| Tuesday | ||||
Castration-resistance… Castration-resistance free survival data for prostate cancer expected in the third quarter of calendar year 2020. Data from the uterine fibroids cohort in the prospective observational bone mineral density study expected in the third quarter of calendar year 2020. Relugolix monotherapy tablet for advanced prostate cancer target action date of December 20, 2020. Data from the LIBERTY randomized withdrawal study expected in the first quarter of calendar year 2021. One-year efficacy and safety data from the SPIRIT extension study expected in the first quarter of calendar year 2021. | ||||
Reports Q1 revenue… Reports Q1 revenue $33.3M, consensus $2.75M. "I am very proud of the many recent accomplishments achieved by Myovant, including positive results from our second Phase 3 study in women with endometriosis, publication of our advanced prostate cancer data in the New England Journal of Medicine, and progress in our commercial readiness, particularly now that relugolix is under Priority Review by the FDA for advanced prostate cancer and the NDA for relugolix combination therapy for uterine fibroids has been submitted for review," said Lynn Seely, M.D., chief executive officer of Myovant Sciences. "The additional financial commitment from Sumitomo Dainippon Pharma and our commercial collaboration agreement with Sunovion we expect will further advance our vision to potentially provide one pill, once-a-day treatment options to the women and men with these common diseases." | ||||
| Over a week ago | ||||
Myovant Sciences… Myovant Sciences announced a $200 million low-interest, five-year term loan commitment from Sumitomo Dainippon Pharma Co, bringing its total financing support for Myovant to $600M, further bolstering Myovant's cash and committed funding and increasing the company's financing flexibility as it prepares for multiple potential product launches to treat advanced prostate cancer, uterine fibroids, and endometriosis. Additionally, Myovant announced that it has entered into a three-year commercial collaboration agreement with Sunovion Pharmaceuticals, an indirect, wholly-owned subsidiary of Sumitomo Dainippon Pharma, for services to support the planned commercialization of investigational drug candidate relugolix. Under the agreement, Sunovion will provide third-party logistics, trade and retail distribution, contract operations, and market access account management services to Myovant and will become a non-exclusive distributor of relugolix for prostate cancer and the exclusive distributor of relugolix combination tablet for uterine fibroids and endometriosis in the U.S. The terms of the new loan facility are expected to be largely consistent with the initial $400 million low-interest, five-year term loan facility from Sumitomo Dainippon Pharma that was announced in December 2019, and does not provide Sumitomo Dainippon Pharma with any rights to relugolix. Myovant will be able to access the facility on a quarterly basis, subject to certain terms and conditions, with no repayments due until the end of the term subject to certain exceptions. The additional funds will be used to fund Myovant's operating expenditures, including preparation for the commercialization of relugolix. | ||||
| Over a month ago | ||||
Myovant Sciences… Myovant Sciences announced the presentation of additional data from clinical studies of its once-daily relugolix combination therapy (relugolix 40 mg plus estradiol 1.0 mg and norethindrone acetate 0.5 mg) in women with heavy menstrual bleeding associated with uterine fibroids. The data were presented in virtual oral and poster sessions during the European Society of Human Reproduction and Embryology, or ESHRE, virtual 36th Annual Meeting. "The additional data being presented at the European Society of Human Reproduction and Embryology Annual Meeting reinforce the potential of relugolix combination therapy to offer women suffering from uterine fibroids meaningful reduction in distress due to bleeding, passing blood clots, and pelvic pressure, as well as improvement in anemia," said Juan Camilo Arjona Ferreira, M.D., chief medical officer of Myovant Sciences. "Furthermore, the data from our ovulation inhibition study showed inhibition in 100% of women on treatment as well as rapid return after stopping treatment, potentially offering women the ability to control their ovulation and fertility goals." Myovant Sciences said in a release, "In the Phase 3 LIBERTY program, women were asked to provide feedback on the Bleeding and Pelvic Discomfort, or BPD, scale, which assesses distress due to heavy menstrual bleeding, passing blot clots, and pelvic pressure/tightness, and the Revised Activitie, or RA, scale, which assesses physical and social activities. In the Phase 3 LIBERTY program, approximately one-third of women had anemia (hemoglobin less than or equal to 10.5 g/dL) at baseline. These women were more likely to be Black/African American (65.2% versus 51.2% in overall study population) and their baseline menstrual blood volume was higher (mean: 285.5 mL versus 228.8 mL in overall study population), where menstrual blood volume greater than 80 mL in a cycle is defined as heavy menstrual bleeding. In a Phase 1 open-label, single-arm ovulation inhibition study, 67 healthy premenopausal women were evaluated over an 84-day treatment period (three cycles) to assess the effects of relugolix combination therapy on ovulation inhibition, per the Hoogland-Skouby assessment scale (score less than 5). A post-treatment follow-up period assessed time to the return of ovulation. Myovant submitted a Marketing Authorization Application to the European Medicines Agency in March 2020 and a New Drug Application to the FDA in May 2020 for relugolix combination tablet (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) for the treatment of women with uterine fibroids. Myovant also recently reported positive data from its second Phase 3 SPIRIT trial evaluating relugolix combination therapy in women with endometriosis." | ||||
After Myovant Sciences… After Myovant Sciences (MYOV) released "positive" data for its second phase 3 trial of once-daily relugolix combination therapy in women with pain associated with endometriosis, BofA analyst Geoff Meacham said he views AbbVie's (ABBV) guidance for $2B in Orilissa sales in 2025 as "more in jeopardy." The consensus estimate has now fallen below $1B, from a consensus forecast for $1.9B worth of Orilissa sales in 2025 as of 12 months ago, and Meacham expects AbbVie will need to revise guidance in the near-term should an inflection point not be seen, he tells investors. Meacham has a Neutral rating on AbbVie with a $95 price target for the shares. | ||||
Evercore ISI analyst… Evercore ISI analyst Joshua Schimmer raised the firm's price target on Myovant Sciences to $55 from $45. Recent Phase 3 data for relugolix in prostate cancer makes the stock look "undervalued for that indication alone" Schimmer tells investors. He also notes that after the company announced positive Phase 3 results for relugolix plus hormone add-back co-formulation that the gynecologist specialists on the call discussed the "obstacles" with AbbVie's (ABBV) Orilissa and how relugolix overcomes those, which for him was an "ah-ha moment." Schimmer keeps an Outperform rating on Myovant shares. | |
Check out this morning's… | |
Management holds a… Management holds a conference call to discuss the positive results from the second Phase 3 study evaluating once-daily Relugolix combination therapy in women with Endometriosis will be held on June 23 at 8:30 am.Webcast Link | |
Myovant Sciences… Myovant Sciences announced top-line results from SPIRIT 1, the second of two Phase 3 studies of once-daily relugolix combination therapy in women with pain associated with endometriosis. Relugolix combination therapy met its co-primary efficacy endpoints and all seven key secondary endpoints in the SPIRIT 1 study. In addition, relugolix combination therapy was generally well-tolerated and resulted in minimal bone mineral density loss over 24 weeks. Consistent with the previously announced SPIRIT 2 study, relugolix combination therapy achieved both co-primary endpoints by demonstrating clinically-meaningful pain reductions for 74.5% of women with dysmenorrhea and 58.5% of women with non-menstrual pelvic pain, compared to 26.9% and 39.6% of women in the placebo group, respectively. On average, women receiving relugolix combination therapy had a 73.3% reduction on the 11-point Numerical Rating Scale for dysmenorrhea from 7.3 to 1.8. All seven key secondary endpoints measured at Week 24 and compared to placebo achieved statistical significance, including changes in mean dysmenorrhea and overall pelvic pain, impact of pain on daily activities as measured by the Endometriosis Health Profile-30 pain domain, greater proportions of women not using analgesics, changes in mean non-menstrual pelvic pain, greater proportions of women not using opioids, and changes in mean dyspareunia. Relugolix combination therapy was generally well-tolerated with minimal bone mineral density loss over 24 weeks. The overall incidence of adverse events in the relugolix combination and placebo groups was similar. In the relugolix combination therapy group, 3.8% of women had adverse events leading to discontinuation of treatment versus 1.9% in the placebo group. The only reported adverse events in at least 10% of women in the relugolix combination group were headache and hot flashes. There was one pregnancy in the relugolix combination group and three in the placebo group. Eligible women who completed the SPIRIT 1 or SPIRIT 2 studies were offered the opportunity to enroll in an extension study and receive relugolix combination therapy for an additional 80-week period, resulting in a total treatment period of up to 104 weeks. The one-year results of this extension study, expected in the first quarter of 2021, will form the basis of the New Drug Application together with the efficacy and safety data from the SPIRIT 1 and SPIRIT 2 studies. | |
Sumitovant Biopharma… Sumitovant Biopharma announced that the FDA has accepted for Priority Review, the New Drug Application, or NDA, submitted by Myovant Sciences, for once-daily, oral relugolix for the treatment of men with advanced prostate cancer. Sumitovant said in a release, "Myovant, a member of the Sumitovant family of companies, is a healthcare company focused on redefining care for women and for men. The FDA grants Priority Review to applications for potential therapies that, if approved, would be significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications. The FDA has set a target action date of December 20, 2020 under the Prescription Drug User Fee Act, or PDUFA. In its acceptance letter, the FDA also stated that it is currently not planning to hold an advisory committee meeting for this application. If approved, relugolix would be the first and only oral gonadotropin-releasing hormone, or GnRH, receptor antagonist treatment for men with advanced prostate cancer. In May 2020, Myovant submitted a separate NDA for once-daily, oral relugolix combination tablet for women with heavy menstrual bleeding associated with uterine fibroids. A Marketing Authorization Application for relugolix combination tablet in women with moderate to severe symptoms associated with uterine fibroids is also under review by the European Medicines Agency. Myovant's Phase 3 clinical program for advanced prostate cancer consisted of a randomized, open-label, parallel-group, multinational clinical study designed to evaluate the safety and efficacy of relugolix in over 900 men with androgen-sensitive advanced prostate cancer who required at least one year of continuous androgen deprivation therapy. Men were randomized 2:1 to receive a single loading dose of relugolix 360 mg followed by relugolix 120 mg once daily, or to treatment with leuprolide acetate 3-month depot injection, respectively." |