Day: July 20, 2017

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Zynerba is Worth Watching

Watch Zynerba ahead of trial data on its its ZYN002 for in adult epilepsy patients

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With #Zynerba Pharmaceuticals (ZYNE) expected to release data from a Phase 2 trial over the next several weeks,#Jefferies analyst Biren #Amin recently argued that a positive update could lead the shares north of $65-$75. However, a lack of treatment effect could drop the stock to $4-$5.

CANNABIDIOL GEL

Over the coming weeks, Zynerba is expected to announce data from its ZYN002 #cannabidiol, or #CBD, gel Phase 2 STAR 1 trial in adult epilepsy patients with refractory focal seizures.

ZYN002 is a synthetic CBD formulated as a permeation-enhanced gel for transdermal delivery.

BINARY EVENT

In a research note to investors, Jefferies’ Amin pointed out that the STAR-1 trial represents a “critical catalyst” for Zynerba as it provides the first proof of concept for transdermally delivered CBD.

Given investors naturally compare the program to GW Pharmaceuticals’ (GWPH) #Epidiolex, and oral CBD, the analyst believes a better comparison would be to therapies tested in patients with partial-onset seizures who are uncontrolled on their current therapy.

Additionally, Amin noted that while the study is designed for a 20% treatment effect over a placebo, an effect greater than 15% could be considered clinically relevant. A key question that remains unanswerable is the extent of activity observed with ZYN002 given this is the first study evaluating efficacy in epilepsy patients, he contended.

He told investors that positive data could lead to shares north of $65-$75, but a lack of treatment effect could drop shares to $4-$5. The analyst assumes ZYN002 is successfully developed and launched for refractory epilepsy in 2019.

Amin reiterated a Buy rating and a $32 price target on the shares.

PRICE ACTION

In Thursday’s trading, shares of Zynerba dropped 2% to $18.81. Over the last month the stock is up 10%, but over the last three months it has declined nearly 24%.

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BankMutual Sold for $482 Milion

Associated Banc-Corp to acquire BankMutual for $10.38 per share

Stocks to Buy on Margin

Associated Banc-Corp (ASB) and Bank Mutual (BKMU) (“Bank Mutual”) announced that they have entered into a definitive agreement under which Bank Mutual will merge with and into Associated. Bank Mutual’s bank subsidiary will also merge with and into Associated’s bank subsidiary, Associated Bank, N.A.

The all stock transaction is valued at approximately $482M, based on Associated’s July 19 closing stock price of $24.60 per share.

Under the terms of the merger agreement, which has been unanimously approved by the boards of directors of both companies, Bank Mutual shareholders will receive 0.422 shares of Associated common stock for each share of Bank Mutual common stock.

The per common share consideration is valued at $10.38 per share based on the closing price of Associated common stock on July 19.

Subject to customary closing conditions, including regulatory approvals and approval by the Bank Mutual shareholders, the transaction is expected to close in the first quarter of 2018.

Associated expects this acquisition to be accretive to earnings per common share in 2019, excluding one-time charges, and expects the transaction to deliver strong returns on capital.

The transaction is expected to produce less than 1% tangible book value per share dilution at closing.

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European Central Bank Keeps Rates Unchanged

ECB leaves key interest rates unchanged

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The Governing Council of the ECB decided that the interest rate on the main refinancing operations and the interest rates on the marginal lending facility and the deposit facility will remain unchanged at 0.00%, 0.25% and -0.40% respectively.

The Governing Council expects the key ECB interest rates to remain at their present levels for an extended period of time, and well past the horizon of the net asset purchases.

Regarding non-standard monetary policy measures, the Governing Council confirms that the net asset purchases, at the current monthly pace of EUR 60B, are intended to run until the end of December 2017, or beyond, if necessary, and in any case until the Governing Council sees a sustained adjustment in the path of inflation consistent with its inflation aim.

The net purchases are made alongside reinvestments of the principal payments from maturing securities purchased under the asset purchase program.

If the outlook becomes less favorable, or if financial conditions become inconsistent with further progress towards a sustained adjustment in the path of inflation, the Governing Council stands ready to increase the program in terms of size and/or duration.

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Stocks to Watch – Ironwood Pharmaceuticals

Ironwood IW-3718 Phase IIb trial meets primary endpoint

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Ironwood Pharmaceuticals (IRWD) announced positive top-line data from a Phase IIb clinical trial evaluating IW-3718 in adult patients with uncontrolled #gastroesophageal #reflux disease.

The trial met its primary endpoint, indicating that twice-daily, oral dosing of IW-3718 1500 mg plus a proton pump inhibitor significantly reduced heartburn severity in patients with uncontrolled GERD compared to patients treated with a PPI alone.

Further, more than half of patients treated with IW-3718 1500 mg plus a PPI achieved a clinically meaningful reduction in heartburn severity. IW-3718 1500 mg was well tolerated in the trial.

#Ironwood plans to have end of Phase II meetings with the U.S. Food and Drug Administration, after which the company expects to advance IW-3718 1500 mg into Phase III development in 2H18.

#IW-3718 is a novel formulation of a bile acid sequestrant designed to release in the stomach over an extended period of time, bind to bile that refluxes into the stomach, and potentially provide symptomatic relief in uncontrolled GERD.

Data from the Phase IIb trial showed a dose response across the primary and key secondary endpoints, with the most pronounced response observed at the highest dose of IW-3718 studied. Top-line data were as follows: Percent Change from Baseline to Week 8 in Weekly Heartburn Severity: patients treated with IW-3718 1500 mg plus a PPI showed a mean decrease of 58% from baseline in heartburn severity compared to 46% in patients treated with a PPI alone.

Clinically Meaningful Degree of Improvement in Weekly #Heartburn Severity: a 45% reduction in weekly heartburn severity was determined to be clinically meaningful for patients in this study based on patient-reported outcome measures.

Heartburn Responder: a heartburn responder was defined as a patient who experienced at least a 45% reduction from baseline in heartburn severity for at least four out of eight weeks, including at least one of the last two weeks. 52.9% of patients treated with IW-3718 1500 mg plus a PPI were heartburn responders, compared to 37.1% of patients treated with a PPI alone.

Percent Change from Baseline to Week 8 in Weekly Regurgitation Frequency: patients treated with IW-3718 1500 mg plus a PPI showed a mean decrease of 55.4% from baseline in regurgitation frequency compared to 37.9% in patients treated with a PPI alone. There were no treatment-related serious adverse events reported with IW-3718 1500 mg.

SIDE EFFECTS

The most common adverse event reported overall was constipation, which was reported in 7.4% of patients on IW-3718 1500 mg plus a PPI compared to 7.1% of patients on a PPI alone. All constipation adverse events reported were mild or moderate in severity.

Discontinuation rates due to adverse events were less than 5% and similar across treatment groups.

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