Agile therapeutics advisory committee. 14, 2020 (GLOBE NEWSWIRE) -- Agile Therapeutics, Inc.
Tiffany M. , including Chief Commercial Officer, Chief Operating Officer, and Chief Executive Officer. Feb 7, 2024 · The ACM was established in January 2017, to encompass pre and post-market advice for medicines, following the consolidation of the previous functions of the Advisory Committee on Prescription Medicines (ACPM), the Advisory Committee on the Safety of Medicines (ACSOM) and the Advisory Committee on Non-Prescription Medicines (ACNM). , May 6, 2024 /PRNewswire/ -- Lykos Therapeutics (formerly MAPS Public Benefit Corporation) ("Lykos"), a company dedicated to transforming mental healthcare, announced that on June 4, 2024, the U. Cash Expected to Enable Company to Fund Operations into the Fourth Quarter of 2019. , July 09, 2024 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. 7 million, compared to a net loss of $3. 01, 2023 (GLOBE NEWSWIRE) -- Agile Therapeutics, Inc. May 12, 2022 · Agile Therapeutics is a women's healthcare company dedicated to fulfilling the unmet health needs of today’s women. 8 million. Gilmore was a principal of Life Sciences Advisory Services, providing consulting services to the pharmaceutical and life science industries. (Nasdaq: AGRX) ("Agile Therapeutics" or the "Company"), a women's healthcare company, today announced the closing of its previously announced upsized public offering of an aggregate of 26,666,666 shares of its common stock (or pre-funded warrants in lieu thereof), together with accompanying common stock warrants, at a Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC) Meeting FDA White Oak Campus, Building 31 Conference Center, the Great Room (Rm. For this work he has been granted several awards including the 2015 scientist of the year award from Radio Canada (CBC), the Order of Manitoba and the Meritorious Service Cross (civil division) of the Governor General of Canada in 2016, and the Manning principal award in 2017. He is the Chairman of Precision Medicine Group, a privately owned clinical research organization, and of Signant Health, a privately owned specialty clinical trials and She has held multiple national leadership positions including President of the American Society for Reproductive Medicine (ASRM), Member of the council of the National Institutes of Child Health and Human Development, Head of the Reproductive Endocrinology and Infertility Division of the American Board of Obstetrics and Gynecology (ABOG Sep 30, 2019 · FDA Advisory Committee Meeting for Twirla® NDA Scheduled for October 30, 2019 Cash Expected to Enable Company to Fund Operations through end of First Quarter 2020 PRINCETON, N. C. Jun 21, 2024 · Proposed Date for Advisory Committee meeting is September 9, 2024. About Agile Therapeutics, Inc. Agile Patch delivers ~30 mcg daily of ethinyl Prior to joining Aprea Therapeutics, Inc. , Oct. Food and Drug Administration (FDA) has approved Twirla ® (levonorgestrel and ethinyl estradiol) transdermal system. , Dec. 14, 2020 (GLOBE NEWSWIRE) -- Agile Therapeutics, Inc. , April 11, 2022 (GLOBE NEWSWIRE) -- Agile Therapeutics, Inc. Coles College of Business at Kennesaw State University. Drugs Advisory Committee of the Food and Drug Administration and that these minutes Agile Therapeutics is followed by the analysts listed. Altomari continued, “After we agree on the Feb 6, 2020 · Agile Therapeutics has a PDUFA for Twirla on February 16th - approval, if it does, could come even earlier. , May 22, 2019 (GLOBE NEWSWIRE) -- Agile Therapeutics, Inc. NDA/BLA# 215455 . Food and Drug Administration’s advisory committees,” continued Mr. Jun 24, 2019 · Meeting Scheduled for October 30, 2019FDA Previously Assigned PDUFA (Prescription Drug User Fee Act) Goal Date is November 16, 2019PRINCETON, N. Altomari held multiple senior management positions at Barrier Therapeutics, Inc. (the “Company”) updated its corporate presentation that it intends to use at conferences and in meetings with investors. ” On March 28, 2024, Agile filed its Annual Report on Form 10-K for the fiscal year ended December 31, 2023 (the “Original Form 10-K”). Jan 18, 2024 · The Pharmacy and Therapeutics Advisory Committee needs qualified candidates to serve as committee members. (5) Dec 12, 2023 · PRINCETON, N. , May 18, 2018 (GLOBE NEWSWIRE) -- Agile Therapeutics, Inc. Jun 27, 2019 · Summary. The Company also expects that the FDA will conduct a pre-approval inspection of the Company’s third-party manufacturer’s facility, which must be successfully Designed to allow shorter, lighter periods; Weeks 1-3 of regimen: Same patch as Twirla ® (levonorgestrel and ethinyl estradiol) transdermal system Week 4: Smaller, lower-dose patch May 17, 2019 · PRINCETON, N. The Company also expects that the FDA will conduct a pre-approval inspection of the Company’s third-party manufacturer’s facility, which must be successfully May 15, 2024 · The Investor Relations website contains information about Agile Therapeutics's business for stockholders, potential investors, and financial analysts. Altomari served as Agile's Executive Chairman from 2004 to 2010. Lisa Knight Chief Intellectual Property Counsel & Associate General Dec 31, 2018 · Cash Expected to Enable Company to Fund Operations into the Fourth Quarter of 2019. , July 06, 2022 (GLOBE NEWSWIRE) -- Agile Therapeutics, Inc. King Assistant General Counsel Northrop Grumman. 09, 2018 (GLOBE NEWSWIRE) -- Agile Therapeutics, Inc. Feb 26, 2020 · Item 7. Twirla and our 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. Agile Therapeutics. (Nasdaq:AGRX), a women’s healthcare company, today announced that the U. Feb 11, 2019 · The FDA has previously informed the Company that in connection with its review of the Twirla NDA, the FDA plans to bring the safety and efficacy of Twirla to an Advisory Committee. Mar 31, 2024 · The Investor Relations website contains information about Agile Therapeutics's business for stockholders, potential investors, and financial analysts. 14, 2019 (GLOBE NEWSWIRE) -- Agile Therapeutics, Inc. Jun 26, 2024 · The Investor Relations website contains information about Agile Therapeutics's business for stockholders, potential investors, and financial analysts. 01 Regulation FD Disclosure . (Nasdaq: AGRX), a women’s healthcare company, today announced it has resubmitted to the U. Jan 9, 2019 · The FDA has previously informed the Company that in connection with its review of the Twirla NDA, the FDA plans to bring the safety and efficacy of Twirla to an Advisory Committee. Hubbard will serve on Agile's Nominating and Corporate Governance Committee. Dec 31, 2019 · FDA Advisory Committee Meeting Completed: As previously announced, in October 2019, The Bone, Reproductive, and Urologic Drugs Advisory Committee (BRUDAC) of the U. (Nasdaq: AGRX), a women's healthcare company, today reported financial results for the three and nine The Board of Directors of Agile Therapeutics (the "Company") sets high standards for the Company's employees, officers and directors. DUBLIN, Ireland and CHICAGO, June 21, 2024 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (Nasdaq: ITRM) (the Company), a clinical-stage pharmaceutical company focused on developing next generation oral and IV antibiotics to treat infections caused by multi-drug resistant pathogens in both community and hospital settings, today Feb 14, 2020 · Twirla ® is a new non-daily, non-invasive contraceptive approved in the U. During the first quarter 2022: Twirla cycles dispensed increased 29% to 16,602; Total prescriptions (TRx) increased 27% to 12,494 Information about FDA public advisory committees, calendar of meetings, meeting materials, how to become an advisory committee member, guidance, and frequently asked questions. (Nasdaq: AGRX), a forward-thinking women’s healthcare company, today announced that the company has nominated Sharon Barbari for election as a class III director to replace Abhijeet Lele, a member of the company’s board of directors and the board’s Lead Independent Director, who will not stand for re-election Hubbard currently serves on the Strategic Advisory Board of Genstar Capital and is responsible for advising the private equity firm on investments in the area of healthcare. 27, 2023 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. The updates include information on the approval of its first product, its plan for the commercialization of that product and recent financing activities, including the net proceeds from Feb 15, 2024 · About Agile Therapeutics, Inc. , (Nasdaq: AGRX) (Agile or the Company), a forward-thinking women’s healthcare company, today announced that the U. 18, 2014 (GLOBE NEWSWIRE) -- Agile Therapeutics, Inc. Food and Drug Administration advisory Jan 4, 2021 · The fireside chat will be available for on-demand listening beginning Monday, January 11, 2021, at 6:00 AM Eastern Time on the Investors section of the Agile Therapeutics website at www. Agile Therapeutics Reports First Quarter 2024 Financial Results and Provides Corporate Update. PRINCETON, N. In addition, in 2020, rather than provide holiday gifts to employees, we donated those funds to various charities. 7 million in net proceeds from the sale of tax benefits pursuant to the Company’s participation in the New Jersey Economic Development Authority (NJEDA) Net Operating Loss (NOL) program under the New Jersey Economic Recovery Act of 2020. Food and Drug Administration (FDA) held on April 16, 2018 to discuss the complete response letter (CRL) issued by the FDA on December 21, 2017 relating to the New Drug Application (NDA Back in May, Agile Therapeutics Agile stated that the FDA accepted the NDA resubmission with the PDUFA date set for November 16 th but without an advisory committee "AdCom. Compensation Committee Nominating and Governance Committee Science and Technology Committee; Sharon Barbari : Audit Committee: Compensation Committee: Nominating and Governance Committee: Sandra Carson, M. , Dec 31, 2016 · The Investor Relations website contains information about Agile Therapeutics's business for stockholders, potential investors, and financial analysts. 01, 2018 (GLOBE NEWSWIRE) -- Agile Therapeutics, Inc. Mar 22, 2023 · About Agile Therapeutics, Inc. EDT. Twirla is less effective in women with a BMI of 25 kg/m 2 or more to less than 30 kg/m 2 and should not be used in women whose BMI is 30 kg/m 2 or more. (Nasdaq: AGRX), a women’s healthcare company Oct 9, 2018 · PRINCETON, N. Nov 9, 2023 · The Investor Relations website contains information about Agile Therapeutics's business for stockholders, potential investors, and financial analysts. (Nasdaq: AGRX), a women's healthcare company, today reported financial results for the three and six months ended June 30, 2019 and provided a corporate update. , March 04, 2019 (GLOBE NEWSWIRE) -- Agile Therapeutics, Inc. (Nasdaq: AGRX), a women’s healthcare company, today announced the U. Oct 30, 2019 · PRINCETON, N. Varying definitions of low-dose estrogen. (Nasdaq: AGRX) (“Agile” or the “Company”), a women's healthcare company, today announced that it has received written notification from the Listing Qualifications Department of the Nasdaq Stock Market LLC (“Nasdaq”) granting the Company’s request for a 180-day extension to regain compliance under Nasdaq May 16, 2019 · FDA Assigns Prescription Drug User Fee Act (PDUFA) Goal Date of November 16, 2019. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced the outcome of the U. Fischer : Independent Jan 25, 2023 · FDA decision expected by PDUFA target action date of March 22, 2023 If approved, rezafungin will be the first new drug for the treatment of candidemia and invasive candidiasis in over a decade SAN DIEGO and PARSIPPANY, N. 25, 2023 — Cidara Therapeutics, Inc. Implicit in this philosophy is the importance of sound corporate governance. Dec 7, 2020 · Once-Weekly Twirla is the first and only contraceptive patch that combines levonorgestrel and ethinyl estradiol (EE). 2069 or email Jessica. 04, 2021 (GLOBE NEWSWIRE) -- Agile Therapeutics, Inc. , Oct 30, 2019 · An FDA advisory committee voted 14 to two on Wednesday to recommend FDA approval of Agile Therapeutics’ birth control patch AG 200-15 (levonorgestrel/ethinyl estradiol). is referred to as “Agile” or the “Company” and, together with. Dec 11, 2018 · Expects to Announce Results of Meeting After Receipt of Final Minutes from FDA. The MTAC's terms of reference: Oct 29, 2013 · Agile President and CEO Appointed as an Officer of the Dean's Advisory Board, Drexel University, Lebow College of Business October 29, 2013 The Dean’s Advisory Board elected five new members and three new officers at its fall meeting – its first held in Gerri C. Appointment Effective August 5, 2019. , July 18, 2019 (GLOBE NEWSWIRE) -- Agile Therapeutics, Inc. (5) Oct 30, 2019 · PRINCETON, N. gov for more information. THE LATEST FROM AGILE THERAPEUTICS ®. Food and Drug Administration’s (“FDA”) Division of Bone, Reproductive, and Urologic Products (“DBRUP”) to discuss the Nov 14, 2019 · PRINCETON, N. May 17, 2019 · PRINCETON, N. 4 million shares of common stock at $0. Food and Drug Administration (FDA) met to discuss the Company’s New Drug Application for Twirla. Oct 31, 2023 · -Exa-cel PDUFA target action date is December 8, 2023 for severe sickle cell disease (SCD)- ZUG, Switzerland and BOSTON, Oct. May 6, 2024 · This will be the first FDA advisory committee meeting to review a potential new PTSD treatment in 25 years. (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. Feb 11, 2019 · Company now focused on completing plan to resubmit NDA in first half of 2019 PRINCETON, N. , (Nasdaq: AGRX), a women’s healthcare company, today announced that on December 11, 2018, it met with the U. , May 15, 2024 (GLOBE NEWSWIRE) -- Agile Therapeutics, Inc. Jul 9, 2024 · Meeting with the recently formed GeMDAC set for August 2, 2024. , May 25, 2023 (GLOBE NEWSWIRE) -- Agile Therapeutics, Inc. Food and Drug Administration (FDA) has been scheduled for October 30, 2019, to review the Company’s New Drug Mar 31, 2019 · Company Plans to Resubmit Twirla® NDA in Second Quarter of 2019. LeBow Hall. , May 02, 2019 (GLOBE NEWSWIRE) -- Agile Therapeutics, Inc. 01, 2019 (GLOBE NEWSWIRE) -- Agile Therapeutics, Inc. Jul 26, 2021 · An independent COVID-19 Therapeutics Advisory Panel (UK-CTAP) will evaluate and prioritise candidate agents for inclusion in the study. The drug’s safety and efficacy are “similar, if not better” than current products on the market, noted Monica Christmas, an assistant professor in the department of Jun 30, 2014 · Agile Therapeutics believes its current cash and cash equivalents are sufficient to fund operations through the first quarter of 2016. , FCP has been appointed to the Company's Board of Directors, effective November 18, 2014. Prior to that, he served in various roles for the Company, including Senior Vice President, Enterprise Planning and Information Management; Senior Vice President of Operations; and Chief Development Officer and Vice President of Operations. The Advisory Committee for Therapeutics (ACT) toolkit provides procedural advice and guidance to replicate the successful TREAT-NMD Advisory Committee for Therapeutics (TACT) model in other rare disease communities. Cash Expected to Enable Company to Fund Operations through the End of 2019. 1 As with all advisory committee meetings, there will be an open public hearing (OPH Mar 25, 2024 · 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. Press Release Details . 30, 2019 (GLOBE NEWSWIRE) -- Agile Therapeutics, Inc. , Feb 1, 2023 · PRINCETON, N. 22, 2024 (GLOBE NEWSWIRE) -- Agile Therapeutics, Inc. Aug 16, 2024 · Shares of Agile Therapeutics Inc. Mar 13, 2024 · Agile Therapeutics® is a forward-thinking women’s healthcare company dedicated to fulfilling the unmet needs of today’s women. Altomari served as President and Chief Executive Officer from 2010 to 2016. Drug name: midomafetamine . Announces Definitive Merger Agreement with Insud Pharma, S. Agile Therapeutics Announces Appointment of Science Advisory Board Member. February 13, 2014 Sep 30, 2018 · Cash Expected to Enable Company to Fund Operations into Second Quarter 2019. Z. (Nasdaq: AGRX), a women’s healthcare company, today announced that it has received a response from FDA’s Office of Agile Therapeutics ® is a forward-thinking women’s healthcare company dedicated to fulfilling the unmet needs of today’s women. , a public bio-pharmaceutical company, from 2008 to 2012. The archived webcast will be available for 30 days. He served as Senior Vice President, General Counsel and Corporate Secretary of Amicus Therapeutics, Inc. She brings over 25 years of industry marketing experience to Agile with a proven track record in product launch and lifecycle management. Jan 23, 2024 · About Agile Therapeutics, Inc. ’s. (Nas Menu icon A vertical stack of three evenly Altomari served as President and Chief Executive Officer from 2010 to 2016. (Nasdaq: AGRX) ("Agile Therapeutics" or the "Company"), a women's healthcare company, today announced the closing of its previously announced public offering of an aggregate of 1,896,286 shares of its common stock (or pre-funded warrants in lieu thereof), together with accompanying common stock warrants, at a public Feb 27, 2023 · PRINCETON, N. Wainwright 22nd Annual Global Investment Virtual Conference on Wednesday, September 16, 2020 at 11:30 a. , (Nasdaq:AGRX) today announced that John Hubbard, Ph. , April 14, 2022 (GLOBE NEWSWIRE) -- Agile Therapeutics, Inc. " Hubbard currently serves on the Strategic Advisory Board of Genstar Capital and is responsible for advising the private equity firm on investments in the area of healthcare. Aug 17, 2020 · He currently serves on the Laidlaw Venture Partners Scientific Advisory Board and the Board of Directors of Voltron Therapeutics as an Independent Director. (4) Ratify the appointment of Ernst & Young LLP as Agile Therapeutics, Inc. The design of AGILE allows for the assessment of multiple candidates at different doses, with the ability to add candidates as they are identified or drop them as their evaluation is completed. Mar 28, 2024 · About Agile Therapeutics, Inc. Jul 18, 2019 · Dennis P. Aug 11, 2022 · Agile Therapeutics is a women's healthcare company dedicated to fulfilling the unmet health needs of today’s women. Agile Therapeutics recently announced the FDA has scheduled an Advisory Committee to review Twirla's NDA on October 30th. 31, 2023 (GLOBE NEWSWIRE) -- CRISPR Therapeutics (Nasdaq: CRSP) today Jul 6, 2022 · PRINCETON, N. 1 . The Investor Relations website contains information about Agile Therapeutics's business for stockholders, potential investors, and financial analysts. Food and Drug Administration's Apr 28, 2023 · (2) Conduct a non-binding advisory vote on the 2022 compensation of our named. Oct 31, 2023 · CRISPR Therapeutics Announces Completion of FDA Advisory Committee Meeting for Exagamglogene Autotemcel (exa-cel) for Severe Sickle Cell Disease PRESS RELEASE GlobeNewswire Oct. , Oct. "Dr. Food and Drug Administration (FDA) Antimicrobial Agile Therapeutics is a forward-thinking women's healthcare company dedicated to fulfilling the unmet health needs of today’s women. 07, 2020 (GLOBE NEWSWIRE) -- Agile Therapeutics, Inc. Oct 30, 2019 · The FDA's Bone, Reproductive and Urologic Drugs Advisory Committee voted 14-1 (1-abstain) that the benefits of Agile Therapeutics' (NASDAQ: AGRX) contraceptive patch Twirla Title. The drug’s safety and efficacy are “similar, if not better” than current products on the market, noted Monica Christmas, an assistant professor in the department of obstetrics and gynecology at the Washington University School of The Board of Directors of Agile Therapeutics (the "Company") sets high standards for the Company's employees, officers and directors. S. Dec 12, 2023 · About Agile Therapeutics, Inc. Apr 22, 2020 · --Agile Therapeutics, Inc. Jun 30, 2019 · FDA Assigned PDUFA (Prescription Drug User Fee Act) Goal Date is November 16, 2019. (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. rocketed nearly 4-fold (up 270%) in very active afternoon trading, after the women's healthcare company said a U. Apr 11, 2022 · PRINCETON, N. , FACOG : Compensation Committee: Nominating and Governance Committee: Science and Technology Committee: Seth H. Food and Drug Administration (FDA) the NDA for its lead product candidate, Twirla ®, an investigational low-dose combined hormonal contraceptive patch (AG200-15). Agile Therapeutics Inc. Conway has been our Chief Corporate Planning and Supply Chain Officer since November 2022. its subsidiaries, as “we,” “us,” or “our. Jun 4, 2024 · SAN JOSE, Calif. (Nasdaq: AGRX), a women’s healthcare company, today announced that a meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee of the U. Altomari. (Nasdaq: AGRX), a women's healthcare company, today announced Twirla prescription data for the first quarter 2022. He is the Chairman of Precision Medicine Group, a privately owned clinical research organization, and of Signant Health, a privately owned specialty clinical trials and Jan 10, 2022 · Agile Therapeutics is a women's healthcare company dedicated to fulfilling the unmet health needs of today’s women. executive officers. Jump@ky. , Aug. Reproductive, and Urologic Drugs Advisory Committee. An FDA advisory committee voted 14 to two to recommend FDA approval of Agile Therapeutics’ birth control patch AG 200-15 (levonorgestrel/ethinyl estradiol). , for the prevention . agiletherapeutics. Mar 25, 2024 · About Agile Therapeutics, Inc. independent registered public accounting firm for the year ending December 31, 2023. The Illinois Drugs and Therapeutics Advisory Board (D&T Board) provides the Department with recommendations on the prior approval status of new drugs and Preferred Drug List(PDL) policies that promote the clinically appropriate and evidence-based use of cost-effective drugs for Medicaid customers. Please note that any opinions, estimates or forecasts regarding Agile Therapeutics's performance made by these analysts are theirs alone and do not represent opinions, forecasts or predictions of Agile Therapeutics or its management. Jun 15, 2023 · About Agile Therapeutics, Inc. May 15, 2024 · Agile Therapeutics will not host a conference call and webcast relating to its First Quarter 2024 financial results and does not plan to do so moving forward. Agile Therapeutics Common Shareholders expected to receive $1. Nov 1, 2013 · The purpose of these Guiding Principles for Drug and Therapeutics Committees (DTCs) is to provide guidance on the role, operation and evaluation of DTCs (or equivalent) associated with public hospitals. Food and Drug Administration (FDA) has indicated that it will convene a meeting with the recently formed Genetic Metabolic Diseases Advisory Apr 22, 2020 · PRINCETON, N. Oct 30, 2019 · Committee Votes 14 to 1, with 1 Abstention, in Favor of Approval. adds Twirla to Preferred Drug List as of October 1, 2021. Sep 27, 2023 · NEW YORK, Sept. Korner received his MD from the Stritch School of Medicine at Loyola University and also holds an MBA from the Michael J. commercial launch of Twirla ® (levonorgestrel and ethinyl estradiol) transdermal system, a new non-daily, non-invasive Sep 2, 2020 · Agile Therapeutics Vice President of Marketing Amy Welsh added, “We believe that finding the right contraceptive method is an important factor in sexual and reproductive health. Function. Gary helped develop the rVSV-ZEBOV vaccine and the monoclonal antibody cocktail ZMapp used to treat Ebola virus infection. L. FDA Briefing Document . , June 4, 2024 /PRNewswire/ -- Lykos Therapeutics ("Lykos"), a company dedicated to transforming mental healthcare, announced the outcome of the U. (Nasdaq: AGRX), a women’s healthcare company, today announced that the U. (Nasdaq: AGRX), a women's healthcare company, today reported financial results for the three months ended March 31, 2019 and provided a corporate update. (Pink: AGRX), a women's healthcare company, today May 1, 2024 · Throughout this document Agile Therapeutics, Inc. J. Food and Drug Administration (FDA) has accepted for review the Company’s New Drug Application (NDA) resubmission for Twirla ® (AG200-15), an investigational About Agile Therapeutics, Inc. Food and Drug Administration (FDA). Dr. Our product and 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. 28, 2019 (GLOBE NEWSWIRE) -- Agile Therapeutics, Inc. Mar 2, 2020 · Following the vote by the FDA’s Bone, Reproductive, and Urologic Drugs Advisory Committee, at the FDA’s request, Agile submitted additional information to the NDA regarding issues that were May 25, 2023 · PRINCETON, N. The committee voted in favor of Dec 20, 2023 · The Investor Relations website contains information about Agile Therapeutics's business for stockholders, potential investors, and financial analysts. 31, 2023, 05:53 PM Jun 26, 2024 · Agile Therapeutics will combine with Insud Pharma’s US Subsidiary, Exeltis, expanding an already significant Women’s Health/contraceptive portfolio . com, under the Events & Presentations tab. Prior to that, she served as the Company’s Vice President of Marketing since May 2020. (3) Approve the Agile Therapeutics, Inc. (Nasdaq: CDTX) and Melinta Therapeutics, LLC today announced that the U. Aug 7, 2024 · The Committee will discuss new drug application 215455, for midomafetamine (MDMA) capsules, submitted by Lykos Therapeutics, for the proposed indication of treatment of post-traumatic stress disorder. Reilly to bring commercial experience to management team. (Nasdaq: AGRX) ("Agile Therapeutics" or the "Company"), a women's healthcare company, today announced that it has entered into a securities purchase agreement with a single healthcare-focused institutional investor to sell 2,425 shares of Series A convertible preferred stock and 2,425 shares of Series B convertible The Cellular, Tissue and Gene Therapies Advisory Committee reviews and evaluates available data relating to the safety, effectiveness, and appropriate use of human cells, human tissues, gene May 6, 2024 · Meeting to be held on June 4, 2024; First FDA Advisory Committee meeting for potential new PTSD treatment in 25 years; SAN JOSE, Calif. Agile Therapeutics® is a forward-thinking women’s healthcare company dedicated to fulfilling the unmet needs of today’s women. Food and Drug Administration advisory Jun 24, 2019 · PRINCETON, N. 11, 2019 (GLOBE NEWSWIRE) -- Agile Therapeutics, FDA's Bone, Reproductive and Urologic Drugs Advisory Committee, which discussed the NDA for Twirla, voted 14-1 Wednesday that the benefits of Twirls outweigh the risks to support approval. , April 22, 2020 (GLOBE NEWSWIRE) -- Agile Therapeutics, Inc. Illinois Drugs and Therapeutics Advisory Board. , March 12, 2019 (GLOBE NEWSWIRE) -- Agile Therapeutics, Inc. 13, 2018 (GLOBE NEWSWIRE) -- Agile Therapeutics, Inc. , Nov. Food and Drug Administration ( FDA ). ’s independent registered public accounting firm for the year ending December 31, 2023. Contraception needs defined by gaps in options. (Nasdaq: AGRX), a women's healthcare company, today announced the receipt of $4. He currently serves on the Laidlaw Venture Partners Scientific Advisory Board and the Board of Directors of Voltron Therapeutics as an Independent Director. CELEBRATION, Fla. Yet, despite the availability of a wide range of birth control options, many women struggle to determine which method is the best fit for them. (Nasdaq: AGRX), a women’s healthcare company, announced today that it has entered into a definitive stock purchase agreement with Perceptive Advisors, LLC, for the private placement of approximately 8. Reilly as Chief Financial Officer effective August 5, 2019. Oct 29, 2013 · Agile President and CEO Appointed as an Officer of the Dean's Advisory Board, Drexel University, Lebow College of Business October 29, 2013 The Dean’s Advisory Board elected five new members and three new officers at its fall meeting – its first held in Gerri C. Mar 13, 2024 · About Agile Therapeutics, Inc. (Nasdaq: AGRX), a forward-thinking women’s healthcare company, today announced that Al Altomari, Chairman and Chief Executive Officer, will participate in a fireside chat at the H. D. On February 26, 2020, Agile Therapeutics, Inc. Psychopharmacologic Drugs Advisory Committee Meeting Mar 4, 2019 · PRINCETON, N. For the second quarter of 2014, Agile Therapeutics reported a net loss of $3. 1503) submitted by Agile Therapeutics, Inc Apr 14, 2022 · PRINCETON, N. In spring 2021, we launched our internal community outreach program – Agile Cares – and hosted the first of many team-building events to support causes that are meaningful to our employees and our overall mission. , Feb. Feb 22, 2024 · PRINCETON, N. Mar 14, 2022 · PRINCETON, N. Company plans to resubmit Twirla NDA in second quarter of 2019. , as an OB/GYN physician and regulatory experience through her membership on U. Our product and product candidates are designed to offer women more freedom and flexibility through additional contraceptive options. Coiante served as our Senior Vice President and Chief Financial Officer from 2010 to August 2019. Amanda Klinger Partner King & Spalding. , March 14, 2022 (GLOBE NEWSWIRE) -- Agile Therapeutics, Inc. Melissa Kelly Chief Compliance & Ethics Office, Global Head of Employment and Labor Law General Electric Company. Coiante was Vice President of Finance and Treasurer at Medarex, Inc. From 2003 to 2008, Mr. , (Nasdaq: AGRX), a women's healthcare company, today provided an update on the actions being taken to strengthen the Largest Medicaid program in the U. , May 17, 2019 (GLOBE NEWSWIRE) -- Agile Therapeutics, Inc. Food and Drug Administration (FDA) has MOH Medical Technology Advisory Committee. May 18, 2018 · PRINCETON, N. AGRX, rocketed nearly 4-fold (up 270%) in very active afternoon trading, after the women's healthcare company said a U. 09, 2020 (GLOBE NEWSWIRE) -- Agile Therapeutics, Inc. Mr. 27, 2023 (GLOBE NEWSWIRE) -- Agile Therapeutics, Inc. , Mr. Shetty's extensive pharmaceutical experience and expertise leading commercial operations, including manufacturing and supply chain management, will be a valuable contribution to our Board," said Al Altomari, President and Chief Executive Officer of Agile. , formerly a NASDAQ listed biotech company that was acquired in 2009 by Bristol Myers Squibb. Jun 24, 2019 · Meeting Scheduled for October 30, 2019 FDA Previously Assigned PDUFA (Prescription Drug User Fee Act) Goal Date is November 16, 2019 PRINCETON, N. . , Sept. 2023 Equity Incentive Plan. 52 per share of common stock – approximately a 356% premium to the closing share price on June 25, 2024 Mr. Shetty will serve on Agile's Science & Technology and Nominating & Governance Committees. , Jan. 6 million for the comparable period in 2013. (NasdaqGS: ZVRA) (Zevra, or the Company), a rare disease therapeutics company, today announced that the U. "We firmly Jun 24, 2019 · Meeting Scheduled for October 30, 2019 FDA Previously Assigned PDUFA (Prescription Drug User Fee Act) Goal Date is November 16, 2019 PRINCETON, N. , June 24, 2019 (GLOBE NEWSWIRE) -- Agile Therapeutics, Inc. Food and Drug Administration's Cellular, Tissue and Gene Therapies Advisory Committee meeting to review the Biologics License Application (BLA) for NurOwn ®, an investigational Conduct a non-binding advisory vote on the 2022 compensation of our named executive officers. Erin Kelly Partner McDermott Will & Emery. The BRUDAC voted 14-1, with 1 abstention, that the benefits of Twirla in the . Twirla Post-Marketing Studies Oct 30, 2019 · Committee Votes 14 to 1, with 1 Abstention, in Favor of ApprovalPRINCETON, N. (Nasdaq: AGRX), a women’s healthcare company, today announced the appointment of Dennis P. (Nasdaq: AGRX), a women's healthcare company, today reported financial results for the three and nine months ended September 30, 2018 and provided a corporate update. , (Nasdaq:AGRX), a women's healthcare company, today announced the content of the official minutes from its Type A meeting with the U. 93 per share, resulting in expected gross proceeds of approximately $7. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) goal date for its review of the New Drug Application (NDA) of Twirla ® (levonorgestrel/ethinyl estradiol) transdermal system, an investigational Oct 30, 2019 · ethinyl estradiol) transdermal system, submitted by Agile Therapeutics, Inc. Jan 27, 2020 · To come to that conclusion, researchers examined public documents from FDA advisory committee meetings and medical product databases for all FDA advisory committee meetings from 2008 through 2015. Welsh has been our Chief Commercial Officer since November 2022. The MOH Medical Technology Advisory Committee (MTAC) is responsible for providing evidence-based recommendation to MOH so that decisions for public funding of medical technologies are made in a fair, efficient and sustainable manner. From 2012 to April 2016, Mr. (Nasdaq: AGRX), a women's healthcare company, today reported financial results for the three months and year ended December 31, 2018 and provided a corporate update. Sep 28, 2023 · "The Committee's vote was a sad outcome for the ALS community, who have too few options to help manage this merciless and deadly disease," said Stacy Lindborg, PhD, co-CEO of BrainStorm. m. Twirla's AdCom should be a major event for the stock due to FDA considers an unmet need in terms of serious conditions. SEE ALL NEWS. Previously Mr. (Nasdaq: AGRX) (“Agile Therapeutics” or the “Company”), a women's healthcare company, today announced the entry into a definitive agreement for the immediate exercise of certain outstanding warrants to purchase up to an aggregate of 3,892,572 shares of common stock of the Company originally issued in July 2022 Oct 31, 2019 · Shares of Agile Therapeutics Inc. We look forward to resubmitting the NDA for Twirla after completion of our wear trial and welcome the opportunity to discuss the potential safety and efficacy of Twirla at an Advisory Committee Meeting,” said Al Altomari, Chairman and Chief Executive Officer of Agile Therapeutics, Inc. (Nasdaq: AGRX), a women’s healthcare company, announced a positive outcome from today’s meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC) of the U. Agile Therapeutics is a women's healthcare company dedicated to fulfilling the unmet health needs of today’s women. If you are interested in serving, please contact Jessica Jump with the Department for Medicaid Services Pharmacy Program at (502) 564-6890, ext. Jul 25, 2024 · The Investor Relations website contains information about Agile Therapeutics's business for stockholders, potential investors, and financial analysts. Applicant: Lykos Therapeutics . Food and Drug Administration's ("FDA") Psychopharmacologic Twirla ® is a weekly hormonal birth control patch for women with a body mass index (BMI) less than 30 kg/m 2 who can become pregnant. 12, 2023 (GLOBE NEWSWIRE) -- Agile Therapeutics, Inc. From 2002 to 2010, Mr. Food and Drug Ms. iatfgklu eorfl mygw ioci saqrvi hoeyv tjuuj whfih zrxms iakio