AGRX - Agile Therapeutics, Inc.

NasdaqGS - NasdaqGS Real Time Price. Currency in USD
1.1200
+0.0100 (+0.90%)
At close: 4:00PM EDT
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Previous Close1.1100
Open1.1200
Bid1.0800 x 1300
Ask1.2400 x 800
Day's Range1.0972 - 1.1700
52 Week Range0.2510 - 1.7000
Volume901,074
Avg. Volume327,719
Market Cap66.418M
Beta (3Y Monthly)-0.60
PE Ratio (TTM)N/A
EPS (TTM)N/A
Earnings DateN/A
Forward Dividend & YieldN/A (N/A)
Ex-Dividend DateN/A
1y Target EstN/A
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News
Press Releases
  • GlobeNewswire

    Agile Therapeutics Announces Full Exercise of Over-Allotment Option by Underwriters

    Agile Therapeutics, Inc. (AGRX), a women’s healthcare company, today announced that the underwriters of its previously announced public offering of common stock have exercised in full their option to purchase an additional 1,894,736 shares of Agile Therapeutics’ common stock. The additional shares were sold at the public offering price of $0.95 per share, before underwriting discounts and commissions. The closing occurred on August 8, 2019, bringing the total number of shares sold by Agile Therapeutics in the public offering to 14,526,315 and total gross proceeds to approximately $13.8 million.  The total net proceeds, after deducting underwriting discounts and commissions and estimated offering expenses, are expected to be approximately $12.6 million from the offering.

  • GlobeNewswire

    Agile Therapeutics Announces Pricing of $12 Million Underwritten Public Offering of Common Stock

    Agile Therapeutics, Inc. (AGRX), a women’s healthcare company, today announced the pricing of its underwritten public offering of 12,631,579 shares of its common stock at a public offering price of $0.95 per share. The gross proceeds from the offering, before deducting underwriting discounts and commissions and estimated offering expenses payable by Agile Therapeutics, are expected to be approximately $12 million.  In addition, Agile Therapeutics has granted the underwriters a 30-day option to purchase up to 1,894,736 additional shares of common stock at the public offering price, less the underwriting discounts and commissions. All shares in the offering will be sold by Agile Therapeutics.

  • GlobeNewswire

    Agile Therapeutics Announces Proposed Underwritten Public Offering of Common Stock

    Agile Therapeutics, Inc. (AGRX), a women’s healthcare company, today announced that it intends to offer and sell shares of its common stock in an underwritten public offering. Oppenheimer & Co., Inc. is acting as the sole book-running manager for the offering.  H.C. Wainwright & Co., LLC  is acting as lead manager for the offering. The shares of common stock described above are being offered by Agile Therapeutics pursuant to its shelf registration statement on Form S-3 previously filed and declared effective by the Securities and Exchange Commission.  The offering is being made only by means of a preliminary prospectus supplement and the accompanying prospectus, copies of which may be obtained, when available, from Oppenheimer & Co., Inc., Attention: Syndicate Prospectus Department, 85 Broad St., 26th Floor, New York, NY 10004, by telephone at (212) 667-8055 or by email at EquityProspectus@opco.com.

  • GlobeNewswire

    Agile Therapeutics Reports Second Quarter 2019 Financial Results

    FDA Assigned PDUFA (Prescription Drug User Fee Act) Goal Date is November 16, 2019 Cash Expected to Enable Company to Fund Operations through the End of 2019 PRINCETON, N.J.,.

  • GlobeNewswire

    Agile Therapeutics Appoints Chief Financial Officer

    Agile Therapeutics, Inc. (AGRX), a women’s healthcare company, today announced the appointment of Dennis P. Reilly as Chief Financial Officer effective August 5, 2019. “We look forward to Dennis joining the Agile team.  He is an experienced CFO who brings a timely combination of financial acumen and commercial and business development experience that can help us prepare for the potential commercialization of our lead product candidate, Twirla®(AG200-15),” said Al Altomari, Chairman and Chief Executive Officer of Agile. Mr. Reilly has had significant experience with commercial companies in the pharmaceutical and diagnostics sectors.

  • GlobeNewswire

    Agile Therapeutics Announces FDA Advisory Committee Meeting for its Investigational Transdermal Low-Dose Contraceptive Patch, Twirla® (AG200-15)

    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.

  • GlobeNewswire

    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

    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

    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

    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).

  • GlobeNewswire

    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

    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

    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.

  • GlobeNewswire

    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

    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

    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.

  • GlobeNewswire

    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

    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.

  • GlobeNewswire

    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

    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

    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

    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.

  • GlobeNewswire

    Agile Therapeutics Reports Third Quarter 2018 Financial Results

    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.