TARRYTOWN, N.Y., July 02, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Lynozyfic™ (linvoseltamab-gcpt) to treat adult patients with relapsed or refractory (R/R) multiple myeloma (MM) who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an...Read more
OXLUMO has been shown to significantly reduce urinary oxalate, which drives the progression of PH1 Disease1 MISSISSAUGA, ON, July 2, 2025 /CNW/ - Alnylam Canada ULC is pleased to announce that OXLUMO® (lumasiran) is now funded across Canada through both public and private plans. OXLUMO is an RNA interference (RNAi) therapeutic administered via subcutaneous injection, indicated for the treatment of primary hyperoxaluria type 1...Read more
Combination treatment of mTNX-1700 (mTFF2-MSA fusion protein) with anti-PD1 antibody was associated with increased survival and decreased metastases in animal models of gastric cancer relative to anti-PD1 treatment alone mTNX-1700 treatment was associated with activation of cancer-killing CD8+ T Cells and limiting neutrophil-mediated immune evasion TNX-1700 (hTFF2-HSA fusion protein) is in preclinical development for gastric and...Read more
SAN FRANCISCO, July 2, 2025 /PRNewswire/ -- Nektar Therapeutics (Nasdaq: NKTR), a clinical-stage biotechnology company focused on the development of innovative medicines in the field of immunotherapy, today announced the closing of its underwritten public offering of $115 million of shares of its common stock. Nektar sold 4,893,618 shares of common stock in the offering, which includes 638,298 shares sold upon exercise in full by the...Read more
500 subjects enrolled across the United States, the United Kingdom, France, Czech Republic, Switzerland, China, Taiwan, and Australia SAN DIEGO, July 02, 2025 (GLOBE NEWSWIRE) -- Belite Bio, Inc. (NASDAQ: BLTE), a clinical-stage drug development company focused on advancing novel therapeutics targeting degenerative retinal diseases that have significant unmet medical needs, today announced the completion of enrollment in the...Read more
WALTHAM, Mass., July 02, 2025 (GLOBE NEWSWIRE) -- Dyne Therapeutics, Inc. (Nasdaq:DYN), a clinical-stage company focused on delivering functional improvement for people living with genetically driven neuromuscular diseases, today announced the closing of its previously announced underwritten public offering of 27,878,788 shares of its common stock at a public offering price of $8.25 per share, which includes 3,636,363 shares issued...Read more
Cerus’ Notified Body, TÜV-SÜD, has completed the review of the clinical module for the CE Mark submission for INTERCEPT Red Blood Cells (RBCs) CONCORD, Calif. / Jul 02, 2025 / Business Wire / Cerus Corporation (Nasdaq: CERS) announced today a European regulatory update on the INTERCEPT RBC program. “We are pleased to report that the European regulatory review for INTERCEPT RBC is advancing ahead of plan and that TÜV-SÜD, our Notified...Read more
4FRONT-1 Phase 3 expected data readout accelerated from H2 2027 to H1 2027 4FRONT-2 Phase 3 trial initiated ahead of schedule Streamlined late-stage clinical and pre-commercial organization aligns with focused pipeline shift, as announced in January 2025 EMERYVILLE, Calif., July 02, 2025 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics (Nasdaq: FDMT, 4DMT or the Company), a leading late-stage biotechnology company advancing...Read more
FLORHAM PARK, N.J., July 02, 2025 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (Nasdaq: CLRB) (the “Company”), a late-stage clinical biopharmaceutical company focused on the discovery and development of drugs for the treatment of cancer, today announced the closing of its previously announced underwritten public offering for gross proceeds of approximately $6.9 million prior to deducting underwriting commissions and offering expenses....Read more
Data show confirmed ORR of 83% (10/12) at doses selected for ongoing expansion study Median follow-up of 9.0 months as of the updated data cutoff Responses observed in patients with low PD-L1 and/or CLDN18.2 expression Company to host investor event on Tuesday, July 8th ROCKVILLE, Md., July 02, 2025 (GLOBE NEWSWIRE) -- I-Mab (NASDAQ: IMAB) (the Company), a U.S.-based, global biotech company, focused on the development of...Read more
US phase 1 trial of ‘2510 is expected to be initiated before the end of 2025 Anticipate ImmuneOnco sharing initial safety and efficacy results from phase 2 trial of ‘2510 + chemo in 1L NSCLC in the second half of 2025 DALLAS, July 02, 2025 (GLOBE NEWSWIRE) -- Instil Bio, Inc. (“Instil”) (NASDAQ: TIL), a clinical-stage biopharmaceutical company focused on developing a pipeline of novel therapies, today announced the clearance of...Read more
Together, Los Angeles Cancer Network and Smilow Cancer Hospital at Yale New Haven add 30 satellite locations to enroll patients in BriaCell’s pivotal Phase 3 study BriaCell’s Phase 3 study currently has 58 active clinical sites across 15 states, including Smilow Cancer Hospital, Los Angeles Cancer Network, University of Arizona, DHR Health Oncology Institute, Sylvester Comprehensive Cancer Center, Cancer Care Northwest, Hematology...Read more
SPEAR Study Group initiated following multiple, independent reports of substantial clinical benefit associated with PEMGARDA® (pemivibart) therapy among people with Long COVID SPEAR Study Group collaborators Drs. Michael Peluso, Amy Proal, and David Putrino are key thought leaders in the clinical and translational biology of Long COVID and Post-Vaccination Syndrome Initial SPEAR clinical efforts to be aimed at rigorous, controlled...Read more
PLYMOUTH MEETING, Pa., July 2, 2025 /PRNewswire/ -- INOVIO Pharmaceuticals, Inc. (Nasdaq: INO), a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases, today announced that it intends to offer and sell shares of its common stock (or pre-funded warrants to purchase its common stock in lieu thereof) and in either...Read more
BRIDGEWATER, N.J., July 02, 2025 (GLOBE NEWSWIRE) -- VYNE Therapeutics Inc. (Nasdaq: VYNE) (“VYNE” or the “Company”), a clinical-stage biopharmaceutical company focused on developing differentiated therapies to treat chronic inflammatory and immune-mediated conditions with high unmet need, today provided a program update for VYN202 following the clinical hold issued by the U.S. Food and Drug Administration (FDA) in April for the Company’s...Read more
Proceeds to drive development of ONP-002, the Company’s lead intranasal drug candidate for mild traumatic brain injury SARASOTA, Fla., July 02, 2025 (GLOBE NEWSWIRE) -- Oragenics, Inc. (NYSE American: OGEN), a clinical-stage biotechnology company pioneering intranasal therapeutics for neurological disorders, today announced the successful closing of its previously announced public offering of Series H Convertible Preferred Stock and...Read more
LEXINGTON, Mass., July 2, 2025 /PRNewswire/ -- Curis, Inc. ("Curis") (NASDAQ: CRIS), a biotechnology company focused on the development of emavusertib (CA-4948), an orally available, small molecule IRAK4 inhibitor, today announced that it has entered into a definitive agreement with a combination of existing and new investors for the purchase of 1,538,460 shares ("Shares") of its common stock in a registered direct offering priced...Read more
1.3 million patients are hospitalized annually in the U.S. from acute heart failure and it is the #1 cause of hospitalization in patients >65 years old If istaroxime is approved in the US for acute heart failure, this patent would provide protection to 2039 WARRINGTON, Pa., July 02, 2025 (GLOBE NEWSWIRE) -- Windtree Therapeutics, Inc. (“Windtree” or the “Company”) (NasdaqCM: WINT), a diversified company focused on revenue...Read more
PASADENA, CALIF, July 02, 2025 (GLOBE NEWSWIRE) -- Lixte Biotechnology Holdings, Inc. (NASDAQ: LIXT) (the “Company”), a clinical stage pharmaceutical company, today announced the closing of a private placement with accredited investors for the purchase and sale of approximately $5.0 million of shares of Common Stock (or Pre-Funded Warrants), Series B Convertible Preferred Stock and Common Warrants. The offering was priced at the market...Read more
SAN RAFAEL, Calif., July 1, 2025 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) said today that it completed the previously announced agreement to acquire Inozyme Pharma, Inc. (Nasdaq: INZY) for $4.00 per share in an all-cash transaction worth approximately $270 million. The acquisition will strengthen BioMarin's enzyme therapies portfolio, adding a late-stage enzyme replacement therapy, INZ-701. The medicine is currently...Read more
Conditional approval based on positive results from the HERIZON-BTC-01 Phase 2b trial DUBLIN, July 1, 2025 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the European Commission (EC) has granted conditional marketing authorization1 for Ziihera® (zanidatamab), a dual human epidermal growth factor receptor 2 (HER2)-targeted bispecific antibody, as monotherapy for the treatment of adults with...Read more
REDWOOD CITY, Calif., July 01, 2025 (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. (Soleno) (NASDAQ: SLNO), a biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today announced that two abstracts featuring data on VYKAT™ XR (diazoxide choline) extended-release tablets, previously known as DCCR, have been selected for presentation at the Annual Meeting of the Endocrine Society (ENDO 2025), which is...Read more
REYKJAVIK, Iceland and LONDON, July 01, 2025 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide and Advanz Pharma Holdco Limited (“Advanz Pharma”), a UK headquartered global pharmaceutical company with a strategic focus on specialty, hospital, and rare disease medicines in Europe, today announced that the companies have...Read more
Apellis to receive $275 million upfront and up to $25 million in milestone payments upon EMA approval in C3G and IC-MPGN Non-dilutive financing further strengthens Apellis’ balance sheet Apellis retains full U.S. commercialization rights for systemic pegcetacoplan Transaction underscores shared confidence in the meaningful growth potential in rare kidney diseases WALTHAM, Mass., July 01, 2025 (GLOBE NEWSWIRE) -- Apellis...Read more
SEATTLE, July 01, 2025 (GLOBE NEWSWIRE) -- Adaptive Biotechnologies Corporation (NASDAQ: ADPT), a commercial stage biotechnology company that aims to translate the genetics of the adaptive immune system into clinical products to diagnose and treat disease, and Flatiron Health, a leading healthtech company dedicated to expanding the possibilities of point-of-care solutions in oncology, today announced the integration of Adaptive’s...Read more
NEWTOWN SQUARE, Pa., July 01, 2025 (GLOBE NEWSWIRE) -- ArriVent BioPharma, Inc. (“ArriVent”) (Nasdaq: AVBP), a clinical-stage company dedicated to accelerating the global development of innovative biopharmaceutical therapeutics, today announced that it intends to offer and sell, subject to market and other conditions, $75 million of its shares of common stock and, in lieu of common stock to certain investors, pre-funded warrants to...Read more
NEW HAVEN, Conn., July 1, 2025 /PRNewswire/ -- Trevi Therapeutics, Inc. (Nasdaq: TRVI), a clinical-stage biopharmaceutical company developing the investigational therapy Haduvio™ (oral nalbuphine ER) for the treatment of chronic cough in patients with idiopathic pulmonary fibrosis (IPF) and in patients with refractory chronic cough (RCC), today announced that Jennifer Good, President and Chief Executive Officer, and Lisa Delfini,...Read more
Financing co-led by Ferring Ventures S.A. and Apeiron Investment Ltd. with participation from new and existing healthcare-focused institutional investors, including Ally Bridge Group and ADAR1 NEW YORK and AMSTERDAM, July 01, 2025 (GLOBE NEWSWIRE) -- atai Life Sciences (NASDAQ: ATAI) (“atai”), a clinical-stage biopharmaceutical company on a mission to develop highly effective mental health treatments to transform patient outcomes, today...Read more
Study met its primary and all key secondary endpoints, and BPL-003 demonstrated rapid, robust and durable antidepressant effects with a single dose Both 8 mg and 12 mg single doses of BPL-003 showed statistically significant and clinically meaningful reductions in depressive symptoms at all time points of the study compared to a 0.3 mg low-dose active control out to Week 8 BPL-003 was generally well-tolerated at all doses, with 99% of...Read more
Abeona will receive a license payment and potential development, regulatory, and sales milestones, and royalties CLEVELAND, July 01, 2025 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced that Beacon Therapeutics, an ophthalmic gene therapy company and Syncona portfolio company, has exercised its option to license Abeona's patented AAV204 capsid for use in potential gene therapies for a range of prevalent...Read more
Brings More Than Twenty Years of Biopharmaceutical Leadership Experience ANN ARBOR, Mich., July 01, 2025 (GLOBE NEWSWIRE) -- Esperion (NASDAQ: ESPR) today announced it has appointed Craig Thompson, Chief Executive Officer of Cerevance, to its Board of Directors. Mr. Thompson will serve as an independent director. With Mr. Thompson’s appointment, Esperion’s Board of Directors now comprises eight members. “We are thrilled to welcome...Read more
VANCOUVER, British Columbia & DALLAS / Jul 01, 2025 / Business Wire / Alpha Cognition Inc. (Nasdaq: ACOG) (“Alpha Cognition” [ACI], or the “Company”), a biopharmaceutical company developing novel therapies for debilitating neurodegenerative disorders, today announced preclinical data supporting the continued development of ALPHA-1062 for the treatment of mild traumatic brain injury (mTBI). The data provides additional evidence of...Read more
NEW YORK, July 01, 2025 (GLOBE NEWSWIRE) -- Indaptus Therapeutics, Inc. (Nasdaq: INDP) (“Indaptus”), a clinical stage biotechnology company dedicated to pioneering innovative cancer and viral infection treatments, today announced the additional sale of approximately $3.4 million in aggregate principal amount of convertible promissory notes and accompanying warrants. Together with a prior sale of $2.3 million of convertible promissory...Read more
DSMB recommended the continuation of trial as planned Topline data expected in Q3 2025 NEW HAVEN, Conn., July 01, 2025 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience, today announced the second positive recommendation by an independent Data Safety Monitoring Board (DSMB) to continue, without...Read more
Sanofi to exercise option on third SAFEbody discovery program and sponsor combination clinical trial with muzastotug Company expects proceeds to extend cash runway into 2027 SAN DIEGO and SUZHOU, China, July 01, 2025 (GLOBE NEWSWIRE) -- Adagene Inc. (“Adagene or the Company”) (Nasdaq: ADAG), a company transforming the discovery and development of novel antibody-based therapies, today announced strategic investment and option...Read more
LONDON and PHILADELPHIA, July 01, 2025 (GLOBE NEWSWIRE) -- Avacta Group plc (AIM: AVCT), a life sciences company developing innovative, targeted oncology drugs, today announces the appointment of David Liebowitz, M.D., Ph.D. as Chief Medical Officer (CMO) and Yulii Bogatyrenko as an advisor in business development. Dr. Liebowitz will lead the Company’s clinical strategy and execution as it continues to advance its pipeline of...Read more
Genitourinary Tumor Study Ongoing with Active Screening and Enrollment MILAN and NEW YORK, July 01, 2025 (GLOBE NEWSWIRE) -- Genenta Science (Nasdaq: GNTA), a pioneer in immuno-oncology, today announced that a total of 38 patients were enrolled in newly diagnosed glioblastoma multiforme (TEM-GBM) study, with 25 patients receiving Temferon. Two patients have been enrolled in the TEM-LT long-term follow-up study, surviving three years...Read more
Verrica to receive a $8 million milestone payment for initiation of the global study in July 2025, ahead of previous schedule Verrica to receive a $10 million milestone payment from Torii in cash upon the approval of YCANTH® (TO-208 in Japan) for molluscum contagiosum in Japan; approval decision expected by the end of 2025 Torii to fund the first $40 million of out-of-pocket costs for the global study, representing...Read more
CHICAGO / Jul 01, 2025 / Business Wire / MAIA Biotechnology, Inc. (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, today announced two upcoming poster presentations at the 49th Federation of European Biochemical Societies (FEBS) 2025 Congress, hosted by the Turkish Biochemical Society, to be held July 5-9, 2025, in Istanbul, Turkey. The...Read more
MOUNTAIN VIEW, Calif., July 01, 2025 (GLOBE NEWSWIRE) -- IGM Biosciences, Inc. (Nasdaq: IGMS), a biotechnology company that has focused on developing engineered IgM-based therapeutic antibodies, today announced that it has entered into a definitive merger agreement (the “Merger Agreement”) with Concentra Biosciences, LLC (“Concentra”), whereby Concentra will acquire IGM Biosciences for $1.247 in cash per share of IGM Biosciences common...Read more
ORR of 50% in treatment-naïve patients with HPV+ R/M HNSCC 12-month landmark survival of 88% and mOS of 32 months BOSTON, July 01, 2025 (GLOBE NEWSWIRE) -- Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of therapeutic biologics to selectively engage and modulate disease-specific T cells for the treatment of autoimmune disease and cancer, today provided an update on its...Read more
Well-established executive with over 20 years of experience building and leading commercial teams across diverse therapeutic markets and geographies Career focused on driving business growth and developing an integrated commercial strategy to deliver results ISELIN, N.J., July 01, 2025 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on enhancing the standard of care for bevacizumab...Read more
PURCHASE, N.Y., July 01, 2025 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc., (the Company or Cognition) (NASDAQ: CGTX), a clinical stage company developing drugs that treat neurodegenerative disorders, announced that the Phase 2 ‘START’ Study surpasses 50% enrollment. The START Study is being conducted with partners at the Alzheimer’s Clinical Trials Consortium (ACTC), with $81 million in grant support from the National Institute of...Read more
PASADENA, CALIF, July 01, 2025 (GLOBE NEWSWIRE) -- Lixte Biotechnology Holdings, Inc. (NASDAQ: LIXT) (the “Company”), a clinical stage pharmaceutical company, today announced that, on June 30, 2025 intraday, it entered into a definitive agreement with accredited investors on the purchase and sale of approximately $5.0 million of shares of Common Stock (or Pre-Funded Warrants), Series B Convertible Preferred Stock and Common Warrants. The...Read more
Active Ingredient Manufacturing Transfer to the U.S. Complete PRINCETON, N.J., July 1, 2025 /PRNewswire/ -- Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that it has successfully completed the transfer of the manufacturing process for its...Read more
Chief Executive Officer (CEO) Christian Kanstrup steps down Chief Scientific Officer Birgitte Rønø appointed interim CEO and search for new CEO has commenced Thomas Schmidt appointed permanent Chief Financial Officer COPENHAGEN, Denmark, July 1, 2025 - Evaxion A/S (NASDAQ: EVAX) (“Evaxion”), a clinical-stage TechBio company specializing in developing AI-Immunology™ powered vaccines, announces several key executive management...Read more
Recruitment initiated into the Phase 2 opaganib plus darolutamide study in patients with advanced prostate cancer, sponsored by ANZUP, and supported by Bayer and Ramsay Hospital Research Foundation Precision medicine approach: The 60-patient Phase 2 study uses the PCPro™ lipid biomarker test to identify patients with poor prognosis most likely to benefit from the combination Led by Professor Lisa Horvath, the study is expected to...Read more
Currently available treatments for IPF are limited to only two approved drugs that come with significant side-effects, limited patient compliance and no impact on survival 2- and 6-week interim safety results demonstrated GRI-0621 to be safe and well-tolerated in the first 12 and 24 patients evaluated, respectively Results on track for 6-week interim biomarker analysis (n=24) in July 2025 and topline data in Q3 2025 LA JOLLA, CA,...Read more
Phase 1b study supports proof-of-concept in DOK7 congenital myasthenic syndromes Decision informed by favorable safety profile and consistent functional improvement over time across multiple efficacy measures Advancing ARGX-119 further validates strong track record of Immunology Innovation Program (IIP), argenx's collaborative discovery model June 30, 2025, 7:00 AM CET - Amsterdam, the Netherlands – argenx SE (Euronext &...Read more
SAN DIEGO, June 30, 2025 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced the initiation of a Phase 1 first-in-human clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of investigational compound NBIP-01435 in healthy adult participants. NBIP-01435 is a long-acting corticotropin-releasing factor type 1 receptor antagonist administered as a subcutaneous...Read more
mRNA-1010 demonstrated superior relative vaccine efficacy that was 26.6% (95% CI; 16.7%, 35.4%) higher than a licensed standard-dose seasonal influenza vaccine in adults aged 50 years and older CAMBRIDGE, MA / ACCESS Newswire / June 30, 2025 / Moderna, Inc. (NASDAQ:MRNA) today announced positive results from a Phase 3 efficacy study (P304) evaluating the relative vaccine efficacy (rVE) against influenza illness of mRNA-1010, the...Read more
BridgeBio has received a $300 million upfront payment, strengthening the Company’s balance sheet, and supporting the launch of Attruby® and ongoing late-stage pipeline programs Transaction monetizes 60% of BridgeBio’s European royalties on the first $500 million of annual BEYONTTRA net sales, with total payments to the investors subject to an initial cap of 1.45x In the ATTRibute-CM study, acoramidis demonstrated the most rapid...Read more
REDWOOD CITY, Calif. and MIAMI, June 30, 2025 (GLOBE NEWSWIRE) -- Revolution Medicines, Inc. (Nasdaq: RVMD), a late-stage clinical oncology company developing targeted therapies for patients with RAS-addicted cancers and Summit Therapeutics, Inc. (Nasdaq: SMMT), a biopharmaceutical oncology company focused on patient-friendly medicinal therapies intended to improve quality of life, increase potential duration of life, and resolve serious...Read more
SAN FRANCISCO, June 30, 2025 /PRNewswire/ -- Nektar Therapeutics (Nasdaq: NKTR), a clinical-stage biotechnology company focused on the development of innovative medicines in the field of immunotherapy, today announced that it has commenced an underwritten public offering of shares of its common stock and, in lieu of common stock to certain investors, pre-funded warrants to purchase shares of its common stock. All of the shares of common...Read more
At an Interim Analysis, Bemarituzumab Plus Chemotherapy Significantly Improved Overall Survival in People With FGFR2b Overexpression Compared to Chemotherapy Alone SHANGHAI & CAMBRIDGE, Mass. / Jun 30, 2025 / Business Wire / Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced the Phase 3 FORTITUDE-101 clinical trial evaluating first-line bemarituzumab plus chemotherapy (mFOLFOX6) met its primary endpoint of overall survival...Read more
A novel oral peptide PN-477o with once-daily dosing, high potency and activation of glucagon-like peptide-1 (GLP-1), glucose-dependent insulinotropic peptide (GIP), and glucagon (GCG) receptors Company will also develop a subcutaneous version, PN-477sc, as a once-weekly injection IND-enabling studies underway, with Phase I study initiation expected in 2Q26 Webcast and conference call to be held today at 4:30 pm ET NEWARK,...Read more
NEW YORK, June 30, 2025 (GLOBE NEWSWIRE) -- Mesoblast (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced alignment with the United States Food and Drug Administration (FDA) on items required for filing a Biologics License Application (BLA) for Revascor® (rexlemestrocel-L) in the treatment of patients with ischemic heart failure with reduced ejection fraction (HFrEF) and...Read more
Single Doses of Aritinercept Led to Robust and Long-Lasting Reductions in Immunoglobulins Pharmacodynamic Effects Supportive of Once-Monthly Dosing Plan to Initiate Clinical Studies in at Least Two Autoimmune Diseases in the Second Half of This Year Aurinia to Host Conference Call Today, June 30, at 8:30 a.m. ET ROCKVILLE, Md. & EDMONTON, Alberta / Jun 30, 2025 / Business Wire / Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) today...Read more
$100 million funded upfront; additional $175 million tied to milestones provides strategic flexibility through key inflection points WALTHAM, Mass., June 30, 2025 (GLOBE NEWSWIRE) -- Dyne Therapeutics, Inc. (Nasdaq: DYN), a clinical-stage company focused on delivering functional improvement for people living with genetically driven neuromuscular diseases, today announced it has entered into a $275 million non-dilutive...Read more
WALTHAM, Mass., June 30, 2025 (GLOBE NEWSWIRE) -- Dyne Therapeutics, Inc. (Nasdaq: DYN), a clinical-stage company focused on delivering functional improvement for people living with genetically driven neuromuscular diseases, today announced that it has commenced an underwritten public offering of $200,000,000 of shares of its common stock. Dyne also intends to grant the underwriters a 30-day option to purchase up to an additional...Read more
The Launch-HTN trial is the largest trial of an aldosterone synthase inhibitor completed in participants with uncontrolled or treatment resistant hypertension Lorundrostat 50 mg once daily demonstrated clinically meaningful reductions in systolic blood pressure, with a 16.9 mmHg reduction at Week 6 and a 19.0 mmHg reduction at Week 12 Lorundrostat was generally well-tolerated; and treatment-emergent adverse events were mostly mild,...Read more
TYRA-300 is the only orally administered investigational agent in clinical development for IR NMIBC Initial 3-month complete response (CR) data expected to be reported in 1H 2026 CARLSBAD, Calif., June 30, 2025 /PRNewswire/ -- Tyra Biosciences, Inc. (Nasdaq: TYRA), a clinical-stage biotechnology company focused on developing next-generation precision medicines that target large opportunities in Fibroblast Growth Factor Receptor...Read more
In the Phase 1 portion of the CELC-G-201 clinical trial evaluating gedatolisib plus darolutamide in men with metastatic castration resistant prostate cancer (“mCRPC”),the six-month radiographic progression free survival (“rPFS”) rate was 66% In a Phase 2 clinical trial of gedatolisib plus trastuzumab-pkrb as 3L+ therapy in patients with HER2+ metastatic breast cancer (“mBC”), the objective response rate (“ORR”) was 43% No patients...Read more
Complete Response Letter (CRL) cited deficiencies previously identified at a third-party manufacturing vendor unrelated to Oxylanthanum Carbonate (OLC) No other concerns stated, including pre-clinical, clinical, or safety data The Company identified a second manufacturing vendor that has already produced OLC drug product, which could also be used to support the resolution of the Clinical Manufacturing and Controls (CMC) issues...Read more
ARCT-810 significantly and consistently reduces biomarker glutamine to levels within normal range 15N-ureagenesis data provide first evidence of an mRNA therapeutic improving urea cycle function Ammonia remained stable and within normal range Multiple administrations of ARCT-810 continue to be safe and well tolerated at all tested dose levels Virtual KOL Presentation at 12:00 p.m. ET Today SAN DIEGO / Jun 30, 2025 / Business Wire /...Read more
Builds on clearances already received by FDA and EMA China has the largest population of patients with hepatocellular carcinoma in the world BRISBANE, Calif., June 30, 2025 (GLOBE NEWSWIRE) -- Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage biotechnology company with a pipeline of first-in-classi targeted and immune-mediated therapeutics to fight cancer, today announced that the company received approval from the...Read more
RP-A701 is a first-in-class gene therapy for the treatment of BAG3-associated dilated cardiomyopathy BAG3-associated dilated cardiomyopathy is a rare, inherited heart condition caused by mutations in the BAG3 gene, leading to early-onset, progressive heart failure due to impaired cardiac function, high morbidity, and premature mortality Rocket plans to conduct a Phase 1 trial in the U.S. and is working towards the first patient...Read more
Written agreement from FDA for single-arm, open-label, baseline-controlled registrational trial evaluating composite primary endpoint of improvement in CGI-I and gain of developmental milestone/skill by video capture Written agreement from FDA to evaluate NGN-401 in females with Rett syndrome ages 3 years and older based on natural history study analysis Registrational trial initiation activities underway Phase 1/2 trial fully...Read more
FRAME study demonstrated a 42.3% ORR and 20.1 months median PFS for all patients with low-grade serous ovarian cancer (LGSOC), regardless of KRAS mutation; for patients with KRAS-mutated LGSOC, ORR and mPFS were 58.3% and 30.8 months, respectively Study conducted by the Institute of Cancer Research and The Royal Marsden NHS Foundation Trust demonstrated the importance of the intermittent dosing schedule of the combination of avutometinib...Read more
Monotherapy efficacy and safety profile provided backbone for clinical development strategy in 1L combination with nivolumab plus chemotherapy ROCKVILLE, MD, June 30, 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 cancer, today announced publication of the first-in-human monotherapy data for...Read more
Funding agreement contemplates a conversion formula with a potential 30% premium upon conversion and positions the Company for growth, and accelerated advancement of its clinical pipeline programs, CYB003 and CYB004 TORONTO / Jun 30, 2025 / Business Wire / Cybin Inc. (NYSE American: CYBN) (Cboe Canada: CYBN) (“Cybin” or the “Company”), a clinical-stage breakthrough neuropsychiatry company committed to revolutionizing mental healthcare...Read more
Dosing is underway in the Phase 3 CYB003 PARADIGM program which comprises two 12-week randomized, double-blind, placebo-controlled studies (APPROACH™ and EMBRACE™) and a long-term extension study (EXTEND), with anticipated combined enrollment of approximately 550 patients1 Strengthened commercial preparations and manufacturing capabilities through partnerships with Osmind and Thermo Fisher Scientific, respectively APPROACH expects to...Read more
Study will evaluate safety and antiviral activity of ABI-1179 in participants with recurrent genital herpes ABI-1179 IND cleared to support study expansion to sites in United States Phase 1b studies for ABI-1179 and ABI-5366 running concurrently with interim data for both candidates on track for fall 2025 SOUTH SAN FRANCISCO, Calif., June 30, 2025 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (Nasdaq: ASMB), a...Read more
Data show that simufilam reduced seizure activity in a preclinical mouse model Presentation also highlights favorable human safety data from 1,929 patient Phase 3 program AUSTIN, Texas, June 30, 2025 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (NASDAQ: SAVA, “Cassava”, the “Company”), a clinical-stage biotechnology company focused on developing novel, investigational treatments for central nervous system (CNS) disorders, today...Read more
No treatment-related neuropsychiatric events seen to date in SAD portion of Phase 1 MAD study on track for completion in Q3 2025 NORWOOD, Mass., June 30, 2025 (GLOBE NEWSWIRE) -- Corbus Pharmaceuticals Holdings Inc. (NASDAQ: CRBP), a clinical-stage company focused on oncology and obesity, today announced the initiation of the multiple ascending dose (MAD) portion of its Phase 1 trial for CRB-913, a highly peripherally restricted CB1...Read more
SEATTLE and VANCOUVER, British Columbia, June 30, 2025 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage specialty pharmaceutical company focused on the global development and commercialization of cytisinicline as a treatment of nicotine dependence for smoking cessation, today announced the closing of its underwritten public offering of 15,000,000 shares of its common stock and accompanying common warrants...Read more
Antev Shareholders to Receive Aggregate ~17% Equity Stake in Medicus plus US$65 Million in Contingent Payments Philadelphia, Pennsylvania--(Newsfile Corp. - June 30, 2025) - Medicus Pharma Ltd. (NASDAQ: MDCX) ("Medicus") and Antev Ltd. ("Antev"), a UK-based clinical-stage drug development company, announced today that they have entered into a definitive agreement dated June 29, 2025 (the "Definitive Agreement") pursuant to which...Read more
Compelling PAX-D results guided Alto’s acquisition of ALTO-207, designed to induce rapid antidepressant effects while mitigating dose-limiting adverse events of pramipexole Alto plans to collaborate with National Health Service, PAX-D clinical sites for the planned Phase 2b trial of ALTO-207, designed to be a potentially pivotal study; trial expected to initiate by mid-2026 MOUNTAIN VIEW, Calif. / Jun 30, 2025 / Business...Read more
SAN DIEGO and CALGARY, Alberta, June 30, 2025 /CNW/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, today announced the appointment of Andrew Aromando as Chief Business Officer. Mr. Aromando most recently served as Chief Operating Officer at Ambrx Biopharma, where his contributions were instrumental in the $2 billion acquisition of the San...Read more
HALIFAX, NS / ACCESS Newswire / June 30, 2025 / MedMira Inc. (MedMira) (TSXV:MIR), reported today on its financial results for the quarter ended January 31, 2025. Corporate update In Q3 FY2025, MedMira launched its recently Health Canada approved Multiplo® Rapid TP/HIV Test (Multiplo® TP/HIV) and its latest generation of its Reveal® Rapid HIV Test in Canada through its partner Trimedic. In addition, the Company continued its regulatory...Read more
Boca Raton, Florida, June 30, 2025 (GLOBE NEWSWIRE) -- INmune Bio Inc. (NASDAQ: INMB) (the “Company”), a clinical-stage inflammation and immunology company, today announced that it has closed its registered direct offering, announced on June 27, 2025, (the "Offering") for the purchase and sale of 3,000,000 shares of its common stock at a purchase price of $6.30 per share, priced at-the-market under Nasdaq rules. The gross proceeds from...Read more
In the Phase 2 MINDFuL trial of XPro™ in patients with early Alzheimer’s Disease (AD) with biomarkers of inflammation, the modified intent-to-treat (mITT) population (n=200) did not meet the primary cognitive endpoint (EMACC), however in a predefined population of amyloid-positive early AD patients with two or more biomarkers of inflammation (n=100), a benefit of XPro™ treatment over placebo was observed in cognitive, behavioral and...Read more
LOS ANGELES, CALIFORNIA / ACCESS Newswire / June 30, 2025 / Renovaro Inc.'s (NASDAQ:RENB) wholly owned subsidiary BioSymetrics has unveiled a proprietary AI-based zebrafish screening platform designed to rapidly identify medical countermeasures for neurotoxic chemical agents, including weaponized substances like Sarin. The platform has been integrated into Renovaro's Defense Countermeasures Program, marking a strategic entry into the...Read more
As of June 30th, 16 participants have enrolled in the Phase 1b, ahead of the original goal of at least 15 total participants by 3Q 2025 Analysis of 90-day biomarker activity from cerebrospinal fluid (CSF) in all participants currently enrolled is now expected to also track earlier; available in 4Q 2025 instead of 1Q 2026 Gain will continue screening patients for enrollment through July 31st, 2025, at the request of clinical...Read more
The primary endpoint of 12-month Event Free Survival (EFS) for OST-HER2- treated patients (35%) was statistically significant (p= 0.0194) when compared with peer-reviewed comparable historical control (20%) Company also provides regulatory update on comparator for OST-HER2 Phase 2b Trial in the Prevention or Delay of Recurrence in Fully Resected, Lung Metastatic Osteosarcoma Responses to recent FDA Type D Meeting follow-up questions...Read more
First Orally Active Fatty Acid Binding Protein 5 Inhibitor Evaluated in Humans First-in-Class Approach Targets Unmet Need in Multibillion-Dollar Pain Management Market SOLANA BEACH, Calif., June 30, 2025 (GLOBE NEWSWIRE) -- Artelo Biosciences, Inc. (Nasdaq: ARTL), a clinical-stage pharmaceutical company focused on modulating lipid-signaling pathways to develop treatments for people living with cancer, pain, dermatological or...Read more
FDA provides supportive feedback on proposed statistical analysis plan for neurofilament biomarker analysis of Clene’s NIH-sponsored Expanded Access Program NfL EAP biomarker analyses to be conducted early in the 4th Quarter of 2025 Clene confirms two additional FDA meetings scheduled for 3rd Quarter of 2025, to discuss ALS survival data and MS clinical development program Submission of new drug application for ALS under the...Read more
As recently announced, initial proof-of-concept results from this ongoing investigator-initiated trial (IIT) show crofelemer reduced the required total parenteral nutrition in the first participating microvillus inclusion disease (MVID) patient by up to 27% and in the first participating short bowel syndrome patient by up to 12.5% The first two patients in this IIT were taken off crofelemer after 12 weeks of treatment for a period...Read more
POTOMAC, MARYLAND / ACCESS Newswire / June 30, 2025 / IGC Pharma, Inc. (NYSE American:IGC) ("IGC" or the "Company"), a clinical-stage biotechnology company leveraging AI to develop innovative treatments for Alzheimer's and metabolic disorders, today unveiled the key achievements and advancements that defined Fiscal Year 2025, ended March 31, 2025. This past year has been nothing short of transformative, marked by significant clinical...Read more
SPRING Trial Data Presented at BSG Live’25 Confirms the Clinical Potential of Nebokitug as a First-in-Class Novel Treatment for PSC and Supports Advancement to Phase 3 Treatment with Nebokitug Is Well-Tolerated and Associated with Substantial Improvements in Multiple Fibrotic and Inflammatory Biomarkers that Represent Slowing of PSC Disease Progression TEL AVIV, Israel and GLASGOW, United Kingdom, June 30, 2025 (GLOBE NEWSWIRE) --...Read more
| Company | Change | Last Trade |
|---|---|---|
| Regeneron Pharmaceuticals | 12.83 2.40 | $547.74 |
| Alnylam Pharmaceuticals | 7.71 2.39 | $329.77 |
| Madrigal Pharmaceuticals | 6.84 2.28 | $307.00 |
| Bolt Biotherapeutics | 5.35 957.25 | $5.91 |
| Vertex Pharmaceuticals | 4.87 1.08 | $457.03 |
| United Therapeutics | 4.50 1.55 | $295.22 |
| CRISPR Therapeutics | 3.92 8.08 | $52.43 |
| Ionis Pharmaceuticals | 3.65 9.14 | $43.59 |
| Soleno Therapeutics | 3.58 4.33 | $86.21 |
| Ultragenyx Pharmaceutical | 3.19 8.80 | $39.46 |
| Praxis Precision Medicines | 3.11 7.20 | $46.32 |
| Sonnet BioTherapeutics | 2.92 241.32 | $4.13 |
| Nutriband | 2.70 33.67 | $10.72 |
| argenx | 2.64 0.49 | $545.11 |
| Nuvalent | 2.49 3.19 | $80.50 |
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...
CLICK TO LEARN MORE
Compass Therapeutics is a clinical-stage, oncology-focused biopharmaceutical company developing proprietary antibody-based therapeutics to treat multiple human diseases. The company's scientific focus is on the relationship between angiogenesis, the immune system, and tumor growth...
CLICK TO LEARN MORE
