The U.S. Food and Drug Administration (FDA) has declined to approve Merck and Daiichi's 'guided missile' cancer drug, marking a setback for the first project under their partnership. Additionally, the FDA has rejected Rocket Pharmaceuticals' gene therapy, Kresladi, designed to treat leukocyte adhesion deficiency-I (LAD-I), a rare and severe pediatric disorder that causes the immune system to malfunction. The rejection of Rocket's therapy, which required 'limited additional' manufacturing information, led to a significant decline in the company's stock, falling over 13% premarket.
Rocket gene therapy rejected by FDA over manufacturing https://t.co/5GmWJciLts $RCKT by @NedPagliarulo
The FDA rejected Rocket Pharmaceuticals’ gene therapy for leukocyte adhesion deficiency-I (LAD-I), requesting “limited additional” manufacturing information. https://t.co/J0YW6SUd8k
Rocket Pharmaceuticals said on Friday the U.S. health regulator declined to approve its gene therapy to treat a rare and severe pediatric disorder that causes the immune system to malfunction, sending its shares down more than 12% in early trading. https://t.co/pBVjMyeLng
🚨 BREAKING: FDA REJECTS ROCKET PHARMA'S GENE THERAPY The FDA has declined to approve Rocket Pharmaceuticals' gene therapy, Kresladi, for a severe immune disorder in children. Rocket's shares fell over 13% premarket on the news. The therapy treats Leukocyte Adhesion… https://t.co/7NZAcb47eq
US FDA declines to approve Rocket Pharma's immune disorder gene therapy https://t.co/iXlVCYICuC https://t.co/ua0t5lSLHO
Rocket Pharmaceuticals said the FDA had rejected its gene therapy for an ultra-rare, sometimes fatal immuno-deficiency syndrome. https://t.co/rIL3nJEI58
$RCKT (-12.0% pre) Rocket stock falls as FDA rejects gene therapy - SA https://t.co/os5pFrku17
The U.S. Food and Drug Administration has declined to approve Rocket Pharmaceuticals' gene therapy to treat a rare and severe pediatric disorder that causes the immune system to malfunction, the company said on Friday. https://t.co/GEhFkCfnek https://t.co/GEhFkCfnek
Daiichi's lung cancer ADC rejected by FDA in blow to first project under Merck partnership https://t.co/S9XHq4zEXi
#US FDA declines to approve Merck-Daiichi's 'guided missile' cancer drug
US FDA declines to approve Merck-Daiichi's 'guided missile' cancer drug https://t.co/bRFjHJgHAg https://t.co/BbXbCdE9qi