The latest domino in the Ariad Pharmaceuticals (NASDAQ: ARIA) saga fell this morning, as the company yanked its troubled, flagship cancer drug ponatinib (Iclusig) from the market.
Cambridge, MA-based Ariad said today that it has “temporarily” suspended the marketing and commercial distribution of ponatinib due to a request from the FDA yesterday afternoon. Ponatinib, Ariad’s only marketed drug, is approved to treat patients with chronic myeloid leukemia who are resistant to or can’t tolerate prior treatments, and patients with Philadelphia-chromosome positive acute lymphoblastic leukemia. Ariad claims to be negotiating updates to the prescribing information for ponatinib and implementing a “risk mitigation strategy.”
Investors aren’t waiting around to see how it turns out. Ariad’s shares plunged more than 35 percent on the news. It’ll hold a conference call this morning to discuss the move.
The decision continues a quick and precipitous fall from grace for Ariad, which was flying high in December when the FDA approved ponatinib ahead of schedule. Ariad also began building a massive new headquarters in Cambridge. But even as the agency gave Ariad the green light, it did so with a black-box warning instructing doctors to watch out for blood clots and liver toxicities. That proved to be an omen of things to come: Ariad pitted ponatinib head to head with imatinib (Gleevec), Novartis’s blockbuster pill, in a clinical trial hoping to prove that its drug could become a frontline treatment for CML patients, but had to halt the study—and later scrap it altogether—earlier this month due to safety concerns. Namely, patients dosed with its drug in the study were experiencing serious blood clots and other toxicities at a higher than expected rate.
Investors fled the stock, sending shares down more than 60 percent. Ariad has lost more than 80 percent of its market value since it halted the ponatinib trial. Shares, which traded at $17.14 before news first broke, changed hands at $2.49 apiece in pre-market trading Thursday.