AGRX - Agile Therapeutics, Inc.

NasdaqGM - NasdaqGM Real Time Price. Currency in USD
0.4810
-0.0309 (-6.04%)
At close: 4:00PM EDT
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Previous Close0.5119
Open0.5039
Bid0.4505 x 1100
Ask0.4900 x 2200
Day's Range0.4705 - 0.5270
52 Week Range0.4400 - 5.6000
Volume599,304
Avg. Volume638,696
Market Cap16.473M
Beta1.53
PE Ratio (TTM)N/A
EPS (TTM)-0.8550
Earnings DateAug 7, 2017 - Aug 11, 2017
Forward Dividend & YieldN/A (N/A)
Ex-Dividend DateN/A
1y Target Est6.00
Trade prices are not sourced from all markets
  • ACCESSWIRE23 days ago

    Free Technical Research on Akorn and Three More Generic Drugs Equities

    WallStEquities.com has selected the following Generic Drugs stocks for review today: Adamas Pharmaceuticals Inc. (NASDAQ: ADMS), Agile Therapeutics Inc. (NASDAQ: AGRX), Akorn Inc. (NASDAQ: AKRX), and Allergan PLC (NYSE: AGN). Companies in the generic pharmaceuticals sector make drugs that are offered cheaper than name-brand pharmaceuticals once patents for the more expensive drugs lapse.

  • Zacks Small Cap Researchlast month

    AGRX: Files Formal Dispute Resolution with the FDA

    On June 7, 2018, Agile Therapeutics, Inc. (AGRX) announced that the company has filed a formal dispute resolution request with the FDA in regards to Twirla®, the company’s once-weekly low–dose combination hormonal contraceptive patch that has completed three Phase 3 clinical trials. Following a Type A meeting with the FDA, the official meeting minutes stated that the agency still had significant concerns regarding the adhesion properties of Twirla® that could not be addressed through the company’s proposed patient compliance program. Agile disagreed with this assessment and thus has begun formal dispute resolution proceedings.

  • Benzingalast month

    Benzinga's Daily Biotech Pulse: EDAP Device Gets FDA Nod, Ampliphi Presents Positive Data, Agile To Cut Jobs

    Here's a roundup of top developments in the biotech space over the last 24 hours. Scaling The Peaks (Stocks hitting 52-week highs on June 7) Baxter International Inc (NYSE: BAX ) Bio-Rad Laboratories, ...

  • GlobeNewswirelast month

    Agile Therapeutics, Inc. Provides Corporate Update and Revised Cash Guidance

    Agile has submitted a formal dispute resolution request (FDRR) with the FDA for Twirla (AG200-15), the Company’s investigational low-dose, non-daily, combination hormonal contraceptive patch. The dispute pertains to the determination from the FDA’s reviewing Division of Bone, Reproductive and Urologic Products (DBRUP), that concerns surrounding the in vivo adhesion properties of Twirla prevent its approval and cannot be addressed through the Company’s proposed patient compliance programs.

  • Zacks Small Cap Research2 months ago

    AGRX: Determining a Path Forward Following Receipt of Meeting Minutes

    According to the minutes, the FDA continues to have significant concerns regarding the adhesion properties of Twirla®, which the agency does not believe can be addressed by the currently available data. The FDA stated that in order to address the concerns the company would need to reformulate the transdermal patch and conduct a formal adhesion study with the new formulation. Following that, a bioequivalence study would need to be performed between the old formulation and new formulation, and if bioequivalence was not shown a new Phase 3 study would need to be conducted with the new formulation.

  • ACCESSWIRE2 months ago

    Today’s Research Reports on Stocks to Watch: Agile Therapeutics and Arrowhead Pharmaceuticals

    NEW YORK, NY / ACCESSWIRE / May 21, 2018 / Agile Therapeutics shares fell hard on Friday after traders pondered the future of the company's Twirla contraceptive Patch. The FDA had a concerning assessment on the patch and has already turned it down twice. Shares of Arrowhead Pharmaceuticals were gaining higher in Friday trading despite any particular news.

  • Reuters2 months ago

    Agile Therapeutics sinks after FDA feedback on contraceptive

    Agile Therapeutics Inc's shares sank 75 percent on Friday after the drug developer said it expects to pursue what could be a prolonged appeal against health regulators' issues over its chief experimental product, a contraceptive patch. The U.S. Food and Drug Administration (FDA) had already declined to approve Twirla, Agile's stick-on contraceptive, on two occasions, and Agile said the agency still had "significant concerns" about the adhesion properties of the patch. "In light of the feedback from the FDA, we also are re-evaluating our business plan to identify ways to extend our ability to fund the company's operations," Agile Chief Executive Officer Al Altomari said in a statement.

  • GlobeNewswire2 months ago

    Consolidated Research: 2018 Summary Expectations for Verint, Mesabi Trust, Clearwater Paper, Agile Therapeutics, Community Trust, and Layne Christensen — Fundamental Analysis, Key Performance Indications

    NEW YORK, May 18, 2018-- In new independent research reports released early this morning, Fundamental Markets released its latest key findings for all current investors, traders, and shareholders of Verint ...

  • GlobeNewswire2 months ago

    Agile Therapeutics, Inc. Provides Regulatory Update on Twirla® (AG200-15) for the Prevention of Pregnancy

    In the official minutes, the FDA informed the Company that it continues to have significant concerns regarding the adhesion of Twirla, which the FDA believes cannot be addressed through the Company’s proposed patient compliance programs, and that the Company needed to address the Twirla adhesion properties by reformulating the transdermal system and conducting a formal adhesion study with the new formulation. The FDA also informed the Company that it would need to demonstrate bioequivalence to the data and information for the original formulation.  The FDA advised the Company that after the Company satisfies the FDA’s questions on adhesion and adequately bridges to the findings in the SECURE Phase 3 trial, it anticipates discussing the safety and efficacy of Twirla at an advisory committee meeting to obtain input on whether the benefits outweigh the risks.  In the absence of a finding of bioequivalence, the Company would need to conduct a new Phase 3 study with the new formulation.  Finally, the FDA provided guidance on the path forward for addressing manufacturing issues related to Twirla, which path is largely based on the materials the Company had previously submitted in December 2017.  To the extent that the Company reformulates Twirla, it may create the need for additional manufacturing work and review by the FDA.

  • Corium International (CORI) Q2 2018 Earnings Conference Call Transcript
    Motley Fool2 months ago

    Corium International (CORI) Q2 2018 Earnings Conference Call Transcript

    CORI earnings call for the period ending March 31, 2018.

  • Zacks Small Cap Research2 months ago

    AGRX: Waiting on Meeting Minutes from FDA; Planning for 2Q18 Twirla® NDA Resubmission

    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. The company has conducted a comprehensive development program for Twirla® that includes three Phase 3 clinical trials.

  • Have Investors Priced In Agile Therapeutics Inc’s (NASDAQ:AGRX) Growth?
    Simply Wall St.2 months ago

    Have Investors Priced In Agile Therapeutics Inc’s (NASDAQ:AGRX) Growth?

    Agile Therapeutics Inc (NASDAQ:AGRX), a pharmaceuticals company based in United States, saw a decent share price growth in the teens level on the NasdaqGM over the last few months. AsRead More...

  • Associated Press2 months ago

    Agile Therapeutics: 1Q Earnings Snapshot

    On a per-share basis, the Princeton, New Jersey-based company said it had a loss of 20 cents. Losses, adjusted for pretax gains, came to 21 cents per share. The results did not meet Wall Street expectations. ...

  • GlobeNewswire2 months ago

    Agile Therapeutics Reports First Quarter 2018 Financial Results

    Agile Therapeutics, Inc. (AGRX), a women's healthcare company, today reported financial results for the three months ended March 31, 2018 and provided a corporate update. Twirla® Update – As previously announced, on December 22, 2017, the U.S. Food and Drug Administration (FDA) issued a complete response letter (CRL) in connection with its review of the New Drug Application (NDA) for the Company’s investigational non-daily, low dose combination hormonal contraceptive patch, Twirla (AG200-15). The CRL informed the Company that the FDA could not approve the NDA in its present form due to deficiencies related to the manufacturing process for Twirla, and questions on the in vivo adhesion properties of Twirla and their potential relationship to the Phase 3 clinical trial results.  At the Company’s request, the FDA had a Type A meeting with the Company to discuss the deficiencies in the Twirla NDA and the potential regulatory path for approval of Twirla.

  • When Can We Expect A Profit From Agile Therapeutics Inc (NASDAQ:AGRX)?
    Simply Wall St.2 months ago

    When Can We Expect A Profit From Agile Therapeutics Inc (NASDAQ:AGRX)?

    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. The US$100.00M market-cap company announced a latestRead More...

  • What Should Investors Know About Agile Therapeutics Inc’s (NASDAQ:AGRX) Long Term Outlook?
    Simply Wall St.4 months ago

    What Should Investors Know About Agile Therapeutics Inc’s (NASDAQ:AGRX) Long Term Outlook?

    In December 2017, Agile Therapeutics Inc (NASDAQ:AGRX) released its latest earnings announcement, which indicated company earnings became less negative compared to the previous year’s level – great news for investorsRead More...

  • Simply Wall St.4 months ago

    Is Agile Therapeutics Inc’s (NASDAQ:AGRX) Balance Sheet A Threat To Its Future?

    While small-cap stocks, such as Agile Therapeutics Inc (NASDAQ:AGRX) with its market cap of US$103.77M, are popular for their explosive growth, investors should also be aware of their balance sheetRead More...

  • Associated Press4 months ago

    Agile Therapeutics reports 4Q loss

    The Princeton, New Jersey-based company said it had a loss of 18 cents per share. The results topped Wall Street expectations. The average estimate of five analysts surveyed by Zacks Investment Research ...

  • Benzinga7 months ago

    Analyst Remains Confident In Corium Despite Partner's Bad FDA News

    The U.S. Food and Drug Administration sent an unfavorable Complete Response Letter  last week to Agile Therapeutics Inc (NASDAQ: AGRX ) regarding approval for the Twirla contraceptive patch. The letter ...