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LXRX

Lexicon

$3.54

-0.01 (-0.28%)

07:02
12/02/19
12/02
07:02
12/02/19
07:02

Lexicon says FDA denies appeal of CRL in relation to sotagliflozin NDA

Lexicon Pharmaceuticals announced that the Office of New Drugs of the U.S. Food and Drug Administration has reiterated the FDA's prior position and denied Lexicon's appeal of the Complete Response Letter in relation to the New Drug Application for sotagliflozin in type 1 diabetes. Lexicon intends to appeal the decision to the Center for Drug Evaluation and Research, or CDER.

LXRX Lexicon
$3.54

-0.01 (-0.28%)

09/11/19
SBSH
09/11/19
NO CHANGE
Target $3
SBSH
Buy
Lexicon settlement with Sanofi removes overhang, says Citi
Citi analyst Yigal Nochomovitz believes Lexicon Pharmaceuticals' (LXRX) settlement with Sanofi (SNY) removes an overhang and that the company's cash runway "may increase modestly." However, the funds are largely already spoken for with respect to continued funding of the core Phase 3 trials in n type 2 diabetes and the outcomes trials, Nochomovitz tells investors in a research note. The analyst keeps a Buy rating on Lexicon shares with a $3 price target.
09/11/19
GABE
09/11/19
UPGRADE
GABE
Buy
Lexicon upgraded to Buy from Hold at Gabelli
09/11/19
GABE
09/11/19
UPGRADE
GABE
Buy
Lexicon upgraded to Buy at Gabelli, says agreement a 'clean break'
Gabelli analyst Kevin Kedra upgraded Lexicon to Buy from Hold after the company said Sanofi (SNY) has finalized its termination of the sotagliflozin collaboration with a $260M payment, citing valuation and increased optimism for sotagliflozin's future. In a research note to investors, Kedra says the agreement is a "clean break" from Sanofi while also modestly extending Lexicon's cash runway, and expects Lexicon to have enough cash to support operations into 2021.
11/08/19
SBSH
11/08/19
DOWNGRADE
Target $4
SBSH
Neutral
Lexicon downgraded to Neutral from Buy at Citi
Citi analyst Yigal Nochomovitz downgraded Lexicon Pharmaceuticals to Neutral from Buy with a price target of $4, up from $3. The analyst says he struggles to recommend the stock at the current valuation until greater clarity on a favorable path forward for sotagliflozin in type 1 diabetes is obtained. Lexicon announced that it filed a formal dispute to the FDA Office of New Drugs appealing the Complete Repose Letter issued for sotagliflozin. The rate of success for these resolutions is around 15% to 20%, Nochomovitz tells investors in a research note.

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