What happened
Shares of AC Immune (ACIU 2.62%) were up more than 54% for the week as of 2:30 p.m. on Friday, after being up by as much as 60.5%, according to data provided by S&P Global Market Intelligence. The clinical-stage biotech company's stock closed last week at $1.90, then reached a 52-week high of $3.82 on Tuesday. The stock is up more than 42% so far this year.
So what
AC Immune focuses on treatments of neurodegenerative diseases that are caused by protein misfolding, including Alzheimer's, Parkinson's, and certain "orphan" neurological diseases. The impetus for the stock's rise this week was the company's announcement on Tuesday that it had received a Fast Track Designation from the Food and Drug Administration (FDA) for ACI-24.060, its active immunotherapy to treat Alzheimer's disease, including individuals with Down syndrome. The company has 16 programs in its pipeline, but ACI-24.060, an anti-amyloid beta vaccine, is set apart now because it has Fast Track Designation and an Investigational New Drug (IND) clearance, both of which help expedite a treatment's progression over certain regulatory hurdles. It earned its Fast Track designation based on the results from an early cohort of its phase 1b/2 trial. AC Immune said it expects an interim readout from that trial in the first half of 2024.
Now what
Most clinical-stage biotech stocks present a high level of risk for investors. While AC Immune doesn't have any products approved for sale yet, it does have one therapy in phase 3 trials. It's collaborating with Life Molecular Imaging on a pivotal phase 3 trial of PI-2620 as a Tau PET (positron emission tomography) imaging agent for Alzheimer's disease. As of the first quarter, AC Immune said it had 122.6 million Swiss Francs (roughly $137 million) in cash on its books -- enough, it said, to fund operations into the third quarter of 2024.
