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Zosano Pharma Corporation (NASDAQ:ZSAN) has partnered with Worldwide Clinical Trials to conduct a pharmacokinetic (PK) study for its Qtrypta™ (zolmitriptan transdermal microneedle system). The FDA provided feedback on the study protocol, which will involve 48 healthy volunteers. The PK study is set to initiate in June 2021 and complete by Q3 2021, with NDA resubmission anticipated by the end of the year, pending positive results. This study aims to address FDA's remaining clinical requests, potentially expanding treatment options for migraine patients.
Zosano Pharma Corporation (NASDAQ: ZSAN) reported its financial results for Q4 and full year 2020, highlighting a net loss of $8.1 million for Q4, down from $8.9 million in 2019. For the full year, the net loss was $33.4 million, an improvement from $37.6 million in 2019. The company has made progress on its Qtrypta™ migraine treatment, planning to resubmit its NDA following FDA feedback on its study protocol. Zosano has also entered feasibility agreements with Mitsubishi Tanabe Pharma for additional therapeutic applications.
Zosano Pharma Corporation (NASDAQ:ZSAN) will present a company overview by its president and CEO, Steven Lo, at the H.C. Wainwright Global Life Sciences Conference on March 9, 2021, at 7:00 am ET. The presentation will be accessible via a webcast on the company’s website, and an archived version will be available for 30 days post-event.
Zosano focuses on transdermal microneedle technology for rapid drug delivery, with its lead product candidate, Qtrypta™ (M207), aimed at treating migraines.
Zosano Pharma Corporation (NASDAQ:ZSAN) announced the receipt of Type A meeting minutes from the FDA regarding its Qtrypta™ NDA resubmission post a Complete Response Letter from October 2020. The FDA agreed with Zosano's expectation for an additional pharmacokinetic (PK) study, recommending a skin assessment for safety information. Zosano plans to submit the study protocol for FDA review before initiating the study, which is essential for the NDA resubmission. The company remains optimistic about Qtrypta as a migraine treatment option.
Zosano Pharma Corporation (NASDAQ:ZSAN) announced promising data from the ZOTRIP trial for its investigational therapy Qtrypta™ aimed at acute migraine treatment, presented at the Annual Headache Cooperative of the Pacific Winter Conference. Analysis indicated significant therapeutic gain at 30 minutes. Specifically, 74% of patients who were pain-free at 30 minutes remained pain-free at 2 hours, compared to 35% in the placebo group. Qtrypta utilizes a novel microneedle system for rapid drug delivery, which is crucial for patients unable to tolerate oral medications.
Zosano Pharma Corporation (NASDAQ: ZSAN) has completed a Type A meeting with the FDA regarding its Qtrypta™ NDA, following a Complete Response Letter in October 2020. The FDA approved the need for an additional pharmacokinetic (PK) study but did not require further clinical efficacy studies. Zosano plans to submit the PK study protocol to the FDA for review before commencing the study. The company is focused on resubmitting the NDA and is optimistic about Qtrypta's potential to treat migraines, leveraging its proprietary microneedle technology.
Zosano Pharma Corporation (NASDAQ: ZSAN) has requested a Type A meeting with the U.S. FDA to discuss the requirements for resubmitting the NDA for Qtrypta™ (zolmitriptan transdermal microneedle system). This request follows a Complete Response Letter received on October 20, 2020. The NDA covers data from 774 subjects across five trials. CEO Steven Lo emphasized the company's focus on addressing FDA comments. The FDA typically responds within 30 days to such meeting requests.
Zosano Pharma Corporation (NASDAQ:ZSAN) announced that its CEO, Steven Lo, will present a company overview at the H.C. Wainwright Virtual BioConnect Conference on January 11, 2021, at 6:00 am ET. A webcast will be available on the company’s website, remaining accessible for 90 days post-event.
The company focuses on developing products for rapid administration of known molecules, addressing patient needs with its proprietary transdermal microneedle technology. Its lead product candidate, Qtrypta™ (M207), targets acute migraine treatment.
Zosano Pharma Corporation (NASDAQ:ZSAN) has announced the granting of a stock option to purchase 100,000 shares to a new employee. The exercise price is set at $0.4777 per share, aligning with the closing price on November 16, 2020. The vesting schedule includes 25% after one year and monthly vesting thereafter. This award complies with Nasdaq Listing Rule 5635(c)(4). Zosano, focused on rapid delivery of therapeutics, is developing Qtrypta™, its lead product for treating migraines utilizing a transdermal microneedle system.
Zosano Pharma Corporation (NASDAQ: ZSAN) reported its Q3 2020 financial results, revealing a net loss of $8.7 million ($0.11 per share), an improvement from a $9.9 million loss in Q3 2019. Research and development expenses decreased to $5.8 million due to lower clinical trial costs. The company is focused on resolving the NDA for Qtrypta™, following a complete response letter from the FDA. Zosano has partnered with Mitsubishi Tanabe Pharma to explore its microneedle system and with EVERSANA for potential commercialization of Qtrypta™ if approved.
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