On February 18, Zosano Pharma Corp. (ZSAN) filed a current report on Form 8-K with the SEC. According to the filing, the company has received a complete response letter regarding the recent resubmission of the New Drug Application for M207. Thus, the company’s resubmitted NDA was also deemed incomplete and unacceptable by the FDA. Consequently, the stock took a harsh hit in the after-hours on Friday.
The stock was already trading in the red during the regular session at a volume of 9.24 million shares. ZSAN closed the session at $0.2159 with a loss of 3.49% after it reached a value of $0.2249. Following the SEC filing, the stock suffered a loss of 28.67% at 4.24 million shares. Hence, ZSAN stock was trading at a value of $0.1540 per share in the after-hours on Friday.
The clinical-stage biopharmaceutical company, Zosano Pharma Corp. has a market capitalization of $37.02 million. Currently, the company has 171.46 million shares outstanding in the market.
Recent Complete Response Letter
Previously, the company had received a complete response letter from the FDA on October 19, 2020, regarding the NDA submission of M207. M207 is the companies investigational zolmitriptan transdermal microneedle system. The CRL highlighted the deficiencies in the NDA submission and suggested further studies and data provision. Therefore, the company conducted a Phase 1 PK study which was recently completed.
On January 18, 2022, ZSAN resubmitted the 505(b)(2) New Drug Application for M207 with the FDA. As per February 18’s filing, the company received a response letter to the resubmission of February 17. According to the response letter, the company has failed to complete all the deficiencies highlighted in the previous CRL. So, the FDA will not be commencing a substantive review of the application unless a complete response is received.
While the company is assessing its best course of action, there is no certainty as to whether it would be able to further pursue the NDA submission of M207. After the financial and strategic evaluation and planning, the company will decide upon a path.
ZSAN’s Q3 Highlights
In the third quarter of 2021, the company had a net loss of $8.7 million ($0.07/share), against $8.7 million ($0.11/share) in the year-ago quarter.
ZSAN ended the quarter with cash and cash equivalents of $17.1 million on September 30, 2021. Comparatively, the company had $35.3 million on December 31, 2020.
