Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) announced that the FDA issued a Complete Response Letter (CRL) for its supplemental New Drug Application (sNDA) for Nuplazid (pimavanserin) for the treatment of hallucinations and delusions associated with dementia-related psychosis (DRP). The CRL cited a lack of statistical significance in some of the subgroups of dementia, and insufficient numbers of patients with certain less common dementia subtypes as lack of substantial evidence of effectiveness to support approval. The company noted that the FDA had agreed to the trial design and the FDA did not raise any concerns regarding the agreed upon study design, including the issues raised in the CRL. Shares fell 17% to $21.18.
Molecular Templates (NASDAQ:MTEM) shares closed Monday down 23% to $9.51 following news it will assume full rights of TAK-169 from its partner Takeda (NYSE:TAK) following Takeda's decision to reprioritize its pipeline. Molecular Templates also announced that it is discontinuing the development of MT-3724, which had previously been placed on clinical hold.
Supernus Pharmaceuticals (NASDAQ:SUPN) announced over the holiday weekend that the FDA approved Qelbree for the treatment of attention-deficit hyperactivity disorder (ADHD) in pediatric patients between the ages of 6 to 17. Shares closed up 13% to $30.11.
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Major price movers (stocks priced > $1.00, volume > 50k listed on NASDAQ/NYSE):
Refer to the BioPharmCatalyst Biotech Stocks page for Top 10 Gainers/Losers/Unusual Volume:
ADVANCERS:
Delcath Systems, Inc. (DCTH): $15.10; +23%.
Greenwich LifeSciences, Inc. (GLSI): $42.39; +22%.
Nurix Therapeutics, Inc. (NRIX): $35.89; +16%.
GT Biopharma, Inc. (GTBP): $8.24; +15%.
Protalix BioTherapeutics, Inc. (PLX): $5.13; +14%.
DECLINERS:
Cyclerion Therapeutics, Inc. (CYCN): $2.96; -10%.
Auris Medical Holding Ltd. (EARS): $3.09; -10%.
Ikena Oncology, Inc. (IKNA): $23.50; -10%.
Aptevo Therapeutics Inc. (APVO): $25.60; -10%.
Benitec Biopharma Inc. (BNTC): $5.28; -9%.
Pipeline updates below: