ObsEva SA
OBSV
recently announced that the European Commission (EC) has granted marketing authorization to its oral GnRH receptor antagonist, linzagolix, for the management of moderate to severe symptoms of uterine fibroids (UF) in adult women of reproductive age. The drug will be marketed under the trade name Yselty.
The approval follows a positive review by the Committee for Medicinal Products for Human Use (CHMP), which recommended the approval of the oral drug in all member states. The decisions by both EC and CHMP are based on data from two phase III PRIMOSE studies. Pooled week 24 data from both these studies show that treatment with a 200 mg dose of the drug with hormonal ABT achieved a responder rate of 84.5% in participants, while a 100 mg dose without ABT achieved a responder rate of 56.5%.
The EC decision makes Yselty the first and currently the only approved GnRH receptor antagonist that offers women with UF flexible dosing options with and without hormonal add-back therapy (ABT). Yselty is the first oral GnRH antagonist to provide therapeutic alternatives for women who are unable to take hormone therapy.
Shares of ObsEva were up 11% in pre-market trading on Jun 17 following the announcement. In the year so far, the stock has decreased 8% compared with the
industry
’s decline of 30.4%.
Image Source: Zacks Investment Research
The company has filed a new drug application (NDA) with the FDA, which is currently under review. A final decision on the NDA is expected by Sep 13, 2022.
ObsEva has signed a strategic licensing agreement with London-based Theramex to commercialize Yselty outside of the United States, Canada and Asia. Per the agreement, ObsEva will be eligible to receive royalties of a mid-thirties percentage on commercial sales of the drug. The agreement makes OBSV eligible to receive potential milestone payments.
We remind investors that ObsEva acquired the in-license rights of linzagolix from Japan-based pharma company Kissei in 2015. The rights include global (excluding Asia) commercial rights for the product.
Zacks Rank & Other Stocks to Consider
ObsEva currently carries a Zacks Rank #2 (Buy). Some other top-ranked stocks in the overall healthcare sector are
Abeona Therapeutics
ABEO
,
Alkermes
ALKS
and
Sesen Bio
SESN
. While Alkermes sports a Zacks Rank #1 (Strong Buy) at present, both Abeona Therapeutics and Sesen Bio carry a Zacks Rank #2. You can see
the complete list of today’s Zacks #1 Rank stocks here
.
Alkermes’ loss per share estimates for 2022 have narrowed from 13 cents to 3 cents in the past 60 days. Shares of Alkermes have risen 3.4% year to date.
Earnings of Alkermes beat estimates in each of the trailing four quarters, the average surprise being 350.5%. In the last reported quarter, ALKS delivered an earnings surprise of 1,100%.
Abeona Therapeutics’ loss per share estimates for 2022 have narrowed from 34 cents to 31 cents in the past 30 days. Shares of Abeona Therapeutics have plunged 42.6% in the year-to-date period.
Earnings of Abeona Therapeutics missed estimates in two of the trailing four quarters and matched the same twice, the average negative surprise being 8.2%. In the last reported quarter, ABEO missed on earnings by 25%.
Sesen Bio’s loss per share estimates for 2022 has declined from 33 cents to 32 cents in the past 60 days. Shares of Sesen Bio have fallen 19.9% in the year-to-date period.
Earnings of Sesen Bio beat estimates in three of the last four quarters and missed the mark once, the average surprise being 69.9%. In the last reported quarter, SESN delivered an earnings surprise of 100%.
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