Lumos Pharma Inc. shares were down 12% to $8.29 after the company said primary six-month data for its phase 2 OraGrowtH210 trial is expected in the second half of 2023.
With the new timeline, the biopharmaceutical company said the treatment period will be extended to 12 months.
The company said the pace of site initiation and enrollment of the trial has been slower than anticipated primarily due to Covid-19 restrictions. That impact has been particularly pronounced at international sites where faster patient enrollment was anticipated. The trial's primary outcome continues to be the preliminary validation of its predictive enrichment markers strategy.
Lumos said the Food and Drug Administration has now requested an extension of the Trial to 12 months. The planned protocol extension mirrors the first six months of the OraGrowtH211 long-term extension study. The FDA has placed the planned long-term extension study on partial clinical hold until additional efficacy data from the trial are available to be reviewed.
Wainwright & Co. lowered its price target on Lumos Pharma to $27 from $34 a share, while keeping a Buy rating on the shares.
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