00:21 , Aug 6, 2019 |  BC Extra  |  Company News

Management tracks: Allogene snags Adaptimmune's Amado; plus Foundation Medicine, CymaBay and more

CAR T therapy company Allogene Therapeutics Inc . (NASDAQ:ALLO) hired Rafael G. Amado as EVP of R&D and CMO, effective Sept. 3. He was president of R&D at Adaptimmune Therapeutics plc (NASDAQ:ADAP). Allogene Executive Chairman...
23:56 , Jul 1, 2019 |  BC Extra  |  Company News

Management Tracks: BioCryst hires its first CBO; plus ObsEva, Veracyte and more

Rare disease company BioCryst Pharmaceuticals Inc. (NASDAQ:BCRX) hired Megan Sniecinski as its first CBO. She was SVP of business operations and program management at PTC Therapeutics Inc. (NASDAQ:PTCT). Reproductive health company ObsEva S.A. (NASDAQ:OBSV; SIX:OBSN)...
00:02 , Jun 26, 2019 |  BC Extra  |  Company News

June 25 Company Quick Takes: Conatus restructuring; plus Almirall-Dermira, Acer, Glenmark and more

Conatus cuts headcount by 40% to extend runway  Conatus Pharmaceuticals Inc. (NASDAQ:CNAT) said it will lay off 40% of its staff and suspend development of caspase 1 inhibitor CTS-2090 in a bid to extend its...
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...