Myovant Sciences Ltd (NYSE: MYOV) is making a run for the top in the market this morning, and for good reason. The company published strong clinical data, exciting investors and sending the stock up nearly 150%. Here’s what’s going on:
MYOV Stock Soars On Data
In a press release issued early this morning, Myovant Sciences announced positive clinical data. The data came from the Phase 3 HERO study of once-daily, oral relugolix.
In the release, MYOV said that the HERO study met its primary efficacy endpoint and all six key secondary endpoints in patients with advanced prostate cancer. As a result, the company believes that the data supports the submission of a New Drug Application with the FDA.
Importantly, the company said that it intends on submitting an application to the FDA in the second quarter of 2020 with submissions in Europe and Japan to follow.
In terms of the primary endpoint, 96.7% of patients that received the treatment achieved sustained testosterone suppression to castrate levels. The five key secondary endpoints, including rapid suppression of testosterone, profound suppression of testosterone, rapid suppression of prostate-specific antigen, and suppression of follicle-stimulating hormone at week 24 were all met.
In a statement Lynn Seely, M.D. President and CEO at MYOV, had the following to offer:
With the exciting results from the HERO study demonstrating the potential of relugolix to provide unique benefits compared to leuprolide, we look forward to submitting an NDA to the FDA.
We are now closer to our goal of bringing a precision oral medicine to the broad spectrum of men with advanced prostate cancer.
Why This News Is So Exciting
Data is released all the time, but it doesn’t always lead to gains well in excess of 100%. So, what’s the deal here? Why are investors so excited? Well, there are a few reasons:
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