Myovant Sciences (NYSE:MYOV) has announced its financial results and corporate updates for Q2 FY2020.
Lynn Seely, the company’s CEO, said that they are delighted with the massive progress made during fiscal Q2 2020. Myovant advanced both relugolix combination tablet and relugolix monotherapy towards possible regulatory approvals in preparation for commercialization in endometriosis, uterine fibroids, and advanced prostate cancer.
Myovant advancing relugolix tablet therapy
Seely said that they have assembled a highly experienced and strong team spanning medical affairs, commercial operations, market access, marketing, and sales. The team will help Myovant to efficiently and rapidly deliver relugolix monotherapy tablets to medical oncologists, urologists, and patients for commercial launch once approved.
Currently, the US FDA is evaluating relugolix monotherapy tablets under Priority Review with a decision expected by the December 20, 2020 action date. Positive Phase 3 HERO study results including a 97% response rate and six positive secondary endpoints support the NDA. The tablet demonstrated a low occurrence of major cardiovascular adverse events relative to the current standard of care.The company released additional seconded endpoint results for castration resistance-free survival study in metastatic prostate cancer patients on September 29, 2020.
The FDA accepted the company’s NDA for relugolix combination tablet in treating women experiencing heavy menstruation-related with uterine fibroids in august 2020. A target action date is set for June 1, 2021. The company presented data from the Phase 3 SPIRIT 1 and SPIRIT 2 trials at the 2020 ASRM Virtual Conference. The data showed that relugolix combination therapy produced clinically significant dysmenorrhea and non-menstrual pelvic pain reduction relative to placebo after 24 weeks of therapy.
Impact of COVID-19 on Myovant’s activities minimal
Interestingly the impact of the pandemic on the company’s ability to advance its clinical programs, preparation for commercialization, and regulatory activities has been minimal. All the company’s announced milestones are on track but if the pandemic persists the company could experience considerable business operations impact. The company ended the quarter with cash, cash equivalents, and investments of $257.6 million including committed amounts under the Sumitomo Dainippon Pharma Loan.