|Bid||1.080 x 1100|
|Ask||1.090 x 4000|
|Day's Range||0.730 - 1.170|
|52 Week Range||0.231 - 5.330|
|Beta (3Y Monthly)||1.07|
|PE Ratio (TTM)||N/A|
|Earnings Date||Aug 7, 2017 - Aug 11, 2017|
|Forward Dividend & Yield||N/A (N/A)|
|1y Target Est||6.00|
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.
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 ...
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.
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...
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. ...
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.
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 ...
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.
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 ...
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 ...
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).
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.
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.
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.
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, ...
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.
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.
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.
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.
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...
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. ...