AGRX - Agile Therapeutics, Inc.
| Previous Close | 0.740 |
| Open | 0.742 |
| Bid | 1.080 x 1100 |
| Ask | 1.090 x 4000 |
| Day's Range | 0.730 - 1.170 |
| 52 Week Range | 0.231 - 5.330 |
| Volume | 25,501,156 |
| Avg. Volume | 3,382,051 |
| Market Cap | 39.396M |
| Beta (3Y Monthly) | 1.07 |
| PE Ratio (TTM) | N/A |
| EPS (TTM) | -0.758 |
| Earnings Date | Aug 7, 2017 - Aug 11, 2017 |
| Forward Dividend & Yield | N/A (N/A) |
| Ex-Dividend Date | N/A |
| 1y Target Est | 6.00 |
- Zacks Small Cap Research•5 days 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•5 days 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 ...
- GlobeNewswire•6 days ago
Agile Therapeutics, Inc. Completes Formal Dispute Resolution Process with the FDA
Agile Therapeutics, Inc. (AGRX), a women’s healthcare company, today announced that it has received a response from FDA’s Office of New Drugs (“OND”) concerning the Company’s formal dispute resolution request. The Company had appealed the decision by the FDA’s Division of Bone, Reproductive and Urological Products (“DBRUP”) that concerns surrounding the in vivo adhesion properties of Twirla prevent its approval.
- Simply Wall St.•last month
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•last month
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•last month
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.
- GlobeNewswire•2 months ago
Consolidated Research: 2018 Summary Expectations for Internap, Approach Resources, Agile Therapeutics, Town Sports International, Dicerna Pharmaceuticals, and Cott — Fundamental Analysis, Key Performance Indications
NEW YORK, Aug. 29, 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 Internap ...
- Zacks Small Cap Research•2 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.
- Associated Press•2 months ago
Agile Therapeutics: 2Q Earnings Snapshot
The Princeton, New Jersey-based company said it had a loss of 16 cents per share. The results surpassed Wall Street expectations. The average estimate of four analysts surveyed by Zacks Investment Research ...
- GlobeNewswire•2 months ago
Agile Therapeutics Reports Second Quarter 2018 Financial Results
Cash Expected to Enable Company to Fund Operations into Second Quarter 2019. PRINCETON, N.J., Aug. 03, 2018-- Agile Therapeutics, Inc., a women's healthcare company, today reported financial results for ...
- ACCESSWIRE•2 months ago
Complimentary Technical Snapshots on Akorn and Three More Generic Drugs Stocks
WallStEquities.com revisits the Generic Drugs market, which can be segmented into biosimilars, simple generic, and super generic. Based on its therapeutics applications, the generic drugs market can be classified into cardiovascular products, anti-infective drugs, anti-arthritis drugs, central nervous system drugs, anti-cancer drugs, respiratory products, and others. Under assessment this morning are these four stocks: Agile Therapeutics Inc. (NASDAQ: AGRX), Akorn Inc. (NASDAQ: AKRX), Collegium Pharmaceutical Inc. (NASDAQ: COLL), and Catalyst Pharmaceuticals Inc. (NASDAQ: CPRX).
- GlobeNewswire•3 months ago
FDA’s Office of Drug Evaluation III Denies Agile Therapeutics, Inc.’s Initial Formal Dispute Resolution Request
Agile Therapeutics, Inc., (AGRX) (the “Company”), a women’s healthcare company, today announced that the Office Director of the FDA’s Office of Drug Evaluation III (ODEIII) has affirmed the position of the Division of Bone, Reproductive and Urologic Products (DBRUP) and denied the Company’s appeal of the December 21, 2017 Complete Response Letter in relation to the New Drug Application (NDA) for Twirla®. The Company had appealed the decision by 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. The Company intends to appeal the ODEIII decision to the Office of New Drugs.
- ACCESSWIRE•4 months 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 Research•4 months ago
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.
- Benzinga•4 months ago
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, ...
- Zacks Small Cap Research•5 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.
- ACCESSWIRE•5 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.
- Reuters•5 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.
Motley Fool•5 months agoCorium International (CORI) Q2 2018 Earnings Conference Call Transcript
CORI earnings call for the period ending March 31, 2018.
- Zacks Small Cap Research•5 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.
- Simply Wall St.•5 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 Press•5 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. ...
