Eli Lilly & Co (NYSE: LLY) ended slightly down on Friday after the U.S. FDA rejected its request of accelerated approval for Donanemab – its Alzheimer’s drug.
Why did the FDA reject its application?
According to the Food and Drug Administration, the pharmaceutical behemoth lacked sufficient data to justify fast-track approval. In particular, the regulator wants Lilly to treat at least 100 people with Donanemab for twelve months or more.
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Phase II data that the Indiana-based Eli Lilly submitted fell six short of that threshold. In the press release, Anne White – the Executive Vice President of the company said:
We look forward to our upcoming confirmatory Phase 3 results and subsequent FDA submission. We’re committed to working with the FDA to ensure the fastest possible path to bring this potential medicine to patients in need.
Lilly stock is currently up more than 15% versus late September.
Should you still buy the Lilly stock?
Despite the setback, Bank of America analyst Geoff Meacham remains bullish on the pharma stock for its Mounjaro drug.
Mounjaro is Lilly’s type-2 diabetes drug that is likely to win approval to also treat obesity in the back half of 2023 (read more).
It’s definitely not a thesis-breaker. People use weakness to buy the stock, and it’s really because the narrative on obesity and on the Mounjaro launch is just so strong.
Eli Lilly & Co did not lower its full-year financial guidance after the FDA’s rejection either. Meacham currently has a price objective of $390 a share on the Lilly stock, which represents about a 13% upside from here.
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