Lexicon Pharmaceuticals Inc Stock Price, News & Analysis

Lexicon Pharmaceuticals (Nasdaq: LXRX) has announced its upcoming second quarter 2024 financial results conference call and webcast, scheduled for August 1, 2024, after market close. The company will host a conference call and live webcast at 5:00 p.m. ET (4:00 p.m. CT) to discuss financial results and provide a business update.

Investors can access the call using the following details:

• U.S. Dial-in: (888) 317-6003
• International Dial-in: (412) 317-6061
• Conference ID: 7023126

Lexicon Pharmaceuticals (Nasdaq: LXRX) announced that the FDA has set a PDUFA goal date of December 20, 2024 for its resubmitted New Drug Application (NDA) for Zynquista™ (sotagliflozin). The drug is being evaluated as an adjunct to insulin therapy for glycemic control in adults with type 1 diabetes and chronic kidney disease (CKD). This resubmission is considered a complete response to the FDA's 2019 action letter.

Lexicon is actively preparing for a potential launch in early 2025. If approved, Zynquista would mark Lexicon's second NDA approval and commercial launch in two years of products originating from their novel discovery platform. The company expressed confidence in sotagliflozin's favorable benefit/risk profile for the target patient population.

Lexicon Pharmaceuticals (Nasdaq: LXRX) announced new data highlighting potential cost-savings of INPEFA® (sotagliflozin) for heart failure treatment. A study published in the Journal of Managed Care + Specialty Pharmacy showed significant financial benefits for hospitals using INPEFA in alternative payment models (APMs). The analysis, based on the SOLOIST-WHF trial, demonstrated that INPEFA reduced hospital readmissions and emergency visits, leading to larger bonus payments under APMs.

Key findings include:

• $4,720 margin increase per admission for the Hospital Readmissions Reduction Program
• $1,200 margin increase for Bundled Payments for Care Improvement-Advanced program
• $1,078 margin increase for Medicare Shared Savings Program

These results align with two other peer-reviewed studies from June 2024, further supporting INPEFA's clinical and financial advantages in heart failure treatment.

Lexicon Pharmaceuticals announced the appointment of Mike Exton, Ph.D., as its new CEO, effective July 8, 2024. Dr. Exton succeeds Lonnel Coats, who retired on July 7, 2024. Exton brings extensive experience from his 14-year tenure at Novartis, where he led the global cardiometabolic therapeutic area and played a key role in commercializing the world’s leading heart failure drug. He also has a strong background in research, development, and strategic acquisitions. Concurrently, Jeff Wade has been promoted to president and COO, having served as Lexicon's president and CFO since October 2021.

Lexicon Pharmaceuticals has resubmitted its New Drug Application (NDA) for sotagliflozin, aimed at improving glycemic control in people with type 1 diabetes and chronic kidney disease (CKD). This follows extensive interactions and recent feedback from the FDA. The company seeks approval for sotagliflozin as an adjunct to insulin therapy. Previously, the FDA issued a complete response letter (CRL) in 2019 regarding the NDA, and a Notice of Opportunity for Hearing (NOOH) was issued in 2021. Lexicon and the FDA agreed to hold NOOH proceedings in abeyance and explored a path for resubmission. The application holds a 'filed' status, with an anticipated six-month review and potential launch by early 2025.

Lexicon Pharmaceuticals announced that their Phase 2 RELIEF-DPN-1 clinical trial results for LX9211, an investigational non-opioid therapy for diabetic peripheral neuropathic pain (DPNP), were published in Diabetes Care. The study, conducted over 11 weeks, showed that LX9211 significantly reduced average daily pain scores in the low-dose group and was well tolerated by patients. The successful outcomes support the commencement of the Phase 2b PROGRESS trial, which is currently enrolling patients in the U.S.

Existing DPNP treatments often provide only modest pain relief and come with significant side effects. LX9211's promising results indicate it may offer a more effective and safer alternative for DPNP sufferers.

Lexicon Pharmaceuticals (Nasdaq: LXRX) has announced that a new analysis published in the Journal of the American College of Cardiology: Heart Failure concludes that INPEFA® (sotagliflozin) is cost-effective for patients with diabetes and recent worsening heart failure. The peer-reviewed study, conducted from a U.S. healthcare perspective, follows Consolidated Health Economic Evaluation Reporting Standards. It reveals that lifetime quality-adjusted life-years (QALYs) were higher for the INPEFA group (4.43) compared to the placebo group (4.04), confirming the drug's economic viability. Another study in the Journal of Comparative Effectiveness Research supports these findings, showing a net QALY gain of 0.425 for INPEFA. Lexicon's senior VP, Craig Granowitz, emphasized the financial and clinical benefits for the U.S. healthcare system.

Lexicon Pharmaceuticals announces three poster presentations at the 84th Scientific Sessions of the American Diabetes Association from June 21-24, 2024, in Orlando, Florida. The presentations will occur on June 23, from 12:30 - 1:30 p.m. ET, focusing on diabetic peripheral neuropathic pain (DPNP) and the efficacy of sotagliflozin. The studies include patient-reported burdens of DPNP, the impact of sotagliflozin as an add-on for inadequately controlled basal insulin-treated type 2 diabetes, and a comparison of sotagliflozin vs. empagliflozin or placebo in type 2 diabetes. This research underscores Lexicon's efforts to address unmet medical needs in diabetes.

Lexicon Pharmaceuticals (Nasdaq: LXRX) announced its participation in the Jefferies Global Healthcare Conference on June 5, 2024. Jeff Wade, president and CFO, along with Craig Granowitz, senior VP and chief medical officer, will join a moderated discussion at 3:00 pm ET. A live webcast will be available on Lexicon's website, with a recording accessible for two weeks post-event.