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Tag: Karyopharm Therapeutics Inc.

  • Selinexor Regulatory Update: Karyopharm Therapeutics Inc. (KPTI) Collapse After Hours

    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.

    Source: Global Regulatory Partners

    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.

  • Karyopharm Theraapeutics Inc. (KPTI) Stock Sinking in Premarket. Here’s the Reason.

    Karyopharm Theraapeutics Inc. (KPTI) Stock Sinking in Premarket. Here’s the Reason.

    Karyopharm Therapeutics Inc. (KPTI) is a commercial-stage biotherapeutics company engaged in developing cancer therapies. The company’s pioneer Selective Inhibitor of Nuclear Export compound technology was developed to address an oncogenesis mechanism of nuclear export dysregulation. XPOVIO is commercialized by the Company in three cancer indications. The company’s candidate pipeline treats endometrial cancer, myelofibrosis, and myelodysplastic disorders.

    The price of KPTI stock during the regular trading on February 7, 2022, was $10.2 with an incline of 5.13%. At last check in the premarket on February 8, 2022, the stock dropped by 13.77%.

    KPTI: Key Financials

    On February 8, 2022, KPTI released its financial results for the fourth quarter of 2021 ended December 31, 2021. Some of the main aspects are mentioned below.

    Revenue

    Net product revenue in Q4 2021 was $29.8 million compared to $20.2 million for the same quarter in 2020. The revenue was up by 47% over the period of the year. The company missed the estimated revenue target of $31.9 million by $2.1 million.

    KPTI: EPS

    Net income per share in Q4 2021 was $38.7 million, or $0.51 (basic) and $0.46 (diluted) compared to a basic and diluted net loss of $43.4 million, or $0.59 per share in the same period of 2020. The company’s EPS beat the analysts’ estimate of $0.42 per share.

    On February 8, 2022, KPTI updated about optimistic top-line outcomes from the Phase 3 Selinexor studies, assessing its safety and efficacy. The study met its prime endpoint of significant improvement in median PFS. On February 1, 2022, KPTI was informed about the grant of stock options for the acquisition of a total of 124,500 shares of its common stock by the company’s BoDs. The stock option was granted to the new employees as inducement materials in accordance with Nasdaq Listing Rules.

    On January 24, 2022, the company reported about the grant of orphan drug designation for eltanexor by the FDA. On January 21, 2022, KPTI updated that the Executive management presented at the Virtual B. Riley Securities Oncology Investor Conference held on January 28, 2022. On January 4, 2022, KPTI informed that its Executive management presented at the Virtual 40th Annual J.P. Morgan Healthcare Conference on January 11, 2022.

    Conclusion

    KPTI stock outperformed in the last six months by 83%. The company’s latest premarket dip is the result of missed revenue target, as it reported the quarterly results. Although the company beat the estimated EPS and reported the positive topline results of its pipeline candidate, it down-performed in the market. The company’s management is quite hopeful to cover the losses of the company in the upcoming period.