Rigel Pharmaceuticals, Inc. (RIGL) Says FDA Not Planning an AdCom for Fostamatinib NDA; Shares Jump 30%


RIGL logoRigel Pharmaceuticals, Inc. (NASDAQ:RIGL) investors have a smile on their faces Monday morning, after the drug maker announced that the FDA is currently not planning to hold an advisory committee meeting (AdCom) to discuss the New Drug Application (NDA) for the company’s ITP treatment fostamatinib. 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. In an earlier communication, the FDA had conditionally approved the proprietary name TavalisseTM.

Rigel Pharmaceuticals shares reacted to the news, jumping nearly 30% to $3.34 in Monday’s trading session. RIGL has a 1-year high of $4.38 and a 1-year low of $1.94. The stock’s 50-day moving average is $2.40 and its 200-day moving average is $2.63.

Rigel CMO Anne-Marie Duliege commented, “Since we submitted our NDA this spring, we have worked collaboratively with the FDA to answer routine questions as they arise,” said Anne-Marie Duliege, MD, executive vice president and chief medical officer of Rigel. “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.”

On the ratings front, RIGL stock has been the subject of a number of recent research reports. In a report issued on September 4, Jefferies analyst Michael Yee reiterated a Buy rating on RIGL, with a price target of $5.00, which represents a potential upside of 71% from where the stock is currently trading. On June 19, BMO’s Do Kim reiterated a Buy rating on the stock and has a price target of $5.00.

According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Michael Yee and Do Kim have a yearly average return of 11% and 27.9% respectively. Yee has a success rate of 66% and is ranked #292 out of 4676 analysts, while Kim has a success rate of 80% and is ranked #234.

Rigel Pharmaceuticals is a clinical stage biotechnology company. It discovers and develops novel, targeted drugs in the therapeutic areas of immunology, oncology and immune oncology. The company focuses on intracellular signaling pathways and related targets that are critical to disease mechanisms. Its current product development programs include Fostamatinib Oral SYK Inhibitor and R348 Topical Ophthalmic JAK/SYK Inhibitor.