Chris Lau
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Chris Lau in Value Stocks,

Regulus Therapeutics Inc. May Recover

Regulus Therapeutics Inc. (RGLS) should have trended higher after reporting clinical results on June 7. The study for Hepatitis C Virus Infection treatment involved 79 subjects.

Per Regulus’ PR:

The study enrolled 79 treatment naïve genotype 1 and 4 HCV patients (Harvoni® arm, n=27, Olysio® arm, n=27, Daklinza™ arm, n=25). The primary endpoint of the study is virologic response 12 weeks following conclusion of treatment.

In short “the results from this interim analysis demonstrate significant virologic response through 24 weeks of follow-up. “

If the CEO’s statement is positive, then why did Regulus’ stock plunge?

"These data strengthen our conviction in the clinical utility of RG-101 to shorten oral HCV treatment regimens to four weeks or less. We are very encouraged by the consistent trend in safety and efficacy, which positions RG-101 to play an important role in advancing the current treatment options for HCV patients worldwide," said Paul Grint, M.D., President and CEO of Regulus.

By the end of June, Regulus put its study on hold. On July 27, the company revealed the FDA wants detailed safety data analysis from the studies. In also asked for additional PK data and more details around hepatoxicity.

Holding Regulus is not for the faint of heart. If the company satisfies the FDA’s concerns, the stock will respond accordingly.