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MYOV

Myovant Sciences

$17.33

-0.42 (-2.37%)

07:43
05/14/19
05/14
07:43
05/14/19
07:43

Myovant Sciences announces LIBERTY 1 trial meets primary efficacy endpoint

Myovant Sciences announced that LIBERTY 1, the first of two Phase 3 studies of once daily relugolix combination therapy met its primary efficacy endpoint and six key secondary endpoints in women with uterine fibroids. Relugolix combination therapy maintained bone mineral density at levels comparable to placebo over 24 weeks and was generally well tolerated. In the primary endpoint analysis, 73.4% of women receiving once daily oral relugolix combination therapy achieved the responder criteria compared with 18.9% of women receiving placebo. A response was defined as a menstrual blood loss volume of less than 80 mL and a 50% or greater reduction from baseline in menstrual blood loss volume during the last 35 days of the 24-week treatment period measured using the alkaline hematin method. On average, women receiving relugolix combination therapy experienced an 84.3% reduction in menstrual blood loss from baseline, a clinically relevant key secondary endpoint. Bone mineral density was comparable between the relugolix combination and placebo groups. The distribution of the change in bone mineral density, including outliers, was similar for the relugolix combination therapy and placebo groups at 24 weeks, as assessed by dual energy x-ray absorptiometry, or DXA. The 24-week study achieved six key secondary endpoints with statistical significance compared to placebo including mean change in menstrual blood loss from baseline to week 24, reduction in pain in women with pain at baseline, improvement in quality of life, amenorrhea defined as no or negligible blood loss, improvement in anemia in those women with anemia at baseline and reduction in uterine volume. The overall incidence of adverse events in the relugolix combination and placebo groups was comparable. In the relugolix combination therapy group 5% of women discontinued treatment early due to adverse events compared with 4% in the placebo group. The only adverse event in the relugolix combination arm occurring in at least 10% of women and more frequently than in the placebo arm was hot flush. There were no pregnancies in the relugolix combination group and one in the placebo group. Myovant expects data from LIBERTY 2, the replicate Phase 3 study evaluating once daily relugolix combination therapy in women with uterine fibroids and heavy menstrual bleeding, in Q3 and, provided the LIBERTY 2 study is successful, plans to submit a new drug application to the FDA in Q4.

MYOV Myovant Sciences
$17.33

-0.42 (-2.37%)

02/13/19
LEHM
02/13/19
UPGRADE
Target $25
LEHM
Overweight
Myovant Sciences upgraded to Overweight from Equal Weight at Barclays
Barclays analyst Geoffrey Meacham upgraded Myovant Sciences to Overweight and raised his price target for the shares to $25 from $22.
02/13/19
LEHM
02/13/19
UPGRADE
Target $25
LEHM
Overweight
Barclays upgrades Myovant to Overweight on bullish women's health survey
Barclays analyst Geoffrey Meacham upgraded Myovant Sciences to Overweight from Equal Weight and raised his price target for the shares to $25 from $22. The analyst says his firm's women's health survey suggests a "robust potential market" for new treatment options for endometriosis and uterine fibroids. Respondents to the survey reported positive experiences with Orilissa and noted increasing patient interest in new therapies, Meacham tells investors in a research note. He believes Myovant will benefit from these market dynamics.
02/13/19
02/13/19
UPGRADE

Fly Intel: Top five analyst upgrades
Catch up on today's top five analyst upgrades with this list compiled by The Fly: 1. Freeport McMoRan (FCX) upgraded to Overweight from Equal Weight at Morgan Stanley with analyst Piyush Sood saying his firm's Metals & Mining team expects copper market tightness to emerge beginning in Q2, given falling global production, low visible inventories and improved demand from China and Freeport's earnings sensitivity to copper is still the highest among its peers. 2. DocuSign (DOCU) upgraded to Buy from Hold at Deutsche Bank with analyst Karl Keirstead saying that after speaking with four large e-signature customers, three using DocuSign and one using Adobe Sign, the analyst believes a "more constructive call on DocuSign shares is now warranted." 3. Bloom Energy (BE) upgraded to Outperform from Market Perform at Raymond James with analyst Pavel Molchanov saying shares are down about 36% since the IPO in July 2018, including a 24% drop since mid-January, the latter due in large part to selling pressure following lockup expiration. 4. Shopify (SHOP) upgraded to Outperform from Sector Perform at RBC Capital with analyst Ross MacMillan saying he anticipates the company to return to new merchant growth this year given its international opportunity and easier comps. 5. Myovant Sciences (MYOV) upgraded to Overweight from Equal Weight at Barclays with analyst Geoffrey Meacham saying his firm's women's health survey suggests a "robust potential market" for new treatment options for endometriosis and uterine fibroids. The analyst also raised his price target for the shares to $25 from $22. This list is just a portion of The Fly's full analyst coverage. To see The Fly's full Street Research coverage, click here.
04/11/19
EVER
04/11/19
INITIATION
Target $30
EVER
Outperform
Myovant Sciences initiated with an Outperform at Evercore ISI
Evercore ISI analyst Ravi Mehrotra initiated Myovant Sciences (MYOV) with an Outperform rating and a price targets of $30. The analyst says the company's lead program relugolix has been clinically de-risked with near-term pivotal data readouts. Mehrotra is modeling revenues of $944M for the program by 2023 thanks to its "commercial advantage of a one-a-day pill" and the "second-mover leverage of competitor AbbVie's (ABBV) efforts to raise awareness and diagnosis" in woman's health market.

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MYOV

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Breaking Syndicate news story on Myovant Sciences »

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16:30
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16:30
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16:30
Options
Preliminary option volume of 15.7M today »

Preliminary option volume…

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