At the last check, FibroGen Inc. (NASDAQ: FGEN) was up 3.23% at $19.17 in premarket hours. At the end of the last trading session, FibroGen stock lost -1.28% to finish at $18.57. In the Friday trading, the price of FGEN stock ranged from $18.12 to $18.98.
More than 4 million shares were traded in the FGEN stock during the last session, compared to daily traded averages of 1.47 million shares. The FGEN stock is surging today because the FDA has granted Fast Track designation to its antibody.
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The antibody was created to treat what?
FibroGen, Inc. is a biopharmaceutical company focused on the discovery, development and commercialization of first-in-class therapeutics. FGEN is advancing innovative medicines to treat unmet needs with its pioneering expertise in hypoxia-inducible factor (HIF) and connective tissue growth factor (CTGF) biology. Roxadustat targets anemia associated with chronic kidney disease (CKD) and is currently being developed and commercialized by FGEN.
A big milestone for FibroGen has been the FDA’s Fast Track designation for pamrevlumab, their anti-CTGF antibody, which will be used to treat people with Duchenne Muscular Dystrophy (DMD), announced FGEN in a press release today.
FGEN’s Phase 2 clinical data from a non-ambulatory single-arm trial in patients with DMD were reviewed for this designation. In addition, FDA officials also acknowledge pamrevlumab as having the potential to address an unmet medical need for patients with this disease. FGEN is currently evaluating Pamrevlumab for the treatment of DMD in two Phase 3 trials.
For FGEN, what did it mean?
Pamrevlumab by FibroGen (FGEN) has been designated as Fast Track by the FDA, which indicates the FDA sees pammrevlumab as a potential treatment for patients suffering from DMD. Mark Eisner, M.D, M.P.H, Chief Medical Officer of FibroGen said that Pamrevlumab is an option for treatment for DMD, which FGEN looks forward to developing in close collaboration with the FDA.