Monday, July 11, 2016

Huge News For Harvoni's Competition

Summary

Regulus came out with important news.

Huge share price move.

Gilead's Harvoni remains best HCV treatment in the market.

Gilead's (NASDAQ:GILD) weak performance over the last months can be blamed, at least partially, on fears about the sustainability of the company's huge revenues, earnings, and cash flows from its HCV franchise. With its drugs Sovaldi and Harvoni Gilead dominated the space over the last quarters, and with its new one pill daily drug Gilead seeks to further establish itself as the number one player in the huge HCV market.

Let's look at what happened with one of Gilead's competitors over the last weeks: Regulus (NASDAQ:RGLS), released some very important news about its HCV drug candidate on Monday: The company's product candidate RG-101 for the treatment of Hepatitis C virus infections has caused a second severe adverse effect (SAE) in a patient who is enrolled in Regulus' phase 1 study of RG-101. The FDA has notified Regulus that the company's Investigational New Drug application for RG-101 has been put on clinical hold, which means that Regulus is not allowed to enroll new patients for clinical testing of its drug candidate RG-101. The drug thus looks pretty much like a failed drug candidate right now, which explains the market's reaction the Monday's news:

After news about the second SAE of a patient treated with RG-101 got public Regulus' shares dropped 50%, and are currently trading at below $3.00, more than 75% below the 52 week high of $11.59.

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