logo-loader
viewAgile Therapeutics

Agile Therapeutics stock rockets after Twirla contraceptive patch gets strong backing from FDA advisory committee

The BRUDAC committee voted 14 to 1, with 1 abstention in favor of approval

Agile Therapeutics - Agile Therapeutics Inc’s Twirla contraceptive patch gets strong backing from FDA advisory committee
Twirla (AG200-15) is a low-dose prescription contraceptive delivered through the skin via the company’s proprietary patch

Agile Therapeutics Inc (NASDAQ:AGRX) stock nearly tripled after it announced a positive outcome for its lead product candidate, Twirla, an investigational prescription contraceptive from Wednesday’s meeting of the Food and Drug Administration’s Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC). 

The BRUDAC met to discuss the Princeton, New Jersey-based women’s healthcare company’s New Drug Application (NDA) for Twirla (AG200-15), a low-dose prescription contraceptive delivered through the skin via the company’s proprietary patch. 

According to the company, the BRUDAC voted 14 to 1, with 1 abstention, that the benefits of Twirla in the prevention of pregnancy outweigh the risks to support approval. 

Investors responded well, with the stock nearly tripling to $1.38 a share midday Thursday.

READ: Agile Therapeutics has productive 3Q as it lays the ground for commercialization of Twirla contraceptive patch

“We are very pleased that BRUDAC voted in favor of Twirla. We look forward to continuing our dialogue with the FDA about the important data presented today and working toward a potential approval of Twirla,” said Agile Therapeutics CEO Al Altomari.

“This vote represents a key step toward providing an important new contraceptive option for women,” he added.

Agile resubmitted the NDA for Twirla on May 16, 2019. The advisory committee’s non-binding vote is taken into consideration by the FDA as part of its evaluation of the NDA. The FDA has assigned a PDUFA (Prescription Drug User Fee Act) goal date of November 16 for the completion of its review of the Twirla NDA.

Agile expects to ship the product to wholesalers and start its commercial launch in the fourth quarter of 2020. The company’s marketing efforts will initially focus on obstetrician-gynecologists in the US, and it plans to use a significant number of samples in the early stage of commercial launch to gain patient trial and acceptance.

— (Adds stock price) — 

Contact Uttara Choudhury at [email protected]

Follow her on Twitter: @UttaraProactive 

Quick facts: Agile Therapeutics

Price: 1.86 USD

NASDAQ:AGRX
Market: NASDAQ
Market Cap: $161.93 m
Follow

Add related topics to MyProactive

Create your account: sign up and get ahead on news and events

NO INVESTMENT ADVICE

The Company is a publisher. You understand and agree that no content published on the Site constitutes a recommendation that any particular security, portfolio of securities, transaction, or investment strategy is...

In exchange for publishing services rendered by the Company on behalf of Agile Therapeutics named herein, including the promotion by the Company of Agile Therapeutics in any Content on the Site, the Company receives...

FOR OUR FULL DISCLAIMER CLICK HERE

Watch

Agile Therapeutics looks forward to Feb 16 PDUFA date

Agile Therapeutics (NASDAQ:AGRX) CEO Al Altomari sat down with Proactive’s Christine Corrado at the Biotech Showcase 2020 in San Francisco. New Jersey-based Agile is focused on seeking FDA approval of its lead drug Twirla, and is looking forward to its Feb 16 PDUFA date

on 01/14/2020

2 min read