PhaseBio Pharmaceuticals Inc. (NASDAQ: PHAS) shares made a sizable gain on Tuesday morning after the U.S. Food and Drug Administration provided a critical update for the firm. Specifically, the FDA granted Breakthrough Therapy designation for PhaseBio’s PB2452, a novel reversal agent for the antiplatelet drug ticagrelor.

The Breakthrough Therapy designation for PB2452 was supported by Phase 1 trial results, in which PB2452 achieved immediate and sustained reversal of ticagrelor’s antiplatelet effects.

Note that Breakthrough Therapy designation is designed to expedite the development and review of promising new drugs for serious or life-threatening conditions when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints.

John Lee, M.D., chief medical officer of PhaseBio, commented:

Breakthrough Therapy designation for PB2452 highlights the critical unmet need for a therapy to reverse the antiplatelet activity of ticagrelor, which is widely prescribed to patients with acute coronary syndrome or a history of heart attack. The results from the Phase 1 clinical trial of PB2452 demonstrated immediate and sustained reversal of the antiplatelet activity of ticagrelor, which could mitigate bleeding concerns associated with use of ticagrelor. Breakthrough Therapy designation supports our goal of making the first approved reversal agent for ticagrelor available to patients and physicians as soon as possible. We look forward to working closely with the FDA throughout the expedited development process.

Excluding Tuesday’s move, PhaseBio has outperformed the broad markets, with its stock up about 307% year to date. Note that most of this gain has come within the past month, with shares up about 350% in that time.

Shares of PhaseBio closed Monday at $12.57, in a post-IPO range of $2.55 to $13.40. The stock has a $16.67 consensus analyst price target. Following the announcement, shares were up about 25% at $15.70 in early trading indications Tuesday.

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