Zosano Pharma Corporation ZSANQ

ZSAN OCT 25TH FDA APPROVAL DATE DELAYED BY FDA!

[Humanist]

FDA trips up Zosano Pharma's migraine patch 3 weeks before approval date
Steven Lo is CEO of Zosano Pharma Corp.
COURTESY OF ZOSANO PHARMA
 By Ron Leuty  – Staff Reporter, San Francisco Business Times
Sep 30, 2020, 5:06pm PDT Updated Sep 30, 2020, 5:28pm PDT

An East Bay drug maker that hoped to win FDA approval next month of its migraine-fighting patch saw its stock tumble Wednesday after disclosing that the regulator raised concerns that put the drug-device's near-term approval in doubt.

Zosano Pharma Corp. (NASDAQ: ZSAN) of Fremont said the Food and Drug Administration questioned why zolmitriptan, a generic drug used in the company's Qtrypta patch to treat migraine symptoms, showed up in higher concentrations in the plasma of five people across two studies. The FDA also asked about differences in zolmitriptan exposures between trial subjects receiving different lots of Qtrypta.

The FDA's "discipline review letter" doesn't represent a final FDA decision on Qtrypta, which was scheduled to be approved by Oct. 20, but Zosano said in a statement after the markets closed Wednesday that approval now is not expected by that date.
With FDA approval, the company had anticipated launching the patch commercially next year.

"We are disappointed in this notification and are in the process of evaluating and addressing FDA's comments," Zosano President and CEO Steven Lo said in a statement.

Shares of Zosano, which had gained two cents Wednesday to close at $1.62 per share, shed 52% of its value in after-hours trading, losing 84 cents.

The company, which had 40 employees at the end of last year, said it had about $43.4 million in cash and equivalents as of Tuesday.
Qtrypta is a system that includes a quarter-sized patch with close to 2,000 microneedles — each about three times the size of a human hair — that are coated with a proprietary formulation of zolmitriptan. The company has said that the system allows rapid absorption of drugs into the bloodstream, positioning Qtrypta as a faster way to relieve the severe headaches, nausea and vomiting that mark migraines.

The company of late has pitched the patch, which looks like an adhesive bandage on the arm, as a way to deliver drugs to treat Covid. The company, which has burned through more than $300 million over its 14 years of existence, also has at various times positioned its technology for osteoporosis and severe hypoglycemia as a result of diabetes treatment.

Zosano's only drug in clinical trials is C-213, a potential treatment for cluster headaches, that is in a mid-stage study.