Deal With Pfizer Sends Myovant Shares Higher: What Investors Need To Know

Myovant Sciences Ltd MYOV stock is adding about one-fourth of its market capitalization Monday following a licensing deal with Pfizer Inc. PFE.

What Happened: Myovant announced a collaboration with Pfizer to develop and commercialize relugolix for oncology indications and women's health in the U.S. and Canada.

Pfizer will receive an exclusive option to commercialize relugolix in oncology outside the U.S. and Canada, excluding certain Asian countries.

Relugolix is a once-daily, oral gonadotropin-releasing hormone receptor antagonist that was approved by the FDA on Dec. 18 to treat adult patients with advanced prostate cancer.

Relugolix combination therapy is being evaluated in two late-stage clinical programs as treatment options for heavy menstrual bleeding associated with uterine fibroids and for endometriosis-related pain.

For uterine fibroid, the FDA has set a PDUFA goal date of June 1, 2021, while for endometriosis, Myovant plans an NDA filing in the first half of 2021.

"Pfizer is the ideal partner for Myovant given its impressive capabilities and track record across both oncology and women's health," Myovant CEO Lynn Seely said in a statement.

"This transformative collaboration will significantly strengthen the upcoming launch of ORGOVYX and the potential launches of relugolix combination tablet in women's health, while substantially enhancing our financial position and enabling us to expand our pipeline of potential new medicines."

The Myovant, Pfizer Deal Terms: Myovant and Pfizer will commercialize relugolix under the brand name Orgovyx in advanced prostate cancer beginning in early 2021.

If it's approved for women's health indications, relugolix combination therapy will also be marketed jointly by the companies in the U.S. and Canada.

Myovant will be responsible for regulatory interactions, drug supply and the clinical development of relugolix combo therapy.

The agreement provides for Myovant receiving up to $4.2 billion, Including an upfront payment of $650 million, $200 million in potential regulatory milestones for FDA approvals for relugolix combination tablet in women's health and tiered sales milestones upon reaching certain thresholds up to $2.5 billion in net sales for prostate cancer and also for the combined women's health indications.

If Pfizer exercises the option to commercialize relugolix outside of U.S. and Canada, Myovant stands to receive $50 million and also double-digit royalties on sales.

MYOV Price Action: At last check, Myovant shares were soaring 22.81% to $27.94.

Market News and Data brought to you by Benzinga APIs