AGRX - Agile Therapeutics, Inc.
| Previous Close | 1.1300 |
| Open | 1.1200 |
| Bid | 1.07 x 800 |
| Ask | 1.10 x 800 |
| Day's Range | 1.0500 - 1.1300 |
| 52 Week Range | 0.2310 - 3.9200 |
| Volume | 519,504 |
| Avg. Volume | 407,050 |
| Market Cap | 36.784M |
| Beta (3Y Monthly) | -1.31 |
| PE Ratio (TTM) | N/A |
| EPS (TTM) | -0.65 |
| Earnings Date | Aug 7, 2017 - Aug 11, 2017 |
| Forward Dividend & Yield | N/A (N/A) |
| Ex-Dividend Date | N/A |
| 1y Target Est | 3.00 |
- Zacks Small Cap Research•6 days 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•7 days 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•11 days 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•last month
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•last month
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•last month
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•2 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•2 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•2 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.•3 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•3 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•4 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 ...
- ACCESSWIRE•4 months ago
Agile Therapeutics Gets a Path Forward for Twirla, Analysts Review and Target
NEW YORK, NY / ACCESSWIRE / October 22, 2018 / Traders News Source, a leading independent equity research and corporate access firm focused on small and mid-cap public companies is issuing a comprehensive report on Agile Therapeutics, Inc. (AGRX), a women's healthcare company dedicated to fulfilling the unmet health needs of women. The company' 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. The company' lead product candidate, Twirla® (levonorgestrel/ethinyl estradiol transdermal system) or AG200-15, is an investigational low-dose, non-daily, prescription contraceptive.
- ACCESSWIRE•4 months ago
Today’s Research Reports on Stocks to Watch: Auris Medical Holding and Agile Therapeutics
NEW YORK, NY / ACCESSWIRE / October 16, 2018 / Biotech stocks Auris Medical Holding and Agile Therapeutics were both seeing big gains on Monday. Traders are waiting for an update from Auris Medical on Wednesday while Agile recently concluded its formal dispute resolution with the FDA over the complete response letter issued for the new drug application of Twirla. Auris Medical Holding AG shares were skyrocketing on Monday with gains of 40.82% and an additional 23.19% in after-hours trading.
- Zacks Small Cap Research•4 months ago
AGRX: FDA Provides Path to NDA Resubmission 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.
- ACCESSWIRE•4 months ago
Today's Research Reports on Trending Tickers: Agile Therapeutics and Horizon Pharma
NEW YORK, NY / ACCESSWIRE / October 10, 2018 / U.S. equities finished mostly lower on Tuesday as interest rate increases and rising bond yields continued to put pressure on stocks. The Dow Jones Industrial ...
- Simply Wall St.•5 months ago
Does Agile Therapeutics Inc (NASDAQ:AGRX) Fall With The Market?
If you’re interested in Agile Therapeutics Inc (NASDAQ:AGRX), then you might want to consider its beta (a measure of share price volatility) in order to understand how the stock couldRead More...
- ACCESSWIRE•5 months ago
Today’s Research Reports on Stocks to Watch: Agile Therapeutics and BioPharmX
NEW YORK, NY / ACCESSWIRE / September 12, 2018 / It was a day of unexplainable gains for two biotech stocks on Tuesday. Both Agile Therapeutics and BioPharmX catapulted higher despite any significant news. ...
- ACCESSWIRE•5 months ago
New Growth Opportunities Jump for 3 Biotech Stocks in 2018
CORAL GABLES, FL / ACCESSWIRE / September 11, 2018 / Biotech stocks continue to present key drivers of returns for many investors. Public equities have delivered strong returns underpinned by large-scale of monetary policy support. It is particularly noteworthy that the California Public Employees' Retirement System is considering the creation of a direct investment program, which would include investment in companies within sectors like healthcare and biotechnology.
- Zacks Small Cap Research•6 months ago
AGRX: Formal Dispute Resolution Continues to Office of New Drugs…
On July 24, 2018, Agile Therapeutics, Inc. (AGRX) announced that the FDA’s Office of Drug Evaluation III (ODEIII) has denied the company’s appeal of the complete response letter issued for the new drug application of Twirla®. The company is planning to appeal the decision of the ODEIII to the Office of New Drugs. FDA regulations for dispute resolution are governed by 21 CFR 10.75, which provides a mechanism whereby an applicant can obtain formal review of any FDA decision by the employee’s supervisor.
