Arrowhead Acquires FDA Priority Review Voucher, Speeding Drug Approval
ARWR has more than doubled off its 52-week low of $15.01.
Summary
Arrowhead has acquired an FDA Priority Review Voucher, a valuable regulatory asset that can shorten the review period for a future drug application from 10 months to 6 months. The voucher can be used for one of its own pipeline candidates or sold—recent transactions have ranged from $100M to $350M. The company plans to use the voucher to accelerate the review of a planned sNDA for plozasiran in severe hypertriglyceridemia. This follows the recent full enrollment of the pivotal Phase 3 YOSEMITE study for zodasiran, indicating the company may be positioning for an expedited regulatory path. The acquisition adds a non-dilutive financial asset and signals confidence in advancing its late-stage pipeline. Terms of the deal were not disclosed, and the agreement was signed with an undisclosed third party.
At the time of this announcement, ARWR was trading at $89.56 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $12.6B. The 52-week trading range was $15.01 to $95.49. This news item was assessed with positive market sentiment and an importance score of 7 out of 10. Source: Dow Jones Newswires.