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
TORONTO, ON / ACCESS Newswire / December 3, 2025 / Biomind Labs Inc. ("Biomind" or the "Company") (CBOE:BMND) (OTC PINK:BMNDF) (FRA:3XI), a clinical-stage biopharmaceutical company focused on transforming breakthroughs in neuroscience and biomedical research into novel pharmaceutical drugs, today announced a major strategic advancement in the development of BMND08, transitioning the program into FDA-directed activities using the Company's newly engineered nano-formulation... 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
VANCOUVER, British Columbia and BOSTON, Dec. 03, 2025 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (Nasdaq: XENE), a neuroscience-focused biopharmaceutical company dedicated to drug discovery, clinical development and commercialization of life-changing therapeutics for patients in need, today announced that the company will host an investor webinar focused on its data presentations at the American Epilepsy Society Annual Meeting (AES 2025), including new long-term data... 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
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
TARA-002 demonstrates 72% complete response rate at any time in BCG-Naïve patients
TARA-002 demonstrates a 69% complete response rate at the 6-month landmark and a 50% complete response rate at the 12-month landmark in BCG-Naïve patients
Favorable safety and tolerability profile observed with no Grade 3 or greater treatment-related adverse events reported
Company obtained written feedback from FDA on registrational path forward for TARA-002 in BCG-Naïve patients
Company... Read more
CAMBRIDGE, Mass., Dec. 3, 2025 /PRNewswire/ -- STRM.BIO, a start-up biotechnology company pioneering non-viral delivery technologies for in vivo cell and gene therapy, today announced that it has been awarded a contract from the Advanced Research Projects Agency for Health (ARPA-H) through its Engineering of Immune Cells Inside the Body (EMBODY) program. EMBODY is led by ARPA-H Program Manager Daria Fedyukina, Ph.D. The award includes up to $8.4 million in funding to support... Read more
Safusidenib demonstrated durable responses, with an ORR of 44% and 88% of patients were progression-free at 24 months
Findings supported recent favorable interactions with FDA where alignment was reached on modifying the ongoing G203 into a pivotal trial in high-grade gliomas NEW YORK / Dec 03, 2025 / Business Wire / Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, today announced the... Read more
Initiation of trial marks milestone for Crinetics’ novel nonpeptide drug conjugate platform SAN DIEGO, Dec. 03, 2025 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) today announced the first patient has been dosed in the Phase 1/2 study evaluating CRN09682 in patients with metastatic or locally advanced somatostatin receptor type 2 (SST2)-positive neuroendocrine tumors and other SST2-expressing solid tumors. CRN09682 is the lead candidate from... Read more
Initial clinical data expected mid-2026 SOUTH SAN FRANCISCO, Calif., Dec. 03, 2025 (GLOBE NEWSWIRE) -- Sutro Biopharma, Inc. (Sutro or the Company) (NASDAQ: STRO), a clinical stage oncology company pioneering site-specific and novel-format antibody drug conjugates (ADCs), today announced that the patients in the first cohort have been dosed in its Phase 1 trial evaluating STRO-004 in a range of Tissue Factor (TF) expressing solid tumors. STRO-004 is the Company’s... Read more
FDA recommended biomarker analyses show statistically significant reductions in NfL and GFAP in participants treated with CNM-Au8
Biomarker improvements are strongly associated with longer survival, reinforcing CNM-Au8’s potential disease modifying activity
Company has requested a Type C meeting in the first quarter of 2026 to present the newly completed analyses supporting a planned NDA submission under the accelerated approval pathway
Clene is hosting an investor... Read more
MALVERN, Pa., Dec. 03, 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 present at the 2025 Annual Meeting of the Parkinson Study Group (PSG), taking place December 4-6, 2025 in San Diego, California.
The presentation builds on momentum... Read more
ZYNLONTA® in combination with glofitamab (COLUMVI®) demonstrated an 89.8% ORR and 77.6% CR across the 49 efficacy-evaluable patients with a minimum of 6 months of follow-up
Combination continues to be generally well-tolerated with a manageable safety profile
LOTIS-7 trial is on track for complete patient enrollment in 1H 2026; plan to share full data at a medical meeting and submit for publication by end of 2026
Company to host conference call today at 8:00 a.m.... Read more
Type C Meeting with U.S. Food and Drug Administration (FDA) Scheduled for Second Half of January PURCHASE, N.Y., Dec. 03, 2025 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc., (the “Company” or “Cognition”) (NASDAQ: CGTX), a clinical-stage company developing drugs that treat neurodegenerative disorders, announced that its expanded access program has reached full enrollment. Each of the individuals enrolled in the program are being treated with 100 mg... Read more
Poster highlights 6-month follow-up data from the ongoing Phase 2 trial of NDV-01 in non-muscle invasive bladder cancer (NMIBC), with favorable overall safety
Relmada plans to advance NDV-01, a sustained release intravesical formulation of gemcitabine/docetaxel (Gem/Doce), into Phase 3 studies in two indications in H1 2026
Company is focused on high-risk NMIBC and intermediate-risk NMIBC, representing about 80% of new NMIBC cases every year, or about 54,000 people in... Read more
Pivotal Phase 3 randomized, double-blind, placebo-controlled study (n=106) met the primary endpoint (PUL v2.0) and the key secondary cardiac endpoint (LVEF), both achieving statistical significance (p=0.03 and p=0.04, respectively)
Statistical significance was achieved in all type 1 error controlled secondary endpoints
Results demonstrate clinically meaningful and statistically significant skeletal and cardiac benefits, supporting Deramiocel as a potential first-in-class... Read more
Silevertinib delivers robust anti-tumor activity as demonstrated by an ORR of 60% and a CNS response rate of 86% in 43 1L NSCLC patients presenting with 35 different non-classical EGFR mutations; no new safety signals observed to date
PFS data for 1L NSCLC patients expected in Q2 2026; Company continues to explore partnership opportunities for pivotal development of silevertinib
Based on encouraging CNS activity of silevertinib in multiple trials across NSCLC and GBM,... Read more
Making HPV Tests & Quality Assessment Products Available across Mexico MISSISSAUGA, Ontario and MEXICO CITY, Dec. 03, 2025 (GLOBE NEWSWIRE) -- Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF, Microbix®), a life sciences innovator, manufacturer, and exporter, and Seegene Mexico S.A.P.I. de C.V. (Seegene Mexico), a firm focused upon transforming molecular diagnostics with innovative multiplex solutions, announce that Microbix external third-party quality assessment... Read more
As previously announced, low dose D-cycloserine has been associated with augmentation of the antidepressant and antisuicidal response achieved by Transcranial Magnetic Stimulation (TMS).
NRx has amended its Investigational New Drug filing for NRX-101 (D-cycloserine/lurasidone) to include its use in association with TMS for the treatment of depression, including suicidal depression. This protocol will be available to patients both through a clinical trial and under NRx’s... Read more
Primary endpoint met; median time to onset of symptom relief achieved in 1.28 hours, significantly faster versus placebo (p<0.0001)
All secondary efficacy endpoints met (p<0.0001), including End of Progression™1 (median 17.47 minutes) and complete symptom resolution (median 11.95 hours)
Well-tolerated safety profile of deucrictibant confirmed
Efficacy and safety outcomes consistent across all HAE subtypes represented (HAE type 1, HAE type 2, and HAE with... Read more
Highlights: New US Department of Defense award to develop two new oral therapeutics targeting Campylobacter and Shigella
Uniformed Services University P2TD clinical study update MELBOURNE, Australia, Dec. 03, 2025 (GLOBE NEWSWIRE) -- Immuron Limited (ASX: IMC; NASDAQ: IMRN), an Australian based and globally integrated biopharmaceutical company, announces a new research agreement with the Naval Medical Research Command (NMRC) and the Walter Reed Army Institute of... Read more
STAFFORD, Texas, Dec. 03, 2025 (GLOBE NEWSWIRE) -- Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating GLSI-100, an immunotherapy to prevent breast cancer recurrences, today provided the following global update on FLAMINGO-01.
Flamingo-01 Progress to Date
The Company has achieved a major milestone by screening over 1,000 patients in Flamingo-01,... Read more
SUNNYVALE, Calif., Dec. 03, 2025 (GLOBE NEWSWIRE) -- BioCardia, Inc. [NASDAQ: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced the election of Mr. Marvin Slosman to its Board of Directors, effective December 2, 2025. Dr. Richard Krasno, who has served on the Board since 2016, has completed his term and departed the Board effective December 2, 2025.
“We are very pleased to... Read more
Mike Bonney and Carolyn Bertozzi to Depart; Company Appoints Stuart Arbuckle as New Independent Director CAMBRIDGE, Mass. / Dec 03, 2025 / Business Wire / Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced changes to its Board of Directors, including the departure of two directors and the appointment of a new independent director. Mike Bonney and Carolyn Bertozzi, Ph.D., who have served in key roles on Alnylam’s... Read more
Webcast set for 8:30 a.m. ET on December 3rd SALT LAKE CITY, Dec. 02, 2025 (GLOBE NEWSWIRE) -- Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries, “Clene”) and its wholly owned subsidiary Clene Nanomedicine Inc., a late clinical-stage biopharmaceutical company focused on revolutionizing the treatment of neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS), today announced it plans provide an update on its CNM-Au8... Read more
Company to host corporate webcast to share updated data on December 3, 2025 LAUSANNE, Switzerland, Dec. 2, 2025 /PRNewswire/ -- ADC Therapeutics SA (NYSE: ADCT), a commercial-stage global leader and pioneer in the field of antibody drug conjugates (ADCs), today announced that it will host a conference call and live webcast on Wednesday, December 3, 2025, at 8:00 a.m. EST to provide an update on the LOTIS-7 Phase 1b open-label clinical trial evaluating the safety and... Read more
Late-breaking HERIZON-GEA-01 presentation highlights the expanding clinical profile of Ziihera across HER2-driven gastrointestinal cancers
Jazz to host investor webcast on Friday, January 9, 2026, to review data DUBLIN, Dec. 2, 2025 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced two abstracts featuring key data for Ziihera® (zanidatamab-hrii) have been accepted for presentation at the American Society of Clinical Oncology... Read more
SAN FRANCISCO, Dec. 02, 2025 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) today announced that the Company will be attending and presenting at the Oppenheimer Movers in Rare Disease Summit being held on December 11, 2025, in New York, NY.
Thane Wettig, Chief Executive Officer of FibroGen, will participate in a panel titled Elevator Pitches from Rare Disease Companies with Key Near-Term, Potentially Stock-Moving Catalysts on Thursday, December 11 at 12:15... Read more
Webcast to be held Wednesday, December 3, at 8:00am ET CAMBRIDGE, Mass., Dec. 02, 2025 (GLOBE NEWSWIRE) -- Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage oncology company developing MasterKey therapies that target families of oncogenic mutations in patients with cancer, will host a webcast to present results from its Phase 2 clinical trial of silevertinib and provide a program update on Wednesday, December 3, 2025, at 8:00am ET.
Webcast information
The... Read more
Toronto, Ontario--(Newsfile Corp. - December 2, 2025) - PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) (the "Company" or "PharmaTher"), a specialty life sciences company focused on unlocking the therapeutic potential of ketamine for neuropsychiatric disorders, today announced it has closed the previously announced sale of its Abbreviated New Drug Application (ANDA #217858) for Ketamine Hydrochloride Injection USP to a leading sterile-injectables pharmaceutical company.
At... Read more
Global assignment of this unique name enhances international clarity, strengthens regulatory positioning, and supports olastrocel’s advancement across large unmet-need global markets PHOENIX, Dec. 02, 2025 (GLOBE NEWSWIRE) -- Creative Medical Technology Holdings, Inc. (NASDAQ: CELZ) (“Creative Medical” or the “Company”), a clinical-stage biotechnology company developing next-generation regenerative and immune cell therapies, today announced that the World... Read more
The patent relates to methods of administering therapeutically effective amounts of isolated allogeneic mesenchymal stem cells (MSCs) to patients with aging-related frailty with inflammaging and also to treat patients with non-ischemic dilated cardiomyopathy
Non-ischemic dilated cardiomyopathy is a progressive disorder with no current cure, often leading to heart transplantation
No approved treatments for aging-related frailty, a syndrome affecting older individuals... Read more
Calgary, Alberta--(Newsfile Corp. - December 2, 2025) - Hemostemix (TSXV: HEM) (OTCQB: HMTXF) (FSE: 2VF0) is proud to announce its participation in DFCon 2025, hosted by the American Limb Preservation Society in San Antonio, Texas - the global epicentre for innovation in diabetic foot care, vascular medicine, and limb preservation. With more than 500 delegates expected, DFCon gathers the widest spectrum of professionals shaping the future of diabetic limb salvage: podiatrists,... Read more
New Caregiver Resource Showcases Expert Contributions and Reinforces IGC Pharma's Leadership in Alzheimer's Innovation POTOMAC, MD / ACCESS Newswire / December 2, 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 the publication of "Caring for a Loved One with Alzheimer's Disease: First Hand Ex... Read more
Jaguar's requesting advice from EMA on EU approval pathway for general diarrhea of FDA conditionally approved Canalevia®
A novel non-antibiotic approach to diarrhea treatment is important because there are no FDA-approved drugs to treat general diarrhea in dogs, the second most common reason for visits to veterinary emergency hospitals SAN FRANCISCO, CA / ACCESS Newswire / December 2, 2025 / Jaguar Health, Inc. (NASDAQ:JAGX) (Jaguar), today announced that its Italian... Read more
FDA approval marks Alpha Tau’s fifth simultaneous active U.S. IDE as the Company expands Alpha DaRT’s reach into recurrent prostate cancer JERUSALEM, Dec. 02, 2025 (GLOBE NEWSWIRE) -- Alpha Tau Medical Ltd. (NASDAQ: DRTS, DRTSW), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT®, today announced that the FDA has approved an Investigational Device Exemption (IDE) application to initiate a pilot study for the treatment of patients with... Read more
Company to Discuss Proposed Amendment to Phase 3 VERSATILE-003 Trial Enabling Potential Accelerated Approval Pathway PRINCETON, N.J., Dec. 02, 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 its request for a Type C Meeting with the FDA has been accepted by the agency, and the... Read more
FDA has determined that NRx’s Abbreviated New Drug Application (ANDA) is “substantially complete” and received for review. Assigned GDUFA goal date is July 29, 2026.
NRx has applied to FDA for use of KETAFREE™ as a proprietary product name, which is subject to review. KETAFREE™ is the first preservative-free ketamine formulation that does not include potentially toxic preservatives used in current multidose presentations of ketamine.
Current worldwide generic... Read more
CAMBRIDGE, Mass., Dec. 02, 2025 (GLOBE NEWSWIRE) -- Fulcrum Therapeutics, Inc.® (Nasdaq: FULC), a clinical-stage biopharmaceutical company focused on developing small molecules to improve the lives of patients with genetically defined rare diseases, will host an investor event on Sunday, December 7, 2025 at 7:00 a.m. ET to review new clinical data from the Phase 1b PIONEER trial of pociredir in sickle cell disease (SCD). These data will also be presented at the 67th American... Read more
LANGHORNE, Pa. / Dec 02, 2025 / Business Wire / Savara Inc. (Nasdaq: SVRA) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, announced the European Patent Office (EPO) has issued patent No. 4 496 611 titled, “Drug-Device Combination Comprising a Liquid Solution and a Nebulizer for Aerosolization of the Liquid Solution.” The patent is jointly held by Savara and PARI and covers the combination of Savara’s investigational therapy,... Read more
