Zosano Pharma Corp (NASDAQ:ZSAN) is a low-priced trading equity in the pharma space that has grabbed hold of the attention of traders during the stock’s recent rip. The breakout is related to the company’s announcement that its lead product candidate, M207, achieved both co-primary endpoints of pain freedom and most bothersome symptom freedom at 2 hours in the recently completed ZOTRIP trial.
According to the release, the ZOTRIP pivotal efficacy 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, to placebo for a single migraine attack. A total of 589 subjects were enrolled at 36 sites across the US. The 3.8mg dose achieved 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).
Zosano Pharma Corp (NASDAQ:ZSAN) trumpets itself as a clinical stage specialty pharmaceutical company that develops a proprietary transdermal microneedle patch system to deliver drug formulations through the skin for the treatment of various indications.
The company’s product candidate is ZP-Triptan, a proprietary formulation of zolmitriptan used for the treatment of migraine, which has completed a Phase I clinical trial. Its product candidates also include ZP-PTH, a proprietary formulation of teriparatide that is used for the treatment of severe osteoporosis; and ZP-Glucagon, a proprietary formulation of glucagon that is intended for the emergency rescue of patients suffering from life-threatening, severe hypoglycemia. The company was founded in 2006 and is headquartered in Fremont, California.
According to company materials, “Zosano Pharma Corporation is an emerging CNS company focusing on providing rapid symptom relief to patients using known therapeutics and altering their delivery profile using the Company’s proprietary intracutaneous delivery system. The Company’s goal is to make intracutaneous drug delivery a standard of care for delivering drugs requiring fast onset of action. Zosano Pharma has developed its proprietary intracutaneous delivery system to administer proprietary formulations of existing drugs through the skin for the treatment of a variety of indications. The Company believes that its intracutaneous delivery system offers rapid and consistent drug delivery combined with ease of use. The Company is focused on developing products that deliver established molecules with known safety and efficacy profiles for markets where patients remain underserved by existing therapies. Zosano Pharma anticipates that many of its current and future development programs may enable the Company to utilize a regulatory pathway that would streamline clinical development and accelerate the path towards commercialization.”
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Stewart Tepper, MD, Professor of Neurology, Geisel School of Medicine at Dartmouth and Director of the Dartmouth Headache Clinic commented, “The ZOTRIP study was successful from the dual perspectives of meeting the co-primary endpoints and no serious adverse events. The study demonstrated a statistically significant 2-hour pain freedom response rate with a low placebo rate for the primary endpoint. The data also indicate a durability of effect at 24 and 48 hours, and meaningful pain freedom rate at 1 hour. If approved by the FDA, M207 has the potential to become an important treatment option for those suffering from migraine.”
Recent action has seen 95% tacked on to share pricing for the stock in the past week, but that move comes in the context of a larger bearish trend. Market participants may want to pay attention to this stock. ZSAN has evidenced sudden upward volatility on many prior occasions. What’s more, Zosano Pharma has witnessed a pop in interest, as transaction volume levels have recently pushed topping 1300% beyond what we have been seeing over the larger time frame.
Currently trading at a market capitalization of $37.5M, Zosano Pharma has a significant war chest ($19.2M) of cash on the books, which is balanced by about $5.9M in total current liabilities. The company is pre-revenue at this point. We will update the story again soon as further details emerge. For continuing coverage on shares of $ZSAN stock, as well as our other hot stock picks, sign up for our free newsletter today and get our next hot stock pick!