Next week is expected to be an exciting week for Curis Inc. (NASDAQ:CRIS). The full data for Curis’ pivotal Phase II clinical trial of Hedgehog pathway inhibitor vismodegib in advanced basal cell carcinoma patients is going to be presented at the 7th Annual Congress of the European Association of Dermato-Oncology, in Nantes, France, June 20-23. Analysts are going to be focusing on the response rates and durations, and that data may contribute to the direction Curis’ shares will trade. Note, after Roche (OTCQX:RHHBY) announced positive results from the trial back in March, Curis’ stock jumped 11%.
For some background, on 3/21 the company announced the positive outcome from the trial. The study met its primary endpoint of achieving a target overall response rate, showing that GDC-0449 shrank advanced BCC tumors in a pre-defined percentage of people in the study. A preliminary safety assessment showed the most common adverse events were consistent with previous experience with vismodegib. The assessment showed the most common adverse events were consistent with previous experience with vismodegib and included muscle spasms, hair loss, altered taste sensation, weight loss, fatigue, nausea, decreased appetite and diarrhea. Serious adverse events were observed, including fatal events. The deaths are being further evaluated, but do not appear to be related to vismodegib.
On 4/28, the company said that it anticipates a U.S. new drug application submission by Roche later this year, which if approved, would be transformative for Curis, as the future milestone and royalty revenue associated with such approval could provide a material source of capital for Curis. Note, the company has basically no revenues and this capital will help it continue developing its pipeline.
The company has a number of other product candidates in the pipeline. It has one other product candidate in Phase II trials, two others in Phase I trials, one in the development stage, and one in the preclinical stage. The stock was on a tear since hitting a low of $1.21 in August of last year, rising all the way to $4.42 earlier this year. Since then, however, the stock has struggled, hitting $3 a share just earlier this week.
Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.