21:28 , Apr 18, 2019 |  BC Extra  |  Financial News

RNA-targeting small molecule company Arrakis raises $75M series B

Arrakis raised $75 million in a series B round led by venBio and Nextech Invest. Also participating were new investors Omega Funds, HBM Healthcare Investments, GV, WuXi AppTec Co. Ltd. (Shanghai:603259; HKSE:2359) and Alexandria Venture...
00:51 , Mar 9, 2019 |  BC Extra  |  Clinical News

AMAG sinks after Makena misses confirmatory trial

AMAG lost $2.43 (18%) to $11.29 on Friday after reporting that intramuscular Makena hydroxyprogesterone caproate -- the drug that created a political firestorm over its pricing eight years ago -- missed the co-primary endpoints in...
00:23 , Jan 12, 2019 |  BioCentury  |  Finance

We all fall down

After an exuberant third quarter that put biotech indexes near their 2015 highs, all market cap tiers fell in 4Q18, eliminating the first nine month’s gains and losing $291.2 billion in aggregate value. Median losses...
17:10 , Nov 16, 2018 |  BC Week In Review  |  Clinical News

FDA approves Antares' Xyosted testosterone replacement therapy

FDA approved in October Xyosted from Antares Pharma Inc. (NASDAQ:ATRS) as a testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone. Antares expects launch the drug by...
23:09 , Apr 6, 2018 |  BioCentury  |  Finance

Fundamentally driven

Continued struggles by the mega-cap bellwethers and the resurgence of volatility in global equity markets were the major themes of 1Q18, whipsawing biotech stocks throughout the quarter but leaving index values little changed on the...
20:45 , Feb 16, 2018 |  BC Week In Review  |  Clinical News

FDA approves AMAG's new Makena formulation

FDA approved an sNDA from AMAG Pharmaceuticals Inc. (NASDAQ:AMAG) for subcutaneous Makena hydroxyprogesterone caproate injection to reduce the risk of preterm birth in women who spontaneously delivered one preterm baby in the past. AMAG plans...
22:42 , Feb 15, 2018 |  BC Extra  |  Company News

AMAG gets second FDA approval in two weeks

FDA approved an sNDA from AMAG Pharmaceuticals Inc. (NASDAQ:AMAG) for subcutaneous Makena hydroxyprogesterone caproate injection to reduce the risk of preterm birth in women who spontaneously delivered one preterm baby in the past. AMAG jumped...
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,...
21:38 , Oct 27, 2017 |  BC Week In Review  |  Clinical News

FDA issues CRL for Antares' hypogonadism candidate

Antares Pharma Inc. (NASDAQ:ATRS) said FDA issued a complete response letter for Xyosted to treat hypogonadism. The company said the CRL raised concerns that Xyosted could lead to a clinically meaningful increase in blood pressure,...
15:17 , Oct 23, 2017 |  BC Extra  |  Clinical News

FDA issues CRL for Antares' hypogonadism candidate

Antares Pharma Inc. (NASDAQ:ATRS) said FDA issued a complete response letter for Xyosted to treat hypogonadism. The company said the CRL raised concerns over a clinically meaningful increase in blood pressure and the occurrence of...