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Axsome FDA application accepted for 2027 target date

Axsome Therapeutics announced that the FDA has accepted its New Drug Application (NDA) for AXS-12, a treatment for cataplexy in narcolepsy. This acceptance sets a formal target action date of May 1, 2027, for the drug, which is designed to address the sudden loss …

Axsome gets FDA filing acceptance for narcolepsy drug AXS-12

Axsome Therapeutics has announced that the FDA has accepted its New Drug Application for AXS-12 (reboxetine) to treat cataplexy in narcolepsy patients, setting a target action date of May 1, 2027. The drug, which has Orphan Drug Designation, targets the sudden muscle tone loss …

Axsome gains FDA review for narcolepsy therapy (AXSM:NASDAQ)

Axsome Therapeutics' shares rose in premarket trading after the U.S. FDA accepted its marketing application for AXS-12 (reboxetine), an experimental therapy for narcolepsy. This marks a significant step for the neurology drug developer in bringing its treatment to market.

FDA accepts Axsome Therapeutics (NASDAQ: AXSM) AXS-12 narcolepsy NDA

Axsome Therapeutics announced that the FDA has accepted its New Drug Application (NDA) for AXS-12 (reboxetine) for the treatment of cataplexy in narcolepsy. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of May 1, 2027, and does not …

Axsome Therapeutics Announces FDA Acceptance of NDA for AXS-12 in Narcolepsy Cataplexy; PDUFA Date Set for May 1, 2027

Axsome Therapeutics has announced that the FDA has accepted its New Drug Application (NDA) for AXS-12, a treatment for cataplexy in narcolepsy, setting a PDUFA target action date of May 1, 2027. The FDA does not plan to hold an advisory committee meeting for …

Axsome Therapeutics Announces FDA Acceptance of New Drug Application for AXS-12 for the Treatment of Cataplexy in Narcolepsy

Axsome Therapeutics announced that the FDA has accepted its New Drug Application (NDA) for AXS-12 (reboxetine) for treating cataplexy in narcolepsy, setting a PDUFA target action date of May 1, 2027. The FDA does not currently plan to hold an advisory committee meeting for …

Axsome’s 60% quarter pauses with a 127% Fair Value premium and lighter volume

AXSM slipped 1.8% for the week but remains only 3.7% below its 52-week high, leaving a constructive trend intact while confirmation has become less forceful.

Axsome Therapeutics Inc (AXSM) extends its CNS-drug stock run

The weekly setup remains active, with improved market pressure offset by only moderate relative-strength confirmation.

Axsome Therapeutics Inc (AXSM) pushes 12-week advance to 62.6%

The CNS-focused biotech remains in an active trend, but confirmation is measured rather than broad-based.

Axsome Therapeutics Inc (AXSM) finishes week 9.8% higher in active trend

The CNS-therapy developer’s twelve-week return is now 62.6%, putting the move in a broader biotech rebound rather than a single-week move.

Accsys Technologies sees promising US volume growth

Accsys Technologies PLC 2026 Q4 - Results - Earnings Call Presentation (OTCMKTS:ACSYF) 2026-06-16

Accsys flags record Accoya sales, strong revenue growth

Accsys Technologies shares rise 10% on upgraded guidance

Accsys Technologies PLC: koersdoel en analistenconsensus | AXS | GB00BQQFX454