Kadmon Holdings, Inc (KDMN) share price was fluctuating on Wednesday, March 10, 2021. In the normal trading session, the stock price of KDMN increase but it went into a negative trend in the after-hours session. It lost 10.57% of its value after the company made an announcement related to its product Belumosudil.
The KDMN announcement said that the Food and Drug Administration (FDA) has extended the review period for the New Drug Application (NDA) for Belumosudil. Belumosudil is used to treat chronic graft-versus-host disease (cGVHD). FDA extended its priority review of Belumosudil to August 30, 2021.
The reason behind the review extension is that the FDA now required more time to review the additional information submitted by KDMN. FDA asked for the additional information to constitute a major amendment to the NDA
The President and CEO of Kadmon, Harlan W. Waksal, M.D., said that they are confident that their data will support the applications for Belumosudil in cGVHD and they are looking forward to working closely with FDA in the review process. He further said that the company is committed to providing relief to the cGVHD patients by bringing Belumosudil to the market once it’s approved.
What is Belumosudil?
Belumosudil (KD025) This drug selectively inhibits Rho-associated coiled-coil kinase (ROCK2), a signaling pathway that modulates inflammatory responses and pro-fibrotic processes.
What is cGVHD
cGVHD is one of the most dangerous complications following hematopoietic stem cell transplantation. When cGVHD occurs, grafted immune cells invade host cells, leading to inflammation and fibrosis of various tissues, including skin, mouth, eye, joints, liver, spleen, esophagus, and gastrointestinal tract. More than 14,000 Americans currently suffer from cGVH.D.
KDMN recent financial results
Earlier on March 5, 2021, Company announced its financial results for the quarter ended December 2020 which top the revenue estimates but the company suffered a quarterly loss of $0.17 per share. The company posted revenue of 0.62 million for the reported quarter, beating the analyst estimates. Kadmon Holdings, Inc. Shares have added about 10.6% since the beginning of the year versus the S&P 500’s gain of 1.7%.