@MelvinRiskMgmt @sciencescanner $AGIO stock would still be down but chances for approval better had the study hit on fatigue. It did not, which is a big problem.
An unfortunate outcome given the need for new sickle cell treatments following the withdrawal of Pfizer's Oxbryta. I wrote a preview of the $AGIO study last week: https://t.co/d4HOAOXY3k
Agios $AGIO reports mixed results from sickle cell study, raising doubts about drug’s future https://t.co/WbuQ34e2mh
@sciencescanner The $AGIO stock reaction to the results are indicative that Hb alone is insufficient to support an approval.
$AGIO mitapivat ph3 sickle cell trial results results, not great. Hit stat sig hemoglobin response, failed on pain crises Fatigue, key secondary, also not met. https://t.co/BoJ69Y0hku
A preview of Agios Pharma’s $AGIO sickle-cell study readout https://t.co/d4HOAOYvSS
In this week's Biotech Scorecard: -- $QURE CEO Matt Kapusta dined privately with investors on Tuesday night -- and said some stuff, according to two attendees who filled me in. -- A preview of $AGIO Pyrukynd Ph3 study in sickle cell disease. The readout is coming in December.
$AGIO Pyrukynd PDUFA for thalassemia extended by 3 months to Dec. 7. Liver toxicity issue. "Following a recent information request from the FDA, Agios submitted a proposed Risk Evaluation and Mitigation Strategy (REMS) to mitigate the risk of hepatocellular injury that was described in the original PYRUKYND sNDA. The submission of the REMS is a major amendment to the PYRUKYND sNDA, resulting in a three-month review extension. This extension is not the result of new or additional efficacy or safety data requested by the FDA or submitted by Agios."
