Supernus Pharmaceuticals

Supernus Pharmaceuticals announced a definitive agreement to acquire Sage Therapeutics for $8.50 per share upfront plus contingent payments up to $3.50 per share, totaling up to $795 million.

Supernus Pharmaceuticals agreed to acquire Sage Therapeutics for up to $795 million, offering $8.50 per share in cash plus contingent value rights worth $3.50 per share based on sales milestones.

Supernus Pharmaceuticals received Paragraph IV Notice Letters from third parties who submitted Abbreviated New Drug Applications (ANDAs) for generic versions of Qelbree (viloxazine extended-release capsules) in 100, 150, and 200 mg strengths.

• Supernus Pharmaceuticals' SPN-820, an mTORC activator for treatment-resistant depression, failed to demonstrate statistical significance against placebo in Phase IIb study, showing only a marginal 0.4-point difference in MADRS scores. • The disappointing results contrast with SPN-820's previous success in a Phase II major depressive disorder trial, where it showed rapid clinical improvement within four hours of dosing. • Following the trial failure, Supernus will analyze data and evaluate future development plans with partner Navitor Pharmaceuticals while focusing on their successful ADHD drug Qelbree.

• Sanofi has reached an agreement with CD&R to sell a 50% stake in its consumer health business Opella, with France's Bpifrance taking an additional 2% stake, deal expected to close in Q2. • Supernus Pharmaceuticals' experimental antidepressant SPN-820 failed to show significant improvement over placebo in a mid-stage study for treatment-resistant depression, sending shares down. • Gilead Sciences sets FDA decision deadline of June 2025 for lenacapavir as HIV pre-exposure prophylaxis (PrEP), potentially offering the first twice-yearly prevention option.

• The FDA is set to decide on Biogen and Eisai's Leqembi for monthly intravenous maintenance in early Alzheimer's disease, potentially improving patient convenience. • AstraZeneca and Daiichi Sankyo await a decision on Dato-DXd for metastatic HR-positive, HER2-negative breast cancer, offering a new antibody-drug conjugate approach. • Vertex's suzetrigine, a non-opioid analgesic for moderate-to-severe acute pain, anticipates FDA verdict, representing a novel drug class for pain management. • SpringWorks' mirdametinib is under priority review for neurofibromatosis type 1-associated plexiform neurofibromas, addressing a significant unmet need.

The FDA has approved ONAPGO (apomorphine hydrochloride) as the first subcutaneous apomorphine infusion device for treating motor fluctuations in advanced Parkinson's disease.

Supernus Pharmaceuticals' SPN-820, a novel mTORC1 modulator, demonstrated safety and efficacy as an adjunctive treatment for major depressive disorder in a Phase IIa trial.

Supernus Pharmaceuticals' SPN-820 demonstrated rapid and substantial improvement in major depressive disorder (MDD) symptoms within two hours in a Phase IIa trial.

The FDA issued a Complete Response Letter (CRL) for Supernus Pharmaceuticals' New Drug Application (NDA) for SPN-830 (apomorphine) for Parkinson's disease.