Zosano Pharma Corp. (NASDAQ: ZSAN) stock gains by 2.92% at last close while the ZSAN stock price surges by 0.68% in the pre-market trading session. Zosano Pharma Corporation is a clinical-stage pharmaceutical business focusing on developing solutions that allow for the fast administration of authorized compounds with well-established safety and effectiveness profiles in areas where existing treatments are inadequate.
ZSAN stock’ Recent Development
The United States Food and Drug Administration (FDA) has given Zosano Pharma Corporation a Type C written response-only meeting. Following receipt of preliminary top-line findings from the pharmacokinetic (“PK”) research, the M207 (zolmitriptan transdermal microneedle device) 505(b)(2) New Drug Application was resubmitted.
The PK research comprised 48 healthy volunteers who assessed about 2,500 samples made with two distinct manufacturing equipment lots of M207. The goal of this research was to evaluate the safety and pharmacokinetics of two 5 mg zolmitriptan doses intranasally to an intranasal control formulation. M207 was free from side effects, according to the safety evaluation, which was consistent with prior trials.
Unless and until the business resubmits an NDA and perhaps obtains FDA clearance, it is impossible to predict a product launch date or revenue for 2022 or beyond.
Steven Lo, president and chief executive officer of Zosano commented,
They are delighted that the early top-line PK study findings revealed no outliers with very high zolmitriptan plasma concentrations. They scheduled a meeting with the FDA to go through the data, which included preliminary bioequivalence data from the various production equipment batches. They aim to improve their approach for resubmitting an NDA after receiving written comments from the FDA following the Type C conference. After they get a formal response from the FDA, which is anticipated by mid-December, they will provide an update on their resubmission intentions. Thousands of people in the United States suffer from migraine episodes that aren’t well serviced by current treatments, and they believe M207 has the potential to give much-needed respite.
