Advancing preparations to begin manufacturing of fibroblast-based spheroids product candidate, CYWC628, for the Phase 1/2 clinical trial evaluating CYWC628 in diabetic foot ulcers (DFU) patients
Preparing to submit Investigational New Drug applications for the treatment of psoriasis with CYPS317 and the treatment of multiple sclerosis with CYMS101 HOUSTON, Oct. 31, 2025 (GLOBE NEWSWIRE) -- FibroBiologics, Inc. (Nasdaq: FBLG) (“FibroBiologics”), a clinical-stage... Read more
TORONTO / Oct 31, 2025 / Business Wire / Cybin Inc. (Cboe CA: CYBN) (NYSE American: CYBN) (“Cybin” or the “Company”), a breakthrough Phase 3 clinical stage neuropsychiatry company committed to revolutionizing mental healthcare through proprietary drug discovery platforms and innovative delivery systems, is pleased to announce that it has closed its previously announced registered direct offering of 22,277,750 common shares in the capital of the Company (a “Common... Read more
LANGHORNE, Pa. / Oct 31, 2025 / Business Wire / Savara Inc. (Nasdaq: SVRA), a clinical stage biopharmaceutical company focused on rare respiratory diseases, today announced the closing of its previously announced underwritten public offering of 28,452,381 shares of common stock, including 4,642,857 shares of common stock sold pursuant to the exercise in full by the underwriters of their option to purchase additional shares, at $4.20 per share. In addition, in lieu of shares... Read more
BOTHELL, Wash. / Oct 31, 2025 / Business Wire / Immunome, Inc. (Nasdaq: IMNM), a biotechnology company focused on developing first-in-class and best-in-class targeted cancer therapies, today announced that Immunome management will present at the 2nd Annual Guggenheim Healthcare Innovation Conference on Tuesday, Nov. 11, 2025 at 8:30 a.m. ET.
Interested parties can access the live audio webcast for this conference from the Investor Relations section of the company’s website... Read more
King of Prussia, Pennsylvania--(Newsfile Corp. - October 31, 2025) - Phio Pharmaceuticals Corp. (NASDAQ: PHIO) is a clinical-stage siRNA biopharmaceutical company developing therapeutics using its proprietary INTASYL® gene silencing technology to eliminate cancer. Phio is pleased to announce that David Deming has been appointed Lead Independent Director of the Board of Directors of Phio Pharmaceuticals.
Mr. Deming brings over 30 years of experience in investment banking... Read more
Company to Host Conference Call on November 10, 2025, at 4:30 p.m. ET SAN DIEGO, Oct. 31, 2025 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment of rare diseases, today announced that it will release its financial results for the third quarter ended September 30, 2025, after the market close on Monday, November 10, 2025. Management will then host a webcast... Read more
BOSTON, Oct. 31, 2025 /PRNewswire/ -- Ginkgo Bioworks (NYSE: DNA) today announced that the company has extended its multi-year strategic partnership with Bayer to advance research and development of biological products for agriculture. With the extension of this partnership, which began in 2017, both parties will build on the success of their ongoing collaboration to develop innovative microbial nitrogen fixation. As with the original agreement, Bayer retains the right... Read more
BOSTON / Oct 31, 2025 / Business Wire / Astria Therapeutics, Inc. (Nasdaq:ATXS), a biopharmaceutical company focused on developing life-changing therapies for allergic and immunologic diseases, today announced that it will present final results from the ALPHA-STAR Phase 1b/2 trial of navenibart in people living with hereditary angioedema (HAE) at the American College of Allergy, Asthma, and Immunology (ACAAI) Annual Scientific Meeting, taking place November 6-10, 2025 in... Read more
Vancouver, Canada, Oct. 31, 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 the publication of a U.S. patent application expanding coverage of its non-hallucinogenic proprietary compound, 5-methoxy-2-aminoindane (MEAI), for the treatment... Read more
SOUTH SAN FRANCISCO, Calif., Oct. 31, 2025 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS), a clinical-stage biopharmaceutical company, today announced that members of its leadership team will conduct one-on-one meetings with investors and participate in a fireside chat presentation at the Guggenheim 2nd Annual Healthcare Innovation Conference, which is being held in Boston, MA. The fireside chat will be on Monday, November 10, 2025 at 8:30 am ET.
A... Read more
SOUTH SAN FRANCISCO, Calif., Oct. 31, 2025 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced upcoming presentations, including three Late Breaking Science presentations related to MAPLE-HCM (Metoprolol vs Aficamten in Patients with LVOT Obstruction on Exercise Capacity in HCM), at the Hypertrophic Cardiomyopathy Medical Society Scientific Sessions on November 7, 2025, and at the American Heart Association Scientific Sessions 2025 taking place... Read more
Phase 2 clinical trial underway with first patient dosed in October to support a clear path to Phase 3 based on previous alignment with FDA
Patients randomized to either 10 or 20 mg/kg of muzastotug, in combination with KEYTRUDA with up to 30 patients per arm
Company anticipates trial completion in early 2027, and potential updates in 2026
Additional updates from the ongoing Phase 1b/2 trial with muzastotug, previously reported at ASCO 2025, are anticipated... Read more
PRINCETON, N.J., Oct. 31, 2025 (GLOBE NEWSWIRE) -- Amicus Therapeutics (Nasdaq: FOLD) today announced that management will participate in upcoming presentations at the following investor conferences in November. 2025 UBS Global Healthcare Conference in Palm Beach Gardens, FL on Monday, November 10, 2025, at 2:45 p.m. ET
Jefferies Global Healthcare Conference 2025 in London, U.K. on Tuesday, November 18, 2025, at 4:30 p.m. GMT A live audio webcast of each presentation... Read more
Conducted by Akeso, HARMONi-A Represents the First Statistically Significant OS Benefit Achieved in a Phase III Study by an Ivonescimab-Containing Regimen MIAMI / Oct 31, 2025 / Business Wire / Summit Therapeutics Inc. (NASDAQ: SMMT) (“Summit,” “we,” or the “Company”) today announced that results from the Phase III HARMONi-A trial, conducted in China and sponsored by our partner, Akeso, Inc. (“Akeso,” HKEX Code: 9926.HK), featuring the novel, potential... Read more
4DMT to receive $85 million upfront cash payment and expect to receive at least $50 million of cost sharing from Otsuka over the next three years for development activities supporting global registration
Up to $336 million in potential regulatory and commercial milestones and tiered double-digit royalties depending on net sales in Otsuka’s territories
Proceeds and cost sharing expected to support global Phase 3 clinical trial in DME and pre-commercial activ... Read more
Study published in the Journal of Atherosclerosis and Thrombosis demonstrates tipelukast (MN-001 and its metabolite MN-002) has influence on cholesterol metabolism in patients LA JOLLA, Calif., Oct. 30, 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), announces the publication of a new research article in the peer-reviewed... Read more
NEW YORK, Oct. 30, 2025 (GLOBE NEWSWIRE) -- Bright Minds Biosciences, Inc. (“Bright Minds,” “BMB” or the “Company”) (NASDAQ: DRUG), a pioneering company focused on developing highly selective 5-HT2 agonists for the treatment of drug-resistant epilepsy, depression, and other central nervous system (CNS) disorders, today announced that the Company will present at the following upcoming conferences:
EVENT:
Guggenheim 2nd Annual Healthcare Innovation... Read more
SAN FRANCISCO, Oct. 30, 2025 (GLOBE NEWSWIRE) -- Olema Pharmaceuticals, Inc. (“Olema” or “Olema Oncology”, Nasdaq: OLMA), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted therapies for breast cancer and beyond, today announced it will present a trial-in-progress poster for the Phase 3 OPERA-02 trial at the 2025 San Antonio Breast Cancer Symposium (SABCS 2025) taking place December 9-12, 2025... Read more
Topline data from the PIPE-307 Phase 2 VISTA trial for the treatment of relapsing-remitting multiple sclerosis (RRMS) is anticipated in the fourth quarter of 2025
Initiation of a global Phase 2 clinical trial of PIPE-791 in idiopathic pulmonary fibrosis (IPF) in the fourth quarter of 2025
Projected cash runway extended to fund planned operations through 2028 SAN DIEGO / Oct 30, 2025 / Business Wire / Contineum Therapeutics, Inc. (NASDAQ: CTNM) (Contineum or the Company),... Read more
Q3 2025 product revenue of $105.5 million reflects 15% year-over-year growth
IBSRELA® Q3 revenue of $78.2 million reflects 92% year-over-year growth; IBSRELA guidance raised, 2025 revenue expected to be between $270-275 million
XPHOZAH® Q3 revenue of $27.4 million, up 9% compared to Q2 2025
Company announces pipeline program for next-generation NHE3 inhibitor; Potential application across multiple therapeutic areas
Conference call scheduled for 4:30 PM Eastern... Read more
Data from Phase 1 Study in healthy volunteers presented at CIA Biennial Symposium HAMPTON, N.J., Oct. 30, 2025 (GLOBE NEWSWIRE) -- Celldex (NASDAQ:CLDX) announced today positive data from the ongoing Phase 1 study of CDX-622, a novel bispecific antibody that targets two non-redundant, complementary pathways implicated in inflammation and fibrosis—mast cell depletion via stem cell factor (SCF) starvation and neutralization of the alarmin thymic stromal lymphopoietin... Read more
U.S. net product sales of FILSPARI® (sparsentan) grew 155% year-over-year to $90.9 million in 3Q 2025; 731 new PSFs received during the quarter
Total revenue for 3Q 2025 was $164.9 million, including U.S. net product sales of $113.2 million
Retired remaining $69 million of 2025 convertible notes and achieved $40 million EU market access milestone, further strengthening financial foundation
2025 KDIGO guidelines and streamlined REMS monitoring strengthen FILSPARI’s... Read more
Webcast event to begin at 8:00am ET on Wednesday, November 12, 2025 CAMBRIDGE, Mass., Oct. 30, 2025 (GLOBE NEWSWIRE) -- Prime Medicine, Inc. (Nasdaq: PRME), a biotechnology company committed to delivering a new class of differentiated one-time curative genetic therapies, today announced that it will host a virtual event on Wednesday, November 12, 2025, to discuss its liver disease franchise and strategy, with a focus on Wilson’s Disease. Prime Medicine remains... Read more
IND application filed for MP0712, the Company’s lead Radio-DARPin candidate targeting DLL3 and co-developed with Orano Med, with Phase 1 initiation expected before year end 2025
First patient images from MP0712 compassionate care program to be presented at TRP in November; additional programs planned for 2026, including MP0726 targeting mesothelin.
Updated data from Phase 1/2a trial of MP0533, a multispecific T cell engager for AML, to be presented at ASH in... Read more
CLEVELAND, Oct. 30, 2025 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO), a commercial-stage biopharmaceutical company developing cell and gene therapies for serious diseases, today announced that the Centers for Medicare and Medicaid Services (CMS) has established a permanent Healthcare Common Procedure Coding System (HCPCS) J-code for ZEVASKYN (prademagene zamikeracel) gene-modified cellular sheets, the Company’s autologous gene therapy for the treatment... Read more
Selects Greenstone Biosciences to Accelerate AI-Driven iPSC Precision Medicine Platform PHOENIX, Oct. 30, 2025 (GLOBE NEWSWIRE) -- Creative Medical Technology Holdings, Inc. (NASDAQ: CELZ) (“Creative Medical” or the “Company”), a clinical-stage leader in regenerative and cellular innovation, today announced the official launch of its BioDefense Inc. Veterans Initiative, believed to be a first-of-its-kind national program to combat the devastating long-term... Read more
WALTHAM, Mass., Oct. 30, 2025 (GLOBE NEWSWIRE) -- Xilio Therapeutics, Inc. (Nasdaq: XLO), a clinical-stage biotechnology company discovering and developing tumor-activated immuno-oncology therapies for people living with cancer, today announced that it will present a late-breaking poster presentation for vilastobart, a tumor-activated, Fc-enhanced anti-CTLA-4, at the Society for Immunotherapy of Cancer (SITC) 40th Annual Meeting, taking place from November 5-9, 2025 in... Read more
NEW YORK, Oct. 30, 2025 (GLOBE NEWSWIRE) -- MiNK Therapeutics, Inc. (NASDAQ: INKT), a clinical-stage biopharmaceutical company pioneering allogeneic invariant natural killer T (iNKT) cell therapies to treat cancer and immune disorders, today announced that late-breaking data demonstrating durable clinical activity of AgenT-797, allo-INKTs, in advanced solid tumors will be presented at the 40th Annual Meeting of the Society for Immunotherapy of Cancer (SITC), taking place... Read more
HOUSTON, Oct. 30, 2025 (GLOBE NEWSWIRE) -- Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), a late-stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat cancers and viral infections, today announced it will present at the 14th Annual Acute Leukemia Meeting being held October 30-31, 2025 at the MD Anderson Cancer Center Spain Foundation in Madrid, Spain.
Details of the presentation are as follows:
Title:... Read more
Trials-in-progress poster of ongoing pivotal Phase 3 trial of DNA-mediated immunotherapy accepted at both IGCS and ESMO Congress 2025 LAWRENCEVILLE, N.J., Oct. 30, 2025 (GLOBE NEWSWIRE) -- IMUNON, Inc. (Nasdaq: IMNN), a clinical-stage company in Phase 3 development with its DNA-mediated immunotherapy, today announced that it has been invited to present a trials-in-progress abstract on the ongoing Phase 3 OVATION 3 clinical trial of IMNN-001, its investigational therapy... Read more
SAN CARLOS, Calif., Oct. 30, 2025 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea”) (Nasdaq: BMEA), a clinical-stage diabetes and obesity medicines company, today announced that it will present poster presentations at ObesityWeek® 2025, taking place November 4-7, 2025 in Atlanta, Georgia.
The presentations will highlight preclinical data for BMF-650, Biomea’s next-generation oral small molecule glucagon-like peptide-1 (“GLP-1”) receptor agonist (“RA”),... Read more
SAN JOSE, Calif., Oct. 30, 2025 (GLOBE NEWSWIRE) -- Rani Therapeutics Holdings, Inc. (“Rani Therapeutics” or “Rani”) (Nasdaq: RANI), a clinical-stage biotherapeutics company focused on the oral delivery of biologics and drugs, today announced that it will present preclinical data on the RaniPill® capsule, the company’s oral delivery platform, at ObesityWeek® 2025 taking place both virtually and in-person on November 4-7, 2025 in Atlanta, Georgia.
Details of... Read more
Once-daily, effective, safe, and well-tolerated ZORYVE cream 0.05% now commercially available for children as young as age 2
ZORYVE cream 0.05% provides rapid clearance of atopic dermatitis
ZORYVE can be used anywhere on the body for any duration and is not a steroid
Atopic dermatitis is the most common type of eczema, affecting approximately 9.6 million children in the U.S. WESTLAKE VILLAGE, Calif., Oct. 30, 2025 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, In... Read more
SUNNYVALE, Calif., Oct. 30, 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 first patient enrolled at University of Wisconsin School of Medicine and Public Health in its ongoing Phase 3 CardiAMP HF II clinical trial.
“CardiAMP cell therapy has shown evidence of benefit for ischemic heart failure patients with elevated... Read more
FLORHAM PARK, N.J., Oct. 30, 2025 (GLOBE NEWSWIRE) -- Celularity Inc. (Nasdaq: CELU) (“Celularity”), a regenerative and cellular medicine company addressing age-related and degenerative diseases, announced today a strategic partnership with DefEYE, Inc. (“DefEYE”), a newly established ophthalmic product and technology company. Celularity has executed an exclusive license & pricing arrangement with DefEYE on the backend of Celularity’s in-kind investment... Read more
Three abstracts accepted for presentation, including one rapid oral abstract session
Presentations to highlight ongoing clinical and translational research across PDS Biotechnology’s immunotherapy platforms PRINCETON, N.J., Oct. 30, 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... Read more
NOVATO, Calif., Oct. 30, 2025 (GLOBE NEWSWIRE) -- Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE) today announced that the first patient has been dosed in the Aurora study (NCT07157254) evaluating the efficacy and safety of GTX-102 (apazunersen), an investigational antisense oligonucleotide (ASO) for Angelman syndrome (AS). Data from the Aurora study will expand the population of Angelman patients treated to include both younger and older patients and those with other... Read more
Lantern showcases two commercially ready, machine learning platforms that have the potential to accelerate drug discovery from months to days and dramatically reduce costs.
predictBBB.ai and LBx-AI, will both be available as open-access services for Lantern's partners and collaborators and are both being advanced as part of a broader multi-agentic initiative at Lantern Pharma. DALLAS / Oct 30, 2025 / Business Wire / Lantern Pharma Inc. (NASDAQ: LTRN)— Lantern today... Read more
Results published in AAST’s Trauma Surgery & Acute Care Open Journal
Study compared outcomes of patients treated with Symvess with patients in PROOVIT registry who were treated with vein
In a comparison to prior results in the PROOVIT registry, outcomes for Symvess and autologous vein were similar for treatment of vascular trauma DURHAM, N.C., Oct. 30, 2025 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a commercial-stage biotechnology... Read more
Generated Q3 2025 Total Net Product Revenues of $851 Million (103% Growth Compared with Q3 2024), Driven Primarily by Total TTR Revenues of $724 Million (135% Growth Compared with Q3 2024)
Continued Broad Access and Balanced Utilization of AMVUTTRA Across All ATTR-CM Patient Segments
Presented New Data from the HELIOS-B Phase 3 Study at Major Congresses Demonstrating Vutrisiran's Long-Term Cardiovascular Benefit and Lower Rates of Gastrointestinal Events in... Read more
WILMINGTON, Del. / Oct 30, 2025 / Business Wire / Incyte (Nasdaq:INCY) announced today that it will present at the following investor conferences during the month of November: Guggenheim Annual Healthcare Innovation Conference on Monday, November 10, 2025 at 10:00 am (EST) Jefferies Global Healthcare Conference (London) on Tuesday, November 18, 2025 at 11:00 am (GMT) The presentations will be webcast live and can be accessed at Investor.Incyte.com and will be available... Read more
SAN DIEGO, Oct. 30, 2025 (GLOBE NEWSWIRE) -- Calidi Biotherapeutics, Inc. (NYSE American: CLDI) (“Calidi” or the “Company”), a clinical-stage biotechnology company pioneering the development of systemically delivered, targeted genetic medicines, today announced the presentation of new data on its first therapeutic candidate from its RedTail platform, CLD-401, at the Society of Immunotherapy for Cancer (SITC) Annual Meeting.
CLD-401 is a tumor-tropic oncolytic virus... Read more
Milestone advances MEAI-based therapy targeting a global Alcohol Use Disorder treatment market projected to surpass $20 billion by 2032 Vancouver, Canada, Oct. 30, 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 psychedelic-derived therapeutics to solve major under-treated health problems, today announced that the last patient... Read more
The paper features a comprehensive evaluation of data, including disease control rate, overall survival, immune activation, abscopal effects, tumor necrosis, dose ranging, and safety
The manuscript is open access
The Company will host a webinar with the paper's lead and senior authors from the University of Southern California to discuss the results on Friday, October 31, 2025, at 9:00 AM (see below) SHELTON, Conn., Oct. 30, 2025 /PRNewswire/ -- Intensity Therapeutics,... Read more
Data presented at the TPD and Induced Proximity Summit demonstrate that novel Selective ARID1B degrader selectively binds and degrades ARID1B; potentially relevant in up to 5% of all solid tumors
Selective CBP degrader is on track for non-GLP toxicology studies in Q4 2025 with potential in EP300-mutant cancers and in ER+ breast cancer; IND-ready in 2026
Selective EP300 degrader demonstrates efficacy and favorable tolerability in preclinical models in hematological... Read more
Agreement combines Turn’s PermaFusion® delivery platform with Medline’s global scale and distribution capabilities to advance professional and retail product opportunities WESTLAKE VILLAGE, Calif., Oct. 30, 2025 (GLOBE NEWSWIRE) -- Turn Therapeutics (Nasdaq: TTRX) (“Turn” or the “Company”), a clinical-stage biotechnology company developing next-generation dermatology, wound, and anti-infective therapies, today announced it has entered into a global supply,... Read more
Metsera Declares Novo Nordisk Proposal "Superior"
Novo Nordisk Proposal Values Metsera at up to $77.75 per Share, a Total of Approximately $9 Billion
Pursuant to Pfizer Merger Agreement, Metsera and Pfizer May Negotiate Potential Adjustments to Existing Transaction
Pfizer Merger Agreement Remains in Effect; No Action Required by Metsera Shareholders NEW YORK, Oct. 30, 2025 /PRNewswire/ -- Metsera, Inc. (NASDAQ: MTSR) ("Metsera") today announced that its Board... Read more
Patients treated with RGX-202 demonstrate consistent, robust microdystrophin expression and functional improvement compared to natural history in Phase I/II portion of AFFINITY DUCHENNE® trial supporting potential approval via the accelerated approval pathway
REGENXBIO continues to enroll patients in the confirmatory trial
First batches intended for commercial supply manufactured at in-house Manufacturing Innovation Center Capacity to produce up to 2,500 RGX-202... Read more
Generated $459 million in 3Q 2025 revenues, including $178 million in U.S. net product sales
Received 152 new patient start forms for EMPAVELI® (pegcetacoplan) in the first two months since launch in C3G and primary IC-MPGN
Reported EMPAVELI U.S. net product revenue of $27 million, reflecting strong early launch in C3G and primary IC-MPGN and continued high patient compliance in PNH
SYFOVRE® (pegcetacoplan injection) total injection demand grew 4% quarter-over-quarter,... Read more
Analysis of the data from the open-label pivotal trial of oxylanthanum carbonate (OLC) highlights that pill burden was significantly reduced in terms of both pill volume (7x) and pill count (2x) from pre-trial phosphate binder therapy LOS ALTOS, Calif., Oct. 30, 2025 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease (the “Company” or “Unicycive”), today... Read more
