प्राथमिक स्रोत रिकॉर्ड
महत्वपूर्णअन्य
Atara: FDA की Type A बैठक ने tab-cel BLA को फिर से प्रस्तुत करने का मार्ग पुष्ट किया
Atara and partner Pierre Fabre received FDA guidance confirming that the existing Phase 3 ALLELE trial data can support a resubmission of the tabelecleucel BLA. The resubmission will include an updated dataset with additional patients and longer follow-up. Atara remains eligible for a $31 million milestone upon FDA approval and double-digit royalties on net sales.
मुख्य तथ्य
- फाइल किया गया
- 12 अग॰ 2026, 08:10 pm
- घटना
- अन्य
- दिशा
- तटस्थ
- संपत्ति
- tabelecleucel
- स्रोत
- SEC 8-K
- विश्वसनीयता
- स्रोत सहित
- मील का पत्थर भुगतान
- FDA अनुमोदन पर $31 मिलियन
स्रोत का अंश
EX-99.1 2 atra-ex99_1.htm EX-99.1 EX-99.1 Exhibit 99.1 Atara Biotherapeutics Announces Second Quarter 2026 Financial Results and Operational Progress Productive Type A Meeting with FDA for tabelecleucel FDA guidance provided on resubmission of tabelecleucel BLA Year over Year costs and operating expenses reduction of 87% THOUSAND OAKS, Calif.--(BUSINESS WIRE)-- Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, today reported financial results for the second quarter 2026 and business updates. “This was an important quarter for Atara. We and our partners, Pierre Fabre Pharmaceuticals (PFP), had a producti
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