On the FDA’s docket this month are two decisions pushed back from 2025, including one for a rare form of obesity and another for dry eye disease.
The FDA will decide on five major drug applications this month, two of which had their reviews delayed from last year. Also lined up are two big pharma verdicts: one for a label expansion and another for a rare liver disease.
Read below for more.
BMS Plots Arthritis Expansion for Sotyktu
Bristol Myers Squibb is looking to add psoriatic arthritis to the label of oral drug Sotyktu, opening its use in adults with active disease. The FDA’s decision is expected by March 6.
The pharma is supporting the expansion bid with data from the pivotal Phase 3 POETYK PsA-1 and POETYK PsA-2 studies. A readout from the latter study in March 2025 showed that 54.2% of patients on Sotyktu achieved at least a 20% improvement in symptoms, as compared with 39.4% of placebo comparators after 16 weeks, a statistically significant advantage for BMS’ drug.
Similarly, POETYK PsA-1 data released in October 2025 showed a significantly higher percentage of patients saw a 20% improvement in symptoms versus placebo.
Sotyktu is an oral tyrosine kinase inhibitor that suppresses the inflammatory cascade. The drug was first approved in September 2022 for moderate-to-severe plaque psoriasis.
Aldeyra Hopes Third Time’s the Charm for Dry Eye Disease Drug
By March 16, the FDA is expected to release a decision on Aldeyra Therapeutics’ RASP modulator reproxalap, which the biotech is proposing for the treatment of dry eye disease.
Reproxalap has had a difficult regulatory run so far. In November 2023, the drug received its first rejection, with the FDA at the time arguing that Aldeyra had failed to sufficiently establish efficacy for ocular symptoms in dry eye disease. Reproxalap was again rejected in April last year, similarly due to questions over efficacy.
Aldeyra filed a resubmission in June 2025—which the FDA accepted in July—including additional data from a dry eye chamber study, which in May last year showed significantly improved ocular discomfort versus vehicle. The target action date for reproxalap’s third trip to the FDA was originally Dec. 16, but that was pushed back three months to allow for a review of additional submissions.
Rhythm Waits Out Delay for Rare Obesity Drug
Like Aldeyra, Rhythm Pharmaceuticals is riding out a regulatory delay for its melanocortin 4 receptor (MC4R) agonist Imcivree, being proposed for the treatment of acquired hypothalamic obesity. The FDA is set to release a decision on or before March 20.
Imcivree’s application is supported by data from the Phase 3 TRANSCEND trial, which found that the drug cut body mass index by 19.8% versus placebo at 52 weeks. The FDA accepted Imcivree’s data package in August last year and originally set a target action date of Dec. 20 but delayed the decision by three months after the biotech filed additional sensitivity data.
Imcivree’s first approval came in November 2020 to help manage weight in patients with obesity due to POMC, PCSK1 or LEPR deficiency. Acquired hypothalamic obesity is a rare form of chronic weight-gain linked to physical damage to, or anatomical abnormalities of the hypothalamus. Dysregulated MC4R signaling is a key pathway in this condition, leading to uncontrolled hunger and weight-gain.
GSK Gears Up For Decision in Rare Autoimmune Liver Disease
By March 24, the FDA will release a decision for GSK’s linerixibat for the treatment of cholestatic pruritus in patients with primary biliary cholangitis (PBC).
Available orally, linerixibat is a targeted blocker of the ileal bile acid transporter, which inhibits the reuptake of bile acid, in turn lowering the levels of several itch mediators across the body. Data from the Phase 3 GLISTEN study, released in May last year, showed that linerixibat significantly improved monthly itch scores versus placebo, while also acing key secondary endpoints such as sleep interference and the speed at which itch was eased.
PBC is a liver disease characterized by the disrupted flow of bile from the liver, leading to excessive bile levels in circulation. The condition can then give rise to cholestatic pruritus, or an internal itch that cannot be addressed by scratching, according to GSK.
Rocket Gives Kresladi Another Try
To close off the month, the FDA on or before March 28 will release a decision on Rocket Pharmaceuticals’ proposal to use the gene therapy Kresladi for leukocyte adhesion deficiency-I (LAD-I).
Delivered using an adeno-associated virus vector, Kresladi provides patients with a functioning copy of the ITGB2 gene, which in turn can encode a key surface protein on immune cells. This protein is otherwise dysfunctional in LAD-I, leading to a compromised immune response that makes patients susceptible to recurrent and severe infections. There are around 300 LAD-I cases worldwide.
Pivotal Phase 1/2 data showed a 100% overall survival rate at 12 months after Kresladi treatment. The FDA in June 2024 rejected Rocket’s application, though the rebuff was due to issues with chemistry, manufacturing and controls. The biotech refiled its approval package mid-2025, which the FDA accepted in October.
