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OBSV

ObsEva

$9.52

-0.19 (-1.96%)

05:22
09/03/19
09/03
05:22
09/03/19
05:22

ObsEva reports new clinical evidence of nolasiban MoA

ObsEva reported results from a mechanism of action, or MoA, trial of its oral oxytocin receptor antagonist, nolasiban. The trial assessed the effect of nolasiban on uterine contractions and endometrial blood flow, both of which are known to be associated with uterine receptivity and embryo implantation, and ultimately pregnancy and live birth following IVF. The effect of nolasiban administration on endometrial gene expression was also investigated. The randomized, double blind trial was conducted in 42 healthy female volunteers, aged 18 to 37 years, who had been pre-treated with a hormonal preparation identical to that used in women undergoing frozen-thawed embryo transfer. On the day corresponding to a Day 5 embryo transfer, subjects received a single, oral administration of the clinical dose of 900 mg nolasiban, a supra-therapeutic dose of 1800 mg nolasiban, or matching placebo. Pharmacodynamic, or PD, assessments up to 24 hours after treatment included measurements of uterine contraction frequency by ultrasound and uterine perfusion by 3D-power Doppler. Endometrial biopsy was obtained following PD assessments, and tissue samples analyzed for differential mRNA expression. "A single oral dose of nolasiban produced measurable and durable effects, with a reduction in the frequency of uterine contractions and a marked and sustained increase in endometrial blood flow. Within 24 hours of nolasiban administration, statistically significant changes were observed in the expression of a set of endometrial genes that have been described as potentially important in endometrial receptivity and embryonic implantation. These nolasiban trial results represent the first in vivo demonstration of the effect of oxytocin receptor inhibition on endometrial blood flow and receptivity-related gene expression. These important new MoA findings support the potential for nolasiban to increase live birth rates following IVF." The trial results are scheduled to be presented at an upcoming international OB/GYN conference.

  • 09

    Sep

OBSV ObsEva
$9.52

-0.19 (-1.96%)

12/03/18
WEDB
12/03/18
NO CHANGE
WEDB
Del Taco, ObsEva added to Best Ideas List at Wedbush
Wedbush expects visibility in 2019 into Del Taco's (TACO) long-term MSD-HSD EBITDA growth algorithm to result in valuation expansion toward its regional Restaurant Brands (QSR) peers, and is adding the stock to its Best Ideas List. Reiterating an Overweight rating on the shares and also adding it to its Best Ideas List, Wedbush says ObsEva (OBSV) continues to deliver stellar clinical results from its drug candidate pipeline. The firm anticipates Linzagolix to be the third entrant in the oral gonadotropin releasing hormone receptor antagonist space, but its differentiated profile and dosing options are likely to be preferred by patients.
03/05/19
FBCO
03/05/19
NO CHANGE
Target $24
FBCO
Outperform
ObsEva setting up steady clinical catalysts lineup, says Credit Suisse
Credit Suisse analyst Martin Auster notes that ObsEva used its earnings call to highlight that it may have six Phase 3 trials active in 2019 across linzagolix and nolasiban, setting up a steady clinical catalysts lineup, with nolasiban IMPLANT 4 results coming in Q4 of 2019. If results are positive, the company plans to file an MAA submission by the end of Q4 2019, with a potential 2020 EU approval, he contends, adding that ObsEva sees nolasiban as having blockbuster potential, with an attractive value proposition to patients, clinics, and the overall health system. Meanwhile, the analyst highlighted that the company plans to meet with FDA Q2 2019 to reach agreement on the U.S. approval strategy for nolasiban. Auster reiterates an Outperform rating and $24 price target on the shares.
06/12/19
WEDB
06/12/19
NO CHANGE
WEDB
Outperform
ObsEva removed from Best Ideas List at Wedbush
Wedbush removed ObsEva from its Best Ideas List due to its investment price discipline. The firm has an Outperform rating on the shares.
07/29/19
FBCO
07/29/19
NO CHANGE
Target $16
FBCO
Outperform
ObsEva price target lowered to $16 from $24 at Credit Suisse
Credit Suisse analyst Martin Auster lowered his price target for ObsEva to $16 from $24 saying that while pipeline has value long-term, he sees some uncertainty on near-term catalysts. The analyst reiterates an Outperform rating on the shares.

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