Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) announced that the FDA has granted approval for their once-daily oral tablet, INPEFA (sotagliflozin). 

This medication aims to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in adults with heart failure or type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors. Lexicon expects to make INPEFA available by the end of June 2023 and plans to set the wholesale acquisition cost comparable to existing branded heart failure medications. 

Following this announcement, $LXRX was trading at $3.74 in after-hours on Friday, reflecting a significant increase of $0.56 or 17.61%.

In another development, Iovance Biotherapeutics, Inc. (Nasdaq: IOVA) revealed that the FDA has accepted its Biologics License Application (BLA) for lifileucel, targeting patients with advanced melanoma. 

Melanoma is a form of skin cancer that originates in melanocytes, the skin cells responsible for pigment control. Lifileucel is a TIL therapy designed for individuals with advanced melanoma who have experienced progression after previous anti-PD-1/L1 therapy and targeted therapy, where applicable. Notably, there are currently no FDA-approved treatments available in this specific treatment setting. 

$IOVA was trading at $8.91 in after-hours on Friday, showing a remarkable gain of $1.36 or 18.01%.

THIS IS NOT A RECOMMENDATION TO BUY OR SELL ANY SECURITY OR DIGITAL ASSET. Please consult with a professional investment advisor before purchasing or selling any securities viewed on or mentioned herein. (Read Full Disclaimer)