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Press releases published on May 14, 2025
Calian Reports Results for the Second Quarter
GlobeNewswire
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May 14, 2025
(All amounts in release are in Canadian dollars) OTTAWA, Ontario, May 14, 2025 (GLOBE NEWSWIRE) -- Calian® Group Ltd. (TSX:CGY), a mission critical solutions company, with a focus on defence, space, healthcare and strategic growth markets, today released …
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 …
LeddarTech Announces the Launch of LeddarSim: Next Leap in Realistic Advanced Driver Assistance Systems (ADAS) and Autonomous Driving (AD) Simulation
GlobeNewswire
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May 14, 2025
QUEBEC CITY, Canada, May 14, 2025 (GLOBE NEWSWIRE) -- LeddarTech® Holdings Inc. (“LeddarTech”) (Nasdaq: LDTC), an AI-powered software company recognized for its innovation in advanced driver assistance systems (ADAS) and autonomous driving (AD), is pleased …
LeddarTech annonce le lancement de LeddarSim : une nouvelle étape dans la simulation réaliste des systèmes avancés d’aide à la conduite (ADAS) et de conduite autonome (AD)
GlobeNewswire
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May 14, 2025
QUÉBEC, Canada, 14 mai 2025 (GLOBE NEWSWIRE) -- LeddarTech® Holdings Inc. (« LeddarTech ») (NASDAQ : LDTC), une société de logiciels alimentés par l’IA et reconnue pour son innovation dans les systèmes avancés d’aide à la conduite (systèmes ADAS) et de …
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- …
Mercury Introduces First Safety-Certifiable, SOSA-aligned Mission Computer for Aviation Platforms
GlobeNewswire
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May 14, 2025
ANDOVER, Mass., May 14, 2025 (GLOBE NEWSWIRE) -- Mercury Systems, Inc. (NASDAQ: MRCY, www.mrcy.com), a technology company that delivers mission-critical processing power to the edge, today introduced the first safety-certifiable, SOSA-aligned aviation …
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…