Zosano Pharma (ZSAN) Announces NDA Resubmission Plans Following Type A Meeting with FDA
- Wall Street ends lower as investors await earnings, inflation data
- Microsoft (MSFT) announces $19.7 billion acquisition of Nuance (NUAN)
- Alibaba (BABA) Gets a Record $2.8 Billion Anti-Monopoly Fine, Shares Soar as a 'Major Overhang' is Lifted
- Tesla (TSLA) Upgraded to 'Buy' at Canaccord Genuity and PT Raised by 155%, as it 'Holds a Several-Year Lead' in EV While Storage Business Accelerates
- Dollar drops as traders prepare for inflation data
News and research before you hear about it on CNBC and others. Claim your 1-week free trial to StreetInsider Premium here.
Zosano Pharma Corporation (NASDAQ: ZSAN), a clinical-stage biopharmaceutical company, today announced that the company completed its Type A meeting with the U.S. Food and Drug Administration (“FDA") Division of Neurology II (the “Division”) regarding the requirements for resubmission of the Qtrypta™ (zolmitriptan transdermal microneedle system) 505(b)(2) New Drug Application (“NDA”) following the Complete Response Letter received on October 20, 2020.
Based on feedback from the Type A meeting held with the Division, the company plans to conduct an additional pharmacokinetic (“PK”) study for inclusion in an NDA resubmission package. During the meeting, the Division did not request that the company conduct any further clinical efficacy studies to support the resubmission. Prior to initiating the PK study, the company plans to submit the study protocol to the Division for additional comment and review. The Division indicated willingness to review the study protocol and provide comments prior to the initiation of the study. The company’s plans for resubmitting the NDA are based on the discussions between the company and the Division during the Type A meeting and may be subject to change upon receipt of the FDA’s official meeting minutes from the Type A meeting.
“We appreciate the FDA’s willingness to discuss our application, and the Division providing confirmation that an additional PK study will be necessary to resubmit the NDA for Qtrypta,” said Steven Lo, President and CEO of Zosano. “We are working to have a protocol for the PK study finalized this quarter. We look forward to initiating and completing the study, and ultimately resubmitting our NDA application. Qtrypta leverages our proprietary microneedle technology that has been supported by data from five trials in 774 subjects, and we are encouraged by its potential to treat patients with debilitating migraines.”
Serious News for Serious Traders! Try StreetInsider.com Premium Free!
You May Also Be Interested In
- Amarin Corp. (AMRN) CEO John Thero to Retire, Karim Mikhail to Succeed
- Instil Bio Inc. (TIL) Highlights Clinical Data in Metastatic Melanoma in Late-Breaking e-Poster
- Applied DNA Sciences (APDN), Evvivax announce positive preliminary Phase I clinical trial results for a LinearDNA COVID-19 vaccine candidate
Create E-mail Alert Related CategoriesCorporate News, FDA, Hot FDA News, Management Comments
Sign up for StreetInsider Free!
Receive full access to all new and archived articles, unlimited portfolio tracking, e-mail alerts, custom newswires and RSS feeds - and more!