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ZSAN

Zosano Pharma

$3.31

-0.09 (-2.65%)

08:34
04/16/19
04/16
08:34
04/16/19
08:34

Zosano Pharma announces publication of Qtrypta analysis

Zosano Pharma announced the peer-reviewed publication of a review and analysis of recently-completed trials using newly FDA-recommended endpoints in the acute treatment of migraine. The review article was published in Headache. In this analysis, researchers reviewed eight published trials designed in accordance with the Guidance for Industry, that recommended using co-primary endpoints of pain freedom and freedom from most bothersome symptom, or MBS, at 2-hours post-treatment. Using the placebo response rates from these various trials, the authors were able to calculate required sample sizes for future trials and compare these calculations to the sample sizes actually used in completed trials. Included in this analysis was Zosano's ZOTRIP trial, in which 41.5% of subjects in the Qtrypta 3.8mg arm achieved pain freedom at two hours and 68.3% achieved freedom from their MBS at two hours, as compared to 14.3% and 42.9% respectively in the placebo group. Furthermore, the analysis showed that the average response rates across all active groups of these trials were 30.4% for pain freedom and 46.7% for MBS freedom, compared to 16.8% and 33% respectively for the placebo groups. Using these averages, future trials would need to enroll approximately 180 subjects per arm to demonstrate statistical significance with 80% power. Researchers noted that the majority of the completed trials enrolled far more than this, with subjects per group reaching as high as 751.

ZSAN Zosano Pharma
$3.31

-0.09 (-2.65%)

06/28/18
BTIG
06/28/18
INITIATION
Target $19
BTIG
Buy
Zosano Pharma initiated with a Buy at BTIG
BTIG analyst Robert Hazlett initiated Zosano Pharma with a Buy rating and a price target of $19 after its M207 - "a promising, rapid-acting ADAM-based form of zolmitriptan completed a pivotal study with very positive results". Hazlett says the drug demonstrated comparable efficacy in the acute treatment of migraine comparable to injectable triptans and also appears to be superior to newer therapeutics in development. The analyst believes that M207 can have a "substantial role in difficult-to-treat well-established migraine", adding that the valuation on Zosano Pharma stock also appears to be "attractive".
06/28/18
06/28/18
INITIATION

On The Fly: Top five analyst initiations
Catch up on today's top five analyst initiations with this list compiled by The Fly: 1. CBS (CBS) initiated with an Outperform at Imperial Capital. 2. Limoneira (LMNR) initiated with a Buy at Stifel. 3. Keryx (KERX) initiated with a Buy at H.C. Wainwright. 4. Zosano Pharma (ZSAN) initiated with a Buy at BTIG. 5. Gilead (GILD) initiated with a Strong Buy at Raymond James. This list is just a portion of The Fly's analyst coverage. To see The Fly's full Street Research coverage, click here.
02/21/19
BTIG
02/21/19
NO CHANGE
BTIG
Buy
BTIG boosts Zosano target to $19 on 'solid' migraine safety data
BTIG analyst Robert Hazlett raised his price target for Zosano Pharma to $19 and keeps a Buy rating on the shares. The stock in morning trading is up 95%, or $2.10, to $4.31. Zosano's 12-month safety study of Qtrypta, its novel acute migraine therapeutic, demonstrates "rapid, robust, and durable efficacy," Hazlett tells investors in a research note. He believes the study announced this morning should finalize the clinical requirements for a New Drug Application in Q4. The data continue to support Qtrypta's "meaningful potential" as an acute migraine treatment, particularly for those with nausea or with difficult-to-treat migraine, says Hazlett. He estimates Qtrypta's approval in 2020 with U.S. peak revenue of ~$300M. The analyst estimates Zosano's standalone net present value at $16.94 per share, and the company's potential as a takeover target boosts his price target to $19.

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