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.
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.