1.4400 0.00 (0.00%)
After hours: 4:00PM EDT
| Previous Close | 1.4300 |
| Open | 1.4400 |
| Bid | 1.4400 x 40700 |
| Ask | 1.4500 x 1100 |
| Day's Range | 1.3700 - 1.4700 |
| 52 Week Range | 0.2310 - 1.7000 |
| Volume | 605,543 |
| Avg. Volume | 198,804 |
| Market Cap | 62.99M |
| Beta (3Y Monthly) | -0.93 |
| PE Ratio (TTM) | N/A |
| EPS (TTM) | N/A |
| Earnings Date | N/A |
| Forward Dividend & Yield | N/A (N/A) |
| Ex-Dividend Date | N/A |
| 1y Target Est | N/A |
Agile Therapeutics, Inc. (AGRX), a women’s healthcare company, today announced that a meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) has been scheduled for October 30, 2019, to review the Company’s New Drug Application (NDA) for its lead product candidate, Twirla® (AG200-15), an investigational low-dose combined hormonal contraceptive patch. Agile resubmitted the NDA for Twirla (AG200-15) on May 16, 2019, and the FDA has assigned a PDUFA (Prescription Drug User Fee Act) goal date of November 16, 2019, for the completion of its review of the Twirla (AG200-15) NDA. “We look forward to the October 30, 2019, meeting with the Advisory Committee, as well as to continuing our dialogue with the FDA about Twirla and the important data, which we believe supports its approval,” said Al Altomari, Chairman and Chief Executive Officer of Agile.
FDA Assigns Prescription Drug User Fee Act (PDUFA) Goal Date of November 16, 2019 PRINCETON, N.J., May 22, 2019 -- Agile Therapeutics, Inc. (Nasdaq:AGRX), a women’s healthcare.
PRINCETON, N.J., May 17, 2019 -- Agile Therapeutics, Inc. (Nasdaq: AGRX), a women’s healthcare company, today announced it has resubmitted to the U.S. Food and Drug.
PRINCETON, N.J., May 09, 2019 -- Agile Therapeutics, Inc. (Nasdaq: AGRX), a women's healthcare company, announced today that its Chairman and Chief Executive Officer, Al.
Agile Therapeutics, Inc., (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 patch, will be presented in an interactive ePoster session at the 2019 Annual Clinical and Scientific Meeting of the American Congress of Obstetricians and Gynecologists (ACOG) being held May 3rd – 6th, 2019 in Nashville, Tennessee. The poster, titled “Safety of AG200-15, an Investigational Transdermal Patch, in Three Phase 3 Studies,” will be presented by lead author Anita Nelson, M.D. Dr. Nelson, Professor and Chair of Obstetrics and Gynecology, Western University of Health Sciences, served as Principle Investigator for SECURE, the pivotal Phase 3 study of Twirla (AG200-15).
Comparative Wear Trial Completed: On February 11, 2019, the Company announced topline results of a comparative wear study of Twirla® and Xulane®, which demonstrated that Twirla was statistically non-inferior to Xulane, a product the U.S. Food and Drug Administration (FDA) considers to have adequate adhesion. The Company had previously reported that in its December 2018 meeting with FDA’s Division of Bone, Reproductive and Urologic Products, (DBRUP), DBRUP agreed that Twirla would show adequate adhesion if it demonstrated statistical non-inferiority to Xulane in this study. In Vivo Adhesion Data from Two Phase 1 Studies Presented: An abstract presenting data from two Phase 1 in vivo wear studies on the adhesion of Twirla was selected for a poster presentation during the 2nd Annual Formulation & Drug Delivery USA Congress. The poster, titled “Results of Two Phase 1 Clinical Trials on the Adhesion Profile of AG200-15, An Investigational Transdermal Contraceptive Delivery System,” was presented by lead author Terrance Ocheltree, PhD, a former FDA Reviewer and Director of the Division of New Drug Quality Assessment II at the FDA.
PRINCETON, N.J., March 28, 2019 -- Agile Therapeutics, Inc. (Nasdaq: AGRX), a women's healthcare company, announced today that its Chairman and Chief Executive Officer, Al.
Agile Therapeutics, Inc., (AGRX), a women's healthcare company, today announced that an abstract presenting data from two Phase 1 in vivo wear studies on the adhesion of Twirla® has been selected for a poster presentation during the 2nd Annual Formulation & Drug Delivery USA Congress being held March 18th – 19th, 2019 in San Diego, California. The poster, titled “Results of Two Phase 1 Clinical Trials on the Adhesion Profile of AG200-15, An Investigational Transdermal Contraceptive Delivery System,” will be presented by lead author Terrance Ocheltree, PhD. Dr. Ocheltree previously served as both an FDA Reviewer and as Director of the Division of New Drug Quality Assessment II at the FDA. The adhesion profile of Twirla (AG200-15) was recently evaluated in two single-center studies.
Cash Expected to Enable Company to Fund Operations into the Fourth Quarter of 2019 Company plans to resubmit Twirla NDA in second quarter of 2019 PRINCETON, N.J., March 12,.
PRINCETON, N.J., March 11, 2019 -- Agile Therapeutics, Inc. (Nasdaq: AGRX), a women's healthcare company, announced today that its Senior Vice President and Chief Financial.
“We are very pleased to have completed this private placement and with the vote of confidence from Perceptive,” said Al Altomari, Chairman and Chief Executive Officer. The securities issued in the private placement have not been registered under the Securities Act of 1933, as amended (the “Securities Act”). Accordingly, these securities may not be reoffered or resold in the United States, except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act. This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of the securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such jurisdiction.
Agile Therapeutics, Inc., (AGRX), a women’s healthcare company, today announced topline results from a comparative wear study testing the adhesion of Twirla® compared to that of Xulane® (the “comparative wear study”), the generic version of the previously marketed Ortho Evra® contraceptive patch, a product the U.S. Food and Drug Administration (“FDA”) considers to have acceptable adhesion. In the study, Twirla met its primary endpoint and demonstrated non-inferior adhesion to Xulane. The Company conducted the comparative wear study as part of its plan to implement the recommendations of the FDA’s Office of New Drugs (“OND”) that were delivered to the Company in OND’s formal dispute resolution decision letter. OND recommended that the Company complete a comparative wear study as part of a potential path forward for seeking regulatory approval of the Twirla NDA.
PRINCETON, N.J., Feb. 07, 2019 -- Agile Therapeutics, Inc. (Nasdaq: AGRX), a women's healthcare company, announced today that its Chairman and Chief Executive Officer, Al.
In its meeting with DBRUP, the Company discussed the specific design and success criteria of the comparative wear study, which is intended to demonstrate adequate adhesion via non-inferiority of Twirla to Xulane, the generic version of the previously marketed Ortho Evra® contraceptive patch, a product the FDA considers to have acceptable adhesion. After consultation with DBRUP, the Company has initiated a crossover wear study in approximately 80 healthy women with a Body Mass Index of less than 35 kg/m2 who will be randomized to wear either Twirla or Xulane for the first week and then switched to the patch not initially worn for the second week. The overall design of this comparative wear study follows the FDA’s guidance with respect to abbreviated new drug applications, entitled Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs.
NEW YORK, Dec. 27, 2018 -- In new independent research reports released early this morning, Fundamental Markets released its latest key findings for all current investors,.
PRINCETON, N.J., Dec. 18, 2018 -- Agile Therapeutics, Inc. (Nasdaq: AGRX), a women's healthcare company, announced today that its Chairman and Chief Executive Officer, Al.
Agile Therapeutics, Inc., (AGRX), a women’s healthcare company, today announced that on December 11, 2018, it met with the U.S. Food and Drug Administration’s (“FDA”) Division of Bone, Reproductive, and Urologic Products (“DBRUP”) to discuss the design of a comparative wear study between Twirla® and Xulane® (the “comparative wear study”) as suggested by FDA’s Office of New Drugs (“OND”) in its decision on the Company’s formal dispute resolution request, which was announced in October 2018. The Company plans to discuss the results of the meeting in more detail after it receives the final meeting minutes from the FDA in January. The Company met with DBRUP on December 11, 2018 in order to discuss the specific design and success criteria of the comparative wear study. In general, the Company expects to conduct a crossover wear study in healthy women with a Body Mass Index (BMI) less than 35 kg/m2 who will be randomized to either Twirla or Xulane for the first week and then switched to the patch not initially worn for the second week.
Cash Expected to Enable Company to Fund Operations into Second Quarter 2019 PRINCETON, N.J., Nov. 01, 2018 -- Agile Therapeutics, Inc. (Nasdaq: AGRX), a women's.
NEW YORK, NY / ACCESSWIRE / October 22, 2018 / Traders News Source, a leading independent equity research and corporate access firm focused on small and mid-cap public companies is issuing a comprehensive report on Agile Therapeutics, Inc. (AGRX), a women's healthcare company dedicated to fulfilling the unmet health needs of women. The company' product candidates are designed to provide women with contraceptive options that offer freedom from taking a daily pill, without committing to a longer-acting method. The company' lead product candidate, Twirla® (levonorgestrel/ethinyl estradiol transdermal system) or AG200-15, is an investigational low-dose, non-daily, prescription contraceptive.
NEW YORK, NY / ACCESSWIRE / October 16, 2018 / Biotech stocks Auris Medical Holding and Agile Therapeutics were both seeing big gains on Monday. Traders are waiting for an update from Auris Medical on Wednesday while Agile recently concluded its formal dispute resolution with the FDA over the complete response letter issued for the new drug application of Twirla. Auris Medical Holding AG shares were skyrocketing on Monday with gains of 40.82% and an additional 23.19% in after-hours trading.
NEW YORK, NY / ACCESSWIRE / October 10, 2018 / U.S. equities finished mostly lower on Tuesday as interest rate increases and rising bond yields continued to put pressure on stocks. The Dow Jones Industrial ...
NEW YORK, NY / ACCESSWIRE / September 12, 2018 / It was a day of unexplainable gains for two biotech stocks on Tuesday. Both Agile Therapeutics and BioPharmX catapulted higher despite any significant news. ...