Soleno Therapeutics: Patient Death and Vykat XR Scrutiny
Soleno's stock dipped after a PWS patient died. Company & doctor say death (pulmonary embolus) was unrelated to VYKAT XR, citing patient's co-morbidities & PWS risks.
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Hims & Hers Revolutionizes Low Testosterone Treatment for Men
Hims & Hers launched affordable, personalized low T treatments to boost energy & sexual health. They offer enclomiphene now, and in 2026, will add FDA-approved oral KYZATREX through a partnership with Marius Pharmaceuticals, plus injectables. Patients start with at-home blood tests.
Travere's FILSPARI: Nearing FDA Approval for FSGS Patients
FILSPARI (sparsentan) for rare kidney disease FSGS is close to FDA approval, with no advisory committee needed! It's the 1st potential treatment, showing strong trial results by reducing protein in urine and lowering kidney failure risk. PDUFA date: Jan 13, 2026.
FDA Fast Tracks Promising Immunotherapy Greenwich's GLSI-100 for Breast Cancer Recurrence
FDA Fast-Tracks GLSI-100, an immunotherapy for HER2+ breast cancer. It aims to prevent recurrence in HLA-A*02 patients. Early data showed >80% reduction in recurrence & good safety. Now in Phase III, it could save lives by preventing metastatic spread.
Ionis' ION582: Breakthrough Therapy for Angelman Syndrome
ION582, a new medicine for Angelman Syndrome, received FDA Breakthrough status! It aims to fix the root cause, showing early promise in improving communication, thinking, and movement for this severe neurological condition.
UnitedHealth Expects Most MA Members in 4 Star or Higher Plans
UnitedHealth is meeting investors Sept 8-10. They're reaffirming 2025 adjusted EPS (at least $16.00), even with Amedisys acquisition costs making it dilutive. They also expect 78% of Medicare Advantage members to be in 4-star or higher plans, eligible for 2027 bonuses.