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...
BioCentury | Jan 11, 2020
Finance

Why buysiders say 2020 could be the year of the CNS

A pair of CNS approvals in the final days of 2019 has only added to the growing momentum buysiders were already tracking for 2020 in the once neglected disease area. Positive regulatory signals are converging...
BC Extra | Dec 30, 2019
Clinical News

Migraine readout completes December hat trick for surging Axsome

Axsome’s winning streak continued as its third auspicious clinical readout this month augurs a planned 2H20 NDA submission that could allow the company to carve out a niche for AXS-07 in acute migraine. Axsome Therapeutics...
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....
BioCentury | Jun 29, 2019
Finance

All eyes on new modality launches, cancer and rare disease data in 3Q19

While the typical summer lull means fewer catalysts in the third quarter, investors will be keeping a close eye on launches of new modality drugs. Of special interest to multiple buysiders is the launch of...
BC Extra | May 6, 2019
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...
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....
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