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...
23:25 , 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...
20:06 , Oct 20, 2017 |  BC Week In Review  |  Clinical News

FDA identifies deficiencies in Antares' Xyosted NDA

On Oct. 13, Antares Pharma Inc. (NASDAQ:ATRS) said FDA identified unspecified deficiencies in an NDA for Xyosted testosterone enanthate that preclude continuing discussions about labeling and postmarketing requirements at this time. The company had said...
22:06 , Oct 13, 2017 |  BC Extra  |  Company News

Antares falls on Xyosted update

Antares Pharma Inc. (NASDAQ:ATRS) plummeted $1.41 (38%) to $2.32 on Friday following its announcement late Thursday that FDA has identified unspecified deficiencies in the NDA for Xyosted testosterone enanthate that preclude continuing discussions about labeling...
23:10 , Oct 6, 2017 |  BioCentury  |  Finance

Coasting on catalysts

While buysiders do not expect any sector-moving milestones in the wake of a catalyst-heavy third quarter, they will have at least 21 Phase III milestones and 23 PDUFA dates on their radar. But the biggest...
00:20 , Jul 8, 2017 |  BioCentury  |  Finance

A clinical quarter

Buysiders will find themselves digesting at least 23 Phase III data readouts in the next quarter, two of which could provide clarity on increasingly competitive markets in lung cancer and hemophilia. The third quarter is...
17:12 , Dec 27, 2016 |  BC Week In Review  |  Clinical News

QuickShot Testosterone regulatory update

Antares said it submitted an NDA to FDA for QuickShot Testosterone to treat hypogonadism. The product is testosterone enanthate delivered using Antares' QuickShot subcutaneous auto-injector. Antares Pharma Inc. (NASDAQ:ATRS), Ewing, N.J.  Product: QuickShot Testosterone ,...