New interim results from the EpiCom trial, a prospective evaluation of behavioral outcomes in patients with tuberous sclerosis complex, suggest improvements in non-seizure outcomes
Eight abstracts, including four late-breaking abstracts, underscore Jazz's continued commitment to the epilepsy community and advancing the comprehensive treatment for rare forms of epilepsy DUBLIN, Dec. 5, 2025 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced... Read more
AMX0114 was generally well-tolerated, with no treatment-related serious adverse events
Amylyx will proceed with opening enrollment of second cohort
Data are being presented at the 36th International Symposium on ALS/MND CAMBRIDGE, Mass. / Dec 05, 2025 / Business Wire / Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX) (“Amylyx” or the “Company”) today announced the presentation of early safety and tolerability data from its Phase 1 LUMINA trial of AMX0114 and results... Read more
Long-term Phase 1/2a and open label extension (OLE) data for zorevunersen on top of standard of care anti-seizure medicines (ASMs) demonstrate durable seizure reductions, including increases in seizure-free days, in addition to improvements in cognition, behavior and quality of life
Propensity score weighted analysis comparing the effects of zorevunersen to natural history showed reductions in seizures and improvements in cognition and behavior with dose levels and timepoints... Read more
Monthly reductions in seizure frequency of 90.9% among participants treated for ≥48 months in the OLE, with 38% achieving ≥1 year of seizure freedom
New X-TOLE OLE data analysis supports the ability to attain and regain extended periods of seizure freedom with long-term use of azetukalner, even in patients with difficult-to-treat disease
Four real-world study posters illustrate significant burden of depression and ASM titration on people living with epilepsy; poster... Read more
EMERYVILLE, Calif., Dec. 05, 2025 (GLOBE NEWSWIRE) -- XOMA Royalty Corporation (“XOMA Royalty”) (Nasdaq: XOMA), the biotech royalty aggregator, today announced it has successfully completed its previously announced acquisition of the entire issued and to be issued share capital of Mural Oncology plc (“Mural”) (Nasdaq: MURA) (the “Acquisition”) pursuant to an Irish High Court sanctioned scheme of arrangement under Chapter 1 of Part 9 of the Companies Act 2014... Read more
Post-hoc analysis of RAP-219 Phase 2a data showed early onset of action and consistency of median response over the entire treatment period, along with consistent efficacy data regardless of patients’ disease severity
RAP-219 demonstrated meaningful improvements in patient-reported seizure severity among those with moderate or greater baseline impairment BOSTON and SAN DIEGO, Dec. 05, 2025 (GLOBE NEWSWIRE) -- Rapport Therapeutics, Inc. (Nasdaq: RAPP) (Rapport... Read more
BOSTON, Dec. 5, 2025 /PRNewswire/ -- Ginkgo Bioworks (NYSE: DNA) today announced it has been awarded by the Environmental Molecular Sciences Laboratory (EMSL) at Pacific Northwest National Laboratory (PNNL) a four-year, up to $47M contract to co-design, build, and integrate a High‑Throughput Automated Phenotyping Platform (HTP‑APP) in support of the Microbial Molecular Phenotyping Capability (M2PC). The platform, selected through a competitive procurement process,... Read more
Cretostimogene demonstrated HG-EFS at 3- 6- and 9-months of 95.7%, 84.6% and 80.4%, respectively, in HR BCG UR Ta/T1 Disease in BOND-003 Cohort P
CORE-008 Cohort A Data in HR BCG-Naïve NMIBC demonstrates 88% CR and favorable safety with optimized administration
Robust clinical pipeline that spans multiple late-stage studies across intermediate- and high-risk NMIBC IRVINE, Calif., Dec. 05, 2025 (GLOBE NEWSWIRE) -- CG Oncology, Inc. (NASDAQ: CGON), a late-stage clinical... Read more
THE WOODLANDS, Texas, Dec. 05, 2025 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) announced clinical data on adipose tissue distribution in non-diabetic patients treated with sotagliflozin will be presented at the 22nd Global Cardio Vascular Clinical Trialists Forum (CVCT 2025). The conference is being held December 8-10, 2025, at the Mayflower Hotel in Washington, D.C.
This data is from SOTA-P-CARDIA, a prospective, randomized, double-blind, placeb... Read more
U.S. FDA grants waiver of application fee for BLA Filing of OST-HER2
Scheduled pre-Marketing Authorisation Application meeting with United Kingdom's Medicines and Healthcare products Regulatory Agency on December 8, 2025
Scheduled Type C Meeting with United States Food & Drug Administration on December 11, 2025 New York, New York--(Newsfile Corp. - December 5, 2025) - OS Therapies Inc. (NYSE American: OSTX) ("OS Therapies" or "the Company"), the world leader... Read more
Boca Raton, FL, Dec. 05, 2025 (GLOBE NEWSWIRE) -- INmune Bio, Inc. (NASDAQ: INMB) (“INmune” or the “Company”), a clinical-stage inflammation and immunology company, announces a recently published overview of future applications and research areas for mesenchymal stromal cell (MSC) therapies, such as INmune’s CORDStrom™ platform. The article, titled, “Fate and Function of Exogenously Administered MSCs: Current Insights and Future Directions,” was published... Read more
Durable Glycemic and C-Peptide Improvements with Icovamenib in Insulin-Deficient Type 2 Diabetes SAN CARLOS, Calif., Dec. 05, 2025 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea” or “Biomea Fusion” or “the Company”) (Nasdaq: BMEA), a clinical-stage diabetes and obesity company, today announced that it presented COVALENT-111 study results at the 23rd WCIRDC which took place December 3-6, 2025 in Los Angeles, California. The data showed durable glycemic... Read more
Houston, Texas and Tuebingen, Germany, December 05, 2025 – Immatics N.V. (NASDAQ: IMTX, “Immatics” or the “Company”), a clinical-stage biopharmaceutical company and the global leader in precision targeting of PRAME, announced today that it has agreed to sell 12,500,000 ordinary shares at $10.00 per share in an underwritten offering. The gross proceeds from the offering, before deducting the underwriting discount and offering expenses, are expected to be $125... Read more
Systemic activity of 35% ORR in 2L+ patients, including in patients with active brain metastases
Manageable safety profile with low discontinuation rate
Enrollment completed; no further development planned in this patient population
Company to host a conference call and webcast on Saturday, December 6, 2025, at 8:00 pm ET SOUTH SAN FRANCISCO, Calif. and SAN DIEGO, Dec. 05, 2025 (GLOBE NEWSWIRE) -- ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology... Read more
Highly differentiated 1L EGFR PACC preliminary systemic activity of 80% ORR and 100% intracranial ORR, including in patients with active brain metastases
36% ORR in median 3L EGFR PACC patients exceeds competitor benchmarks
Competitive safety profile, with no significant off-target toxicity and manageable on-target toxicity, resulting in low discontinuation rate
Enrollment and follow-up continue in 1L EGFR PACC patients at selected dose of 80 mg once daily, with next... Read more
ROCKVILLE, Md. and SUZHOU, China, Dec. 04, 2025 (GLOBE NEWSWIRE) -- Ascentage Pharma Group International (NASDAQ: AAPG; HKEX: 6855), a global, commercial stage, integrated biopharmaceutical company engaged in the discovery, development and commercialization of novel, differentiated therapies to address unmet medical needs in cancer, announced that it has received clearance from the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to conduct... Read more
Phase 2b trial showed significant improvements on primary and key secondary outcomes measures, most prominently in patients without AD co-pathology
Significant reduction in key neurodegeneration biomarker correlated with treatment response, suggesting neflamapimod may act on underlying disease
CervoMed preparing to initiate Phase 3 registrational trial in patients with DLB in the second half of 2026 BOSTON, Dec. 04, 2025 (GLOBE NEWSWIRE) -- Today in a late-breaking... Read more
WASHINGTON, Dec. 4, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Nasdaq: VNDA) today announced that the U.S. Food and Drug Administration (FDA) has lifted the partial clinical hold on protocol VP-VLY-686-3403, which until today limited the protocol to a maximum of 90 doses of tradipitant.
The lift followed Vanda's formal dispute resolution request and an expedited re-review conducted by CDER leadership under the collaborative framework established between Vanda and... Read more
NEW YORK, Dec. 04, 2025 (GLOBE NEWSWIRE) -- Protara Therapeutics, Inc. (Nasdaq: TARA) (“Protara”), a clinical-stage company developing transformative therapies for the treatment of cancer and rare diseases, today announced that it has commenced an underwritten public offering of $75 million in aggregate of shares of its common stock or, in lieu of issuing common stock to certain investors, pre-funded warrants to purchase shares of its common stock. All of the shares... Read more
Successful interim analysis triggered early stop for efficacy
Topline study results to be shared at the American Epilepsy Society Annual Meeting on December 6, 2025
Praxis confirms an upcoming meeting with the FDA to discuss the results and NDA path BOSTON, Dec. 04, 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... Read more
EMERYVILLE, Calif. / Dec 04, 2025 / Business Wire / OmniAb, Inc. (NASDAQ: OABI) today announced it will hold a virtual investor event to showcase the launch of OmniUltra™ on Monday, December 15, 2025, beginning at 5:00 p.m. Eastern time.
The event is expected to last approximately one hour and will include a review of OmniAb’s newest technology offering, OmniUltra, the industry's only transgenic chicken engineered to express ultralong CDRH3 domains on a human antibody... Read more
Praxis confirms plans to submit the essential tremor NDA for ulixacaltamide in early 2026 BOSTON, Dec. 04, 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 its pre-NDA (New Drug Application)... Read more
ARLINGTON, Mass., Dec. 04, 2025 (GLOBE NEWSWIRE) -- KALA BIO, Inc. (NASDAQ:KALA) (“KALA” or the “Company”), today announced that it has entered into definitive agreements for the purchase of an aggregate of 10,000,000 shares of its common stock (or pre-funded warrants in lieu thereof), at a purchase price of $1.00 per share (or pre-funded warrant in lieu thereof) in a registered direct offering priced at-the-market under Nasdaq rules. The closing of the offering... Read more
AGOURA HILLS, Calif., Dec. 04, 2025 (GLOBE NEWSWIRE) -- Oncotelic Therapeutics, Inc. (OTCQB: OTLC) 45% owned Joint Venture, Sapu Nano today announced new biomarker data identifying a molecular signature that predicts sensitivity to Sapu003, the company’s intravenous Deciparticle™ formulation of everolimus. These data will be presented at the 2025 San Antonio Breast Cancer Symposium (SABCS) Dec 9-12. This work describes the first prospective biomarker framework... Read more
Calgary, Alberta--(Newsfile Corp. - December 4, 2025) - Hemostemix Inc. (TSXV: HEM) (OTCQB: HMTXF) (FSE: 2VF0) ("Hemostemix" or the "Company"), a leader in autologous stem cell therapeutics for ischemic diseases, is pleased to announce the appointment of Shaune Harding, OStJ, RN non-practicing, as Director of Patient Care & Clinical Operations. In this senior clinical role, Ms. Harding will oversee: On-boarding of all new patients entering Hemostemix treatment p... Read more
BGE-102 was well-tolerated in SAD and initial MAD cohorts, with a pharmacokinetic profile supporting once-daily oral dosing
Strong target engagement: BGE-102 achieved 90-98% suppression of IL-1β, a cytokine directly downstream of NLRP3, at Day 14
High brain penetration: BGE-102 doses of 60 mg and higher exceeded target IC90 levels in cerebrospinal fluid (CSF) at Day 14
Company is expanding the Phase 1 trial to include MAD cohorts in participants with obesity and elevated... Read more
Pancreatic cancer multi-center clinical trial in U.S. is underway; patient recruitment expected to be completed by the end of Q1 2026 JERUSALEM, Dec. 04, 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®, announced today that two abstracts have been accepted to the 2026 American Society of Clinical Oncology (ASCO) Gastrointestinal... Read more
QUÉBEC, Dec. 4, 2025 /CNW/ - Devonian Health Group Inc. ("Devonian" or the "Corporation") (TSXV: GSD) (OTCQB: DVHGF), a biopharmaceutical corporation specializing in the development of prescription drugs targeting fibroinflammatory diseases, is pleased to announce the publication of a peer-reviewed article in Biomedicines titled "Thykamine™: A New Player in the Field of Anti-Inflammatory Drugs." The study presents notable evidence supporting the potent multi-target... Read more
SOUTH SAN FRANCISCO, Calif., Dec. 04, 2025 (GLOBE NEWSWIRE) -- Senti Biosciences, Inc. (Nasdaq: SNTI) (“Senti Bio”), a clinical-stage biotechnology company developing next-generation cell and gene therapies using its proprietary Gene Circuit platform, today announced it will host a conference call and webcast to discuss updated clinical results from SENTI-202 being presented at the ASH Annual Meeting on Tuesday, December 9, 2025 at 8:00 AM ET.
The call will be... Read more
Partnership expands access to LYMPHIR for patients with cutaneous T-cell lymphoma across Turkey, Bahrain, Qatar, Oman, Kuwait, Saudi Arabia, and the UAE
LYMPHIR international availability extends to 19 markets outside the U.S. CRANFORD, N.J., Dec. 4, 2025 /PRNewswire/ -- Citius Oncology, Inc. ("Citius Oncology") (Nasdaq: CTOR), the oncology-focused subsidiary of Citius Pharmaceuticals, Inc. ("Citius Pharma") (Nasdaq: CTXR), today announced that it has entered into... Read more
IRVING, Texas, Dec. 4, 2025 /PRNewswire/ -- Caris Life Sciences® (NASDAQ: CAI), a leading, patient-centric, next-generation AI TechBio company and precision medicine pioneer, today announced that the company and collaborators from leading cancer centers, including those within the Caris Precision Oncology Alliance ™ (Caris POA), will collectively present 19 studies across a range of breast cancer types at the San Antonio Breast Cancer Symposium (SABCS)... Read more
The new patent granted in South Korea is added to earlier patents already granted by the United States Patent and Trademark Office (USPTO), Europe, Canada and other jurisdictions and will expire in the U.S. in July 2042.
Aramchol is a first-in-class, Phase 3 ready, drug candidate, that showed robust fibrosis improvement in advanced clinical studies.
Aramchol's excellent safety and tolerability is a perfect drug candidate to be combined with other MASH drugs, approved... Read more
APONVIE, an aprepitant product, highlighted as the only FDA-approved IV formulation Neurokinin-1 (“NK-1”) antagonist indicated for the prevention of PONV in adults, with a long half-life and quicker onset than oral aprepitant
Aprepitant alone, or added to a multimodal regimen, recognized as significantly reducing the risk of PONV, and aprepitant monotherapies are noted as more effective compared to 5-HT3 receptor antagonists for postoperative vomiting prevention... Read more
Study to evaluate safety and efficacy of novel anti-PRLR antibody; interim data anticipated in the second half of 2026
Trial design leverages operational synergies to enable accelerated registrational trials for androgenetic alopecia (AGA) and Phase 2 for endometriosis
KOL seminar scheduled for December 11 to discuss new human ex vivo data, clinical trial design, and market opportunity in AGA VANCOUVER, Wash. and NEW YORK, Dec. 04, 2025 (GLOBE NEWSWIRE) -- Absci... Read more
Company positioned to pursue expedited regulatory pathways in metastatic, neoadjuvant, and risk-reduction settings SEATTLE, Dec. 4, 2025 /PRNewswire/ -- Atossa Therapeutics, Inc. (Nasdaq: ATOS) ("Atossa" or the "Company"), a clinical-stage biopharmaceutical company focused on transforming breast cancer treatment and prevention, announced the completion of a Type C meeting with the U.S. Food and Drug Administration ("FDA") on November 17, 2025, to review regulatory... Read more
An independent Data Safety Monitoring Board (DSMB) confirms EB103’s favorable safety profile with no treatment-related serious adverse events (SAEs) even in high-risk patients who are ineligible for currently available commercial CD19 products
DSMB recommends advancement of STARLIGHT-1 to Phase II at the Recommended Phase II Dose (RP2D)
High-dose cohort of Phase I achieved a 100% complete response (CR) rate at Month 1
Data supports EB103’s potential as a best-in-class... Read more
Management to meet with investors and potential partners during Biotech Showcase 2026 CAMBRIDGE, Mass. / Dec 04, 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 the company will present and participate in the Sachs Associates 9th Annual Neuroscience Innovation Forum... Read more
Nes-Ziona, Israel, Dec. 04, 2025 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, “Enlivex” or “the Company”), today announced that it will host a virtual fireside chat on Thursday, December 11, 2025 at 11:00 am ET.
Shai Novik, Executive Chairman of Enlivex, will provide an update on the Company’s plans following its recently closed $212,000,000 private placement. Mr. Novik will discuss the launch of Enlivex’s digital asset treasury strategy built... Read more
NEW YORK, Dec. 04, 2025 (GLOBE NEWSWIRE) -- Lexeo Therapeutics, Inc. (Nasdaq: LXEO), a clinical stage genetic medicine company dedicated to pioneering novel treatments for cardiovascular diseases, today announced plans to host a virtual event, “A Clinician’s Perspective: Holistic Approach to Managing PKP2-Associated Arrhythmogenic Cardiomyopathy,” at the 22nd Global Cardiovascular Clinical Trialists (CVCT) Forum on Tuesday, December 9th at 3 PM ET.
The session will... Read more
SHELTON, Conn., Dec. 4, 2025 /PRNewswire/ -- Intensity Therapeutics, Inc. (Nasdaq: INTS) ("Intensity" or "the Company"), a late-stage clinical biotechnology company focused on the discovery and development of proprietary cancer therapies using its non-covalent, drug-conjugation technology that creates drug products designed to kill tumors and increase immune system recognition of cancers, today announces two presentations at the upcoming 2025 San Antonio Breast Cancer Symposium... Read more
CAMBRIDGE, Mass., Dec. 4, 2025 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) ("NeuroSense"), a late-clinical stage biotechnology company developing novel treatments for severe neurodegenerative diseases, today announced that following a productive discussion with Health Canada ("Agency"), the Company is resuming its regulatory advancement in Canada for PrimeC in amyotrophic lateral sclerosis (ALS).
After outlining the remaining requirements,... Read more
Cohort 1 data from multiple dose ReSPECT- Leptomeningeal Metastases (LM) trial showed no dosage limiting toxicity
ReSPECT-Glioblastoma (GBM) trial of REYOBIQ as a novel therapeutic for recurrent GBM demonstrated promising safety and efficacy signal, supporting continued Phase 2 enrollment and investigation
MRI combined with SPECT imaging biomarkers effectively evaluate overall survival response with REYOBIQ in recurrent GBM treatment and help guide personalized patient... Read more
One complete response and three partial responses observed in heavily pretreated ICI-secondary refractory patients in high dose cohorts
Deep and durable ongoing responses with median time on treatment of 15 months
Company to accelerate development of PLN-101095 with initiation of a Phase 1b expansion trial in 2026
Strong cash position supports planned operations through 2028 SOUTH SAN FRANCISCO, Calif., Dec. 04, 2025 (GLOBE NEWSWIRE) -- Pliant Therapeutics,... Read more
NEW YORK and SOUTH SAN FRANCISCO, Calif., Dec. 04, 2025 (GLOBE NEWSWIRE) -- Royalty Pharma plc (Nasdaq: RPRX) and Denali Therapeutics, Inc. (Nasdaq: DNLI) today announced a $275 million synthetic royalty funding agreement based on future net sales of tividenofusp alfa.
Tividenofusp alfa is Denali’s lead investigational TransportVehicleTM-enabled enzyme replacement therapy for the treatment of mucopolysaccharidosis type II (MPS II, or Hunter syndrome). A Biologics License... Read more
LEXINGTON, Mass. and AMSTERDAM, Dec. 04, 2025 (GLOBE NEWSWIRE) -- uniQure N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, today announced that the company received final meeting minutes from the U.S. Food and Drug Administration (FDA) regarding a pre-Biologics License Application (BLA) meeting held on October 29, 2025 to discuss the application for AMT-130, an investigational gene therapy for... Read more
Vancouver, British Columbia--(Newsfile Corp. - December 4, 2025) - PreveCeutical Medical Inc. (CSE: PREV) (OTCID: PRVCF) (FSE: 18H0) (the "Company" or "PreveCeutical") is pleased to announce that the Australian Patent Office has granted Australian Patent No. AU2020212659, titled "A Cyclic Peptide", which relates to the Company's pain therapy program. This patent represents a significant milestone in the development and protection of PreveCeutical's proprietary... Read more
SOUTH SAN FRANCISCO, Calif. and NEW YORK, Dec. 04, 2025 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (Nasdaq: DNLI) and Royalty Pharma plc (Nasdaq: RPRX) today announced a $275 million synthetic royalty funding agreement based on future net sales of tividenofusp alfa.
Tividenofusp alfa is Denali’s lead investigational TransportVehicle™-enabled enzyme replacement therapy for the treatment of mucopolysaccharidosis type II (MPS II, or Hunter syndrome). A Biologics License... Read more
PRAGUE, Czech Republic and DURHAM, N.C., Dec. 04, 2025 (GLOBE NEWSWIRE) -- SCTbio, a leading European CDMO specializing in GMP manufacturing for cell-based products, and Fortrea, a leading global contract research organization (CRO), today announced a strategic collaboration agreement between the two companies. This partnership aims to streamline development, accelerate timelines and bring advanced therapies to patients faster.
This collaboration represents a forward-looking... Read more
Topline results from Phase 2 ZEPHYR trial of ML-007C-MA for schizophrenia expected in the second half of 2026
Topline results from Phase 2 VISTA trial of ML-007C-MA for Alzheimer’s disease psychosis expected in the second half of 2027
Raised $296.5 million in gross proceeds from initial public offering and concurrent private placement completed in October 2025
Cash, cash equivalents and short-term investments sufficient to fund operations through 2027 SAN FRANCISCO... Read more
New data showcase the versatility and anti-tumor activity of the CAPTN-3 platform and its unique multi-arm design in treatment-resistant cancers REHOVOT, Israel, Dec. 04, 2025 (GLOBE NEWSWIRE) -- Purple Biotech Ltd. (“Purple Biotech” or “the Company”) (NASDAQ/TASE: PPBT), a clinical-stage company developing first-in-class therapies that seek to overcome tumor immune evasion and drug resistance, today announced that it will present new preclinical data from... Read more
