Rigel Pharmaceuticals' NDA For Tavalisse Accepted By FDA

Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL) announced that the FDA has accepted its new drug application (NDA) seeking approval for its oral spleen tyrosine kinase inhibitor, fostamatinib for the treatment of patients with chronic and persistent immune thrombocytopenia (ITP). The drug will be marketed by the trade name of Tavalisse.

The company expects a decision from the FDA on Apr 17, 2018. The drug had been previously granted Orphan Drug designation for the same indication.

Shares of company were up 11.2% after the announcement of the news. In fact, shares of Rigel have increased 16.9% so far this year, outperforming the Zacks classified Medical – Drugs industry, which rose 5.2% in the same period.

The company filed the NDA in Apr 2017 based on data from a phase III program comprising three studies. While two studies (Studies 047 and 048) compared Tavalisse to placebo, the remaining one was an open-label extension study (study 049).

The data from studies 047 and 048 showed an overall response rate of 29% for Tavalisse compared to 2% for placebo. The response rate was measured as patients achieving platelet counts over 50,000/μL. Study 049 evaluated Tavalisse in patients who were treated with the candidate in either 047 or 048 study. The data showed that patients maintained median platelet count of more than 100000/μL over a period of 16 months during the study.

In ITP, the immune system of the patients attacks and destroys the body's own blood platelets, which help in blood clotting and healing. Patients with chronic ITP live with increased risk of severe bleeding events that can result in serious medical complication, or even death.

Tavalisse is an oral product, which impedes platelet destruction in ITP by inhibiting SYK kinase whereas the available therapies either modulate the immune system or stimulate platelet production.

Tavalisse is also being developed in two phase II studies for treating autoimmune hemolytic anemia and IgA nephropathy.

Zacks Rank & Stocks to Consider

Rigel currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the health care sector include Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) , VIVUS, Inc. (NASDAQ:VVUS) and MEI Pharma, Inc. (NASDAQ:MEIP) . All the three companies sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Regeneron’s earnings estimates moved up from $10.16 to $10.52 for 2017 and from $10.90 to $12.10 for 2018, over the last 60 days. The company delivered a positive earnings surprise in two of the last four quarters, with an average beat of 0.45%.

VIVUS’ loss estimates narrowed from 50 cents to 39 cents for 2017 over the last 60 days. The company came up with a positive earnings surprise in three of the four trailing quarters with an average beat of 233.69%.

MEI Pharma‘s estimates changed from a loss 1 cent to a gain of 1 cent for 2017 while for 2018 the loss estimates narrowed from $1.39 to $1.38, over the last 60 days. The company delivered a positive earnings surprise in three of the four trailing quarters with an average beat of 66.56%.

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