Zosano Pharma Corp (NASDAQ:ZSAN) announced financial results for the fourth quarter and year ended December 31, 2016.
“The past year was an important period of progress for the Company as we initiated and in the fourth quarter completed ZOTRIP, our pivotal efficacy trial in migraine,” commented Konstantinos Alataris, PhD, President and Chief Executive Officer of Zosano Pharma. “Subsequent to the fiscal year end, we announced positive results from the ZOTRIP trial, which not only advances our lead migraine program towards FDA approval but also further validates the effectiveness of our technology platform. If approved, M207 could be an important new therapeutic option for migraine patients.”
The ZOTRIP trial was designed to be a registration-enabling, pivotal efficacy trial of M207 as an acute treatment for migraine. The study was a multicenter, double-blind, randomized, placebo-controlled, dose-ranging trial comparing three doses (1.0mg, 1.9mg and 3.8mg) of M207, a novel transdermal therapeutic, for a single migraine attack. A total of 589 subjects were enrolled at 36 sites across the United States. Dosing of ZOTRIP’s first subject was announced in July of 2016. This past November, the Company announced the completion of ZOTRIP’s enrollment.
Recent Highlights and Key Upcoming Milestones
- In January 2017, and in line with previously provided guidance, the Company announced the treatment of the last patient in ZOTRIP.
- In February 2017, the Company announced statistically significant results from the Phase 2/3 ZOTRIP trial, which demonstrated that the 3.8mg dose of M207 met both co-primary endpoints, achieving pain freedom and most bothersome symptom freedom at 2 hours. The 3.8mg dose achieved statistical significance in the secondary endpoints of pain freedom at 45 minutes and 1 hour, and showed durability of effect on pain freedom at 24 and 48 hours. Additionally, M207 was not associated with any Serious Adverse Events (SAEs).
- The FDA has indicated that a single, positive, pivotal efficacy study, in addition to a safety study of M207, will be sufficient to file for approval under a 505(b)(2) pathway. The Company plans to initiate the safety study in the second half of 2017.
Shares of Zosano Pharma are currently trading at $2.65, down $0.03 or -1.22%. ZSAN has a 1-year high of $3.54 and a 1-year low of $0.45. The stock’s 50-day moving average is $1.61 and its 200-day moving average is $0.99.
On the ratings front, Roth Capital analyst Scott Henry reiterated a Buy rating on ZSAN, with a price target of $3.25, in a report issued on February 14. The current price target represents a potential upside of 21% from where the stock is currently trading. According to TipRanks.com, Henry has a yearly average loss of 0.9%, a 39% success rate, and is ranked #3581 out of 4503 analysts.
Zosano Pharma Corp. operates as a biopharmaceutical company. It engages in developing products based on the novel transdermal drug delivery technology. The company is developing products by using micro needle patch system, which delivers therapeutic compounds through the skin and provides rapid systemic drug delivery in a convenient, needle-free and pain-free system.