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FDA Decisions Expected: May 2026

Your monthly synopsis of new drugs expected to hit the market 

April 9, 2026

Drug pipeline for May 2026

At Prime Therapeutics (Prime), we have positioned ourselves to best prepare our clients to manage new drugs. Our clinical and trade relations teams keep a keen eye on drugs awaiting approval by the United States (U.S.) Food and Drug Administration (FDA).
May 2026: brimonidine tartrate 0.35% (PDP-716) 

Ocuvex has resubmitted a New Drug Application (NDA) for PDP-716, a once-daily ophthalmic suspension containing brimonidine tartrate 0.35%, for the treatment of glaucoma or ocular hypertension. The NDA was submitted under the 505(b)(2) pathway which allows data from previously approved active ingredients. This is the second FDA review of PDP-716, following a Complete Response Letter (CRL) issued in 2022 based on inspection findings at a third-party Active Pharmaceutical Ingredient (API) manufacturing facility. In a Phase 3 trial, PDP-716 demonstrated intraocular pressure (IOP) reductions and safety profile comparable to that reported with brimonidine tartrate 0.1% ophthalmic solution (Alphagan-P).¹ Currently marketed brimonidine tartrate products require three times daily dosing and are available in concentrations of 0.1% (Alphagan-P, generic), 0.15% (Alphagan-P, Qoliana, generic) and 0.2% (generic). If approved, PDP-716 would be the first brimonidine formulation offering once-daily dosing. 

May 16, 2026: golimumab (BAT2506) 
Bio-Thera is awaiting FDA decision for BAT2506, a golimumab biosimilar candidate to Janssen Biotech’s brand Simponi, which carries indications for active rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS) and ulcerative colitis (UC). If FDA approved, BAT2506 will be the first golimumab biosimilar and is anticipated to launch in 2026. Bio-Thera has requested that it receive interchangeability status. 
May 31, 2026: dexmethylphenidate hydrochloride (CTx-1301) 
CTx-1301 is a once-daily formulation of dexmethylphenidate hydrochloride developed by Cingulate Therapeutics and is awaiting FDA approval for the treatment of attention deficit hyperactivity disorder (ADHD). The NDA was submitted under the 505(b)(2) regulatory pathway. In Phase 3, placebo controlled clinical trials, CTx-1301 improved ADHD signs and symptoms in adult and pediatric patients 6 years of age and older. Efficacy was assessed using the ADHD ratings scale 5 (ADHD-RS-5), Clinical Global Impression-Severity (CGI-S) scales and Permanent Product Measure of Performance (PERMP).²˒³ CTx-1301 is designed to deliver three distinct releases of dexmethylphenidate at predefined time, ratio, and style of release in one tablet, with the aim to address gaps in symptom control during the evening hours. In clinical trials, a single daily dose of CTx-1301 produced a rapid onset of action that was sustained for approximately 12 to 16 hours.