Lilly investors hungry for news on Alzheimer's drug get a clearer picture of Q4 FDA filing

If Eli Lilly has anything going on beyond the Alzheimer’s disease therapy donanemab, analysts weren’t interested in them during the company’s second quarter earnings call.

The company reaffirmed its plan to submit the drug to the FDA by the end of the year and said that enrollment has completed for the Trailblazer-ALZ clinical trial. Results from that phase 3 study will be used to form the package that Lilly will send off to the FDA.

SVP and Chief Scientific and Medical Officer Daniel Skovronsky, M.D., Ph.D., said that the final patient will be dosed by the end of the third quarter after screenings and imaging, putting the completion date to about 18 months later.

Daniel Skovronsky (Eli Lilly)

Analysts peppered the Indianapolis pharmaceutical company with questions about the Alzheimer's treatment. Executives refused to divulge any information on a possible pricing strategy, despite numerous queries. 

Lilly’s shares bounced up 3% to $255 Tuesday, which Cantor Fitzgerald attributed to investors’ confidence that the company can get donanemab across the regulatory finish line. Lilly’s second quarter earnings results were otherwise mixed, or “ho-hum," according to Bernstein analysts.

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The Alzheimer’s pipeline was set ablaze in June after the FDA gave a controversial green light to Biogen’s therapy, developed with Eisai. The FDA granted the drug accelerated approval, which inherently means that the therapy hasn't been shown in clinical testing to improve clinical outcomes but can improve a biomarker linked to disease progression. In Aduhelm's case, approval was based on data on a biomarker called amyloid beta, but those results as well as the developmental and regulatory process has come under fire.

“Donanemab could become the leading disease-modifying treatment for Alzheimer’s disease given its best-in-class efficacy, and we believe Lilly has the competitive advantage on pricing because it is coming to market behind Biogen’s Aduhelm,” Cantor Fitzgerald’s analysts wrote in a note.

Lilly revealed two new analyses last week, one that showed that patients who received donanemab had a greater change in amyloid plaque levels and another on the drug’s rapid reduction of another key biomarker. The company is confident that enough safety data will be available to support the donanemab filing.

RELATED: 'Let the games begin': Reinvigorated Alzheimer's pipeline breaches the levee with planned Lilly filing, Bristol Myers opt-in

Bernstein said Lilly is setting up for "a very robust/scientific-focused launch," which could separate donanemab from "the more ‘questionable’ Aduhelm."