23:25 , Jan 9, 2018 |  BioCentury  |  Finance

Stars in China

A major clinical flop and a spate of weak earnings reports by U.S. large cap biotechs reverberated throughout the sector in the fourth quarter, breaking a three-quarter-long streak of outperformance. Across all market cap bands,...
17:38 , Jan 5, 2018 |  BC Week In Review  |  Clinical News

Agile gets second CRL for Twirla

Agile Therapeutics Inc. (NASDAQ:AGRX) said on Dec. 22, 2017, that FDA issued a second complete response letter for Twirla (AG200-15), a once-weekly transdermal contraceptive patch. Agile said the CRL "identifies deficiencies relating to quality adhesion...
20:33 , Dec 22, 2017 |  BC Extra  |  Company News

Agile gets second CRL for Twirla

Agile Therapeutics Inc. (NASDAQ:AGRX) was off $2.24 (47%) to $2.52 on Friday after FDA issued a second complete response letter for Twirla (AG200-15), its once-weekly transdermal contraceptive patch. Agile said the CRL "identifies deficiencies relating...
23:29 , Oct 6, 2017 |  BioCentury  |  Finance

High as a Kite

The acquisition of Kite Pharma Inc. by Gilead Sciences Inc. turned what would have been a flattish quarter into another period of outperformance, and relieved the cash constraints that could have prevented specialists from continuing...
23:07 , Aug 28, 2017 |  BC Week In Review  |  Clinical News

FDA reviewing Agile's resubmitted NDA for contraceptive

Agile Therapeutics Inc. (NASDAQ:AGRX) said FDA accepted for review its resubmitted NDA for Twirla (seven-day contraceptive patch, AG200-15). Its PDUFA date is Dec. 26. FDA issued a complete response letter in 2013, requesting an additional...
20:31 , Apr 21, 2017 |  BC Week In Review  |  Clinical News

Twirla: Ph III SECURE data

The open-label, U.S. Phase III SECURE trial in 2,032 sexually active healthy women ages ≥18 who were at risk for pregnancy showed that once-weekly transdermal Twirla for 12 months demonstrated comparable contraceptive efficacy as measured...
07:00 , Apr 4, 2016 |  BioCentury  |  Finance

Fundamental reset

Steve Edelson, Senior Editor   After three months of carnage, buysiders acknowledge their conservative prediction of biotech keeping pace with the broader markets is unlikely to occur this year. Instead, investors are looking for the...
08:00 , Feb 8, 2016 |  BC Week In Review  |  Financial News

Agile Therapeutics financial update

Agile Therapeutics Inc. (NASDAQ:AGRX), Princeton, N.J.   Business: Genitourinary, Endocrine/Metabolic   Date announced: 2016-02-04   Note: Agile Therapeutics raised $5.2 million through the sale of 826,771 shares at $6.35 to cover the overallotment from its...
08:00 , Jan 25, 2016 |  BC Week In Review  |  Financial News

Agile Therapeutics completes follow-on

Agile Therapeutics Inc. (NASDAQ:AGRX), Princeton, N.J.   Business: Genitourinary, Endocrine/Metabolic   Date completed: 2016-01-22   Type: Follow-on   Raised: $35 million   Shares: 5.5 million   Price: $6.35   Shares after offering: 27.8 million  ...
08:00 , Mar 2, 2015 |  BC Week In Review  |  Financial News

Agile Therapeutics Inc completes debt financing

Agile Therapeutics Inc . (NASDAQ:AGRX), Princeton, N.J.   Business: Genitourinary, Endocrine/Metabolic   Date completed: 2015-02-24   Type: Debt financing   Raised: $16.5 million   Investor: Hercules Technology Growth Capital   Note: Agile Therapeutics drew down...