XLRN - In a first FDA cites Acceleron for not submitting trial results to clinicaltrials.gov

The FDA has issued a notice of noncompliance to Acceleron Pharma (XLRN) for failing to submit data from a phase 2 trial of an oncologic to the clinicaltrials.gov database as required.The trial involved explored a combination of dalantercept and axitinib compared to axitinib and placebo alone in advanced renal cell carcinoma.The company was warned about the non compliance in a July 20, 2020 letter.Requirements mandate that "certain results" from trials be submitted to the the federal government database no later than a year after trial completion.The FDA says it make seek a civil penalty against Acceleron.Acceleron shares closed up 2% to $126.95.

For further details see:

In a first, FDA cites Acceleron for not submitting trial results to clinicaltrials.gov