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FDA Grants Breakthrough Status to Biopharma's Lead Candidate for Liver Disease
Research Report

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The California firm's most advanced asset is advancing through Phase 2b, according to a ROTH Capital Partners report.

Periportal steatosis of the liver. Source: Nephron

In a Feb. 19 research note, analyst Yasmeen Rahimi reported that CymaBay Therapeutics Inc. (CBAY:NASDAQ) is having a strong Q1/19 with respect to continued execution of its clinical programs for its most advanced therapeutic, seladelpar, in nonalcoholic steatohepatitis (NASH) and primary biliary cholangitis (PBC).

Most recently, on Jan. 19, CymaBay announced that enrollment finished, ahead of schedule, of 181 NASH patients for its Phase 2b, proof-of-concept study of seladelpar. The primary efficacy outcome will be the change from baseline in liver fat content at 12 weeks, determined by magnetic resonance imaging employing the proton density fat fraction method. These 12-week results are now anticipated in Q2/19, in about mid to late May.

On Jan. 15, the FDA granted breakthrough status to CymaBay's seladelpar for the treatment of PBC. "In regards to PBC specifically, we believe meaningful differentiation for seladelpar will be able to mitigate potential pricing pressures in a market that appears larger than previously thought," Rahimi commented.

Also concerning seladelpar for PBC, the interim Phase 3 NASH data Intercept just released is not expected to negatively impact it, noted Rahimi. In those results, 25 milligrams (25 mg) of obeticholic acid(OCA) showed a one point improvement in fibrosis, alluding to the possibility a 10 mg OCA dose could be included in the label.

Such an FDA-approved expanded label could result in pressure to lower "the PBC pricing for OCA," wrote Rahimi, but likely would not affect the cost of seladelpar for PBC were it approved. This is because seladelpar's other benefits should support a higher cost. Those include no worsening of pruritus at a minimum, no liver impairment, and no worsening of or improvement in fatigue, other quality of life factors and LDL cholesterol.

ROTH has a Buy rating and a $26 per share 12-month price target on CymaBay, whose stock is currently trading at $11.82 per share.


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Disclosures from ROTH Capital Partners, CymaBay Therapeutics Inc., Flash Note, February 19, 2019

Regulation Analyst Certification ("Reg AC"): The research analyst primarily responsible for the content of this report certifies the following under Reg AC: I hereby certify that all views expressed in this report accurately reflect my personal views about the subject company or companies and its or their securities. I also certify that no part of my compensation was, is or will be, directly or indirectly, related to the specific recommendations or views expressed in this report.

ROTH makes a market in shares of CymaBay Therapeutics, Inc., Intercept Pharmaceuticals, Inc. and Madrigal Pharmaceuticals and as such, buys and sells from customers on a principal basis.

Within the last twelve months, ROTH has received compensation for investment banking services from Madrigal Pharmaceuticals.

Within the last twelve months, ROTH has managed or co-managed a public offering for Madrigal Pharmaceuticals.

ROTH Capital Partners, LLC expects to receive or intends to seek compensation for investment banking or other business relationships with the covered companies mentioned in this report in the next three months.

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