Biogen and Eisai said the FDA had accepted and given priority review to their application for aducanumab. The drug will undergo an advisory committee meeting at an undisclosed date. Biogen's stock rose 10%, but analysts had mixed opinions.
The FDA has 60 days to decide whether or not to accept the application. An analyst wrote that the agency accepting it with a priority or standard review may signal whether the agency is seriously considering approval or has continued reservations about the amyloid beta-targeting drug's clinical benefit.
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
Shares of the biotech company were up following the presentation on the drug, aducanumab, but investment bank analysts continued to raise questions about its future, particularly its prospects of FDA approval.
The company said a subsequent analysis of the Phase III studies of aducanumab, which it had stopped for futility in march, showed that one of them had been successful. A filing with the FDA is planned for early 2020.
Tetra Discovery Partners announced the initiation of a Phase II study of BPN14770, which targets phosphodiesterase-4D, or PDE4D. The trial is expected to enroll about 255 patients at 60 sites in the US.
Biogen halting its Phase III trial of aducanumab last month had many proclaiming the amyloid beta hypothesis' demise. But many doctors soldier on, while others see potential alternative uses for Abeta-targeting drugs.
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
After Thursday's halt to aducanumab's development dealt a significant blow to the amyloid beta hypothesis in Alzheimer's, analysts had expected BAN 2401 - developed under a partnership with Biogen - to be shelved as well.
The news sent Biogen's shares down more than 26 percent pre-market, but analysts also wrote that it deals a significant blow to amyloid beta as a target in Alzheimer's disease.
Eli Lilly announced Wednesday that its late-stage trial of solanezumab did not slow progression of Alzheimer's disease in patients with mild symptoms, triggering a number of biotech shares to fall.