|Bid||0.4505 x 1100|
|Ask||0.4900 x 2200|
|Day's Range||0.4705 - 0.5270|
|52 Week Range||0.4400 - 5.6000|
|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|
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.
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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.
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.
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 ...
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.
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. ...
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.
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...
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...
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...
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 ...
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 ...