Amylyx Pharmaceuticals
NEWS
Clene, Inc. released data that shows its add-on treatment, CNM-Au8, significantly improved survival in patients with amyotrophic lateral sclerosis (ALS) by 70%.
As the calendar pages continue to turn, the FDA has a slew of novel drugs awaiting approval, several of which are likely to become game-changers for patients and key assets for companies.
The approval of AMX0035, which will be marketed under the brand name Albrioza, marks the first new ALS drug approved in Canada since 2018.
Amylyx Pharmaceuticals shared news that the FDA has extended the review period for AMX0035, a combination drug treatment with the potential to treat patients with ALS.
In honor of ALS Awareness Month, BioSpace spoke with leading researchers like Dr. Matthew Harms of Columbia University and Drs. Howard Berman and Stanley Appel at Coya Therapeutics.
A post hoc analysis of data from the Phase II CENTAUR study showed a 10.6-month longer median survival duration for AMX0035 participants, Amylyx announced Thursday.
In a meeting of the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee, six members voted not to approve the NDA for Amylyx’s ALS candidate, AMX0035, while four voted in favor.
A meeting with an amyotrophic lateral sclerosis (ALS) patient in Israel who could only speak with the assistance of a computer changed the life and direction of NeuroSense CEO Alon Ben-Noon.
Data from Clene’s RESCUE-ALS trial showed that treatment with CNM-Au8 significantly slowed progression of ALS and improved quality of life.
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