Lexicon to Reposition as Clinical Development-Focused Company Following Regulatory Update From FDA
Lexicon Pharmaceuticals (LXRX) announced a strategic restructuring to eliminate its commercial operations and focus on clinical development following FDA's deficiency letter regarding Zynquista™. The company will reduce its workforce by approximately 60% by December 31st and expects to reduce 2025 operating costs by $100 million, in addition to previously announced $40 million savings.
The company will prioritize its R&D pipeline, including the Phase 2b PROGRESS study of LX9211 for diabetic peripheral neuropathic pain, the Phase 3 SONATA HCM study of sotagliflozin, and IND-enabling studies of LX9851 for obesity. INPEFA® will continue to be available but without promotional efforts.
Lexicon Pharmaceuticals (LXRX) ha annunciato una ristrutturazione strategica per eliminare le sue operazioni commerciali e concentrarsi sullo sviluppo clinico dopo la lettera di inadeguatezza ricevuta dalla FDA riguardo a Zynquista™. L'azienda prevede di ridurre la propria forza lavoro di circa il 60% entro il 31 dicembre e si aspetta di ridurre i costi operativi del 2025 di 100 milioni di dollari, oltre ai precedenti risparmi annunciati di 40 milioni di dollari.
L'azienda darà priorità al suo pipeline di R&S, incluso lo studio PROGRESS di Fase 2b di LX9211 per il dolore neuropatico periferico diabetico, lo studio SONATA HCM di Fase 3 di sotagliflozin e gli studi abilitanti IND di LX9851 per l'obesità. INPEFA® continuerà a essere disponibile, ma senza sforzi promozionali.
Lexicon Pharmaceuticals (LXRX) anunció una reestructuración estratégica para eliminar sus operaciones comerciales y enfocarse en el desarrollo clínico tras la carta de deficiencia de la FDA respecto a Zynquista™. La compañía reducirá su plantilla en aproximadamente un 60% para el 31 de diciembre y espera reducir los costos operativos de 2025 en 100 millones de dólares, además de los ahorros de 40 millones de dólares previamente anunciados.
La compañía priorizará su pipeline de I+D, incluyendo el estudio PROGRESS de Fase 2b de LX9211 para el dolor neuropático periférico diabético, el estudio SONATA HCM de Fase 3 de sotagliflozina, y los estudios habilitantes IND para LX9851 en obesidad. INPEFA® seguirá estando disponible, pero sin esfuerzos promocionales.
Lexicon Pharmaceuticals (LXRX)는 Zynquista™에 대한 FDA의 부족 통지서를 받은 후 상업 운영을 종료하고 임상 개발에 집중하기 위한 전략적 구조 조정을 발표했습니다. 이 회사는 12월 31일까지 약 60%의 인력을 줄이고, 2025년 운영 비용을 1억 달러 줄일 것으로 예상하며, 이전에 발표된 4000만 달러의 절감 효과도 추가됩니다.
회사는 당뇨 퍼리페럴 신경병성 통증을 위한 LX9211의 2b상 PROGRESS 연구, 소타글리플로진의 3상 SONATA HCM 연구, 비만에 대한 LX9851의 IND 허가 연구에 우선 순위를 둘 것입니다. INPEFA®는 프로모션 없이 계속 사용 가능할 것입니다.
Lexicon Pharmaceuticals (LXRX) a annoncé une restructuration stratégique pour éliminer ses opérations commerciales et se concentrer sur le développement clinique après avoir reçu une lettre de carence de la FDA concernant Zynquista™. La société prévoit de réduire son effectif d'environ 60% d'ici le 31 décembre et s'attend à réduire ses coûts d'exploitation en 2025 de 100 millions de dollars, en plus des économies de 40 millions de dollars déjà annoncées.
La société mettra l'accent sur son pipeline de R&D, y compris l'étude PROGRESS de phase 2b de LX9211 pour la douleur neuropathique périphérique diabétique, l'étude SONATA HCM de phase 3 de sotagliflozine, et les études habilitantes IND de LX9851 pour l'obésité. INPEFA® restera disponible, mais sans efforts promotionnels.
Lexicon Pharmaceuticals (LXRX) hat eine strategische Umstrukturierung angekündigt, um seine kommerziellen Aktivitäten einzustellen und sich auf die klinische Entwicklung zu konzentrieren, nachdem es einen Mangelbrief von der FDA bezüglich Zynquista™ erhalten hat. Das Unternehmen wird bis zum 31. Dezember seine Belegschaft um etwa 60% reduzieren und erwartet, die Betriebskosten für 2025 um 100 Millionen Dollar zu senken, zusätzlich zu den zuvor angekündigten Einsparungen von 40 Millionen Dollar.
Das Unternehmen wird seinen F&E-Pipeline priorisieren, einschließlich der Phase 2b PROGRESS-Studie von LX9211 für diabetische periphere Neuropathieschmerzen, der Phase 3 SONATA HCM-Studie von Sotagliflozin und IND-erlaubenden Studien von LX9851 für Fettleibigkeit. INPEFA® wird weiterhin verfügbar sein, jedoch ohne Werbemaßnahmen.
- Expected $100 million reduction in 2025 operating costs, plus additional $40 million in savings
- Continued development of three promising pipeline candidates
- Significant cost reduction through 60% workforce reduction
- FDA identified deficiencies in Zynquista NDA for type 1 diabetes
- Complete elimination of commercial operations and promotional activities
- Discontinuation of all planned commercial activities for ZYNQUISTA
Insights
This strategic restructuring marks a significant pivot for Lexicon, driven by FDA setbacks with Zynquista. The
The pipeline now becomes the primary value driver, with key catalysts including LX9211's Phase 2b DPNP data in Q1 2025 and the ongoing Phase 3 SONATA HCM study. While this restructuring preserves cash runway, it also indicates significant near-term revenue challenges with the effective abandonment of INPEFA commercialization. The market will likely reprice LXRX based on pipeline value rather than commercial potential.
The FDA's "deficiencies preclude discussion" letter for Zynquista represents a major setback in the type 1 diabetes and CKD space. The pipeline refocus prioritizes three key programs: LX9211 for DPNP, sotagliflozin for HCM and LX9851 for obesity. The DPNP program is most advanced with near-term data, while the obesity candidate enters a highly competitive market dominated by GLP-1 drugs.
The decision to maintain INPEFA availability while eliminating promotional efforts suggests minimal confidence in its commercial potential. This transformation to a pure clinical development company allows focused resource allocation but increases dependence on clinical trial outcomes for future value creation.
Implementing Strategic Restructuring to Eliminate Commercial Organization and Rationalize Operations Across All Functions
Prioritizing Strong R&D Pipeline Including Ongoing Studies in DPNP, HCM and Obesity
Efforts Expected to Reduce 2025 Operating Costs by
Conference Call and Webcast at 9:00 am ET
THE WOODLANDS, Texas, Nov. 22, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that the company has made the strategic decision to eliminate its commercial operations and rationalize resources across all functions in order to preserve cash and focus its resources on advancing its promising clinical development pipeline. This prioritization of investment is designed to advance the research and development programs that have the greatest potential for value creation and patient impact.
This decision follows the receipt of a “deficiencies preclude discussion” letter from the U.S. Food and Drug Administration (FDA) regarding the Company’s 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 letter noted deficiencies with the application that preclude discussion of labeling and/or post-marketing requirements and commitments at this time.
"While this decision was not made lightly, it reflects our commitment to make prudent business decisions that enhance value across our portfolio and deliver on our Lead to Succeed strategy," said Mike Exton, Ph.D., Lexicon’s chief executive officer and director. "We see significant potential in our strong pipeline of R&D opportunities, and we will focus our resources on programs with the potential for the greatest impact. We are confident that by carefully selecting therapeutic areas where we are the first and only therapy in class, and focusing our R&D efforts where there are significant needs, we can deliver innovations that will meaningfully benefit patients while simultaneously positioning Lexicon to fully realize future growth opportunities."
Details of the Strategic Restructuring
- Complete elimination of the Company’s commercial field team and reduction in size of other functions across the organization, including the elimination of all promotional efforts for INPEFA® and all planned commercial activities for ZYNQUISTA.
- A total reduction of approximately 60 percent of employees, effective for most affected employees by December 31st.
- INPEFA to continue to be manufactured and made available to patients and existing prescribers.
- An expected reduction of 2025 full year operating costs by
$100 million . This amount is in addition to the$40 million in expected 2025 cost savings announced in August as part of a realignment of resources.
Reemerging as a Clinical Development-Focused Company
Lexicon will concentrate its resources on the continued research and development of its strong pipeline, including:
- The Phase 2b PROGRESS study evaluating LX9211 in diabetic peripheral neuropathic pain (DPNP), with topline data anticipated in Q1 2025.
- The pivotal Phase 3 SONATA HCM study evaluating sotagliflozin in hypertrophic cardiomyopathy (HCM), with enrollment underway.
- IND-enabling studies of LX9851, a novel, non-incretin oral development candidate in obesity and associated cardiometabolic disorders.
- Advancing earlier stage opportunities for LX9211 and LX9851 in additional indications.
- Exploring strategic partnerships to advance and accelerate the value of our pipeline.
Conference Call and Webcast Information
Lexicon management will hold a live conference call and webcast today at 9:00 am ET / 8:00 am 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://www.lexpharma.com/media-center/events. 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 website for 14 days.
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 a pipeline of promising drug candidates in discovery and clinical and preclinical development in neuropathic pain, metabolism and other therapeutic areas. For additional information, please visit www.lexpharma.com.
Safe Harbor Statement
This press release contains “forward-looking statements,” including 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, conduct preclinical and clinical development and obtain necessary regulatory approvals of sotagliflozin, 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.
Investor Contact
Lisa DeFrancesco
Lexicon Pharmaceuticals, Inc.
lexinvest@lexpharma.com
Media Contact
Molly Devlin
Real Chemistry
corpcomm@lexpharma.com
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