Lexicon (LXRX) Up as FDA Maintains Action Date for Zynquista
Lexicon Pharmaceuticals, Inc. LXRX announced that the FDA plans to hold an advisory panel meeting to give a recommendation on whether to approve Zynquista (sotagliflozin), which has been developed as an adjunct to insulin therapy for glycemic control in adults with type 1 diabetes and chronic kidney disease (CKD).
The meeting of the Endocrinologic and Metabolic Drugs Advisory Committee is scheduled to be held on Oct 31, 2024.
However, despite scheduling an advisory committee meeting, the FDA did not change the PDUFA date for Zynquista.
Shares of the company were up 13.7% on Aug 21, following the announcement of the news.
Per the notice provided to the company, the regulatory body is planning to make the background materials available to the public no less than two business days before the meeting is held.
Shares of Lexicon have gained 24.9% so far this year compared with the industry’s growth of 1.7%.
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Investors should remember that last month, the FDA accepted LXRX’s resubmitted new drug application (NDA) seeking approval for sotagliflozin as an adjunct to insulin therapy for glycemic control in adults with type 1 diabetes and CKD.
If approved, the product will be marketed under the brand name Zynquista.
Lexicon had submitted an NDA in 2018 for sotagliflozin in T1D indication. However, the FDA issued a complete response letter (CRL) to the NDA in 2019 after one of the organization’s advisory committees issued a split opinion regarding the approval. Management stated that the agency considers the resubmission as a complete response to this CRL.
We note that the FDA approved sotagliflozin under the brand name of Inpefa to reduce the risk of death and hospitalization in adults with either heart failure or those with type II diabetes mellitus, CKD and other cardiovascular risk factors in May 2023.
Earlier this month, LXRX announced a portfolio reprioritization plan to focus on reducing operational expenses and driving the growth of the commercial portfolio.
The company is looking to refocus and optimize its promotional efforts for Inpefa (sotagliflozin) in heart failure and reallocate resources to support the potential commercial launch of Zynquista (sotagliflozin).
Zacks Rank & Stocks to Consider
Lexicon currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the healthcare sector are Illumina, Inc. ILMN, Fulcrum Therapeutics, Inc. FULC and Bioventus Inc. BVS, each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Illumina’s 2024 earnings per share have moved up from $1.07 to $3.16. Earnings per share estimates for 2025 have improved from $2.93 to $4.50. Year to date, shares of ILMN have lost 4.7%.
ILMN’s earnings beat estimates in each of the trailing four quarters, the average surprise being 463.46%.
In the past 60 days, estimates for Fulcrum Therapeutics’ 2024 loss per share have narrowed from $1.24 to 48 cents. Loss per share estimates for 2025 have narrowed from $1.71 to $1.51. Year to date, shares of FULC have surged 41.3%.
FULC’s earnings beat estimates in each of the trailing four quarters, the average surprise being 393.18%.
In the past 60 days, estimates for Bioventus’ 2024 earnings per share have moved up from 27 cents to 40 cents. Earnings per share estimates for 2025 have improved from 43 cents to 45 cents. Year to date, shares of BVS have rallied 73%.
BVS’ earnings beat estimates in three of the trailing four quarters while missing the same on the remaining occasion, the average surprise being 102.86%.
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