Record mula sa primary source
Decision-gradeNaitakda ang petsa ng PDUFA
Outlook Therapeutics: Petsa ng target na PDUFA ng FDA para sa ONS-5010 ay Disyembre 31, 2025
Kinumpirma ng 8-K na itinakda ng FDA ang PDUFA goal date na December 31, 2025 para sa ONS-5010 BLA sa wet AMD. Ito ang huling regulatory milestone bago ang posibleng desisyon sa pag-apruba sa U.S. para sa ophthalmic formulation ng bevacizumab.
Mahahalagang fact
- Na-file
- Dis 19, 2025, 01:30 PM
- Kaganapan
- Naitakda ang petsa ng PDUFA
- Direksyon
- Neutral
- Kumpanya
OTLKOutlook Therapeutics, Inc.- Asset
- bevacizumab-vikg
- Pinagmulan
- SEC 8-K
- Kumpiyansa
- May source
- Kalendaryo
- Desisyon ng FDA (PDUFA) · Hul 29, 2026 · Complete response letter
Sipi mula sa source
EX-99.1 2 tm2533934d1_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 Outlook Therapeutics Reports Financial Results for Fiscal Year 2025 ISELIN, N.J., December 19, 2025 — Outlook Therapeutics, Inc . (Nasdaq: OTLK), a biopharmaceutical company focused on enhancing the standard of care for bevacizumab for the treatment of retina diseases, today announced financial results for fiscal year 2025. Financial Highlights for the Fiscal Year Ended September 30, 2025 For the fiscal year ended September 30, 2025, Outlook Therapeutics reported net loss attributable to common stockholders of $62.4 million, or $1.79 per basic and diluted share, and $1.4 million of revenue. This compares with net loss attributable to common stockholders of $75.4 million, or $4.06 per basic and diluted share, and no revenue for
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