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 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 | 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 | 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 | 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 --...
BioCentury | Mar 21, 2019
Company News

FDA approves Jazz's Sunosi for daytime sleepiness

...approval after market close on Wednesday. Brian Moy, Assistant Editor Solriamfetol (JZP-110, adx-n05, ARL-N05, SKL-N05) Jazz Pharmaceuticals plc Dopamine transporter Norepinephrine transporter Excessive...
BioCentury | Mar 13, 2019
Company News

FDA approves Aerie glaucoma therapy Rocklatan

...fixed-dose combination of Aerie's Rhopressa netarsudil 0.02%, a dual inhibitor of Rho kinase and the norepinephrine transporter...
...after market close, when it announced the approval. Chris Lieu, Staff Writer Rocklatan, Roclatan, netarsudil/latanoprost (PG324) Aerie Pharmaceuticals Inc. Norepinephrine transporter Rho...
BioCentury | Feb 22, 2019
Targets & Mechanisms

Solid checkpoint for CARs

...targeted therapies and neuroblastoma three targeted therapies -- two against GD2 and one against the norepinephrine transporter...
BioCentury | 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...
BioCentury | Aug 10, 2018
Financial News

Zogenix, Progenics raise follow-ons

...von Emster Azedra (iobenguane i 131, ultratrace i-131-mibg, ultratrace iobenguane i 131) fenfluramine (ZX008, brabafen) Progenics Pharmaceuticals Inc. Zogenix Inc. Norepinephrine transporter Serotonin...
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