Agile Therapeutics noch investieren? (Seite 11)

[TYard]

First Target: 10 $ +++

[Naggn]

hmmm wie ist eure Meinung? geht es weiter Richtung norden oder greifen die Shorts an und wir erleben es die 500% erneut? das Volumen ist ja bombe

[bkiesel]

Antwort auf Beitrag Nr.: 60.217.286 von Lucky72 am 28.03.19 11:22:56

Ho Ho Ho, da geht was +500%

das ist doch mal was

[Lucky72]

Kurs ist weiter stabil!

[Lucky72]

Agile Therapeutics to Present In Vivo Adhesion Data from Two Phase 1 Studies at the 2nd Annual Formulation & Drug Delivery USA Congress
GlobeNewswire•March 15, 2019

PRINCETON, N.J., March 15, 2019 (GLOBE NEWSWIRE) -- Agile Therapeutics, Inc., (AGRX), a women's healthcare company, today announced that an abstract presenting data from two Phase 1 in vivo wear studies on the adhesion of Twirla® has been selected for a poster presentation during the 2nd Annual Formulation & Drug Delivery USA Congress being held March 18th – 19th, 2019 in San Diego, California. The poster, titled “Results of Two Phase 1 Clinical Trials on the Adhesion Profile of AG200-15, An Investigational Transdermal Contraceptive Delivery System,” will be presented by lead author Terrance Ocheltree, PhD. Dr. Ocheltree previously served as both an FDA Reviewer and as Director of the Division of New Drug Quality Assessment II at the FDA.

The adhesion profile of Twirla (AG200-15) was recently evaluated in two single-center studies. The company performed the first, a single-arm pilot wear study (ATI-CL26), to inform the design of the second, a crossover wear study (ATI-CL25) comparing Twirla to Xulane®, a marketed generic contraceptive patch. The poster presentation will include adhesion and safety data from both studies. The results of these studies support an acceptable in vivo adhesion profile for Twirla, and both patches were generally well tolerated.

About Twirla® (AG200-15)
Twirla (levonorgestrel/ethinyl estradiol transdermal system) or AG200-15 is an investigational low-dose, once-weekly combined hormonal contraceptive (“CHC”) patch that contains the active ingredients ethinyl estradiol (“EE”), a type of estrogen, and levonorgestrel (“LNG”), a type of progestin. Twirla is designed to be applied once weekly for three weeks, followed by a week without a patch. The Company has completed its Phase 3 clinical trials of Twirla and is pursuing regulatory approval in the U.S. Agile received a complete response letter (“CRL”) from the FDA in December 2017 relating to the New Drug Application (“NDA”) for Twirla. In the CRL, the FDA informed the Company that the product could not be approved in its present form. The Company plans to resubmit the Twirla NDA in the first half of 2019.

About Agile Therapeutics, Inc.
Agile Therapeutics is a forward-thinking women's healthcare company dedicated to fulfilling the unmet health needs of today's women. Our 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. Our lead product candidate, Twirla® (levonorgestrel/ethinyl estradiol transdermal system), also known as AG200-15, is an investigational low-dose, non-daily, prescription contraceptive. Twirla is based on our proprietary transdermal patch technology, called Skinfusion®, which is designed to allow drug delivery through the skin. For more information, please visit the company website at www.agiletherapeutics.com. The Company may occasionally disseminate material, nonpublic information on the Company’s website.

Follow Agile on Linked In and Twitter: @AgileTher.

Xulane® is a registered trademark of Mylan N.V.

https://finance.yahoo.com/news/agile-therapeutics-present-vi…

[Lucky72]

[Lucky72]

[Lucky72]

AGRX: Numerous Catalysts in 2019…
Zacks Small Cap Research
March 14, 2019

By David Bautz, PhD

NASDAQ:AGRX

READ THE FULL AGRX RESEARCH REPORT

Business Update

Agile Therapeutics, Inc. (AGRX) is a women’s healthcare company focused on developing healthcare products to fulfill the unmet contraceptive needs of women. 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. Following receipt of a complete response letter (CRL) in Dec. 2017 for the new drug application (NDA) filed for Twirla®, the company pursued a formal dispute resolution with the FDA, which the agency denied. However, the FDA provided an alternative pathway to approval by recommending the company perform a comparative wear study to compare the adhesion profile of Twirla® to that of Xulane®, the generic version of the contraceptive patch Ortho Evra®. The company successfully completed the comparative wear study and is now prepared to refile the NDA.

Multiple Catalyst Ahead in 2019

Agile now has all the pieces in place for a path to approval for Twirla®:

• The NDA will be refiled in the second quarter of 2019. This will be a complete response to the CRL received in Dec. 2017 and will include results from the comparative wear study (discussed below), additional information on the company’s manufacturing process, and additional analyses that were performed as a response to issues brought up in the CRL.

• We anticipate that an Advisory Committee (“AdComm”) meeting will take place during the second half of 2019 to discuss the Twirla® NDA and will likely focus on the safety and efficacy of Twirla®, which could include a discussion of the Pearl Index from the Phase 3 Secure trial.

• A reinspection of the third-party manufacturing facility will likely take place during the second half of 2019.

• Assuming the NDA is refiled in the second quarter of 2019, and given a six-month review period, we anticipate a PDUFA date near the end of 2019.

Adhesion Study Successful

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®. It was a randomized, open label, crossover adhesion study that randomized a total of 83 women between the ages of 18-35 years and a body mass index (BMI) <35 kg/m2. Seventy-nine subjects completed the study and 77 were included in the per protocol population for the primary analysis. Study subjects were randomized to wear either Twirla® or Xulane® for one week and then switch to the other patch for the second week. Adhesion of each patch was quantified daily through the following scale:

0 = ≥ 90% adhered (essentially no lift off the skin)
1 = ≥ 75% to < 90% adhered (only some edges lift off the skin)
2 = ≥ 50% to < 75% adhered (less than half is lifted off the skin
3 = > 0% to < 50% adhered (not detached, but more than half lifts off the skin)
4 = 0% adhered (detached and completely off the skin)

Results showed that the mean adhesion score difference between Twirla® and Xulane® was -0.25 with the upper bound of the 95% confidence limit for the mean difference of -0.16. Following discussion with the FDA in December 2018, it was decided that Twirla® would be considered statistically non-inferior to Xulane® if the upper 95% confidence limit of the mean difference was less than +0.15, thus Twirla® met the definition of non-inferiority. The negative value for the difference in mean adhesion score indicates that the mean score for Xulane® was higher than the mean score for Twirla®. The results are summarized below.


View Exhibit I

Financial Update

On March 12, 2019, Agile reported financial results for the fourth quarter and full year 2018. As expected, the company did not report any revenues for the fourth quarter of full year 2018. Net loss for the fourth quarter of 2018 was $3.8 million, or $0.11 per share, compared to a net loss of $6.2 million, or $0.18 per share, for the fourth quarter of 2017. R&D expenses in the fourth quarter of 2018 were $1.9 million compared to $2.7 million for the fourth quarter of 2017. G&A expenses in the fourth quarter of 2018 were $1.6 million compared to $3.3 million for the corresponding time period in 2017.

Net loss for 2018 was $19.8 million, or $0.58 per share, compared to a net loss of $28.3 million, or $0.91 per share, in 2017. R&D expenses in 2018 were $9.8 million compared to $14.4 million in 2018. The decrease in R&D expenses is primarily due to a decrease in manufacturing expenses, clinical development expenses, and regulatory expenses. G&A expenses in 2018 were $8.7 million compared to $12.4 million in 2017. The decrease was primarily due to decreased commercial development expenses and professional fees partially offset by an increase in personnel costs.

As of Dec. 31, 2018, Agile had approximately $7.9 million in cash and cash equivalents. In March 2018, the company announced a private placement of approximately 8.4 million shares at $0.93 per share for gross proceeds of $7.8 million. We estimate that the company currently has sufficient capital to fund operations into the fourth quarter of 2018, however it will require additional funds for the launch and commercialization of Twirla®, if approved.

Conclusion

Agile is set up for an exciting 2019, as all the pieces are in place for the resubmission of the Twirla® NDA and its potential approval in late 2019. The stock has had a nice run recently following the news of the positive adhesion study and the private placement, however we see additional upside in the shares ahead of all the catalysts to come in 2019. We believe the third time will be the charm and Twirla® will be approved in late 2019 with a commercial launch in 2020. We estimate peak sales of $400 million in 2027 and applying a 13% discount rate our discounted cash flow model yields a current valuation of $4 per share.

SUBSCRIBE TO ZACKS SMALL CAP RESEARCH to receive our articles and reports emailed directly to you each morning. Please visit our website for additional information on Zacks SCR.


https://finance.yahoo.com/news/agrx-numerous-catalysts-2019-…

[Lucky72]

March 12, 2019 at 4:15 PM EDT
Agile Therapeutics Reports Fourth Quarter and Full Year 2018 Financial Results


Cash Expected to Enable Company to Fund Operations into the Fourth Quarter of 2019

Company plans to resubmit Twirla NDA in second quarter of 2019

PRINCETON, N.J., March 12, 2019 (GLOBE NEWSWIRE) -- Agile Therapeutics, Inc. (Nasdaq: AGRX), a women's healthcare company, today reported financial results for the three months and year ended December 31, 2018 and provided a corporate update.

Fourth quarter 2018 and other recent corporate developments:

Twirla® Update

Formal Dispute Resolution Ended: As previously announced, in October 2018, the U.S. Food and Drug Administration’s (FDA) Office of New Drugs (OND) formally denied the Company’s formal dispute resolution (FDR) appeal and provided an alternative path forward for resubmission of the new drug application (NDA) for Twirla, the Company’s lead product candidate. In its FDR decision, the OND recommended that the Company conduct a comparative wear study to evaluate whether Twirla demonstrates a generally similar adhesion performance to Xulane®, the generic version of the previously marketed Ortho Evra® contraceptive patch, a product the FDA considers to have acceptable adhesion.

Comparative Wear Trial Completed: On February 11, 2019, the Company announced topline results of a comparative wear study of Twirla and Xulane®, which demonstrated that Twirla was statistically non-inferior to Xulane. The Company had previously reported that in its December 2018 meeting with FDA’s Division of Bone, Reproductive and Urologic Products, (DBRUP), DBRUP agreed that Twirla would show adequate adhesion if it demonstrated statistical non-inferiority to Xulane in this study.

NDA Resubmission Plans: The Company plans to resubmit its Twirla NDA in the second quarter of 2019. The planned resubmission is intended to be a complete response to the complete response letter the Company received from the FDA in December 2017 (2017 CRL) and will include the results from the comparative wear study, additional information on the Company’s manufacturing process, and other analyses responding to the 2017 CRL.

Financing Update

On March 4, 2019, the Company completed the sale of approximately 8.4 million shares of common stock at $0.93 per share to an institutional accredited investor through a private placement, resulting in gross proceeds of approximately $7.8 million.

“We are pleased to have completed our private placement and appreciate the support from our new investor,” said Al Altomari, Chairman and Chief Executive Officer of Agile. ”We believe we now have the funding in place to execute our regulatory strategy to seek the approval of Twirla. We continue to believe that Twirla, if approved, will provide women with an important contraception option they do not currently have – a once-weekly contraceptive patch designed to deliver a low dose of estrogen.”

Fourth Quarter Financial Results

Cash and cash equivalents: As of December 31, 2018, Agile had $7.8 million of cash and cash equivalents compared to $35.9 million of cash and cash equivalents as of December 31, 2017. The Company believes its cash and cash equivalents as of December 31, 2018 along with the proceeds from its private placement completed in March 2019, will be sufficient to meet its projected operating requirements into the fourth quarter of 2019. The Company will require additional capital to fund operating needs for the remainder of the fourth quarter of 2019 and beyond, which will include, among other items, the completion of its commercial plan for Twirla, if approved, which primarily includes validation of the commercial manufacturing process and the commercial launch, and advancing the development of its other potential product candidates.

Research and development (R&D) expenses: R&D expenses were $1.9 million for the quarter ended December 31, 2018 and $9.8 million for the year ended December 31, 2018, compared to $2.7 million and $14.4 million for the comparable periods in 2017. The decrease in R&D expenses was primarily due to a decrease in manufacturing and commercialization expenses reflecting reduced activity associated with the scale-up process and the on-going qualification process of the commercial manufacturing equipment primarily as a result of the receipt of the 2017 CRL.

General and administrative (G&A) expenses: G&A expenses were $1.6 million for the quarter ended December 31, 2018 and $8.7 million for the year ended December 31, 2018, compared to $3.3 million and $12.4 million for the comparable periods in 2017. The decrease in G&A expenses was primarily due to the suspension of pre-commercialization activities as a result of the receipt of the 2017 CRL.

Net loss: Net loss was $3.8 million, or $0.11 per share, for the quarter ended December 31, 2018, compared to a net loss of $6.2 million, or $0.18 per share, for the quarter ended December 31, 2017. Net loss for the year ended December 31, 2018 was $19.8 million, or $0.58 per share, compared to a net loss of $28.3 million or $0.91 per share for the year ended December 31, 2017.

Shares Outstanding: At December 31, 2018, Agile had 34,377,329 shares of common stock outstanding.

About Twirla® (AG200-15)

Twirla (ethinyl estradiol and levonorgestrel transdermal system) or AG200-15 is an investigational low-dose, once-weekly combined hormonal contraceptive (CHC) patch that contains the active ingredients ethinyl estradiol (EE), a type of estrogen and levonorgestrel (LNG), a type of progestin. Twirla is designed to be applied once weekly for three weeks, followed by a week without a patch. The Company has completed its Phase 3 clinical trials of Twirla and is pursuing regulatory approval in the U.S. Agile received a complete response letter (“CRL”) from the FDA in December 2017 relating to the New Drug Application (“NDA”) for Twirla. In the CRL, the FDA informed the Company that the product could not be approved in its present form. The Company plans to resubmit the Twirla NDA in the second quarter of 2019.

Xulane® is a registered trademark of Mylan N.V., and Ortho Evra® is a registered trademark of Johnson & Johnson.

About Agile Therapeutics, Inc.
Agile Therapeutics is a forward-thinking women's healthcare company dedicated to fulfilling the unmet health needs of today’s women. Our 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. Our lead product candidate, Twirla®, (ethinyl estradiol and levonorgestrel transdermal system), also known as AG200-15, is an investigational low-dose, non-daily prescription contraceptive. Twirla is based on our proprietary transdermal patch technology, called Skinfusion®, which is designed to allow drug delivery through the skin. For more information, please visit the company website at www.agiletherapeutics.com. The Company may occasionally disseminate material, nonpublic information on the Company’s website.

Forward-Looking Statement
Certain information contained in this press release includes “forward-looking statements”, within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, related to our regulatory submissions and projected cash position. We may, in some cases use terms such as “predicts,” “believes,” “potential,” “continue,” “anticipates,” “estimates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “likely,” “will,” “should” or other words that convey uncertainty of the future events or outcomes to identify these forward-looking statements. Our forward-looking statements are based on current beliefs and expectations of our management team that involve risks, potential changes in circumstances, assumptions, and uncertainties, including statements regarding statements regarding the fact that our existing cash and cash equivalents likely will not be sufficient to fund our current and planned operations beyond the fourth quarter of 2019, which raises substantial doubt about our ability to continue as a going concern, and which, in turn, may create negative reactions to the price of our common stock making it more difficult to obtain financing in the future, our expectations about Twirla and its NDA, and the use of the net proceeds of our recently completed private placement. Any or all of the forward-looking statements may turn out to be wrong or be affected by inaccurate assumptions we might make or by known or unknown risks and uncertainties. These forward looking statements are subject to risks and uncertainties including risks related to our available cash and our ability to obtain additional funding to fund our business plan without delay and to continue as a going concern, our ability to adequately and timely respond to the deficiencies in the second Twirla CRL issued by the FDA on December 21, 2017, the potential that the FDA determines that our data do not support resubmission or approval of Twirla NDA and requires us to conduct additional studies to address the concerns raised in the 2017 CRL, our ability to resubmit the Twirla NDA and obtain and maintain regulatory approval of our product candidates, and the labeling under any approval we may obtain, our ability to obtain a favorable Advisory Committee vote in the likely event the FDA requires an Advisory Committee to review the benefit and risk profile of Twirla, the accuracy of our estimates regarding expenses, future revenues, capital requirements and needs for additional financing, our third-party manufacturer, Corium International, Inc.’s (Corium) inability to complete any work or provide any data and other information necessary to support the resubmission and approval of our Twirla NDA, our ability along with Corium to complete successfully the scale-up of the commercial manufacturing process for Twirla, including the qualification and validation of equipment related to the expansion of Corium's manufacturing facility and to pass a likely FDA pre-approval inspection, the performance and financial condition of Corium or any of the suppliers to our third-party manufacturer, the success and timing of our clinical trials or other studies, our ability to retain key employees, regulatory and legislative developments in the United States and foreign countries, our plans to commercialize Twirla and develop our other potential product candidates, the size and growth of the potential markets for our product candidates and our ability to serve those markets, the rate and degree of market acceptance of any of our product candidates, our ability to obtain and maintain intellectual property protection for our product candidates, the successful development of our sales and marketing capabilities, our inability to timely obtain from our third-party manufacturer, Corium, sufficient quantities or quality of our product candidates or other materials required for a clinical trial or other tests and studies, our ability to successfully implement our strategy and the other risks set forth in our filings with the U.S. Securities and Exchange Commission, including our Annual Report on Form 10-K and our Quarterly Reports on Form 10-Q. For all these reasons, actual results and developments could be materially different from those expressed in or implied by our forward-looking statements. You are cautioned not to place undue reliance on these forward-looking statements, which are made only as of the date of this press release. We undertake no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstances.

Source: Agile Therapeutics

Contact: Investor Relations -- 609-683-1880


https://ir.agiletherapeutics.com/news-releases/news-release-…

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Läuft wohl richtung 2$