Zosano Pharma Requests Type A Meeting with the FDA to Review Resubmission Plans for Qtrypta™ New Drug Application
January 04 2021 - 4:05PM
Zosano Pharma Corporation (NASDAQ:ZSAN), a clinical-stage
biopharmaceutical company, today announced that on December 30,
2020 the company requested a Type A meeting with the U.S. Food and
Drug Administration (FDA).
The purpose of the Type A meeting is to receive FDA input on the
requirements for the resubmission of the Qtrypta™ (zolmitriptan
transdermal microneedle system) 505(b)(2) New Drug Application
(NDA) following the Complete Response Letter (CRL) received on
October 20, 2020. Qtrypta is Zosano’s proprietary investigational
formulation of zolmitriptan delivered utilizing its proprietary
transdermal microneedle system developed for the acute treatment of
migraine. The NDA included data on a total of 774 subjects across 5
trials who were administered or dosed with Qtrypta.
“We have been working diligently to prepare the meeting package
required at the time a Type A meeting request is submitted to FDA.
We are sharply focused on the resubmission of the NDA for Qtrypta
and have been preparing strategies to address the comments
received,” said Steven Lo, President and CEO of Zosano. “We look
forward to discussing our proposed plans with the FDA, and we
expect that the Type A meeting will provide valuable insight into
the agency’s expectations for a resubmission package.”
The FDA typically responds to a sponsor’s request for a Type A
meeting, if granted, with a meeting scheduled within 30 days from
the receipt of the request.
About Zosano PharmaZosano Pharma Corporation is
a clinical-stage biopharmaceutical company focused on developing
products where rapid administration of approved molecules with
established safety and efficacy profiles may provide substantial
benefit to patients, in markets where patients remain underserved
by existing therapies. The company’s transdermal microneedle system
technology consists of titanium microneedles coated with drug that
are designed to enable rapid systemic administration of
therapeutics to patients. Zosano’s lead product candidate is
Qtrypta™ (M207), which is a proprietary formulation of zolmitriptan
designed to be delivered via its transdermal microneedle system
technology, as an acute treatment for migraine. Learn more at
www.zosanopharma.com.
Forward-Looking StatementsThis press release
contains forward-looking statements. All statements other than
statements of historical facts contained herein are forward-looking
statements reflecting the current beliefs and expectations of
management made pursuant to the safe harbor provisions of the
Private Securities Litigation Reform Act of 1995, including, but
not limited to, the company’s plan to have a Type A meeting with
the FDA and the company’s expectations with respect to the timing
of the meeting with the FDA. Such forward-looking statements
involve known and unknown risks, uncertainties, and other important
factors that may cause the company’s actual results, performance,
or achievements to be materially different from any future results,
performance, or achievements expressed or implied by the
forward-looking statements. For a further description of the risks
and uncertainties that could cause actual results to differ from
those expressed in these forward-looking statements, as well as
risks relating to the company’s business in general, see the most
recent Annual Report on Form 10-K and Quarterly Reports on Form
10-Q filed with the Securities and Exchange Commission. The company
does not plan to publicly update or revise any forward-looking
statements contained in this press release, whether as a result of
any new information, future events, changed circumstances, or
otherwise, except as required by law.
Zosano Contacts:Christine MatthewsChief
Financial Officer510-745-1200
Zosano PR:Sylvia Wheeler or Alexandra
Santosswheeler@wheelhouselsa.com or asantos@wheelhouselsa.com
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