Arena Pharmaceuticals, Inc.
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Latest From Arena Pharmaceuticals, Inc.
Amylyx’s Relyvrio Could See Fast Sales Growth, But Also Spark Pricing Debate
The FDA gave full approval based on a Phase II study, without the need for Phase III confirmatory data, for Amylyx’s ALS drug Relyvrio but the $158,000 WAC could spark a debate over pricing.
Gamida Set For Breakthrough Transplant Therapy Approval – But Cash Problems Could Hit Launch
With a new CEO at the helm, Gamida is closing in on an FDA approval, but a lack of cash could hobble its US launch efforts for allogeneic cell therapy product omidubicel.
Galecto Validates LOXL2 Targeting With Interim Myelofibrosis Phase II Success
The US biotech’s LOXL2 inhibitor candidate has reduced collagen fibrosis of the bone marrow in a small number of Phase II patients, helping validate a historically tricky approach attempted by few.
Amylyx's Relyvrio: The Road To Regulatory Flexibility And US FDA Approval
A Pink Sheet timeline shows the regulatory highs and lows of AMX0035's path to US approval for treatment of amyotrophic lateral sclerosis.
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- Beacon Discovery Inc.