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Zosano Pharma Corporation (NASDAQ:ZSAN) has received a complete response letter (CRL) from the FDA regarding its Qtrypta™ New Drug Application. The CRL highlighted inconsistent exposure levels of zolmitriptan across clinical studies and suggested a repeat bioequivalence study. Additionally, it noted that a lack of product quality validation data was a concern, and inspections of the company's manufacturing facilities are required for approval. Zosano plans to request a Type A meeting with the FDA to discuss addressing these issues.
Zosano Pharma Corporation (NASDAQ: ZSAN) announced that its CEO, Steven Lo, will present at the H.C. Wainwright 22nd Annual Global Investment Conference on September 14, 2020, at 1:30 PM ET. A live webcast will be accessible on the company's website, with an archive available for 30 days post-event. The company focuses on developing a transdermal microneedle system for rapid drug delivery, particularly its lead candidate Qtrypta™ (M207), aimed at migraine treatment, leveraging established safety and efficacy.
Zosano Pharma Corporation (Nasdaq: ZSAN) announced the launch of an underwritten public offering of its common stock. The offering is contingent upon market conditions, with no assurance regarding its completion or the final terms. BTIG is the sole book-running manager for this offering. The company has filed a registration statement with the SEC, effective as of April 16, 2020. Zosano focuses on developing innovative drug delivery systems to benefit patients, particularly those underserved by current therapies.
Zosano Pharma Corporation (NASDAQ: ZSAN) announced a feasibility study agreement with Mitsubishi Tanabe Pharma Corporation to evaluate the potential of its proprietary microneedle drug delivery system. This partnership aims to enhance drug development by combining Zosano's technology with Mitsubishi's pharmaceutical agent, focusing on significant unmet medical needs. The agreement involves in vitro and in vivo research phases, and Mitsubishi receives an option for exclusive licensing rights based on study outcomes. Financial details of the agreement remain undisclosed.
Zosano Pharma Corporation (NASDAQ: ZSAN) has partnered with EVERSANA to commercialize and distribute its migraine treatment, Qtrypta™, pending FDA approval. The agreement outlines a $250 million commercialization budget over five years, leveraging EVERSANA's expertise in marketing, distribution, and patient support. Qtrypta, a transdermal microneedle product, aims to provide an innovative solution for the acute treatment of migraine. FDA's decision is expected by October 20, 2020, marking a significant step forward for Zosano in addressing the unmet needs of migraine patients.
Zosano Pharma Corporation (NASDAQ:ZSAN) reported its financial results for Q2 2020, showing a net loss of $7.9 million or $0.14 per share, improved from a net loss of $9.4 million or $0.55 per share in Q2 2019. The company highlighted the acceptance of the NDA filing for its migraine treatment Qtrypta™ by the FDA, noting its potential to fill a significant treatment gap. Research and development expenses decreased to $4.9 million from $6.6 million year-over-year. Cash reserves improved to $10.5 million, up from $6.3 million at the end of 2019.
Zosano Pharma Corporation (NASDAQ: ZSAN) will present a company overview at the BTIG Biotechnology Conference 2020 on August 11, 2020, at 3:00 pm ET. CEO Steven Lo will lead the presentation, which will be available via a live webcast on the company’s website. The archived version will remain accessible for 30 days post-event. Zosano is focused on developing rapid administration therapies, including its lead candidate Qtrypta™ (M207), aimed at treating migraines with a transdermal microneedle system technology. This approach may enhance patient care in underserved markets.
Zosano Pharma Corporation (NASDAQ: ZSAN) announced the presentation of new post-hoc efficacy analyses of Qtrypta™ at the 2020 American Headache Society’s Virtual Annual Scientific Meeting. The analyses showed that the efficacy results in treating approximately 6,000 migraine attacks in a long-term safety study were consistent with positive outcomes in the pivotal Zotrip study. Notably, Qtrypta demonstrated improved pain relief at 2 hours, with adverse events primarily mild and resolving quickly. The potential approval of Qtrypta could provide an innovative treatment option for millions suffering from migraines.
Zosano Pharma Corporation (Nasdaq: ZSAN) has announced a shift to a virtual-only format for its Annual Meeting of Stockholders, scheduled for June 25, 2020, at 8:30 a.m. Pacific time. This change is a response to the COVID-19 pandemic, prioritizing the health of stockholders and employees. Eligible stockholders from the record date of May 11, 2020, can attend the meeting online using a provided control number. The Company focuses on developing rapid administration drug systems, with its lead candidate Qtrypta™ (M207) targeting acute migraine treatment.
Zosano Pharma Corporation (NASDAQ: ZSAN) has reported its financial results for Q1 2020, highlighting FDA acceptance of its NDA for Qtrypta™, a potential migraine treatment. The company recorded a net loss of $8.7 million, or $0.24 per share, an improvement from a $9.4 million loss in Q1 2019. Research and development expenses decreased to $5.5 million, down from $6.6 million, due to completed clinical trials. Cash reserves as of March 31, 2020, increased significantly to $18.6 million from $6.3 million at year-end 2019, indicating stronger liquidity for ongoing projects.
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