On Thursday, Baird reaffirmed its Outperform rating on Applied Therapeutics (NASDAQ:APLT) stock, with a price target of $14.00. The analyst's optimism is partly due to recent developments regarding the company's drug, govorestat, designed to treat galactosemia. Applied Therapeutics was informed that the previously planned advisory committee (AdCom) meeting has been canceled; however, the Prescription Drug User Fee Act (PDUFA) goal date is still set for November 28.
The company's management remains positive after the late-cycle review meeting for govorestat, and anticipates the next phase will involve discussions about post-marketing requirements. This forward movement in the drug's approval process appears to be a contributing factor to the analyst's positive rating.
The analyst also highlighted the upcoming PDUFA date for another of the company's drugs, Zevra arimoclomol, scheduled for September 21, 2024. Approval of Zevra arimoclomol is expected to act as a catalyst for the company's stock. The similarities between this drug and another, Skyclarys, are seen as indicators of a potential positive outcome, which could further drive the stock's upward trajectory.
Applied Therapeutics focuses on developing novel drug candidates to treat metabolic diseases. The company's approach to drug development and the recent progress with its drug candidates have contributed to the analyst's continued expectation of positive performance for the company's shares in the market.
InvestingPro Insights
Applied Therapeutics (NASDAQ:APLT) holds a distinctive position in the market, with a market capitalization of $901.54 million, reflecting investor confidence in its future prospects. Analysts have taken note of the company's financial health, as evidenced by the InvestingPro Tip that APLT holds more cash than debt on its balance sheet, which can be crucial for sustaining operations and funding ongoing drug development projects.
Moreover, the stock's recent performance has been noteworthy, with a significant return over the last week of 60.86%, and a robust year-to-date price total return of 134.33%. This aligns with the analyst's upbeat perspective on the potential of govorestat and Zevra arimoclomol to act as catalysts for the stock. Investors should be aware, however, that the company's stock price movements have been quite volatile, as highlighted by another InvestingPro Tip. This volatility could be indicative of market sensitivity to news regarding the company's drug approval processes and other developments.
It's also worth mentioning that Applied Therapeutics has been trading at a high Price / Book multiple of 12.45, which may suggest a premium valuation relative to its book value. This metric, coupled with the fact that the company is not expected to be profitable this year and has not been profitable over the last twelve months, provides a nuanced view of the company's valuation and future earnings potential.
For more detailed analysis and additional InvestingPro Tips on Applied Therapeutics, investors can visit https://www.investing.com/pro/APLT, where 15 more tips are available to provide further insights into the company's financial health and market performance.
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