SCYNEXIS, Inc. | MedPath

FDA Approves Blujepa, First New Class of Oral Antibiotic for UTIs in Nearly 30 Years

2 months ago

• GSK's Blujepa (gepotidacin) has received FDA approval for treating uncomplicated urinary tract infections, marking the first new class of oral antibiotics for UTIs in nearly three decades. • The novel triazaacenaphthylene antibiotic demonstrated non-inferiority or superiority to nitrofurantoin in clinical trials, offering a new treatment option amid rising antibiotic resistance concerns. • Blujepa works through a unique dual-enzyme inhibition mechanism that may reduce the potential for resistance development, with commercial availability expected in the second half of 2025.

Incyte Reports Strong 2024 Growth with $4.2B Revenue, Outlines Ambitious 2025 Pipeline Milestones

3 months ago

• Incyte achieved total revenues of $4.2 billion in 2024, marking a 15% year-over-year growth, driven by strong performance of Jakafi ($2.8B) and Opzelura ($508M). • The company anticipates four new product launches in 2025, including Niktimvo for chronic GVHD and expanded indications for existing therapies in atopic dermatitis and lymphoma. • Incyte's R&D pipeline shows significant advancement with plans for four pivotal study readouts, three Phase 3 study initiations, and seven proof-of-concept study results expected in 2025.

SCYNEXIS Initiates Dosing in Phase 1 Trial of SCY-247 for Invasive Fungal Infections

5 months ago

SCYNEXIS, Inc. has commenced dosing in a Phase 1 trial for SCY-247, a second-generation antifungal aimed at treating severe invasive fungal infections. The trial focuses on safety, tolerability, and pharmacokinetics in healthy subjects.

FDA Grants Priority Review to GSK's Gepotidacin for Uncomplicated Urinary Tract Infections

7 months ago

• The FDA has granted priority review to GSK's new drug application for gepotidacin, an oral antibiotic for uncomplicated urinary tract infections (uUTIs). • Gepotidacin could be the first new class of oral antibiotics for uUTIs in over 20 years, offering a novel mechanism of action against resistant uropathogens. • The NDA is supported by Phase III EAGLE-2 and EAGLE-3 trials, demonstrating non-inferiority and superiority to nitrofurantoin in treating uUTIs. • The PDUFA action date is set for March 26, 2025, with potential for gepotidacin to address the increasing need for new treatments due to rising drug resistance.