Leerink Maintains Achillion Pharma (ACHN) at 'Market Perform'; Says MAD Study Questions Raised
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Leerink affirms Achillion Pharma (NASDAQ: ACHN) at Market Perform following Q3 results and update issued earlier Thursday.
The firm commented today:
We believe today's stock weakness is related to caution due to ACHN's disclosure of two cases of liver enzyme elevations in the ongoing multiple ascending dose (MAD) Phase I study of ACH-4471. This update was mentioned in the company's 3Q financial results press release, but no conference call was held and we have not yet heard back from the company.
Given the importance of the complement program to ACHN who otherwise is dependent on JNJ (OP) remaining committed to its HCV development program in a deteriorating marketplace, investors are understandably focused on the well being of this program, which we continue to view as high-risk/high-return.
ACHN's 3Q financial press release highlights two patient experiences which are raising some concern. ACHN noted that "to date in the MAD study, ACH-4471 has been generally well tolerated across three dose cohorts (200 mg, 500 mg or 800 mg given every 12 hours) with no treatment-related serious adverse events (SAE) reported. Two cases of self-limited, ALT elevations (Grade 3 and 4) were observed post-treatment in the mid- and high dose groups, respectively, with neither subject exhibiting signs or symptoms of hepatic decompensation. Both subjects' ALT levels normalized without intervention during follow up. Further, no treatment-associated fever or infections were observed. Achillion anticipates announcing interim results from this phase I study in the first half of 2017."
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