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...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...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....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...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...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,...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...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...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...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...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...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...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...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...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...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...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...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...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...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...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...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...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...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...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...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...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...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,...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...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...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...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,...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...Read more
First and only investigational medicine for this rare, often fatal neurological condition On track to submit new drug application (NDA) in Q1 2026 CARLSBAD, Calif. / Dec 02, 2025 / Business Wire / Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to zilganersen for the treatment of Alexander disease (AxD), a rare,...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...Read more
PASADENA, Calif. / Dec 02, 2025 / Business Wire / Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that the United States Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to investigational plozasiran as an adjunct to diet to reduce triglyceride (TG) levels in adults with severe hypertriglyceridemia (SHTG) (TG levels greater than or equal to 500 mg/dL). There are currently limited and inadequate...Read more
PLYMOUTH MEETING, Pa. / Dec 02, 2025 / Business Wire / Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY), today announced that it will highlight new open-label extension data from the company’s investigation of EPX-100 (clemizole hydrochloride) in the ongoing Phase 3 ARGUS trial for the treatment of Dravet syndrome at the 2025 American Epilepsy Society (AES) Annual Meeting being held December 5 – December 9, 2025, in Atlanta, GA. The ARGUS...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...Read more
SAN DIEGO, Dec. 02, 2025 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (Nasdaq: KURA, “Kura”), a biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, today announced the first U.S. commercial sale of KOMZIFTI™ (ziftomenib) has been completed. Under Kura’s collaboration and license agreement with Kyowa Kirin Co. Ltd. and Kyowa Kirin, Inc. (collectively, “Kyowa Kirin”), this...Read more
Strengthening our Advisory Board with addition of Mark McKenna as Strategic Advisor and Peter Libby, MD as a Clinical Advisor Expanding the Phase 2 recurrent pericarditis study into Canada, EU and the UK to evaluate QD dose ranging in preparation for the global Phase 3 development plan Interim analysis for the ongoing Phase 2 recurrent pericarditis study to now be presented as part of Ventyx’s R&D Day planned for Q1 2026 SAN...Read more
CELEBRATION, Fla., Dec. 02, 2025 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company), a commercial-stage company focused on providing therapies for people living with rare disease, today announced the appointment of Alicia Secor to the Company’s Board of Directors (Board). The Company also announced the retirement of director Wendy Dixon, PhD, effective today. "We are pleased to welcome Alicia to our...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...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...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...Read more
Participants who lost 24% total body weight (>50 lbs.) on GLP-1 drugs maintained stable weight 6 months after GLP-1 discontinuation and single Revita treatment 1.5% mean weight change observed with Revita (n=17); published third-party studies after GLP-1 withdrawal alone have shown ~10% weight regain at similar time points Upcoming randomized 6-month REMAIN-1 Midpoint Cohort data expected in January 2026; topline 6-month Pivotal...Read more
Study, Which Enrolled 27 Patients, Met Primary Endpoint with a Significant Reduction in Hearing Loss in 3-18 Year Old Patients who Received PEDMARK® when Compared with Historically Reported Rates of Hearing Loss in Patients Receiving Cisplatin Alone (16-24% versus 56-63%, Respectively) PEDMARK® Showed No Interference with Cisplatin Antitumor Activity as Evidenced by an Approximate 95% Clinical Response Rate The Company...Read more
Veteran gastroenterologist and clinical development leader with deep expertise driving global Phase 2/3 programs across immunology, neurology, and gastrointestinal disease Carlsbad, CA, Dec. 02, 2025 (GLOBE NEWSWIRE) -- Palisade Bio, Inc. (Nasdaq: PALI) (“Palisade” or the “Company”), a clinical-stage biopharmaceutical company advancing next-generation, once daily, oral PDE4 inhibitor prodrugs for patients with inflammatory and...Read more
Immunotherapy-chemotherapy combination of eftilagimod alfa (efti) and paclitaxel led to strong objective response rates and immune activation in heavily pretreated metastatic breast cancer patients AIPAC-003 has resulted in successful completion of FDA’s Project Optimus requirements and selection of 30 mg as efti’s optimal biological dose SYDNEY, AUSTRALIA, Dec. 02, 2025 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP)...Read more
BOSTON, Dec. 02, 2025 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies, today announced that it intends to develop its fully human anti-IL-6 receptor (IL-6R) monoclonal antibody, TZLS-501, and related assets (together “TZLS-501”) via a spinout into a separate publicly traded company, to enhance the strategic focus of...Read more
RICHMOND, Calif., Dec. 02, 2025 (GLOBE NEWSWIRE) -- Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicine company, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to ST-503, an investigational epigenetic regulator for the treatment of intractable pain due to small fiber neuropathy (SFN), a type of chronic neuropathic pain. Fast Track Designation aims to facilitate the...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,...Read more
NEWTON, Mass., Dec. 02, 2025 (GLOBE NEWSWIRE) -- Acumen Pharmaceuticals, Inc. (NASDAQ: ABOS), a clinical-stage biopharmaceutical company developing a novel therapeutic that targets soluble amyloid beta oligomers (AβOs) for the treatment of Alzheimer’s disease (AD), today announced new research at the 18th Annual Clinical Trials on Alzheimer’s Disease (CTAD) conference, taking place December 1-4, 2025, in San Diego and online. Results...Read more
CAMBRIDGE, Mass., Dec. 2, 2025 /PRNewswire/ -- Insilico Medicine ("Insilico"), a global leader in AI-powered drug discovery, and Atossa Therapeutics ("Atossa") (Nasdaq: ATOS), a clinical-stage biopharmaceutical company developing novel treatments for breast cancer and other serious conditions, announce the publication of a joint study evaluating the potential of (Z)-endoxifen for glioblastoma multiforme (GBM). The peer-reviewed article,...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...Read more
1st of two presentations with results from Phase 2b study of neflamapimod at the 18th Clinical Trials on Alzheimer's Disease (CTAD) Conference Data demonstrates neflamapimod treatment led to significant reductions in plasma glial fibrillary acidic protein (GFAP), a key marker of neuroinflammation-associated neurodegeneration, and increased beta amyloid (A) 42/40 ratio in DLB Correlation of the effects of neflamapimod on plasma GFAP...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...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...Read more
Reductions in airway hyperresponsiveness and suppressed eosinophilic response at both 6 weeks and 12 weeks observed after a single 180mg dose of Briquilimab in the ETESIAN Study Preliminary data from ETESIAN study supports further development of briquilimab in asthma Jasper also announces completion of internal BEACON study investigation noting no deviations or issues with drug product utilized Jasper to host conference call and...Read more
AGOURA HILLS, Calif., Dec. 02, 2025 (GLOBE NEWSWIRE) -- Oncotelic Therapeutics, Inc. (OTCQB: OTLC) 45% owned Joint Venture, Sapu Nano, a clinical-stage nanomedicine company, today announced new data demonstrating that its proprietary Deciparticle™ platform enables broad and consistent formulation of structurally diverse hydrophobic therapeutics—including macrolide mTOR inhibitors, cyclic peptides, linear peptides, ascomycin...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...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...Read more
Three poster presentations at the San Antonio Breast Cancer Symposium (SABCS), now available and to be presented on December 10, 2025, highlight robust survival and clinical benefit data in Phase 2, plus positive key biomarker data from the pivotal Phase 3 The pivotal Phase 3 study of Bria-IMT+CPI in advanced metastatic breast cancer is ongoing with an interim analysis expected in 1H2026 PHILADELPHIA and VANCOUVER, British...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...Read more
New Peer-Reviewed Publication Highlights Phase 2 SPRING Trial Data Supporting the Disease Modifying Potential of Nebokitug in PSC and Supports Advancement to a Phase 3 Registration Trial TEL AVIV, Israel, Dec. 02, 2025 (GLOBE NEWSWIRE) -- Chemomab Therapeutics Ltd. (Nasdaq: CMMB), (Chemomab), a clinical stage biotechnology company developing innovative therapeutics for fibro-inflammatory diseases with high unmet need, today announced...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...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...Read more
Extends cash runway through at least the first half of 2028 Led by healthcare-dedicated investors, including Vivo Capital, Janus Henderson Investors, Coastlands Capital, Columbia Threadneedle Investments, Adage Capital Partners and Squadron Capital Management MIAMI, Dec. 02, 2025 (GLOBE NEWSWIRE) -- Pasithea Therapeutics Corp. (“Pasithea” or the “Company”) (Nasdaq: KTTA; KTTAW), a clinical-stage biotechnology company developing...Read more
Positive feedback reinforces Silexion’s trajectory toward its planned Phase 2/3 trial initiation in Q2 2026 Company plans to complete regulatory submissions to the Israeli Ministry of Health by the end of Q4 2025 and in Germany during Q1 2026 GRAND CAYMAN, Cayman Islands, Dec. 02, 2025 (GLOBE NEWSWIRE) -- Silexion Therapeutics Corp. (NASDAQ: SLXN) (“Silexion” or the “Company”), a clinical-stage biotechnology company developing RNA...Read more
Ra’anana, Israel, Dec. 02, 2025 (GLOBE NEWSWIRE) -- Polyrizon Ltd. (Nasdaq: PLRZ) (“Polyrizon” or the “Company”), a biotechnology company developing intranasal products based on its proprietary Capture & Contain (C&C) platform, today announced the successful completion of a major manufacturing upscaling milestone for its proprietary nasal-spray product platform. This achievement marks a critical step toward supporting upcoming...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...Read more
New U.S. Patent Extends Protection Through 2042 Patent Allowance Secures Highest Level of Intellectual Property Protection for MPAR® SAN DIEGO, CA / ACCESS Newswire / December 2, 2025 / Ensysce Biosciences, Inc. (NASDAQ:ENSC) ("Ensysce" or the "Company"), a clinical-stage pharmaceutical company pioneering next-generation pain and central nervous system therapeutics designed to minimize abuse and overdose risk, today...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)...Read more
Vancouver, Canada, Dec. 02, 2025 (GLOBE NEWSWIRE) -- Clearmind Medicine Inc. (Nasdaq: CMND), (FSE: CWY0) (“Clearmind” or the "Company"), a clinical-stage biotech company focused on discovery and development of novel neuroplastogen-derived therapeutics to solve major under-treated health problems, today announced another key milestone in its Phase I/IIa clinical trial for the treatment of Alcohol Use Disorder (AUD): the first participant...Read more
JERUSALEM, Dec. 2, 2025 /PRNewswire/ -- Scinai Immunotherapeutics Ltd. (Nasdaq: SCNI) ("Scinai", or the "Company"), a biopharmaceutical company developing innovative inflammation and immunology (I&I) therapeutics and operating a growing boutique CDMO business unit, today reported its financial results and corporate highlights for the nine months ended September 30, 2025. First Nine Months 2025 Financial Summary Revenues for the...Read more
TSRA-196 is a potential one-time treatment to precisely correct the genetic mutation underlying AATD, with Investigational New Drug filing expected by the end of the year Tessera to receive $150 million, inclusive of a cash upfront and equity investment from Regeneron; companies to share worldwide development costs and future profits 50:50 Collaboration combines Regeneron’s long-standing expertise in genetics, genetic medicines and...Read more
WILMINGTON, Del. / Dec 01, 2025 / Business Wire / Incyte (Nasdaq:INCY) announces the appointment of Richard Hoffman as Executive Vice President and General Counsel effective today, December 1, 2025. In his new role, Mr. Hoffman will serve as a key member of the Executive Leadership Team and be responsible for the Company’s legal and compliance teams. “Richard joins us with a distinguished background, including many years of experience as a...Read more
On track to submit supplemental new drug application by end of year CARLSBAD, Calif. / Dec 01, 2025 / Business Wire / Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to olezarsen as an adjunct to diet to reduce triglyceride (TG) levels in adults with severe hypertriglyceridemia (sHTG) (TG greater than or equal to 500 mg/dL)....Read more
ROCKVILLE, Md. and SUZHOU, China, Dec. 01, 2025 (GLOBE NEWSWIRE) -- Ascentage Pharma Group International (NASDAQ: AAPG; HKEX: 6855) (“Ascentage Pharma” or the “Company”), 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 today that Chairman & CEO, Dr. Dajun Yang, and others...Read more
SAN DIEGO, Dec. 01, 2025 (GLOBE NEWSWIRE) -- Belite Bio, Inc (NASDAQ: BLTE) (“Belite Bio” or the “Company”), a clinical-stage drug development company focused on advancing novel therapeutics targeting degenerative retinal diseases that have significant unmet medical needs, today announced that it has commenced an underwritten public offering of American Depositary Shares (“ADSs”), each representing one of its ordinary shares. All of...Read more
Tinlarebant is the first therapeutic candidate to demonstrate clinical efficacy in a global Phase 3 trial for Stargardt disease, achieving a statistically significant p-value of 0.0033 Tinlarebant met the primary efficacy endpoint, demonstrating clinical benefit by significantly reducing the lesion growth rate by 36% compared to placebo, as measured by retinal imaging Tinlarebant was well tolerated throughout the trial Stargardt...Read more
Proof-of-concept study underway for investigational oral therapy in Fragile X syndrome; top-line data from Phase 2 expected in 2027 FOSTER CITY, Calif. / Dec 01, 2025 / Business Wire / Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM), a leading rare disease company, today announced that the first participant has been enrolled in the BLOOM Phase 2 clinical study evaluating MRM-3379 in Fragile X syndrome (FXS). Caused by a mutation of the...Read more
B7H3 and PTK7 is co-expressed in multiple solid tumor types, including lung, colorectal, and head and neck cancers, at approximately 30%, 46%, and 27%, respectively Deep and durable regressions observed with IDE034 monotherapy in multiple preclinical in-vivo models with B7H3 and PTK7 co-expression Enhanced durability with IDE034 and IDE161 PARG inhibitor combination in preclinical in vivo models; targeting to share...Read more
Salt Lake City, Dec. 01, 2025 (GLOBE NEWSWIRE) -- Recursion (Nasdaq: RXRX) a leading clinical stage TechBio company decoding biology to radically improve lives, announced today that it will present a new clinical readout from the ongoing TUPELO Phase 1b/2 trial of REC-4881 in FAP at an upcoming company webinar. The webinar will be held on December 8, 2025 at 8:00 am ET / 6:00 am MT / 1:00 pm GMT, and will be streamed live on...Read more
New analyses from the ongoing open label extension (OLE) studies and findings from electroencephalogram (EEG) assessments in patients with Dravet syndrome treated with zorevunersen support the potential for disease modification BEDFORD, Mass. & CAMBRIDGE, Mass. / Dec 01, 2025 / Business Wire / Stoke Therapeutics, Inc. (Nasdaq: STOK), a biotechnology company dedicated to restoring protein expression by harnessing the body’s...Read more
If approved, ReadyFlow Autoinjector would deliver an IV-equivalent diuretic dose (subcutaneous furosemide injection 80 mg/ml) in under 10 seconds Would potentially provide a cost-effective and convenient option to address episodes of fluid buildup at home, benefiting patients, providers and payors PDUFA target action date of July 26, 2026 WESTLAKE VILLAGE, Calif. and BURLINGTON, Mass., Dec. 01, 2025 (GLOBE NEWSWIRE) -- MannKind...Read more
SAN FRANCISCO, Dec. 01, 2025 (GLOBE NEWSWIRE) -- Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted protein degradation medicines in oncology and autoimmune diseases, today announced that the company will host a live webcast on Monday, December 8, 2025, at 8:15 p.m. ET, to review new and updated clinical data from the ongoing Phase...Read more
CARLSBAD, Calif., Dec. 1, 2025 /PRNewswire/ -- Tyra Biosciences, Inc. (Nasdaq: TYRA), a clinical-stage biotechnology company focused on developing next-generation precision medicines that target large opportunities in Fibroblast Growth Factor Receptor (FGFR) biology, announced today the appointment of two key members of its leadership team: Bhavesh Ashar as Chief Operating Officer and Heather Faulds as Chief Regulatory Officer....Read more
CHICAGO / Dec 01, 2025 / Business Wire / Xeris Biopharma Holdings, Inc. (Nasdaq: XERS), a fast-growing biopharmaceutical company committed to improving patient lives by developing and commercializing innovative products across a range of therapies, today announced that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for its subsidiary Xeris Pharmaceuticals Inc.’s U.S. patent application covering...Read more
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. 01, 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 a poster presentation highlighting data from a Phase 1b trial of enozertinib (ORIC-114) at...Read more
Phase 1 data demonstrates durable responses and rPFS coupled with a manageable safety profile rPFS of 7.9-8.9 months in heavily pre-treated mCRPC patients Preliminary results are encouraging with deep PSA reductions and a promising CRS profile in taxane-naïve Phase 1b expansion study Initial results support a patient-friendly Q2W dosing schedule Janux to host virtual investor event today at 4:30 PM Eastern Time SAN DIEGO /...Read more
| Company | Change | Last Trade |
|---|---|---|
| Vertex Pharmaceuticals | 29.98 6.92 | $463.13 |
| Capricor Therapeutics | 22.80 358.49 | $29.16 |
| Alnylam Pharmaceuticals | 8.36 1.80 | $473.29 |
| Sutro Biopharma | 7.97 1,092.11 | $8.70 |
| Arrowhead Pharmaceuticals | 7.12 12.29 | $65.08 |
| Praxis Precision Medicines | 7.03 3.92 | $186.15 |
| United Therapeutics | 6.82 1.44 | $480.96 |
| Madrigal Pharmaceuticals | 6.74 1.18 | $579.89 |
| argenx | 6.44 0.70 | $921.80 |
| Pharvaris | 5.83 24.17 | $29.95 |
| Axsome Therapeutics | 5.72 4.03 | $147.81 |
| Apogee Therapeutics | 5.42 7.84 | $74.55 |
| Bolt Biotherapeutics | 4.78 855.28 | $5.34 |
| CRISPR Therapeutics | 4.41 8.55 | $55.99 |
| Arcellx | 4.13 6.00 | $72.94 |
C4 Therapeutics is pioneering a new class of small-molecule drugs that selectively destroy disease-causing proteins via degradation using the innate machinery of the cell. This targeted protein degradation approach offers advantages over traditional drugs, including the potential to treat a wider range of diseases...
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Chimerix is on a mission to develop medicines that meaningfully improve and extend the lives of patients facing deadly diseases. The company is devoted to filling gaps in the treatment paradigm. Chimerix’s most advanced clinical-stage program is in development for H3 K27M-mutant glioma....
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