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Press releases published on May 14, 2025
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 …
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- …
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 …
PolyPid Provides Corporate Update and Reports First Quarter 2025 Financial Results
GlobeNewswire
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May 14, 2025
PolyPid Successfully Completed Enrollment in Phase 3 SHIELD II Trial of D-PLEX100, with Top-Line Results Anticipated in Current Quarter Company Continues to Advance Regulatory Submission Preparations, Commercial Launch Preparations and Partnering …
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 …
Foghorn Therapeutics Provides First Quarter 2025 Financial and Corporate Update
GlobeNewswire
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May 14, 2025
FHD-909 (LY4050784) advancing in Phase 1 dose escalation trial in SMARCA4 (BRG1) mutated cancers, with non-small cell lung cancer (NSCLC) as the primary target population Data presented at AACR show synergistic activity with FHD-909 in combination with …
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 …
Climb Bio Reports First Quarter 2025 Financial Results and Provides Business Updates
GlobeNewswire
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May 14, 2025
Clinical Trials of Budoprutug in Primary Membranous Nephropathy (pMN), Immune Thrombocytopenia (ITP), and Systemic Lupus Erythematosus (SLE) on Track to Initiate in 2025 CLYM116 Progressing Towards Anticipated IND or CTA Submission in Second Half 2025 …
BioCryst Announces FDA Acceptance of NDA for ORLADEYO® (berotralstat) Oral Granules in Patients with Hereditary Angioedema Aged 2 to 11 Years
GlobeNewswire
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May 14, 2025
–FDA grants Priority Review of application, with PDUFA target action date of September 12, 2025– –ORLADEYO would be the first targeted oral prophylactic therapy for patients with HAE under the age of 12, if approved– RESEARCH TRIANGLE PARK, N.C., May 14, …
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…
Ocular Therapeutix™ to Participate in Upcoming Investor Conferences
GlobeNewswire
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May 14, 2025
BEDFORD, Mass., May 14, 2025 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc. (NASDAQ: OCUL, “Ocular”), a fully-integrated biopharmaceutical company committed to redefining the retina experience, today announced participation in several upcoming investor …
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 …
Sernova Biotherapeutics Provides Positive Interim Data from Ongoing Phase 1/2 Clinical Trial of Cell Pouch Bio-hybrid Organ in Patients Living with Type 1 Diabetes
GlobeNewswire
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May 14, 2025
Clinical Study on Track to Meet its Primary and Secondary Endpoints Data Demonstrate That Metabolic Measures Improve with Cumulative Quantities of Transplanted Donor Islets Data Demonstrate Islet Engraftment in Cell Pouch and Islet Functionality, Including …
atai Life Sciences Reports First Quarter 2025 Financial Results and Recent Corporate Updates
GlobeNewswire
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May 14, 2025
With clinical momentum across its pipeline, atai strengthens its position as a leader in potentially transformative psychedelic mental health treatments Anticipate topline data midyear from the Phase 2b clinical trial of BPL-003 in patients with treatment- …
Sanara MedTech Inc. Reports First Quarter 2025 Financial Results (Unaudited)
GlobeNewswire
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May 14, 2025
Q1 Net Revenue Increased 26% Year-Over-Year FORT WORTH, TX, May 14, 2025 (GLOBE NEWSWIRE) -- Sanara MedTech Inc. (“Sanara,” the “Company,” “we,” “our” or “us”) (Nasdaq: SMTI), a medical technology company focused on developing and commercializing …
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 …