FDA Starts Reviewing Rigel Pharma’s (RIGL) Orphan Drug Application

Rigel Pharmaceuticals Inc (NASDAQ:RIGL) is making some serious gains today, currently up 27 cents at $2.77 – a 10.8 percent boost. The surge arrived on the heels of the announcement that the US Food and Drug Administration (FDA) has accepted the company’s New Drug Application (NDA) for review.

The biotech’s shares aren’t just going up in price – the stock is also exploding on volume. More than 7.4 million shares of Rigel have changed hands today, while the stock’s average daily volume is just 863,000 on a typical day.

Now that the FDA says it is reviewing the company’s NDA, it says that it will finish its review by April 17th, 2018. Rigel’s drug, called Tavalisse, was developed by the San Francisco-based biotech for the treatment of chronic or persistent immune thrombocytopenia (ITP). The FDA had already given Tavalisse Orphan Drug designation for the same indication.

“If approved, we believe Tavalisse will provide a new treatment option for patients with chronic or persistent ITP,” said the company’s President and Chief Executive Officer, Raul Rodriguez. “We look forward to working closely with the FDA as they review our submission.”

Patients who have been diagnosed with ITP have limited treatment options as it is, and not all patients benefit from therapies that are currently commercially available. The condition involves patients’ immune systems attacking and destroying their bodies’ own blood platelets – which have an important part in blood clotting and wound healing.

ITP patients often suffer from excessive bruising and bleeding, and have an elevated risk of experiencing severe bleeding events that could end in hospitalization – or even death.

The FDA designated Tavalisse as an orphan drug due to the fact that there is such a large, unmet medical need in this area – and currently available therapies aren’t cutting it for these patients.

Tavalisse is different than other ITP treatment courses because, rather than modulating the immune system in some way or stimulating platelet production, it targets the underlying cause of platelet destruction associated with the disease. The drug was developed to inhibit SYK kinase, which is an important signaling member during the immune process that causes platelet destruction in ITP patients.

Following the news of FDA accepting the Tavalisse NDA, BMO Capital Markets announced this morning that it was lifting its price target on Rigel’s common stock from $4.00 to $5.00 – while maintaining an Outperform rating. The Wall Street firm also lifted its likelihood of success for the drug from 70 percent to 80 percent.

The author of this article holds no position in any of the companies mentioned above.

Tim is a contributing analyst for EconomicCalendar.com and specializes in equities trading and public offerings. He is a graduate of UCLA and began his career doing capital markets research for a top investment banking software provider.