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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Continued advancement of two Phase 2 clinical trials evaluating tibulizumab in hidradenitis suppurativa (HS) (TibuSHIELD) and systemic sclerosis (SSc) (TibuSURE), with topline data expected in the second half of 2026. Reported $139.0 million in cash and cash equivalents as of September 30, 2025, which is expected to fund planned operations through 2027. HENDERSON, Nev. / Nov 13, 2025 / Business Wire / Zura Bio Limited (Nasdaq: ZURA)...Read more
LEHI, Utah / Nov 13, 2025 / Business Wire / Owlet, Inc. (“Owlet” or the “Company”) (NYSE:OWLT), the pioneer of smart infant monitoring, today reports financial results for the third quarter ended September 30, 2025. Owlet’s Chief Executive Officer and President, Jonathan Harris, and Chief Financial Officer, Amanda Twede Crawford, will host a conference call to review the Company’s results and provide a business and corporate update today,...Read more
Novel combination with neoadjuvant eftilagimod alfa (efti) achieves significant 51.5% tumour hyalinization/fibrosis across multiple soft tissue sarcoma subtypes including rare and highly aggressive tumours with poor prognosis Early translational data show a strong immune system activation inline with efti’s mode of action with statistically-significant increases in multiple cytokines and chemokines High levels of key immune...Read more
Presented new subgroup analyses from phase 3 clinical trial of CAN-2409 in localized prostate cancer at the American Society for Radiation Oncology (ASTRO) 2025 meeting, demonstrating improved prostate cancer-specific disease-free survival (DFS), independent of radiation therapy modality...Read more
Phase 1 clinical trial to evaluate the PK of a combination of denifanstat and resmetirom ongoing with data readout expected 1H 2026 First-in-human Phase 1 clinical trial of FASN inhibitor TVB-3567 ongoing Ascletis announced completion of its pre-NDA consultation with China’s NMPA and plans to submit an NDA for denifanstat in China for treatment of moderate-to-severe acne vulgaris SAN MATEO, Calif., Nov. 13, 2025...Read more
DURHAM, N.C., Nov. 13, 2025 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, today announced the details of six presentations on the Company’s acellular tissue engineered vessel (ATEV™) that are scheduled for the 52nd Annual Symposium on Vascular and Endovascular Issues, Techniques And Horizons...Read more
TriSalus Reports $11.6 million in Revenue, Up 57% Year-over-Year, Reflecting Strong Liver Embolization growth Investigator Published Data Show TriNav Enables Safe, Effective Thyroid Embolization Alternative to Surgery Reaffirmed revenue guidance of at least 50% growth due to continued commercial momentum Hosting Conference Call and Webcast today at 4:30pm ET DENVER / Nov 13, 2025 / Business Wire / TriSalus Life Sciences, Inc....Read more
RESEARCH TRIANGLE PARK, N.C., Nov. 13, 2025 (GLOBE NEWSWIRE) -- Fennec Pharmaceuticals Inc. (NASDAQ:FENC) (TSX:FRX) (“Fennec” or the “Company”), a specialty pharmaceutical company, today announced that it intends to offer and sell its common shares in an underwritten registered public offering. In addition, Fennec intends to grant the underwriters a 30-day option to purchase up to an additional 15% of its common shares sold in the public...Read more
Q3 2025 Total Net Product Sales of $12.5 Million, 79% Year Over Year Growth Q3 2025 Positive Cash Flow from Operations, Cash Position Grew to $22 Million Japan Clinical Trial (STS-J01) Preliminary Results Expected in Q4 2025 RESEARCH TRIANGLE PARK, N.C., Nov. 13, 2025 (GLOBE NEWSWIRE) -- Fennec Pharmaceuticals Inc. (NASDAQ:FENC; TSX: FRX), a specialty pharmaceutical company, today reported its financial results...Read more
US launch off to a strong start. First commercial Genio implants completed with widespread payer coverage drives initial revenue. Mont-Saint-Guibert, Belgium – November 13, 2025, 10:10pm CET / 4:10 pm ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), a medical technology company that develops breakthrough treatment alternatives for Obstructive Sleep Apnea (OSA) through neuromodulation, today reported...Read more
Financings are comprised of equity investments, including from Cochlear, Resmed and Nyxoah’s Chairman and Management, and a convertible bond. Mont-Saint-Guibert, Belgium – November 13, 2025, 2025, 10:11pm CET / 4:11 pm ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (OSA)...Read more
BOSTON, Nov. 13, 2025 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies with its lead development candidate, intranasal foralumab, a fully human, anti-CD3 monoclonal antibody, today announced that its senior leadership team will present at the prestigious Jefferies London Healthcare Conference. Chief Executive Officer...Read more
TORONTO, Nov. 13, 2025 (GLOBE NEWSWIRE) -- Profound Medical Corp. (NASDAQ:PROF; TSX:PRN) (“Profound” or the “Company”), a commercial-stage medical device company that develops and markets AI-powered, MRI-guided, incision-free therapies for the ablation of diseased tissue, today reported unaudited financial results for the third quarter ended September 30, 2025. Unless specified otherwise, all amounts in this press release are expressed in...Read more
100% LLDAS response rate observed in patients with SLE who received Descartes-08 in Phase 2 open-label trial reaching Month 3 follow-up (n=3) Disease remission reported as DORIS response seen in 2 out of 3 patients reaching Month 3 follow-up (n=3) Descartes-08 in SLE patients was observed to have a favorable safety profile supporting outpatient administration without the need for lymphodepleting chemotherapy Myositis seamless...Read more
Live demonstrations of Nanox.ARC X to be featured at RSNA booth (3914, South Hall Level 3) every 30 minutes Innovation Theater presentation to highlight development of pulmonary nodule AI solution, as future component of Nanox.ARC X; Dec 2 at 11:00am (Innovation Theater, Booth # 3316, South Hall A) Poster presentation: “Applications of Digital Tomosynthesis in the Musculoskeletal System” (Learning Center, East Level 3) Dr. Lawrence...Read more
Following FDA clearance for confirmatory Phase 3 trial TELLOMAK-3, lacutamab is progressing toward Phase 3 initiation in H1 2026 and potential accelerated approval in Sézary syndrome IPH4502 Nectin-4 ADC Phase 1 enrollment continues to progress well - pharmacologically active dose reached Monalizumab PACIFIC-9 on track to deliver data in H2 2026 Cash position of € 56.4 million1 as of September 30, 2025, anticipated cash runway until...Read more
Adjusted EBITDA grew 19% in Q3 and 25% year-to-date Cash from operations grew 67% in Q3 and 121% year-to-date Announced new credit facility with lower rates, increased flexibility and reduced F/X risk Bempedoic acid approval expected in Q4 2025; preparations underway for Q2 2026 launch TORONTO, Nov. 13, 2025 /CNW/ - HLS Therapeutics Inc. ("HLS" or the "Company") (TSX: HLS), a pharmaceutical company focused...Read more
In the ongoing Phase 2 AMPLIFY-7P study evaluating ELI-002 7P in patients with pancreatic ductal adenocarcinoma (“PDAC”), fewer disease progressions and deaths than projected have been observed as of November 6, 2025. Based on 2:1 randomization with twice as many patients in the ELI-002 7P treatment arm compared to the observation arm, Elicio believes the lower-than-projected number of disease progressions and deaths may reflect...Read more
Veris Health launched commercial phase of strategic partnership and relaunched development of implantable physiological monitor PAVmed signed letter of intent (LOI) to license groundbreaking endoscopic esophageal imaging technology Conference call and webcast to be held today, November 13, at 8:30 AM EST NEW YORK, Nov. 13, 2025 /PRNewswire/ -- PAVmed Inc. (NASDAQ: PAVM) ("PAVmed" or the "Company"), a diversified...Read more
Study conducted in collaboration with the Alzheimer’s Clinical Trials Consortium PURCHASE, N.Y., Nov. 13, 2025 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc., (the Company or Cognition) (NASDAQ: CGTX), a clinical stage company developing drugs that treat neurodegenerative disorders, announced that the company has reached target enrollment of 540 participants in the randomized, placebo-controlled Phase 2 ‘START’ Study. A number of...Read more
Results from PIVOT-PO Phase 3 trial evaluating tebipenem HBr in complicated urinary tract infection (cUTI) presented as IDWeek late-breaker in October 2025 Spero’s development partner, GSK, plans to submit data from the PIVOT-PO trial as part of a planned US Food and Drug Administration (FDA) filing in 4Q 2025 Company expects current cash and cash equivalents to fund operations into 2028 CAMBRIDGE, Mass., Nov. 13, 2025 (GLOBE...Read more
Agreement with Day One Biopharmaceuticals 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. 13, 2025 (GLOBE NEWSWIRE) -- Mersana Therapeutics, Inc. (Nasdaq: MRSN), a clinical-stage...Read more
Positive 9-month follow-up data for NDV-01 showed a 92% overall response rate at any time in non-muscle invasive bladder cancer (NMIBC), with favorable overall safety Secured FDA alignment on key elements of Phase 3 program with two independent paths for approval in two separate NMIBC indications: High-risk 2nd line BCG-unresponsive, and Intermediate-risk patients in the adjuvant setting; Studies expected to begin H1 2026 Completed...Read more
Key Highlights ZUNVEYL Launch Momentum: Completed the second quarter of commercialization, generating approximately $2.8 million in total revenue for the quarter. Significant Growth: 102% quarterly increase in pharmacy orders, with record prescription volumes achieved each month during the quarter. Expanding Prescriber Base: Q3 prescribers surpassed 500, representing 55% growth over the prior quarter. Disciplined Expense Management:...Read more
PALISADE-3 Phase 3 Public Speaking Challenge Study of Fasedienol for the Acute Treatment of Social Anxiety Disorder is Complete; Topline results expected by calendar year end SOUTH SAN FRANCISCO, Calif. / Nov 13, 2025 / Business Wire / Vistagen (Nasdaq: VTGN), a late clinical-stage biopharmaceutical company pioneering neuroscience with nose-to-brain neurocircuitry to develop and commercialize a new class of intranasal product...Read more
Authorization Received from UK and EU Authorities to Activate ex-US Clinical Trial Sites Supporting the Ongoing Patient Enrollment of FT819, an Off-the-Shelf CD19-targeted CAR T-cell Product Candidate that Utilizes Less-intensive or No Conditioning, Enabling Broad Patient Accessibility First Systemic Sclerosis Patient treated in Phase 1 Study of FT819 Following Fludarabine-free Conditioning; Dose Expansion Designed to Evaluate Patient...Read more
Updated MDNA11 Clinical Data from the ABILITY-1 Study will be Presented at the European Society for Medical Oncology (ESMO) Immuno-Oncology Congress on 10th December, 2025 Fondazion Melanoma Onus will sponsor a new clinical trial (NEO-CYT) at up to 12 cancer centres in Italy to evaluate if MDNA11 in combination with leading check-point inhibitors, prior to surgery (neoadjuvant), can improve outcomes in patients with earlier stage...Read more
SALT LAKE CITY, Nov. 13, 2025 /PRNewswire/ -- Sera Prognostics Inc., The Pregnancy Company® (Nasdaq: SERA), focused on improving maternal and neonatal health by providing innovative pregnancy biomarker information to doctors and patients, today announced financial results for the third quarter of 2025 ended September 30, 2025. Third Quarter and Recent Highlights: Meaningful progress on payer initiatives, including an inaugural...Read more
AUSTIN, Texas / Nov 13, 2025 / Business Wire / Anebulo Pharmaceuticals, Inc. (Nasdaq: ANEB), a clinical-stage pharmaceutical company developing novel solutions for people suffering from acute cannabis-induced toxic effects (the “Company” or “Anebulo”), today announced financial results for the three months ended September 30, 2025, and recent updates. First Quarter Fiscal Year 2026 and Subsequent Highlights: On September 25, 2025,...Read more
Company plans to initiate Phase 1 clinical study of semaglutide implant for chronic weight management in the first half of 2026 and parallel investments in studies to enable rapid initiation of Phase 2 dose-ranging study, pending Phase 1 results and regulatory feedback 3Q 2025 private placement, together with October financings, generated approximately $25.7M in cash and cash commitments to support accelerated development of NPM-139...Read more
Once issued, this new U.S. patent covers the use of CardiolRx™ and CRD-38 for a broad range of cardiac disorders, including atherosclerosis and heart failure, significantly expanding intellectual property protection in the world's largest pharmaceutical market. This allowance fortifies Cardiol's global intellectual property portfolio, adding to granted and pending patent applications in Europe, Japan, Canada, Australia, and...Read more
First patient dosed in Phase 1 clinical trial evaluating AXN-2510/IMM2510 (“’2510”) monotherapy in adult patients with advanced solid tumors DALLAS, Nov. 13, 2025 (GLOBE NEWSWIRE) -- Instil Bio, Inc. (“Instil”) (Nasdaq: TIL), a clinical-stage biopharmaceutical company focused on developing a pipeline of novel therapies, today reported its third quarter 2025 financial results and provided a corporate update. Recent Highlights: In...Read more
SAN DIEGO and SUZHOU, China and SPRING HOUSE, Pa., Nov. 13, 2025 (GLOBE NEWSWIRE) -- Adagene Inc. (“Adagene”) (Nasdaq: ADAG) and Third Arc Bio, Inc. (“Third Arc Bio”), today announced a licensing agreement under which Third Arc Bio will utilize Adagene’s SAFEbody technology platform to generate masked CD3 T cell engagers against unique tumor associated antigens. Under the terms of the agreement, Third Arc Bio will receive rights to...Read more
GUILFORD, Conn. / Nov 13, 2025 / Business Wire / Hyperfine, Inc. (Nasdaq: HYPR), the groundbreaking health technology company that has redefined brain imaging with the first FDA-cleared AI-powered portable magnetic resonance (MR) brain imaging system—the Swoop® system—today announced third quarter 2025 financial results and provided a business update. “In the third quarter, we began to reap the benefits of two key growth catalysts with the...Read more
Entered into an exclusive license agreement with Dynavax for the Company’s COVID-19 oral pill vaccine candidate for potential cumulative proceeds of up to $700 million plus royalties Completed enrollment of approximately 5,400 participants in COVID-19 Phase 2b trial with topline data expected in late 2026; Topline data from 400-person sentinel cohort anticipated in the first quarter of 2026 Reported additional supportive data from...Read more
As the U.S. Food and Drug Administration (FDA) proposed, Clene is concluding analyses of its ALS biomarker data with completion planned shortly The FDA advised Clene to request a Type C meeting to review these further ALS biomarker data analyses The Company plans to submit a New Drug Application (NDA) in the first quarter of 2026 under an accelerated approval pathway The Company expects to have the first patient dosed in the...Read more
Key Data Highlighting Vidofludimus Calcium's Therapeutic Potential in Multiple Sclerosis Presented at 41st Congress of ECTRIMS Phase 2 CALLIPER Data Demonstrated Statistically Significant 24-Week Confirmed Disability Improvement in Progressive Multiple Sclerosis, With Consistent Signals for Slowing Disability Progression Across Subgroups and Endpoints, Supporting Vidofludimus Calcium's Neuroprotective Potential and Nurr1...Read more
THE SKNJCT-003 CLINICAL STUDY EXPANSION INTO THE UNITED KINGDOM TO FURTHER ENABLE GLOBAL PATIENT RECRUITMENT AND CLINICAL DATASET TOWARD A PIVOTAL STUDY PROGRAM PHILADELPHIA, PA / ACCESS Newswire / November 13, 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 therapeutics assets, is pleased...Read more
Third quarter 2025 revenue was $5.0 million, compared to $7.4 million in the third quarter of 2024, and $5.4 million in the second quarter of 2025 Targeting $12.4 million in new business, reflecting both committed annual recurring revenue ("CARR") and late-stage opportunities nearing completion; 2026 pipeline expanded to $69 million Exceeded 2025 goal of 40 new signed accounts for 2026 revenue, with 45 new signed accounts to...Read more
Multiple Late-Stage Data Readouts Reinforce Telitacicept’s Broad Potential Across Autoimmune DiseasesExpansion of Executive Leadership and Board Strengthens Global Development Capabilities Expected gross proceeds of $115 million raised in the November 2025 underwritten public offering, including the underwriters’ full exercise of the option to purchase additional shares BOSTON, Nov. 13, 2025 (GLOBE NEWSWIRE) -- Vor Bio (Nasdaq:...Read more
Prescription Drug User Fee Act (PDUFA) goal date of December 31, 2025 ISELIN, N.J., Nov. 13, 2025 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on enhancing the standard of care for bevacizumab for the treatment of retina diseases, today announced that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of the resubmission of the Biologics License Application (BLA)...Read more
Advancement of ACR-368 in registrational-intent Phase 2b trial for the treatment of patients with endometrial cancer Preparing for initial clinical data disclosure for ACR-2316 from the Phase 1 trial in AP3-prioritized solid tumor types Expanding power of Generative Phosphoproteomics AP3 supersedes conventional target-centric drug discovery, yielding differentiated compounds with desired pathway effects Cash, cash equivalents and...Read more
Pre-NDA meeting with FDA to discuss brilaroxazine’s path to approval for schizophrenia planned in Q4 2025 Potential NDA submission for schizophrenia indication targeted for Q2 2026 European patent granted covering use of brilaroxazine for the treatment of pulmonary fibrosis adds to existing patent protection in key global markets CUPERTINO, Calif., Nov. 13, 2025 (GLOBE NEWSWIRE) -- Reviva Pharmaceuticals Holdings,...Read more
PORTLAND, Maine, Nov. 13, 2025 (GLOBE NEWSWIRE) -- ImmuCell Corporation (Nasdaq: ICCC) (“ImmuCell” or the “Company”), a growing animal health company that develops, manufactures and markets scientifically proven and practical products that improve the health and productivity of dairy and beef cattle, today announced its unaudited financial results for the quarter ended September 30, 2025. Product Sales Highlights: During the...Read more
Commercial Readiness Plans Accelerating in Anticipation of FDA 510(k) Clearance for Groundbreaking 12-lead Electrocardiogram (ECG) Synthesis Software for Arrhythmia Assessment Anticipated FDA Clearance in Q4 2025 is a Major Inflection Point as HeartBeam Evolves into a Commercial-Stage Company Focused on Growth Announced Partnership with HeartNexus to Provide On-Demand Cardiologist Reviews of Synthesized 12-Lead ECGs for Arrhythmia...Read more
Closed financing of up to $50 million; initial tranche of $30 million provides runway through 2027 Hosted key opinion leader event highlighting the important role of the Aryl Hydrocarbon Receptor (AhR) in intestinal inflammation, the unmet medical need in ulcerative colitis, and the potential clinical utility of EQ504, a novel oral AhR modulator EQ504 Phase 1 clinical study initiation planned for mid-2026 LA JOLLA, Calif., Nov. 13,...Read more
SOUTH SAN FRANCISCO, Calif., Nov. 13, 2025 (GLOBE NEWSWIRE) -- Senti Biosciences, Inc. (Nasdaq: SNTI) (“Senti Bio”), a clinical-stage biotechnology company developing next-generation cell and gene therapies using its proprietary Gene Circuit platform, today reported financial results for the third quarter of 2025 and provided a summary of recent pipeline and corporate highlights. “Our team is laser focused on driving SENTI-202 clinical...Read more
Announced U.S. Food and Drug Administration (FDA) Acceptance for Reviewof New Drug Application (NDA) for GTx-104 FDA Established April 23, 2026 as PDUFA Target Date for Review of Submission Seeking Approval for GTx-104 in the Treatment of Patients with aneurysmal Subarachnoid Hemorrhage (aSAH) Phase 3 STRIVE-ON Safety Trial Data Presented at 2025 Neurocritical Care Annual Meeting Granted Sixth U.S. Patent Covering IV Dosing Regimen...Read more
Toronto, Ontario and Boston, Massachusetts--(Newsfile Corp. - November 13, 2025) - Sernova Biotherapeutics (TSX: SVA) (OTC: SEOVF) (FSE: PSH) ("Sernova or the Company)") a leading regenerative medicine company focused on developing its Cell Pouch Bio-hybrid Organ as a functional cure for type 1 diabetes (T1D), today announced the closing of the first tranche of a private placement totaling CAD $874,600 in gross proceeds from...Read more
MALVERN, Pa., Nov. 13, 2025 (GLOBE NEWSWIRE) -- TELA Bio, Inc. ("TELA Bio"), a commercial-stage medical technology company focused on providing innovative soft-tissue reconstruction solutions, today reported financial results for the third quarter ended September 30, 2025. Third Quarter 2025 Financial Highlights Revenue of $20.7 million, a 9% increase from the third quarter of 2024 Revised full year 2025 revenue guidance of at least...Read more
MALVERN, Pa., Nov. 13, 2025 (GLOBE NEWSWIRE) -- TELA Bio, Inc. ("TELA"), a commercial-stage medical technology company focused on providing innovative soft-tissue reconstruction solutions, today announced the pricing of an underwritten registered direct offering of 4,189,000 shares of its common stock at a price of $1.11 per share and, in lieu of common stock to investors who so choose, pre-funded warrants to purchase 7,523,000 shares of...Read more
Conference call to discuss financial and operational results scheduled for Friday, November 14 at 8:30 a.m. U.S. Eastern Time HENDERSON, Nevada, Nov. 13, 2025 /PRNewswire/ -- VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition"), a multi-national epigenetics company, today announces financial results and a business update for the third quarter ended September 30, 2025. Volition management will host a conference call tomorrow,...Read more
Third quarter 2025 revenue of $9.5 million, up 10% year-over-year Amended credit agreement with Avenue Capital Group which strengthens our balance sheet with an additional $2.5 million of cash, and extends the interest only-period through December 31, 2026, with an additional $2.5 million available and an additional extension of the interest-only period to June 30, 2027 with DrugSorb-ATR FDA marketing approval Implemented...Read more
HUNTSVILLE, Nov. 13, 2025 (GLOBE NEWSWIRE) -- Serina Therapeutics, Inc. (“Serina” or the "Company") (NYSE American: SER), a clinical-stage biotechnology company advancing its lead Investigational New Drug ("IND") candidate, SER-252, for advanced Parkinson's disease, enabled by its proprietary POZ Platform™ drug optimization technology, today announced its financial results for the third quarter ended September 30, 2025, along with...Read more
Update on regulatory strategy for govorestat for the treatment of CMT-SORD following receipt of Type C meeting minutes Meeting scheduled with the FDA in 4Q 2025 to discuss govorestat for the treatment of Classic Galactosemia New data on govorestat for the treatment of PMM2-CDG published in JIMD and presented at the 2025 ASHG Annual Meeting Announces Board of Directors Leadership Transition NEW YORK, Nov. 13, 2025 (GLOBE NEWSWIRE)...Read more
Allo-Evasion™ 5.0-engineered iPSC beta islets are designed to overcome immune rejection and provide durable glucose control without chronic immunosuppression Compelling preclinical data demonstrate rapid reversal of diabetes and sustained normoglycemia, human C‑peptide production and mature GSIS, supported by scalable bioreactor-based manufacturing Investigational New Drug (IND)-enabling studies on track to initiate by year-end 2025;...Read more
Announced iPSC derived beta islet cell program for Type 1 diabetes (T1D); Investigational New Drug (IND)-enabling studies expected to initiate by year-end 2025; IND submission planned in 2026 CNTY-308 advancing through IND-enabling studies to support planned clinical study initiation in 2026 Estimated cash runway into 4Q 2027 PHILADELPHIA, Nov. 13, 2025 (GLOBE NEWSWIRE) -- Century Therapeutics, Inc. (‘Century’, NASDAQ: IPSC), a...Read more
Company Announced Completion of VERSATILE-002 Phase 2 trial of PDS0101 + Pembrolizumab in HPV16-Positive Recurrent/Metastatic Head and Neck Cancer Phase 2 Results Lead Company to Seek Expedited Approval Pathway in OngoingVERSATILE-003 Phase 3 Trial Design Conference Call and Webcast today at 8:00 a.m. Eastern Time PRINCETON, N.J., Nov. 13, 2025 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB) (“PDS Biotech” or the...Read more
Company achieved FDA alignment on Phase 3 Oz-V trial for the treatment of 2L+ OPSCC, which will evaluate dual primary endpoints with potential of achieving accelerated approval followed by full approval Company is in advanced stages to finalize a strategic transaction with a potential partner and we remain on track to complete the transaction by year end BA3182 trial in advanced adenocarcinomas is currently ongoing and evaluating...Read more
Transformational Quarter Marked by Clinical Validation, Regulatory Progress, and Strategic Momentum in Commercial AI Platform Launch LP-184 Phase 1a clinical trial results demonstrate all primary endpoints achieved with 48% clinical benefit rate in evaluable cancer patients at or above therapeutic dose threshold; marked tumor reductions observed in patients with DNA damage repair mutations including CHK2, ATM, and STK11/KEAP1...Read more
Reported late-breaking Phase 2 data at SITC for vilastobart demonstrating a 40% ORR in heavily pretreated patients with MSS mCRC without liver metastases and high plasma tumor mutational burden Presented Phase 1 data at SITC for efarindodekin alfa showing promising monotherapy anti-tumor activity and generally well-tolerated safety profile in patients with advanced solid tumors Announced new preclinical data at SITC for masked T...Read more
September 30, 2025 Cash and Cash Equivalents at $10 million Revenue Expected to Grow in 2026 and Continue to Offset Cash Burn Management to Host Conference Call Today at 4:30 p.m. ET MOUNTAIN VIEW, Calif., Nov. 13, 2025 (GLOBE NEWSWIRE) -- RenovoRx, Inc. (Nasdaq: RNXT) (“RenovoRx” or the “Company”), a life sciences company developing innovative targeted oncology therapies and commercializing RenovoCath®, a novel, FDA-cleared...Read more
Company outlines continued progress executing operational transformation and growth strategy across its dental and medical segments ROSELAND, N.J., Nov. 13, 2025 (GLOBE NEWSWIRE) -- Milestone Scientific Inc. (NYSE: MLSS), a leading developer of computerized drug delivery instruments that provide painless and precise injections, today announced financial results and provided a business update for the third quarter ended September 30,...Read more
POTOMAC, MARYLAND / ACCESS Newswire / November 13, 2025 / IGC Pharma, Inc. ("IGC Pharma," "IGC," or the "Company") (NYSE American:IGC), a clinical-stage biotechnology company leveraging Artificial Intelligence ("AI") to develop innovative treatments for Alzheimer's disease, today announced that the United States Patent and Trademark Office ("USPTO") has granted the company U.S. Patent No. 12,465,589, titled "Methods and Composition for...Read more
RA'ANANA, Israel, Nov. 13, 2025 (GLOBE NEWSWIRE) -- Inspira™ Technologies OXY B.H.N. Ltd. (NASDAQ: IINN) ("Inspira," “Inspira Technologies,” or the “Company”), a pioneer in innovative life-support and diagnostic technologies, today announced the completion of the clinical study for its HYLA, non-invasive blood sensor, toward regulatory submission and future commercialization. Based on the clinical trial results and ongoing lab...Read more
DARE to PLAY™ Sildenafil Cream on Track to Launch Before Year End via 503B Pathway, Paving the Way for Near-Term Product Revenue Positive Interim DSMB Outcome for Ovaprene® Phase 3 Study Supports Continued Enrollment Multiple Grant-Funded Programs Advance, Including to Address HPV and Long-Acting as well as Non-Hormonal Contraception Four Commercially Available Solutions for Women Expected Over the Next Two Years In addition to DARE...Read more
Third quarter total revenue of $22.1 million, up 26% year-over-year Positive cash flows, with Adjusted EBITDA(1) of $1.5 million, up 98% year-over-year, and our 27th consecutive quarter of positive Adjusted EBITDA Investor webinar scheduled for Thursday, November 13, 2025 at 10:00 AM ET / 7:00 AM PT TORONTO / Nov 13, 2025 / Business Wire / NeuPath Health Inc. (TSXV:NPTH), (“NeuPath” or the “Company”), owner and operator of a network...Read more
Reports Significant Revenue Growth to $590K and Substantial Increase in Gross Profit to $575K Launched Sales of Arbli™, the First FDA-Approved Ready-To-Use Liquid Formulation of Losartan for Hypertension COMMACK, NY, Nov. 13, 2025 (GLOBE NEWSWIRE) -- SCIENTURE HOLDINGS, INC. (NASDAQ: SCNX), a holding company for existing and planned pharmaceutical operating companies focused on providing enhanced value to patients, physicians and...Read more
Cue Biopharma is developing the first-ever class of therapeutics for the treatment of cancer that mimic the natural signals, or “Cues”, of the immune system. This novel class of injectable biologics selectively engages and modulates tumor-specific T cells directly within the patient’s body to transform...
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Chimerix is on a mission to develop medicines that meaningfully improve and extend the lives of patients facing deadly diseases. The company is devoted to filling gaps in the treatment paradigm. Chimerix’s most advanced clinical-stage program is in development for H3 K27M-mutant glioma....
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