics, Inc. (Nasdaq: SPRO), a clinical-stage biopharmaceutical company focused on identifying and developing novel treatments for rare diseases and multi-drug resistant (MDR) bacterial infections, today announced that its development partner, GSK, filed a New Drug Application (NDA) resubmission to the U.S. Food and Drug Administration (FDA) for tebipenem HBr, an investigational oral carbapenem antibiotic... Read more
NORCROSS, Ga., Dec. 19, 2025 (GLOBE NEWSWIRE) -- Galectin Therapeutics Inc. (NASDAQ:GALT), the leading developer of galectin-3-targeted therapeutics for patients with MASH cirrhosis and portal hypertension, today announced that the U.S. Food and Drug Administration (FDA) has provided a written response, and subsequent communications, to the Company’s previously submitted Type C meeting request regarding the development program for belapectin, its investigational... Read more
BioMarin to Gain Galafold® (migalastat) for Fabry Disease and Pombiliti® (cipaglucosidase alfa-atga) + Opfolda® (miglustat) for Pompe Disease, Adding Two Marketed, High-Growth Products with $599 Million in Revenue Over Past Four Quarters
Provides Opportunity to Expand Access to Galafold and Pombiliti + Opfolda to Patients in New Markets Across BioMarin's Global Footprint; Pending U.S. Galafold Patent Litigation Resolved
Will Accelerate Revenue Growth Immediately... Read more
With approximately $9.5 million in cash reserves and no debt, the Company is ready to leverage strengthened vertical integration as clinical-grade psilocybin moves into Phase IIb trials NEW YORK, Dec. 19, 2025 (GLOBE NEWSWIRE) -- Psyence Biomedical Ltd. (Nasdaq: PBM) (“Psyence BioMed” or the “Company”), a biopharmaceutical company advancing nature-derived psilocybin and ibogaine therapies for unmet mental health needs, today announced that the Bellberry Human Research... Read more
Improvements observed in key non-invasive markers of fibrosis across treatment arms versus placebo, with continued reductions from 24-week timepoint
Additional weight loss from 24 to 48 weeks with 1.8 mg dose, without plateauing
Favorable tolerability profile of pemvidutide preserved at 48 weeks, reinforced by low treatment-related discontinuation rate
End-of-Phase 2 meeting with FDA supports advancing to registrational Phase 3 trial in MASH patients with moderate... Read more
PALO ALTO, Calif., Dec. 18, 2025 /PRNewswire/ -- Kodiak Sciences Inc. (Nasdaq: KOD), a precommercial retina focused biotechnology company committed to researching, developing and commercializing transformative therapeutics, today announced the closing of its previously announced underwritten public offering of 8,000,000 shares of its common stock, which includes 1,043,478 shares sold pursuant to the underwriters' exercise in full of their option to purchase additional shares,... Read more
Enrollment will begin in January 2026
Participants will be treated with buntanetap for 36 months
The study aims to enroll 500 patients MALVERN, Pa., Dec. 18, 2025 (GLOBE NEWSWIRE) -- Annovis Bio, Inc. (NYSE: ANVS) (“Annovis” or the “Company”), a late-stage clinical drug platform company pioneering transformative therapies for neurodegenerative diseases such as Alzheimer's disease (AD) and Parkinson's disease (PD), today announced it will begin an Open-Label... Read more
Event to be held January 6th, 2026, at 10 a.m. EST BETHESDA, Md., Dec. 18, 2025 (GLOBE NEWSWIRE) -- Gain Therapeutics, Inc. (Nasdaq: GANX) (“Gain”, or the “Company”), a clinical-stage biotechnology company leading the discovery and development of the next generation of allosteric small molecule therapies, today announced that it will host a virtual key opinion leader (KOL) event, “Understanding GCase Substrates in Parkinson’s Disease: Perspectives... Read more
Trial to assess cadisegliatin as potential adjunctive therapy to insulin in patients with T2D HIGH POINT, N.C., Dec. 18, 2025 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (Nasdaq: VTVT), a late-stage biopharmaceutical company, today announced a Phase 2 clinical study protocol developed in collaboration with M42’s Insights Research Organization & Solutions (IROS), a leading United Arab Emirates (UAE)-based contract research organization, has been submitted to the... Read more
SAN DIEGO / Dec 18, 2025 / Business Wire / Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced that it will present at the 44th Annual J.P. Morgan Healthcare Conference in San Francisco, CA. Catherine Owen Adams, Chief Executive Officer will represent the company in a session scheduled on Tuesday, January 13, 2026, at 9:45 a.m. Pacific Time / 12:45 p.m. Eastern Time.
A live webcast of Acadia’s presentation will be accessible on the company’s website, acadia.com,... Read more
CAMBRIDGE, Mass., Dec. 18, 2025 (GLOBE NEWSWIRE) -- Beam Therapeutics Inc. (Nasdaq: BEAM), a biotechnology company developing precision genetic medicines through base editing, today announced that John Evans, chief executive officer of Beam, will present at the 44th Annual J.P. Morgan Healthcare Conference on Tuesday, January 13, 2026, at 5:15 p.m. PT in San Francisco.
The live webcast will be available in the investor section of the company's website at www.beamtx.com... Read more
The overview presentation will review some of the Company’s recent achievements as well as the outlook for upcoming data milestones JERUSALEM, Dec. 18, 2025 (GLOBE NEWSWIRE) -- Alpha Tau Medical Ltd. ("Alpha Tau", or the “Company”) (NASDAQ: DRTS, DRTSW), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT®, today announced that CEO Uzi Sofer and CFO Raphi Levy will present a corporate overview and update at the J.P. Morgan 2026 Healthcare... Read more
MINNEAPOLIS / Dec 18, 2025 / Business Wire / DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company developing novel treatments for preeclampsia (PE), fetal growth restriction (FGR) and acute ischemic stroke (AIS), today announced completion of a productive in-person pre-IND meeting with the United States Food and Drug Administration (FDA) for a planned study evaluating DM199 in preeclampsia. Minutes from the meeting affirmed the FDA’s request... Read more
CHICAGO and FORT WORTH, Texas, Dec. 18, 2025 (GLOBE NEWSWIRE) -- Actuate Therapeutics, Inc. (NASDAQ: ACTU) (“Actuate” or the “Company”), a clinical-stage biopharmaceutical company focused on developing therapies for the treatment of high-impact, difficult-to-treat cancers through the inhibition of glycogen synthase kinase-3β (GSK-3β), today announced that data from its Phase 2 study evaluating elraglusib in metastatic pancreatic cancer have been selected for an... Read more
Pulmatrix continues to support Cullgen in seeking approval for their merger from the China Securities Regulatory Commission FRAMINGHAM, Mass., Dec. 18, 2025 /PRNewswire/ -- Pulmatrix, Inc. ("Pulmatrix" or the "Company") (Nasdaq: PULM), a biopharmaceutical company that has focused on the development of novel inhaled therapeutic products intended to prevent and treat migraine and respiratory diseases with important unmet medical needs using its patented iSPERSE™... Read more
STAAR study demonstrated positive mean annualized estimated glomerular filtration rate (eGFR) slope at 52-weeks across all dosed patients in the study, which U.S. Food and Drug Administration (FDA) has agreed will serve as an endpoint to support accelerated approval pathway
Isaralgagene civaparvovec continues to show favorable safety and tolerability profile
Sangamo expects to complete Biological License Application (BLA) submission under accelerated approval... Read more
Subject enrollment expected to begin in Q1 2026
CDI-988 is the first oral broad-spectrum antiviral drug candidate for potential prevention of norovirus outbreaks and treatment of acute viral gastroenteritis caused by norovirus infection
There are no approved treatments or vaccines currently available for norovirus infection BOTHELL, Wash., Dec. 18, 2025 (GLOBE NEWSWIRE) -- Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) announces the... Read more
WILMINGTON, Del. / Dec 18, 2025 / Business Wire / Incyte (Nasdaq:INCY) announced today that it will present at the 44th Annual J. P. Morgan Healthcare Conference on Monday, January 12, 2026 at 8:15 am (PST).
The presentation will be webcast live and can be accessed at Investor.Incyte.com and will be available for replay for 30 days.
About Incyte
A global biopharmaceutical company on a mission to Solve On., Incyte follows the science to find solutions for patients with... Read more
The LOI Aligns with Federal Priorities on Fentanyl Crisis, Artificial Intelligence, and Quantum Technology ORLANDO, Fla., Dec. 18, 2025 (GLOBE NEWSWIRE) -- Nutriband Inc. (NASDAQ: NTRB) (NASDAQ: NTRBW) ("Nutriband" or the "Company"), a developer of transdermal pharmaceutical products including abuse-deterrent technologies, today announced the signing of a non-binding Letter of Intent ("LOI") with the Qvanta Group of Companies.
The Qvanta Group comprises Qvanta LLC... Read more
BALA CYNWYD, Pa., Dec. 18, 2025 (GLOBE NEWSWIRE) -- Larimar Therapeutics, Inc. (Larimar) (Nasdaq: LRMR), a clinical-stage biotechnology company focused on developing treatments for complex rare diseases, today announced that members of the company’s management team will present and participate in 1x1 investor meetings at the 44th Annual J.P. Morgan Healthcare Conference, taking place in San Francisco, CA from January 12 – 15, 2026.
Details on the... Read more
WOBURN, Mass., Dec. 18, 2025 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (Nasdaq: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced that members of the Replimune management team will present at the 44th Annual J.P. Morgan Healthcare Conference on Wednesday, January 14, 2025 at 1:30 PM PT.
A simultaneous webcast will be available in the Investors section of Replimune’s website at replimune.com. A... Read more
DefenCath® demonstrated a 72% reduction in CRBSI and 70% reduction in hospitalizations secondary to CRBSI BERKELEY HEIGHTS, N.J., Dec. 18, 2025 (GLOBE NEWSWIRE) -- CorMedix Therapeutics (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases and conditions, today announced interim results for the Company’s ongoing real-world evidence study being conducted in conjunction with U.S. Renal... Read more
OV350 showed a good safety profile, supporting the advancement of the Company’s KCC2 portfolio, including the first oral direct activator, OV4071
There were no treatment-related laboratory findings, no safety findings, and no treatment-related serious adverse events (SAEs)
Exploratory quantitative electrophysiology results suggest OV350 had central activity and spectral power consistent with expected physiological effects of KCC2 modulation; aligned with expected... Read more
REDWOOD CITY, Calif., Dec. 18, 2025 (GLOBE NEWSWIRE) -- Revolution Medicines, a late-stage clinical oncology company developing targeted therapies for patients with RAS-addicted cancers, today announced the first patient has been randomized in the RASolute 304 trial. RASolute 304 is a global, open-label, Phase 3 clinical trial evaluating the safety and efficacy of daraxonrasib, a RAS(ON) multi-selective inhibitor, in patients with resectable pancreatic ductal adenocarcinoma... Read more
Study results support advancing SGX945 in this difficult-to-treat orphan disease
Results suggest potential durability of response for maintenance therapy PRINCETON, N.J., Dec. 18, 2025 /PRNewswire/ -- Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that the results from its Phase 2a proof... Read more
No treatment-related adverse toxicity was observed across completed GLP studies, with consistent systemic exposure following oral administration. MIAMI, FL / ACCESS Newswire / December 18, 2025 / Telomir Pharmaceuticals, Inc. (NASDAQ:TELO) ("Telomir" or the "Company"), a preclinical-stage biotechnology company developing therapies that target epigenetic and metabolic drivers of cancer and age-related disease, today announced favorable results from a comprehensive series... Read more
NEW YORK, Dec. 18, 2025 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company focused on developing innovative treatments for Alzheimer's disease, Parkinson's disease, schizophrenia, neurodevelopmental, neurodegenerative, and rare diseases, including Rett syndrome, and other central nervous system (CNS) disorders, today announced that it has requested the European Medicines Agency (“EMA”)... Read more
Large, well-powered Phase 1b study, designed to generate clinically and biologically meaningful insights in early Alzheimer’s disease
Clear and near-term value inflection points, with blinded 6-month interim data expected in Q2 2026 and final unblinded top-line results anticipated in Q4 2026 Cambridge, Massachusetts, Dec. 18, 2025 (GLOBE NEWSWIRE) -- ProMIS Neurosciences Inc. (Nasdaq: PMN), a clinical-stage biotechnology company focused on the generation and development... Read more
ROCKVILLE, Md., Dec. 18, 2025 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced it will present at the 44th Annual J.P. Morgan Healthcare Conference.
Presentation DetailsDate and Time: Wednesday, January 14, 2026 at 10:30 a.m. PT Location: Westin St. Francis, San Francisco, CA
A live webcast of the presentation can be accessed in the Investors section of REGENXBIO's website at www.regenxbio.com. An archived replay of the webcast will be available... Read more
Phase 3 Development Program of Novel Selective Estrogen Receptor Modulator (SERM) Represents Potential Multi-Billion Dollar Opportunity as Treatment Option for Patients with ESR1-Mutations
Financing Co-Led by Commodore Capital, Perceptive Advisors and TCGX Supports Development of Lasofoxifene through Phase 3 Clinical Topline Data Readout and Regulatory Milestones
Conference Call Today at 8:30 am Eastern Time BOTHELL, Wash., Dec. 18, 2025 (GLOBE NEWSWIRE) -- Athira... Read more
RYBREVANT FASPRO™ is approved across all indications of RYBREVANT® (amivantamab-vmjw) SAN DIEGO, Dec. 18, 2025 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) (Halozyme) today announced that Johnson & Johnson has received approval from the U.S. Food and Drug Administration (FDA) for RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj), which is co-formulated with ENHANZE® for patients with epidermal growth factor receptor (EGFR)-mutated locally... Read more
NEW YORK / Dec 18, 2025 / Business Wire / Mind Medicine (MindMed) Inc. (NASDAQ: MNMD) (the “Company” or “MindMed”), a late-stage clinical biopharmaceutical company developing novel product candidates to treat brain health disorders, today announced that Rob Barrow, Chief Executive Officer, will present at the 44th Annual J.P. Morgan Healthcare Conference in San Francisco on Wednesday, January 14, 2026 at 2:15 p.m. PT.
“It is a privilege to participate in the J.P.... Read more
46% confirmed objective response rate (ORR) and 92% disease control rate (DCR) observed with MICVO as monotherapy in 2L+ R/M HNSCC at 5.4 mg/kg 71% confirmed ORR and 100% DCR observed with MICVO in combination with KEYTRUDA® (pembrolizumab) in 1L/2L+ R/M HNSCC at 3.6 mg/kg and 4.4 mg/kgUpdated data from ongoing Phase 1 monotherapy study in 2L+ R/M HNSCC expected mid-2026; updated data from ongoing Phase 1/2 study evaluating MICVO in combination with KEYTRUDA®, including... Read more
Collaboration to leverage CAMP4’s RAP Platform® to accelerate development of novel antisense oligonucleotides (ASOs) for neurodegenerative and renal diseases
CAMP4 to receive $17.5 million upfront and eligible for additional milestone-based payments, in addition to tiered royalties CAMBRIDGE, Mass., Dec. 18, 2025 (GLOBE NEWSWIRE) -- CAMP4 Therapeutics Corporation (“CAMP4” or “the Company”) (Nasdaq: CAMP), a clinical-stage biopharmaceutical company... Read more
Results showed CNS target engagement with reduction in GCase substrate glucosylsphingosine (GluSph) in cerebrospinal fluid (CSF), a prespecified endpoint
The reduction in GluSph in CSF, a first-ever observation following the administration of a GCase modulator to PD patients, suggests increased GCase activity in the brain, which is expected to impact the progression of Parkinson’s disease (PD)
KOL event planned for early January to discuss the results; registration... Read more
The combination of denifanstat and resmetirom was generally well-tolerated
Pharmacokinetic (PK) results support further development of the combination
A Phase 2 trial of a denifanstat/resmetirom combination in F4 MASH patients is planned to initiate in 2H 2026 SAN MATEO, Calif., Dec. 18, 2025 (GLOBE NEWSWIRE) -- Sagimet Biosciences Inc. (Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing novel therapeutics targeting dysfunctional metabolic and fibrotic... Read more
BOSTON and SAN DIEGO, Dec. 18, 2025 (GLOBE NEWSWIRE) -- Rapport Therapeutics, Inc. (Nasdaq: RAPP) (“Rapport” or the “Company”), a clinical-stage biotechnology company dedicated to the discovery and development of small molecule precision medicines for patients with neurological and psychiatric disorders, today announced that management plans to present at the 44th Annual J.P. Morgan Healthcare Conference on Wednesday, January 14, 2026, at 11:15 a.m. PST / 2:15 p.m.... Read more
LA JOLLA, Calif., Dec. 18, 2025 (GLOBE NEWSWIRE) -- MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the Standard Market of the Tokyo Stock Exchange (Code Number: 4875), today announced the successful completion of patient enrollment in the randomized, placebo-controlled Phase 2 clinical trial, the OXTOX study (Oxaliplatin Neurotoxicity study in patients with metastatic colorectal cancer). This study, an investigator-initiated... Read more
BioNTech has completed its exchange offer to acquire CureVac
Acquisition complements BioNTech’s capabilities and proprietary technologies in mRNA design, delivery formulations, and mRNA manufacturing
In total, approximately 86.75% of CureVac shares were tendered; BioNTech expects to complete the compulsory acquisition of the remaining CureVac shares in January 2026 as part of the previously announced post-offer reorganization
CureVac will continue to operate under... Read more
BOSTON, Dec. 18, 2025 (GLOBE NEWSWIRE) -- Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of therapeutic biologics to selectively engage and modulate disease-specific T cells for the treatment of autoimmune disease, today announced that it is commencing an underwritten public offering of shares of its common stock (or pre-funded warrants to purchase common stock in lieu thereof) and accompanying warrants to purchase... Read more
December 18, 2025 - Biodexa Pharmaceuticals PLC, (Nasdaq: BDRX) (“Biodexa” or the “Company”), a clinical stage biopharmaceutical company developing a pipeline of innovative products for the treatment of diseases with unmet medical needs, today announced the pricing of a best efforts public offering of an aggregate of (i) 157,000 units (the “ADS Units”), with each unit consisting of (A) one American depositary share (representing 100,000 of the Company’s ordinary... Read more
WINNIPEG, Manitoba, Dec. 18, 2025 (GLOBE NEWSWIRE) -- Kane Biotech Inc. (TSX-V:KNE) (the “Company”, “Kane” or “Kane Biotech”) announces that today it has completed its previously announced non-brokered private placement offering (the “Offering”) of common shares of the Company (“Shares”). At the closing of the Offering, Kane issued 14,000,000 Shares at a price of $0.05 per Share for gross proceeds of $700,000 to an insider of the Company.
The net proceeds... Read more
