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AGRX

Agile Therapeutics

$0.79

0.0101 (1.29%)

16:17
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Agile Therapeutics provides regulatory update, reaffirms cash guidance

Agile Therapeutics announced that on January 9, 2019 it received final meeting minutes from its December 11, 2018 meeting with the U.S. Food and Drug Administration's Division of Bone, Reproductive, and Urologic Products. The company met with DBRUP to discuss the design of a comparative wear study between Twirla and Xulane as suggested by FDA's Office of New Drugs in its decision on the company's previously announced formal dispute resolution request. In its meeting with DBRUP, the company discussed the specific design and success criteria of the comparative wear study, which is intended to demonstrate adequate adhesion via non-inferiority of Twirla to Xulane, the generic version of the previously marketed Ortho Evra contraceptive patch, a product the FDA considers to have acceptable adhesion. After consultation with DBRUP, the company has initiated a crossover wear study in approximately 80 healthy women with a Body Mass Index of less than 35 kg/m2 who will be randomized to wear either Twirla or Xulane for the first week and then switched to the patch not initially worn for the second week. The overall design of this comparative wear study follows the FDA's guidance with respect to abbreviated new drug applications, entitled Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs. The FDA has previously informed the company that in connection with its review of the Twirla NDA, the FDA plans to bring the safety and efficacy of Twirla to an Advisory Committee. The company also expects that the FDA will conduct a pre-approval inspection of the company's third-party manufacturer's facility, which must be successfully completed prior to approval. The company believes that its unaudited cash and cash equivalents as of December 31, 2018, will be sufficient to meet its projected operating requirements into the second quarter of 2019, which will include completion of the comparative wear study. The company will require additional capital to fund operating needs for the remainder of the second quarter of 2019 and beyond, including among other items, preparation for an anticipated Advisory Committee meeting to discuss safety and efficacy of Twirla, the completion of its commercial plan for Twirla, which primarily includes validation of the commercial manufacturing process and the commercial launch of Twirla, if approved, and advancing the development of its other potential product candidates.

AGRX Agile Therapeutics
$0.79

0.0101 (1.29%)

05/21/18
HCWC
05/21/18
NO CHANGE
Target $4
HCWC
Buy
Agile Therapeutics price target lowered to $4 from $8 at H.C. Wainwright
H.C. Wainwright analyst Oren Livnat lowered his price target for Agile Therapeutics to $4 but keeps a Buy rating on the shares. Agile's updated regulatory status of Twirla-weekly transdermal contraceptive patch "was not pretty," Livnat tells investors in a research note. The FDA is now concerned with the patch detachment rate, in and of itself, and is unmoved by Agile's plan to deal with detached patches in practice, he adds. The analyst pushed out his estimate for the new drug application filing to Q1 of 2019 from Q3 of 2018. He also applies a lower 40% probability of success. However, Livnat views the risk/reward on shares of Agile Therapeutics as "extremely positive" at current stock levels.
05/21/18
RBCM
05/21/18
NO CHANGE
Target $3
RBCM
Outperform
Agile Therapeutics price target lowered to $3 from $7 at RBC Capital
RBC Capital analyst Randall Stanicky lowered his price target on Agile Therapeutics to $3, saying the minutes of its meeting with the FDA regarding Twirla suggest a more challenging path toward approval ahead that will likely hinge on dispute resolution. Longer term, the analyst keeps his Outperform rating on Agile Therapeutics, noting that the Twirla contraceptive patch offers convenience and compliance benefits that would "appeal to the core patient base". Stanicky adds that he still sees a "moderate" likelihood of Twirla approval through the dispute resolution process with the FDA.
10/09/18
HCWC
10/09/18
NO CHANGE
Target $4
HCWC
Buy
Agile dispute resolution for Twirla a positive, says H.C. Wainwright
H.C. Wainwright analyst Oren Livnat views Agile Therapeutics' outcome from the Formal Dispute Resolution for Twirla as a positive. Since typical wear studies are short one-week Phase 1 studies, the analyst assumes any reasonable study could "hopefully" start before end of 2018 and be done within three months. The Office of New Drugs indicated Agile should only have to show Twirla similar adhesion to Xulane to satisfy remaining adhesion questions before resubmitting the new drug application, Livnat tells investors in a research note. He expects a Twirla NDA resubmission in the first half of 2019, which would only be a potential short delay versus his prior Q1 of 2019 expectation. Livnat maintains his projection for Twirla approval by end of 2019 with a launch in 2020. However, he expects Agile will have to raise money, once to get through regulatory, another before launch, and assumes "substantial dilution before launch." While he pushed out his revenue estimates, the analyst still see peak sales greater than $400M for Twirla. He reiterates a Buy rating on Agile Therapeutics with a $4 price target.
11/29/18
MAXM
11/29/18
INITIATION
Target $3
MAXM
Buy
Agile Therapeutics initiated with a Buy at Maxim
Maxim analyst Caroline Palomeque initiated Agile Therapeutics (AGRX) with a Buy rating and a price target of $3, saying that she likes the risk-reward on the stock as the company approaches an NDA resubmission for its Twirla - a low-dose combined hormone contraceptive transdermal patch. The analyst cites the large potential market opportunity for the product, with combined hormone contraceptive market generating about $4B and the current patch availability being limited to Mylan's (MYL) Xulane. Palomeque further contends that Twirla "offers a low-dose, safer estradiol, potentially with no 'black box' warning."

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