COPENHAGEN, Denmark, Nov. 17, 2025 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that pivotal Week 52 results from its randomized double-blind, placebo-controlled ApproaCH Trial of investigational once-weekly TransCon® CNP (navepegritide) in children with achondroplasia have been published in JAMA Pediatrics, a journal of the American Medical Association. In the publication, titled “Once-Weekly Navepegritide in...Read more
Ziihera plus chemotherapy showed a clinically meaningful and statistically significant improvement in PFS versus trastuzumab and chemotherapy, and a clinically meaningful effect with a strong trend toward statistical significance for OS at the first OS interim analysis Ziihera plus the PD-1 inhibitor Tevimbra® (tislelizumab) and chemotherapy demonstrated clinically meaningful and statistically significant improvements in OS...Read more
SAN DIEGO and UTRECHT, The Netherlands and CAMBRIDGE, Mass., Nov. 17, 2025 /PRNewswire/ -- Merus N.V. (Nasdaq: MRUS) ("Merus"), an oncology company developing innovative, full-length multispecific antibodies and antibody drug conjugates (Biclonics®, Triclonics® and ADClonics®), and Halozyme Therapeutics, Inc. (Nasdaq: HALO) ("Halozyme"), a leader in subcutaneous drug delivery solutions, today announced they have entered into a global...Read more
In 253 ALK TKI pre-treated patients, ORR by BICR was 31% (95% CI: 26, 37), with initial estimated durability of response of 64% and 53% at the 12-month and 18-month landmarks, respectively In the subset of 63 TKI pre-treated patients who were lorlatinib-naïve, ORR by BICR was 46% (95% CI: 33, 59), with initial estimated durability of response of 80% and 60% at the 12- and 18-month landmarks, respectively Neladalkib demonstrated...Read more
CAMBRIDGE, Mass., Nov. 17, 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 it has commenced an underwritten public offering of shares of Class A common stock. Nuvalent is offering $500.0 million of shares in the offering. The offering is subject to market and other...Read more
MINNEAPOLIS, Nov. 17, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced the completion of the submission of its New Drug Application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) for gedatolisib in hormone receptor positive (“HR+”), human epidermal growth factor receptor 2 negative (“HER2-”), advanced breast...Read more
Prescription Drug User Fee Act (PDUFA) target action date set for June 29, 2026 If approved, ZORYVE cream 0.3% would be the first and only topical PDE4 inhibitor indicated for plaque psoriasis in children as young as 2 WESTLAKE VILLAGE, Calif., Nov. 17, 2025 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in...Read more
Ziihera® plus chemotherapy showed a clinically meaningful and statistically significant improvement in PFS versus trastuzumab and chemotherapy, and a clinically meaningful effect with a strong trend toward statistical significance for OS at the first OS interim analysis Ziihera plus Tevimbra® (tislelizumab) and chemotherapy demonstrated clinically meaningful and statistically significant improvements in OS and PFS versus trastuzumab...Read more
Despite treatment with standard-of-care anti-seizure medicines, children with Dravet syndrome experienced high seizure burden and plateaued in neurodevelopment, resulting in a widening gap relative to children with typical development Findings underscore the urgent need for new medicines that target the underlying genetic cause of Dravet syndrome to improve long-term outcomes BEDFORD, Mass., & CAMBRIDGE, Mass. / Nov...Read more
Anzu-cel (anzutresgene autoleucel, IMA203) PRAME Cell Therapy: Global, randomized, controlled Phase 3 trial, SUPRAME, in previously treated advanced melanoma ongoing; interim and final analyses will occur in 2026 Anzu-cel (IMA203) PRAME Cell Therapy: One-time infusion continues to show strong clinical benefit and favorable tolerability in 16 patients with metastatic uveal melanoma in latest update on Phase 1b data presented at the ESMO...Read more
Olutasidenib continued to demonstrate durable efficacy and a manageable safety profile in a broad range of patients with R/R mIDH1 AML, including those previously treated with venetoclax-based regimens Rigel advances its strategic collaborations to further evaluate olutasidenib with the activation of a fifth study with MD Anderson and enrollment of the first patient in the CONNECT TarGeT-D study SOUTH SAN FRANCISCO, Calif., Nov. 17,...Read more
NEW HAVEN, Conn., Nov. 17, 2025 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Invivyd) (Nasdaq: IVVD) today announced that it has commenced an underwritten public offering of shares of its common stock. In addition, Invivyd intends to grant the underwriters an option for a period of 30 days to purchase up to an additional 15% of the shares of Invivyd common stock sold in the public offering at the public offering price, less underwriting discounts...Read more
Announces EPS-3903, an Oral, Once-Daily STAT6 Inhibitor Development Candidate with Rapid, Continuous and Complete (>90%) In Vivo pSTAT6 Suppression and Efficacy Comparable to Dupilumab in Asthma and Atopic Dermatitis Disease Models Announces EDP-978, an Oral, Once-Daily KIT Inhibitor Clinical Candidate with Plans to File an Investigational New Drug Application in Q1 2026 Reported Positive Topline Data for RSVHR, a Phase 2b Study of...Read more
Non-exclusive license providing Solid’s proprietary, next-generation capsid, AAV-SLB101, to Andelyn Biosciences, a full-service cell and gene therapy Contract Development and Manufacturing Organization (CDMO) AAV-SLB101 has been generally well tolerated in the 23 participants dosed in the Phase 1/2 INSPIRE DUCHENNE clinical trial as of a safety cutoff of October 31, 2025 Solid continues to expand collaborative efforts for AAV-SLB101...Read more
NEEDHAM, Mass., Nov. 17, 2025 (GLOBE NEWSWIRE) -- Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical-stage biopharmaceutical company focused on developing multimodal biological immunotherapies to help patients fight cancer, today announced it will host a virtual Research and Development (R&D) Event from 11:00 am – 1:45 pm ET on Friday, December 5, 2025. Candel’s R&D Day will include presentations and...Read more
RESEARCH TRIANGLE PARK, N.C., Nov. 17, 2025 (GLOBE NEWSWIRE) -- Fennec Pharmaceuticals Inc. (NASDAQ:FENC) (TSX:FRX) (“Fennec” or the “Company”), a specialty pharmaceutical company, today announced the closing of its underwritten registered public offering of 5,366,667 common shares (which amount includes exercise in full of the underwriters’ option to purchase additional common shares) at a public offering price of $7.50 per share....Read more
Agreement is focused on OmnidAb™ single domain technology OmniAb to receive revenue for discovery services as well as potential equity and royalties EMERYVILLE, Calif. & DENVER / Nov 17, 2025 / Business Wire / OmniAb, Inc. (NASDAQ: OABI) and ArrowMark Partners (“ArrowMark”) today announced the signing of a license and services agreement for novel OmniAb-derived antibody discovery programs with Mabtrx Biosciences, a wholly owned...Read more
NEW YORK, Nov. 17, 2025 (GLOBE NEWSWIRE) -- Protara Therapeutics, Inc. (Nasdaq: TARA), a clinical-stage company developing transformative therapies for the treatment of cancer and rare diseases, today announced that interim data from Cohort A of the ongoing Phase 2 open-label ADVANCED-2 trial of TARA-002 in BCG-Naïve patients with non-muscle invasive bladder cancer (NMIBC) will be featured during a poster session at the upcoming 26th...Read more
TONMYA is now available by prescription and available for pharmacy ordering nationwide TONMYA is the first FDA-approved treatment for fibromyalgia in more than 15 years TONMYA is a unique, non-opioid, once-daily bedtime analgesic that significantly reduces fibromyalgia pain and is generally well-tolerated CHATHAM, N.J., Nov. 17, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”),...Read more
MARSEILLE, France / Nov 17, 2025 / Business Wire / Regulatory News: Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) (“Innate” or the “Company”) today announces its participation in the Jefferies Global Healthcare Conference 2025. Members of its executive team will participate in one-on-one meetings and present on Monday, November 17, 2025. Jefferies Global Healthcare Conference Date: November 17, 2025 Time: 2:30–2:55 PM GMT /...Read more
SAN JOSE, Calif., Nov. 17, 2025 /PRNewswire/ -- Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, today announced that the International Nonproprietary Names (INN) Expert Committee of the World Health Organization (WHO) approved "liraltagene autoleucel" for the non-proprietary name of the Company's novel FSHR-targeted CAR-T therapy for...Read more
Published article outlines rationale for multi-pathway efficacy for (Z)-endoxifen in Duchenne Muscular Dystrophy (DMD); November scientific presentation to spotlight potential in Duchenne carrier–associated pathologies SEATTLE, Nov. 17, 2025 /PRNewswire/ -- Atossa Therapeutics, Inc. (Nasdaq: ATOS) ("Atossa" or the "Company"), a clinical-stage biopharmaceutical company developing innovative medicines in oncology, announces a growing...Read more
NEWTON, Mass., Nov. 17, 2025 (GLOBE NEWSWIRE) -- Acumen Pharmaceuticals, Inc. (NASDAQ: ABOS), a clinical-stage biopharmaceutical company developing a novel therapeutic that targets soluble amyloid beta oligomers (AβOs) for the treatment of Alzheimer’s disease (AD), today announced that the first participant has been dosed in the open-label extension (OLE) portion of its Phase 2 ALTITUDE-AD clinical trial evaluating sabirnetug (ACU193) in...Read more
Strong Nine-Month Performance Driven by Strategic Investment Portfolio; Total Assets Increase 42% to $220.5 Million NEW YORK, Nov. 17, 2025 /PRNewswire/ -- Oramed Pharmaceuticals Inc. (Nasdaq: ORMP) (TASE: ORMP), a platform technology pioneer in the field of oral delivery solutions for drugs currently delivered via injection, today announced its unaudited financial results for the nine months ended September 30,...Read more
Buntanetap significantly improves cognition in all Parkinson’s patients, with those exhibiting Alzheimer’s co-pathology showing a three-times greater response New data demonstrate reductions in plasma biomarkers pTau217, total tau, and brain-derived tau following buntanetap treatment Findings support buntanetap's potential to address cognitive decline in Parkinson's disease, show disease-modifying efficacy, and inform future clinical...Read more
SKNJCT-003 Doxorubicin containing Microneedle Array (D-MNA) clinical development program to non-invasively treat BCC aligns with national priorities of public health impact, unmet medical need, access, affordability, domestic manufacturing and rare-disease alignment. PHILADELPHIA, PENNSYLVANIA / ACCESS Newswire / November 17, 2025 / Medicus Pharma Ltd. (NASDAQ:MDCX) ("Medicus" or the "Company"), a biotech/life sciences company...Read more
EMERYVILLE, Calif., Nov. 17, 2025 (GLOBE NEWSWIRE) -- Metagenomi, Inc. (Nasdaq: MGX) (the “Company”), an in vivo genome editing company capitalizing on its proprietary technologies to create curative genetic medicines for patients, today announced that Jian Irish, Ph.D., M.B.A, President and Chief Executive Officer of Metagenomi, will be presenting at the Jefferies Global Healthcare Conference in London on Thursday, November 20, 2025, at...Read more
Type C Meeting with US FDA set for December 11, 2025 to address key items following August 27, 2025 End of Phase 2 Meeting regarding Phase 2b clinical trial of OST-HER2: prevention or delay of recurrent, fully-resected pulmonary metastatic osteosarcoma US Biologics Licensing Application (BLA) and UK MHRA Marketing Authorization Application filings for OST-HER2 expected in January 2025 leveraging Project Orbis UK MHRA pre-Marketing...Read more
NRx has refiled its Abbreviated New Drug Application for KETAFREE™ (preservative free ketamine), received supportive correspondence from FDA, and expects Q2 2026 GDUFA date. HOPE Therapeutics is now operating three revenue-generating facilities in Florida and expects six or more by year-end providing neuroplastic drugs, transcranial magnetic stimulation, hyperbaric therapy, and digital therapeutics to treat suicidal depression and...Read more
Company Accelerates Phase 2 Alzheimer's Program and Gains National Institute on Aging (NIA) Recognition for AI Leadership POTOMAC, MARYLAND / ACCESS Newswire / November 17, 2025 / IGC Pharma, Inc. (NYSE American:IGC) ("IGC" or the "Company"), a clinical-stage biotechnology company leveraging Artificial Intelligence (AI) to develop innovative treatments for Alzheimer's disease, today announced financial results for the quarter ended...Read more
Extends cash runway into first half of 2027, beyond planned first half of 2026 proof of concept (“POC”) data readouts of SIM0505 (CDH6 ADC) and LNCB74 (B7-H4 ADC) Led by Ikarian Capital, Squadron Capital Management, Affinity Healthcare Fund, and Exome Asset Management in a private placement of common stock priced at the market BELTSVILLE, Md., Nov. 17, 2025 (GLOBE NEWSWIRE) -- NextCure, Inc. (Nasdaq: NXTC), a clinical-stage...Read more
SHELTON, CONNECTICUT / ACCESS Newswire / November 17, 2025 / NanoViricides, Inc. (NYSE Amer.:NNVC) (the "Company"), reports that it has filed its Quarterly Report on Form 10-Q for the fiscal quarter ending September 30, 2025 with the Securities and Exchange Commission (SEC) on Friday, November 14, 2025. The report can be accessed at the SEC website or by clicking here. Clinical Stage NV-387, a Single Drug, Meets Many Unmet Medical Needs...Read more
Patent covers the use of GLIX1 for treating cancers in which cytidine deaminase (CDA) is not over-expressed (representing over 90% of cancers) Patent further broadens and strengthens GLIX1 patent protection until 2040, with a possible patent-term extension of up to five years TEL AVIV, Israel, Nov. 17, 2025 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a clinical development stage biopharmaceutical company...Read more
Toronto, Ontario--(Newsfile Corp. - November 17, 2025) - PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) (the "Company" or "PharmaTher"), a specialty life sciences company focused on unlocking the therapeutic potential of ketamine for neuropsychiatric disorders, today announced that it has entered into an Exclusive Evaluation and Option-to-License Agreement (the "Agreement") with Oakwood Laboratories, LLC ("Oakwood") for the...Read more
MELVILLE, N.Y., Nov. 17, 2025 (GLOBE NEWSWIRE) -- BioRestorative Therapies, Inc. (“BioRestorative”, “BRTX” or the “Company”) (NASDAQ:BRTX), a regenerative medicine innovator focused on stem cell-based therapies and products, today announced that it has been granted a Type B meeting with the U.S. Food and Drug Administration (“FDA”) to discuss a potential accelerated Biologics License Application (“BLA”) approval pathway for the...Read more
Accomplished drug development leader to advance TransCode's mission of defeating cancer through RNA innovation and translational excellence BOSTON, Nov. 17, 2025 /PRNewswire/ -- TransCode Therapeutics, Inc. (NASDAQ: RNAZ), an immuno-oncology and targeted cancer therapy company with a focus on treating advanced malignancy, announced today the appointment of Dr. Michel Janicot, Ph.D., as consultant Senior Development Officer. Dr....Read more
SAN DIEGO, Nov. 17, 2025 (GLOBE NEWSWIRE) -- Calidi Biotherapeutics, Inc. (“Calidi” or the “Company”) (NYSE American: CLDI), a clinical-stage biotechnology company pioneering the development of targeted therapies with the potential to deliver genetic medicines to distal sites of disease, is pleased to invite investors to a webinar on November 19, 2025, at 1:15 p.m. PT. The exclusive event, hosted by RedChip Companies, will feature...Read more
Presenting INTASYL siRNA Drug Technology King of Prussia, Pennsylvania--(Newsfile Corp. - November 17, 2025) - Phio Pharmaceuticals Corp. (NASDAQ: PHIO) is a clinical-stage siRNA biopharmaceutical company developing therapeutics using its proprietary INTASYL® gene silencing technology to eliminate cancer. Phio announced today that a podium presentation highlighting INTASYL® siRNA Drug Technology will be held at the Advanced Therapies...Read more
Initial results of ongoing investigator-initiated proof-of-concept trial demonstrate crofelemer can potentially extend the lives of infants born with intestinal failure due to microvillus inclusion disease (MVID), reducing the volume of the total parenteral support (PS) necessary for them to survive, though with associated toxicity; Groundbreaking PS reduction of up to 37%; No approved treatments exist for MVID Company completed...Read more
The top-line results from the study showed that the 3-drugs' synergistic effect has the potential as a new fixed-dose combination treatment, enhancing the effect of Bayer's top selling cancer drug, Stivarga® (regorafenib); such combination could potentially become a life-cycle IP strategy when Stivarga's® main European and U.S. patents expires in August 2028 and July 2032, respectively. New patent applications (US 63/786,370...Read more
Funding supports Phase 3 clinical development of PF614 and continued innovation in abuse- and overdose-resistant analgesics SAN DIEGO, CA / ACCESS Newswire / November 17, 2025 / Ensysce Biosciences, Inc. (NASDAQ:ENSC)("Ensysce" or the "Company"), pioneering novel solutions for severe pain with built-in abuse and overdose protection, today announced the closing of a $4 million convertible preferred stock financing, with upside to...Read more
Cash expected to fund operations into the second half of 2026 Company focused on advancing next-generation anti-cancer therapies derived from well-established drug classes, now engineered to cross the blood-brain barrier, potentially enhancing efficacy for patients Lead program, TPI 287, progressing toward Phase 2 study for treatment of glioblastoma multiforme (GBM), one of the most aggressive types of brain cancer, with a median...Read more
NEW YORK, Nov. 17, 2025 (GLOBE NEWSWIRE) -- Indaptus Therapeutics, Inc. (Nasdaq: INDP) (“Indaptus” or the “Company”), a clinical stage biotechnology company dedicated to pioneering innovative cancer and viral infection treatments, today announced that Michael Newman, Ph.D., Founder and Chief Scientific Officer, will present at the 3rd Donor Selection & Cell Source Summit, taking place November 19–20, 2025, in San Diego,...Read more
Vancouver, Canada, Nov. 17, 2025 (GLOBE NEWSWIRE) -- Clearmind Medicine Inc. (Nasdaq: CMND), (FSE: CWY0) (“Clearmind” or the "Company"), a clinical-stage biotech company focused on discovery and development of novel psychedelic-derived therapeutics to solve major under-treated health problems, today announced the filing of an Israeli patent application for its innovative combination therapy of 5-methoxy-2-aminoindane (MEAI) and...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
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
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
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
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
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
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
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
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
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
- 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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
| Company | Change | Last Trade |
|---|---|---|
| Jazz Pharmaceuticals | 29.02 20.57 | $170.09 |
| Madrigal Pharmaceuticals | 24.21 4.57 | $553.42 |
| argenx | 21.63 2.38 | $929.61 |
| Ascendis Pharma | 12.16 5.95 | $216.56 |
| Nuvalent | 11.50 11.92 | $108.00 |
| Alnylam Pharmaceuticals | 11.38 2.53 | $460.54 |
| Praxis Precision Medicines | 11.16 5.99 | $197.58 |
| Regeneron Pharmaceuticals | 10.81 1.56 | $704.31 |
| Axsome Therapeutics | 5.87 4.20 | $145.56 |
| United Therapeutics | 5.52 1.18 | $471.92 |
| Zymeworks | 5.31 28.67 | $23.83 |
| Seres Therapeutics | 4.98 29.89 | $21.64 |
| Insmed | 4.18 2.16 | $197.40 |
| Bolt Biotherapeutics | 3.94 705.01 | $4.50 |
| Terns Pharmaceuticals | 3.44 15.25 | $26.00 |
Immix Biopharma is a clinical-stage biopharmaceutical company pioneering a novel class of CAR-T cell therapies and Tissue-Specific Therapeutics targeting oncology and immuno-dysregulated diseases with >75 patients treated to-date. The company's lead cell therapy asset is NXC-201 in multiple myeloma...
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Amneal Pharmaceuticals is a fully-integrated essential medicines company. We make healthy possible through the development, manufacturing, and distribution of generic and specialty pharmaceuticals. The Company has a diverse portfolio of over 250 products in its Generics segment and is expanding across...
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