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Back in May, Agile Therapeutics ( AGRX ), revealed that they resubmitted their NDA for its primary product candidate, Twirla, a low-dose combination hormonal contraceptive patch. Shortly after, Agile announced that the FDA accepted Twirla's NDA resubmission with the PDUFA date set for No...
Meeting Scheduled for October 30, 2019 FDA Previously Assigned PDUFA (Prescription Drug User Fee Act) Goal Date is November 16, 2019 PRINCETON, N.J., June 24, 2019 (GLOBE NEWSWIRE) -- Agile Therapeutics, Inc. (Nasdaq: AGRX), a women’s healthcare company, today announced that...
Argenx (NASDAQ: AGRX ) initiated with Buy rating and €140 (28% upside) price target at Kepler Cheuvreux. More news on: Agile Therapeutics, Inc., Village Farms International, Inc., Savara Inc., Healthcare stocks news, Stocks on the move, , Read more ...
Agile Therapeutics ( AGRX ), recently publicized that they resubmitted their NDA for its principal candidate, Twirla, a low-dose combined hormonal contraceptive patch. This recent resubmission was the end result of a CRL back in December 2017. The resubmitted NDA is comprised of the mar...
FDA Assigns Prescription Drug User Fee Act (PDUFA) Goal Date of November 16, 2019 PRINCETON, N.J., May 22, 2019 (GLOBE NEWSWIRE) -- Agile Therapeutics, Inc. (Nasdaq:AGRX), a women’s healthcare company, today announced that the U.S. Food and Drug Administration (FDA) ha...
Agile Therapeutics (NASDAQ: AGRX ) has resubmitted to FDA, the NDA for Twirla, an investigational low-dose combined hormonal contraceptive patch (AG200-15). More news on: Agile Therapeutics, Inc., Healthcare stocks news, Stocks on the move, Read more ...
PRINCETON, N.J., May 17, 2019 (GLOBE NEWSWIRE) -- Agile Therapeutics, Inc. (Nasdaq: AGRX), a women’s healthcare company, today announced it has resubmitted to the U.S. Food and Drug Administration (FDA) the NDA for its lead product candidate, Twirla ® , an investigational low-do...
PRINCETON, N.J., May 09, 2019 (GLOBE NEWSWIRE) -- Agile Therapeutics, Inc. (Nasdaq: AGRX), a women's healthcare company, announced today that its Chairman and Chief Executive Officer, Al Altomari, will present at the 2019 RBC Capital Markets Global Healthcare Conference on Wednesday, May 22...
PRINCETON, N.J., May 03, 2019 (GLOBE NEWSWIRE) -- Agile Therapeutics, Inc., (Nasdaq: AGRX), a women's healthcare company, today announced that the combined safety data from three Phase 3 studies of Twirla ® (AG200-15), an investigational, once weekly, low-dose hormonal contraceptive p...
Agile Therapeutics (NASDAQ: AGRX ): Q1 GAAP EPS of -$0.13 misses by $0.03 . More news on: Agile Therapeutics, Inc., Earnings news and commentary, Healthcare stocks news, , Read more ...
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First Quarter Net Revenue Increased 58% and Factory Sales Increased 3% from Fourth Quarter 2023 Twirla First Quarter 2024 Demand Rebounded 18% from Fourth Quarter 2023 PRINCETON, N.J., May 15, 2024 (GLOBE NEWSWIRE) -- Agile Therapeutics, Inc. (Pink: AGRX), a women's healthcare com...
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Full Year 2023 Net Revenue Increased 80% from 2022 While OPEX Decreased 33% Twirla Demand and Factory Sales Up 121% and 114% Respectively in 2023 vs 2022 Company Completes Pay-Off of Debt Facility in First Quarter 2024 Twirla Demand Expected to Rebound in First Quarter 2...