This full Week in Review is a comprehensive review of the week's covered stories across oncology, kidney and immune disease, respiratory disease, metabolic disease, neuroscience, rare disease and ophthalmology, plus financings, deals and five events ahead. Gilead's anito-cel gets its full peer-reviewed Phase 1 record before a December FDA target; myeloma groups define cure; and Genentech's Gazyva wins approval to reduce relapse risk in childhood-onset nephrotic syndrome. Also in the review: Lilly's once-weekly Onswik approval, Otsuka and Ionis's Phase 3 ulefnersen result in FUS-ALS, Beacon's pivotal laru-zova win, and regulatory, safety and evidence updates across the covered therapeutic areas, followed by the week ahead.

Alex Mercer and Maya Patel host. Get the daily rundown in your inbox — subscribe at https://thepharmacloseout.com.

Mirum's Atebrioz (zilurgisertib) wins FDA approval for FOP despite a primary-endpoint miss; Carvykti (ciltacabtagene autoleucel) shows five-year disease control without maintenance in half of 20 myeloma patients. aTyr plans another efzofitimod trial in sarcoidosis. The roundup covers Pharming's Joenja (leniolisib), ADARx's IPO, Canada's Epkinly (epcoritamab) expansion, Novo–Nanexa's long-acting peptide deal, FDA nominee Heidi Overton's hearing, and Medicaid's GENEROUS pricing plan. September 25 edition, published September 26: relative dates and pending events reflect the original reporting cutoff.

Alex Mercer and Maya Patel host. Get the daily rundown in your inbox — subscribe at https://thepharmacloseout.com.

Welireg plus Lenvima gains FDA approval in advanced clear-cell kidney cancer, with better disease control but no demonstrated survival advantage. Lilly says FDA approved weekly insulin Onswik, entering a market where Novo’s Awiqli is already available. Merck’s remigromig meets its pivotal vision goal, but safety and dosing questions remain. Plus: Acadia advances after a Phase 2 miss; Kyverna reports autoimmune follow-up; Elevar gains bile-duct cancer approval; Takeda’s Adzynma gets a boxed warning; and Gossamer files despite PROSERA’s miss.

Alex Mercer and Maya Patel host. Get the daily rundown in your inbox — subscribe at https://thepharmacloseout.com.

GRAIL’s Galleri won backing from FDA advisers, but the narrow effectiveness split and a missed late-stage-cancer endpoint keep the label and coverage case in focus. Roche and Ionis report that sefaxersen reduced proteinuria in Phase 3 IgA nephropathy, while longer-term kidney-function data remain blinded and Novartis’s Fabhalta (iptacopan) sets the benchmark. Vertex tests inaxaplin in additional APOL1 kidney disease groups, and Amgen’s dazodalibep succeeds in systemic Sjögren’s disease. Plus: Immunovant halts its cutaneous lupus program, Oruka extends psoriasis follow-up, Boehringer Ingelheim signs an Envisagenics cancer-target pact, and Enveda raises $311 million.

Alex Mercer and Maya Patel host. Get the daily rundown in your inbox — subscribe at https://thepharmacloseout.com.

Celldex's pivotal barzolvolimab wins in chronic hives carry an anaphylaxis signal. Otsuka and Ionis report a joint-endpoint ALS result for ulefnersen, while Iambic's IPO filing puts its AI platform and early cancer data before investors. Johnson & Johnson's Caplyta (lumateperone) reports bipolar mania data, Compass faces a filing-path question, and Roche's enicepatide and Viking's VK2735 add metabolic results. We also cover NewAmsterdam and Menarini's European obicetrapib authorization and Merck's Winrevair (sotatercept-csrk) label update in pulmonary arterial hypertension.

Alex Mercer and Maya Patel host. Get the daily rundown in your inbox — subscribe at https://thepharmacloseout.com.

Beacon’s pivotal VISTA trial met its endpoint in inherited vision loss, with low-light gains and surgical risks shaping the next questions. Telix’s $1.65 billion ITM deal combines isotope supply with an investigational cancer therapy facing manufacturing hurdles. Novo’s CagriSema result in diabetes, Cue’s chronic-hives data and Insmed’s ARIKAYCE (amikacin liposome inhalation suspension) review show different evidence and regulatory paths. FDA opens clearer routes for validated non-animal methods, while a Wednesday panel will examine GRAIL’s Galleri cancer-screening claims.

Alex Mercer and Maya Patel host. Get the daily rundown in your inbox — subscribe at https://thepharmacloseout.com.

Novo adds obesity programs as its Ascendis collaboration ends, while ivonescimab's China survival results sharpen the test facing its global lung-cancer program. Europe moves Corcept's Lifyorli toward authorization and backs broader perioperative use of Padcev with Keytruda, while Bayer's Kerendia, Vera's Trutakna, Xenon's azetukalner and Vertex's pediatric cystic-fibrosis applications show different regulatory and evidence paths. Gilead's lenacapavir agreements separate preparation for an investigational annual formulation from procurement of the approved twice-yearly option, with Merck's Winrevair label review and Novo's investor day ahead. Alex Mercer and Maya Patel host. Get the daily rundown in your inbox — subscribe at https://thepharmacloseout.com.

FDA fully approved Lilly's Inluriyo (imlunestrant) plus Verzenio (abemaciclib) after progression in ESR1-mutated advanced breast cancer; evidence is exploratory in 159 patients versus Inluriyo alone, and overall survival remains immature. LEO says FDA accepted dersimelagon's filing with Priority Review—not approval—for light-sensitive EPP and XLP. Novo signed an asset purchase agreement for three Kallyope obesity programs and an Orbis cardiometabolic discovery pact; Electra priced an IPO, and BMS halted Orum's AML/MDS program. CHMP gave MaaT a negative Xervyteg opinion after re-examination in severe gut graft-versus-host disease, while backing Pebrilzo's pertuzumab-biosimilar path and earlier-line Tecvayli monotherapy for multiple myeloma.

Alex Mercer and Maya Patel host. Get the daily rundown in your inbox — subscribe at https://thepharmacloseout.com.