Rigel Pharmaceuticals, Inc. (NASDAQ: RIGL) said that its candidate for autoimmune platelet disease met primary endpoint in a Phase 3 study. The candidate, fostamatinib, is being evaluated in two Phase 3 trials with results from the second Phase 3 study expected out in October or November.
If the pending Phase 3 trial of fostamatinib is successful, Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL) intends to speed up application for regulatory approval as early 1Q2017. Some analysts say that fostamatinib could generate $360 million in annual sales for Rigel in case the approval limits its use to only patients who have failed treatment with existing therapies.
Rigel reported statistically significant outcome from the first Phase 3 study of fostamatinib in patients afflicted by autoimmune platelet disease. The condition is characterized by a patient’s own immune system turns against platelets and destroys them, thus reducing platelet count in the blood. Platelet is the component of blood that helps with blood clotting to support healing of wounds.
In the Phase 3 study, 18% of the patients who received fostamatinib treatment registered stable platelet response. None of the study subject who received a placebo in place of fostamatinib achieved comparable outcome.
Though a statistically significant result, the 18% success rate achieved with fostamatinib in autoimmune platelet patients was below the mid-20% that analysts were expecting from the study. As such, investors will be closely watching the outcome of the second Phase 3 study to see which way RIGL goes with fostamatinib.
How Rigel Pharmaceuticals, Inc. (NASDAQ: RIGL) fared in 2Q
Rigel Pharmaceuticals, Inc. (NASDAQ: RIGL) generated revenue of $8.6 million in 2Q2016, primarily from contract deals given that the company doesn’t have a marketable product. The company’s expenses rose to $22.3 million from $19.2 million in the year-ago period. The spike in expenses was due to higher costs related to the ongoing studies, including fostamatinib clinical programs.
Rigel said its $95 million cash balance is sufficienct to push it through for at least the next 12 months.