Weekly Buzz: NVS, MRK Win FDA Nod; LLY Snaps Up ATAI; MANE Shines On Hair Loss Data
View original at nasdaq.comWeekly Buzz: NVS, MRK Win FDA Nod; LLY Snaps Up ATAI; MANE Shines On Hair Loss Data (RTTNews) - This week, the healthcare sector saw multiple U.S FDA and European Commission approvals, strategic licensing and M&A activity, as well as pivotal clinical trial readouts and regulatory setbacks…
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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% confidenceThe 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% confidenceFabhalta 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% confidenceIn the aggregate CALM-1/CALM-2 data, the limited efficacy demonstrated by camlipixant is unlikely to transform patient care.
60% confidenceVDPHL01 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% confidenceCAD-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% confidenceBPL-003 (mebufotenin benzoate), in a Phase 2b study, showed rapid and durable reductions in depressive symptoms.
60% confidenceThe 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% confidencePhase 3 VIKTORIA-1 trial data showed significant progression-free survival benefit for REVTORPYK with both doublet and triplet regimens.
60% confidenceTPIP'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% confidenceAstraZeneca 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% confidenceThe 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% confidenceThe 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% confidenceA 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% confidenceThe 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% confidenceLIPFENDRA 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% confidenceOASIS 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
Data points we hold from this source
| Novo Nordisk · stock price | 50.32 USD |
| AstraZeneca AB · stock price | 168.90 USD |