On March 01, Karyopharm Therapeutics Inc. (KPTI) provided U.S. regulatory updates on Selinexor in advanced or recurrent endometrial cancer. Consequently, the stock suffered a huge blow and collapsed in the after-hours on Tuesday.
During the regular trading session, KPTI stock varied between a high of $10.71 and a low of $10.20. The stock closed the session in the green with a small gain of 0.58% as 2.74 million shares exchanged hands. Thus, at the close of the regular trading session, KPTI had a value of $10.39 per share. Following the announcement, the stock collapsed in the after-hours to reach $7.69. Hence, the stock suffered a loss of 25.99% or $2.70 in the after-hours on Tuesday.
The commercial-stage pharmaceutical company, Karyopharm Therapeutics Inc. has a market capitalization of $782.46 million. Currently, the company has 75.75 million shares outstanding in the market. So far 2022 has proved a very fruitful year for the stock as it has increased by 61.59% year to date, while it lost 21.23% last year.
KPTI’s Regulatory Update
The company has been in discussions with the FDA regarding a supplemental New Drug Application (sNDA) of selinexor. The company had previously planned the sNDA submission on Phase 2 SIENDO study data. The SIENDO study is assessing selinexor as front-line maintenance therapy after chemotherapy in advanced or recurrent endometrial cancer patients.
Recently, the company had a productive meeting regarding the submission with the FDA. As per the feedback, the FDA has deemed the current top-line results of SIENDO study as unlikely to support sNDA approval. The company and FDA had differing views regarding the matter and further exploration of advanced or recurrent endometrial cancer with p53 wild-type was discussed.
KPTI is further analyzing the SEINDO study data and plans to work with the FDA for exploring all regulatory pathways. Moreover, the company plans to commence a new clinical study in p53 wild-type endometrial cancer patients with data expected in H1 2024.
Inducement Grants
On February 28, the company announced granting stock options of purchasing 168,500 common shares and 112,200 restricted stock units to nine new employees. The equity awards were granted as inducement material to the employees under its 2022 Inducement Stock Incentive Plan.
KPTI’s Financials
As reported, KPTI’s net product revenue increased by 47% YOY to $29.8 million in the fourth quarter of 2021.
Furthermore, the company had a net income of $38.7 million or $0.46 on a diluted share basis in Q4 2021. Comparatively, the company had a net loss of $43.4 million or $0.59 per share in Q4 2020.
