Ethinylestradiol

Agile Therapeutics Provides Clinical Update on Twirla and Status of Pipeline Evaluation

Retrieved on: 
Wednesday, February 1, 2023
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PRINCETON, N.J., Feb. 01, 2023 (GLOBE NEWSWIRE) -- Agile Therapeutics, Inc. (Nasdaq: AGRX), a women's healthcare company, today provided an update on the Twirla® post-marketing studies and status of its ongoing evaluation of the Company’s pipeline.

Key Points: 
  • PRINCETON, N.J., Feb. 01, 2023 (GLOBE NEWSWIRE) -- Agile Therapeutics, Inc. (Nasdaq: AGRX), a women's healthcare company, today provided an update on the Twirla® post-marketing studies and status of its ongoing evaluation of the Company’s pipeline.
  • Upon Twirla’s approval, Agile also agreed to an FDA-requested post-marketing commitment study to assess the residual drug content and strength of Twirla (PMC).
  • As previously disclosed, all work on Agile’s pipeline has been halted since 2021 as the Company concentrates its efforts the commercialization of Twirla.
  • “Our primary focus since the launch of Twirla has been the commercial growth of Twirla.

EQS-News: Women’s Healthcare Company Agile Therapeutics Says It Believes It Has An Effective Business Plan In Place For Growth And Generating Positive Cash Flow

Retrieved on: 
Sunday, November 27, 2022
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On Nov. 7, Agile released financial results for the three months that ended Sept. 30 and provided a corporate update.

Key Points: 
  • On Nov. 7, Agile released financial results for the three months that ended Sept. 30 and provided a corporate update.
  • This was an increase of 43% from the second quarter of 2022 the largest quarter-over-quarter increase the Company has achieved.
  • The decrease reflects the elimination of an inventory obsolescence reserve, which the company established in the third quarter of 2021.
  • Agile Therapeutics is a women's healthcare company dedicated to fulfilling the unmet health needs of todays women.

Agile Therapeutics Reports Third Quarter 2022 Financial Results and Provides Corporate Update

Retrieved on: 
Monday, November 7, 2022
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Agile Therapeutics is a women's healthcare company dedicated to fulfilling the unmet health needs of todays women.

Key Points: 
  • Agile Therapeutics is a women's healthcare company dedicated to fulfilling the unmet health needs of todays women.
  • Twirla is based on our proprietary transdermal patch technology, called Skinfusion, which is designed to allow drug delivery through the skin.
  • Unless otherwise noted, the prescription data results reported in this press release are reported as of September 30, 2022, by Symphony Health Solutions.
  • For all these reasons, actual results and developments could be materially different from those expressed in or implied by our forward-looking statements.

Agile Therapeutics Announces Reorganization of Leadership Team

Retrieved on: 
Friday, October 7, 2022
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PRINCETON, N.J., Oct. 07, 2022 (GLOBE NEWSWIRE) -- Agile Therapeutics, Inc. (Nasdaq: AGRX), a women's healthcare company, today announced that it has reorganized and streamlined its executive leadership team to align with its business plan to promote Twirla® (levonorgestrel and ethinyl estradiol) transdermal system growth. As part of the changes, the Company announced the appointment of Amy Welsh to Chief Commercial Officer effective November 1, 2022. Additionally, James P. Tursi, M.D. has informed the Company that he will resign from the Company’s board of directors effective October 7, 2022.

Key Points: 
  • Our focus in 2022 has been on growing Twirla and advancing towards generating positive cash flow, said Agile Therapeutics Chairman and Chief Executive Officer Al Altomari.
  • The changes to our leadership team we are announcing today are expected to help us consolidate the efficiency gains we have made in our operations by streamlining my executive team and maintaining our focus on executing our business plan.
  • In addition to her current responsibilities leading the Twirla marketing team, Ms. Welsh, as Chief Commercial Officer, will assume responsibility for all the Companys commercial functions.
  • Agile Therapeutics is a women's healthcare company dedicated to fulfilling the unmet health needs of todays women.

Agile Therapeutics Announces Findings of First-Year Post-Marketing Pharmacovigilance in ACOG Poster Presentation

Retrieved on: 
Thursday, May 5, 2022
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No venous thromboembolic events (VTEs) were reported, and two serious adverse events (SAEs) were reported, findings which are consistent with the safety profile reported in the SECURE study.

Key Points: 
  • No venous thromboembolic events (VTEs) were reported, and two serious adverse events (SAEs) were reported, findings which are consistent with the safety profile reported in the SECURE study.
  • These data from real-world use among a diverse US population further support the Twirla safety and tolerability profile established in the SECURE clinical trial, said Paul Korner, MD, MBA, Chief Medical Officer of Agile Therapeutics.
  • In addition to the safety findings, reports of TDS adhesion issues were rare, and only 14 individuals received a replacement patch over the 12-month period.
  • For all these reasons, actual results and developments could be materially different from those expressed in or implied by our forward-looking statements.

Agile Therapeutics® Announces Poster Presentation at the 2022 Annual Clinical and Scientific Meeting of the American College of Obstetricians and Gynecologists (ACOG)

Retrieved on: 
Thursday, April 7, 2022
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Agile Therapeuticsis a forward-thinking women's healthcare company dedicated to fulfilling the unmet health needs of todays women.

Key Points: 
  • Agile Therapeuticsis a forward-thinking women's healthcare company dedicated to fulfilling the unmet health needs of todays women.
  • Securities and Exchange Commission, including our Annual Report on Form 10-K and our Quarterly Reports on Form 10-Q.
  • You are cautioned not to place undue reliance on these forward-looking statements, which are made only as of the date of this press release.
  • We undertake no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstances.

Agile Therapeutics® Announces First Twirla® Commercial Targeting Gen Z

Retrieved on: 
Thursday, March 31, 2022
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PRINCETON, N.J., March 31, 2022 (GLOBE NEWSWIRE) -- Agile Therapeutics, Inc. (Nasdaq: AGRX), a women’s healthcare company, today announced the launch of its first consumer commercial intended to increase awareness of the Twirla weekly birth control patch.

Key Points: 
  • The commercial highlights consumer attitudes that may lead to interest in using Twirla for birth control, telling a story about reproductive health choices through a playful and realistic lens.
  • Our Gen Z target appreciates transparency and authenticity, said Amy Welsh, vice president of marketing for Agile Therapeutics.
  • When we saw Mayas previous work and learned more about her philosophy for reaching Gen Z through believable character development, we knew she would be the right fit for us.
  • She helped us cast a diverse set of Gen Z actors who feel like real women on screen.

Agile Therapeutics and Afaxys Partner to Expand Access to Twirla® (Levonorgestrel and Ethinyl Estradiol) Transdermal System

Retrieved on: 
Monday, January 10, 2022
Public health, CHC, Levonorgestrel, Body mass index, Patient, Physician, Birth, Therapy, CEO, Woman, Nasdaq, LNG, HCPS, LLC, GLOBE, BMI, Ethinylestradiol, Birth control, Contraceptive patch

This agreement expands access of Twirla in the U.S. family planning community and for the patients who rely on healthcare in this setting.

Key Points: 
  • This agreement expands access of Twirla in the U.S. family planning community and for the patients who rely on healthcare in this setting.
  • Afaxys and Agile Therapeutics are aligned on a mutual goal to provide reliable, affordable contraceptive access to women on their sexual and reproductive health journeys, said Ronda Dean, President, CEO & Co-Founder of Afaxys.
  • Twirla (levonorgestrel and ethinyl estradiol) transdermal system is a once-weekly combined hormonal contraceptive (CHC) patch that contains the active ingredients levonorgestrel (LNG), a type of progestin, and ethinyl estradiol (EE), a type of estrogen.
  • The Afaxys enterprise comprises a family of companies that operate under two wholly owned subsidiaries: Afaxys Pharma, LLC and Afaxys GroupServices, LLC (AGS).

Agile Therapeutics Announces Addition of Twirla® to a Preferred Drug Position on Medi-Cal Formulary

Retrieved on: 
Monday, October 4, 2021
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PRINCETON, N.J., Oct. 04, 2021 (GLOBE NEWSWIRE) -- Agile Therapeutics, Inc. (Nasdaq: AGRX ), a women's healthcare company, announced today that the California Medicaid Program, Medi-Cal, has placed Twirla on the preferred drug formulary list as of October 1, 2021.

Key Points: 
  • PRINCETON, N.J., Oct. 04, 2021 (GLOBE NEWSWIRE) -- Agile Therapeutics, Inc. (Nasdaq: AGRX ), a women's healthcare company, announced today that the California Medicaid Program, Medi-Cal, has placed Twirla on the preferred drug formulary list as of October 1, 2021.
  • This development secures a preferred position for Twirla on the formulary for Medi-Cal and related programs which provide health care to approximately 15 million beneficiaries.
  • We continue to pursue expanding access to Twirla to as many women as possible.
  • Twirla is based on our proprietary transdermal patch technology, called Skinfusion, which is designed to allow drug delivery through the skin.

Voluntary Nationwide Recall: One Lot of Mirvala™ 28 (desogestrel and Ethinyl Estradiol Tablets, Usp) 0.150 Mg / 0.030 Mg Due to Possibility of One Placebo Pill in Place of An Active Pill

Retrieved on: 
Thursday, September 30, 2021
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Mirvala 28 (Desogestrel and Ethinyl Estradiol Tablets, USP 0.150 mg / 0.030 mg) is indicated for conception control.

Key Points: 
  • Mirvala 28 (Desogestrel and Ethinyl Estradiol Tablets, USP 0.150 mg / 0.030 mg) is indicated for conception control.
  • The product is packaged as 28 tablets in a blister packet.
  • The impacted lot was distributed nationwide in Canada to wholesalers, distributors and pharmacies by Apotex between December 08, 2020 and August 24, 2021.
  • Patients who have received the impacted lot of Mirvala 28 (Desogestrel and Ethinyl Estradiol Tablets, USP 0.150 mg / 0.030 mg) should return the product to a pharmacy for replacement.