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THE WOODLANDS, Texas - Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX), a $523 million market cap biotech company with a strong liquidity position, is moving forward with the 10 mg dose of its experimental pain medication pilavapadin into Phase 3 development for diabetic peripheral neuropathic pain (DPNP), the company announced Tuesday. According to InvestingPro data, the company maintains more cash than debt on its balance sheet, though analysts don’t expect profitability this year.
The U.S. Food and Drug Administration has accepted Lexicon’s request for an end-of-Phase 2 meeting following additional analyses of data from the company’s Phase 2 clinical program, which included more than 600 patients across two studies.
According to a company presentation at the 19th Annual Pain Therapeutics Summit, the 10 mg once-daily dose demonstrated a clinically meaningful 2-point reduction in average daily pain scores from baseline at 12 weeks. The company reported that analyses showed a linear relationship between increased plasma levels of pilavapadin and pain reduction. With a current ratio of 4.16, InvestingPro analysis shows Lexicon’s liquid assets comfortably exceed its short-term obligations, providing financial flexibility for this development phase.
The company indicated that the 10 mg dose showed an acceptable tolerability profile with treatment completion rates similar to placebo. Safety data revealed no prolonged QTc interval with pilavapadin treatment and no significant impact on the drug’s pharmacokinetics from mild to moderately impaired renal function.
A post-hoc pooled analysis of the Phase 2 RELIEF-DPN 1 and Phase 2b PROGRESS studies suggested that participants in the 20 mg dose group were less adherent than those in other study arms, potentially explaining the lack of dose response observed at that level.
Pilavapadin is an oral, selective inhibitor of AAK1, a target for neuropathic pain that inhibits reuptake and recycling of neurotransmitters involved in pain signaling without affecting opiate pathways.
Lexicon stated that partnership discussions for the development program are actively progressing. The information was based on a company press release statement and presentation at the pain therapeutics conference. Despite current unprofitability, the company has shown remarkable revenue growth of over 1,500% in the last twelve months. Discover more insights about Lexicon’s financial health and growth potential through the comprehensive Pro Research Report, available exclusively on InvestingPro, along with 10+ additional ProTips and detailed metrics.
In other recent news, Lexicon Pharmaceuticals has submitted additional clinical data to the U.S. Food and Drug Administration (FDA) to support the potential resubmission of its New Drug Application for Zynquista. This submission includes findings from three ongoing studies evaluating sotagliflozin as an adjunct to insulin for glycemic control in adults with type 1 diabetes. The FDA, which was expected to provide feedback by the end of September, now anticipates offering its response in the fourth quarter. Meanwhile, H.C. Wainwright has reiterated its Buy rating and $4.00 price target for Lexicon Pharmaceuticals. This decision follows the company’s presentation of preclinical data demonstrating pilavapadin’s potential in reducing neuropathic pain in animal models. Additionally, Lexicon presented data at the European Society of Cardiology Congress, examining sotagliflozin’s efficacy in older heart failure patients. These developments have maintained investor interest in the company’s ongoing research and potential drug approvals.
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