प्राथमिक स्रोत रिकॉर्ड
FDA ने tebipenem HBr NDA के लिए PDUFA तिथि 18 जून 2026 निर्धारित की। NDA GSK द्वारा दिसंबर 2025 में प्रस्तुत की गई थी और इसे Phase 3 PIVOT-PO परीक्षण द्वारा समर्थित किया गया है, जिसे मई 2025 में प्रभावकारिता के लिए जल्दी रोक दिया गया था।
EX-99.1 2 d147628dex991.htm EX-99.1 EX-99.1 Exhibit 99.1 Spero Therapeutics Announces First Quarter 2026 Operating Results and Provides Business Update • New Drug Application (NDA) for tebipenem HBr for complicated urinary tract infections (cUTI), including pyelonephritis, is under review at the FDA, with PDUFA date of June 18, 2026 • Spero maintains its cash runway guidance into 2028 CAMBRIDGE, Mass., May 13, 2026 — Spero Therapeutics , Inc. (Nasdaq: SPRO), a clinical-stage biopharmaceutical company focused on identifying and developing novel treatments for rare diseases and diseases with high unmet need, today announced financial results for the first quarter ended March 31, 2026, and provided a business update. “We continue to make solid progress on the tebipenem HBr program al