The Pharma Closeout | Daily Pharmaceutical and Biotech News in 15 Minutes

Vera reports a 76% reduction in composite kidney-disease progression risk and near-stable two-year kidney function for TRUTAKNA (atacicept-vymj) in sponsor topline data, addressing the clinical-benefit question behind its accelerated approval in IgA nephropathy. Curium's BEXLUTRY (lutetium Lu 177 dotatate) brings an adult neuroendocrine-tumor competitor to Lutathera, with delivery and access questions still open. GSK buys a preclinical myeloma development bet, while Lilly backs nervous-system genetic-medicine delivery. We also examine Connect's mixed asthma data, portfolio changes, longer-term lung-cancer evidence and the FDA's trial-startup pilot.Alex Mercer and Maya Patel host. Get the daily rundown in your inbox — subscribe at https://thepharmacloseout.com.

Enhertu delayed lung cancer progression in a Phase 3 trial, but immature survival results and fatal lung toxicity complicate the first-line case. Definium reports a second Phase 3 anxiety-study win for DT120, while new ivonescimab results quantify a survival benefit previously announced. We also cover Sanofi's proposed Cheplapharm transaction, Cellectis's gene-editing pivot, Corbus's oral obesity candidate and regulatory updates from Amgen and Telix. This is the September 14 edition, released September 15.Alex Mercer and Maya Patel host. Get the daily rundown in your inbox — subscribe at https://thepharmacloseout.com.

AstraZeneca's broader-use trial of Etcamah (camizestrant)missed its primary goal in advanced breast cancer, while the existing approval stands. Scholar Rock's ISEMBYLD (apitegromab) adds a muscle-directed option inspinal muscular atrophy, while Roivant's mosliciguat links vascular improvement with better walking distance in pulmonary hypertension associated with interstitial lung disease. Novartis faces pipeline and acquisition scrutiny asBiohaven pauses new BHV-7000 enrollment and Karyopharm confronts near-term financing pressure. Encoded's ETX101 results frame its Dravet syndromefinancing, and BioNTech's lung-cancer presentations lead the week ahead.Alex Mercer and Maya Patel host. Get the daily rundown inyour inbox — subscribe at https://thepharmacloseout.com.

FDA extended its review of Exelixis's zanzalintinib-Tecentriq combination for metastatic colorectal cancer to March 3, 2027, after classifying updated data as a major amendment. Karyopharm missed a $15.8 million loan payment and secured a creditor standstill through October 15 tied partly to its selinexor-ruxolitinib myelofibrosis filing. Roche's Enspryng gained Priority Review in MOGAD; COSCIENS bought oral-film manufacturer Nualtis, and Frazier raised more than $1.1 billion for its Public Fund. Plus, Telix's Pixclara FDA decision remained unverified at our reporting cutoff.Alex Mercer and Maya Patel host the Daily Roundup for September 11. Get the daily rundown in your inbox — subscribe at https://thepharmacloseout.com.

Biohaven's FDA partial hold pauses new epilepsy-trialenrollment; the company still expects RISE-3 results this year. AbbVie reports LUNA menstrual-migraine results for oral Qulipta (atogepant), while Shionogi misses a stroke endpoint and Disc Medicine reports fewer blood-removalprocedures in early polycythemia vera data. Novartis faces shareholder pressure, Solstice raises $225 million, and MannKind partners with Rose Pharma on inhaled weight management. NICE questions the value of Gilead's lenacapavir for HIV prevention, and new consensus guidance addresses type 1 diabetes screening.Alex Mercer and Maya Patel host the Daily Roundup forSeptember 10. Get the daily rundown in your inbox — subscribe at https://thepharmacloseout.com.