Lexicon Announces Receipt of Complete Response Letter for Zynquista™ (sotagliflozin)
Lexicon Pharmaceuticals, Inc. (LXRX)
Last lexicon pharmaceuticals, inc. earnings: 4/27 07:00 am
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Source: GlobeNewswire
THE WOODLANDS, Texas, Dec. 20, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced it has received a complete response letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the 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). This expected communication from the FDA aligns with the company’s previously disclosed strategic decision to discontinue launch preparations for Zynquista and focus solely on its clinical development pipeline. "We are sincerely grateful to the patients and physicians who participated in our Zynquista™ clinical trials, and the broader diabetes community who strongly advocated for Zynquista’s approval," said Mike Exton, Ph.D., chief executive officer and director of Lexicon. “Although this was not our desired outcome for sotagliflozin in this indication, we remain steadfast in our co
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News
- Lexicon Announces Receipt of Complete Response Letter for Zynquista™ (sotagliflozin) [Yahoo! Finance]Yahoo! Finance
- Lexicon completes subject enrolment for DPNP trial of LX9211 [Yahoo! Finance]Yahoo! Finance
- Lexicon Announces Completion of Enrollment in Phase 2B PROGRESS Study of LX9211 in Diabetic Peripheral Neuropathic Pain (DPNP) [Yahoo! Finance]Yahoo! Finance
- Lexicon Announces Completion of Enrollment in Phase 2B PROGRESS Study of LX9211 in Diabetic Peripheral Neuropathic Pain (DPNP)GlobeNewswire
- Lexicon Pharmaceuticals to Participate in December Investor Conferences [Yahoo! Finance]Yahoo! Finance
LXRX
Earnings
- 11/12/24 - Miss
LXRX
Sec Filings
- 12/16/24 - Form 3
- 12/9/24 - Form SC
- 12/2/24 - Form 4
- LXRX's page on the SEC website