Q2 2026 Preview: 6 FDA Decisions to Watch

The first quarter of 2026 established a brisk regulatory pace that Q2 shows no signs of slowing. In the span of 3 months, the United States Food and Drug Administration (US FDA) cleared deucravacitinib for psoriatic arthritis (PsA) — the first TYK2 inhibitor approved for the indication — navepegritide for achondroplasia, and sublingual epinephrine film as the first needle-free epinephrine option for anaphylaxis. The Commissioner's National Priority Voucher program continued to make headlines, most recently with the fastest New Molecular Entity (NME) approval since 2002 in early April.

Q2 now arrives with a calendar that spans nephrology, endocrinology, cardiology, pulmonology, and dermatology — and that carries several decisions with genuine first-in-class or first-in-indication stakes. April brings what could be a long-awaited milestone for the rare kidney disease community, with a ruling expected on sparsentan in focal segmental glomerulosclerosis, a condition affecting more than 40,000 patients in the US for which no approved pharmacologic therapy currently exists. May narrows to a single high-profile call on whether to approve inhaled insulin for children and adolescents ages 4–17 — a decision that, if favorable, would represent the first needle-free insulin option for pediatric patients in over a century of insulin therapy. June closes the quarter with 3 decisions clustered near month's end: cytisinicline's potential to become the first new smoking cessation pharmacotherapy in nearly 20 years, a pediatric label expansion for roflumilast cream, and a pair of cardiometabolic rulings on olezarsen and baxdrostat that could introduce first-in-class mechanisms to severe hypertriglyceridemia and treatment-resistant hypertension, respectively.

Here are the 6 FDA decisions to watch in Q2 2026, listed chronologically by expected decision date.

1. Sparsentan (Filspari)

Company: Travere Therapeutics

PDUFA date: April 13, 2026

Indication: Focal segmental glomerulosclerosis (FSGS) in adults

Summary: The FDA extended the review timeline for the supplemental New Drug Application (sNDA) of sparsentan (Filspari) for focal segmental glomerulosclerosis, pushing the PDUFA date from January 13, 2026, to April 13, 2026, following Travere's submission of additional data requested by the FDA to further characterize the drug's clinical benefit — with no safety or manufacturing concerns raised. Sparsentan is a non-immunosuppressive, oral medication that directly targets podocyte injury by selectively blocking the endothelin A receptor and the angiotensin II subtype 1 receptor, with the sNDA supported by the phase 3 DUPLEX and phase 2 DUET studies. While DUPLEX achieved its pre-specified interim FSGS partial remission of proteinuria endpoint with statistical significance at 36 weeks, it did not achieve the primary efficacy eGFR slope endpoint over 108 weeks of treatment. Two-year DUPLEX data published in the New England Journal of Medicine showed significant proteinuria reduction, higher remission rates, and a lower rate of end-stage kidney disease compared to active control irbesartan.

2. Insulin Human Inhalation Powder (Afrezza)

Company: MannKind Corporation

PDUFA date: May 29, 2026

Indication: Type 1 or type 2 diabetes in children and adolescents aged 4–17 years

Summary: MannKind's sBLA for Afrezza in pediatric patients is supported by phase 3 INHALE-1 study results, which compared Afrezza in combination with a basal insulin against multiple daily injections in children and adolescents with type 1 or type 2 diabetes. Notably, the INHALE-1 study did not meet its primary endpoint of noninferiority with respect to HbA1c, but investigators reported greater treatment satisfaction and reduced weight gain in the Afrezza arm — points the FDA will weigh in its benefit-risk assessment. If approved, Afrezza would offer young children and teenagers with diabetes a potential alternative to multiple daily injections or an insulin pump system — representing the first needle-free insulin option for pediatric patients since insulin therapy was first developed over a century ago.

3. Cytisinicline

Company: Achieve Life Sciences

PDUFA date: June 20, 2026

Indication: Nicotine dependence for smoking cessation in adults

Summary: The NDA for cytisinicline is supported by data from more than 2,000 participants in the phase 3 ORCA-2 and ORCA-3 trials, where cytisinicline demonstrated significantly higher smoking abstinence rates compared to placebo. Cytisinicline is a plant-derived alkaloid that acts on nicotinic acetylcholine receptors, reducing nicotine craving and the rewarding properties of tobacco use. Its receptor selectivity profile has been associated with a lower rate of nausea than older agents, a tolerability advantage the company has emphasized ahead of the review. The drug carries Breakthrough Therapy designation for the separate indication of e-cigarette or vaping cessation. If approved for smoking cessation, cytisinicline has the potential to become the first new FDA-approved treatment option in nearly 20 years — entering a market still anchored by varenicline and nicotine replacement therapy.

4. Baxdrostat

Company: AstraZeneca

PDUFA date: Q2 2026

Indication: Hard-to-control hypertension as add-on to antihypertensive therapy in adults

Summary: The BaxHTN trial demonstrated a −14.5 to −15.7 mmHg change in systolic blood pressure with baxdrostat compared to −5.8 mmHg with placebo, and AstraZeneca expects the FDA to act on the NDA during Q2 2026 following Priority Review acceptance and the use of a Priority Review voucher. Baxdrostat selectively inhibits aldosterone synthase (CYP11B2), reducing aldosterone production without meaningfully affecting cortisol — a mechanistic specificity that distinguishes it from older antihypertensive classes. The phase 3 BaxHTN results, published simultaneously in the New England Journal of Medicine and presented at the European Society of Cardiology 2025, met the primary and all secondary endpoints. If approved, baxdrostat would become the first aldosterone synthase inhibitor authorized for clinical use.

5. Olezarsen (Tryngolza)

Company: Ionis Pharmaceuticals

PDUFA date: June 30, 2026

Indication: Severe hypertriglyceridemia (sHTG; triglycerides ≥500 mg/dL) in adults

Summary: The sNDA for olezarsen in severe hypertriglyceridemia was granted Priority Review by the FDA on the strength of phase 3 CORE and CORE2 data, which across 1,061 patients demonstrated a placebo-adjusted mean reduction in triglycerides of up to 72.2% at 6 months and an 85% relative reduction in acute pancreatitis events — results published in the New England Journal of Medicine and accompanied by the FDA's Breakthrough Therapy designation in November 2025. Olezarsen is an antisense oligonucleotide targeting apolipoprotein C-III, dosed once monthly by subcutaneous injection. The drug is already approved as Tryngolza for the rarer indication of familial chylomicronemia syndrome; the sHTG sNDA represents a meaningful expansion into a larger patient population.

6. Roflumilast Cream 0.3% (Zoryve)

Company: Arcutis Biotherapeutics

PDUFA date: June 29, 2026

Indication: Plaque psoriasis in children aged 2 to 5 years

Summary: The FDA accepted Arcutis's sNDA for roflumilast (Zoryve) cream 0.3% to expand the plaque psoriasis (PsO) indication to children aged 2–5 years, assigning a PDUFA date of June 29, 2026. Roflumilast cream 0.3% is currently approved for plaque psoriasis in adults and children down to age 6. The sNDA is supported by a 4-week Maximal Usage Systemic Exposure study in children aged 2–5 demonstrating minimal-to-no systemic absorption, as well as long-term open-label data showing sustained efficacy and tolerability across age groups. Plaque psoriasis in this younger age group commonly affects sensitive areas including the face and intertriginous regions, where steroid use is particularly challenging. If approved, roflumilast cream 0.3% would be the first topical PDE4 inhibitor indicated for plaque psoriasis in children as young as 2, adding to a portfolio that already includes approvals in atopic dermatitis (ages 2+) and seborrheic dermatitis.

References

1. Travere Therapeutics. Travere Therapeutics announces FDA acceptance of sNDA for FILSPARI® (sparsentan) in FSGS. Business Wire. May 2025. https://ir.travere.com/press-releases/news-details/2025/Travere-Therapeutics-Announces-FDA-Acceptance-of-sNDA-for-FILSPARI-sparsentan-in-FSGS/default.aspx

2. US Food and Drug Administration. FDA approves first new molecular entity under National Priority Voucher program. FDA.gov. April 1, 2026. https://www.fda.gov/news-events/press-announcements/fda-approves-first-new-molecular-entity-under-national-priority-voucher-program