The U.S. Food and Drug Administration is preparing for a busy third quarter in 2026, with seven significant drug decisions expected, including potential firsts in Alzheimer’s disease care and treatments that could impact recent pharmaceutical acquisitions.
Vera Therapeutics is seeking FDA approval for its investigational fusion protein atacicept for IgA nephropathy, with a target action date of July 7. The application is supported by data from the Phase 3 ORIGIN 3 study, which showed a 46% decrease in proteinuria at 36 weeks compared to baseline and elimination of blood in the urine in 81% of patients. Guggenheim Partners said these results indicate a “compelling profile” for atacicept and noted its “excellent safety profile that is comparable to placebo.” If approved, atacicept would compete with Otsuka Pharmaceuticals’ Voyxact and Novartis’ Fabhalta, while Vertex Pharmaceuticals also pursues approval for povetacicept later this year.
Moderna’s mRNA-1010 flu vaccine faces an FDA decision expected by August 5. After initially receiving a refusal-to-file letter due to concerns over comparator groups used in studies, Moderna resubmitted an adjusted application following discussions with the agency. The vaccine has shown improved efficacy over licensed comparators and recently received unanimous support from the FDA’s Vaccines and Related Biological Products Advisory Committee for both full approval (adults aged 50–64) and accelerated approval (adults aged 65+).
Capricor Therapeutics awaits an Aug. 22 decision on deramiocel, its cell therapy candidate for Duchenne muscular dystrophy. Previously rejected due to insufficient evidence of effectiveness, deramiocel was resubmitted after new Phase 3 data demonstrated statistically significant improvements in upper-limb function and slowed cardiac decline compared to placebo.
Ultragenyx expects two gene therapy decisions: DTX401 for glycogen storage disease type 1a (Aug. 23) and UX111 for Sanfilippo syndrome type A (Sept. 19). UX111 had been previously rejected due to manufacturing issues not related directly to product quality; both therapies aim to address rare genetic disorders with limited treatment options.
Eisai and Biogen are awaiting an Aug. 24 verdict on their subcutaneous formulation of Leqembi Iqlik as an induction therapy for Alzheimer’s disease—a move that could make it the first anti-amyloid treatment available entirely via at-home dosing throughout therapy.
Nuvalent’s ROS1 inhibitor zidesamtinib is up for review by Sept. 18 following GSK's $10.6 billion acquisition agreement with Nuvalent earlier this year; trial data showed objective response rates between forty-four percent overall and fifty-one percent among certain patient groups treated previously with tyrosine kinase inhibitors.
Scholar Rock anticipates a Sept. 30 decision on apitegromab—its myostatin blocker intended as a treatment option for spinal muscular atrophy—after refiling its application following prior rejection related to manufacturing site violations.
