BioMarin maintains its lead in the race to win approval for a hemophilia A gene therapy in the US by resubmitting Roctavian two years after the FDA issued a CRL in response to the original BLA.

Eisai and Biogen had double-digit stock price gains based on the positive Phase III readout for lecanemab. The good news also lifted competitors Lilly and Roche as well as earlier-stage Alzheimer’s drug developers.

Eisai and Biogen, who have an accelerated approval decision pending in the US, said they will seek traditional approvals for lecanemab by Q1 2023 based on positive results from the Phase III Clarity AD trial.

Ponda Motsepe-Ditshego, who leads Amgen’s clinical trial diversity efforts, admits they are in early stages but noted progress internally and externally at better representing diverse patient groups.

VC funding slowed recently, but public company financings kept up a brisk pace with follow-on public offerings for Allakos and Alpine, private placements for Ventyx and Syros, and Albireo’s royalty deal. In restructuring updates, Biogen raised $592m in a real estate deal and Acerus is assessing options.

Private Company Edition: Acelyrin will use its latest funding for Phase III development of izokibep in inflammatory diseases. Also, ArsenalBio raised $220m to take its programmable cell therapies into the clinic and RayzeBio’s $160m series D round will fund clinical trials for its radiopharmaceuticals.