CD388 is an investigational long-acting, strain-agnostic antiviral agent currently in Phase 3, designed to prevent influenza infection in individuals at higher risk of influenza complications Acquisition aligns with Merck’s science-led business development strategy, diversifying and expanding the company’s pipeline RAHWAY, N.J. & SAN DIEGO, Calif. / Nov 14, 2025 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the...Read more
CAMBRIDGE, Mass., Nov. 14, 2025 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) has completed the acquisition of Alcyone Therapeutics, a clinical-stage biotechnology company known for its innovative CNS therapy delivery solutions, such as the ThecaFlex DRx™ drug delivery system. ThecaFlex DRx™ is an investigational implantable device designed to provide an alternative to repeat lumbar punctures in chronic intrathecal administration of...Read more
ROSA® Knee with OptimiZe™ Offers Personalized Surgical Planning and Drives Confidence in Delivering Accurate and Reproducible Outcomes1 WARSAW, Ind., Nov. 14, 2025 /PRNewswire/ -- Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global medical technology leader, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance of ROSA® Knee with OptimiZe™, an enhanced version of its ROSA® Knee System that...Read more
Tempus Launches Its First Study With a Nonprofit Foundation Collaborator to Create Robust FL Dataset CHICAGO / Nov 14, 2025 / Business Wire / Tempus AI, Inc. (NASDAQ: TEM), a technology company leading the adoption of AI to advance precision medicine, today announced a new research study sponsored by Tempus and being run in collaboration with the Institute for Follicular Lymphoma Innovation (IFLI), a global, nonprofit, private...Read more
Recommendation based on breadth of clinical evidence demonstrating significant HAE attack rate reduction with DAWNZERA European Commission decision expected in Q1 2026 CARLSBAD, Calif. / Nov 14, 2025 / Business Wire / Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) and Otsuka Pharmaceutical Co., Ltd. (Otsuka) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a...Read more
IRVINE, Calif. / Nov 14, 2025 / Business Wire / Masimo (NASDAQ: MASI) today issued the following statement in response to the jury verdict announced in the U.S. District Court for the Central District of California, which confirmed the validity of Masimo Patent No. 10,433,776, found Apple infringed this patent, and awarded Masimo $634 million in damages: “We are pleased by this outcome, and appreciate the time and attention given to our...Read more
LONG BEACH, Calif. / Nov 14, 2025 / Business Wire / Molina Healthcare, Inc. (NYSE: MOH) (“Molina”) announced today that the Florida Agency for Health Care Administration (AHCA) has issued a Notice of Agency Decision that it intends to award Molina Healthcare of Florida a contract to provide Statewide Medicaid Managed Care (SMMC) Program and Children’s Health Insurance Program (CHIP) services to enrollees of the Title XIX and Title XXI...Read more
Company to host webcast and conference call on November 17, 2025 at 8:00am ET CAMBRIDGE, Mass., Nov. 14, 2025 /PRNewswire/ -- Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced that the company will host a webcast and conference call on Monday, November 17, 2025 at 8:00 a.m. ET, to...Read more
WAYNE, Pa., Nov. 14, 2025 (GLOBE NEWSWIRE) -- Management of Teleflex Incorporated (NYSE: TFX) is scheduled to speak at the Jefferies Global Healthcare Conference in London on Tuesday, November 18, 2025, at 10:00 a.m. (GMT). A live audio webcast of the conference presentation will be available on the investor section of the Teleflex website at teleflex.com. About Teleflex Incorporated As a global provider of medical technologies,...Read more
Completed constructive and collaborative in-person Type A meeting with U.S. Food and Drug Administration (FDA) on November 12th for apitegromab biologics license application (BLA) for the treatment of children and adults with spinal muscular atrophy (SMA) Catalent Indiana, LLC (part of Novo Nordisk) participated in the Type A meeting in person and presented the progress made in implementing the remediation plan; confirmed to FDA that the...Read more
Initiated rolling Biologics License Application (BLA) submission to U.S. FDA for cretostimogene monotherapy in high-risk (HR) BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) Demonstrated continued best-in-disease durability and tolerability in BOND-003 Cohort C with robust 24-month complete response (CR) rate of 41.8% observed for cretostimogene monotherapy in patients with HR NMIBC unresponsive to Bacillus Calmette Guerin...Read more
CAMBRIDGE, Mass., Nov. 14, 2025 (GLOBE NEWSWIRE) -- Vericel Corporation (NASDAQ:VCEL), a leader in advanced therapies for the sports medicine and severe burn care markets, today announced that the Company will participate in a fireside chat at the Stephens Annual Investment Conference at 11:00 a.m. ET (10:00 a.m. CT) on Thursday, November 20, 2025. A webcast of the presentation will be available on the Investor Relations section of the...Read more
CAMBRIDGE, Mass. / Nov 14, 2025 / Business Wire / Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced an update to the prescribing information for ELEVIDYS (delandistrogene moxeparvovec-rokl), the only approved gene therapy for Duchenne muscular dystrophy (DMD). As previously disclosed, the ELEVIDYS label now includes several key updates, including: A boxed warning for...Read more
FOSTER CITY, Calif., Nov. 14, 2025 (GLOBE NEWSWIRE) -- Terns Pharmaceuticals, Inc. (“Terns” or the “Company”) (Nasdaq: TERN), a clinical-stage oncology company, today announced that members of senior management will be presenting at the Jefferies Global Healthcare Conference in London on Monday, November 17, 2025 at 4:30 p.m. GMT. A live webcast of the presentation will be available on the investor relations page of the Terns...Read more
SOUTH SAN FRANCISCO, Calif. / Nov 14, 2025 / Business Wire / Twist Bioscience Corporation (NASDAQ: TWST), a mid-cap growth and value biotech company, today announced financial results and business highlights for the fourth quarter and full year fiscal 2025 ended September 30, 2025. Visit the Events and Presentations page of the Investor Relations section under the “Company” tab at www.twistbioscience.com to view the detailed fiscal fourth...Read more
SAN DIEGO, Nov. 14, 2025 /PRNewswire/ -- Inhibrx Biosciences, Inc. (Nasdaq: INBX) ("Inhibrx" or the "Company") today reported financial results for the third quarter of 2025. Following the completion of the sale of INBRX-101 (the "101 Transaction") by Inhibrx, Inc. (the "Former Parent") to Sanofi S.A. and the Former Parent's concurrent spin-off of the Inhibrx business in May 2024, the biopharmaceutical company now has two programs in...Read more
Second study to be presented at the 2nd European Congress on Dermato-Oncology demonstrates DecisionDx-Melanoma can identify patients with a negative sentinel lymph node who have a higher risk of poor outcomes FRIENDSWOOD, Texas, Nov. 14, 2025 (GLOBE NEWSWIRE) -- Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, today announced new data demonstrating the clinical...Read more
Conference Call Scheduled for Monday, November 17 at 11:30 AM EST Northvale, New Jersey--(Newsfile Corp. - November 14, 2025) - Elite Pharmaceuticals, Inc. (OTCQB: ELTP) ("Elite" or the "Company"), a specialty pharmaceutical company developing niche generic products, announced results for the second quarter of fiscal year 2026 ended September 30, 2025 ("Second Quarter"). Consolidated revenues for the three-month period ending...Read more
NORCROSS, Ga., Nov. 14, 2025 (GLOBE NEWSWIRE) -- Galectin Therapeutics, Inc. (NASDAQ: GALT), the leading developer of therapeutics that target galectin proteins, today reported financial results and provided a business update for the three and nine months ended September 30, 2025. “The new NAVIGATE data presented at AASLD further strengthen the clinical and mechanistic profile of belapectin. We continue to see encouraging consistency...Read more
fast Track Designation was granted for BB-301 following U.S. Food and Drug Administration (FDA) review of positive interim clinical study results and proprietary Responder Analysis planned for use in pivotal study for BB-301 Positive interim clinical study results from the Phase 1b/2a trial of BB-301, showed a 100% responder rate, with all six patients in Cohort 1 meeting the formal statistical criteria for response to BB-301 First...Read more
Company plans to request re-examination after CHMP opinion feedback following its oral explanation FDA advises Company to meet and discuss Company’s Alzheimer's Disease clinical trial results NEW YORK, Nov. 14, 2025 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company focused on developing innovative treatments for Alzheimer's disease, Parkinson's...Read more
BRISBANE, Calif., Nov. 14, 2025 (GLOBE NEWSWIRE) -- Annexon, Inc. (“Annexon”) (Nasdaq: ANNX), a biopharmaceutical company advancing a late-stage clinical platform targeting neuroinflammation across life-changing complement-mediated diseases of the body, brain, and eye, today announced the closing of its previously announced underwritten public offering of 29,423,075 shares of its common stock, which includes the full exercise of the...Read more
Olympe Imagerie to deploy Nanox.ARC at Paris-area Hospital Privé Jacques Cartier MASSY for lung cancer screening applications PETACH TIKVA, Israel, Nov. 14, 2025 (GLOBE NEWSWIRE) -- NANO-X IMAGING LTD (“Nanox” or the “Company”, Nasdaq: NNOX), an innovative medical imaging technology company, today announced a collaboration with Olympe Imagerie, a Paris-based group of independent radiologists, to deploy the Nanox.ARC and expand its...Read more
Three clinical trial readouts for FB102 expected in 2026, including phase 2 in celiac disease and phase 1b in both vitiligo and alopecia areata DALLAS / Nov 14, 2025 / Business Wire / Forte Biosciences, Inc. (www.fortebiorx.com) (NASDAQ: FBRX), a clinical-stage biopharmaceutical company focused on autoimmune and autoimmune-related diseases, today announced its third quarter 2025 financial results and provided a business update. “We...Read more
Day One Biopharmaceuticals, Inc. to Acquire Mersana Therapeutics, Inc. Agreement provides for upfront consideration of $25.00 per share in cash, plus potential contingent value rights cash payments of up to an aggregate of $30.25 per share, for aggregate deal value of up to approximately $285 million Closing is expected to occur by the end of January 2026 CAMBRIDGE, Mass., Nov. 14, 2025 (GLOBE NEWSWIRE) -- Mersana Therapeutics,...Read more
Appointed Mark Nawacki, seasoned M&A expert, co-founder, president & former CEO of Searchlight Pharma, to Board of Directors Completed IND submission to the U.S. FDA and global regulatory filings to advance a Phase 2 clinical trial of SAT-3247 in children with Duchenne muscular dystrophy (DMD) Dosed first patient in open-label, long-term follow-up study (LT-001) of SAT-3247 in adults with DMD Ended the third quarter of 2025...Read more
FDA Agreement on BMD as Primary Endpoint for EB613 Registrational, Phase 3 Study EB613 Phase 2 Data Demonstrating Consistent Efficacy across Younger Post-Menopausal Women with Osteoporosis and its Impact on Trabecular and Cortical Bone Indices, Highlighted at NAMS and ASBMR Next-Generation EB613 Remains on Track for Phase 1 Initiation in Late 2025 Pre-Clinical Data for Oral OXM in Obesity and Oral GLP-2 in Short Bowel Syndrome in...Read more
BOSTON and ATLANTA, Nov. 14, 2025 (GLOBE NEWSWIRE) -- Inhibikase Therapeutics, Inc. (Nasdaq: IKT) (“Inhibikase” or “Company”), a clinical-stage pharmaceutical company developing therapeutics to modify the course of cardiopulmonary diseases namely, Pulmonary Arterial Hypertension (“PAH”), today reported financial results for the quarter ended September 30, 2025 and highlighted recent developments. “During our third quarter of 2025, we...Read more
Data from Phase 2 BESTOW trial demonstrated a favorable safety and tolerability profile, substantially reducing the metabolic, neurologic, and cardiovascular toxicities commonly associated with tacrolimus Data supports advancement into Phase 3 development as a potential new standard for the prevention of kidney transplant rejection Strengthened balance sheet with $57.5 million financing to advance transplantation...Read more
Total net revenue increased 20.5% to $17.6 million for third quarter of 2025 compared to the third quarter of 2024 Fortress subsidiary Checkpoint Therapeutics acquired by Sun Pharma; Fortress received ~$28 million at closing and is eligible to receive up to an additional $4.8 million under a contingent value right (CVR), plus a 2.5% royalty on future net sales of UNLOXCYT™ (cosibelimab-ipdl) Dotinurad, a next-generation URAT1...Read more
New responsibilities recognize Mr. Sardano’s significant accomplishments in securing CPT® codes for office-based SRT and the growing commercial opportunity the Company now faces BOCA RATON, Fla. / Nov 14, 2025 / Business Wire / Sensus Healthcare, Inc. (Nasdaq: SRTS), a medical device company specializing in highly effective, non-invasive, minimally-invasive and cost-effective treatments for oncological and non-oncological skin...Read more
- Each shareholder is estimated to receive US$1.82 per share plus one CVR per common share - - Transaction expected to close in the first quarter of 2026 - - Additional portfolio monetization efforts continue - - Company reports 3Q 2025 financial results - - $112.6 million in cash and cash equivalents and marketable securities as of September 30, 2025, as compared to $109.5 million at June 30, 2025 - CAMBRIDGE, Mass. & MONTREAL...Read more
Clinical development programs for doxorubicin-containing microneedle array (D-MNA) and Teverelix, a next generation GnRH antagonist, are steadily advancing PHILADELPHIA, PENNSYLVANIA / ACCESS Newswire / November 14, 2025 / Medicus Pharma Ltd. (NASDAQ:MDCX) ("Medicus" or the "Company"), a biotech/life sciences company focused on advancing the clinical development programs of novel and potentially disruptive therapeutic assets,...Read more
New clinical data show durable remissions and long-tail survivors including >2-year complete remissions in chemotherapy- and checkpoint-refractory cancers GVHD trial launching through non-dilutive funding from NIH- and philanthropic grants Launching Phase 2+ trial in severe pulmonary disease in US population with FDA-validated endpoints Added national leaders in pulmonary medicine, trauma, and biodefense join MiNK management (Dr....Read more
Topline data from Phase 3 (IOB-013) clinical trial in advanced melanoma presented at ESMO; data highlights improvements in PFS achieved in overall population and across virtually all subgroups, although statistical significance on the PFS primary endpoint was narrowly missed Meeting scheduled with FDA in December to align on the design of a potential new Phase 3 registrational trial for IO102-IO103 in patients with advanced...Read more
FDA Approval to Advance Final FemBloc® Trial with Clear Pathway to Potentially Achieve U.S. FDA Approval $12 Million Financing Strengthens Balance Sheet and Extends Cash Runway ATLANTA, Nov. 14, 2025 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQ: FEMY), a leading biomedical innovator making fertility and non-surgical permanent birth control more accessible and cost-effective to women worldwide, announced its financial results for the...Read more
Company reports $14.3 million in revenue in Q3’25, consisting of $3.6 million in YCANTH® revenue and $10.7 million of license and collaboration revenue Reports positive feedback from the FDA and alignment regarding the study design of a Phase 3 program for VP-315 in basal cell carcinoma; Company presented new data on VP-315 at the recent Society for Immunotherapy of Cancer conference Received positive feedback from European Medicines...Read more
Over $450,000 Adjusted EBITDA and $275,000 positive operating cash flow for the quarter NEW HAVEN, Conn., Nov. 14, 2025 (GLOBE NEWSWIRE) -- Specialty cancer diagnostics company Precipio, Inc. (NASDAQ: PRPO), filed its 10-Q report today. The following are the highlights of the Company’s financial performance and outlook for the remainder of 2025. Q3-2025 Financial Results: Revenues. Q3-2025 revenues reached $6.8M, a 30%...Read more
Targets $3 Billion "Almost-Pumper" Market with First Simplified and Removable/Replaceable Insulin Patch Pump Aims to Improve Patient and Clinician Experience for the Care of Diabetes SAN DIEGO, CA / ACCESS Newswire / November 14, 2025 / Modular Medical, Inc. (NASDAQ:MODD) ("Modular Medical" or the "Company") today announced the 510(k) premarket submission of its next generation Pivot™ tubeless patch pump to the U.S. Food and...Read more
SHELTON, CONNECTICUT / ACCESS Newswire / November 14, 2025 / NanoViricides, Inc. (NYSE American:NNVC) (the "Company"), a clinical stage leader developing revolutionary broad-spectrum antiviral drugs that the virus cannot escape, announced that it will be presenting today, Friday, November 14th, at 11:25am ET at the Pharma Partnering Summit 2025 held at the Hilton Boston Logan Airport in Boston, MA. Event...Read more
LITTLE ELM, Texas / Nov 14, 2025 / Business Wire / Retractable Technologies, Inc. (NYSE American: RVP) reports total net sales of $10.1 million for the third quarter of 2025 and an operating loss of $3.7 million for the period, as compared to total net sales for the same period last year of $10.3 million and an operating loss of $5.1 million. For the first nine months of the year, net sales were $28.8 million and operating losses were $13.5...Read more
LITTLE ELM, Texas / Nov 14, 2025 / Business Wire / Retractable Technologies, Inc. (NYSE American: RVP) announces its EasyPoint® Blood Collection Tube Holder with Needle has received an Innovative Technology designation from Vizient®, the largest healthcare performance improvement company in the country. Each year, healthcare experts serving on one of Vizient’s client-led councils review select products and technologies for their potential...Read more
Company to host investor conference call and webcast on Monday, November 17th, at 9:00am EST PITTSBURGH, Nov. 14, 2025 (GLOBE NEWSWIRE) -- Predictive Oncology (Nasdaq: POAI), an AI-driven drug discovery company that has expanded its business to include a digital asset strategy focused on ATH, the native utility token of the Aethir network, today reported financial and operating results for the quarter ended September 30, 2025,...Read more
Commercially Launched ORLYNVAH™ in the United States in August 2025 Extended Cash Runway into Q2 2026 Company to host conference call today at 8:30amET DUBLIN, Ireland and CHICAGO, Nov. 14, 2025 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (Nasdaq: ITRM) (the Company or Iterum), a company focused on delivering next generation oral and IV antibiotics to treat infections caused by multi-drug resistant pathogens in both community and...Read more
SOUTH SAN FRANCISCO, CA / ACCESS Newswire / November 14, 2025 / CASI Pharmaceuticals, Inc. (NASDAQ:CASI), a clinical-stage biopharmaceutical company focused on the development of CID-103, a potential best-in-class, anti-CD38 monoclonal antibody for patients with organ transplant rejection and autoimmune diseases, today reported business and financial results for the quarter ended September 30, 2025 (the "third quarter"). "We are focused...Read more
ENGLEWOOD, Colo., Nov. 14, 2025 /PRNewswire/ -- Zynex, Inc. (NASDAQ: ZYXI), an innovative medical technology company specializing in the manufacture and sale of non-invasive medical devices for pain management and rehabilitation, today announced a series of strategic initiatives aimed at positioning Zynex for long-term success. Zynex has engaged Province, LLC, an internationally recognized financial advisory firm, to assist on evaluating...Read more
Received FDA Fast Track designation for stenoparib in advanced ovarian cancer Reported landmark median overall survival now exceeding 25 months in ongoing Phase 2 trial Advanced DRP® platform through new licensing agreement TARPON SPRINGS, Fla., November 14, 2025 – Allarity Therapeutics, Inc. (“Allarity” or the “Company”) (NASDAQ: ALLR), a Phase 2 clinical-stage pharmaceutical company dedicated to developing stenoparib (2X-121)—a...Read more
LEXINGTON, Mass., Nov. 14, 2025 /PRNewswire/ -- Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of emavusertib (CA-4948), an orally available, small molecule IRAK4 inhibitor, today announced that Curis will report emavusertib and BTKi clinical data in Primary CNS Lymphoma (PCNSL) and Secondary CNS Lymphoma (SCNSL) in three presentations and preclinical data on emavusertib in an oral presentation at the 30th...Read more
DUBLIN, Nov. 14, 2025 (GLOBE NEWSWIRE) -- Trinity Biotech plc (Nasdaq: TRIB), a commercial-stage biotechnology company focused on human diagnostics and diabetes management solutions, including wearable biosensors, today announced a strategic collaboration with a leading bioinformatics company to conduct advanced analysis on clinical trial data for EpiCapture, the company’s PCR-based epigenetic liquid biopsy test for monitoring the risk of...Read more
Received FDA IND clearance to evaluate CDI-988 as both norovirus preventive and treatment Expects to initiate CDI-988 Phase 1b norovirus challenge study in Q1 2026 Granted NIH SBIR award to advance influenza A/B replication inhibitor program BOTHELL, Wash., Nov. 14, 2025 (GLOBE NEWSWIRE) -- Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) reports financial results for the three and nine months ended September...Read more
APOLLO study showed encouraging overall responses and favorable safety profile in relapsed/refractory B-cell lymphoma MT-601 demonstrated 66% objective response rate with 50% complete response in relapsed Non-Hodgkin lymphoma (NHL) patients in the ongoing APOLLO study First patient treated in Off-the-Shelf program (RAPID study) investigating MAR-T cells in patients with Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome...Read more
LOS GATOS, CA / ACCESS Newswire / November 14, 2025 / Tenon Medical, Inc. (NASDAQ:TNON) ("Tenon" or the "Company"), a company transforming care for patients suffering with certain sacro-pelvic disorders, today announced the successful closing of its previously announced at-the-market private investment in public equity (the "PIPE") financing. As part of the closing of the PIPE, Tenon Medical has issued an aggregate of 2,217,904 shares of...Read more
BOSTON, Nov. 14, 2025 (GLOBE NEWSWIRE) -- Sensei Biotherapeutics, Inc. (Nasdaq: SNSE), a clinical stage biotechnology company focused on the discovery and development of next-generation therapeutics for cancer patients, today reported financial results for the third quarter 2025. On October 30, 2025, the Company announced that its Board of Directors determined, after extensive consideration of the Company’s development pipeline and...Read more
Phase 1 trial evaluating GTB-3650 TriKE® for relapsed or refractory (r/r) CD33 expressing hematologic malignancies continues to actively enroll with the next update anticipated in Q1 2026 GTB-5550 TriKE® IND submission for B7H3-expressing solid tumors expected in late December 2025 or January 2026 SAN FRANCISCO, CALIFORNIA, Nov. 14, 2025 (GLOBE NEWSWIRE) -- GT Biopharma, Inc. (the “Company”) (NASDAQ: GTBP), a clinical stage...Read more
Record quarter of ReWalk systems placed for Medicare beneficiaries since fee schedule established Ongoing efficiency initiatives drive 16% year-over-year decrease in quarterly cash burn and 27% decrease in quarterly Non-GAAP operating loss Entered into $3.0 million loan agreement with Oramed Ltd. providing additional capital support MARLBOROUGH, Mass. and YOKNEAM ILLIT, Israel, Nov. 14, 2025 (GLOBE NEWSWIRE) --...Read more
TORONTO, ONTARIO, Nov. 14, 2025 (GLOBE NEWSWIRE) -- COSCIENS Biopharma Inc. (TSX: CSCI) (FINRA: CSCIF) (“COSCIENS” or the “Company”), a life science company focused on natural ingredients and pharmaceutical solutions, announced today that Peter H. Puccetti, CFA, Chairman of the Company’s board of directors (the “Board”), has been appointed Interim Chief Executive Officer, effective immediately. Peter succeeds Anna Biehn, who has stepped...Read more
Company achieves 86% increase in CyPath® Lung testing revenue, strengthens balance sheet SAN ANTONIO / Nov 14, 2025 / Business Wire / bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company focused on providing noninvasive, accurate detection of early-stage lung cancer and other lung diseases, today reported financial results for the three months ended September 30, 2025. Key Highlights CyPath® Lung revenues...Read more
GLEN ALLEN, Va., Nov. 14, 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 provided a business update and reported its financial results for the third quarter of 2025. Cary Claiborne, CEO of Adial Pharmaceuticals, commented, “We continue...Read more
MIRAMAR, Fla., Nov. 14, 2025 (GLOBE NEWSWIRE) -- HCW Biologics Inc. (the “Company” or “HCW Biologics”) (NASDAQ: HCWB), a clinical-stage biopharmaceutical company focused on discovering and developing novel immunotherapies to lengthen healthspan by disrupting the link between inflammation and diseases, today reported financial results and recent business highlights for its third quarter ended September 30, 2025. The Company anticipates...Read more
Initiated development of a second CAPTN-3 tri-specific antibody targeting TROP2 Manufacturing milestone achieved for IM1240, the first tri-specific 5T4-targeting antibody from the CAPTN-3 platform Cash position of $10.5 million as of September 30, 2025, with an anticipated cash runway into the first half of 2027, supporting the development of our CAPTN-3 technology platform through significant milestones REHOVOT, Israel, Nov. 14,...Read more
NEW YORK, Nov. 14, 2025 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (OTCQB: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced financial results for the third quarter ended September 30, 2025, and provided a corporate update. "We are making steady progress toward stabilizing our financial situation and initiating our Phase 3b study of NurOwn, designed to generate...Read more
Third Quarter Highlighted by Initiation of Phase 3 Study of PF614, Underscoring Progress Toward Market Readiness and Commitment to Novel Opioid Solutions Further Program Advancement Supported by Preferred Stock Financing SAN DIEGO, CA / ACCESS Newswire / November 14, 2025 / Ensysce Biosciences, Inc. (NASDAQ:ENSC) ("Ensysce" or the "Company"), a clinical-stage pharmaceutical company pioneering next-generation severe pain therapeutics...Read more
Continues Execution of Strategic Transformation and Advancement of Biologics Pipeline FREMONT, CA / ACCESS Newswire / November 14, 2025 / Tivic Health® Systems, Inc. (Nasdaq:TIVC), a diversified immunotherapeutics company, today announced financial results for the third quarter and nine months ended September 30, 2025 and provided a business update. "Following our discussions at the Military Health System Research Symposium and...Read more
In Q3, Enveric continued toward clinical readiness for lead candidate EB-003, targeting neuropsychiatric indications, announcing additional positive data in a preclinical model of PTSD, successful completion of dose range finding studies, and receipt of FDA response to pre-IND meeting request. CAMBRIDGE, Mass. / Nov 14, 2025 / Business Wire / Enveric Biosciences (NASDAQ: ENVB) (“Enveric” or the “Company”), a biotechnology company...Read more
BOULDER, CO / ACCESS Newswire / November 14, 2025 / Encision Inc. (PK:ECIA), a medical device company owning patented Active Electrode Monitoring (AEM®) Technology that prevents dangerous radiant energy burns in minimally invasive surgery, today announced financial results for its fiscal 2026 second quarter that ended September 30, 2025. The Company posted quarterly product net revenue of $1.48 million and service net revenue of $46...Read more
Dermata announced a strategic pivot to develop and commercialize over-the-counter (OTC) skin care treatments Dermata plans to launch its first OTC product, a once weekly acne kit with its Spongilla technology, in the middle of 2026 SAN DIEGO, CALIFORNIA / ACCESS Newswire / November 14, 2025 / Dermata Therapeutics, Inc. (Nasdaq:DRMA; DRMAW) ("Dermata," or the "Company"), a science-driven leader in dermatologic solutions, today...Read more
Completes IPO, Expands Patent Portfolio, and Strengthens Board Independence TUCSON, Ariz., Nov. 14, 2025 (GLOBE NEWSWIRE) -- Picard Medical, Inc. (NYSE American: PMI) (“Picard” or the “Company”), parent company of SynCardia Systems LLC, maker of the world’s first total artificial heart approved by both the U.S. FDA and Health Canada, today announced financial results for the three and nine months ended September 30, 2025. Patrick NJ...Read more
Company to offer the first clinically validated dietary management of sarcopenia, now available for GLP-1 muscle loss, positioning Wellgistics to help 6,500+ independent pharmacy network ('Pharmacy Network') and telehealth partners mitigate patient muscle loss in the GLP-1 drug market, estimated to grow to $150 billion by 2030 Company to offer first SARS-CoV-2 related natural antiviral combo for Long COVID with addition of 3CL...Read more
The Novel HIV Therapy has the Potential to Expand Options for Virologically Suppressed Adults Treated with Complex ART Regimens Phase 3 Results from ARTISTRY-1 and 2 Trials will Form the Basis of Regulatory Submissions FOSTER CITY, Calif. / Nov 13, 2025 / Business Wire / Gilead Sciences, Inc. (NASDAQ: GILD) today announced positive topline results from the Phase 3 ARTISTRY-1 trial. The open-label trial evaluated the...Read more
Acquisition brings highly differentiated clinical-stage obesity candidates with potential to reshape the treatment landscape Complements and transforms Pfizer’s Internal Medicine portfolio Positions Pfizer to lead in one of the most dynamic and high-growth therapeutic areas NEW YORK / Nov 13, 2025 / Business Wire / Pfizer Inc. (NYSE: PFE) today announced the successful completion of its acquisition of Metsera, Inc. (NASDAQ: MTSR), a...Read more
Oral presentation of Lynozyfic™ (linvoseltamab-gcpt) data in newly diagnosed multiple myeloma from LINKER-MM4, the first trial to evaluate a BCMAxCD3 bispecific antibody as a monotherapy in this setting Additional oral presentation spotlights data for odronextamab in combination with chemotherapy, without rituximab, as a frontline treatment for diffuse large B-cell lymphoma Other presentations span a broad range of hematologic...Read more
Alloy Partners, Elanco and other corporate partners join forces to develop new venture studio INDIANAPOLIS, Nov. 13, 2025 /PRNewswire/ -- Alloy Partners today announced the launch of OneHealth Studio, a first-of-its-kind venture studio designed specifically to create and scale new companies at the convergence of animal, plant and human health in partnership withElanco Animal Health (NYSE: ELAN). Located in the OneHealth Innovation...Read more
Nation's Largest HSA Custodian Leverages Parloa’s Advanced AI Technology to Deliver Personalized, Conversational Support for Millions of Members DRAPER, Utah, Nov. 13, 2025 (GLOBE NEWSWIRE) -- HealthEquity, Inc. (Nasdaq: HQY), the nation's largest Health Savings Account (HSA) and consumer-directed benefits administrator, today announced a new development in building upon its technology investments to transform member experience. The...Read more
31,000-square-foot site expands Legend’s U.S. R&D footprint and strengthens its position as a global leader in cell therapy innovation The facility will support CAR-T R&D in potential oncology and immunology indications SOMERSET, N.J., Nov. 13, 2025 (GLOBE NEWSWIRE) -- Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a U.S.-based global leader in cell therapy, today announced the official opening and ribbon...Read more
VAUGHAN, Ontario / Nov 13, 2025 / Business Wire / Bausch + Lomb Corporation (NYSE/TSX: BLCO), a leading global eye health company dedicated to helping people see better to live better, will outline the next chapter of its evolution today during an investor day event at the New York Stock Exchange. Leading Through Reinvention Over the past few years, Bausch + Lomb has undergone a complete transformation by redefining how it operates. The...Read more
SOUTH JORDAN, Utah, Nov. 13, 2025 (GLOBE NEWSWIRE) -- Merit Medical Systems, Inc. (NASDAQ: MMSI), a global leader of healthcare technology, announced today that the U.S. Centers for Medicare & Medicaid Services (“CMS”) has notified Merit that its application for Transitional Pass-Through (“TPT”) incremental payment for WRAPSODY® Cell-Impermeable Endoprosthesis (“CIE”) procedures in the outpatient and ambulatory surgery center (“ASC”)...Read more
First-to-market complex injectable with expected launch in Q1 2026 BRIDGEWATER, N.J., Nov. 13, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) (Nasdaq: AMRX) today announced the U.S. Food and Drug Administration (FDA) has approved the Company’s iohexol injection (300 mg Iodine/mL), the first generic version of GE Healthcare’s Omnipaque® (iohexol) injection. Amneal expects to launch the product in the...Read more
Investigational ZORYVE cream 0.05% was formulated for the delicate skin of infants and young children with mild to moderate atopic dermatitis Topline results anticipated in Q1 2026 The U.S. FDA approved ZORYVE cream 0.05% for the treatment of mild to moderate atopic dermatitis in children ages 2 to 5 years in October 2025 Atopic dermatitis impacts 9.6 million children in the U.S., with up to 60% developing symptoms within their first...Read more
NEW YORK, Nov. 13, 2025 (GLOBE NEWSWIRE) -- Progyny, Inc. (Nasdaq: PGNY), a global leader in women’s health and family building solutions, today announced that Mark Livingston, Progyny’s Chief Financial Officer, will participate in a fireside chat at the Jefferies Global Healthcare Conference on Tuesday, November 18, 2025, at 3:00 p.m. GMT / 10:00 a.m. ET. A live audiocast and replay will be available from the Events and Presentations...Read more
PAPZIMEOS (zopapogene imadenovec-drba) received full approval by the FDA in August PAPZIMEOS launched with a broad label in the US as the first and only FDA-approved treatment for adults with RRP PAPZIMEOS is now available and shipping to prescribers in the US for the treatment of adults with RRP To date, over 100 patients have been registered in the PAPZIMEOS Patient Hub The Company has made significant progress with private health...Read more
Company preparing to initiate comprehensive Phase 3 program for chronic cough in patients with idiopathic pulmonary fibrosis in first half of 2026 Company ended the third quarter of 2025 with $194.9 million in cash, cash equivalents and marketable securities with expected cash runway into 2028 Management to host a conference call and webcast today at 4:30 p.m. EST NEW HAVEN, Conn., Nov. 13, 2025 /PRNewswire/ -- Trevi...Read more
Efficacy data remain consistent with prior disclosure and continue to demonstrate broad and deep PSA responses, with 55% PSA50 response rate and 20% PSA90 response rate Rapid and deep ctDNA reductions were observed in 76% of patients and ctDNA clearance was observed in 59% of patients, underscoring potential for long-term treatment and survival benefit PSA responses and ctDNA reductions were observed across all ORIC-944 dose levels...Read more
Announced completion of dose exploration portion of ORIC-944 Phase 1b clinical trial and presented data that continues to demonstrate potential best-in-class efficacy and safety Bolstered leadership team with the appointment of Kevin Brodbeck, PhD, as Chief Technical Officer to further support ORIC’s transition to potential late-stage development Cash and investments of approximately $413 million expected to provide runway into 2H...Read more
Publication of Interim Results and Presentation at Recent Industry Event Demonstrate Clinical Benefit Associated with Use of EPIEFFECT When Compared to Standard of Care (“SOC”) Publication Adds to Large Compendium of Evidence for MIMEDX’s Leading Product Portfolio Trial Enrollment Ongoing MARIETTA, Ga., Nov. 13, 2025 (GLOBE NEWSWIRE) -- MiMedx Group, Inc. (Nasdaq: MDXG) (“MIMEDX” or the “Company”) today announced the publication...Read more
PALO ALTO, Calif., Nov. 13, 2025 /PRNewswire/ -- Kodiak Sciences Inc. (Nasdaq: KOD), today reported recent business highlights and financial results for the third quarter ended September 30, 2025. "Kodiak Sciences has entered a period of strong, sustained momentum driven by compelling clinical data, accelerated execution and growing external enthusiasm...across all three of our late-stage programs," said Victor Perlroth, M.D., Chief...Read more
Company Reports $13.8M in Q3 Revenue as Refocusing and Cost Cutting Initiatives Drive Improved Late Quarter Performance with Accelerated Sequential Improvements Expected in Q4 and into 2026 HALLANDALE BEACH, Fla., Nov. 13, 2025 /PRNewswire/ -- NextPlat Corp (NASDAQ: NXPL, NXPLW) ("NextPlat" or the "Company"), a global consumer products and services company providing healthcare and technology solutions through e-commerce...Read more
NPM1 mutations, one of the most common genetic drivers of AML, are now actionable for patients Acute unmet need in R/R NPM1-mutated AML defined by historically poor outcomes and low survival rates at relapse FDA grants full approval of KOMZIFTI ahead of PDUFA target action date Approval is based on the KOMET-001 trial, in which KOMZIFTI demonstrated deep responses, a potentially best-in-class safety profile, once-daily...Read more
Acquisition expands Day One’s portfolio with novel antibody-drug conjugate (ADC) emiltatug ledadotin (Emi-Le) Emi-Le has demonstrated early anti-tumor activity in an ongoing Phase 1 study for adenoid cystic carcinoma type-1 (ACC-1), a cancer with high unmet need and a lack of therapeutic options Day One will apply existing scientific and commercial capabilities to this investigational innovative therapeutic with a clear potential...Read more
NEW HAVEN, Conn., Nov. 13, 2025 /PRNewswire/ -- Biohaven Ltd. (NYSE: BHVN), a global clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of life-changing therapies to treat a broad range of rare and common diseases, today announced the closing of its underwritten public offering of 26,833,334 of its common shares, which includes the full exercise of the underwriters' option to purchase...Read more
Strong financial position with cash, cash equivalents and marketable securities of $93.7M Moderna litigation U.S. trial scheduled for March 2026 Favorable claim construction ruling in Pfizer-BioNTech litigation issued in September 2025 Additional analysis of imdusiran (AB-729) clinical data shows: 46% of Phase 2a patients met criteria to discontinue all treatment 94% of long-term follow-up patients remain off all treatment for...Read more
Entered into broad strategic collaboration with Eli Lilly and Company (“Lilly”) in the area of ophthalmology, granting Lilly worldwide exclusive rights to the Company’s AAV-AIPL1 program for treatment of one of the most severe inherited retinopathies, Leber congenital amaurosis 4 (LCA4) Released material under the Company’s Specials license for a second rare pediatric ophthalmology condition caused by mutations in BBS10, with the...Read more
SOUTH SAN FRANCISCO, Calif., Nov. 13, 2025 (GLOBE NEWSWIRE) -- CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of masked, conditionally activated biologics, today announced that Sean McCarthy, D.Phil., chief executive officer and chairman, will participate in a fireside chat at the Jefferies Global Healthcare Conference in London on Thursday, November 20, 2025, at 9:00 a.m. GMT. A live webcast of the presentation will be...Read more
This science-backed blend of Niagen and clinically studied actives is designed to support healthy skin, hair, and nails LOS ANGELES / Nov 13, 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 announced the launch of Tru Niagen® Beauty, the first-ever beauty supplement in the US featuring Niagen (patented...Read more
SOUTH SAN FRANCISCO, Calif., Nov. 13, 2025 (GLOBE NEWSWIRE) -- Alumis Inc. (Nasdaq: ALMS), a clinical-stage biopharmaceutical company developing next-generation targeted therapies for patients with immune-mediated diseases, today reported financial results for the quarter ended September 30, 2025, and highlighted recent achievements. “As we continue to advance our pipeline, we are entering an important period for Alumis. Our teams have...Read more
Conference Call Today at 4:30 p.m. ET SEATTLE / Nov 13, 2025 / Business Wire / Omeros Corporation (Nasdaq: OMER) today announced recent highlights and developments as well as financial results for the third quarter ended September 30, 2025, which include: Net loss for the third quarter of 2025 was $30.9 million, or $0.47 per share, compared to a net loss of $32.2 million, or $0.56 per share for the third quarter of 2024. For the...Read more
BOSTON / Nov 13, 2025 / Business Wire / Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with RAS/MAPK pathway-driven cancers, today announced that it intends to offer and sell shares of its common stock in an underwritten public offering. In connection with the offering, Verastem Oncology intends to grant the underwriters a 30-day option to purchase up to an additional 15% of...Read more
MENLO PARK, Calif., Nov. 13, 2025 (GLOBE NEWSWIRE) -- PacBio (NASDAQ: PACB), a leading developer of high-quality, highly accurate sequencing solutions, announced today that management will be participating in the following upcoming investor conferences: Wolfe Research Healthcare Conference 2025 in New York, NY Fireside chat on Tuesday, November 18 at 8:40 AM ET Jefferies Global Healthcare Conference in London, UK Hosting 1x1...Read more
WILMETTE, Ill., Nov. 13, 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 third quarter 2025 financial results and recent developments. Recent Developments ALXN1840 for Wilson Disease On September 14-15, 2025, the Company presented new data on the long-term...Read more
The 52-week symptom data reported for Cohort 6 patients is consistent with the long-term durability data previously reported from Cohort 5; Cohorts 5 & 6 are the only groups to reach 52 weeks thus far. In Cohort 6, a durable clinical symptom response was observed 52 weeks after a single administration of EP-104GI. All 3 patients in Cohort 6 maintained a clinical benefit and 2 out of 3 patients remain in clinical remission 52 weeks...Read more
WARSAW, Ind., Nov. 13, 2025 (GLOBE NEWSWIRE) -- OrthoPediatrics Corp. (“OrthoPediatrics” or the “Company”) (Nasdaq: KIDS), a company focused exclusively on advancing the field of pediatric orthopedics, today announced the expansion of its OrthoPediatrics Specialty Bracing (“OPSB”) portfolio with two new products launches, the PediHip™ Rigid Brace and PediHip™ Modular Abduction Systems. The company now has 31 systems within its OPSB...Read more
Partnership deployed touchless prior authorization system in eight weeks, achieving 95% reduction in authorization workload CERRITOS, Calif. and NEW YORK, Nov. 13, 2025 (GLOBE NEWSWIRE) -- Ascertain, a healthcare technology company pioneering agentic AI to automate administrative workflows, and The Oncology Institute, Inc. (NASDAQ: TOI), a leading value-based oncology care provider, today announced a co-development partnership to...Read more
CERRITOS, Calif., Nov. 13, 2025 (GLOBE NEWSWIRE) -- The Oncology Institute, Inc. (NASDAQ: TOI) (“TOI” or the “Company”), one of the largest value-based community oncology groups in the United States, today reported financial results for its three months ended September 30, 2025 and updated its full year 2025 guidance. Recent Operational Highlights Fee-for-service revenue growth of 13% over Q3 2024, driven by continued organic growth...Read more
LINCOLN, Neb. / Nov 13, 2025 / Business Wire / NRC Health, the leader in healthcare experience management, is proud to announce a new partnership with BJC Health System, one of the nation’s largest nonprofit integrated healthcare delivery organizations. The collaboration will unify and elevate patient and employee experiences across BJC’s hospitals, clinics, and academic partners, reinforcing its mission to improve the health and well-being...Read more
Aura Provides Phase 3 CoMpass Trial Completion Guidance: 2026 Enrollment Completion and Q4 2027 Topline Data Readout for the 15-Month Primary Endpoint Immune Profiling Data Reveal Bel-sar’s Potential to Convert ‘Cold’ to ‘Hot’ Tumors, Supporting a Frontline Therapy Across the Bladder Cancer Spectrum; Phase 1b/2 Trial is on Track for Data Mid-2026 BOSTON, Nov. 13, 2025 (GLOBE NEWSWIRE) -- Aura Biosciences, Inc. (NASDAQ: AURA), a...Read more
Reported positive interim data from NGN-401 Phase 1/2 gene therapy trial for Rett syndrome demonstrating multidomain, durable gains, with 35 total developmental milestones/skills acquired across eight participants First participant dosed in Embolden™ registrational trial of NGN-401 for Rett syndrome, with complete enrollment expected in three to six months Strong cash position provides runway through first quarter of 2028 NEW YORK /...Read more
QUEENSBURY, N.Y. / Nov 13, 2025 / Business Wire / Delcath Systems, Inc. (Nasdaq: DCTH), (“Delcath” or the “Company”) an interventional oncology company focused on the treatment of primary and metastatic liver cancers, today announced the publication of results from a retrospective analysis conducted by researchers at the University of Tubingen, Germany. The study, titled “Characterization of long-term survivors with liver metastases from...Read more
Deep TMS™ becomes first and only TMS device cleared in treatment of patients aged 15 to 86 suffering from depression BURLINGTON, Mass. and JERUSALEM, Israel, Nov. 13, 2025 (GLOBE NEWSWIRE) -- BrainsWay Ltd. (NASDAQ & TASE: BWAY) (“BrainsWay” or the “Company”), a global leader in advanced noninvasive neurostimulation treatments for mental health disorders, today announced that the U.S. Food and Drug Administration (FDA) has...Read more
LEXINGTON, Mass. / Nov 13, 2025 / Business Wire / Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a biotechnology company devoted to discovering and developing innovative therapies designed to treat immune-mediated diseases, today announced at a research and development webcast the expansion of the RASP platform to include programs in central nervous system diseases associated with inflammation, and provided updated manufacturing...Read more
Closed registered direct offering for aggregate gross proceeds of US$175 million (the “Registered Direct Offering”) led by a syndicate of prominent biopharmaceutical institutional investors On track to report topline data from Phase 2 study evaluating CYB004 for the treatment of Generalized Anxiety Disorder (“GAD”) in Q1 20261 Continues to advance Phase 3 studies of CYB003 for the adjunctive treatment of major depressive...Read more
Viking Therapeutics is a clinical-stage biopharmaceutical company focused on the development of novel first-in-class or best-in-class therapies for the treatment of metabolic and endocrine disorders, with three compounds currently in clinical trials. Viking’s research and development activities leverage...
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Terns Pharmaceuticals is a clinical-stage biopharmaceutical company developing a portfolio of small-molecule product candidates to address serious diseases, including oncology and obesity. Terns’ pipeline contains three clinical stage development programs including GLP-1 receptor...
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