Zosano Pharma

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After Hours: 0.4024 -0.0002 -0.05% 17:30 10/27 EDT
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The Week Ahead In Biotech: Kala FDA Decision, Merck & Pfizer Earnings, Vaccine Updates And IPOs
Biotech stocks posted weekly declines in the week ended Oct. 23, pressured by the broader market decline amid mixed earnings reports and the impasse on fiscal stimulus.
Benzinga · 2d ago
Zosano Pharma Receives Complete Response Letter from FDA for Qtrypta
\--FDA feedback consistent with FDA’s preliminary communication in September-- \--Company requesting meeting with FDA to discuss next steps required to resubmit the NDA--FREMONT, Calif., Oct. 21, 2020 (GLOBE NEWSWIRE) -- Zosano Pharma Corporation (NASDAQ:ZSAN), a clinical-stage biopharmaceutical company, announced today that it has received a complete response letter (CRL) 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).The CRL cited inconsistent zolmitriptan exposure levels observed across clinical pharmacology studies, which had been previously identified in the FDA’s discipline review letter in September. Specifically, the CRL noted differences in zolmitriptan exposures observed between subjects receiving different lots of Qtrypta in the company’s trials and inadequate pharmacokinetic bridging between the lots that made interpretation of some safety data unclear. The CRL referenced unexpected high plasma concentrations of zolmitriptan observed in five study subjects enrolled in the company’s pharmacokinetic studies. The FDA recommended that the company conduct a repeat bioequivalence study between three of the lots used during development. The NDA included data on a total of 774 subjects across 5 trials who were administered or dosed with Qtrypta.The CRL noted that additional product quality validation data, which were planned to be submitted following approval, if received, were required to be submitted with the application. In addition, the CRL mentioned that due to U.S. Government and/or Agency-wide restrictions on travel, inspections of Zosano’s contract manufacturing facilities were not able to be conducted but would be required before the application may be approved.Zosano will request a Type A meeting with the FDA to discuss strategies to address the FDA’s comments.“We are working diligently to address the deficiencies identified by the FDA and look forward to the possibility of resubmitting our NDA,” said Steven Lo, president and chief executive of Zosano. “We expect that the Type A meeting with the FDA will provide clarity on the next steps for the program, which we will communicate once solidified. There are thousands of people suffering from migraine attacks that are not adequately addressed with available drugs, and we continue to believe that Qtrypta, if approved, could offer a much-needed new therapy for these patients.”About Zosano Pharma Zosano 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 or connect through LinkedIn and Twitter.Forward-Looking Statements This 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 request a Type A meeting with the FDA to discuss strategies to address the FDA’s comments in the CRL and the company’s expectations with respect to 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 Matthews Chief Financial Officer 510-745-1200Zosano PR: Sylvia Wheeler or Alexandra Santos or
GlobeNewswire · 6d ago
FDA rejects Zosano Pharma application for Qtrytpa
As expected, Zosano Pharma (ZSAN) has received a Complete Response Letter ((CRL)) from the FDA regarding its marketing application for Qtrypta (zolmitriptan transdermal microneedle system) for the acute treatment of
Seekingalpha · 6d ago
The Daily Biotech Pulse: Aptinyx Jumps On Positive Readout, Cara Executes Korsuva Licensing Deal, Cleveland BioLabs Rallies On Reverse Merger
Here's a roundup of top developments in the biotech space over the last 24 hours: Scaling The Peaks (Biotech Stocks Hitting 52-week Highs Oct. 19)
Benzinga · 10/20 12:17
The Week Ahead In Biotech: Spectrum Pharma FDA Decision, Biogen And Abbott Earnings, Cancer Conference
Biopharma stocks, which started the week on a firm footing, lost momentum mid-way through amid market-wide sell-off triggered by waning stimulus hopes.
Benzinga · 10/18 16:50
Stocks To Watch: GM's Hummer Charges The EV Party, Earnings Blitz
Welcome to Seeking Alpha's Stocks to Watch - a preview of key events scheduled for the next week. Follow this account and turn the e-mail alert on to receive this article in your inbox every Saturday morning. A podcast of Stocks to Watch is also available on Sundays on Seeking Alpha, Apple Podcasts, Stitcher and Spotify (click the highlighted links). The earnings season heats up next week, with high-fliers Netflix (NFLX), Tesla (TSLA) and Chipotle (CMG) all reporting. Coming off the heels of a strong retail sales report, economic reports of interest in the week ahead include looks at the
Seekingalpha · 10/17 11:51
The Week Ahead In Biotech: Avenue's FDA Decision, Alkermes Adcom Meeting, Aziyo Biologics IPO
Biotech stocks made a steady recovery over the week ended Oct. 2, although Friday's weakness trimmed some of the gains of the week.
Benzinga · 10/04 14:00
Bronstein, Gewirtz & Grossman, LLC Notifies Investors of Zosano Pharma Corporation (ZSAN) Investigation
NEW YORK, NY / ACCESSWIRE / October 2, 2020 / Bronstein, Gewirtz & Grossman, LLC is investigating potential claims on behalf of purchasers of Zosano Pharma Corporation ("Zosano" or "the Company") (NASDAQ:ZSAN).
ACCESSWIRE · 10/02 15:00
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Based on 3 analysts


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Analyst Price Target
The average ZSAN stock price target is 2.000 with a high estimate of 2.500 and a low estimate of 1.500.
Institutional Holdings
Institutions: 46
Institutional Holdings: 7.51M
% Owned: 9.42%
Shares Outstanding: 79.69M
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Biotechnology & Medical Research
Pharmaceuticals & Medical Research
Key Executives
John Walker
Chief Executive Officer/Director
Steven Lo
Chief Financial Officer
Christine Matthews
Senior Vice President
Dushyant Pathak
Vice President
Eric Scharin
Thorsten von Stein
Linda Grais
Joseph Hagan
Independent Director
Steven Elms
Independent Director
Kenneth Greathouse
Independent Director
Kleanthis Xanthopoulos
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About ZSAN
Zosano Pharma Corporation is a clinical-stage biopharmaceutical company. The Company is focused on providing systemic administration of therapeutics to patients using its Adhesive Dermally-Applied Microarray (ADAM) technology. ADAM is an intracutaneous delivery system designed to offer drug absorption into the bloodstream. ADAM consists of an array of drug-coated titanium microneedles mounted on an adhesive backing that is pressed on to the skin using a reusable handheld applicator. The Company’s Qtrypta (M207) is a formulation of zolmitriptan delivered utilizing its ADAM technology. Qtrypta (M207) is being investigated as a treatment to provide relief of migraine symptoms in the migraine cycle. The Company has developed its transdermal delivery system to administer novel formulations of existing drugs through the skin for the treatment of a variety of indications.
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