ZSAN - ZSAN STOCK NEWS

Zosano Pharma Corporation (NASDAQ: ZSAN) has successfully formulated a COVID-19 vaccine candidate utilizing its microneedle patch system. The system features nearly 2,000 drug-coated titanium microneedles on an adhesive patch that can be administered using a reusable applicator. This technology aims to provide a more convenient alternative to traditional injections, with patches designed for room-temperature stability, facilitating broader distribution. The company remains focused on its M207 New Drug Application resubmission while exploring partnership opportunities to expand its technology's potential.

Zosano Pharma Corporation (NASDAQ:ZSAN) reported its third-quarter 2021 financial results, showing a net loss of $8.7 million, or $0.07 per share, unchanged from Q3 2020. The company is progressing towards the resubmission of its NDA for M207, supported by new pharmacokinetic study data. Zosano expects FDA feedback by mid-December to refine its regulatory strategy. R&D expenses rose to $6.0 million from $5.8 million in the previous year, while general and administrative costs decreased to $2.5 million. As of September 30, 2021, Zosano's cash and equivalents were $17.1 million.

Zosano Pharma Corporation (NASDAQ:ZSAN) has received a Type C meeting response from the FDA concerning the resubmission of its M207 New Drug Application. The recent pharmacokinetic study demonstrated that M207, a zolmitriptan transdermal microneedle system, was generally well tolerated among 48 healthy volunteers. Preliminary results indicated no unexpected high plasma concentrations of zolmitriptan, addressing previous FDA concerns. However, Zosano cannot estimate the timeline for product launch or revenues until the NDA resubmission is completed and approved.

Zosano Pharma Corporation (NASDAQ:ZSAN) will present a company overview at the H.C. Wainwright Global Investment Conference, available on demand starting September 13, 2021, at 7:00 AM ET. The presentation will be led by CEO Steven Lo.

A live webcast of the event can be found on the company's website, and the archived version will be accessible for 30 days post-event. Zosano Pharma is focused on rapid administration of approved molecules through its transdermal microneedle system, aiming to improve patient care in underserved markets.

Zosano Pharma Corporation (NASDAQ:ZSAN) reported its second-quarter financial results for 2021, posting a net loss of $6.1 million ($0.06 per share), an improvement from a net loss of $7.9 million ($0.14 per share) in Q2 2020. The company initiated a pharmacokinetic study required for the resubmission of its New Drug Application (NDA) for M207, planning to submit by year-end pending positive data. Additionally, Zosano received a new U.S. patent for M207's use in rapidly achieving therapeutic migraine levels. As of June 30, 2021, cash reserves were reported at $22.1 million.

Zosano Pharma Corporation (NASDAQ: ZSAN) has been granted U.S. Patent No. 11,058,630, enhancing its patent portfolio for M207, a treatment for migraines. The patent covers methods for rapid drug delivery using microneedles, enabling therapeutic levels in approximately 30 minutes. Zosano aims to complete pharmacokinetic studies for potential NDA resubmission for M207. This innovative delivery system addresses a substantial need, as 74% of migraine patients experience inadequate treatment responses, leading to lost productivity costs of $36 billion annually in the U.S.

Zosano Pharma Corporation (NASDAQ:ZSAN) announced the publication of a study in The Journal of Headache and Pain regarding the long-term safety and efficacy of Qtrypta™ (M207) for migraine treatment. The study followed 335 participants over a year, revealing that 81% achieved pain relief within two hours post-treatment. The findings align closely with previous results from the pivotal ZOTRIP study, suggesting Qtrypta™ could become a crucial long-term option for migraine sufferers. The trial highlighted that adverse events were mostly mild, indicating substantial tolerability.

Zosano Pharma Corporation (NASDAQ:ZSAN) has appointed Kathy McGee to its board of directors. McGee, a seasoned biopharmaceutical executive, brings extensive experience in operations, strategic planning, and product development. Zosano is preparing to initiate a pharmacokinetic (PK) study for its lead product, Qtrypta™, a transdermal microneedle patch aimed at treating acute migraines. The company emphasizes the potential of Qtrypta to provide rapid treatment for patients, enhancing therapeutic options in the market.

Zosano Pharma Corporation (NASDAQ: ZSAN) reported its financial results for Q1 2021, featuring a net loss of $8.1 million or $0.08 per share, an improvement from a loss of $8.7 million or $0.24 per share in Q1 2020. Service revenue was recognized from agreements with three pharmaceutical companies for R&D services. R&D expenses slightly decreased to $5.3 million, while general and administrative expenses fell to $2.8 million. The company's cash and cash equivalents stood at $26.9 million, down from $35.3 million at the end of 2020. The firm is preparing to resubmit its Qtrypta NDA by year-end, pending positive PK study data.