Narcolepsy can lead to excessive daytime sleepiness, as well as cataplexy, a sudden loss of muscle tone. Other symptoms can include sleep paralysis and hallucinations that occur both during sleep ...
The FDA has granted Breakthrough Therapy designation to alixorexton for the treatment of narcolepsy type 1 (NT1).
Alkermes plc (Nasdaq: ALKS) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to alixorexton for the treatment of narcolepsy type 1 (NT1), ...
Alkermes wins FDA Breakthrough Therapy status for alixorexton in NT1 after Vibrance-1 data shows improvement in wakefulness.
TipRanks on MSN
Alkermes gains FDA breakthrough status for narcolepsy drug
The latest announcement is out from Alkermes ( (ALKS) ).
Potential blockbusters and root-cause treatments from Eli Lilly, Merck, Takeda and others could get a regulatory nod this ...
The biopharmaceutical company accepted for filing a supplemental new drug application for AXS-05 to treat Alzheimer's disease agitation, and has granted the application priority review designation, ...
PLYMOUTH MEETING, Pa.-- (BUSINESS WIRE)--January 12, 2026-- ...
Alkermes (ALKS) shifts to fully integrated biopharma, leveraging Vibrance-2, Lybalvi growth, and Avadel buy to de-risk ...
Axsome Therapeutics AXSM announced the initiation of the phase III study called FORWARD with the dosing of the first patient, ...
Clinical Trials Arena on MSN
Axsome begins Phase III AXS-14 FORWARD trial for fibromyalgia management
Axsome Therapeutics has initiated the FORWARD Phase III trial evaluating AXS-14 for the management of fibromyalgia, with the ...
WAKIX 2025 Preliminary Net Revenue of ~$868 Million; 2026 WAKIX Net Revenue Guidance of $1.0 – $1.04 Billion on Track for Blockbuster Status in NarcolepsyOn Track to Extend the Pitolisant Franchise ...
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