AXSM Axsome

AXS-12 NDA accepted; PDUFA set for May 1, 2027

FDA accepted the NDA for AXS-12 (reboxetine) for cataplexy in narcolepsy and assigned a PDUFA target action date of May 1, 2027. This establishes the next regulatory milestone for the asset.

Axsome: FDA accepts NDA for AXS-12 (reboxetine) in cataplexy; PDUFA May 1, 2027

FDA accepted the NDA for AXS-12 (reboxetine) for cataplexy in narcolepsy. The agency set a PDUFA target action date of May 1, 2027 and stated it does not currently plan to hold an advisory committee meeting.

Axsome initiates FOCUS-3 Phase 3 trial of solriamfetol in adolescent ADHD

Axsome has started the FOCUS-3 Phase 3 trial, dosing the first adolescent patient with ADHD. The randomized, double-blind, placebo-controlled study will enroll 468 patients aged 12-<18 years across two solriamfetol doses versus placebo for 6 weeks. Primary endpoint is change in ADHD-RS-5 total score at week 6.

Axsome settles all SUNOSI patent litigation with first-to-file generic

Axsome resolved all outstanding SUNOSI patent litigation by entering a settlement with the sole remaining first-to-file generic applicant. The agreement grants five companies the right to market generic solriamfetol on or after September 1, 2040 (with pediatric exclusivity) or March 1, 2040 (without), subject to FDA approval. No other SUNOSI patent litigation remains pending.

Axsome: FDA approves AUVELITY for Alzheimer’s agitation

FDA approved AUVELITY for agitation associated with dementia due to Alzheimer’s disease, expanding its label from MDD to a second indication. The company states the commercial launch is on track for June 2026. This approval adds a new, first-in-class indication to the marketed product.

Axsome Therapeutics: FDA approves AUVELITY for Alzheimer’s agitation

FDA approved AUVELITY (dextromethorphan HBr/bupropion HCl) for agitation associated with dementia due to Alzheimer’s disease. The approval was supported by Phase 3 ADVANCE-1 and ACCORD-2 trials showing statistically significant improvement in agitation symptoms and longer time to relapse versus placebo. AUVELITY received Breakthrough Therapy designation and Priority Review for this indication.

Axsome acquires balipodect (TAK-063) from Takeda for schizophrenia

Axsome obtained exclusive global rights to the selective PDE10A inhibitor balipodect via an asset purchase agreement with Takeda. The company plans to develop balipodect for schizophrenia and Tourette syndrome, with Phase 3 trial-enabling activities for schizophrenia slated to begin in 2026. Balipodect has already completed a 164-patient Phase 2 proof-of-concept trial in schizophrenia.

AXS-05 sNDA for Alzheimer’s agitation granted Priority Review, PDUFA April 30, 2026

The FDA accepted the sNDA for AXS-05 in Alzheimer’s disease agitation and granted Priority Review with a PDUFA target action date of April 30, 2026. AXS-05 already holds Breakthrough Therapy designation for this indication. The filing acceptance sets a firm regulatory timeline for potential approval.

Axsome settles SUNOSI patent litigation with Alkem; generic entry 2040

Axsome entered a settlement agreement with Alkem Laboratories resolving patent litigation over SUNOSI (solriamfetol). Alkem receives a license to market a generic version of SUNOSI on or after September 1, 2040 (or March 1, 2040 if no pediatric exclusivity is granted), subject to FDA approval and customary conditions.

AXS-05 sNDA for Alzheimer’s agitation accepted with April 30, 2026 PDUFA

FDA accepted the supplemental NDA for AXS-05 in Alzheimer’s agitation and granted Priority Review, setting a PDUFA target action date of April 30, 2026. The filing is supported by four Phase 3 trials and a long-term safety study. Priority Review shortens the FDA review clock to six months.

Axsome submits sNDA for AXS-05 in Alzheimer’s disease agitation

Axsome has submitted a supplemental NDA to the FDA for AXS-05 in Alzheimer’s disease agitation. The company plans to announce the FDA’s decision on acceptance of the filing. AXS-05 has Breakthrough Therapy designation for this indication.