Rigel Pharma Rises Following FDA Approval
Rigel Pharmaceuticals watched its shares make a handy uptick on Monday after the FDA approved its New Drug Application for the use of Tavalisse in patients with chronic or persistent immune thrombocytopenia.
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Shares of Rigel Pharmaceuticals Inc. (NASDAQ: RIGL) saw a handy uptick on Monday after the U.S. Food and Drug Administration (FDA) approved its New Drug Application (NDA) for the use of Tavalisse (fostamatinib disodium) in patients with chronic or persistent immune thrombocytopenia (ITP).
For some brief background: ITP is a bleeding disorder in which blood does not clot as it should due to a low level of platelets, or thrombocytes. People suffering with chronic ITP may live with increased risk of severe bleeding events that can result in serious medical complication, or even death.
Overall, the firm expects the Prescription Drug User Fee Act (PDUFA) action date to be April 17, 2018. The FDA previously granted Orphan Drug designation to Tavalisse for the treatment of patients with ITP.
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The NDA submission is supported by data from the recent Phase 3 clinical program for fostamatinib in ITP. Together with an initial proof of concept study, the NDA included 163 ITP patients. Across all indications, fostamatinib has been evaluated in over 4,600 subjects.
Excluding Monday’s move, the stock is up 5% year to date. Over the past 52 weeks, the stock is up less than 1%.
Raul Rodriguez, Rigel’s president and CEO, commented:
The FDA acceptance for filing of our NDA is an exciting milestone for Rigel. If approved, we believe TAVALISSE™ will provide a new treatment option for patients with chronic or persistent ITP. We look forward to working closely with the FDA as they review our submission.
Shares of Rigel were last seen up about 16% to $2.91 on Monday, with a consensus analyst price target of $6.20 and a 52-week range of $1.94 to $4.38.
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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.
