What happened?At 11:05 AM EDT Thursday, shares of Eli Lilly (NYSE.LLY) rose 7.8%. After the drugmaker revealed that donanemab, an experimental drug for Alzheimer's disease, had been granted Breakthrough Therapy status by the U.S. Food and Drug Administration (FDA), the big gain was realized. Lilly said it also plans to file for FDA expedited approval of the drug in the latter part of this year.What are you waiting for?Breakthrough Therapy allows for expedited review of drugs targeted at serious conditions. This designation is granted when there is preliminary clinical evidence that the drug may show substantial improvement over existing therapy on a clinically important endpoint.In April, Dan Skovronsky, chief scientist at Lilly, stated that the company would not seek an accelerated approval based upon phase 2 results for donanemab. The big drugmaker is now moving ahead. What has changed? What changed?Lilly presented promising results from a phase 2 trial of donanemab in March. Comparing to placebo, the drug showed significant cognitive decline slowing down on a common scale. Many expected Lilly would push for an expedited approval path for its Alzheimer's candidate after Biogen won FDA approval for Aduhelm.What now?Today's Lilly news is good news for investors. Another positive sign could be on the horizon for big pharma stock. Olumiant is expected to be approved by the FDA in the first quarter of 2013.
