This week, PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, Animal Health, and Biosimilars. Check out our full report below:
Ionis Highlights P-III (CORE & CORE2) Trials Results of Olezarsen for Severe Hypertriglyceridemia (sHTG) at AHA 2025
Read More: Ionis
AstraZeneca Reports P-III (NATRON) Trial Data on Fasenra (Benralizumab) to Treat Hypereosinophilic Syndrome (HES)
Read More: AstraZeneca
Merck Reveals P-III (CORALreef HeFH) Trial Data on Enlicitide Decanoate for Heterozygous Familial Hypercholesterolemia (HeFH)
Read More: Merck
Genentech (Roche) Reveals P-III Trials Findings on Fenebrutinib in Relapsing and Primary Progressive Multiple Sclerosis
Read More: Genentech
Cogent Biosciences Reports P-III (PEAK) Trial Data on Bezuclastinib Combination for Gastrointestinal Stromal Tumors (GIST)
Read More: Cogent Biosciences
Daiichi Sankyo Reports First Patient Dosing in P-I Trial of DS3610 for Solid Tumors
Read More: Daiichi Sankyo
Novartis Reports P-III (KALUMA) Trial Data of KLU156 for Uncomplicated Malaria
Read More: Novartis
Neurogene Reports Interim P-I/II Trial Results on NGN-401 to Treat Pediatric Patients with Rett Syndrome
Read More: Neurogene
Vera Therapeutics Reports the US FDA’s BLA Submission for Atacicept to Treat IgA Nephropathy
Read More: Vera Therapeutics
March Biosciences’ MB-105 Receives the Regenerative Medicine Advanced Therapy Designation for R/R CD5+ T-Cell Lymphoma
Read More: March Biosciences
ITM Reports the US FDA’s NDA Acceptance for ¹⁷⁷Lu-edotreotide to Treat Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs)
Read More: ITM
Lundbeck Reports the MHLW’s NDA Acceptance of Vyepti (Eptinezumab) for the Preventive Treatment of Migraine
Read More: Lundbeck
Outlook Therapeutics Reports the US FDA’s BLA Acceptance of ONS-5010 to Treat Wet Age-Related Macular Degeneration (wAMD)
Read More: Outlook Therapeutics
Kura Oncology and Kyowa Kirin Report the US FDA’s Approval Komzifti (Ziftomenib) for NPM1-Mutated Acute Myeloid Leukemia (AML)
Read More: Kura Oncology and Kyowa Kirin
Eisai and BioArctic Report the MHRA Approval of Leqembi (Lecanemab) as a Maintenance Therapy to Treat Early Alzheimer’s Disease
Read More: Eisai and BioArctic
SanegeneBio Collaborates with Eli Lilly to Advance RNAi Therapeutics for Metabolic Diseases
Read More: SanegeneBio & Eli Lilly
Transition Bio Inks ~$500M Pact with Voyager Therapeutics to Develop Small Molecules for Neurodegenerative Diseases
Read More: Transition Bio & Voyager Therapeutics
Lyell Immunopharma Acquires Global Rights to LYL273 from Innovative Cellular Therapeutics in ~$860M Deal
Read More: Lyell Immunopharma & Innovative Cellular Therapeutics
Chiesi Group Collaborates with Aliada Therapeutics to Develop Enzyme Replacement Therapies for Lysosomal Storage Disorders
Read More: Chiesi Group & Aliada Therapeutics
Adagene Enters ~$845M Licensing Deal with Third Arc Bio to Develop Masked CD3 T Cell Engagers
Read More: Third Arc Bio and Adagene
Geneseeq’s PanTRKare NTRK Gene Fusion Detection Kit Receives NMPA Approval as Companion Diagnostic
Read More: Geneseeq
Promega’s OncoMate MSI Dx Analysis System Receives FDA Approval as a Companion Diagnostic
Read More: Promega
Thermo Fisher Scientific’s EXENT System Receives the US FDA’s 510(k) Clearance to Aid Multiple Myeloma Diagnosis
Read More: Thermo Fisher Scientific
Rapid Nexus Reports the US FDA’s 510(k) Clearance of Hemastyl Gel Device to Support Wound Healing
Read More: Rapid Nexus
Day One Biopharmaceuticals to Acquire Mersana Therapeutics for ~$285M
Read More: Day One & Mersana Therapeutics
EirGenix Enters ~$152M Licensing Deal with Sandoz to Commercialize EG1206A (Biosimilar, Perjeta)
Read More: EirGenix & Sandoz
INBRAIN Neuroelectronics Partners with Microsoft to Advance AI-Enabled Brain-Computer Interface Therapeutics
Read More: INBRAIN Neuroelectronics & Microsoft
Minze Health Partners with Medtronic to Expand Digital Bladder Monitoring Across EMEA
Read More: Minze Health & Medtronic
Doc.com Launches AI & Blockchain Telemedicine Platform in the US
Read More: Doc.com
RION Launches RION Vet to Advance Platelet-Derived Biologics in Animal Health
Read More: RION Vet
Related Post: PharmaShots Weekly Snapshots (Nov 03, 2025 – Nov 07, 2025)