BioCentury | Apr 27, 2020
Product Development

After hitting primary endpoint, Axsome planning second trial in Alzheimer’s agitation

Already headed for an FDA submission this year in depression, Axsome’s multimodal NMDA receptor agonist now has pivotal data for a second indication: agitation associated with Alzheimer’s disease. New data showing that AXS-05 significantly improved...
BioCentury | Mar 31, 2020
Product Development

March 30 Quick Takes: Axsome misses in treatment-resistant depression, on track for NDA; plus AstraZeneca and Innovent-Alector

Axsome dips on Phase III depression data  AXS-05 from Axsome Therapeutics Inc. (NASDAQ:AXSM) missed the primary endpoint of depressive symptoms compared with bupropion at week 6 in the Phase III STRIDE-1 trial for treatment-resistant depression....
BioCentury | Mar 20, 2020
Product Development

Axsome speeds Alzheimer's agitation trial, citing patient vulnerability and FDA guidance

While some biotechs are delaying or pausing clinical studies during the COVID-19 crisis, Axsome is hurrying one trial along to an early finish -- and citing FDA guidance issued this week as part of its...
BC Extra | Dec 17, 2019
Clinical News

Axsome continues ascent with Phase III success in depression

With its depression therapy meeting in Phase III and plans to submit an NDA next year, Axsome has more than quadrupled its market cap since October, when it received a bump from a Phase II...
BioCentury | Oct 16, 2019
Product Development

Relmada data offer hope of safer option for depression

Relmada more than doubled its share price Tuesday after reporting Phase II data hinting that REL-1017 could be as effective at treating depression as J&J’s Spravato without the psychotomimetic side effects that require physician monitoring....
BC Week In Review | Apr 25, 2019
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....
BioCentury | Apr 6, 2019

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...
BC Extra | Mar 25, 2019
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 --...
BC Week In Review | Jan 11, 2019
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...
BC Week In Review | Apr 27, 2018
Company News

Orexigen accepts $75M stalking horse bid

On April 23, Orexigen Therapeutics Inc. (NASDAQ:OREX) accepted a $75 million cash bid from an investor group including Pernix Therapeutics Holdings Inc. (NASDAQ:PTX) to acquire Orexigen assets including worldwide rights to obesity drug Contrave naltrexone/bupropion....
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