May 2025 Drug Pipeline Outlook
As the pharmaceutical landscape continues to evolve, Prime Therapeutics remains at the forefront, guiding clients through the influx of innovative therapies approaching FDA review. Our clinical and trade relations teams closely monitor drug development activity to ensure preparedness for market-shaping changes. The following are key therapies anticipated to receive U.S. Food and Drug Administration (FDA) decisions in May 2025, spanning biosimilars, rare disease treatments, and next-generation therapies.
Ustekinumab Biosimilar (BAT2206) – May–June 2025
Developer: Bio-Thera Solutions
Bio-Thera seeks FDA approval for BAT2206, an interchangeable biosimilar to ustekinumab (Stelara®), a human interleukin-12/23 antagonist indicated for plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis. If approved, BAT2206 would become the eighth Stelara biosimilar cleared by the FDA—and only the second with an interchangeable designation, enabling pharmacy-level substitution without prescriber involvement.
Pegzilarginase – May 5, 2025
Developer: Immedica
Pegzilarginase is under FDA review for arginase 1 deficiency (ARG1-D), a rare urea cycle disorder marked by excessive arginine accumulation due to deficient arginase enzyme activity. This leads to elevated ammonia levels and can result in spasticity, seizures, gait abnormalities, and developmental delays. The current standard of care relies on strict protein restriction and ammonia scavengers.
Pegzilarginase, a pegylated recombinant human ARG1 enzyme, demonstrated a 76.7% reduction in plasma arginine in the Phase 3 PEACE trial. Though it did not achieve statistically significant functional mobility gains, data suggest potential for clinical stabilization over longer use. If approved, pegzilarginase would be the first therapy designed to normalize plasma arginine levels in ARG1-D patients. It has received multiple FDA designations, including Breakthrough Therapy and Priority Review.
Sodium Dichloroacetate (SL-1009) – May 27, 2025
Developer: Saol Therapeutics
SL-1009 is an oral solution candidate for pyruvate dehydrogenase complex deficiency (PDCD), a rare mitochondrial disorder impairing cellular energy production. PDCD manifests with neurologic and metabolic complications and often presents in infancy or early childhood.
SL-1009 has completed a Phase 3 double-blind, placebo-controlled crossover study assessing motor function and plasma lactate reduction. While formal trial results are pending public release, a survival analysis comparing treated patients to a natural history cohort supported the New Drug Application. The drug has received Fast Track, Orphan Drug, Rare Pediatric Disease, and Priority Review designations. If approved, SL-1009 would be the first FDA-approved therapy for PDCD.
Telisotuzumab Vedotin (Teliso-V) – May 27, 2025
Developer: AbbVie
AbbVie is pursuing Accelerated Approval for Teliso-V in adults with previously treated, locally advanced or metastatic EGFR wild-type nonsquamous non-small cell lung cancer (NSCLC) exhibiting c-Met overexpression. Teliso-V is a first-in-class antibody-drug conjugate (ADC) that targets c-Met, a receptor frequently overexpressed in solid tumors.
In the Phase 2 LUMINOSITY trial, Teliso-V demonstrated a 28.6% overall response rate and a median response duration of 8.3 months. Despite isolated reports of serious treatment-related adverse events, the therapy shows promise for addressing a critical unmet need. If approved, Teliso-V will be the first targeted treatment for c-Met–positive NSCLC.
Acoltremon (AR-15512) – May 30, 2025
Developer: Alcon
Acoltremon is a first-in-class TRPM8 receptor agonist submitted for FDA approval for the treatment of dry eye disease (DED). In the Phase 3 COMET-2 and COMET-3 trials, acoltremon significantly increased tear production within 14 days, with effects sustained through 90 days.
Patients received the ophthalmic solution twice daily. Results indicated rapid and lasting symptom relief, with a novel mechanism of action distinct from existing DED therapies. If approved, acoltremon would represent a new category of treatment for millions affected by this chronic condition.
mRNA-1283 COVID-19 Vaccine – May 30, 2025
Developer: Moderna
Moderna’s next-generation COVID-19 vaccine, mRNA-1283, is designed for improved stability and storage while maintaining efficacy. In the Phase 3 NextCOVE trial, mRNA-1283 demonstrated non-inferiority to the bivalent mRNA-1273 (Spikevax®) vaccine, with comparable immune response and no myocarditis or pericarditis cases reported.
Administered at a lower dose (10 µg vs. 50 µg), mRNA-1283 may provide logistical and manufacturing advantages. The vaccine was submitted under Priority Review and, if approved, will expand immunization options as public health strategies adapt to the endemic phase of COVID-19.