Stifel downgraded Alcobra (NASDAQ:ADHD) to “hold” from “buy” and slashed its price target to $3 from $17 after the FDA issued a clinical hold on the company’s Phase 3 study of metadoxine extended release (MDX) in adult patients with ADHD, known as the “MEASURE” study.
Shares of Alcobra were quoted at $2.55 at midday Friday.
The FDA’s letter to Alcobra provided little additional information regarding preclinical toxicities observed other than electrophysiological neurological findings but no clinical safety issues in the MEASURE study or previous human studies, writes analyst Annabel Samimy. The FDA’s Division of Psychiatry Products recommended Alcobra hold a meeting to discuss these issues.
“In the meantime, we believe the clinical hold has compromised the statistics of the pivotal program and injected indefinite delays into the program,” she said.
“Best case, enrollment is reinitiated within six months, pushing program completion and future launch timing to at least 2020,” Ms. Samimy added.
