प्राथमिक स्रोत रिकॉर्ड
निर्णायकPDUFA तारीख़ बढ़ाई गई
Achieve Life Sciences को cytisinicline NDA पर 20 जून 2026 तक FDA से CRL (कम्प्लीट रिस्पॉन्स लेटर) मिलने की आशंका
The document states that the prior third-party manufacturer received an OAI classification, leading the company to expect a Complete Response Letter on or before the June 20, 2026 PDUFA date. Achieve plans to resubmit the NDA in Q4 2026 with Adare Pharma Solutions as the new primary manufacturing partner, targeting U.S. commercial launch in H1 2027.
मुख्य तथ्य
- फाइल किया गया
- 12 मई 2026, 11:20 am
- घटना
- PDUFA तारीख़ बढ़ाई गई
- दिशा
- नकारात्मक
- संपत्ति
- cytisinicline
- स्रोत
- SEC 8-K
- विश्वसनीयता
- स्रोत सहित
- कैलेंडर
- FDA फ़ैसला (PDUFA) · 20 जून 2026 · पूर्ण प्रतिक्रिया पत्र
स्रोत का अंश
EX-99.1 2 d854692dex991.htm EX-99.1 EX-99.1 Exhibit 99.1 Achieve Life Sciences Reports First Quarter 2026 Financial Results and Provides Business Updates Closed Private Placement of Up to $354 Million, Including $180 Million Upfront and $174 Million in Milestone-Driven Warrants Appoints New CEO and Expands Board of Directors Advances U.S.-based Manufacturing Transition & Partnership Conference Call Scheduled for 8:30 AM EDT Today, May 12, 2026 SEATTLE and VANCOUVER, British Columbia, May 12, 2026 (GLOBE NEWSWIRE) — Achieve Life Sciences, Inc. (Achieve or the Company) (Nasdaq: ACHV), a late-stage specialty pharmaceutical company focused on the global development and commercialization of cytisinicline as a treatment for nicotine dependence, today announced financial results for the f
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