RBC Capital analyst Leonid Timashev initiates coverage on $Applied Therapeutics (APLT.US)$ with a hold rating, and sets the target price at $12.
According to TipRanks data, the analyst has a success rate of 50.6% and a total average return of 17.9% over the past year.
Furthermore, according to the comprehensive report, the opinions of $Applied Therapeutics (APLT.US)$'s main analysts recently are as follows:
The Complete Response Letter issued by the FDA for govorestat in galactosemia was unexpected and confusing, especially as the FDA seemed unable to overlook the missed primary endpoint when considering full approval. The likelihood of success in galactosemia is now perceived at 50%, following this recent regulatory feedback. Nonetheless, the SORD program, which is assessed separately under accelerated approval by Neurology I, is considered to represent significant value, justifying continued positive sentiment towards the company's prospects.
The FDA's issuance of a complete response letter for govorestat in the treatment of galactosemia was seen as a significant setback, perceived to harm the drug's credibility in a manner difficult to recover from. Details regarding the adverse aspects of the review remain scarce. Expectations have shifted, indicating that forthcoming reviews in similar treatments are likely to be met with increased skepticism by the investment community. Nonetheless, the potential for a commercial opportunity remains robust, with anticipations of a recovery in valuation following potential approval in the coming year.
Note:
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