FDA Decisions Expected in March 2026 for Multiple Biotech Drug Candidates

As March approaches, the FDA is expected to announce key decisions on the New Drug Applications for Reproxalap, Linerixibat, Kresladi, and LNTH-2501. For Kresladi, this marks a second bid for approval, while Reproxalap is making its third attempt. Meanwhile, approved therapies Sotyktu and Imcivree await decisions on label expansions, adding further regulatory catalysts to the month.

The FDA decision on Bristol-Myers Squibb's Sotyktu in the expanded indication of treatment of adults with active psoriatic arthritis is due on March 6, 2026. Sotyktu, which selectively targets and blocks tyrosine kinase 2 (TYK2) enzyme, is an oral prescription pill that is already approved in the U.S. and numerous countries around the world for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. In the pivotal clinical trials evaluating Sotyktu in adults with active psoriatic arthritis, a significantly higher percentage of patients treated with Sotyktu achieved an ACR20 response - defined as at least a 20% improvement in disease signs and symptoms - at 16 weeks compared with those receiving placebo. The drug generated annual sales of $291 million in 2025, up 19% over the prior year.

Lantheus Holdings' New Drug Application seeking approval for a new formulation of its F 18 PSMA (prostate-specific membrane antigen) imaging agent awaits the FDA decision on March 6, 2026. The company already markets FDA-approved Pylarify (piflufolastat F 18) injection, a PSMA-targeted PET imaging agent. It enables visualization of lymph nodes, bone and soft tissue metastases to determine the presence or absence of recurrent and/or metastatic prostate cancer. The proposed new formulation optimizes the manufacturing process and is expected to increase batch size by roughly 50%, allowing Lantheus to treat substantially more patients while maintaining the same standards of Pylarify. The new formulation increases the radioactive concentration of the agent and has the potential to expand patient access in new geographic locations, according to the company.

Aldeyra Therapeutics' drug candidate Reproxalap, proposed for the treatment of dry eye disease, is back at the FDA altar again, with a decision expected on March 16, 2026. Reproxalap is a first-in-class small-molecule modulator of RASP (reactive aldehyde species), formulated as an eye drop. Reproxalap has been twice rejected by the FDA for the treatment of dry eye disease. In November 2023, the regulatory agency turned down the New Drug Application (NDA), saying that the drug candidate did not demonstrate sufficient efficacy in treating ocular symptoms associated with dry eyes. The FDA requested at least one additional adequate and well-controlled study to support the drug's effectiveness. In response, Aldeyra completed a phase 3 dry eye chamber trial and resubmitted the NDA in October 2024. However, the second attempt also fell short, with the FDA refusing to approve Reproxalap again in April 2025, stating that it "failed to demonstrate efficacy in adequate and well-controlled studies" and reiterated the need for further clinical evidence focused on symptom relief. Addressing the concerns, the company resubmitted the NDA for Reproxalap in June 2025 and was initially assigned a decision date of December 16, 2025. In December 2025, the FDA extended the decision date to March 16, 2026.

Rhythm Pharmaceuticals has sought to expand the FDA approval of Imcivree to include the indication of acquired hypothalamic obesity, and a decision is due on March 20, 2026. Acquired hypothalamic obesity is a rare form of obesity that occurs following damage to the hypothalamic region of the brain, which includes the melanocortin-4 receptor (MC4R) pathway and is responsible for controlling physiological functions such as hunger and weight regulation. Acquired hypothalamic obesity most frequently follows the growth or surgical removal of craniopharyngioma, astrocytoma, or other rare brain tumors. IMCIVREE is already approved by the FDA to reduce excess body weight and maintain weight reduction long term in adult and pediatric patients 2 years of age and older with syndromic or monogenic obesity due to Bardet-Biedl syndrome (BBS), POMC, PCSK1 or LEPR deficiency as determined by an FDA-approved test demonstrating variants in POMC, PCSK1 or LEPR genes that are interpreted as pathogenic, likely pathogenic, or of uncertain significance. Global sales of IMCIVREE for the fourth quarter of 2025 are expected to be approximately $57 million.

Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT) is a fully integrated, late-stage biotechnology company advancing a sustainable pipeline of investigational genetic therapies designed to correct the root cause of complex and rare disorders. The Chief Executive Officer will take part in a fireside chat and management will host investor meetings at the TD Cowen 46th Annual Health Care Conference on March 2, 2026, and the Leerink Partners Global Healthcare Conference on March 10, 2026.