Myovant Sciences Ltd. (MYOV - Free Report) announced encouraging data from the phase III HERO study evaluating its oral cancer candidate, relugolix, in patients with androgen-sensitive advanced prostate cancer. Data from the study showed that the study has met the primary endpoint of achieving and maintaining testosterone suppression to castrate levels (< 50 ng/dL) through 48 weeks.
Based on the study data, the company is planning to file a new drug application ("NDA") with the FDA in the second quarter of 2020.
Shares of Myovant skyrocketed 113.2% following the solid study data readout. However, shares of the company have declined 21.3% so far this year against the industry’s growth of 2.5%.
The HERO study compared the safety and efficacy of relugolix monotherapy with one of the current standard-of-care, leuprolide acetate, for treating advanced prostate cancer. Both relugolix and leuprolide acetate are gonadotropin-releasing hormone, or GnRH, antagonists. Data from the study showed that treatment with once-daily 120mg dosage of relugolix achieved sustained testosterone suppression to castrate levels in 96.7% of patients compared to 88.8% for leuprolide acetate. Data from the late-stage study also showed that treatment with relugolix met its secondary endpoints, including superiority to leuprolide acetate on rapid suppression of testosterone and prostate-specific antigen.
The overall incidence of adverse events and patient discontinuation was similar in both relugolix and comparator arms.
Relugolix, if approved, will become the first oral GnRH antagonist for treating advanced prostate cancer.
Apart from prostate cancer, Myovant is also developing relugolix in combination with estradiol and norethindrone acetate for treating uterine fibroids and endometriosis-associated pain.
Earlier this year, the company announced positive data from two phase III studies — LIBERTY 1 & 2 — evaluating the relugolix combo regimen as a treatment for uterine fibroids. It is planning to file an NDA in April 2020 seeking approval for the same. Top-line data from two phase III studies — SPIRIT 1 & 2 — evaluating the relugolix combo in patients suffering from endometriosis-associated pain are expected in the first half of 2020. The company is also developing another pipeline candidate, MVT-602, as a potential treatment for female infertility.
Notably, Myovant has in-licensed both relugolix and MVT-602 from Takeda (TAK - Free Report) .
Potential approval of relugolix for treating prostate cancer and uterine fibroids in 2020 will be significant milestones for Myovant and likely boost its share price.
We note that there are several drugs approved for prostate cancer including J&J’s (JNJ - Free Report) Erleada and Zytiga, and Pfizer’s Xtandi. Moreover, there are several generic versions of Zytiga available in the market. Moreover, AbbVie’s (ABBV - Free Report) GnRH antagonist, Orilissa, is available for treating moderate to severe pain associated with endometriosis. It is also seeking a label expansion of the drug for treating uterine fibroids. If approved, Relugolix is likely to face competition from these drugs.
Myovant currently carries a Zacks Rank #3 (Hold).
You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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