प्राथमिक स्रोत रिकॉर्ड
महत्वपूर्णPDUFA तारीख़ तय
Unicycive, वर्ष के अंत तक OLC NDA फिर से प्रस्तुत करने की योजना बना रहा है; नई PDUFA तिथि H1 2026 में
Company intends to resubmit the NDA for oxylanthanum carbonate by December 31, 2025 after a Type A meeting with FDA that addressed the single manufacturing deficiency cited in the June CRL. FDA indicated no other issues remain; a new PDUFA date is expected in the first half of 2026.
मुख्य तथ्य
- फाइल किया गया
- 12 नव॰ 2025, 02:12 pm
- घटना
- PDUFA तारीख़ तय
- दिशा
- सकारात्मक
- कंपनी
UNCYUnicycive- संपत्ति
- oxylanthanum carbonate
- स्रोत
- SEC 8-K
- विश्वसनीयता
- स्रोत सहित
- कैलेंडर
- FDA फ़ैसला (PDUFA) · 29 जून 2026 · पूर्ण प्रतिक्रिया पत्र
स्रोत का अंश
EX-99.1 2 ea026522701ex99-1_unicycive.htm PRESS RELEASE OF UNICYCIVE THERAPEUTICS, INC. DATED NOVEMBER 12, 2025 Exhibit 99.1 Unicycive Therapeutics Announces Third Quarter 2025 Financial Results and Provides Business Update - Remain on track to resubmit the New Drug Application (NDA) for oxylanthanum carbonate (OLC) by year end - Presented new analysis of OLC data at American Society of Nephrology (ASN) which demonstrates that OLC significantly reduced pill burden in terms of both pill volume (7x) and pill count (2x) compared to currently available phosphate binders - Ended Q3 with $42.7 million of cash with expected runway into 2027 LOS ALTOS, California, November 12, 2025 -- Unicycive Therapeutics, Inc. (“Unicycive” or the “Company”) (Nasdaq: UNCY), a clinical-stage biotechnolog
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