Arcturus cut to Neutral at Citi on COVID vaccine ARCT-154 'too risky' path ahead
400tmax/iStock via Getty Images

Arcturus Therapeutics (NASDAQ:ARCT) was downgraded to Neutral at Citi with a price target of $29, down from $86, as the firm noted that the path forward for the company's mRNA vaccine ARCT-154 was 'too risky.'
On April 20, the company reported data from an ongoing phase 1/2/3 trial of ARCT-154 showing 95% overall efficacy in preventing severe COVID-19.
However, the two-dose regimen of ARCT-154 at 5-mcg doses showed only 55% efficacy for preventing symptomatic COVID-19, as per the efficacy portion of the trial, which involved over 16K people in Vietnam.
Citi analyst Yigal Nochomovitz said they believe the headline 55% efficacy will not inspire FDA to act with urgency to approve ARCT-154 given â market availability of three very effective vaccines, Moderna (MRNA), Pfizer (PFE)/BioNTech (BNTX) and Johnson & Johnson (J&J), for primary vaccination and as a single-dose booster including as 'mix-and-match'; a phase 3 primary vaccine study for ARCT-154 conducted only ex-US.
The analyst added that an emergency use authorization (EUA) application for ARCT-154 remains under review in Vietnam. However, with >80% of Vietnam vaccinated, demand for a primary vaccination with ARCT-154 will likely be minimal.
The analyst added that they believe that it will be very challenging to make the argument for an ARCT-154 booster regimen to the FDA given reliance on foreign phase 3 data testing ARCT-154 as a primary vaccine, even with Arcturusâ proposed ~2.4K-patient pivotal booster study complementing the filing.
In addition, even if the FDA was amenable to Arcturus' proposed pivotal booster strategy, the firm struggles to see a meaningful commercial opportunity for ARCT-154 in the U.S./EU given a saturated market with multiple options for primary and booster doses, Nochomovitz added.
ARCT -4.05% to $23.48 pre-market April 21