ADMA Biologics

A.F., M.E.S., S.R.W., C.M.E., N.R., C.L.G., K.L.K., J.A.G., E.A.H., and M.D.T. disclosed various research grants, advisory board fees, and institutional funding from pharmaceutical companies and NIH/NIAID, indicating potential conflicts of interest relevant to the manuscript's content.

DelveInsight's 'Respiratory Syncytial Virus Pipeline Insight, 2024' report details 50+ companies developing 50+ therapies, including Nirsevimab, Sisunatovir, and RSVpreF, across various stages of clinical trials. Key companies include GSK, Pfizer, and Sanofi, with recent successes like GSK's Arexvy vaccine and MSD's clesrovimab. The report covers mechanism of action, route of administration, and market dynamics.

AbbVie announced positive results from the phase III TEMPO-1 study, showing tavapadon significantly improved early Parkinson’s disease symptoms in 26 weeks. The drug met primary and secondary endpoints, with a consistent safety profile. AbbVie plans to seek regulatory approval using these data.

S&P Dow Jones Indices to adjust S&P 500, S&P MidCap 400, and S&P SmallCap 600 indices on Sept 23, ensuring market cap representation. Palantir, Dell, and Erie Indemnity to join S&P 500, replacing American Airlines, Etsy, and Bio-Rad Laboratories. American Airlines to replace TEGNA in S&P MidCap 400, and TEGNA to replace Designer Brands in S&P SmallCap 600. Etsy to replace Haverty Furniture in S&P SmallCap 600. Bio-Rad Laboratories to replace Erie Indemnity in S&P MidCap 400.

Aldeyra Therapeutics' lead candidate, reproxalap, is in phase III for dry eye disease and allergic conjunctivitis. Following FDA feedback, a new study is planned for 2024 to address efficacy concerns, aiming for NDA resubmission. Shares surged 43.3% after the development plan announcement. Aldeyra also has ADX-629 in phase II for other conditions.

Vertex Pharmaceuticals announced FDA's rolling NDA submission for suzetrigine (VX-548) in moderate-to-severe acute pain, aiming for completion by Q2 2024. Supported by phase III results, suzetrigine showed significant pain reduction. Also, Vertex is advancing suzetrigine for neuropathic pain, with phase III DPN studies planned for H2 2024.

Stoke Therapeutics reported positive data from STK-001 studies in Dravet syndrome patients, showing significant seizure reduction and cognitive improvements. The FDA approved a dosing regimen, and the company plans regulatory discussions for a registrational study. STOK stock surged following the update.