Axsome Therapeutics Announces Planned NDA Submission for AXS-14 for the Management of Fibromyalgia [Financial Post (Toronto, Ontario, Canada)]
Axsome Therapeutics, Inc. (AXSM)
Last axsome therapeutics, inc. earnings: 3/12 07:00 am
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Source: Financial Post
NEW YORK, June 15, 2021 (GLOBE NEWSWIRE) — Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced its plan to submit a New Drug Application (NDA) for AXS-14 for the management of fibromyalgia following a pre-NDA meeting with the U.S. Food and Drug Administration (FDA). AXS-14 (esreboxetine) is a novel, oral, potent, and highly selective norepinephrine reuptake inhibitor. The NDA submission is currently anticipated in the fourth quarter of 2022 pending successful completion of manufacturing and other activities related to the product candidate. Acceptance of the NDA will be subject to the FDA's review of the complete filing. “Fibromyalgia is a debilitating central nervous system condition with limited treatment options. Results from two placebo-controlled trials demonstrate the potential for AXS-14 to significantly improve the symptoms of this serious condition,” s
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News
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- Axsome Therapeutics, Inc. (NASDAQ: AXSM) had its "buy" rating re-affirmed by analysts at Truist Financial Co.. They now have a $150.00 price target on the stock.MarketBeat
- Axsome Therapeutics, Inc. (NASDAQ: AXSM) had its price target raised by analysts at HC Wainwright from $180.00 to $190.00. They now have a "buy" rating on the stock.MarketBeat
- Axsome Therapeutics, Inc. (NASDAQ: AXSM) had its price target raised by analysts at Citigroup Inc. from $125.00 to $127.00. They now have a "buy" rating on the stock.MarketBeat
AXSM
Earnings
- 2/20/24 - Miss
AXSM
Sec Filings
- 3/25/24 - Form 8-K
- 3/25/24 - Form 8-K
- 3/19/24 - Form 8-K
- AXSM's page on the SEC website