Three pharma stocks that stand to benefit from the announcement by Eli Lilly & Co. (LLY) - Get Eli Lilly and Company Report and Incyte (INCY) - Get Incyte Corporation Report that the FDA rejected their rheumatoid arthritis pill baricitinib were up Monday.
Gilead Sciences (GILD) - Get Gilead Sciences, Inc. Report shares rose 56 cents in early trading Monday to $67.06 while Pfizer (PFE) - Get Pfizer Inc. Report was up 9 cents to $33.97 and Abbvie (ABBV) - Get AbbVie, Inc. Report up 38 cents to $64.51.
In a statement Friday, Lilly said the FDA has requested additional clinical data to determine appropriate doses of baricitinib. The FDA also asked for more safety data.
Baricitinib was expected to secure U.S. approval and deliver $2 billion or more in peak sales as the most effective, once-daily oral JAK inhibitor for rheumatoid arthritis, supplanting Pfizer's Xeljanz. Lilly was counting on the greater efficacy of a higher baricitinib dose to separate from Xeljanz. If Lilly can only move forward with a lower, 2 mg dose of baricitinib, it risks losing an efficacy advantage over its oral JAK inhibitor competitor.
The FDA action was a win for Pfizer because Xeljanz escapes competition for one year maybe even longer.
Gilead wins because its oral JAK inhibitor filgotinib -- currently in a phase III study for rheumatoid arthritis, among other indications -- has a good chance to catch up.
As marketers of TNF inhibitor injections for rheumatoid arthritis, Abbvie, Amgen (AMGN) - Get Amgen Inc. Report and Johnson & Johnson (JNJ) - Get Johnson & Johnson Report all win from the delay of another oral competitor.
win because they'll now have more time to establish a marketing presence for their IL-6 inhibitor sarilumab, assuming the injected drug can overcome a manufacturing delay and win FDA approval later this year.
Adam Feuerstein writes regularly for TheStreet. In keeping with company editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet. He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback; click here to send him an email.