Q3 2026 Preview: 4 FDA Decisions to Watch

Q3 opens with a concentrated slate of regulatory decisions spanning nephrology, cardiovascular disease, women's health, and infectious diseases. July begins with what could be one of the year's most consequential nephrology approvals as the US Food and Drug Administration (FDA) weighs atacicept for immunoglobulin A nephropathy (IgAN), a decision that could add a novel dual BAFF/APRIL-targeting therapy to the rapidly evolving treatment landscape. Later in the month, regulators will consider MannKind's ReadyFlow Autoinjector for Furoscix, which could significantly simplify outpatient management of edema associated with chronic kidney disease or congestive heart failure by reducing administration time from hours to seconds, before closing July with a decision on a once-weekly lower-estrogen transdermal contraceptive patch designed to expand hormonal birth control options for appropriate candidates.

The quarter's final anticipated decision arrives in early August, when the FDA is expected to rule on Moderna's mRNA-1010. If approved, the investigational vaccine would become the first mRNA-based seasonal influenza vaccine available in the United States, introducing a new platform to seasonal flu prevention for adults 50 years of age and older ahead of the 2026–2027 influenza season.

Here are the FDA decisions to watch in Q3 2026, listed chronologically by expected decision date.

1. Atacicept

Company: Vera Therapeutics

PDUFA Date: July 7, 2026

Indication: IgA Nephropathy (IgAN)

Summary: Atacicept is an investigational recombinant fusion protein, containing the soluble transmembrane activator and calcium-modulating cyclophilin ligand interactor receptor, which binds to the cytokines B-cell activating factor (BAFF) and A PRoliferation-Inducing Ligand (APRIL). BAFF and APRIL are members of the tumor necrosis superfamily, playing crucial roles in immune system regulation, and promote B-cell survival and autoantibody production associated with IgAN, lupus nephritis, and other autoimmune kidney diseases.

The BLA submission was supported by data from the ORIGIN 3 trial’s prespecified interim analysis. The phase 3 trial met its primary endpoint of reduction in proteinuria at week 36 in June 2025, with a 46% reduction compared to baseline, and a 42% reduction compared to placebo (P < .0001). During the randomized trial period, the safety profile was comparable between atacicept and placebo. Through 96 weeks, atacicept demonstrated further improvements in Gd-IgA1, hematuria, and proteinuria, as well as stabilization of estimated glomerular filtration rates (eGFR).

2. Furoscix ReadyFlow

Company: MannKind Corporation

PDUFA Date: July 26, 2026

Indication: Treatment of Edema in CKD or CHF

Summary: The Furoscix ReadyFlow Autoinjector would reduce administration time from 5 hours with the FDA-approved Furoscix On-body Infusor to under 10 seconds. The sNDA is supported by positive study results announced in August 2024. In the open-label, single-center, single-dose, randomized, two-way crossover study, furosemide via the ReadyFlow Autoinjector demonstrated a bioavailability of 107.3% (90% CI, 103.9 – 110.8), achieving the 90% confidence interval limit of 80 to 125 percent. Additionally, participants who utilized ReadyFlow Autoinjector had similar urine output, urinary sodium excretion and urinary potassium excretion at 6, 8, and 12 hours compared to IV furosemide, and was generally well tolerated with respect to injection site pain.

3. 150 mcg Norelgestromin and 17.5 mcg Ethinyl Estradiol

Company: Viatris

PDUFA Date: July 30, 2026

Indication: Contraception

Summary: The investigational treatment is a once-weekly transdermal contraceptive patch being developed for women of childbearing potential with a BMI < 30 kg/m² who are appropriate candidates for combined hormonal contraception and who prefer a noninvasive, reversible option with a lower estrogen dose. The patch delivers approximately 150 mcg of norelgestromin and 17.5 mcg of ethinyl estradiol per day and is applied once weekly for 3 weeks, followed by a one-week patch-free period.

The NDA is supported by results from the phase 3 Luminous Study, which demonstrated a favorable efficacy and safety profile and strong patch adhesion performance.

4. mRNA-1010

Company: Moderna

PDUFA Date: August 5, 2026

Indication: Seasonal Flu

Summary: mRNA-1010 is an investigational, messenger RNA (mRNA) seasonal influenza vaccine designed to protect against major circulating strains. In response to a prior Refusal-to-File (RTF) letter, parent company Moderna engaged with theFDA in a Type A meeting and proposed a revised regulatory approach for mRNA-1010. To advance the review, Moderna proposed a regulatory pathway based on age, seeking full approval for adults 50 to 64 years of age and accelerated approval for adults 65 and older, along with a post-marketing requirement to conduct an additional study in older adults.

Following submission of the amended application, the FDA accepted the BLA for review. If approved, mRNA-1010 would be available for US adults 50 years of age and older, including adults 65 and older, for the 2026/2027 flu season.

References

1. Hillenbrand A. FDA Grants Priority Review Of Biologics License Application For Atacicept In IgA Nephropathy. HCPLive. January 7, 2026. Accessed June 29, 2026. https://www.hcplive.com/view/fda-grants-priority-review-of-biologics-license-application-for-atacicept-in-iga-nephropathy

2. Livingston R. FDA Accepts sNDA for Furosemide Autoinjector for Chronic Heart Failure and CKD. HCPLive. December 1, 2025. Accessed June 29, 2026. https://www.hcplive.com/view/fda-accepts-snda-for-furosemide-autoinjector-for-chronic-heart-failure-and-ckd

3. Viatris. Viatris Provides Pipeline Update on Four Regulatory Milestones. December 18, 2025. Accessed June 29, 2026. https://investor.viatris.com/news-releases/news-release-details/viatris-provides-pipeline-update-four-regulatory-milestones

4. Moderna. Moderna Announces the U.S. Food and Drug Administration will Initiate the Review of Its Investigational Seasonal Influenza Vaccine Submission. February 18, 2026. Accessed June 29, 2026. https://feeds.issuerdirect.com/news-release.html?newsid=8923338804483797&symbol=MRNA