Zosano Pharma Receives Preliminary FDA Communication on Qtrypta™ NDA
September 30 2020 - 5:40PM
Zosano Pharma Corporation (NASDAQ:ZSAN), a clinical-stage
biopharmaceutical company today announced that it has received a
discipline review letter (DRL) from the U.S. Food and Drug
Administration (FDA) in connection with the Qtrypta™ (zolmitriptan
transdermal microneedle system) 505(b)(2) New Drug Application
(NDA). A DRL is used by the FDA to convey preliminary comments on
deficiencies identified during the NDA review with respect to a
particular review discipline.
The DRL described two concerns with respect to the clinical
pharmacology section of the NDA. First, the FDA raised questions
regarding unexpected high plasma concentrations of zolmitriptan
observed in five study subjects from two pharmacokinetic studies
and how the data from these subjects affect the overall clinical
pharmacology section of the application. Second, the FDA raised
questions regarding differences in zolmitriptan exposures observed
between subjects receiving different lots of Qtrypta in the
company’s clinical trials.
Although a DRL reflects preliminary comments
that are subject to change, and does not reflect the FDA’s final
decision on the NDA, approval of Qtrypta by the Prescription Drug
User Fee Act goal date of October 20, 2020 is not expected given
the letter.
“We are disappointed in this notification and are in the process
of evaluating and addressing FDA’s comments,” said Steven Lo,
president and chief executive of Zosano. “We believe Qtrypta
represents an attractive therapeutic alternative for patients
suffering from migraines and look forward to working with FDA
through the NDA review process.”
As of September 29, 2020, the Company had
approximately $43.4 million in cash and cash equivalents. This cash
and cash equivalents information is preliminary and subject to
completion, including the completion of customary financial
statement closing and review procedures for the quarter ending
September 30, 2020. As a result, the preliminary information set
forth above reflects the Company’s preliminary estimate with
respect to such information, based on information currently
available to management, and may vary from the Company’s actual
cash and cash equivalents as of September 29, 2020.
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 delivered via its transdermal
microneedle system technology, as an acute treatment for migraine.
The company anticipates that many of its current and future
development programs may enable the company to utilize a regulatory
pathway that has the potential to streamline clinical development
and accelerate the path towards commercialization. Learn more at
www.zosanopharma.com or connect through LinkedIn and Twitter.
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, statements regarding the Company’s cash and cash
equivalents as of September 29, 2020 and the Company’s expectations
with respect to approval of Qtrypta by the Prescription Drug User
Fee Act goal date. 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 Officer 510-745-1200
Zosano PR:Sylvia Wheeler or Alexandra
Santosswheeler@wheelhouselsa.com or
asantos@wheelhouselsa.com
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