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Apellis
Apellis Pharmaceuticals Reports the US FDA’s sNDA Acceptance & Priority Review of Empaveli for C3 Glomerulopathy and Primary IC-MPGN
Shots: The US FDA has accepted sNDA & granted priority review to Empaveli for C3 glomerulopathy (C3G) & primary immune complex membranoproliferative glomerulonephritis (IC-MPGN) pts (PDUFA: Jul 28, 2025) Submission was backed by P-III (VALIANT) trial assessing Empaveli (Q2W) vs PBO in C3G & primary IC-MPGN pts (≥12yrs., n=124) for 26wks. followed by 26wk. open-label…
April 2, 2025
Daiichi Sankyo
Daiichi Sankyo Reports the First Patient Dosing in P-III (DESTINY-Gastric05) Trial of Enhertu Regimen to Treat G/GEJ Cancer
Shots: Daiichi has reported first pts dosing in its P-III (DESTINY-Gastric05) trial assessing Enhertu regimen in 1L, inoperable, locally advanced or metastatic HER2+ (IHC 3+ or IHC 2+/ISH+) G/GEJ cancer pts, with PD-L1 CPS ≥1 Trial will assess efficacy & safety of Enhertu (5.4mg/kg) + Keytruda + fluoropyrimidine-based CT vs trastuzumab + Keytruda + Pt-based…
April 2, 2025
Axsome
Axsome Therapeutics Reports Topline Data of P-III (PARADIGM) Trial of Solriamfetol for Major Depressive Disorder (MDD) regardless of Excessive Daytime Sleepiness (EDS)
Shots: Axsome reported topline data of PoC P-III (PARADIGM) trial assessing solriamfetol (300mg) vs PBO in MDD pts with severe EDS (ESS ≥16; n=51) & those without severe EDS (n=295) Trial showed no significant MADRS total score change (1EP) in the overall population. However, EDS pts saw depressive symptom improvements across MADRS total score, MADRS…
April 2, 2025
Lexicon & Novo Nordisk
Lexicon Enters a Global Licensing Agreement with Novo Nordisk for LX9851
Shots: Lexicon has granted Novo Nordisk exclusive global rights to develop, manufacture & commercialize LX9851 (oral ACSL5 inhibitor) in all indications As per the deal, Lexicon will receive $45M upfront, ~$485M in regulatory & launch milestones, ~$475M in sales milestones, & tiered royalties from single to low-double-digit % of annual net sales. Lexicon will complete…
April 2, 2025
Pfizer New
Pfizer Secures the EC’s Approval for Abrysvo (Respiratory Syncytial Virus Vaccine) for RSV Lower Respiratory Tract Disease
Shots: The EC has approved Abrysvo to prevent lower respiratory tract disease (LRTD) caused by RSV in individuals (aged 18-59yrs.) across all EU states including Iceland, Liechtenstein, and Norway. Approval was based on a pivotal P-III (MONeT) study that assesses the safety, tolerability & immunogenicity of Abrysvo vs PBO in adults (aged 18-59yrs.) at risk…
April 1, 2025
EchoIq, Sciimage & Medaxiom
Echo IQ Enters into Strategic Partnership And Integration Agreements With ScImage And MedAxiom for EchoSolv AS
Shots: This collaboration will broaden the availability of EchoSolv AS, integrating its AI cardiology technology into a wide network of US hospitals and cardiology practices As per the agreement, EchoSolv AS will be deployed across 36 MedAxiom/ScImage-affiliated hospitals and cardiology practices, providing physicians access to AI-driven diagnostics via ScImage's image management and workflow platform. By leveraging…
April 1, 2025
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