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AGRX

Agile Therapeutics

$3.37

-0.1 (-2.88%)

14:16
05/07/17
05/07
14:16
05/07/17
14:16

Agile Therapeutics reports additional data from Phase 3 Twirla study

Agile Therapeutics announced the presentation of additional results of its Phase 3 SECURE trial of its investigational low-dose combination hormone contraceptive patch, Twirla. The summary of SECURE clinical trial results, which included new data on the bleeding profile of clinical trial subjects, was presented at the Annual Clinical and Scientific Meeting of the American Congress of Obstetricians and Gynecologists. Regarding the bleeding profile, analyses demonstrated that unscheduled bleeding/spotting days per month decreased from a mean of 3.1 days in Cycle 1 to 1.6 days in Cycle 13. In addition, scheduled bleeding/spotting remained consistent during all cycles, with a reported mean of 3.1 to 3.7 days per month. "We are pleased with the results of the SECURE trial and believe our study may set a new standard for hormonal contraceptive studies. Our study entry criteria resulted in the inclusion of a real-world study population, including women who have frequently been underrepresented in past contraceptive studies," noted Agile.

AGRX Agile Therapeutics
$3.37

-0.1 (-2.88%)

01/04/17
JANY
01/04/17
NO CHANGE
Target $15
JANY
Buy
Selloff an overreaction to Agile Therapeutics data, says Janney Capital
Janney Capital analyst Ken Trbovich contends that the market over reacted to the Pearl Index reported by Agile Therapeutics from its Phase 3 SECURE clinical trial of Twirla, noting that the contraceptive patch's reported PI is greater than the reference set by the product with the highest approved PI. As trials become more representative of real-world populations, PI has consistently increased in FDA-approved products over the past 35 years, said Trbovich, who keeps a Buy rating on Agile and argues that Twirla can still gain FDA approval.
01/04/17
WBLR
01/04/17
NO CHANGE
WBLR
Outperform
William Blair thinks Agile approval 'not out of the question'
While the Pearl score data in last night's Phase 3 SECURE trial was below expectations, there is not a zero percent probability of approval for Agile Therapeutics' Twirla upon resubmission, William Blair analyst Tim Lugo tells investors in a research note. The data suggest a less effective contraception than its peers, but Twirla has a potential route for approval considering the product's safety versus Ortho Evra and known issues with running contraception trials, the analyst contends. He believes the probability of approval is likely under 50%, however. Lugo keeps an Outperform rating on shares of Agile with the stock trading down 61% to $1.97 in the pre-market.
01/27/17
RBCM
01/27/17
NO CHANGE
RBCM
Agile Therapeutics shares undervalued, says RBC Capital
After meeting with Agile Therapeutics' management, RBC Capital analyst Randall Stanicky believes that the stock does not "appropriately price in" a possible rally in the shares. The analyst says that the company has a "solid case" for FDA approval of its lead contraceptive patch, Twirla, He adds that Agile could be acquired if the patch is approved in Q4, in-line with the company's target. The analyst keeps an $8 price target and an Outperform rating on the shares. .
03/06/17
03/06/17
NO CHANGE

FBR sees 'prime' merger environment for biotechs under Trump
Potential tax reform and FDA policy changes under President Trump could "prime the pump" for acquisitions of clinical-stage biotech companies by Big Pharma, FBR Capital analysts led by Chris Meekins tell investors in a research note. These police moves, coupled with the repeal of some taxes associated with the Affordable Care Act, are likely to increase funds for companies looking to make acquisitions, the analysts contend. Within its coverage universe, FBR sees TESARO (TSRO), Agile Therapeutics (AGRX), Kite Pharma (KITE), Juno Therapeutics (JUNO), Acceleron Pharma (XLRN), Abeona Therapeutics (ABEO), Aurinia Pharmaceuticals (AUPH), Geron (GERN) and Genocea Biosciences (GNCA) as "primary targets for those looking to make acquisitions."

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