(Correction: This article has been corrected to reflect that the approval of Iclusig was in Dec. 2012.)
Last December, the FDA approved sale of Iclusig to treat two certain types of Lukemia (Chronic myeloid leukemia (CML) and Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL)), three months ahead of schedule. FDA was supposed to complete the review of the application by the product's prescription user fee goal date of March 27, 2013, however was able to complete the review much earlier than anticipated (FDA reviewed the Iclusig drug application under the agency's priority review program).
Earlier this year, FDA had asked Ariad Pharmaceuticals (ARIA) to temporarily suspend marketing and sales of Iclusig, because of reports that the drug may present risk of life-threatening blood clots and severe narrowing of blood vessels, while the issue was investigated.
Following FDA's announcement, shares of Ariad Pharmaceuticals, tanked losing more than 80% of the market value over a four-week period, triggering slew of shareholder lawsuits.
However share prices appear to be making a comeback, after positive news from EMA (European Medicines Agency) and FDA. In November, European regulators announced that they will allow Iclusig to stay on the market at this time. The news was a boon for investors, who, after recent announcements from FDA, were left wondering if their investment was dead in the water.
Things continue to look up for the company, as patient advocacy groups took up the cause of ensuring the drug is available for sale to those patients that are benefiting from it. Under pressure from doctors and patients advocacy groups, FDA instituted a special program, under which FDA allowed patients who had benefited from the drug to continue to purchase it. The successful lobbying effort may underscore a growing movement of patients who may play a role in bringing the drug back to the market.
On the other front, Joel Sendek, at Stifel Nicolas, upgraded the stock to buy from hold, with a price target of $7.00, representing about 40% worth of upside to yesterday's close, due in part to the recent developments.
Conclusion: It is yet to be seen whether recent developments are any indication of returning Iclusig, Ariad Pharmaceuticals star drug, back to the market, however given the current news from FDA and EMA, it is likely that investors may be able to recover some if not all of their investment in the stock.