Gracell Biotech slumps on delaying U.S. regulatory filing for lead drug

Hanall Biopharma

14/03/2022 16:28

** U.S.-listed shares of China-based biopharma co  GRCL.O 
decline 20.8% to $2.02, hitting lowest levels since market debut
in August 2021 
    ** Stock among biggest pct decliners on the Nasdaq
Biotechnology Index  .NBI  
    ** Co now plans to file investigational new drug application
with U.S. health regulator for its lead drug, GC012F, during H2
2022 vs previous timeline of H1 2022  urn:newsml:reuters.com:*:nPn29WPTfa 
    ** Says revised timeline is due to manufacturing capacity
constraints at its CDMO (contract development and manufacturing
organization)  urn:newsml:reuters.com:*:nGNX4NfCb3 
    ** In an early-stage study in China, co is studying GC012F
as a potential treatment of multiple myeloma, a type of cancer
that forms in plasma cells 
    ** Separately, GRCL posts quarterly net loss of RMB 128.6
mln ($20.19 mln) vs loss of RMB 83.6 mln; says R&D expenses in
quarter grew by 77.3% to RMB107.6 mln 
    ** Up to Friday's close, GRCL had fallen ~90% since IPO 


($1 = 6.3607 Chinese yuan renminbi)

 (Reporting by Bhanvi Satija in Bengaluru)
 ((Bhanvi.Satija@thomsonreuters.com; Outside U.S. +91
9873062788;))