CAMBRIDGE, Mass., Sept. 17, 2025 (GLOBE NEWSWIRE) -- Vor Bio (Nasdaq: VOR), a clinical-stage biotechnology company transforming the treatment of autoimmune diseases, today announced that 48-week clinical data from the Phase 3 study in China evaluating telitacicept in adults with generalized myasthenia gravis, a study sponsored by Vor’s collaborator RemeGen Co., Ltd (HKEX: 9995, SHA: 688331), will be presented as an oral presentation at the American Association of Neuromuscular... Read more
REDWOOD CITY, Calif., Sept. 17, 2025 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT) (“Rezolute” or the “Company”), a late-stage rare disease company focused on treating hypoglycemia caused by hyperinsulinism, today reported financial results and provided a business update for the fourth quarter and full fiscal year ended June 30, 2025.
“We have made substantial progress this year across our two indications for ersodetug in both congenital and tumor hyperi... Read more
Complete 26-week results further demonstrate that combining semaglutide with trevogrumab (anti-GDF8/anti-myostatin) helped prevent about half of semaglutide-induced loss of lean mass, while increasing fat mass loss
Numeric improvements in metabolic and lipid parameters including waist circumference, blood pressure, cholesterol, triglycerides and A1C, were observed across all treatment groups TARRYTOWN, N.Y., Sept. 17, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals,... Read more
PALI-2108 demonstrated favorable safety, with no serious adverse events, lab abnormalities, or EKG concerns
Phase 1b data demonstrated 100% clinical response and promising signals regarding the efficacy of PALI-2108 in ulcerative colitis (UC) using FDA-defined endpoints
Biomarker analyses showed normalization of 186 genes linked to fibrosis and Crohn’s disease strictures, supporting translational potential in fibrostenotic Crohn’s disease (FSCD)
Patient dosing... Read more
BOSTON and LONDON, Sept. 17, 2025 (GLOBE NEWSWIRE) -- Akari Therapeutics, Plc (Nasdaq: AKTX), an oncology biotechnology company developing novel payload antibody drug conjugates (ADCs), today announced that it has filed a provisional patent application with the United States Patent and Trademark Office (USPTO) covering the Company’s antibody drug conjugate (ADC) platform using Akari’s spliceosome payload PH1 for treating cancer by modulating alternative splicing within... Read more
Strategic Commercial Supply Agreement Positions Lead Asset CTx-1301 for Launch Pending FDA Approval KANSAS CITY, Kan., Sept. 17, 2025 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products, today announced it has entered into a commercial supply agreement with Bend Bio... Read more
PETACH TIKVA, Israel, Sept. 17, 2025 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) ("PolyPid" or the "Company"), a late-stage biopharma company aiming to improve surgical outcomes, today announced that management will be presenting at the Lytham Partners Fall 2025 Virtual Investor Conference on September 30, 2025. Additionally, management will be participating in the upcoming 4th Annual ROTH Healthcare Opportunities Conference on October 9, 2025.
Lytham Partners... Read more
Presentation to highlight preclinical data from the company’s lead cell therapy, ERNA-101, demonstrating potential to reprogram the ovarian tumor microenvironment and advance toward clinical trials CAMBRIDGE, Mass., Sept. 17, 2025 (GLOBE NEWSWIRE) -- Ernexa Therapeutics (Nasdaq: ERNA), developing innovative cell therapies for the treatment of advanced cancer and autoimmune disease, today announced preclinical data will be presented at the inaugural AACR Special Conference... Read more
Icotrokinra demonstrated superior skin clearance at Weeks 16 and 24 compared to deucravacitinib and similar adverse event rates to placebo in Phase 3 ICONIC-ADVANCE studies
Icotrokinra also showed sustained skin clearance and favorable safety profile in both adults and adolescents at Week 52 in Phase 3 ICONIC-LEAD study
Preclinical proof-of-concept data on PN-881, a first-in-class oral peptide targeting the IL-17 pathway, and part of Protagonist's fully owned development... Read more
NEEDHAM, Mass., Sept. 17, 2025 (GLOBE NEWSWIRE) -- Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical-stage biopharmaceutical company focused on developing multimodal biological immunotherapies to help patients fight cancer, today announced that an abstract was accepted for an oral presentation at the 2025 American Society for Radiation Oncology (ASTRO) Annual Meeting, taking place from September 27 to October 1, 2025, in San Francisco, CA. The... Read more
Research published in ACS Chemical Biology and BioDesign Research describes new approaches for producing tryptamine and MDMA-derived compounds CAMBRIDGE, Mass. / Sep 17, 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 the publication of two peer-reviewed research papers describing... Read more
ELI-002 induced mKRAS-specific T cell responses in 99% of evaluable patients (89 of 90) who were treated with the investigational vaccine immunotherapy
Robust mKRAS-specific T cell responses were observed with an average of 145.3x increase over baseline (median 44.3x; range 2.13-1310x), consistent with prior ELI-002 Phase 1 trial results
T cell responses included both mKRAS-specific CD4 and CD8 T cells in 85% of patients BOSTON, Sept. 17, 2025 (GLOBE NEWSWIRE) --... Read more
TARPON SPRINGS, Fla., September 17, 2025 – Allarity Therapeutics, Inc. (“Allarity” or the “Company”) (NASDAQ: ALLR), a Phase 2 clinical-stage pharmaceutical company dedicated to developing stenoparib—a differentiated, dual PARP and WNT pathway inhibitor—today announced that its CEO, Thomas Jensen, has been invited to present at the upcoming Biomarkers & Precision Medicine 2025 conference in London, organized by Oxford Global.
In addition to his presentation,... Read more
Results Support Potential for STAR-0310 to be Best-in-Class OX40 Antagonist
STAR-0310 Exhibits Longest-in-Class Half-Life of 68 Days and Cytokine Suppression Lasting At Least 20 Weeks After a Single 300 mg SC Injection, Supporting Potential Every-Six-Month Administration
STAR-0310 Was Well-Tolerated, with no ADCC-Related Treatment-Emergent Adverse Events, Supporting a Wider Therapeutic Window with the Potential to Drive Greater Efficacy than First-Generation... Read more
- Efficacy and safety results from successful NAVIGATE Phase 2b trial of CD388 for prevention of influenza illness featured in late-breaking presentation
- Preclinical data demonstrating potential efficacy of CD388 to prevent H5N1 infection featured in oral presentation SAN DIEGO, Sept. 17, 2025 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company using its proprietary Cloudbreak® platform to develop drug-Fc conjugate (DFC)... Read more
Calgary, Alberta--(Newsfile Corp. - September 17, 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 Florida's SB 1768, is pleased to announce... Read more
Peer-reviewed publication highlights potential breakthrough anti-fibrotic properties of LTI-03 in lung tissue from IPF patients AUSTIN, Texas, Sept. 17, 2025 (GLOBE NEWSWIRE) -- Rein Therapeutics ("Rein") (NASDAQ: RNTX), a biopharmaceutical company advancing a novel pipeline of first-in-class medicines to address significant unmet medical needs in orphan pulmonary and fibrosis indications, today announced the publication of novel data on its lead drug candidate,... Read more
BOSTON, Sept. 17, 2025 (GLOBE NEWSWIRE) -- CervoMed Inc. (NASDAQ: CRVO), a clinical stage company focused on developing treatments for age-related neurologic disorders (CervoMed or the Company), today announced that the promising development program and potential benefits of neflamapimod for the treatment of Dementia with Lewy Bodies (DLB) were highlighted in a presentation on advances in DLB drug development by Dr. James Galvin at the 150th Annual American Neurological... Read more
Arch acquires a new CKD platform that has the potential to produce next-generation CKD drugs for the pharmaceutical industry
Based on a novel mechanism of action involving IL-32 and directly implicated in CKD, discovered in pre-clinical studies led by Dr. Justin Chun
The Company has filed both composition and method of use patents relating to the CKD platform.
The Arch CKD program will be led by Dr. Justin Chun, who joins the Company as a Principal Scientist
CKD is... Read more
FOP is a disease in which muscles, tendons and ligaments are progressively replaced by bone, leading to eventual incapacitation
Garetosmab is the first and only treatment to demonstrate a dramatic reduction in both number and volume of abnormal bone lesions (heterotopic ossification, or HO lesions) in adults with FOP
Primary endpoint was met, showing a 90% or greater reduction in new HO lesions at 56 weeks, and garetosmab also led to a greater than 99% reduction in... Read more
Data support advancement of GS-6791 into clinical testing in patients with inflammatory diseases; first-in-human Phase 1 trial in healthy volunteers is ongoing
Data are being presented at the European Academy of Dermatology and Venereology (EADV) Congress SAN FRANCISCO, Sept. 17, 2025 (GLOBE NEWSWIRE) -- Nurix Therapeutics, Inc. (Nasdaq: NRIX) today announced the presentation of preclinical data from GS-6791/NX-0479, a novel IRAK4 protein degrader discovered... Read more
Once-daily oral brepocitinib 30 mg demonstrated clinically meaningful and statistically significant improvement compared to placebo on the primary endpoint and all nine key secondary endpoints, including measurements of skin disease, muscle disease, steroid-sparing effect, and rapidity of onset
On the primary endpoint, brepocitinib 30 mg achieved a week 52 mean Total Improvement Score (TIS) of 46.5 compared to 31.2 for placebo (p=0.0006), even with nearly twice as... Read more
Pilavapadin 10 mg resulted in a two-point reduction from baseline in average daily pain scores (ADPS) by week 11 and was well tolerated in PROGRESS Phase 2b study THE WOODLANDS, Texas, Sept. 17, 2025 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced the presentation of clinical data from the company’s Phase 2b PROGRESS study for its investigational, AAK1-inhibitor, pilavapadin, for the treatment of diabetic peripheral neuropathic... Read more
Featured presentations showcase the positive Phase 1 healthy volunteer trial results supporting KT-621’s oral, dupilumab-like profile
KT-621 BroADen Phase 1b trial in moderate to severe atopic dermatitis (AD) patients on track to report data in 4Q25
KT-621 Phase 2b trials in AD and asthma on track to initiate in 4Q25 and 1Q26, respectively WATERTOWN, Mass., Sept. 17, 2025 (GLOBE NEWSWIRE) -- Kymera Therapeutics, Inc. (NASDAQ: KYMR), a clinical-stage biopharmaceutical... Read more
Positive Phase 1 study showed safety, tolerability and a linear pharmacokinetic: pharmacodynamic: efficacy relationship (1: 1: 1)
Planning adaptive Phase 2/3 study
Approximately 70 million people that are eligible for treatment live in areas of the U.S. in which Lyme Disease is endemic CHATHAM, N.J., Sept. 17, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully-integrated biopharmaceutical company... Read more
Six poster presentations showcase clinical and real-world data in major depressive disorder, Alzheimer’s disease agitation, narcolepsy, and obstructive sleep apnea NEW YORK, Sept. 17, 2025 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced six presentations across its broad portfolio of innovative neuroscience products and product candidates... Read more
Highlights discovery of novel targets in T cell-driven autoimmune disorders; initial findings to be presented at the ACR Convergence 2025 WALTHAM, Mass., Sept. 17, 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 acceptance of two abstracts, one as an oral... Read more
Supporting Clinical Labs in Accurately Identifying HPV-associated Head and Neck Cancers MISSISSAUGA, Ontario and HELSINKI, Sept. 17, 2025 (GLOBE NEWSWIRE) -- Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF, Microbix®), a life sciences innovator, manufacturer, and exporter, and Labquality Oy (Labquality), announce a novel external quality assessment (“EQA”) program to help ensure clinical laboratories accurately identify head and neck cancers associated with... Read more
Denifanstat met all primary and secondary endpoints versus placebo
Denifanstat was generally well tolerated
Sagimet initiated first-in-human Phase 1 clinical trial of a second FASN inhibitor, TVB-3567, for development in acne SAN MATEO, Calif., Sept. 17, 2025 (GLOBE NEWSWIRE) -- Sagimet Biosciences Inc. (Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing novel therapeutics targeting dysfunctional metabolic and fibrotic pathways, today reported that... 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 binding the receptor tyrosine... Read more
New analysis of ZORYVE foam 0.3% demonstrates reduction in signs and symptoms of seborrheic dermatitis in individuals with diverse skin types
New 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 dermatitis
Data demonstrate both ZORYVE cream 0.3% and ZORYVE foam 0.3% improved signs and symptoms of plaque psoriasis in individuals with facial and/or genital involvement WESTLAKE... Read more
In process of adopting a Director stock ownership policy to reinforce commitment of aligning the Board’s interests with stockholders
Vaxart encourages all stockholders of record on July 29, 2025, who have not yet voted FOR the reverse stock split, to do so by 11:59 p.m. Eastern Time on September 18, 2025 SOUTH SAN FRANCISCO, Calif., Sept. 17, 2025 (GLOBE NEWSWIRE) -- Vaxart, Inc. (OTCQX: VXRT), a clinical-stage biotechnology company... 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) Phase 3 Spongilla Treatment... Read more
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 (13.8%-27.7%) and HiSCR100 (9.2%-21.3%)... 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 completion, following discussions... 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 Antimicrobial Wound Gel... 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. commercial exosome... 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 September 17-21 in San Diego. The results... 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 the Securities Act of... 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 company committed to realizing the... 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 Florida's SB 1768, announces that... 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) to its request for a P... 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 centralized educational resource 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 therapeutics, today announced a 100% remission... 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) inspection by the Israeli... 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 tumor (GIST) and thymic carcinoma.
Biomarker... 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 presentation, which will include... 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 Southeastern University on September 12,... 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 function and pro-inflammatory cytokines;... 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 for the treatment of recurrent... Read more
