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Press releases published on May 5, 2025
BioCryst Reports First Quarter 2025 Financial Results and Provides Business Update
GlobeNewswire
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May 5, 2025
—Q1 2025 ORLADEYO net revenue of $134.2 million (+51 percent y-o-y)— —Full year 2025 ORLADEYO revenue guidance increased to $580 million to $600 million— —Company now expects to be profitable for full year 2025, a year ahead of schedule— —Company pays down …
Regeneration Biomedical to Present Updated Phase 1 Trial Data on Autologous Stem Cell Therapy Injected Directly into the Brain for Alzheimer’s Disease in Podium Presentation at the ISCT 2025 Scientific Annual Meeting
GlobeNewswire
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May 5, 2025
Abstract selected for a podium presentation and winner of the Host Region (US West) Award First-in-human data now includes five patients, with follow-up ranging from 23 weeks to over a year post-treatment Injections of Wnt-activated, autologous, expanded, …
Teva and Alvotech Announce FDA Approval of Interchangeability for SELARSDI™ (ustekinumab-aekn) with Stelara® (ustekinumab)
GlobeNewswire
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May 5, 2025
The U.S. FDA has approved SELARSDI™ (ustekinumab-aekn) as interchangeable with the reference biologic Stelara® (ustekinumab) in all presentations matching the reference product, effective as of April 30, 2025 SELARSDI is approved for all indications …
Ichnos Glenmark Innovation (IGI) Receives U.S. FDA Fast Track Designation for ISB 2001 for Relapsed/Refractory Multiple Myeloma
GlobeNewswire
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May 5, 2025
NEW YORK, May 05, 2025 (GLOBE NEWSWIRE) -- IGI, Inc., a global, fully integrated clinical-stage biotechnology company focused on developing multispecifics™ in oncology, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track …
Aquestive Therapeutics to Participate in Citizens Life Sciences Conference
GlobeNewswire
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May 5, 2025
WARREN, N.J., May 05, 2025 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST) ("Aquestive" or the "Company"), a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science and …
Aptose Provides Clinical Update for the Tuspetinib-based Triple Drug Frontline Therapy in Newly Diagnosed AML Patients from the Phase 1/2 TUSCANY Trial
GlobeNewswire
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May 5, 2025
Aptose is developing TUS+VEN+AZA as a one-of-a-kind safe and mutation agnostic frontline triple drug therapy for newly diagnosed AML patients First two dose cohorts of TUS+VEN+AZA triplet demonstrate safety, complete remissions, and MRD negativity across …
Foghorn Therapeutics to Participate in the Citizens Life Sciences Conference
GlobeNewswire
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May 5, 2025
CAMBRIDGE, Mass., May 05, 2025 (GLOBE NEWSWIRE) -- Foghorn® Therapeutics Inc. (Nasdaq: FHTX), a clinical-stage biotechnology company pioneering a new class of medicines that treat serious diseases by correcting abnormal gene expression, today announced …
Apollo Silver Appoints Ross McElroy as President and CEO
GlobeNewswire
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May 5, 2025
VANCOUVER, British Columbia, May 05, 2025 (GLOBE NEWSWIRE) -- Apollo Silver Corp. (“Apollo” or the “Company”) (TSX.V:APGO, OTCQB:APGOF, Frankfurt:6ZF0) is pleased to announce the appointment of Mr. Ross McElroy as President and CEO, effective immediately, …
ANI Pharmaceuticals Announces Presentation of Preclinical Data on the Use of Purified Cortrophin® Gel in an Experimental Autoimmune Uveitis (EAU) Mouse Model
GlobeNewswire
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May 5, 2025
Demonstrated Dose Dependent Effect in EAU Presented in a podium presentation at The Association for Research in Vision and Ophthalmology (ARVO) 2025 annual meeting PRINCETON, N.J., May 05, 2025 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the …
Dianthus Therapeutics Completes Enrollment of Phase 2 MaGic Trial of DNTH103 in Generalized Myasthenia Gravis With Top-Line Results Expected in September
GlobeNewswire
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May 5, 2025
MaGic trial exceeded enrollment target of 60 patients Top-line results anticipated this September will be the first of three DNTH103 catalysts by YE'26 Building a neuromuscular franchise with DNTH103 in gMG, CIDP and MMN with a potential best-in-class, …
Kamada Announces Launch of a Comprehensive Post-Marketing Research Program for CYTOGAM®
GlobeNewswire
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May 5, 2025
Program Aimed at Generating Key Data in Support of the Benefits of CYTOGAM® in the Management of Cytomegalovirus (CMV) in Solid Organ Transplantation A Total of 10 Studies will be Conducted in Collaboration with Leading U.S. Physicians, Primarily as …
Algorhythm Holdings Acquires SemiCab India, Expands Global AI Transportation Footprint
GlobeNewswire
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May 5, 2025
Acquisition Adds Multiple Multinational Customers in India and Unlocks Scalable Growth Opportunities in Rapidly Growing Indian Market Fort Lauderdale, FL, May 05, 2025 (GLOBE NEWSWIRE) -- Algorhythm Holdings, Inc. (“Algorhythm”) (NASDAQ: RIME), a …
AAFA Calls on Congress to Restore Lifesaving National Asthma Control Program
GlobeNewswire
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May 5, 2025
Washington, DC, May 05, 2025 (GLOBE NEWSWIRE) -- On May 6, 2025 – World Asthma Day – the Asthma and Allergy Foundation of America (AAFA) will visit the U.S. Capitol to call on Congress to protect the 28 million people in the U.S. with asthma and restore …
Eupraxia Pharmaceuticals Announces Sustained Positive Treatment Outcomes in Patients with Eosinophilic Esophagitis (EoE) After Nine Months of Receiving EP-104GI
GlobeNewswire
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May 5, 2025
Eupraxia continues to observe positive treatment outcomes in its ongoing Phase 1b/2a trial, including for the first time clinical responses measured 9 months after dosing with EP-104GI At 9 months active drug continued to be released into the esophagus in …
Ocular Therapeutix™ Reports First Quarter 2025 Results and Business Highlights
GlobeNewswire
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May 5, 2025
AXPAXLI™ SOL trials for wet AMD progressing rapidly following recent updates to accelerate and enhance the registrational program Following positive FDA feedback for potential AXPAXLI NPDR registrational trial, Ocular is actively planning next steps in …
Grassy Mountain Gold Project Selected for US Government FAST-41 Program
GlobeNewswire
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May 5, 2025
WINNEMUCCA, Nev., May 05, 2025 (GLOBE NEWSWIRE) -- Paramount Gold Nevada Corp. (NYSE American: PZG) (“Paramount” or the “Company”) announced today that the high-grade Grassy Mountain gold project in Malheur County, Oregon, has been selected for inclusion …
TG Therapeutics Reports First Quarter 2025 Financial Results and Raises BRIUMVI Full Year Revenue Guidance
GlobeNewswire
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May 5, 2025
First quarter 2025 BRIUMVI U.S. net revenue of $119.7 million Raises full year 2025 global net revenue target to approximately $575 million and raises full year BRIUMVI U.S. net revenue target to approximately $560 million Conference call to be held today, …
Update to Zijin Put Option and Exclusivity Arrangements
GlobeNewswire
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May 5, 2025
TORONTO, May 05, 2025 (GLOBE NEWSWIRE) -- Xanadu Mines Ltd (ASX: XAM, TSX: XAM) (Xanadu or the Company) refers to its announcement dated 7 April 2025 in relation to the Extension of the Zijin Put Option and Exclusivity Arrangements1 with its major …
INmune Bio Inc. to Report First Quarter 2025 Financial Results and Provide Corporate Update on Thursday, May 8th
GlobeNewswire
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May 5, 2025
Boca Raton, Florida, May 05, 2025 (GLOBE NEWSWIRE) -- INmune Bio Inc. (NASDAQ: INMB) (the “Company”), a clinical-stage inflammation and immunology company targeting microglial activation and neuroinflammation as a cause of Alzheimer’s Disease (AD), today …
Mobilicom’s Cybersecure Drone and Robotics Solutions to Feature at Key U.S. Defense & Autonomy Industry Events
GlobeNewswire
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May 5, 2025
XPONENTIAL 2025 in Houston where Mobilicom CEO Oren Elkayam will deliver presentations on securing autonomous vehicles and navigating electromagnetic warfare Special Operations Forces (SOF) Week 2025 in Tampa Modern Day Marine Expo in Washington D.C. Palo …