Zanzalintinib in combination with atezolizumab demonstrated a statistically significant reduction in risk of death versus regorafenib in intent-to-treat population ALAMEDA, Calif. / Jun 22, 2025 / Business Wire / Exelixis, Inc. (Nasdaq: EXEL) today announced positive topline results from the STELLAR-303 phase 3 pivotal trial in which zanzalintinib in combination with atezolizumab (Tecentriq®) demonstrated a statistically significant...Read more
MP0726, a Radio-DARPin candidate targeting mesothelin (MSLN) and intended for the treatment of ovarian cancer, is nominated for development under strategic partnership with Orano Med Promising tumor accumulation and attractive biodistribution shown in vivo, selective binding to membrane-bound MSLN with positive tumor to kidney ratio ZURICH-SCHLIEREN, Switzerland and CONCORD, Mass. and PARIS, June 22, 2025 (GLOBE NEWSWIRE) -- Ad hoc...Read more
Treatment with apelin receptor agonist enhanced glycemic control and demonstrated cardioprotective effects, with additive benefits observed in combination with incretin therapy Data support development of next-generation APJ agonists for obesity and key comorbidities EMERYVILLE, Calif., June 21, 2025 (GLOBE NEWSWIRE) -- BioAge Labs, Inc. (Nasdaq: BIOA) (“BioAge”, “the Company”), a clinical-stage biotechnology company developing...Read more
Results from the study continue to demonstrate the transformative potential of zimislecel with consistent and durable patient benefit All 12 patients with at least one year of follow-up who received a full dose of zimislecel as a single infusion achieved ADA-recommended target HbA1c levels <7% and >70% time-in-range (70-180 mg/dL), and 10/12 patients were insulin free Data presented at ADA simultaneously published in the New...Read more
Approval based on pivotal results showing improvements in sustained disease remission and reductions in itch and oral corticosteroid use compared to placebo in adults with BP BP is a chronic, debilitating and relapsing rare skin disease affecting approximately 27,000 adults in the U.S. whose disease is uncontrolled by systemic corticosteroids Dupixent is now approved in the U.S. to treat eight distinct diseases with underlying type 2...Read more
VYVGART® SC, first-and-only IgG Fc-antibody fragment which specifically targets the neonatal Fc receptor (FcRn), now approved for use in Europe for CIDP Approval based on ADHERE clinical trial, the largest study of CIDP patients to date First novel mechanism of action for CIDP treatment in more than 30 years Amsterdam, the Netherlands – argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the...Read more
Data Add to Growing Body of Evidence Demonstrating Functional and Quality of Life Improvements in Patients Treated with INGREZZA for Tardive Dyskinesia Findings Presented at the 2025 American Association of Nurse Practitioners (AANP) National Conference SAN DIEGO, June 20, 2025 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced the presentation of new analyses from a Phase 4 randomized...Read more
Positive recommendation based on resmetirom’s favorable profile including positive results from the pivotal Phase 3 MAESTRO-NASH trial European Commission decision expected in August 2025; if approved, resmetirom will be the first medication for people living with MASH in the E.U. CONSHOHOCKEN, Pa., June 20, 2025 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ: MDGL), a biopharmaceutical company focused on...Read more
– If approved, nirogacestat will be the first and only therapy with marketing authorization in the EU for the treatment of desmoid tumors – – Decision from European Commission expected in the third quarter of 2025 – STAMFORD, Conn., June 20, 2025 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, announced today that the European...Read more
Conference is the first-ever international meeting jointly hosted by the Prader-Willi Syndrome Association | USA, the Foundation for Prader-Willi Research, and the International Prader-Willi Syndrome Organisation REDWOOD CITY, Calif., June 20, 2025 (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. (Soleno) (NASDAQ: SLNO), a biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today announced one...Read more
SAN FRANCISCO, June 20, 2025 (GLOBE NEWSWIRE) -- Structure Therapeutics Inc. (NASDAQ: GPCR), a clinical-stage global biopharmaceutical company developing novel oral small molecule therapeutics for metabolic diseases, today announced two upcoming late-breaking poster presentations at the American Diabetes Association 85th Scientific Sessions, being held from June 20-23 in Chicago, IL. “The amylin receptor is rapidly gaining clinical...Read more
Presentation to highlight WVE-007 (INHBE GalNAc-siRNA) as a potential novel and unique obesity treatment leading to healthy weight loss and supporting preclinical data demonstrating potent and durable reduction in Activin E resulting in fat loss with muscle preservation New preclinical data demonstrate that a single dose of INHBE siRNA leads to lower inflammation of adipose tissue with strong suppression of pro-inflammatory M1...Read more
Virtual webinar on June 23, 2025 at 8:00 am ET NEWTOWN SQUARE, Pa., June 20, 2025 (GLOBE NEWSWIRE) -- ArriVent BioPharma, Inc. (Company or ArriVent) (Nasdaq: AVBP), a clinical-stage company dedicated to accelerating the global development of innovative biopharmaceutical therapeutics, today announced the Company will host a virtual investor event to discuss the firmonertinib clinical program for the treatment of EGFR PACC mutant...Read more
DUBLIN, June 20, 2025 (GLOBE NEWSWIRE) -- GH Research PLC (Nasdaq: GHRS), a clinical-stage biopharmaceutical company dedicated to transforming the lives of patients by developing a practice-changing treatment in depression, today announced that, in June, it submitted its complete response to the previously announced clinical hold of its Investigational New Drug Application (IND) for GH001 to the U.S. Food and Drug Administration...Read more
Four-year data show preservation of cardiac function, including LVEF Skeletal muscle disease progression continues to slow with extended treatment (PUL v2.0) Deramiocel’s long-term safety profile remains favorable Results presented at PPMD’s 2025 Annual Conference SAN DIEGO, June 20, 2025 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics...Read more
Conference call and webcast on Monday, June 23, 2025 at 8:00 am EDT BALA CYNWYD, Pa., June 20, 2025 (GLOBE NEWSWIRE) -- Larimar Therapeutics, Inc. (Larimar) (Nasdaq: LRMR), a clinical-stage biotechnology company focused on developing treatments for complex rare diseases, today announced that the Company will host a conference call and webcast to discuss regulatory updates for the Company’s nomlabofusp clinical development program for...Read more
Phase 2 highlights robust biomarker identification and survival correlations in first-line metastatic pancreatic cancer (mPDAC) treated with elraglusib CHICAGO and FORT WORTH, Texas, June 20, 2025 (GLOBE NEWSWIRE) -- Actuate Therapeutics, Inc. (NASDAQ: ACTU) (“Actuate” or the “Company”), a clinical-stage biopharmaceutical company focused on developing therapies for the treatment of high-impact, difficult-to-treat cancers through the...Read more
TORONTO and HAIFA, Israel, June 20, 2025 (GLOBE NEWSWIRE) -- NurExone Biologic Inc. (TSXV: NRX) (OTCQB: NRXBF) (FSE: J90) (“NurExone” or the “Company”), a biotech company developing exosome-based therapies for central nervous system injuries, announced today that it has been accepted into the HealthTech Hub (“HTH”) Accelerator Program. Based in Boston, Massachusetts, home to more than 1,000 biotech companies1, HTH is operated by the...Read more
TROY, Mich. / Jun 20, 2025 / Business Wire / ZIVO Bioscience, Inc. (OTCQB: ZIVO), a biotech and agtech R&D company engaged in the development of therapeutic and nutritional products derived from proprietary algal cultures, announces it has entered into a relationship with one of the world’s leading animal health companies to advance ZIVO’s novel immune-boosting compounds for use in multiple poultry market segments. The collaboration is...Read more
Dr. Rioux to Highlight Industry-Leading Clinical Programs in MELAS and Leigh Syndrome Spectrum San Diego, California--(Newsfile Corp. - June 20, 2025) - Thiogenesis Therapeutics, Corp. (TSXV: TTI) (OTCQX: TTIPF) ("Thiogenesis" or the "Company"), a clinical-stage biopharmaceutical company developing sulfur-based therapeutics for rare pediatric and inherited mitochondrial disorders, today announced that its Chief Executive Officer,...Read more
GENEVA, SWITZERLAND / ACCESS Newswire / June 20, 2025 / RELIEF THERAPEUTICS Holding SA (SIX:RLF)(OTCQB:RLFTF)(OTCQB:RLFTY ) (Relief or the Company), a biopharmaceutical company committed to delivering innovative treatment options for select specialty, unmet and rare diseases, today announced that its initial request for Qualified Infectious Disease Product (QIDP) designation for RLF-TD011 for the treatment of epidermolysis bullosa (EB)...Read more
SEATTLE, WASHINGTON / ACCESS Newswire / June 20, 2025 / Aptevo Therapeutics Inc. (Nasdaq:APVO), a clinical-stage biotechnology company focused on developing novel immune-oncology therapeutics based on its proprietary ADAPTIR™ and ADAPTIR-FLEX™ platform technologies, today announced the closing of its previously announced offering of (i) 2,465,000 shares of its common stock or pre-funded warrants in lieu thereof and (ii) warrants to...Read more
Mipletamig-driven clinical validation of the CRIS-7 derived CD3-binding domain underpins Aptevo's expansion from hematologic to solid tumors New candidate APVO455 targets Nectin-4+ cancers, joins mipletamig (AML) and APVO442 (prostate) in Aptevo's tumor-directed CD3 suite SEATTLE, WASHINGTON / ACCESS Newswire / June 20, 2025 / Aptevo Therapeutics Inc. ("Aptevo" or the "Company") (Nasdaq:APVO), a clinical-stage biotechnology company...Read more
KUALA LUMPUR, June 20, 2025 (GLOBE NEWSWIRE) -- Cyclacel Pharmaceuticals, Inc. (“Cyclacel”) (NASDAQ: CYCC, NASDAQ: CYCCP), a biopharmaceutical company that develops innovative cancer medicine, today announced that it has entered into a securities purchase agreement for the sale of its convertible Series F Preferred Stock (“Preferred Stock”) in a private placement to certain accredited investors yielding gross proceeds of $3.0 million...Read more
HOUSTON, June 20, 2025 (GLOBE NEWSWIRE) -- Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), a late-stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors and viruses, today announced the pricing of a public offering consisting of 16,080,000 shares of common stock (or pre-funded warrants in lieu thereof) and Series E warrants to purchase up to 48,240,000 shares of its...Read more
Monjuvi® (tafasitamab-cxix) in combination with rituximab and lenalidomide is the first FDA-approved CD19- and CD20-targeted immunotherapy combination for adult patients with follicular lymphoma (FL) Patients with relapsed or refractory FL achieved significantly improved progression-free survival with Monjuvi in combination with rituximab and lenalidomide in the Phase 3 registration trial This milestone represents the second approved...Read more
CAMBRIDGE, Mass., June 18, 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 the appointment of Christy Oliger to its Board of Directors. "Christy's proven success in delivering new therapies to patients living with cancer strengthens our Board as we evolve from...Read more
NEW YORK, June 18, 2025 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced that data from across the SYMBRAVO® (meloxicam and rizatriptan) clinical program will be presented at the 67th Annual Scientific Meeting of the American Headache Society (AHS), being held June 19-22, 2025, in Minneapolis,...Read more
Patients receiving apitegromab with tirzepatide over 24 weeks showed a 54.9% preservation of lean mass (+4.2 lbs of lean mass) versus tirzepatide alone (p=0.001) Patients receiving apitegromab with tirzepatide over 24 weeks lost 18.8 lbs of fat mass while those on tirzepatide alone lost 17.7 lbs of fat mass Patients receiving apitegromab with tirzepatide over 24 weeks lost 12.3% of body weight while those on tirzepatide alone lost 13.4%...Read more
BOSTON / Jun 18, 2025 / Business Wire / Astria Therapeutics, Inc. (Nasdaq:ATXS), a biopharmaceutical company focused on developing life-changing therapies for allergic and immunologic diseases, today announced that it will participate in a panel discussion at the Oppenheimer Innovators in Immunology & Inflammation (I&I) Summit on June 25 in New York, NY. Jill C. Milne, Ph.D., Chief Executive Officer, will participate in a panel...Read more
Oral presentation on study demonstrating the ability of sotagliflozin to reduce the risk of hypoglycemic events regardless of kidney function in people with type 1 diabetes THE WOODLANDS, Texas, June 18, 2025 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that data from a study evaluating the impact of sotagliflozin on hypoglycemia in people with type 1 diabetes will be delivered as an...Read more
Dr. Clark Brings 25 Years of Experience Treating Retina Diseases and Developing Emerging Therapies as a Principal Investigator in Over 70 Clinical Trials and as an Early Pioneer of VEGF Inhibitors ANX007 is the Only Investigational Program Shown to Significantly Preserve Vision and Central Retinal Photoreceptors Critical for Visual Acuity Enrollment of Phase 3 ARCHER II Trial Expected to be Completed in Q3 2025, with Topline Data...Read more
Virtual investor event planned for July 8th at 2:00pm EDT Event to follow presentation of new Phase 1b combination dose escalation data for givastomig (Claudin 18.2 x 4-1BB bispecific antibody) at ESMO GI on July 2, 2025 ROCKVILLE, Md., June 18, 2025 (GLOBE NEWSWIRE) -- I-Mab (NASDAQ: IMAB) (the “Company”), a U.S.-based, global biotech company, focused on the development of precision immuno-oncology agents for the treatment of...Read more
FDA priority review and approval based on interim results sets a positive precedent, paving the path for future Multikine approval Multikine reduced the risk of death by 66% compared to standard of care in the target population of patients with low and zero PD-L1, while Keytruda reduced the risk of recurrence and progression (EFS) by 30% compared with standard of care in patients whose tumors expressed higher PD-L1 without demonstrating...Read more
Presentation underscores unique potential for atrioventricular interval modulation (“AVIM”) therapy to manage blood pressure in older, high-risk patients who have indicators of diastolic dysfunction and progression to heart failure with preserved ejection fraction (“HFpEF”) Hypertensive heart disease represents over 7.7 million U.S. patients, the same population with hypertension and elevated cardiovascular risk cited in the recent FDA...Read more
Robust intellectual property portfolio, built over more than a decade, designed to protect core innovations for treating metabolic diseases New U.S. patents strengthen Fractyl’s leadership in metabolic innovation by expanding its patent coverage of duodenal resurfacing, including thermal and non-thermal electrical energy applications BURLINGTON, Mass., June 18, 2025 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (the...Read more
HOUSTON / Jun 18, 2025 / Business Wire / Coya Therapeutics, Inc. (NASDAQ: COYA) (“Coya” or the “Company”), a clinical-stage biotechnology company developing biologics intended to enhance regulatory T cell (Treg) function, announces that Chief Executive Officer Arun Swaminathan, Ph.D. will present at the iAccess Alpha Virtual Best Ideas Summer Conference on Tuesday, June 24, 2025. Event: iAccess Alpha Virtual Best Ideas...Read more
Nutriband and Kindeva have completed commercial manufacturing process scale-up for its lead product Aversa™ Fentanyl, an abuse-deterrent fentanyl patch Nutriband is partnering with Kindeva to develop Aversa™ Fentanyl which combines Nutriband’s Aversa™ abuse-deterrent technology with Kindeva’s FDA-approved fentanyl patch ORLANDO, Fla., June 18, 2025 (GLOBE NEWSWIRE) -- Nutriband Inc. (NASDAQ:NTRB)(NASDAQ:NTRBW), a company engaged in...Read more
Dose-dependent, marked reductions in food intake and significant weight loss observed in obese cynomolgus monkeys BMF-650 compared favorably to published data of a leading GLP-1 RA candidate IND filing on track for the second half of 2025; with Phase I study initiation in obese, otherwise healthy volunteers anticipated late 2025 REDWOOD CITY, Calif., June 18, 2025 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea,” “Biomea Fusion”...Read more
TORONTO / Jun 18, 2025 / Business Wire / Satellos Bioscience Inc. (TSX: MSCL, OTCQB: MSCLF) (“Satellos” or the “Company”), a biotech company developing new small molecule therapeutic approaches to improve the treatment of muscle diseases and disorders, today announced the election of Iris Loew-Friedrich, M.D., Ph.D., and Selwyn Ho, MBBS, to its Board of Directors. “I am so excited to welcome Dr. Loew-Friedrich and Dr. Ho to our Board at...Read more
Financing priced at a premium; led by healthcare-focused institutional investor Nantahala Capital with participation from existing Quince stockholders including ADAR1 Capital Management, along with members of Quince’s senior management Cash runway now extends through Phase 3 NEAT into at least the second quarter of 2026 Phase 3 NEAT enrollment momentum continues with 95 total participants enrolled to date; topline results expected in...Read more
Study used cell lines obtained from the Progeria Research Foundation to evaluate Telomir-1's effects on key drivers of accelerated aging MIAMI, FLORIDA / ACCESS Newswire / June 18, 2025 / Telomir Pharmaceuticals, Inc. (NASDAQ:TELO), a preclinical-stage biotechnology company focused on reversing biological aging and age-related diseases, today announced compelling new preclinical data showing that its lead candidate, Telomir-1,...Read more
Agreement to support future studies investigating the combination of ateganosine and atezolizumab for safe and effective cancer treatments CHICAGO / Jun 18, 2025 / Business Wire / MAIA Biotechnology, Inc. (NYSE American: MAIA), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, today announced its entry into a clinical master supply agreement with Roche for future studies investigating...Read more
WAYNE, Pa., June 18, 2025 (GLOBE NEWSWIRE) -- Avalo Therapeutics, Inc. (Nasdaq: AVTX), a clinical stage biotechnology company focused on the treatment of immune dysregulation, today announced the appointment of Rita Jain, M.D. to its Board of Directors. “We are pleased to welcome Dr. Jain to Avalo’s Board of Directors,” said Michael Heffernan, Chairman of the Board. “Rita’s extensive experience spanning clinical development, regulatory...Read more
Differentiated PH1 payload is a spliceosome inhibitor designed to inhibit RNA splicing, leading to cancer cell death and activation of immune system through multiple mechanisms India represents a key territory with a rapidly growing incidence rate of cancer cases, projected to increase to 2.08 million by 20401 BOSTON and LONDON, June 18, 2025 (GLOBE NEWSWIRE) -- Akari Therapeutics, Plc (Nasdaq: AKTX), an oncology biotechnology...Read more
SOUTH SAN FRANCISCO, Calif., June 18, 2025 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (Nasdaq: ALGS) a clinical stage biopharmaceutical company focused on improving patient outcomes through best-in-class therapies for liver and viral diseases, today announced the appointment of Kieron Wesson, PhD as Vice President, Head of Chemistry Manufacturing Controls (CMC), effective immediately. “I am pleased to welcome Kieron to Aligos,” said...Read more
ASCO 2025 overall survival data bolster IMNN-001’s potential in advanced ovarian cancer, supported by robust translational results at ESMO Results from OVATION 2 Study reinforce IMNN-001 mechanism of action, producing IL-12 and key anti-cancer immune cytokines in the tumor-microenvironment post-treatment Company currently advancing Phase 3 pivotal trial of IMNN-001, with first two sites initiated LAWRENCEVILLE, N.J., June 18, 2025...Read more
VANCOUVER, British Columbia, June 18, 2025 – TheNewswire - BetterLife Pharma Inc. (“BetterLife” or the “Company”) (CSE: BETR / OTCQB : BETRF / FRA: NPAU), an emerging biotech company focused on the development of BETR-001, a non-hallucinogenic neuroplastogen in the treatment of psychiatric and neurological disorders, is pleased to announce that the United States Patent and Trademark Office (US PTO) has filed ISSUE NOTIFICATION...Read more
Ongoing progress in Phase 1 clinical trial of SENTI-202 for the treatment of Acute Myeloid Leukemia (AML) 20,800 newly diagnosed AML patients in the U.S. every year1 with 60% of patients experiencing relapse or death within 12 months2 Management releases Virtual Investor “What This Means” segment; Access here SOUTH SAN FRANCISCO, Calif., June 18, 2025 (GLOBE NEWSWIRE) -- Senti Biosciences, Inc. (Nasdaq: SNTI) (“Senti Bio” or the...Read more
First use of camel hemoglobin as a universal oxygen carrier Unique properties make it an ideal ingredient for oxygen transport BOSTON, MASSACHUSETTS, June 18, 2025 (GLOBE NEWSWIRE) -- BIOXYTRAN, INC. (OTCQB: BIXT) (the “Company”), a clinical stage biotechnology company developing drugs to treat stroke, Alzheimer’s disease, and viruses, has a secured a GMP quality source of camel hemoglobin with help from the Heme Foundation. The...Read more
HOTH announces strong preclinical data for HT-KIT showing dose-dependent liver activity with zero observed toxicity – key milestone as the company prepares for IND filing. Study Results: Liver weight increased from 1.11g → 1.32g across 0 → 3.0 mg/kg No adverse effects on kidney, spleen, or thymus 100% clean safety profile — no visible lesions or gross pathology Validates safety of HT-KIT in vivo Robb Knie, CEO:...Read more
85% remission rate observed in evaluable frontline AML patients Mipletamig combination enables rare pathway to transplant in a previously ineligible unfit patient No dose-limiting toxicities observed among evaluable patients; safety profile remains strong Evidence mounts for mipletamig as a potentially transformational addition to standard of care in frontline AML as targeted CD123 x CD3 approach showing power and precision, limited...Read more
90th participant enrolled in landmark clinical trial in patients with Major Depressive Disorder Targets October 2025 for initial results presentation Vancouver, British Columbia – TheNewswire - June 18, 2025 – MindBio Therapeutics Corp. (CSE: MBIO; Frankfurt: WF6), (“MindBio”), (the “Company”), a clinical-stage biopharma/biotechnology company dedicated to developing novel and effective mental health treatments, is...Read more
Annamycin aims to eliminate cardiotoxicity associated with anthracyclines used to treat about 60% of all children with cancer FDA recommends inclusion of patients as young as 6 months – younger than Moleculin had proposed – to be allowed in the pediatric clinical study Enrollment and dosing are ongoing in pivotal, adaptive design Phase 3 MIRACLE trial of Annamycin in adult patients with R/R AML; Initial data readout is on track...Read more
CARDIFF, UNITED KINGDOM / ACCESS Newswire / June 18, 2025 / When it comes to type 1 diabetes, treating this chronic condition can be difficult. After all, with this type of diabetes, the body's immune system attacks and destroys the beta cells that produce insulin. Without the natural ability to produce insulin, glucose from the bloodstream isn't absorbed into cells to provide energy. Since there is no cure, patients with type 1 diabetes...Read more
Dr. Charles, Accomplished Immunology-Focused Drug Developer, Brings More Than 20 years of Biopharma Leadership, Clinical Development, and Operations Expertise Company Also Hires Cindy J. Driscoll, MBA, Financial Executive with Over Two Decades of Experience Guiding Biotechnology Companies, as Senior Vice President, Finance WELLESLEY HILLS, Mass., June 18, 2025 (GLOBE NEWSWIRE) -- Climb Bio, Inc. (Nasdaq: CLYM), a clinical stage...Read more
LYL314 demonstrated robust clinical responses, with an 88% overall response rate and a 72% complete response rate in patients treated in the third- or later-line setting (N = 25) 71% of patients with complete response remained in complete response at ≥ 6 months Manageable safety profile appropriate for outpatient administration with no Grade ≥ 3 cytokine release syndrome and low rates of Grade ≥ 3 ICANS with rapid resolution Pivotal...Read more
Based on Type C meeting and new data, Dyne submitted revised ACHIEVE trial protocol to FDA elevating vHOT to primary endpoint for U.S. Accelerated Approval New positive clinical data from Phase 1/2 ACHIEVE trial support vHOT as early indicator of clinical benefit with DYNE-101 in DM1 Ongoing Registrational Expansion Cohort in ACHIEVE trial to enroll 60 participants and include sites in U.S. Company to host an...Read more
SPY002 and SPY072 were well tolerated, exhibited PK that supports quarterly or less frequent dosing, and fully engaged TL1A through up to 20 weeks of follow-up; ~75 day half-life demonstrated, more than 3-fold greater than first-generation anti-TL1A antibodies SKYLINE-UC platform study evaluating three optimized monotherapies and three potentially paradigm-changing combinations in ulcerative colitis, initiated in May 2025 SKYWAY-RD...Read more
Explore-CKD met its primary endpoint; lorundrostat 25 mg once daily achieved a 9.3 mmHg reduction in systolic blood pressure, and a 7.5 mmHg placebo-adjusted reduction (p=0.0024) at four weeks Lorundrostat showed a clinically meaningful reduction in the pre-defined endpoint spot urine albumin-to-creatinine ratio of 31% (p<0.0001) Lorundrostat demonstrated a favorable safety and tolerability profile Conference...Read more
U.S. FDA grants Orphan Drug Designation to Deramiocel for the treatment of Becker Muscular Dystrophy, broadening Capricor’s focus in neuromuscular diseases Capricor remains on track for the August 31, 2025, PDUFA date for Deramiocel in Duchenne Muscular Dystrophy following successful FDA Pre-License Inspection SAN DIEGO, June 17, 2025 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing...Read more
Veteran executive with over 20 years of oncology leadership and clinical experience with proven track record of success in bringing development candidates through late-stage clinical development Company will hold a conference call on July 29 at 4:30 p.m. ET/1:30 p.m. PT to share additional clinical data from its randomized Phase 2 CRDF-004 trial evaluating onvansertib + standard of care for the treatment of first-line...Read more
LEXINGTON, Mass. / Jun 17, 2025 / Business Wire / Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a biotechnology company devoted to discovering and developing innovative therapies designed to treat immune‑mediated and metabolic diseases, today announced the resubmission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for topical ocular reproxalap, an investigational new drug candidate, for the treatment...Read more
The study met its primary goal of establishing safety and tolerability of VTX3232 in patients with early-stage Parkinson’s disease CSF and plasma exposures reinforce VTX3232’s potential as a once-daily oral therapy for neurodegenerative diseases VTX3232 treatment resulted in significant reductions in NLRP3-related biomarkers in CSF and plasma, demonstrating sustained target engagement VTX3232 is also being studied in a...Read more
Company to generate and analyze molecular profiles from over 17,000 samples from the HUNT Biobank in Norway to accelerate discovery of drug targets for aging-related diseases New data deepen platform insights into the biology of resilience across multiple therapeutic indications EMERYVILLE, Calif., June 17, 2025 (GLOBE NEWSWIRE) -- BioAge Labs, Inc. (Nasdaq: BIOA) ("BioAge", “the Company”), a clinical-stage biotechnology company...Read more
Partnership aims to accelerate precision immunotherapy by leveraging AI-powered virtual cell models to identify which patients are most likely to benefit from BOT/BAL treatment Collaboration builds on landmark 2024 Cancer Discovery study elucidating botensilimab’s unique FcγR-mediated immune activation underlying activity in refractory tumors. Supports AI-enabled biomarker discovery, aligning with the national priorities and the FDA to...Read more
BOSTON, June 17, 2025 (GLOBE NEWSWIRE) -- Elicio Therapeutics, Inc. (Nasdaq: ELTX, “Elicio” or the “Company”), a clinical-stage biotechnology company developing a pipeline of novel immunotherapies for the treatment of cancer, today announced that it will host a virtual key opinion leader (“KOL”) event on Wednesday, June 25, 2025 at 2:00 PM ET to discuss the significant unmet need and current treatment landscape for mutant-KRAS (“mKRAS”)...Read more
94% OS and 72% PFS observed at 6 months for atebimetinib (IMM-1-104) in combination with modified Gemcitabine/nab-paclitaxel (mGnP), N=34; median OS and PFS not yet reached Striking tumor reductions with 39% overall response rate and 81% disease control rate observed as of the data cutoff, including many patients with deepening, durable regressions and multiple examples of individual lesions rendered undetectable Markedly...Read more
Joint Clinical Study with Massachusetts General Hospital Could Pave the Way for Testing Efficacy of Quantum’s Investigational MS drug, Lucid-21-302 TORONTO, June 17, 2025 (GLOBE NEWSWIRE) -- Quantum BioPharma Ltd. (NASDAQ: QNTM) (CSE: QNTM) (FRA: 0K91) (“Quantum BioPharma” or the “Company”), a biopharmaceutical company dedicated to building a portfolio of innovative assets and biotech solutions, announces that the first person with...Read more
REDWOOD CITY, Calif., June 17, 2025 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea”) (Nasdaq: BMEA), a clinical-stage diabetes and obesity company, announced today that it has commenced an underwritten public offering of shares of its common stock and accompanying warrants to purchase shares of its common stock (or pre-funded warrants in lieu thereof) and, in lieu of common stock to certain investors, pre-funded warrants to purchase...Read more
SAN DIEGO, June 17, 2025 (GLOBE NEWSWIRE) -- Skye Bioscience, Inc. (Nasdaq: SKYE) (“Skye”), a clinical-stage biotechnology company focused on unlocking new therapeutic pathways for obesity and other metabolic health disorders, today announced that it was selected to present new nimacimab data in its expanded preclinical model at the upcoming American Diabetes Association’s (ADA) 85th Scientific Sessions. Skye will present in multiple...Read more
Broad Use of Suprachoroidal Injection Platform Highlighted Across Retinal Indications CLS-AX Combines the Flexibility of Anti-VEGF Therapies with the Long-Lasting Benefits of a Tyrosine Kinase Inhibitor ALPHARETTA, Ga., June 17, 2025 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (Nasdaq: CLSD) (“Clearside” or the “Company”), a biopharmaceutical company revolutionizing the delivery of therapies to the back of...Read more
Topline results of PALISADE-3 Phase 3 Trial of fasedienol for acute treatment of social anxiety disorder expected in the fourth quarter of this year PALISADE-4 Phase 3 Trial topline results expected in the first half of 2026 Company showcases promising clinical-stage pipeline of five novel intranasal pherine candidates targeting six highly prevalent and underserved disorders SOUTH SAN FRANCISCO, Calif. / Jun 17, 2025 / Business Wire...Read more
Showcasing Global Utility of its QAPs at Point-of-Care Testing Conference MISSISSAUGA, Ontario, June 17, 2025 (GLOBE NEWSWIRE) -- Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF, Microbix®), a life sciences innovator, manufacturer, and exporter, announces that it is attending and presenting at the 2nd Asia Pacific Conference on Point of Care Testing for Infectious Diseases, taking place in Bangkok, Thailand from 19 to 21 June, 2025...Read more
Evan Bailey, MD, promoted to Chief Medical Officer, succeeding Riccardo Perfetti, MD, PhD Dottie Caplan promoted to Executive Vice President, Patient Advocacy and Government Affairs NEW YORK, June 17, 2025 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (Nasdaq: APLT), a biopharmaceutical company dedicated to creating transformative treatments for rare disease, today announced key appointments to its executive leadership team with...Read more
San Diego, California--(Newsfile Corp. - June 17, 2025) - Thiogenesis Therapeutics, Corp. (TSXV: TTI) (OTCQX: TTIPF) ("Thiogenesis" or the "Company") a clinical-stage biopharmaceutical company developing sulfur-based therapeutics for serious pediatric and inherited mitochondrial diseases, today announced the recent activation of its French clinical site for Thiogenesis' ongoing Phase 2 clinical trial evaluating TTI-0102 in patients with...Read more
Click here to register SAN FRANCISCO, CA / ACCESS Newswire / June 17, 2025 / Jaguar Health, Inc. (NASDAQ:JAGX) today announced that Lisa Conte, the company's founder, president and CEO, will present virtually on Wednesday, June 18, 2025 at the Emerging Growth Conference. Participation Instructions for Jaguar's Virtual Presentation at the Emerging Growth Conference When: Wednesday, June 18, 2025 from 9:40 - 10:10 AM Eastern...Read more
Expanded alliance combines Lisata’s drug development expertise with GATC’s AI-powered Multiomics Advanced Technology® platform to accelerate and improve success rates of next-generation drug development Lisata to lead development efforts to advance GATC’s AI-discovered therapeutic for opioid use disorder into human clinical trials early in 2026 BASKING RIDGE, N.J. and IRVINE, Calif., June 17, 2025 (GLOBE NEWSWIRE) -- Lisata...Read more
Calgary, Alberta--(Newsfile Corp. - June 17, 2025) - Hemostemix Inc. (TSXV: HEM) (OTCQB: HMTXF) (FSE: 2VF0) ("Hemostemix" or the "Company") announces the closing of a non brokered private placement with in the amount of CAD $469,366 by the issuance of 3,911,385 Common Shares at CAD $0.12 each, subject to the approval of the TSXV Exchange. All securities issued in connection with the Offering will be subject to a four-month hold period...Read more
Webcast of virtual fireside chat today, June 17th, at 7:00 a.m. ET CAMBRIDGE, Massachusetts, June 17, 2025 (GLOBE NEWSWIRE) -- ProMIS Neurosciences Inc. (Nasdaq: PMN), a clinical-stage biotechnology company committed to the discovery and development of therapeutic antibodies selective for toxic oligomers associated with the development and progression of neurodegenerative diseases such as Alzheimer’s Disease (AD), amyotrophic lateral...Read more
HOUSTON, June 17, 2025 (GLOBE NEWSWIRE) -- Marker Therapeutics, Inc. (Nasdaq: MRKR), a clinical-stage immuno-oncology company focusing on developing next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, today announced a collaboration with Cellipont Bioservices, a leading cell therapy Contract Development and Manufacturing Organization (CDMO), for current good...Read more
Clinical Data Highlight PlaCCine’s Six-Month Durability, Temperature Stability, and Manufacturing Advantages Over mRNA Vaccines IMUNON Seeks Strategic Partner for PlaCCine® to Advance Novel Technology and Fund Core Pipeline with Non-Dilutive Capital LAWRENCEVILLE, N.J., June 17, 2025 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company focused on developing non-viral DNA-mediated immunotherapies and evaluating...Read more
As previously reported, 15 out of 16 (94%) patients in Phase 2b in the Per Protocol Population experienced Clinical Cure (CC) and all 15 of 15 (100%) remained free of C. difficile infection (CDI) recurrence through one month after EOT In contrast, 2 of 14 (14%) patients treated with the standard of care, oral vancomycin, experienced recurrent infection within one month after EOT When Phase 2b results are combined with...Read more
Phase 2 study, led by Dr. Antonio Jimeno at the University of Colorado Anschutz Medical Campus will evaluate NT219 in combination with either pembrolizumab or cetuximab as a strategy to overcome tumor resistance REHOVOT, Israel, June 17, 2025 (GLOBE NEWSWIRE) -- Purple Biotech Ltd. ("Purple Biotech" or "the Company") (NASDAQ/TASE: PPBT), a clinical-stage company developing first-in-class therapies that seek to overcome tumor immune...Read more
The data supports Filament's PEX010 drug development program targeting stimulant use disorders PEX010 is a first-in-class botanical psilocybin drug candidate currently under investigation in 52 clinical trials worldwide for 14 mental health indications VANCOUVER, BC, June 17, 2025 /CNW/ - Filament Health Corp. (OTC: FLHLF) ("Filament" or the "Company"), a clinical–stage natural psychedelic drug development company, today...Read more
Drug candidate ATR12-351 has been generally safe and well-tolerated with occasional, transient, mild to moderate symptoms at application site Trial is 50% enrolled; six patients have received ATR12-351, a live precision dermatology therapeutic candidate Azitra presenting at the 2025 BIO International Convention BRANFORD, Conn., June 17, 2025 /PRNewswire/ -- Azitra, Inc. (NYSE American: AZTR), a clinical stage biopharmaceutical...Read more
PITTSBURGH, June 17, 2025 (GLOBE NEWSWIRE) -- Lipella Pharmaceuticals Inc. (Nasdaq: LIPO) (“Lipella” or the “Company”), a clinical-stage biotechnology company focused on developing therapies for diseases with significant unmet need, today announced the issuance of U.S. Patent No. 12,326,492, titled “Systems and Methods of Detecting Interstitial Cystitis.” The patent was issued by the United States Patent and Trademark Office on June 10,...Read more
BRIDGEWATER, NEW JERSEY / ACCESS Newswire / June 17, 2025 / Tharimmune, Inc. (NASDAQ:THAR), a clinical-stage biotechnology company developing a portfolio of therapeutic candidates for inflammation and immunology, today announced significant appointments to its executive leadership and board of directors, reinforcing its commitment to advancing its pipeline and strategic initiatives. The Company is advancing its lead candidate TH104...Read more
$452.5 million in total milestone payments $2.5 million in near-term payments Double-digit royalties on future net product sales 3.5% equity stake in Intact Therapeutics HANOVER, Md., June 17, 2025 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (Nasdaq: PCSA), today announced that it has entered into a binding term sheet with Intact Therapeutics, Inc. (“Intact”) granting Intact the exclusive option to license PCS12852, a...Read more
Three Phase 1 studies support once-daily inhaled administration of mosliciguat with no evidence of serious systemic side effects Results informed the ongoing Phase 2 PHocus study of mosliciguat for the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD) WALTHAM, Mass., June 16, 2025 (GLOBE NEWSWIRE) -- Pulmovant, a clinical-stage biotechnology company dedicated to developing innovative therapies to...Read more
| Company | Change | Last Trade |
|---|---|---|
| Regeneron Pharmaceuticals | 9.42 1.83 | $523.00 |
| Ascendis Pharma | 6.19 3.63 | $176.90 |
| Unicycive Therapeutics | 5.67 849.81 | $6.34 |
| Bolt Biotherapeutics | 5.23 935.78 | $5.79 |
| Quantum BioPharma | 4.82 15.97 | $35.00 |
| argenx | 4.23 0.79 | $542.15 |
| Verona Pharma | 3.40 3.74 | $94.32 |
| Insmed | 3.22 3.24 | $102.68 |
| Madrigal Pharmaceuticals | 3.01 1.06 | $285.73 |
| BioNTech | 2.13 2.04 | $106.53 |
| Forte Biosciences | 1.95 15.66 | $14.40 |
| BridgeBio Pharma | 1.73 4.32 | $41.73 |
| Sagimet Biosciences | 1.68 23.86 | $8.72 |
| Disc Medicine | 1.52 3.03 | $51.61 |
| ImmuCell | 1.48 24.18 | $7.60 |
C4 Therapeutics is pioneering a new class of small-molecule drugs that selectively destroy disease-causing proteins via degradation using the innate machinery of the cell. This targeted protein degradation approach offers advantages over traditional drugs, including the potential to treat a wider range of diseases...
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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. Our lead cell therapy asset is NXC-201...
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