Across both STOP-HS1 and STOP-HS2, povorcitinib treatment resulted in continued clinically meaningful and statistically significant improvements for patients with active moderate to severe hidradenitis suppurativa (HS) through Week 24 At Week 24, nearly 60% of efficacy-evaluable patients among both povorcitinib treatment groups achieved HiSCR50 Additionally, patients treated with povorcitinib achieved HiSCR75 (31.0%-40.3%), HiSCR90...Read more
New analysis of ZORYVE foam 0.3% demonstrates reduction in signs and symptoms of seborrheic dermatitis in individuals with diverse skin typesNew data show improved quality of life and decreased impact on families for investigational ZORYVE cream 0.05% in children aged 2–5 years with atopic dermatitisData demonstrate both ZORYVE cream 0.3% and ZORYVE foam 0.3% improved signs and symptoms of plaque psoriasis in individuals with facial and/or...Read more
Rapid and sustained efficacy regardless of baseline IgE levels in patients with CSU HAMPTON, N.J., Sept. 17, 2025 (GLOBE NEWSWIRE) -- Celldex (NASDAQ:CLDX) announced today new data demonstrating rapid and strong efficacy regardless of baseline immunoglobulin E (IgE) levels in patients with chronic spontaneous urticaria (CSU), an immune-related condition driven by mast cell activation. Barzolvolimab specifically targets mast cells by...Read more
IPH4502 Nectin-4 ADC Phase 1 enrollment progressing well: Preclinical update and Trial In Progress presented at AACR Annual Meeting 2025 and ASCO 2025 Annual Meeting. Lacutamab BTD and Phase 3 preparation: FDA Breakthrough Therapy Designation (BTD) in February 2025 based on long-term follow-up data from the TELLOMAK clinical study presented at ASCO Annual Meeting 2025. Preparation of the confirmatory Phase 3 trial protocol is close to...Read more
- Abstract highlights additional primary and secondary data from Phase 3 STAR-1 clinical study of XYNGARI™ for the treatment of moderate-to-severe acne - SAN DIEGO, CA / ACCESS Newswire / September 17, 2025 / Dermata Therapeutics, Inc. (Nasdaq:DRMA)(Nasdaq:DRMAW) ("Dermata" or the "Company"), a science-driven leader in dermatologic solutions, today announced the presentation of an abstract from its XYNGARI™ (also known as DMT310)...Read more
SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C. / Sep 16, 2025 / Business Wire / United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, announced today that Martine Rothblatt, Ph.D., Chairperson and Chief Executive Officer, will provide an overview and update on the company during a fireside chat session at the Bernstein 2nd Annual Healthcare Forum in New York. The session will take place on Tuesday, September...Read more
Additional Data from SAVITRI™ Study Expand on Top-Line Results Announced in April 2024 SAVITRI Poster Presentation Chosen as Finalist for Psych Congress Poster Awards SAN DIEGO, Sept. 16, 2025 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced that it will present new data from the Phase 2 SAVITRI study of osavampator in adults with major depressive disorder at Psych Congress 2025, taking place...Read more
Preliminary analysis showed the 2025-2026 formula of Spikevax generated greater than an 8-fold increase in LP.8.1-neutralizing antibodies across age groups Clinical findings reinforce preclinical data supporting recent FDA approval of 2025-2026 formula of Spikevax CAMBRIDGE, MA / ACCESS Newswire / September 16, 2025 / Moderna, Inc. (NASDAQ:MRNA) today announced positive preliminary immunogenicity data for the 2025-2026 formula of...Read more
Posters support Ohtuvayre® (ensifentrine) as a first-in-class selective dual inhibitor of PDE3 and PDE4 for a broad COPD population LONDON and RALEIGH, N.C., Sept. 16, 2025 (GLOBE NEWSWIRE) -- Verona Pharma plc (Nasdaq: VRNA) (“Verona” or the “Company”), a biopharmaceutical company focused on respiratory diseases, announces two posters on additional analyses from its Phase 3 ENHANCE studies with Ohtuvayre (ensifentrine) for the...Read more
SOUTH SAN FRANCISCO, Calif., Sept. 16, 2025 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (“Cytokinetics”) (Nasdaq: CYTK) today announced its intention to offer, subject to market conditions and other factors, $550.0 million aggregate principal amount of convertible senior notes due 2031 (the “notes”) in a private placement (the “offering”) to persons reasonably believed to be qualified institutional buyers pursuant to Rule 144A under...Read more
SOUTH SAN FRANCISCO, Calif., Sept. 16, 2025 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (“Cytokinetics”) (Nasdaq: CYTK) today announced the pricing of its offering of $650.0 million aggregate principal amount of 1.75% convertible senior notes due 2031 in a private placement (the “offering”) to persons reasonably believed to be qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the...Read more
Analyst/Investor event showcases opportunities for KO-2806 (darlifarnib) in combination with PI3Kα inhibitors, KRAS inhibitors and antiangiogenic tyrosine kinase inhibitors (TKIs) Preliminary clinical data and KO-2806 development plans to be presented in October 2025 in conjunction with the ESMO Congress 2025 SAN DIEGO, Sept. 16, 2025 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical...Read more
A premier resource for NAD+ science—highlighting nicotinamide riboside (NR)—the newly evolved site features peer-reviewed studies, educational content, and a categorized research library. LOS ANGELES / Sep 16, 2025 / Business Wire / Niagen Bioscience, Inc. (NASDAQ: NAGE), the global authority on NAD+ (nicotinamide adenine dinucleotide) with a focus on the science of healthy aging, today unveils the newly evolved AboutNADⓇ, a...Read more
LONDON and GAITHERSBURG, Md., Sept. 16, 2025 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), an early commercial-stage biopharmaceutical company developing, manufacturing and delivering next-generation programmed T cell therapies, announces the online publication of an abstract submitted to the American College of Rheumatology (ACR) Convergence 2025, to be held October 24-29, 2025, in Chicago. Autolus will have a poster...Read more
NEW YORK, Sept. 16, 2025 (GLOBE NEWSWIRE) -- Immuneering Corporation (Nasdaq: IMRX), a clinical-stage oncology company focused on keeping cancer patients alive, today announced the appointment of Thomas J. Schall, Ph.D., to Chairman of the Board of Directors. Dr. Schall is a renowned biotech executive and scientist with more than 30 years of leadership in drug discovery and development. He is best known as the founder and longtime CEO...Read more
Agenda to feature latozinemab and AL101, along with progress in Alector Brain Carrier–enabled programs, including new lead candidates SOUTH SAN FRANCISCO, Calif., Sept. 16, 2025 (GLOBE NEWSWIRE) -- Alector, Inc. (Nasdaq: ALEC), a late-stage clinical biotechnology company focused on developing therapies to counteract the devastating progression of neurodegeneration, today announced management will host a virtual event to discuss the...Read more
SAN DIEGO, Sept. 16, 2025 /CNW/ -- Oncolytics Biotech® Inc. (Nasdaq: ONCY) ("Oncolytics" or the "Company"), a clinical-stage immunotherapy company developing pelareorep, today announced updates on enrollment progress, U.S. site expansion, and expected data readouts from the ongoing GOBLET trial evaluating pelareorep in gastrointestinal cancers. The study is supported in part by a grant from the Pancreatic Cancer Action Network...Read more
Dose optimization data from the Phase 1/2 study to be presented next month at ESMO 2025 Second Fast Track designation granted by FDA for CRB-701 NORWOOD, Mass., Sept. 16, 2025 (GLOBE NEWSWIRE) -- Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) (“Corbus” or the “Company”), a clinical stage oncology and obesity company, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to CRB-701...Read more
In a rodent model of T2D, icovamenib in combination with low-dose semaglutide promoted enhanced glycemic control and body weight reduction with preservation of lean mass, outperforming the group given semaglutide alone. U.S. Food and Drug Administration (FDA) clearance of the Investigational New Drug Application (IND) for BMF-650, Biomea’s next-generation investigational oral glucagon-like-peptide-1 (GLP-1) receptor agonist (RA), was...Read more
SAN DIEGO and SUZHOU, China, Sept. 16, 2025 (GLOBE NEWSWIRE) -- Adagene Inc. (“Adagene”) (Nasdaq: ADAG) today announced an amendment to the 2021 collaboration and license agreement with Exelixis. Under the terms of the amended agreement, Exelixis will utilize Adagene’s SAFEbody technology platform to generate a masked monoclonal antibody from the company’s pipeline for the development of an antibody-drug conjugate (ADC) against an...Read more
COYA 303 is an investigational proprietary combination of LD-IL-2 and GLP-1RA for subcutaneous administration, under development for the treatment of diseases, including Alzheimer's Disease, driven by chronic and sustained inflammation; COYA 303 demonstrated significant attenuation of neuroinflammation in cortex and hippocampus brain regions and upregulation of anti-inflammatory markers, and significant improvement of systemic Treg...Read more
Secures Incentive Offer of up to US$255K to Establish Operations in Indianapolis TORONTO and HAIFA, Israel and INDIANAPOLIS, Sept. 16, 2025 (GLOBE NEWSWIRE) -- NurExone Biologic Inc. (TSXV: NRX) (OTCQB: NRXBF) (FSE: J90) (“NurExone” or the “Company”), a biopharmaceutical innovator in exosome-based regenerative therapies, is pleased to announce that its U.S. subsidiary, Exo-Top Inc. (“Exo-Top”), is planning to establish its first U.S....Read more
LA JOLLA, Calif., Sept. 16, 2025 (GLOBE NEWSWIRE) -- MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the Standard Market of the Tokyo Stock Exchange (Code Number: 4875), today announced that an abstract regarding the Phase 2b/3 COMBAT clinical trial of MN-166 (ibudilast) in Amyotrophic Lateral Sclerosis (ALS) patients has been selected for a poster presentation at 36th...Read more
Peer-reviewed study reports a 78% reduction in hospital-wide CLABSI rates from 2023 to 2024 MISSISSAUGA, Ontario / Sep 16, 2025 / Business Wire / Covalon Technologies Ltd. (the "Company" or "Covalon") (TSXV: COV; OTCQX: CVALF), an advanced medical technologies company, today announced the publication of results from a peer-reviewed clinical study investigating the use of Covalon’s VALGuard® Vascular Access Line Guard in the Journal of...Read more
Key Manufacturing Milestone Strengthens PolyPid’s Position as it Advances Towards Global Commercialization of D-PLEX₁₀₀ Following Successful SHIELD II Phase 3 Trial PETACH TIKVA, Israel, Sept. 16, 2025 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) ("PolyPid" or the "Company"), a late-stage biopharma company aiming to improve surgical outcomes, today announced the successful completion of a routine Good Manufacturing Practice (GMP)...Read more
MALVERN, Pa., Sept. 16, 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 the publication of a new article in a peer-reviewed journal Biomolecules, which describes the pharmacokinetic (PK) profile of a new crystal...Read more
LP-184 achieves all primary endpoints and demonstrates a favorable safety and tolerability profile positioning it for both monotherapy or synergistic combinations with PARP inhibitors and immunotherapies. Clinical benefit observed in 48% of evaluable cancer patients at or above the therapeutic dose threshold. Durable clinical benefits were observed in hard-to-treat tumors like glioblastoma multiforme (GBM), gastrointestinal stromal...Read more
Montreal, Quebec--(Newsfile Corp. - September 16, 2025) - Defence Therapeutics Inc. (CSE: DTC) (FSE: DTC) (OTCQB: DTCFF) ("Defence" or the "Company"), a leading biotechnology company specialized in drug delivery technologies, is pleased to announce the appointment of Dr. Amie Phinney, PhD, MBA to its Board of Directors, effective immediately. Dr. Phinney recently joined Defence as a Strategy and Business Advisor, working closely...Read more
Provides Patent Protection in Europe Through at Least December 2040 Further IP Protection for TNX-103 (Oral Levosimendan) and Other Drug Formulations, and its Active Metabolites, in PH-HFpEF Also Provides Patent Protection for Wide Range of Levosimendan Doses, and its Use in Combination with Various Cardiovascular Drugs in PH-HFpEF CHAPEL HILL, N.C., Sept. 16, 2025 (GLOBE NEWSWIRE) -- Tenax Therapeutics, Inc. (Nasdaq: TENX)...Read more
Calgary, Alberta--(Newsfile Corp. - September 16, 2025) - Hemostemix Inc. (TSXV: HEM) (OTCQB: HMTXF) (FSE: 2VF0), the leading autologous (patient's own) stem cell therapy company offering VesCell™ (ACP-01) to individuals suffering from peripheral arterial disease, chronic limb threatening ischemia, angina, ischemic cardiomyopathy, non-ischemic dilated cardiomyopathy, congestive heart failure, and total body ischemia, in Florida under...Read more
Lead product candidate will be advanced to late IND-enabling studies to prepare for clinical trials for evaluation in the treatment of solid tumors Discovery of unique combination of cytokines in multi-functional fusion protein molecule that exhibits ability to expand TPEX cells without cytokine storm in preclinical studies Definitive data from preclinical studies shared at Scientific Seminar Series held at Nova...Read more
FDA Minutes Reflect Constructive Dialogue and Successful Meeting Outcome with Alignment on Upcoming Phase 3 Clinical Trial Design for AD04 In Alcohol Use Disorder GLEN ALLEN, Va., Sept. 16, 2025 (GLOBE NEWSWIRE) -- Adial Pharmaceuticals, Inc. (NASDAQ: ADIL) (“Adial” or the “Company”), a clinical-stage biopharmaceutical company focused on developing therapies for the treatment and prevention of addiction and related disorders, today...Read more
WINNIPEG, Manitoba, Sept. 16, 2025 (GLOBE NEWSWIRE) -- Kane Biotech Inc. (TSX-V:KNE) (“Kane Biotech” or the “Company”) today announces that it has completed a U.S. Food and Drug Administration (“FDA”) 510(k) clearance submission for its revyve® Antimicrobial Wound Cleanser. revyve Antimicrobial Wound Cleanser is the Company’s third product in its revyve product line and complimentary to Kane’s revyve Antimicrobial Wound Gel and...Read more
First patient in South Korea dosed MIAMI, Sept. 16, 2025 (GLOBE NEWSWIRE) -- Pasithea Therapeutics Corp. (NASDAQ: KTTA) (“Pasithea” or the “Company”), a clinical-stage biotechnology company developing PAS-004, a next-generation macrocyclic MEK inhibitor today announced activation of two South Korean clinical trial sites participating in its Phase 1/1b open label study to assess the safety, tolerability, pharmacokinetics (PK) and...Read more
No dose-limiting toxicities or cytokine release syndrome observed in RAINIER to date; mipletamig shows consistently favorable safety and tolerability Trial progressing efficiently, Cohort 4 open for enrollment SEATTLE, WA / ACCESS Newswire / September 16, 2025 / Aptevo Therapeutics ("Aptevo" or "the Company") (NASDAQ:APVO), a clinical-stage biotechnology company developing novel bispecific and trispecific immuno-oncology...Read more
Enveric expects to file Investigational New Drug application for EB-003 in early 2026 CAMBRIDGE, Mass. / Sep 16, 2025 / Business Wire / Enveric Biosciences (NASDAQ: ENVB) (“Enveric” or the “Company”), a biotechnology company advancing next-generation neuroplastogenic small molecules to address psychiatric and neurological disorders, today announced that it has received a written response from the U.S. Food and Drug Administration (FDA)...Read more
SAN DIEGO, Sept. 15, 2025 /PRNewswire/ -- Avidity Biosciences, Inc. (Nasdaq: RNA), a biopharmaceutical company committed to delivering a new class of RNA therapeutics called Antibody Oligonucleotide Conjugates (AOCs™), today announced that it has closed its previously announced underwritten public offering of 17,250,000 shares of its common stock, including 2,250,000 shares sold pursuant to the underwriters' full exercise of their...Read more
Revised label allows treatment of DEB patients from birth VYJUVEK can now be applied by patients and caregivers PITTSBURGH, Sept. 15, 2025 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS) announced today that the United States Food and Drug Administration (FDA) approved a label update for VYJUVEK® (beremagene geperpavec-svdt) that expands the VYJUVEK eligible patient population to include dystrophic...Read more
NEWARK, CALIFORNIA / ACCESS Newswire / September 15, 2025 / Protagonist Therapeutics, Inc. ("Protagonist" or the "Company") announced that data from the Phase 2b ANTHEM-UC study with icotrokinra in ulcerative colitis will be the focus of a brief oral presentation at the United European Gastroenterology Week 2025 being held in Berlin, Germany from October 4th through June 7th, 2025. Presentation Details: Presenting author: Maria Abreu,...Read more
Enrollment complete in VRDN-003’s phase 3 clinical trials in thyroid eye disease (TED), REVEAL-1 and REVEAL-2, with each study exceeding its enrollment target due to strong patient demand; topline data on track for first half of 2026 VRDN-003 composition of matter patent granted by the USPTO with term to 2041 and potential to extend exclusivity Veligrotug Biologics License Application (BLA) submission on track and...Read more
SPY072 is a potential first- and best-in-class anti-TL1A antibody for rheumatic diseases targeting quarterly or twice-yearly subcutaneous dosing SKYWAY study is evaluating SPY072 in patients with moderate-to-severely active rheumatoid arthritis (RA), psoriatic arthritis (PsA), and axial spondyloarthritis (axSpA) Proof-of-concept data for all three indications are expected in 2026 SKYLINE and SKYWAY trials are expected to provide 9...Read more
Meaningful vision gains are rapidly achieved as early as week 4 and more than half of patients in the top two dose levels improved 3-lines or more on the eye chart (≥15 letter gain) A single dose of KSI-101 resulted in the majority of patients achieving resolution of intra-retinal and sub-retinal fluid and over 90% of patients achieved retinal dryness by Week 8 The Phase 3 PEAK and PINNACLE studies of KSI-101 are actively...Read more
Novartis receives an exclusive license to an undisclosed discovery target Novartis also receives options to license two programs from Monte Rosa’s growing preclinical immunology portfolio Monte Rosa to receive an upfront payment of $120 million, plus option maintenance payments, and is eligible for option exercise payments and development, regulatory, and sales milestones, as well as tiered royalties on global net sales...Read more
Upfront fees and near-term development milestone payments totaling up to $7.5 million Potential sales milestones of $180 million or more in first 10 years of commercialization Royalties equaling 25% of net sales Ocugen to manufacture and supply OCU400 MALVERN, Pa., Sept. 15, 2025 (GLOBE NEWSWIRE) -- Ocugen, Inc. (“Ocugen” or the “Company”) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases,...Read more
Results were published in the Journal of Vascular Surgery Publication described treatment of patients with Symvess who had hospital-acquired iatrogenic injuries or complications of vascular surgical procedures Patients treated with Symvess were observed to have high levels of patency, 100% limb salvage, and zero cases of conduit infection DURHAM, N.C., Sept. 15, 2025 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq:...Read more
BOSTON, Sept. 15, 2025 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies with its lead development candidate, intranasal foralumab, a fully human, anti-CD3 monoclonal antibody, today announced that the U.S. Department of Defense (DoD) has awarded a research grant to study the use of intranasal anti-CD3 therapy in traumatic...Read more
Oral presentation to include topline efficacy and safety data for 6 patients with up to 9 months of follow up Enrollment for registrational Phase 3 portion of KYSA-6 trial in MG on track to initiate by year-end 2025 EMERYVILLE, Calif., Sept. 15, 2025 (GLOBE NEWSWIRE) -- Kyverna Therapeutics, Inc. (Nasdaq: KYTX), a clinical-stage biopharmaceutical company focused on developing cell therapies for patients with...Read more
Additional data continues to support highly differentiated profile for FB102 in celiac disease DALLAS / Sep 15, 2025 / Business Wire / Forte Biosciences, Inc. (www.fortebiorx.com) (NASDAQ: FBRX), a clinical-stage biopharmaceutical company focused on autoimmune and autoimmune-related diseases, announced additional details from the oral presentation “FB102 prevents histological damage and mitigates gluten challenge-induced symptoms in a...Read more
Study did not meet primary endpoint in change from baseline in mean daily oral corticosteroid (OCS) dose at week 48, although clinical benefit for efzofitimod observed across multiple study parameters. 52.6% of patients treated with 5.0 mg/kg efzofitimod achieved complete steroid withdrawal at week 48 vs 40.2% on placebo (p=0.0919). Clinical improvement in King’s Sarcoidosis Questionnaire (KSQ)-Lung score at week 48 observed in the...Read more
Positive start to FY 2026 with steady revenue, data growth and new leadership HACKENSACK, NJ / ACCESS Newswire / September 15, 2025 / Champions Oncology, Inc. (Nasdaq:CSBR), a leading translational oncology research organization, today announced its financial results for its first quarter of fiscal 2026, ended July 31, 2025. First Quarter and Recent Highlights: Total revenue of $14 million Adjusted EBITDA of...Read more
Company to hold conference call on September 15, 2025, at 10:30 ET to review corporate highlights AUSTIN, Texas / Sep 15, 2025 / Business Wire / MindWalk Holdings Corp.™ (“MindWalk™”, “Company”, “we” or “us”) (NASDAQ: HYFT), a Bio-Native AI company operating at the intersection of TechBio and next-generation drug discovery, today announced financial results for its first fiscal quarter of 2026, ended July 31, 2025. All numbers are...Read more
Preclinical Data for OPK-8801003 Demonstrate Substantially Longer Biological Half-Life with Peak Plasma Levels Comparable to Gattex®, the Only Approved GLP-2 Therapy Oral GLP-2 Tablet Could Transform Treatment Paradigm for 30,000 Short Bowel Syndrome (SBS) Patients Currently Dependent on Daily Injections of the Peptide JERUSALEM, Sept. 15, 2025 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX), a leader in the development of oral...Read more
ATH434 demonstrated clinically meaningful efficacy in modifying disease progression and was well tolerated at both 50 and 75 mg doses MELBOURNE, Australia and SAN FRANCISCO, Sept. 15, 2025 (GLOBE NEWSWIRE) -- Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) (“Alterity” or “the Company”), a biotechnology company dedicated to developing disease modifying treatments for neurodegenerative diseases, today announced that data from the...Read more
BOCA RATON, Fla., Sept. 15, 2025 (GLOBE NEWSWIRE) -- INmune Bio Inc. (NASDAQ: INMB) (“INmune” or “the Company”), a clinical-stage inflammation and immunology company focused on developing treatments that harness the patient’s innate immune system to fight disease, today announced the successful completion of its first full-scale pilot commercial manufacturing run of CORDStrom™, an off-the-shelf, allogeneic, umbilical cord tissue-derived...Read more
Montreal, Quebec--(Newsfile Corp. - September 15, 2025) - Defence Therapeutics Inc. (CSE: DTC) (OTCQB: DTCFF) (FSE: DTC) ("Defence" or the "Company"), a leading biotechnology company specialized in drug delivery technologies, is pleased to announce the closing of its previously announced non-brokered private placement of debenture units (the "Units") at a price of $1,000 per Unit for aggregate gross proceeds of $2,000,000 (the...Read more
REHOVOT, Israel, Sept. 15, 2025 /PRNewswire/ -- CollPlant Biotechnologies (NASDAQ: CLGN), or 'CollPlant', a regenerative and aesthetics medicine company developing innovative technologies and products based on its non-animal-derived collagen for tissue regeneration and medical aesthetics, today announced the expansion of its European distribution network for Vergenix™ STR through the signing of a new agreement in Poland. Vergenix™STR...Read more
Acquisition significantly enhances the Company’s pipeline by adding novel assets in acute and chronic anticoagulation settings Company is strategically poised to deliver differentiated therapeutics across the spectrum of cardiovascular thrombotic risk PONTE VEDRA, Fla., Sept. 15, 2025 (GLOBE NEWSWIRE) -- Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a biopharmaceutical company developing transformative therapeutics to overcome the...Read more
$4.7 million upfront with up to an additional approximately $8.3 million of potential aggregate gross proceeds upon the exercise in full of warrants BOTHELL, Wash., Sept. 15, 2025 (GLOBE NEWSWIRE) -- Cocrystal Pharma, Inc., (Nasdaq: COCP) (the “Company” or “Cocrystal”), today announced the closing of its previously announced registered direct offering priced at-the-market under Nasdaq rules for the purchase and sale of 2,764,710...Read more
Ramat Gan, Israel, Sept. 15, 2025 (GLOBE NEWSWIRE) -- Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company developing a pipeline of proprietary small molecule drugs targeting oncological and inflammatory diseases, today announced a significant new clinical finding under its compassionate use program in decompensated liver cirrhosis. The patient, previously reported by Can-Fite to have experienced the...Read more
PITTSBURGH, Sept. 15, 2025 /PRNewswire/ -- Lipella Pharmaceuticals Inc. (OTC: LIPO) ("Lipella" or the "Company"), a clinical-stage biotechnology company transforming care with innovative mucosal delivery solutions, today announced that Jonathan Kaufman, Chief Executive Officer of Lipella, will present a corporate overview and final results from Phase 2a trial of LP-10 in oral lichen planus at the Zacks SCR Life Sciences Virtual...Read more
WILMETTE, Ill., Sept. 14, 2025 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (“Monopar” or the “Company”) (Nasdaq: MNPR), a clinical-stage biopharmaceutical company developing innovative treatments for patients with unmet medical needs, today announced that new data on the long-term neurological efficacy and safety of its investigational therapy ALXN1840 (tiomolybdate choline) for Wilson disease will be presented at the 150th American...Read more
Results of the successful phase 3 TETON-2 study of inhaled treprostinil in idiopathic pulmonary fibrosis will be presented in an oral presentation SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C. / Sep 12, 2025 / Business Wire / United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, today announced that recent research across its commercial and development portfolio will be presented at the European...Read more
Findings reinforce efficacy and tolerability profile in patients prescribed DAYBUE in the U.S. for as long as 12 months, consistent with the Phase 3 LAVENDER™ trial that supported FDA approval and open-label LILAC, LILAC-2 and DAFFODIL studies SAN DIEGO / Sep 12, 2025 / Business Wire / Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced that the journal Developmental Medicine and Child Neurology published interim results from...Read more
Tinlarebant has been granted Breakthrough Therapy, Fast Track, and Rare Pediatric Disease Designations in the U.S.; Orphan Drug Designation in the U.S., Europe, and Japan; and Pioneer Drug Designation in Japan for Stargardt disease Last subject visit completed in the pivotal Phase 3 DRAGON trial of Tinlarebant in Stargardt disease Topline data expected in Q4 2025 SAN DIEGO, Sept. 12, 2025 (GLOBE NEWSWIRE) -- Belite Bio...Read more
Clinical data from Phase 1b prostate cancer trial to be released in Q4/25 Additionally, updated 2-year overall survival data from all 40 patients in the Phase 2b clinical trial of OST-HER2 in the prevention of delay of recurrent, fully resected, pulmonary metastatic osteosarcoma to be released on October 10, 2025 New York, New York--(Newsfile Corp. - September 12, 2025) - OS Therapies Inc. (NYSE American: OSTX) ("OS Therapies" or...Read more
TORONTO, Sept. 12, 2025 (GLOBE NEWSWIRE) -- Quantum BioPharma Ltd. (NASDAQ: QNTM) (CSE: QNTM) (FRA: 0K91) (Upstream: QNTM) (“Quantum BioPharma” or the “Company”), a biopharmaceutical company dedicated to building a portfolio of innovative assets and biotech solutions for the treatment of challenging neurodegenerative and metabolic disorders and alcohol misuse disorders with drug candidates in different stages of development, today...Read more
Dr. Barbara Klencke is an accomplished clinical leader with a distinguished track record in oncology drug development who currently serves on the Company’s Board of Directors and will step down from the Board to join ALX as Interim Chief Medical Officer Alan Sandler, M.D. resigns as Chief Medical Officer and will return to his position serving on the Company’s Board of Directors SOUTH SAN FRANCISCO, Calif., Sept. 12, 2025 (GLOBE...Read more
DURHAM, N.C. / Sep 12, 2025 / Business Wire / Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage gene editing company utilizing its novel proprietary ARCUS® platform to develop in vivo gene editing therapies for high unmet need diseases, today announced that the Company presented clinical data from the Phase 1 ELIMINATE-B trial of PBGENE-HBV in patients with chronic Hepatitis B. The data was presented at the International...Read more
BOTHELL, Wash., Sept. 12, 2025 (GLOBE NEWSWIRE) -- Cocrystal Pharma, Inc. (Nasdaq: COCP) announces that President and co-CEO Sam Lee, PhD discussed the scientific foundation and clinical progress with the Company’s lead pan-viral protease inhibitor CDI-988 during a podium presentation at the 9th International Calicivirus Conference, held September 7–11, 2025 in Banff, Alberta. Based on a novel mechanism of action and superior...Read more
$4.7 million upfront with up to an additional approximately $8.3 million of potential aggregate gross proceeds upon the exercise in full of warrants BOTHELL, Wash., Sept. 12, 2025 (GLOBE NEWSWIRE) -- Cocrystal Pharma, Inc., (Nasdaq: COCP) (the “Company” or “Cocrystal”), today announced that it has entered into definitive agreements for the purchase and sale of 2,764,710 shares of its common stock (or common stock equivalents in lieu...Read more
Ra’anana, Israel, Sept. 12, 2025 (GLOBE NEWSWIRE) -- Polyrizon Ltd. (Nasdaq: PLRZ) (“Polyrizon” or the “Company”), a biotechnology company focusing on the development of intranasal products, today announced encouraging preclinical results supporting the performance of its PL-14 Allergy Blocker, part of its proprietary Capture & Contain (C&C) platform. The study, conducted in collaboration with the University of Parma...Read more
Biodexa Pharmaceuticals PLC (Nasdaq: BDRX), a clinical stage biopharmaceutical company developing a pipeline of innovative products for the treatment of diseases with unmet medical needs, today announces its unaudited interim results for the six months ended June 30, 2025 which will also be made available on the Company’s website at www.biodexapharma.com. OPERATIONAL HIGHLIGHTS The Company announced the following in the six months ended...Read more
Icotrokinra is a first-in-class investigational targeted oral peptide that selectively blocks the IL-23 receptor 1 Filing based on four Phase 3 studies that met all primary and co-primary endpoints. This unprecedented data package includes head-to-head superiority comparisons versus deucravacitinib, adolescent data, and evaluation of difficult to treat skin sites2,3,4,5,6 Submission underscores that icotrokinra has the potential to...Read more
MORRISVILLE, N.C., Sept. 11, 2025 (GLOBE NEWSWIRE) -- Liquidia Corporation (NASDAQ: LQDA), a biopharmaceutical company developing innovative therapies for patients with rare cardiopulmonary disease, announced today that the company will present four posters at the Pulmonary Hypertension Professional Association (PHPN) Symposium taking place September 18 – 20, 2025, in Seattle. In a live thematic poster session, Liquidia will...Read more
SAN FRANCISCO and BOSTON, Sept. 11, 2025 (GLOBE NEWSWIRE) -- Apogee Therapeutics, Inc., (Nasdaq: APGE), a clinical-stage biotechnology company advancing optimized, novel biologics with potential for best-in-class profiles in the largest inflammatory and immunology (I&I) markets, today announced data from the Phase 2 APEX trial of APG777 for moderate-to-severe atopic dermatitis was accepted for a late-breaker oral presentation at the...Read more
NEW YORK and WALTHAM, Mass., Sept. 11, 2025 (GLOBE NEWSWIRE) -- Dianthus Therapeutics, Inc. (Nasdaq: DNTH), a clinical-stage biotechnology company dedicated to advancing the next generation of antibody complement therapeutics to treat severe autoimmune diseases (“Dianthus” or the “Company”), today announced that it closed its previously announced underwritten public offering of 7,627,879 shares of its common stock, including the full...Read more
EKTERLY® now approved in the US and UK; first and only oral on-demand therapy for acute attacks of hereditary angioedema Initiated US EKTERLY launch in July; received 460 patient start forms through August European Medicines Agency adopted a positive opinion recommending approval of sebetralstat and confirmed maintenance of orphan designation in EU; decision expected early October $191M in cash, providing runway into 2027 Management...Read more
Performance and scalability of Oracle Cloud Infrastructure AI infrastructure enables Absci to accelerate biologics design cycles and reduce costs AUSTIN, Texas and VANCOUVER, Washington, Sept. 11, 2025 (GLOBE NEWSWIRE) -- Absci, a clinical-stage biotech company advancing novel therapeutics with generative AI, today announced a collaboration with Oracle Cloud Infrastructure (OCI) and AMD to accelerate generative AI-driven drug...Read more
Presentations collectively highlight pilavapadin’s potential to improve pain management care for patients with diabetic peripheral neuropathic pain (DPNP) Breadth of the data across Phase 2 program to be discussed at Arrowhead’s 19th Annual Pain Summit THE WOODLANDS, Texas, Sept. 11, 2025 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced the presentation of clinical data for its investigational,...Read more
GlyphAgo is an oral prodrug of agomelatine, a medicine with established clinical efficacy in generalized anxiety disorder (GAD) GlyphAgo is designed to overcome a key limitation of agomelatine by shifting absorption toward the intestinal lymphatics, avoiding first-pass liver metabolism, and increasing systemic exposure of the drug Phase 1 proof-of-concept study will evaluate the safety, tolerability, and pharmacokinetics of GlyphAgo and...Read more
NEW YORK, Sept. 11, 2025 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) (“SELLAS” or the “Company”), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, today announced the immediate exercise of warrants, previously issued in January 2025, to purchase up to 19,685,040 shares of its common stock for gross cash proceeds of approximately...Read more
SEATTLE and VANCOUVER, British Columbia, Sept. 11, 2025 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage specialty pharmaceutical company focused on the global development and commercialization of cytisinicline for treatment of nicotine dependence for smoking cessation, today announced Mark Rubinstein, M.D., will assume the role of Interim Chief Medical Officer (CMO). Dr. Rubinstein will succeed Cindy...Read more
CARMIEL, ISRAEL / ACCESS Newswire / September 11, 2025 / Protalix BioTherapeutics, Inc. (NYSE American:PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx® plant cell-based protein expression system, today announced that Eyal Rubin, the Company's former Sr. Vice President and Chief Financial Officer, will present at the...Read more
CHICAGO and FORT WORTH, Texas, Sept. 11, 2025 (GLOBE NEWSWIRE) -- Actuate Therapeutics, Inc. (NASDAQ: ACTU) (“Actuate” or the “Company”), a clinical-stage biopharmaceutical company focused on developing therapies for the treatment of high-impact, difficult-to-treat cancers through the inhibition of glycogen synthase kinase-3 beta (GSK-3β), today announced the closing of its $17.25 million underwritten public offering of 2,464,286 shares...Read more
SOUTH SAN FRANCISCO, Calif. / Sep 11, 2025 / Business Wire / Quince Therapeutics, Inc. (Nasdaq: QNCX), a late-stage biotechnology company dedicated to unlocking the power of a patient’s own biology for the treatment of rare diseases, today announced that it will host a virtual Investor Day on Thursday, October 2, 2025, from 10:00 a.m. and 12:00 p.m. Eastern Time. Quince’s virtual Investor Day will feature presentations from the company’s...Read more
TORONTO and HAIFA, Israel, Sept. 11, 2025 (GLOBE NEWSWIRE) -- NurExone Biologic Inc. (TSXV: NRX) (OTCQB: NRXBF) (FSE: J90) (“NurExone” or the “Company”), a pioneering biopharmaceutical company developing exosome-based regenerative therapies, is pleased to provide the following corporate updates. Israeli Patent Grant Expands Global Jurisdiction The Israel Patent Office has granted the Company’s Patent, entitled “Production of...Read more
Dr. Chang led XOLAIR® from invention through FDA approval and commercialization, exceeding $5 billion in sales so far Los Angeles, CA, Sept. 11, 2025 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. (“Company”, “We” or “Us”), a clinical-stage biopharmaceutical company developing cell therapies for AL Amyloidosis and other serious diseases, today announced that Nancy T. Chang, former Tanox, Inc. CEO and proven biotechnology...Read more
CHICAGO, Sept. 11, 2025 (GLOBE NEWSWIRE) -- MAIA Biotechnology, Inc. (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, today highlighted positive efficacy data from its Phase 2 clinical trial, THIO-101, evaluating ateganosine (THIO) sequenced with the immune checkpoint inhibitor (CPI) cemiplimab (Libtayo®) in patients with advanced non-small...Read more
MOUNTAIN VIEW, Calif., Sept. 11, 2025 (GLOBE NEWSWIRE) -- RenovoRx, Inc. (“RenovoRx” or the “Company”) (Nasdaq: RNXT), a life sciences company developing innovative targeted oncology therapies and commercializing RenovoCath®, a patented, FDA-cleared drug-delivery device, today announced that Shaun Bagai, Chief Executive Officer, will present at the iAccess Alpha Virtual Best Ideas Fall Investment Conference 2025, held on September 16-17,...Read more
Pilot studies underway to advance IND-enabling preclinical development HOUSTON, Sept. 11, 2025 (GLOBE NEWSWIRE) -- FibroBiologics, Inc. (Nasdaq: FBLG) (“FibroBiologics”), a clinical-stage biotechnology company with 270+ patents issued and pending with a focus on the development of therapeutics and potential cures for chronic diseases using fibroblasts and fibroblast-derived materials, today announced positive IND-enabling updates...Read more
| Company | Change | Last Trade |
|---|---|---|
| Bolt Biotherapeutics | 4.58 817.86 | $5.14 |
| CRISPR Therapeutics | 3.35 5.79 | $61.19 |
| Apollomics | 2.92 31.43 | $12.21 |
| SIGA Technologies | 2.81 45.47 | $8.99 |
| Ascendis Pharma | 2.52 1.29 | $197.24 |
| Monopar Therapeutics | 2.51 4.61 | $57.00 |
| Regeneron Pharmaceuticals | 2.47 0.43 | $575.06 |
| Arcellx | 2.15 2.86 | $77.35 |
| Vericel | 1.81 5.76 | $33.23 |
| Corcept Therapeutics | 1.79 2.57 | $71.32 |
| Seres Therapeutics | 1.71 10.90 | $17.40 |
| Beam Therapeutics | 1.63 7.66 | $22.91 |
| Insmed | 1.61 1.12 | $144.75 |
| Structure Therapeutics | 1.59 7.87 | $21.79 |
| Praxis Precision Medicines | 1.55 3.83 | $42.00 |
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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Cue Biopharma is developing the first-ever class of therapeutics for the treatment of cancer that mimic the natural signals, or “Cues”, of the immune system. This novel class of injectable biologics selectively engages and modulates tumor-specific T cells directly within the patient’s body to transform...
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