Biogen/Ionis ALS Therapy Tofersen is Getting FDA Priority Review

The FDA is granting the Biogen/Ionis ALS therapy drug tofersen, specific to SOD1 ALS, priority review an should have a decision by January 25th, 2023. This review is sped up to 6 months, compared to a 10 month review.

For more information regarding the priority review and tofersen, check out the press release: https://seekingalpha.com/news/3860495-biogenionis-als-therapy-tofersen-gets-fda-priority-review?source=apple_news&utm_medium=referral

June 3, 2022 – Biogen Presents Promising Data from the Phase 3 Tofersen Study

The results from the Phase 3 VALOR Trial and Open-Label Extension were presented at the 20th meeting of the European Network for the Cure of Amyotrophic Lateral Sclerosis (ENCALS) in Edinburgh, Scotland. The presentation slides can be found here.

The data shows that Tofersen use is associated with clinically meaningful benefits in people with SOD1 ALS.

Biogen's Press Release: https://investors.biogen.com/news-releases/news-release-details/new-12-month-tofersen-data-presented-encals-meeting-show

March 17, 2022 – Abstract Accepted for Presentation at the Annual EAN Congress

The abstract was submitted to the European Academy of Neurology for presentation at their annual meeting. It gives an overview of a recent CNS study that investigated the occurrence of alpha-synuclein in ALS spinal fluid.

The presentation will be given by Dr. Smith on June 27th, 2022 in Vienna, Austria. More details can be found here.