Several FDA decisions across multiple specialties are expected this month. May 2026 could bring several regulatory decisions, including potential label expansions and new treatment options in neurology, endocrinology, psychiatry, and ophthalmology.

Neurology

VYVGART

The FDA has granted priority review to argenx’s supplemental Biologics License Application for VYVGART for adults with acetylcholine receptor antibody–negative generalized myasthenia gravis, with a PDUFA target action date of May 10, 2026. VYVGART is an FcRn blocker that reduces circulating IgG autoantibodies. In the Phase 3 ADAPT SERON trial, patients with MuSK+, LRP4+, and triple-seronegative gMG experienced rapid and increasingly pronounced improvements across treatment cycles, as measured by MG-ADL and QMG scores, supporting VYVGART’s efficacy and safety across gMG patients regardless of antibody status.

Source: Argenx

LEQEMBI IQLIK

Eisai and Biogen reported new real-world data showing long-term treatment persistence with intravenous lecanemab-irmb (LEQEMBI) in U.S. clinical practice. In a subgroup with long-term follow-up, 78.4% of patients remained on treatment at 18 months, 71.7% at 20 months, and 67.3% at 24 months. The companies also noted that the FDA accepted the sBLA for LEQEMBI IQLIK, the subcutaneous autoinjector formulation, for initiation treatment in January 2026 and granted Priority Review, with a PDUFA action date of May 24, 2026. LEQEMBI IQLIK was previously approved for subcutaneous maintenance dosing. LEQEMBI is an anti-amyloid beta protofibril antibody; in Clarity AD, lecanemab reduced cognitive decline vs placebo on CDR-SB at 18 months.

Source: Biogen

Endocrinology

Afrezza

The FDA has accepted for review a supplemental biologics license application (sBLA) for insulin human (Afrezza) for the treatment of children and adolescents aged 4–17 years with type 1 or type 2 diabetes, with a PDUFA target action date of May 29, 2026. Afrezza is an inhaled, rapid-acting insulin designed for mealtime glucose control and is currently approved to improve glycemic control in adults with diabetes mellitus.

Data from the INHALE-1 study evaluated dosing and titration patterns of Afrezza in pediatric patients. If approved for pediatric use, Afrezza would be the first needle-free insulin option for children in more than 100 years of insulin therapy.

Afrezza carries a boxed warning for risk of acute bronchospasm in patients with chronic lung disease (eg, asthma or COPD) and is contraindicated in these populations. The most common adverse reactions include hypoglycemia, cough, and throat pain or irritation.

Source: MannKind

Psychiatry

CTx-1301

The FDA has accepted Cingulate’s NDA for CTx-1301, a once-daily dexmethylphenidate HCl formulation for ADHD, with a PDUFA target action date of May 31, 2026. In a randomized, double-blind, placebo-controlled Phase 3 trial in children and adolescents with ADHD, CTx-1301 met its primary endpoint, showing dose-dependent improvements on ADHD-RS-5 and CGI-S scales, with rapid onset and sustained symptom relief up to 12 hours post-dose. Safety and tolerability were consistent with the stimulant class, with no unexpected adverse events reported.

Source: Cingulate

Ophthalmology

ONS-5010 / LYTENAVA

Outlook Therapeutics expects feedback from the FDA in May 2026 after completing a Federal Dispute Resolution meeting with the Office of New Drugs. The process follows a December 30, 2025 Complete Response Letter for the Biologics License Application for ONS-5010/LYTENAVA (bevacizumab-vikg) for neovascular age-related macular degeneration. ONS-5010/LYTENAVA is an ophthalmic formulation of bevacizumab produced in the US and remains investigational domestically. If approved, it would be the first approved ophthalmic formulation of bevacizumab for retinal conditions, including wet age-related macular degeneration.

Source: Outlook Therapeutics

Looking Ahead: 

Veligrotug 

Veligrotug is currently under FDA Priority Review for thyroid eye disease, with a PDUFA target action date set for June 30, 2026. The company’s clinical program included two global Phase 3 trials, THRIVE and THRIVE-2, which studied patients with active and chronic disease. In both trials, the primary endpoint and all secondary endpoints were achieved based on topline results. Veligrotug received Breakthrough Therapy Designation in 2025.

Source: Viridian Therapeutics