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
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
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
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
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
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
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
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
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
Extends cash runway into first half of 2028, beyond planned completion of ViraxImmune™ US based regulatory study in post-acute sequelae of COVID-19 ("PASC", or long COVID) and submission to the FDA, completion of UK based regulatory study in post-acute infection syndrome (PAIS) and submission to MHRA along with expansion of our immune-profiling platform and partnerships. LONDON, Dec. 4, 2025 /PRNewswire/ -- Virax Biolabs Group Limited ("Virax" or the "Company")... Read more
SAN DIEGO, Dec. 04, 2025 (GLOBE NEWSWIRE) -- Capricor Therapeutics, Inc. (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics, today announced the commencement of a proposed underwritten public offering of shares of its common stock. In addition, Capricor intends to grant the underwriters a 30-day option to purchase an additional number of shares of common stock equal to 15% of the aggregate number of shares of its common... Read more
Ragistomig is a 4-1BB X PD-L1 bispecific antibody, designed to treat patients who are relapsed or refractory to checkpoint inhibitors, a multi-billion dollar drug class hampered by widespread resistance
The Phase 1 ragistomig study achieved its objective, as the new Q6W extended dosing interval produced strong anti-tumor efficacy in PD-L1-non-responders, with an improved safety profile
The interim results, including immunological data on CD8+ cell proliferation and... Read more
Robust and clinically meaningful benefits across all three key markers of disease – 68% reduction in proteinuria, stabilization of kidney function, and substantial clearance of C3 deposits
Consistent results across adolescent and adult patients with C3G and primary IC-MPGN, including patients with C3G recurring after transplant
EMPAVELI is the first FDA-approved treatment for C3G and primary IC-MPGN patients 12 and older WALTHAM, Mass., Dec. 03, 2025 (GLOBE NEWSWIRE)... Read more
Event to Review R&D Progress and Outline Exelixis’ Strategy for Building Next-generation Oncology Franchises
ALAMEDA, Calif. / Dec 03, 2025 / Business Wire / Exelixis, Inc. (Nasdaq: EXEL) today announced that it will webcast its virtual event, Exelixis 2025 R&D Day: Building Next-generation Oncology Franchises, on Wednesday, December 10, 2025, from 1:00 p.m. to 3:30 p.m. EST. During the event, featured speakers will review the progress of Exelixis’ R&D... Read more
WALTHAM, Mass., Dec. 03, 2025 (GLOBE NEWSWIRE) -- TScan Therapeutics, Inc. (Nasdaq: TCRX), a clinical-stage biotechnology company focused on the development of T cell receptor (TCR)-engineered T cell (TCR-T) therapies for the treatment of patients with cancer, today announced the Company will host a virtual key opinion leader (KOL) event to discuss updated data from the ALLOHA™ Phase 1 trial being presented at the 67th American Society of Hematology (ASH) Annual Meeting... Read more
Company to host a conference call and webcast on Saturday, December 6, 2025, at 8:00 pm ET SOUTH SAN FRANCISCO and SAN DIEGO, Dec. 03, 2025 (GLOBE NEWSWIRE) -- ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, today announced two late-breaking oral presentations highlighting data from a Phase 1b trial of enozertinib (ORIC-114) at the ESMO Asia Congress 2025... Read more
NEW YORK, Dec. 3, 2025 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ: HOTH), a patient-focused clinical-stage biopharmaceutical company, today issued a comprehensive update on its therapeutic pipeline. The Company detailed meaningful progress across HT-001, HT-KIT, HT-ALZ, and its newly launched GDNF-based metabolic program, while continuing to strengthen its global intellectual-property portfolio and expand strategic research partnerships.
Pipeline Highlights
HT-001... Read more
LONDON, Dec. 3, 2025 /PRNewswire/ -- Virax Biolabs Group Limited ("Virax" or the "Company") (Nasdaq: VRAX), an innovative biotechnology company dedicated to the advancement of immunology research and diagnostics, announced today that it has entered into definitive agreements for the purchase and sale of 12,500,000 ordinary shares (or ordinary share equivalents) and preferred investment options to purchase up to an aggregate of 12,500,000 ordinary shares at a purchase... Read more
Superior Mucoadhesion may potentially Translate into More Reliable Opioid Overdose Reversal in Real-World Emergencies Ra’anana, Israel, Dec. 03, 2025 (GLOBE NEWSWIRE) -- Polyrizon Ltd. (Nasdaq: PLRZ) (“Polyrizon” or the “Company”), a biotechnology company focusing on the development of intranasal products, today announced compelling new preclinical data showing its proprietary naloxone hydrogel adheres to nasal tissue longer than an approved and marketed... Read more
AGOURA HILLS, Calif., Dec. 03, 2025 (GLOBE NEWSWIRE) -- Oncotelic Therapeutics, Inc. (OTCQB: OTLC) 45% owned Joint Venture, Sapu Nano today announced new pharmacokinetic (PK) and tissue-distribution results demonstrating that Sapu003, the company’s intravenous (IV) Deciparticle™ formulation of everolimus, substantially reduces gastrointestinal (GI) drug accumulation, addressing one of the most significant and well-recognized limitations of oral everolimus (Afinitor®).... Read more
Biomarker-activated cancer drug-candidate LP-184 demonstrates encouraging efficacy signals in DNA damage repair deficient tumors with an acceptable safety and tolerability profile – meeting all primary endpoints.
LP-184 demonstrated clinical benefit in multiple highly aggressive cancers with a 54% disease control rate at or above therapeutic dose levels.
Multiple Phase 1b/2 clinical trials are now being planned across cancer indications and supported by 3 FDA Orphan... Read more
CAMBRIDGE, Mass., Dec. 03, 2025 (GLOBE NEWSWIRE) -- Ernexa Therapeutics (Nasdaq: ERNA), an industry innovator developing novel cell therapies for the treatment of advanced cancer and autoimmune disease, today announced that data from its novel cell therapy platform will be shared in an oral presentation at the 67th ASH Annual Meeting, being held December 6-9, 2025 in Orlando, FL.
“Being selected to give an oral presentation at ASH is a tremendous honor and a major m... Read more
Findings further validate FABP5 inhibition and strengthen the therapeutic potential of Artelo’s FABP5 platform for mood and stress-related disorders SOLANA BEACH, Calif., Dec. 03, 2025 (GLOBE NEWSWIRE) -- Artelo Biosciences, Inc. (Nasdaq: ARTL) (“Artelo” or the “Company”), a clinical-stage pharmaceutical company focused on modulating lipid-signaling pathways to develop treatments for people living with cancer, pain, dermatological, or neurological conditions,... Read more
NDA to be Submitted on a Rolling Basis, Beginning Early 2026 PETACH TIKVA, Israel, Dec. 03, 2025 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) (“PolyPid” or the “Company”), a late-stage biopharma company aiming to improve surgical outcomes, today announced that it has received a formal pre-New Drug Application (“NDA”) meeting minutes from the U.S. Food and Drug Administration (“FDA”) supporting the NDA submission of D-PLEX100, the Company’s lead... Read more
