Two biologic therapeutic candidates met their primary endpoints in separate Phase III trials: AstraZeneca’s Ultomiris and Argenx’s Vyvgart.

Shares of Applied Therapeutics plunged in premarket trading on January 3 after the company announced it is unable to seek regulatory approval of the Galactosemia therapeutic AT-007 at this time.

The U.S. Food and Drug Administration approved Intra-Cellular Therapies Inc.’s Caplyta for the treatment of depressive episodes associated with bipolar I or II disorder in adults, as monotherapy and as adjunctive therapy with lithium or valproate.

Investigators at Washington University School of Medicine in St. Louis identified a compound that can help sensory neurons in the central nervous system to heal.

Biogen and Capsigen forged a strategic collaboration to engineer novel adeno-associated virus (AAV) capsids that have the potential to become transformative gene therapies that treat underlying genetic causes of various central nervous system and neuromuscular disorders.

Find out which biopharma companies are raking in the cash this week, as companies from around the globe provide updates on their financing rounds and IPOs.

AstraZeneca released new results from the company’s ADAURA Phase III trial showing that Tagrisso (osimertinib) demonstrated clinically meaningful improvement in central nervous system disease-free survival in the adjuvant treatment of patients with early-stage epidermal growth factor receptor-mutated non-small cell lung cancer (NSCLC), after complete tumor resection.

The U.S. Food and Drug Administration approved Roche’s Enspryng for the central nervous system disorder neuromyelitis optica, putting the Swiss drugmaker head-to-head with Alexion’s Soliris in a costly treatment area.

Seattle-based Athira Pharma closed on a Series B financing worth $85 million, led by Perceptive Advisors.

Kallyope, based in the Alexandria Center for Life Science in New York City, secured $112 million in a Series C financing round that will be used to advance the company’s gut-brain axis field-focused programs into clinical trials.