William Blair upgraded Agile Therapeutics (NASDAQ:AGRX) to “outperform” after an FDA advisory committee voted overwhelmingly to approve its resubmitted NDA for the Twirla transdermal combined hormonal contraceptive patch. The stock closed at 37 cents on Oct. 30.
The vote followed release of FDA briefing documents prior to the advisory committee that called into question the medical need, safety, and efficacy for Agile’s contraceptive patch, writes analyst Tim Lugo.
“While it is unusual for the FDA not to approve a therapy after a clearly positive AdCom vote, the PDUFA date of Nov. 16 still holds risk as the FDA arguments during the AdCom suggested the agency was not supportive of approval of the product,” he added. “However, the agency often leaned heavily on data that was not comparable to the population enrolled in Agile’s SECURE study.”
Mr. Lugo said that in the AdCom’s pre-vote questions to both the FDA and Agile, the novelty of this data was a central issue. “Ultimately, most members who voted yes voiced their strong support for providing additional non-oral and non-invasive hormonal contraceptive options, something which has also consistently come up in the company’s own market research.”
In the final vote, he said the risks of lower efficacy did not ultimately outweigh the potential benefit to patients and many AdCom members agreed to “not let perfection be the enemy of the good.”
In addition, he said all AdCom members expressed the need for further clarity on which patient populations are most at risk or are most likely to benefit from the patch, suggesting a number of post-marketing studies will likely be planned.
