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PTC Therapeutics, Inc. (NASDAQ: PTCT) provided an update on July 25 regarding its discussions with European regulators and the path forward with the FDA, in association with Translarna.
Wedbush’s Heather Behanna maintains a Neutral rating on the company, while lowering the price target from $12 to $10.
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New Study Needed
“The delayed CHMP decision is a positive, in our view; we believe Translarna will remain on the market in the near-term,” Behanna mentioned.
However, the analyst believes there could be increased long-term risk, given the need to conduct another study, although a new study might also provide upside if it can lead to an FDA approval.
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Behanna prefers to remain on the sidelines due to the continued pricing and regulatory risks for Translarna in Europe.
Decision Delayed
The analyst expects the CHMP decision on Translarna’s conditional approval to be delayed beyond mid-2016, despite the two oral sessions that discussed the potential full approval of the product for DMD. The decision has been delayed pending an agreement on a new trial design.
According to the Wedbush report, “PTC has appealed FDA’s refuse to file decision, escalating its case to upper FDA management. PTC is willing to have its application looked at for accelerated approval while running another study; optimally, it will be able to run one study to satisfy EMA and FDA.”
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New research shows the biggest crypto buyers are back. And this time? They could hold for the possibility that Bitcoin will surpass $100,000 in 2024. You don’t want to miss the next massive crypto bull run like we saw in 2020 and 2021. To know exactly what’s going on and what to buy… Get Access To Benzinga’s Best Crypto Research and Investments For Only $1.