The Food and Drug Administration (FDA) is set to deliver decisions on five significant drug applications in March, including two that experienced review delays from the previous year. The lineup features major pharmaceutical companies seeking approvals for label expansions and treatments for rare diseases.
Bristol Myers Squibb (BMS) is awaiting an FDA verdict by March 6 regarding the potential expansion of its oral drug Sotyktu to include treatment for adults with active psoriatic arthritis. The company has submitted data from two pivotal Phase 3 studies, POETYK PsA-1 and POETYK PsA-2, to support this application. Results from POETYK PsA-2 released in March 2025 indicated that 54.2% of patients taking Sotyktu achieved at least a 20% improvement in symptoms after 16 weeks, compared to 39.4% in the placebo group. Similar findings were reported in POETYK PsA-1 data published in October 2025. Sotyktu was initially approved in September 2022 for moderate-to-severe plaque psoriasis.
Aldeyra Therapeutics is also anticipating an FDA decision by March 16 on its RASP modulator reproxalap, proposed for dry eye disease. Reproxalap has previously been rejected twice due to insufficient evidence of efficacy for ocular symptoms, first in November 2023 and again in April last year. Aldeyra resubmitted its application in June 2025 with additional data showing improved ocular discomfort versus vehicle, leading the FDA to accept the filing in July and delay the target action date from December to March.
Rhythm Pharmaceuticals is awaiting a decision on Imcivree, a melanocortin 4 receptor agonist aimed at treating acquired hypothalamic obesity—a rare condition linked to physical damage or abnormalities of the hypothalamus resulting in uncontrolled hunger and weight gain. Supported by results from the Phase 3 TRANSCEND trial demonstrating a nearly 20% reduction in body mass index compared to placebo over one year, Rhythm’s application was delayed three months after additional sensitivity data was submitted.
GlaxoSmithKline (GSK) expects an FDA ruling by March 24 on linerixibat as a treatment for cholestatic pruritus associated with primary biliary cholangitis (PBC), a liver disease marked by disrupted bile flow and severe itching unresponsive to scratching. Linerixibat works by blocking bile acid reuptake; Phase 3 GLISTEN study results showed significant improvements over placebo across multiple measures.
Rocket Pharmaceuticals will receive an FDA decision by March 28 regarding Kresladi, a gene therapy designed for leukocyte adhesion deficiency-I (LAD-I), a rare immune disorder affecting approximately 300 people worldwide. Kresladi uses an adeno-associated virus vector to deliver a functional ITGB2 gene copy into patients’ cells. In pivotal trials, all treated patients survived at least one year post-treatment. The FDA previously rejected Rocket’s application due to chemistry and manufacturing concerns but accepted a revised submission last October.
In related developments, Rocket Pharmaceuticals recently halted its fanca-cel gene therapy program for Fanconi anemia as part of a strategic realignment initiative announced last July (source).
