Lexicon Pharmaceuticals Receives December 20, 2024 PDUFA Goal Date for Sotagliflozin Type 1 Diabetes NDA Resubmission
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.
- FDA set PDUFA goal date of December 20, 2024 for Zynquista NDA resubmission
- Potential for second NDA approval and commercial launch in two years
- Active launch preparations for early 2025
- Expanding portfolio of assets from novel discovery platform
- Previous FDA rejection in 2019 for the same drug application
- Approval still pending, success not guaranteed
Insights
Lexicon Pharmaceuticals has taken a significant step forward with the resubmission of its NDA for Zynquista™ (sotagliflozin) to the FDA. The importance of this event cannot be understated, as it marks progress in potentially offering a new therapeutic option for managing type 1 diabetes in adults, particularly those with chronic kidney disease (CKD). The PDUFA goal date of December 20, 2024, is a key milestone, indicating that the FDA deems the resubmission response complete.
From a clinical perspective, sotagliflozin holds promise due to its unique mechanism as an adjunct to insulin therapy. By targeting dual sodium-glucose co-transporters, it aims to improve glycemic control and potentially offer renal protective benefits. These dual actions could address two significant complications within the patient population – blood sugar management and kidney function.
Investors should note that the success of this resubmission hinges on demonstrating substantial improvements in safety and efficacy profiles compared to existing treatments. Should the FDA approve this NDA, it could position Lexicon as a pivotal player in the diabetes care market, which has been evolving with numerous advancements and increasing competition.
The news from Lexicon Pharmaceuticals regarding the PDUFA date for their NDA resubmission has significant financial implications. The approval of Zynquista™ could lead to substantial revenue growth, especially since this would be the second NDA approval for the company in two years. A successful launch in early 2025 could positively affect the company’s earnings trajectory, boosting investor confidence.
From a financial standpoint, investors should consider the potential market size for a new diabetes therapy. The market for type 1 diabetes treatments is large and growing, driven by rising incidences worldwide. If sotagliflozin achieves approval, Lexicon could tap into a lucrative segment, especially considering the additional benefit for patients with CKD.
However, it is prudent to be aware of the inherent risks. Drug approvals come with uncertainties, including regulatory setbacks or market adoption issues. The company's ability to execute a successful product launch and navigate competition from established players will be critical. Monitoring upcoming financial reports for insights into their launch preparations will be key for a thorough investment analysis.
Launch Preparations Actively Underway; Launch Planned for Early 2025
Lexicon Seeks Approval for Zynquista™ (sotagliflozin) as an Adjunct to Insulin Therapy for Glycemic Control in Adults with Type 1 Diabetes and Chronic Kidney Disease
THE WOODLANDS, Texas, July 16, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today announced that the U.S. Food and Drug Administration (FDA) has acknowledged the resubmission of its New Drug Application (NDA) for Zynquista™ (sotagliflozin) as an adjunct to insulin therapy for glycemic control in adults with type 1 diabetes and chronic kidney disease (CKD). The FDA indicated that it considers the resubmission to be a complete response to the FDA’s 2019 action letter regarding the sotagliflozin NDA for type 1 diabetes, providing a Prescription Drug User Fee Act (PDUFA) goal date of December 20, 2024.
“Lexicon has continued confidence in the favorable benefit/risk profile of sotagliflozin for adults with type 1 diabetes and CKD. With a PDUFA date now in hand, we can begin the next phase of launch preparation for Zynquista,” said Dr. Mike Exton, chief executive officer and director. “If approved, this will mark Lexicon’s second NDA approval and commercial launch in two years of products that originated from our novel discovery platform and advanced to regulatory approval and commercialization. With an exciting and diverse portfolio of assets, Lexicon is well-positioned for strong future value creation for all stakeholders.”
About Lexicon Pharmaceuticals
Lexicon 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 treat disease safely and effectively. Lexicon has commercially launched one of these medicines, INPEFA® (sotagliflozin) in the United States, and has a pipeline of other promising drug candidates in discovery and clinical and preclinical development in neuropathic pain, diabetes and metabolism and other indications. For additional information, please visit www.lexpharma.com.
Safe Harbor Statement
This press release contains “forward-looking statements,” including statements relating to the therapeutic and commercial potential, research and clinical development and regulatory status of sotagliflozin in type 1 diabetes. In addition, this press release may also contain forward looking statements relating to Lexicon’s financial position and long-term outlook on its business, growth and future operating results, discovery and development of products, strategic alliances and intellectual property, as well as other matters that are not historical facts or information. All forward-looking statements are based on management’s current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including Lexicon’s ability to meet its capital requirements, successfully commercialize INPEFA® (sotagliflozin) in heart failure, conduct preclinical and clinical development and obtain necessary regulatory approvals of sotagliflozin in type 1 diabetes and other indications, LX9211, LX9851 and its other drug candidates on its anticipated timelines, achieve its operational objectives, obtain patent protection for its discoveries and establish strategic alliances, as well as additional factors relating to manufacturing, intellectual property rights, and the therapeutic or commercial value of its drug candidates. Any of these risks, uncertainties and other factors may cause Lexicon’s actual results to be materially different from any future results expressed or implied by such forward-looking statements. Information identifying such important factors is contained under “Risk Factors” in Lexicon’s annual report on Form 10-K for the year ended December 31, 2023, and other subsequent disclosure documents filed with the Securities and Exchange Commission. Lexicon undertakes no obligation to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.
For Investor Inquiries:
Lisa DeFrancesco
Lexicon Pharmaceuticals, Inc.
lexinvest@lexpharma.com
For Media Inquiries:
Alina Cocuzza
Lexicon Pharmaceuticals, Inc.
acocuzza@lexpharma.com
FAQ
What is the PDUFA date for Lexicon's sotagliflozin NDA resubmission for type 1 diabetes?
What is the target patient population for Lexicon's sotagliflozin (Zynquista™)?
When does Lexicon Pharmaceuticals (LXRX) plan to launch Zynquista if approved?
How many NDA approvals would Zynquista represent for Lexicon Pharmaceuticals (LXRX) if approved?
