19:37 , May 6, 2019 |  BC Extra  |  Company News

May 6 Company Quick Takes: Esperion, BioMarin, WuXi AppTec, Axsome, Harbour BioMed/CTTQ, GW, Adynxx

FDA accepts Esperion NDAs for LDL-C-lowering indications  Esperion Therapeutics Inc. (NASDAQ:ESPR) gained $5 (12%) to $48.24 on Monday after FDA accepted for review a pair of NDAs for bempedoic acid (ETC-1002) and a bempedoic acid/ezetimibe...
21:50 , Apr 25, 2019 |  BC Week In Review  |  Clinical News

Axsome's AXS-05 meets in Phase II for smoking cessation

Axsome said twice-daily AXS-05 met the primary endpoint of reducing the mean number of cigarettes smoked per day assessed over a 3-week period vs. bupropion in a Phase II trial for smoking cessation (8.49 vs....
00:04 , Apr 6, 2019 |  BioCentury  |  Finance

Everybody up

Biotech stocks were off to a strong start in 1Q19, with 71% of companies tracked by BioCentury seeing market cap growth in the quarter. Across all market cap bands, biotechs saw a median gain of...
21:05 , Mar 25, 2019 |  BC Extra  |  Clinical News

Avanir's AVP-786 meets in Phase III for Alzheimer's agitation

Avanir said one of two doses of AVP-786 met the primary endpoint of improving agitation symptoms in the Phase III 15-AVP-786-301 trial to treat agitation in patients with Alzheimer's dementia. AVP-786 comprises deuterium-modified dextromethorphan --...
17:47 , Jan 11, 2019 |  BC Week In Review  |  Clinical News

Axsome's AXS-05 meets in Phase II for MDD

Axsome Therapeutics Inc. (NASDAQ:AXSM) added $4.24 (161%) to $6.87 on Jan. 7 after reporting that AXS-05 met the primary endpoint in the Phase II ASCEND trial to treat moderate-to-severe major depressive disorder (MDD). On the...
22:10 , Jan 7, 2019 |  BC Extra  |  Clinical News

Sage rebounds after next-gen postpartum depression readout

Sage Therapeutics Inc. (NASDAQ:SAGE) gained $41.62 (43%) to $139.13 on Monday after it said SAGE-217 met the primary endpoint in the Phase III ROBIN trial to treat women with severe postpartum depression. The move translates...
18:16 , Jan 12, 2018 |  BC Week In Review  |  Clinical News

IDMC recommends discontinuing Phase III of Axsome's AXS-02 for complex regional pain syndrome

Axsome Therapeutics Inc. (NASDAQ:AXSM) said an IDMC recommended discontinuing for futility the Phase III CREATE-1 trial of once-weekly oral AXS-02 (disodium zoledronate tetrahydrate) for six weeks to treat pain associated with complex regional pain syndrome...
18:02 , Jan 12, 2018 |  BC Week In Review  |  Clinical News

IDMC recommends continuation of Phase III knee OA trial for Axsome's AXS-02

Axsome Therapeutics Inc. (NASDAQ:AXSM) said an IDMC recommended continuing the Phase III COAST-1 trial of AXS-02 (disodium zoledronate tetrahydrate) to treat pain caused by osteoarthritis (OA) of the knee associated with bone marrow lesions following...
00:38 , Jan 6, 2018 |  BioCentury  |  Finance

Burgeoning bellwethers

  The miserable performance of large cap biotechs last quarter is likely to be a boon for small- and mid-cap players this year, in more ways than one. Buysiders spent most of 2017 focusing to...
04:17 , Dec 8, 2017 |  BC Week In Review  |  Financial News

Axsome raises $9.5M in direct offering

CNS company Axsome Therapeutics Inc. (NASDAQ:AXSM) raised $9.5 million through the sale of 1.8 million units at $5.33 in a registered direct offering led by HC Wainwright. Each unit represents one share of common stock...