Shares of Provention Bio (PRVB) - Get Report dropped on Friday after the biopharma provided an update on the Food and Drug Administration's review of its biologic license application for a diabetes treatment, teplizumab.
The FDA has identified deficiencies that preclude discussion of labeling and post-marketing requirement and commitments, Provention said Friday.
"While we believe the FDA's initial feedback will likely result in a delay in timelines within which teplizumab has the potential to be approved by FDA and be made available for at-risk T1D patients, we believe in the comparability of the drug product produced by our partner AGC biologics with Eli Lilly (LLY) - Get Report manufactured product," Provention Chief Executive Ashleigh Palmer said.
The FDA will continue the review of clinical data submitted and will conduct an advisory committee meeting on May 27.
Provention used teplizumab as its lead drug for a $56 million initial public offering filing, Benzinga reported.
"We look forward to working closely with the agency to address its additional data requirement, so we can deliver teplizumab to patients as soon as possible," Palmer said.
RBC analyst Greg Renza dropped his rating on the company to sector perform from outperform and cut his price target to a Wall Street low $10 a share from $25.
“Signs of regulatory risk have been emerging from past regulatory communications and company disclosures, compounded by extrinsic FDA pressures on the sector,” Renza said.
The deficiency notice could signal a risk in the clinical-data package as investors debate the specifics of the small patient study, according to Renza.
Provention shares at last check were down 15% at $8.32.