- The Food and Drug Administration on Tuesday canceled an advisory committee meeting scheduled to discuss Intra-Cellular Therapeutics' leading drug candidate, creating confusion over the status of the experimental schizophrenia treatment.
- Intra-Cellular was expecting that July 31 meeting would set the stage for an FDA approval decision on lumateperone by Sept. 27. The biotech said the cancellation came after it provided additional non-clinical study information requested by the agency. The FDA now needs additional time to review that data, the biotech stated.
- With little to go on, investors sold off Intra-Cellular's stock. Shares dropped from $12 to $8 within an hour of the news hitting Tuesday afternoon, and continued to fall Wednesday morning. All told, the stock has lost about 35% in value.
"This is obviously a frustrating situation," wrote Marc Goodman, an SVB Leerink analyst, highlighting how little is known about the FDA's request and subsequent cancellation of the advisory committee.
Intra-Cellular did specify the additional data is only pre-clinical, meaning it is not related to results from other lumateperone clinical studies.
Earlier this month, for instance, the company released mixed topline results for the drug in two Phase 3 studies of bipolar disorder. One trial showed lumateperone reduced the severity of depressive episodes, while the other failed to find a statistical difference between the drug and placebo.
Goodman speculated the FDA's request could be related to a 2017 concern over lumateperone's non-clinical toxicity data. At that time, the agency requested data to confirm the drug does not pose a long-term safety risk in humans.
"We are not sure yet whether the non-clinical studies are related to the same safety concern," Goodman wrote.
Intra-Cellular said it plans to meet with the FDA "shortly" and then provide a further update. The timeline for that meeting is not clear, as is any potential impact on the September deadline for an agency regulatory decision.
Cantor Fitzgerald analyst Charles Duncan wrote Wednesday that he envisions this could push back that deadline by three to six months, although he remained positive on the drug's chances of approval.
For its part, the FDA said it "intends to continue evaluating the application and, as needed, will announce future meeting dates in the Federal Register."
Lumateperone is Intra-Cellular's lead drug, and schizophrenia is its lead indication. The New York City-based biotech licensed the compound in 2005 from Bristol-Myers Squibb.
The company did not elaborate beyond its published statement in a response to questions from BioPharma Dive.