What’s Next for PhaseBio’s Antiplatelet Reversal Agent

By Chris Lange Updated Jan 11, 9:26AM EST · Published Apr 9, 9:05AM EDT

Follow 24/7 Wall St. on Google

This post may contain links from our sponsors and affiliates, and Flywheel Publishing may receive compensation for actions taken through them.

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.

[nativounit]

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.

[recirclink id=540012]
[wallst_email_signup]

About the Author Chris Lange →

Chris Lange is a writer for 24/7 Wall St., based in Houston. He has covered financial markets over the past decade with an emphasis on healthcare, tech, and IPOs. During this time, he has published thousands of articles with insightful analysis across these complex fields. Currently, Lange's focus is on military and geopolitical topics.

Lange's work has been quoted or mentioned in Forbes, The New York Times, Business Insider, USA Today, MSN, Yahoo, The Verge, Vice, The Intelligencer, Quartz, Nasdaq, The Motley Fool, Fox Business, International Business Times, The Street, Seeking Alpha, Barron’s, Benzinga, and many other major publications.

A graduate of Southwestern University in Georgetown, Texas, Lange majored in business with a particular focus on investments. He has previous experience in the banking industry and startups.