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Press releases published on May 14, 2025
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 …
LAVA Reports First Quarter 2025 Financial Results, Provides Business Update
GlobeNewswire
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May 14, 2025
Focused on evaluation of strategic alternatives, with restructuring and closure of the Netherlands operations Enrollment in LAVA-1266 Phase 1 continues to progress Cash, cash equivalents and short-term investments of $66.6 million as of March 31, 2025 …
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 …
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…