|Bid||1.00 x 500|
|Ask||6.50 x 500|
|Day's Range||3.55 - 3.75|
|52 Week Range||1.93 - 5.60|
|PE Ratio (TTM)||N/A|
|Earnings Date||Aug 7, 2017 - Aug 11, 2017|
|Forward Dividend & Yield||N/A (N/A)|
|1y Target Est||7.40|
NEW YORK, Jan. 24, 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 ...
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 ...
Shares of Agile Therapeutics Inc. plunged 71% toward a record low in premarket trade Friday, after the company said it received a complete response letter (CRL) from the Food and Drug Administration stating ...
Agile Therapeutics Inc said on Friday the U.S. Food and Drug Administration declined to approve the company's contraceptive patch, citing deficiencies related to its adhesion test methods. The health regulator ...
PRINCETON, N.J., Dec. 22, 2017-- Agile Therapeutics, Inc.,, a women’ s healthcare company, today announced that the U.S. Food and Drug Administration issued a complete response letter in response to the ...
In this analysis, my focus will be on developing a perspective on Agile Therapeutics Inc’s (NASDAQ:AGRX) latest ownership structure, a less discussed, but important factor. Ownership structure has been foundRead More...
If H.C. Wainwright analysts are right, a great deal of upside potential hangs in the balance for two biotech players: Synergy Pharmaceuticals Inc (NASDAQ:SGYP) and Agile Therapeutics Inc (NASDAQ:AGRX). With both companies approaching PDUFA dates with destiny, H.C. Wainwright is upbeat on chances for FDA approval, as Synergy eyes a green light in IBS-C and Agile is raring to hit the contraceptive patch market. In reaction, the analyst maintains a Buy rating on Synergy stock while trimming the price target from $8 to $7 to reflect the latest financing move.
Agile Therapeutics Inc (NASDAQ:AGRX), a pharmaceuticals company based in United States, received a lot of attention from a substantial price increase on the NasdaqGM in the over the last fewRead More...
Commercial-stage biopharma company Corium International Inc (NASDAQ: CORI ) reported Thursday 19 percent revenue growth for its fiscal year fourth quarter of 2017, while its loss per share narrowed to ...
While small-cap stocks, such as Agile Therapeutics Inc (NASDAQ:AGRX) with its market cap of USD $150.42M, are popular for their explosive growth, investors should also be aware of their balanceRead More...
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.
PRINCETON, N.J., Oct. 31, 2017 /PRNewswire/ -- Agile Therapeutics, Inc., (AGRX), a women's healthcare company, today announced additional data from its Phase 3 SECURE trial of Twirla® (AG200-15), an investigational, once-weekly, low-dose hormonal contraceptive patch, which showed women experienced mean decreases in length of bleeding and spotting episodes. Over 12 months, women on Twirla reported a gradual decrease in the mean total number of bleeding and/or spotting episodes from 6.0 to 4.9 days from cycles two through 13. Scheduled bleeding, or withdrawal bleeding during the patch-free week, decreased from 4.7 days at cycle two to 4.1 days at the end of the trial.
For investors with a high-risk tolerance, tracking key FDA approval dates for drug candidates is a smart strategy for potentially generating huge returns.
PRINCETON, N.J., Oct. 16, 2017 /PRNewswire/ -- Agile Therapeutics, Inc., (AGRX), a women's healthcare company, today announced the presentation of additional results from the Phase 3 SECURE trial of its investigational low-dose combination hormonal contraceptive patch, Twirla® (AG200-15). Anita Nelson, MD, Professor and Chair of Obstetrics and Gynecology at the College of Osteopathic Medicine of the Pacific, presented new data on the Twirla bleeding profile during a poster presentation at the 2017 National Association for Family Planning (NAFFP), "The Forum" in Atlanta, GA. The poster presentation provided detailed analyses on scheduled (withdrawal) and unscheduled (breakthrough) bleeding and/or spotting episodes. Rates of unscheduled bleeding and/or spotting decreased during the study period. Similarly, the mean length of both unscheduled and scheduled bleeding and/or spotting episodes decreased during the study period. Few subjects discontinued from the trial for bleeding-related issues, and rates of unscheduled bleeding and/or spotting decreased over the 12-month study period.
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. On October 10, 2017, Agile hosted an analyst day and provided a comprehensive overview of Twirla®, including a full discussion of the data from the Phase 3 SECURE trial in the context of other clinical and real world data seen with other combination hormonal contraceptive products.
On July 27, 2017, Agile (AGRX) announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for its lead product, Twirla® (AG200-15), a once-weekly low–dose combination hormonal contraceptive patch. The FDA set the Prescription Drug User Fee Act (PDUFA) date as Dec. 26, 2017. Leading up to the PDUFA date, a number of pre-commercialization activities will take place, including a potential pre-approval inspection (PAI) of the manufacturing facility by the FDA for the company’s contract manufacturing organization (CMO) partner Corium.