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Lexicon Pharmaceuticals to Announce Topline Results from Phase 2b PROGRESS Study Evaluating Pilavapadin (LX9211) in Adults with Diabetic Peripheral Neuropathic Pain

1. LXRX to hold a call on March 3, 2025, for Phase 2b results. 2. Study involved 496 patients assessing pilavapadin for diabetic neuropathic pain. 3. Pilavapadin is a novel AAK1 inhibitor targeting neuropathic pain without opioids. 4. Approximately 9 million U.S. patients suffer from diabetic peripheral neuropathic pain. 5. Results could impact regulatory decisions and market positioning for LXRX.

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Why Bullish?

The announcement of positive topline results could drive investor interest. Historical examples show FDA approvals often lead to significant stock price boosts.

How important is it?

The success of pilavapadin could significantly influence LXRX's market valuation. Given the substantial patient population, the potential market impact is considerable.

Why Short Term?

Immediate market reactions expected post-announcement. Positive results could quickly enhance investor sentiment.

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Conference call and webcast at 8:00 a.m. ET on Monday, March 3, 2025 March 02, 2025 16:13 ET  | Source: Lexicon Pharmaceuticals, Inc. THE WOODLANDS, Texas, March 02, 2025 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced the Company will hold a conference call and webcast on Monday, March 3, 2025 at 8:00 a.m. ET to share topline results from the Phase 2b PROGRESS (A Phase 2b, Dose-ranging, Randomized, Double-blind, PlacebO-controlled, Parallel-GRoup, MulticEnter Study with an Open-label Extension in PatientS with Diabetic Peripheral Neuropathic Pain) study evaluating pilavapadin (LX9211), an oral, non-opioid investigational adaptor-associated kinase 1 (AAK1) inhibitor in adult patients with moderate to severe diabetic peripheral neuropathic pain (DPNP). Conference Call and Webcast InformationLexicon management will hold a live conference call and webcast on Monday, March 3, 2025, at 8:00 a.m. ET / 7:00 a.m. CT to review the details of this announcement. Participants can access the conference call live via webcast on the Events page of the Company’s website at https://investors.lexpharma.com/. Participants who wish to ask a question may register here to receive dial-in numbers and a unique pin to join the call. An archived version of the webcast will be available on the Lexicon website. About the PROGRESS StudyThe PROGRESS study commenced in December 2023 and enrolled 496 adult patients with a diagnosis of diabetes (type 1 or type 2) and moderate to severe DPNP. The study was placebo-controlled with a primary endpoint of change from baseline to Week 8 in ADPS as compared to placebo and evaluated three treatment groups receiving once daily pilavapadin doses of 10 mg, 20 mg or 20 mg for seven days followed by 10 mg thereafter. Secondary endpoints included change from baseline to Week 8 in burning pain and pain interference on sleep. Study design permitted patients to remain on one stable-dose DPNP therapy (e.g. gabapentin, pregabalin or duloxetine) without withdrawing from therapies that, although inadequate, may be providing some benefit – aligning with how new DPNP drugs are likely to be used in practice. About Diabetic Peripheral Neuropathic Pain (DPNP)DPNP is a debilitating chronic complication of diabetes which can result in burning pain, numbness, and other symptoms in the hands, feet, legs and arms. There are approximately 9 million patients in the U.S. who are suffering with DPNP. About PilavapadinDiscovered using Lexicon’s unique approach to gene science, pilavapadin (LX9211) is a potent, once-daily, orally delivered, selective, investigational small molecule inhibitor of AAK1, a novel target for neuropathic pain which inhibits reuptake and recycling of neurotransmitters involved in pain signaling without affecting opiate pathways. Lexicon identified AAK1 in its target discovery efforts as a promising approach for the treatment of neuropathic pain. Preclinical studies of pilavapadin demonstrated central nervous system penetration and reduction in pain behavior in models of neuropathic pain without affecting opiate pathways. About Lexicon PharmaceuticalsLexicon is a biopharmaceutical company with a mission of pioneering medicines that transform patients’ lives. Through the Genome5000™ program, Lexicon’s unique genomics target discovery platform, Lexicon scientists studied the role and function of nearly 5,000 genes and identified more than 100 protein targets with significant therapeutic potential in a range of diseases. Through the precise targeting of these proteins, Lexicon is pioneering the discovery and development of innovative medicines to safely and effectively treat disease. Lexicon has advanced multiple medicines to market and has a pipeline of promising drug candidates in discovery and clinical and preclinical development in heart failure, neuropathic pain, obesity, cardiology, diabetes and other indications. For additional information, please visit www.lexpharma.com.   For Investor and Media Inquiries:Lisa DeFrancesco Lexicon Pharmaceuticals, Inc.lexinvest@lexpharma.com

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