Weekly Buzz: NVS, MRK Win FDA Nod; LLY Snaps Up ATAI; MANE Shines On Hair Loss Data

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The claims Via News extracted from this document. We point to the source; we don't replace it.

• The FDA complete response letter was tied to deficiencies at a third-party manufacturing site, not the clinical data; Phase 3 CARES-310 showed a median overall survival of 23.8 months, the longest reported to date in first-line HCC.

  60% confidence

• The 60 mg dose of Diranersen showed the strongest response, slowing cognitive decline by 42% on ADAS-Cog13, 50% on MMSE, and 26% on CDR-SB compared to placebo.

  60% confidence

• BPL-003 (mebufotenin benzoate), in a Phase 2b study, showed rapid and durable reductions in depressive symptoms.

  60% confidence

• The combined Matinas/GH Power entity plans to accelerate commercialisation, expand project development across North America and Europe, and leverage public capital markets to support growth.

  60% confidence

• A single Revita procedure reduced weight regain by approximately 40% versus sham at one year, and the FDA-mandated co-primary endpoint of responder rate was achieved by 73% of Revita patients, rising to 91% in those with complete ablation.

  60% confidence

• OASIS Phase 3 data showed approximately 17% weight loss with oral Wegovy versus 3% with placebo, with 1 in 3 patients losing 20% or more of their body weight.

  60% confidence

• AstraZeneca will make an upfront payment to Dizal of $600 million, with additional payments of up to $900 million upon achievement of specific development, regulatory, and sales-related milestones for Zegfrovy.

  60% confidence

• The combined Glucotrack/Lokahi organization integrates Lokahi's dual-engine model and AI-driven asset sourcing and advancement platform with Glucotrack's existing technology infrastructure to create a scalable framework.

  60% confidence

• CAD-1005 showed improved efficacy, with treated patients experiencing more than a 25% reduction in new or worsening thrombotic events compared with the placebo arm, alongside no new safety signals.

  60% confidence

• Fabhalta reduced eGFR decline and proteinuria with consistent safety in the Phase 3 APPLAUSE-IgAN trial, and is the first complement inhibitor approved for adults with primary IgAN at risk of progression.

  60% confidence

• Phase 3 VIKTORIA-1 trial data showed significant progression-free survival benefit for REVTORPYK with both doublet and triplet regimens.

  60% confidence

• TPIP's findings highlight sustained improvements across key efficacy measures and reinforce its potential as a next-generation prostanoid treatment, with no new safety concerns identified at doses up to 1,280 µg once daily.

  60% confidence

• The SimpliDerm divestiture aligns with Elutia's strategy to focus its resources on NXT-41x, its antibiotic-eluting biomatrix in development for the $1.5 billion U.S. plastic and reconstructive surgery market.

  60% confidence

• LIPFENDRA is the first once-daily oral PCSK9 inhibitor for adults with hypercholesterolemia including HeFH, cutting LDL-C by up to 59% versus placebo in the Phase 3 CORALreef trial.

  60% confidence

• In the aggregate CALM-1/CALM-2 data, the limited efficacy demonstrated by camlipixant is unlikely to transform patient care.

  60% confidence

• VDPHL01 was generally well tolerated and produced clinically meaningful hair growth, with participants experiencing increases in non-vellus terminal hair counts after six months of treatment.

  60% confidence

• The KEYTRUDA/KEYTRUDA QLEX plus Padcev approvals, based on Phase 3 KEYNOTE-B15 trial results in 808 patients, mark the first PD-1 inhibitor plus ADC regimens authorised for MIBC regardless of cisplatin eligibility.

  60% confidence

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