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Press releases published on May 14, 2025
Abeona Therapeutics® and Lurie Children's Open First Center for ZEVASKYNTM Gene Therapy to Treat Wounds in Painful Skin Disorder
GlobeNewswire
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May 14, 2025
- ZEVASKYN, the first and only cell-based gene therapy for patients with recessive dystrophic epidermolysis bullosa (RDEB), now commercially available in the U.S. - - Ann …
BioVie to Host Virtual KOL Event to Discuss the Phase 2 Study of Bezisterim for the Treatment of Parkinson's Disease on May 28, 2025
GlobeNewswire
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May 14, 2025
CARSON CITY, Nev., May 14, 2025 (GLOBE NEWSWIRE) -- BioVie Inc. (NASDAQ: BIVI), (“BioVie” or the “Company”), a clinical-stage company developing innovative drug therapies for the treatment of neurological and neurodegenerative disorders and advanced liver …
Moleculin Reports First Quarter 2025 Financial Results and Provides Corporate Update
GlobeNewswire
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May 14, 2025
Enrollment and dosing underway in Phase 3 clinical trial (the “MIRACLE” trial) evaluating Annamycin (naxtarubicin) for the treatment of R/R AML Regulatory and site selection progress to date supports interim data readout expected in the second half of …
Arbutus Reports First Quarter 2025 Financial Results and Provides Corporate Update
GlobeNewswire
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May 14, 2025
Imdusiran combination therapy has functionally cured 8 patients with chronic hepatitis B (cHBV) to date, including 2 patients who received no interferon AB-101, oral small-molecule PD-L1 inhibitor, shown generally safe and well-tolerated with evidence of …
Inozyme Pharma Reports First Quarter 2025 Financial Results and Provides Business Highlights
GlobeNewswire
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May 14, 2025
- Interim data from ENERGY 3 trial highlight INZ-701’s potential to modify disease course in ENPP1 Deficiency, with sustained phosphate increases and favorable safety and immunogenicity profile to date - - ENERGY 3 trial on track for topline data in first …
Milestone Pharmaceuticals Reports First Quarter 2025 Financial Results and Provides Regulatory and Corporate Update
GlobeNewswire
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May 14, 2025
Resolution of CRL Manufacturing issues in progress - Type A meeting requested No clinical safety or efficacy concerns raised by FDA MONTREAL and CHARLOTTE, N.C., May 14, 2025 (GLOBE NEWSWIRE) -- Milestone Pharmaceuticals Inc. (Nasdaq: MIST) today reported …
Pasithea Therapeutics Announces Initiation of Phase 1/1B Study of PAS-004 in Adult NF1 Patients and Activation of First Clinical Trial Site
GlobeNewswire
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May 14, 2025
-- First patient expected to be dosed during Q2 2025 -- -- Trial will evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy in both plexiform neurofibromas and cutaneous neurofibromas -- -- Starting dose of 4mg tablet …
Editas Medicine Reports New In Vivo Data Highlighting the Potential of Editas’ Gene Upregulation Strategy in HSCs at the American Society of Gene and Cell Therapy Annual Meeting
GlobeNewswire
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May 14, 2025
Data demonstrate therapeutically relevant editing levels using a clinically validated strategy, supporting its development as a novel, in vivo approach to treating sickle cell disease and beta thalassemia CAMBRIDGE, Mass., May 14, 2025 (GLOBE NEWSWIRE) -- …
Invivyd Files Citizen Petition Urging FDA to Focus on Monoclonal Antibodies For Endemic-Virus-Era COVID-19 Prevention, and to Re-Assess COVID-19 Vaccine Efficacy
GlobeNewswire
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May 14, 2025
WALTHAM, Mass., May 14, 2025 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD) today announced it has submitted a Citizen Petition with the U.S. Food and Drug Administration (FDA) calling on the Agency to evolve from historical approaches to the development …
Centessa Pharmaceuticals Reports Financial Results and Business Highlights for the First Quarter of 2025
GlobeNewswire
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May 14, 2025
Advancing a broad, potential best-in-class orexin receptor 2 (OX2R) agonist franchise, with key data readouts expected this year ORX750 Phase 2a CRYSTAL-1 study for the treatment of narcolepsy type 1 (NT1), narcolepsy type 2 (NT2) and idiopathic …
Benitec Biopharma Releases Third Quarter 2025 Financial Results
GlobeNewswire
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May 14, 2025
HAYWARD, Calif., May 14, 2025 (GLOBE NEWSWIRE) -- Benitec Biopharma Inc. (NASDAQ: BNTC) (“Benitec” or “Company”), a clinical-stage, gene therapy-focused, biotechnology company developing novel genetic medicines based on its proprietary “Silence and Replace …
Tisento Highlights Two Venues Advancing Patient-Focused Therapeutic Development for Mitochondrial Diseases
GlobeNewswire
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May 14, 2025
Tisento to Present at the “Primary Mitochondrial Diseases” Therapeutic Development Workshop Hosted by the Reagan-Udall Foundation for the FDA on May 22, 2025 Tisento to Sponsor the First Externally Led Patient-Focused Drug Development Meeting Dedicated to …
Tilray Brands Announces the Launch of XMG Atomic Sours: New THC Beverages and Edibles
GlobeNewswire
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May 14, 2025
TORONTO, May 14, 2025 (GLOBE NEWSWIRE) -- Tilray Brands, Inc. (Nasdaq: TLRY; TSX: TLRY), a global lifestyle and consumer packaged goods company at the forefront of beverage, cannabis and wellness industries, is excited to announce that its wholly-owned …
Ligand to Ring the Nasdaq Opening Bell on May 19, 2025
GlobeNewswire
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May 14, 2025
JUPITER, Fla., May 14, 2025 (GLOBE NEWSWIRE) -- Ligand Pharmaceuticals Incorporated (Nasdaq: LGND) today announced that the company will ring The Nasdaq Stock Market Opening Bell on Monday, May 19, 2025. CEO Todd Davis will be joined by members of Ligand’s …
OrthoPediatrics Corp. Continued Leading Sponsorship at 2025 POSNA Annual Meeting
GlobeNewswire
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May 14, 2025
WARSAW, Ind., May 14, 2025 (GLOBE NEWSWIRE) -- OrthoPediatrics Corp. (“OrthoPediatrics” or the “Company”) (Nasdaq: KIDS), a company focused exclusively on advancing the field of pediatric orthopedics, today announced its continued support of the 2025 …
Kamada Reports Strong First Quarter 2025 Financial Results with Year Over Year Top Line Growth of 17% and a 54% Increase in Profitability
GlobeNewswire
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May 14, 2025
Revenues for First Quarter of 2025 of $44.0 Million, Representing a 17% Year-over-Year Increase First Quarter Adjusted EBITDA of $11.6 Million, Up 54% Year-over-Year Strong Financial Position to Accelerate Growth Through M…
Tonix Pharmaceuticals Announces Appointment of Joseph Hand, Esq., as General Counsel and Executive Vice President of Operations
GlobeNewswire
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May 14, 2025
Mr. Hand brings more than 20 years of strategic legal and business leadership experience across multiple functions in the biopharmaceutical industry, including nearly a decade in senior executive positions at Celgene Served on Celgene’s Executive Committee …
GT Biopharma Appoints New Member to its Board of Directors
GlobeNewswire
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May 14, 2025
SAN FRANCISCO, CALIFORNIA, May 14, 2025 (GLOBE NEWSWIRE) -- GT Biopharma, Inc. (the “Company”) (NASDAQ: GTBP), a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company's proprietary TriKE® natural killer ( …
ARS Pharmaceuticals Reports First Quarter 2025 Financial Results and Highlights Progress in U.S. Commercial Launch of neffy® (epinephrine nasal spray)
GlobeNewswire
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May 14, 2025
$7.8 million in total neffy U.S. net product revenue in first quarter of 2025 neffy 1 mg available nationwide for children aged four and older and co-promotion agreement with ALK-Abelló Inc. increases neffy promotional reach to nearly 20,000 healthcare …
Preclinical insights into dosing for first-in-human in vivo liver-directed gene therapy for MMA delivered in an oral presentation at the ASGCT Annual Meeting
GlobeNewswire
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May 14, 2025
PRESS RELEASE Preclinical insights into dosing for first-in-human in vivo liver-directed gene therapy for MMA delivered in an oral presentation at the ASGCT Annual Meeting Milan, ITALY – 14 May 2025 – Genespire, a biotechnology company developing off-the- …