4 years from clinic to approval — Precigen's ‘unprecedented' FDA nod and what comes next [Yahoo! Finance]
Precigen, Inc. (PGEN)
Last precigen, inc. earnings: 3/2 04:05 pm
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Source: Yahoo! Finance
In the grand scheme of drug development, Precigen's recent approval for the immunotherapy Papzimeos was a long time coming. The condition Papzimeos treats — a rare, potentially deadly disease called recurrent respiratory papillomatosis — was discovered a century ago but has never had an approved drug. And Precigen, formerly known as Intrexon, chugged along for nearly three decades before finally getting a treatment across the finish line. But once the company kicked into clinical gear, the process was “rapid,” said Helen Sabzevari, Precigen's CEO. Trials started in 2021 , and despite pandemic-related slowdowns, the drug was ultimately approved just four years later. And although Papzimeos was once on a path to accelerated approval, which would require a post-market confirmatory trial, the FDA instead gave it a full nod. What's more, the August decision came almost two weeks earlier than the scheduled PDUFA date. “This is somewhat unprecedented,” Sabzevari said. The approval
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News
- Precigen Is Still A Buy After The Papzimeos Rally [Seeking Alpha]Seeking Alpha
- Vaxart, Precigen among biotech gainers after Q3 results [Seeking Alpha]Seeking Alpha
- Precigen (NASDAQ:PGEN) had its price target raised by analysts at HC Wainwright from $8.50 to $9.00. They now have a "buy" rating on the stock.MarketBeat
- Precigen Inc (PGEN) Q3 2025 Earnings Call Highlights: FDA Approval and U.S. ... [Yahoo! Finance]Yahoo! Finance
- Precigen to Announce Third Quarter 2025 Financial Results and Provide Business Updates on November 13 [Yahoo! Finance]Yahoo! Finance
PGEN
Earnings
- 11/13/25 - Miss
PGEN
Sec Filings
- 11/21/25 - Form SCHEDULE
- 11/21/25 - Form 4
- 11/20/25 - Form 144
- PGEN's page on the SEC website