ObsEva SA OBSV announced the completion of patient recruitment in its second pivotal phase III study, PRIMROSE 1, evaluating oral gonadotropin releasing hormone (GnRH) receptor antagonist, linzagolix, for the treatment of heavy menstrual bleeding (HMB) associated with uterine fibroids (UF). Uterine fibroids are common non-cancerous tumors that grow within the muscular wall of the uterus.
PRIMROSE 1 will randomize about 500 patients who are diagnosed with HMB associated with UF. The patients will receive either a once daily dose of 100 mg or 200 mg of linzagolix, or placebo. Primary endpoint of PRIMROSE 1 is a clinically meaningful and statistically significant reduction in menstrual bleeding, as assessed by the alkaline hematin method, which is a validated, quantitative measurement of menstrual blood loss. Six-month primary endpoint data from the study are anticipated in the first half of 2020.
The company is also conducting another phase III study, PRIMROSE 2, simultaneously in the United States and Europe. The study is testing the same treatment arms at 102 sites, where about 500 patients have also been randomized. The company expects to report six-month primary endpoint data from the study in the fourth quarter of 2019.
The company’s shares have declined 11.5% year to date against the industry’s growth of 4.3%.
We remind investors that another pharma company, AbbVie Inc. ABBV, is also evaluating elagolix for uterine fibroids. The candidate is in phase III studies and the company expects to file a new drug application this year.
Zacks Ranks and Stocks to Consider
ObsEvacurrently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Applied Genetics Technologies Corp. AGTC and Acorda Therapeutics Inc. ACOR. While Applied Genetics sports a Zacks Rank #1 (Strong Buy), Acorda carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Applied Genetics’ loss per share estimates have narrowed from $2.39 to $2.15 for 2020 in the past 90 days. The company surpassed estimates in three of the trailing four quarters, with average positive surprise of 83.47%.
Acorda’s loss per share estimates have narrowed from $3.16 to $3.09 for 2020 in the past 60 days. The company outpaced estimates in the trailing four quarters, the average being 79.32%.
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