AGRX - Agile Therapeutics, Inc.
| Previous Close | 1.3100 |
| Open | 1.3100 |
| Bid | 1.2900 x 800 |
| Ask | 1.4200 x 3000 |
| Day's Range | 1.2950 - 1.3400 |
| 52 Week Range | 0.2310 - 1.7000 |
| Volume | 70,278 |
| Avg. Volume | 216,922 |
| Market Cap | 58.178M |
| Beta (3Y Monthly) | -0.93 |
| PE Ratio (TTM) | N/A |
| EPS (TTM) | -0.5020 |
| Earnings Date | Aug 7, 2017 - Aug 11, 2017 |
| Forward Dividend & Yield | N/A (N/A) |
| Ex-Dividend Date | N/A |
| 1y Target Est | 3.80 |
- GlobeNewswire•25 days ago
Agile Therapeutics Announces FDA Acceptance of the NDA Resubmission of Twirla®
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.
- GlobeNewswire•last month
Agile Therapeutics Resubmits New Drug Application (NDA) for its Transdermal Low-Dose Contraceptive Patch, Twirla®
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.
- GlobeNewswire•last month
Agile Therapeutics to Present at the 2019 RBC Capital Markets Global Healthcare Conference
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.
- GlobeNewswire•last month
Agile Therapeutics to Present Combined Safety Data from Three Phase 3 Studies at the 2019 ACOG Annual Meeting
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).
- Associated Press•last month
Agile Therapeutics: 1Q Earnings Snapshot
The Princeton, New Jersey-based company said it had a loss of 13 cents per share. The results did not meet Wall Street expectations. The average estimate of four analysts surveyed by Zacks Investment Research ...
- GlobeNewswire•last month
Agile Therapeutics Reports First Quarter 2019 Financial Results
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.
- GlobeNewswire•3 months ago
Agile Therapeutics to Present at the H.C. Wainwright Global Life Sciences Conference in London, UK
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.
- GlobeNewswire•3 months ago
Agile Therapeutics to Present In Vivo Adhesion Data from Two Phase 1 Studies at the 2nd Annual Formulation & Drug Delivery USA Congress
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.
- Zacks Small Cap Research•3 months ago
AGRX: Numerous Catalysts in 2019…
Agile Therapeutics, Inc. (AGRX) is a women’s healthcare company focused on developing healthcare products to fulfill the unmet contraceptive needs of women. The company’s lead candidate product, Twirla® (AG200-15), is a once-weekly low-dose hormonal contraceptive patch that contains the active ingredients ethinyl estradiol (EE, a synthetic estrogen) and levonorgestrel (LNG, a type of progestin). The patch utilizes the company’s Skinfusion technology, which allows Twirla® to be the first contraceptive patch capable of delivering LNG across the skin in a reliable manner.
- Associated Press•3 months ago
Agile Therapeutics: 4Q Earnings Snapshot
The Princeton, New Jersey-based company said it had a loss of 11 cents per share. The results exceeded Wall Street expectations. The average estimate of three analysts surveyed by Zacks Investment Research ...
- GlobeNewswire•3 months ago
Agile Therapeutics Reports Fourth Quarter and Full Year 2018 Financial Results
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,.
- GlobeNewswire•3 months ago
Agile Therapeutics to Present at Upcoming Investor Conferences
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.
- GlobeNewswire•3 months ago
Agile Therapeutics Announces $7.8 Million Private Placement
“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.
- Zacks Small Cap Research•4 months ago
AGRX: Positive Results for Twirla® Adhesion Study; NDA Resubmission in 2Q19
On February 11, 2019, Agile Therapeutics, Inc. (AGRX) announced positive topline results for the comparative adhesion study that tested the company’s investigational low-dose once-weekly contraceptive patch (Twirla®) against Xulane®, the generic version of the contraceptive patch Ortho Evra®. The trial was designed to show non-inferiority in adhesion between Twirla® and Xulane®.
- GlobeNewswire•4 months ago
Agile Therapeutics, Inc. Announces that Twirla® Meets Primary Endpoint in Comparative Wear Study and Demonstrates Non-Inferior Adhesion to Xulane®
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.
- GlobeNewswire•4 months ago
Agile Therapeutics to Present at the 2019 BIO CEO and Investor Conference
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.
- Zacks Small Cap Research•5 months ago
AGRX: Twirla® Adhesion Study Underway; NDA Resubmission in 2Q19…
The meeting was held to discuss the company’s comparative wear study between Twirla® and Xulane®, the generic version of the contraceptive patch Ortho Evra®, including the specific design and success criteria. The trial is designed to show non-inferiority in adhesion between Twirla® and Xulane®. Following receipt of the official meeting minutes, Agile has initiated the adhesion study in approximately 80 healthy women with a body mass index (BMI)
- Benzinga•5 months ago
The Daily Biotech Pulse: Agile Gives Regulatory Update On Contraceptive Patch, Advaxis Misses Estimates, Ocular Submits sNDA
Here's a roundup of top developments in the biotech space over the last 24 hours: Scaling The Peaks The following biotech stocks hit 52-week highs Jan. 10: Takeda Pharmaceutical Co Ltd (NYSE: TAK*) Veracyte ...
- GlobeNewswire•5 months ago
Agile Therapeutics, Inc. Provides Regulatory Update and Reiterates Cash Guidance
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.
- GlobeNewswire•6 months ago
Factors of Influence in 2019, Key Indicators and Opportunity within Halozyme Therapeutics, Capricor Therapeutics, Appian, Yext, Agile Therapeutics, and Corbus Pharmaceuticals — New Research Emphasizes Economic Growth
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,.
- GlobeNewswire•6 months ago
Agile Therapeutics to Present at Biotech Showcase 2019
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.
- GlobeNewswire•6 months ago
Agile Therapeutics, Inc. Meets With FDA on Comparative Wear Study of Twirla® and Xulane®
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.
- Simply Wall St.•7 months ago
Agile Therapeutics Inc (NASDAQ:AGRX): Are Analysts Optimistic?
Agile Therapeutics Inc’s (NASDAQ:AGRX): Agile Therapeutics, Inc., a women’s healthcare company, focuses on the development and commercialization of prescription contraceptive products for women. With the latest financial year loss of Read More...
- Zacks Small Cap Research•7 months ago
AGRX: Awaiting Details of Adhesion Study for Twirla®…
On October 9, 2018, Agile Therapeutics, Inc. (AGRX) announced that the company has concluded the formal dispute resolution with the U.S. Food and Drug Administration (FDA) regarding the complete response letter (CRL) issued for the new drug application (NDA) of Twirla®. While the FDA’s Office of New Drugs (OND) denied the company’s appeal, the agency did provide the company with a potential path to an NDA resubmission that would not include reformulating Twirla® or doing any type of bridging studies.
- Associated Press•7 months ago
Agile Therapeutics: 3Q Earnings Snapshot
On a per-share basis, the Princeton, New Jersey-based company said it had a loss of 11 cents. The results surpassed Wall Street expectations. The average estimate of four analysts surveyed by Zacks Investment ...
