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Press releases published on June 16, 2025
Beyond Air Submits FDA PMA Supplement for Next Generation LungFit® PH
GlobeNewswire
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June 16, 2025
LungFit PH II’s smaller, lightweight, transport-ready design is expected to open the entirety of the NO market Final design based upon substantial feedback from respiratory therapists across the country GARDEN CITY, N.Y., June 16, 2025 (GLOBE NEWSWIRE) -- …
Immuneering to Provide Updates from Phase 2a Clinical Trial of IMM-1-104 in First-Line Pancreatic Cancer Patients on Tuesday, June 17, 2025
GlobeNewswire
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June 16, 2025
CAMBRIDGE, Mass., June 16, 2025 (GLOBE NEWSWIRE) -- Immuneering Corporation (Nasdaq: IMRX), a clinical-stage oncology company outpacing cancer to help patients outlive their disease, today announced that it will host a conference call and live webcast at 8 …
FOXO TECHNOLOGIES INC. CREATES ACQUISITION VEHICLE AND APPOINTS NEW INTERIM CFO
GlobeNewswire
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June 16, 2025
WEST PALM BEACH, FLORIDA, June 16, 2025 (GLOBE NEWSWIRE) -- FOXO Technologies Inc. (NYSE American: FOXO) (“FOXO” or the “Company”) today announced that it formed a new, wholly-owned subsidiary intended to be used to acquire identified acquisition targets …
Onco360 Has Been Selected as a National Specialty Pharmacy Partner for IBTROZI™ (taletrectinib), Manufactured by Nuvation Bio Inc.
GlobeNewswire
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June 16, 2025
LOUISVILLE, Ky., June 16, 2025 (GLOBE NEWSWIRE) -- Onco360®, the nation’s leading independent Specialty Pharmacy, has been selected as a pharmacy partner by Nuvation Bio Inc. for IBTROZI™ (taletrectinib), a kinase inhibitor approved for the treatment of …
Emory University and Micron Biomedical Launch First-in-Human Clinical Trial of Next-Generation Rotavirus Vaccine Delivered via Dissolvable Microarray Technology
GlobeNewswire
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June 16, 2025
Trial represents first-ever CDC-sponsored clinical trial of vaccine delivered via “patch” technology and utilizes Micron’s first-in-class dissolvable microarray technology Research builds on Emory’s research on influenza vaccines self-administered via …
Aurora Spine Surpasses 1,500 Successful Surgeries Using DEXA-C™
GlobeNewswire
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June 16, 2025
Please click to view image CARLSBAD, CALIFORNIA, June 16, 2025 (GLOBE NEWSWIRE) -- Aurora Spine Corporation (“Aurora Spine” or the “Company”) (TSXV: ASG) (OTCQB: ASAPF), a leader in innovative spinal implant technology, is proud to announce that its DEXA-C …
NextCure and Simcere Zaiming Announce Strategic Partnership for a Novel Antibody-Drug Conjugate Targeting CDH6
GlobeNewswire
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June 16, 2025
NextCure gains global rights to SIM0505 excluding greater China, where Simcere Zaiming will retain rights Phase 1 clinical trial ongoing for SIM0505 in China; U.S. Phase 1 clinical trial is expected to begin in the third quarter of 2025 Initial Phase 1 …
Ocugen, Inc. Announces U.S. FDA Clearance of Investigational New Drug Amendment to Initiate Phase 2/3 Pivotal Confirmatory Clinical Trial of OCU410ST—Modifier Gene Therapy Candidate for Stargardt Disease
GlobeNewswire
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June 16, 2025
MALVERN, Pa., June 16, 2025 (GLOBE NEWSWIRE) -- Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared …
Jiangsu Hengrui Pharmaceuticals and Kailera Therapeutics Announce Clinical Data Presentations at the American Diabetes Association 85th Scientific Sessions
GlobeNewswire
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June 16, 2025
– Hengrui to present six abstracts highlighting clinical progress of GLP-1/GIP dual receptor agonist HRS9531 (KAI-9531) and GLP-1 receptor agonist HRS-7535 (KAI-7535) in type 2 diabetes and obesity – JIANGSU, China and BOSTON, June 16, 2025 (GLOBE NEWSWIRE …
Supernus Pharmaceuticals to Acquire Sage Therapeutics, Strengthening its Neuropsychiatry Product Portfolio
GlobeNewswire
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June 16, 2025
Proposed acquisition expected to accelerate mid- to long-term revenue and cash flow growth and further diversify revenue base. Strengthens Supernus’ leading presence in neuropsychiatric conditions with an innovative commercial product, ZURZUVAE® ( …
Eolo Pharma Publishes First-in-Human Study in Nature Metabolism on Novel Obesity Drug Activating Energy-Burning Pathway
GlobeNewswire
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June 16, 2025
- New data show clinical safety and early efficacy of SANA, a first-in-class compound that targets creatine-dependent thermogenesis MONTEVIDEO, Uruguay, June 16, 2025 (GLOBE NEWSWIRE) -- Eolo Pharma, a clinical-stage biotechnology company developing …
EyePoint Reports Inducement Grants Under NASDAQ Listing Rule 5635(c)(4)
GlobeNewswire
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June 16, 2025
WATERTOWN, Mass., June 16, 2025 (GLOBE NEWSWIRE) -- EyePoint Pharmaceuticals, Inc. (Nasdaq: EYPT), a company committed to developing and commercializing therapeutics to help improve the lives of patients with serious retinal diseases, today announced that …
BioCryst Presents New Data on the Long-term Efficacy and Safety of ORLADEYO® (berotralstat) Across all Ages at EAACI
GlobeNewswire
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June 16, 2025
—Data across pediatric, adolescent, and adult populations demonstrate sustained reductions in HAE attacks and consistent safety profile— —Patients report improved quality of life and daily functioning with ORLADEYO— RESEARCH TRIANGLE PARK, N.C., June 16, …
Ocular Therapeutix™ to Participate in Clinical Trials at the Summit (CTS) 2025
GlobeNewswire
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June 16, 2025
BEDFORD, Mass., June 16, 2025 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc. (NASDAQ: OCUL, “Ocular”), a fully-integrated biopharmaceutical company committed to redefining the retina experience, today announced participation at Clinical Trials at the Summit …
Pulmovant Announces Publication of Pharmacokinetics and Lung Deposition Data for Inhaled Mosliciguat in Clinical Pharmacokinetics
GlobeNewswire
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June 16, 2025
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 …
Helius Medical Technologies, Inc. Announces Claim Authorization by CignaHealth, for its Portable Neuromodulation Stimulator (PoNS®) Device
GlobeNewswire
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June 16, 2025
- CignaHealth becomes fifth major payer to authorize claim for PoNS Device at out-of-network adjusted negotiated list price of $19,161- -This follows another recent authorization by Anthem Multiplan for PoNS Device at out-of-network negotiated price of $19 …
Aquestive Therapeutics Announces FDA Acceptance of New Drug Application and PDUFA Date for Anaphylm™ for the Treatment of Severe Allergic Reactions
GlobeNewswire
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June 16, 2025
FDA assigns PDUFA target action date of January 31, 2026 WARREN, N.J., June 16, 2025 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST) (“Aquestive” or the “Company”), a pharmaceutical company advancing medicines to bring meaningful …
Tonix Pharmaceuticals Presented Data and Analyses of TNX-102 SL Treatment Effects on Fibromyalgia at the Annual European Congress of Rheumatology (EULAR) 2025
GlobeNewswire
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June 16, 2025
TNX-102 SL is a sublingual formulation of cyclobenzaprine designed for transmucosal delivery and durable activity in treating fibromyalgia: FDA PDUFA goal date of August 15, 2025 TNX-102 SL demonstrated statistically significant improvement in the primary …
Axsome Therapeutics Proudly Supports Migraine and Headache Awareness Month Alongside the Association of Migraine Disorders
GlobeNewswire
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June 16, 2025
NEW YORK, June 16, 2025 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, is proud to recognize Migraine and Headache Awareness Month …
iBio Initiates Non-Human Primate Study of First-in-Class Activin E Antibody Following Positive Preclinical Data Demonstrating Prevention in Weight Regain After GLP-1 Treatment
GlobeNewswire
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June 16, 2025
iBio nominates IBIO-610 as development candidate for its first-in-class Activin E antibody New study aims to evaluate the half-life of IBIO-610 in obese, elderly non-human primates (NHP) and assess early signs of efficacy on fat reduction and body …