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Zosano Pharma Announces Inducement Grant Under Nasdaq Listing Rule 5635(c)(4)
FREMONT, Calif., Nov. 16, 2020 (GLOBE NEWSWIRE) -- Zosano Pharma Corporation (NASDAQ:ZSAN), a clinical-stage biopharmaceutical company, today announced that the Compensation Committee of the Board of Directors granted a stock option to purchase 100,000 shares of Zosano’s common stock to a new employee as an inducement award.
GlobeNewswire · 11/16 23:30
Zosano Pharma Q3 EPS $(0.11) Up From $(0.55) YoY
Zosano Pharma (NASDAQ:ZSAN) reported quarterly losses of $(0.11) per share. This is a 80 percent increase over losses of $(0.55) per share from the same period last year.
Benzinga · 11/13 21:12
Zosano Pharma EPS misses by $0.01
Zosano Pharma  (ZSAN): Q3 GAAP EPS of -$0.11 misses by $0.01.Cash and equivalents were $43.6MPress Release
Seekingalpha · 11/13 21:12
Is a Disappointment in Store for Zosano (ZSAN) Q3 Earnings?
Investors will be keen on updates on Qtrypta when Zosano (ZSAN) reports Q3 results.
Zacks · 11/02 15:50
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 www.zosanopharma.com 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 swheeler@wheelhouselsa.com or asantos@wheelhouselsa.com
GlobeNewswire · 10/21 13:30
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 · 10/21 13:16
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
Mid-Afternoon Market Update: Nasdaq Jumps 150 Points; Selecta Biosciences Shares Plunge
Toward the end of trading Thursday, the Dow traded up 0.07% to 27801.83 while the NASDAQ rose 1.34% to 11,318. The S&P also rose, gaining 0.43% to 3,377.47.
Benzinga · 10/01 18:47
BBBY, AMAG, GNFT and ZSAN among midday movers
Gainers: Solid Biosciences (SLDB) +114%.Enlivex Therapeutics (ENLV) +45%.AMAG Pharmaceuticals (AMAG) +45%.American Equity Investment Life (AEL) +40%.Gridsum (GSUM) +36%.Bed Bath & Beyond (BBBY) +33%.Watford Holdings (WTRE) +26%.Advanced Emissions Solutions (ADES) +25%.Westwater Resources
Seekingalpha · 10/01 16:39
Solid Biosciences, Enlivex Therapeutics leads healthcare gainers, Zosano Pharma, LogicBio Therapeutics among major losers
Gainers: Solid Biosciences (SLDB) +121%, Enlivex Therapeutics (ENLV) +49%, AMAG Pharmaceuticals (AMAG) +45%, ProPhase Labs (PRPH) +14%, Odonate Therapeutics (ODT) +14%.Losers: Zosano Pharma (ZSAN) -54%, LogicBio Therapeutics (LOGC) -31%, Selecta Biosciences (SELB) -31%, Genfit (GNFT) -15%, Soleno Therapeutics (SLNO) -13%.
Seekingalpha · 10/01 15:10
GNW, SELB among premarket losers
Zosano Pharma (ZSAN) -53% after FDA discipline review letter for Qtrypta.Selecta Biosciences (SELB) -44% after SEL-212 misses primary endpoint in mid-stage gout study.LogicBio Therapeutics (LOGC) -26% on launch of equity offering.ChinaNet Online Holdings (CNET) -22%.CynergisTek (CTEK)
Seekingalpha · 10/01 12:16
Zosano plunges after FDA discipline review letter for Qtrypta; approval not expected by October 20
Zosano Pharma (ZSAN) plummets 52% after-hours in reaction to receiving a discipline review letter ((DRL)) from the FDA in connection with the Qtrypta (zolmitriptan transdermal microneedle system) 505(b)(2) New Drug Application ((NDA)).A DRL is
Seekingalpha · 10/01 05:53
Zosano Pharma Receives Preliminary FDA Communication On Qtrypta NDA
Zosano Pharma Receives Preliminary FDA Communication on Qtrypta™ NDA FREMONT, Calif., Sept. 30, 2020 (GLOBE NEWSWIRE) -- Zosano Pharma Corporation (NASDAQ:ZSAN), a clinical-stage biopharmaceutical company today
Benzinga · 09/30 21:45
Zosano Pharma Receives Preliminary FDA Communication on Qtrypta™ NDA
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
GlobeNewswire · 09/30 21:40
Zosano Pharma prices public offering; shares under pressure
Zosano Pharma (ZSAN -8.0%) priced its underwritten public offering of 15.9M shares for gross proceeds of approximately $20.8M. Offer expected to close on o
Seeking Alpha - Article · 09/01 13:57
Zosano Prices ~15.94M Share Common Stock Offering For Gross Proceeds Of ~$20.8M
FREMONT, Calif., Sept. 01, 2020 (GLOBE NEWSWIRE) -- Zosano Pharma Corporation(NASDAQ:ZSAN), a clinical-stage biopharmaceutical company, today announced the pricing of an underwritten public offering of 15,937,130 shares
Benzinga · 09/01 13:03
ZSAN, VVPR among premarket losers
Zosano Pharma (ZSAN) -14% on planned equity offering.VivoPower International (VVPR) -10%.FSD Pharma (HUGE) -8%.
Seekingalpha · 09/01 12:12
Zosano Pharma Announces Proposed Public Offering of Common Stock
FREMONT, Calif., Aug. 31, 2020 (GLOBE NEWSWIRE) -- Zosano Pharma Corporation (Nasdaq:ZSAN), a clinical-stage biopharmaceutical company, today announced that it has commenced an underwritten public offering of shares of its common stock. All of the shares to be sold in the offering will be offered by
GlobeNewswire · 08/31 21:05
Zosano Pharma under pressure on planned equity offering
Zosano Pharma (ZSAN) launches a public offering of common stock. Price, volume and terms have yet to be announced.Shares down 14% after hours.
Seekingalpha · 08/31 20:31
Zosano Pharma announces a public stock offering
Zosano Pharma (ZSAN), announces that it has commenced an underwritten public offering of shares.Size and terms are yet to be finalised.BTIG is the sole book-running manager for the proposed offering.
Seekingalpha · 08/31 20:12
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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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