PTC Therapeutics, Inc. (PTCT) COMMENT
Our thoughts on US and EU updates
■ Our model does not assume any ataluren sales in US, so fundamentally today’s sell-off seems like an over-reaction: PTC provided an update around the US appeal process that they received a denial to the first appeal at the end of last week. Our current TP $15 does not include any value from the US market as we continue to see uncertainty in the FDA appeal process. On Feb 22, 2016, FDA’s Division of Neurological Products sent a refuse to file letter to Translarna, which was conditionally approved in EU. From speaking to management, the FDA review process goes through levels so there are more points of review. PTCT is currently down ~30%, which we think is an over-reaction based on our fundamental analysis but it seems there was some expectation post-Sarepta approval of at least FDA accepting the filing. We noted PTC was up 20% the day Sarepta got approved (link to note).
■ As it relates to the process in the US, we would expect that the FDA's refuse to file review process could take until 2017 to reach a final conclusion: As we said above, the review process at the FDA goes through levels. Currently PTC went through one of the initial levels that included review from agency people like Temple and Unger (who did not support Sarepta to our knowledge). There could be another 1-2 levels before it gets to Dr. Woodcock. From speaking to PTC, each step of the process takes about 30-60 days though the last step took 75 days. The process can be a little longer if the company has a face-to-face meeting with the agency.
Fluidigm outlook still positive, says Cantor After Fludigm reported weaker than expected results, Cantor analyst Bryan Brokmeier is "concerned that the company may be seeing continued weakness in both BioMark and C1 instrument sales," and he thinks that the C1 and Applied businesses may be suffering from low utilization rates. .Brokmeier cut his price target on the stock to $9 from $11, but he continues to believe that the company can obtain a "significant share of the rapidly growing single-cell biology market over the next three to five years." The analyst thinks that the company can turn itself around soon ,and he keeps a Buy rating on the shares.
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