Inovio announces U.S. FDA accepted BLA for INO-3107 [Yahoo! Finance]
Inovio Pharmaceuticals, Inc. (INO)
NASDAQ:AMEX Investor Relations:
ir.inovio.com/investors/default.aspx
Company Research
Source: Yahoo! Finance
The review classification designated by FDA is Standard. The FDA assigned INO-3107 a Prescription Drug User Fee Act, PDUFA, review goal date of October 30, 2026, which is the date by which it intends to take action on the application. The FDA has indicated that it is not currently planning to hold an advisory committee meeting to discuss this application. INOVIO filed its BLA under the accelerated approval pathway. In the file acceptance letter, the FDA noted as a potential review issue its preliminary conclusion that the company has not submitted adequate information to justify eligibility for the accelerated approval pathway. INOVIO continues to believe that INO-3107 provides a meaningful therapeutic benefit over existing treatments and fulfills the criteria for accelerated approval. INOVIO plans to request a meeting with FDA to discuss next steps to remain eligible under the accelerated approval program. INOVIO is not currently planning to seek approval for INO-3107 under the tradi
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News
- Inovio Pharmaceuticals: Speculative Buy Thesis Hinges On INO-3107 [Seeking Alpha]Seeking Alpha
- INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Inovio Pharmaceuticals, Inc. - INOPR Newswire
- INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Inovio Pharmaceuticals, Inc. - INOGlobeNewswire
- INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Inovio Pharmaceuticals, Inc. - INOGlobeNewswire
- Inovio Pharmaceuticals (NASDAQ:INO) had its "neutral" rating reaffirmed by analysts at HC Wainwright.MarketBeat
INO
Earnings
- 11/10/25 - Miss
INO
Sec Filings
- 12/29/25 - Form 8-K
- 12/8/25 - Form SCHEDULE
- 12/5/25 - Form SCHEDULE
- INO's page on the SEC website