FDA Approves Ultragenyx's GENGLYCOS at $2.7M, Launch in 30-60 Days
RARE sits 42% above its 52-week low of $18.29.
Summary
The FDA granted accelerated approval to Ultragenyx's gene therapy GENGLYCOS (DTX401) for GSDIa, with a price of $2.7M and rollout to qualified centers within 30-60 days. The company will run a 10-year Disease Monitoring Program to track safety and efficacy. Shares rose ~6-7.5% on the news. This follows the initial approval announcement on August 19; today's report adds commercial details and the monitoring program. The launch timeline and pricing are key for revenue modeling.
At the time of this announcement, RARE was trading at $25.90 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $2.5B. The 52-week trading range was $18.29 to $39.89. This news item was assessed with positive market sentiment and an importance score of 7 out of 10. Source: Wiseek News.