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Myovant Eyes Relugolix Approval for Advanced Prostate Cancer
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Myovant Sciences announced that it has submitted a new drug application (NDA) to the FDA seeking approval for its oral cancer candidate, relugolix (120 mg), for the treatment of men with advanced prostate cancer.
The NDA was based on positive data from the phase III HERO study, which evaluated the candidate in patients with androgen-sensitive advanced prostate cancer. Data from the study showed that the study met the primary endpoint of achieving and maintaining testosterone suppression to castrate levels (< 50 ng/dL) through 48 weeks.
The company also announced its plans to submit another NDA, seeking approval for a combination regimen of oral relugolix (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) as a treatment for women with heavy menstrual bleeding associated with uterine fibroids next month. Last year, the company had announced positive data from two phase III studies — LIBERTY 1 & 2 — evaluating the relugolix combo regimen as a treatment for uterine fibroids.
Shares of Myovant have declined 25.4% so far this year against the industry’s growth of 3.3%.
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.
Myovant is also developing relugolix in combination with estradiol and norethindrone acetate for treating endometriosis-associated pain. 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 will be significant milestones for Myovant and will likely boost its share price.
However, we note that there are several drugs approved for prostate cancer including J&J’s (JNJ - Free Report) Erleada and Zytiga, and Pfizer’s (PFE - Free Report) Xtandi. Moreover, there are several generic versions of Zytiga available in the market. If approved, Relugolix is likely to face competition from these drugs.
Each was hand-picked by a Zacks expert as the #1 favorite stock to gain +100% or more in 2020. Each comes from a different sector and has unique qualities and catalysts that could fuel exceptional growth.
Most of the stocks in this report are flying under Wall Street radar, which provides a great opportunity to get in on the ground floor.
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Myovant Eyes Relugolix Approval for Advanced Prostate Cancer
Myovant Sciences announced that it has submitted a new drug application (NDA) to the FDA seeking approval for its oral cancer candidate, relugolix (120 mg), for the treatment of men with advanced prostate cancer.
The NDA was based on positive data from the phase III HERO study, which evaluated the candidate in patients with androgen-sensitive advanced prostate cancer. Data from the study showed that the study met the primary endpoint of achieving and maintaining testosterone suppression to castrate levels (< 50 ng/dL) through 48 weeks.
The company also announced its plans to submit another NDA, seeking approval for a combination regimen of oral relugolix (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) as a treatment for women with heavy menstrual bleeding associated with uterine fibroids next month. Last year, the company had announced positive data from two phase III studies — LIBERTY 1 & 2 — evaluating the relugolix combo regimen as a treatment for uterine fibroids.
Shares of Myovant have declined 25.4% so far this year against the industry’s growth of 3.3%.
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.
Myovant is also developing relugolix in combination with estradiol and norethindrone acetate for treating endometriosis-associated pain. 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 will be significant milestones for Myovant and will likely boost its share price.
However, we note that there are several drugs approved for prostate cancer including J&J’s (JNJ - Free Report) Erleada and Zytiga, and Pfizer’s (PFE - Free Report) Xtandi. Moreover, there are several generic versions of Zytiga available in the market. If approved, Relugolix is likely to face competition from these drugs.
Myovant Sciences Ltd. Price
Myovant Sciences Ltd. price | Myovant Sciences Ltd. Quote
Zacks Rank
Myovant currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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Each was hand-picked by a Zacks expert as the #1 favorite stock to gain +100% or more in 2020. Each comes from a different sector and has unique qualities and catalysts that could fuel exceptional growth.
Most of the stocks in this report are flying under Wall Street radar, which provides a great opportunity to get in on the ground floor.
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