Applied Therapeutics appoints new Chief Regulatory Officer

Published 19/03/2025, 12:10
Applied Therapeutics appoints new Chief Regulatory Officer

NEW YORK - Applied Therapeutics, Inc. (NASDAQ:APLT), a clinical-stage biopharmaceutical company with a market capitalization of approximately $61 million focused on developing treatments for rare diseases, has announced the appointment of Todd F. Baumgartner, MD, MPH, as its new Chief Regulatory Officer. Dr. Baumgartner will be joining the company’s executive leadership team to lead global regulatory strategies. According to InvestingPro data, the company maintains a strong balance sheet with more cash than debt, positioning it well for its development initiatives.

With over 35 years of experience in the pharmaceutical industry, Dr. Baumgartner’s career has been marked by senior roles in regulatory, clinical development, and medical affairs. His track record includes leading 12 New Drug Applications to approval, a testament to his expertise in navigating the complex drug approval process.

Prior to his new role at Applied Therapeutics, Dr. Baumgartner held significant positions at Ovid Therapeutics, where he managed global regulatory affairs and other development functions. His previous experience also includes serving as Senior Vice President of Regulatory Affairs at Acorda Therapeutics and as Chief Medical Officer at Purdue Pharma, among other leadership positions at AstraZeneca Pharmaceuticals and Bristol-Myers Squibb. The appointment comes at a crucial time, as the company’s stock has experienced significant volatility, with InvestingPro analysis showing a 92% decline in share price over the past year, though current valuations suggest the stock may be undervalued.

John H. Johnson, Executive Chairman of Applied Therapeutics, expressed confidence in Dr. Baumgartner’s abilities, noting his extensive development experience and successful interactions with regulatory bodies as instrumental for the company’s future endeavors.

Dr. Baumgartner, expressing his enthusiasm about his new role, emphasized his commitment to advancing medical breakthroughs for rare diseases. He looks forward to contributing to the development of govorestat, Applied Therapeutics’ lead drug candidate, which targets CNS rare metabolic diseases.

Applied Therapeutics, currently in the clinical stage, is dedicated to the discovery of novel drugs aimed at validated molecular targets in rare diseases. Their primary focus is on govorestat, an Aldose Reductase Inhibitor for CNS rare metabolic diseases.

The press release includes forward-looking statements under the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Applied Therapeutics cautions that plans and objectives may change due to future events or developments. InvestingPro analysis reveals that three analysts have revised their earnings expectations downward for the upcoming period, with sales decline anticipated in the current year. The company’s filings with the U.S. Securities and Exchange Commission provide more detailed information on potential risk factors. For comprehensive analysis including 12 additional ProTips and detailed financial metrics, investors can access the full Applied Therapeutics research report on InvestingPro.

This article is based on a press release statement from Applied Therapeutics.

In other recent news, Applied Digital Corporation reported fiscal second quarter results that exceeded analyst expectations. The company achieved adjusted earnings per share of -$0.06, outperforming the consensus estimate of -$0.14. Revenue for the quarter reached $63.9 million, a 51% increase year-over-year, surpassing the projected $63.39 million. Growth was notably driven by the Cloud Services segment, which saw a 523% increase in revenue to $27.7 million. Additionally, Applied Digital’s Data Center Hosting business contributed $36.2 million in revenue. The company also announced a $5 billion perpetual preferred equity financing facility with Macquarie Asset Management to bolster its high-performance computing business.

Meanwhile, Applied Therapeutics, Inc. has been notified by the Nasdaq Stock Market of non-compliance with the minimum bid price requirement. The company’s stock has closed below the $1.00 minimum bid price for 30 consecutive business days. Applied Therapeutics has until August 6, 2025, to regain compliance by maintaining a closing bid price of at least $1.00 per share for 10 consecutive business days. The company is evaluating its options to address the issue, with the possibility of transferring its listing to the Nasdaq Capital Market if necessary. Investors are advised to keep an eye on these developments, as they could impact the company’s financial stability and market presence.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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