The Food and Drug Administration (FDA) is preparing to issue several important decisions before the end of 2025, with determinations pending on therapies for asthma, rare obesity, dry eye disease, gastroparesis, Cushing’s syndrome, and bipolar depression.
GSK is awaiting two decisions regarding its ultra-long-acting antibody depemokimab. The company seeks approval for use in both asthma and chronic rhinosinusitis with nasal polyps (CRSwNP). The FDA’s rulings are expected by December 16. Depemokimab targets the IL-5 cytokine involved in immune-mediated diseases. In clinical trials SWIFT-1 and SWIFT-2 for asthma, the treatment reduced annualized exacerbation rates by up to 58% compared to placebo. For CRSwNP, ANCHOR-1 and ANCHOR-2 trials showed significant improvements in nasal polyp scores and obstructions. GSK states that if approved, depemokimab would be the first biologic of its kind available for dosing every six months.
Aldeyra Therapeutics is also awaiting an FDA decision by December 16 for reproxalap, a drug candidate for dry eye disease. This marks the third regulatory review after previous rejections due to insufficient evidence of efficacy. Aldeyra resubmitted its application following a successful dry eye chamber trial agreed upon with the FDA.
Rhythm Pharmaceuticals has proposed expanding use of Imcivree—already approved for certain genetic forms of obesity—to treat acquired hypothalamic obesity, a rare condition linked to hypothalamic injury or abnormalities. A decision is expected by December 20. Data from Rhythm’s Phase III TRANSCEND study indicated a nearly 20% reduction in body mass index versus placebo in affected patients.
Vanda Pharmaceuticals anticipates an FDA verdict on tradipitant for gastroparesis by December 30 after a prior rejection and public disputes with the agency over evidence requirements and decision-making transparency. Vanda claims multiple studies support efficacy but faced regulatory skepticism over statistically significant results.
Corcept Therapeutics awaits word on relacorilant as a potential new treatment option for Cushing’s syndrome, also expected by December 30. Relacorilant selectively targets glucocorticoid receptors to address symptoms caused by excessive cortisol production. Clinical studies have demonstrated improvements in various symptoms associated with hypercortisolism.
Finally, NRx Pharmaceuticals expects a decision “prior to December 31” on NRX-101 for bipolar depression in patients at risk of akathisia—a movement disorder often linked to suicidality and antidepressant use. NRX-101 combines D-cycloserine and lurasidone; while Phase IIb/III data suggested reductions in suicidality and akathisia symptoms, these findings were not statistically significant. If approved, NRX-101 would be the first regimen specifically indicated for severe bipolar depression with acute or sub-acute suicidal ideation or behavior.
The series of upcoming decisions could introduce new therapies addressing unmet needs across multiple conditions as the year concludes.
