FDA Update Keeps Rigel Pharmaceuticals Above Water

Health and Healthcare

Published: October 2, 2017 10:40 am

Last Updated: September 17, 2020 12:39 pm

Shares of Rigel Pharmaceuticals Inc. (NASDAQ: RIGL) saw a solid gain to start off the week after the company gave an update from its meeting with the U.S. Food and Drug Administration (FDA). Rigel has suffered over the past year, but it seems this update may be the catalyst it has been looking for.

During the meeting, the FDA said that it is not planning to hold an Oncology Drugs Advisory Committee (ODAC) meeting to discuss the New Drug Application (NDA) for fostamatinib in patients with chronic or persistent immune thrombocytopenia (ITP).

With ITP, the immune system attacks and destroys the body’s own blood platelets, which play an active role in blood clotting and healing. People suffering with chronic ITP may live with increased risk of severe bleeding events that can result in serious medical complication, or even death.

Additionally, the FDA indicated that it anticipates meeting the Prescription Drug User Fee Act (PDUFA) action date for the application review, which is April 17, 2018. Earlier, the FDA had conditionally approved the proprietary name Tavalisse.

Anne-Marie Duliege, M.D., executive vice president and chief medical officer of Rigel, commented:

Since we submitted our NDA this spring, we have worked collaboratively with the FDA to answer routine questions as they arise. Our positive interactions with the FDA, including their customary biomedical monitoring (BIMO) inspections at our facilities and clinical sites, are in-line with our expectations and have progressed well. We will continue to work closely with the agency and remain committed to bringing fostamatinib to patients with ITP who are in need of new treatment options.

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Excluding Monday’s move, Rigel had underperformed the broad markets, with the stock up 6.7% year to date. Over the past 52 weeks, the stock is down about 29%.

Shares of Rigel were last seen up about 20% at $3.05, with a consensus analyst price target of $5.25 and a 52-week range of $1.94 to $4.38.

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