Today, investors in Cel-Sci (NYSEMKT:CVM) and CVM stock are seeing a very red day. Indeed, the fact that shares of CVM stock are down nearly 50% at the time of writing is a bit of a shocker to many investors.
CVM stock soared from around $12 to start the year to more than $27 per share on some pretty bullish sentiment. Indeed, the company’s Multikine immunotherapy treatment for patients undergoing chemotherapy appeared to be a key candidate for U.S. Food and Drug Administration approval.
However, today, investors aren’t so sure.
Let’s dive into the results Cel-Sci reported today, and why investors are selling this stock off today on heavy volume.
CVM Stock Plummeting on Phase 3 Data Results
Today, Cel-Sci reported its head and neck cancer Phase 3 study results. Among the key highlights from the study are the following:
- Data indicate significant overall survival (OS) benefit for patients who received the Multikine treatment regimen followed by surgery and radiotherapy, but not for patients who had chemotherapy added to the same treatment. The group showing significant survival benefit (no chemotherapy) represents approximately 155,000 patients per year globally, or about 40% of newly diagnosed advanced primary head and neck cancer patients
- Patients treated with the Multikine treatment regimen followed by surgery and radiotherapy (no chemotherapy) demonstrated statistically significant OS advantage vs. Standard of Care (SOC) alone; the 3-year survival advantage was 4.9% (72.4% vs 67.5%) and the 5-year survival advantage was 14.1% (62.7% vs 48.6%) for the pre-defined population receiving no chemotherapy. The Multikine treatment regimen followed by surgery and radiotherapy(no chemotherapy) exhibited consistent OS advantage.
- No safety issues were found for Multikine in the treated population
That said, shares plummeted on the news that the primary endpoint for head and neck cancer was missed. The primary endpoint was a 10% improvement in overall survival in both lower risk and higher risk patients. The results showed that the survival advantage in the group receiving chemotherapy was only 4.9%.
Indeed, interpreting these results can be difficult. However, it appears the key factor investors were focusing on didn’t perform to expectations.
The company expects to pursue FDA approval for this drug.
On the date of publication, Chris MacDonald did not have (either directly or indirectly) any positions in the securities mentioned in this article. The opinions expressed in this article are those of the writer, subject to the InvestorPlace.com Publishing Guidelines.
