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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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) -- 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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Recursion Pharmaceuticals is a clinical stage TechBio company leading the space by decoding biology to industrialize drug discovery. Enabling its mission is the Recursion OS, a platform built across diverse technologies that continuously expands one of the world’s largest....
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