ObsEva SA (OBSV), a biopharmaceutical company, has increased by 7.76% in the premarket trading session. As a result, OBSV stock is trading at $2.36 at the time of the writing. The increase is attributable to the announcement of positive CHMP opinion for Linzagolix. On Thursday, OBSV closed the day at $2.19 after declining 2.23% during regular trading hours.
Why OBSV Rising?
On Thursday, OBSV announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has formulated a positive opinion regarding the Linzogolix, an oral GnRH antagonist which manages symptoms of uterine fibroids (UF) in adult women having a reproductive age. While adopting the positive opinion, CHMP has recommended approval of Linzagolix. The company submitted a marketing authorization application based on positive data from two Phase 3 PRIMROSE trials. If it gets the nod of approval, Linzagolix would be the first and only approved GnRH receptor antagonist having a non-hormonal option.
Q3 2021 Operational Results
In early November, OBSV released the operational results for the third quarter of the fiscal year 2021. The quarter ended on 30th September 2021. The total operating expenses bore by the company during the period were $18.5 million against $23.6 million for the same period of 2020. The operating income generated by the company during the three months was $1.5 million against the operating loss of $23.6 million for the same period of 2020. The net income generated by the company during the period was $0.81 million (or $0.01 per basic and diluted share) against the net loss of $24.3 million (or $0.49 per basic and diluted share) for the same period of 2020.
Brian O’Callaghan, CEO of OBSV, while commenting on the results said that the recent months have been quite noteworthy for the company due to several reasons, especially due to the progress made in defining the future of the Linzagolix program. The company is confident in its ability to continually follow the growth trajectory and redefine its future.
Future Outlook for OBSV
The last three months have seen OBSV stock decline more than 30%. With the uncertainty associated with the company’s programs, especially Linzagolix, the OBSV stock continually tumbled during the period. However, the positive developments for Linzagolix mean that the stock is shaping up nicely for the future.