BELLUS Health Shares (NASDAQ: BLUE) have added 5.2% at $10.17 in afternoon trading and, if the gains hold, the stock is on track to post a second consecutive positive session.
The Canadian biotech presented on Tuesday its plans for the Phase 3 development of its cough treatment candidate BLU-5937 following an End of Phase 2 (EOP2) meeting with the US FDA.
BELLUS (BLU) said it will conduct two pivotal trials – the CALM-1 and CALM-2 studies – which will be designed to assess the efficacy, safety and tolerability of BLU-5937 in approximately 675 adult patients.
RBC Capital Markets reiterated its outperform rating on the stock on Tuesday while raising the price target from $5 to $19, nearly double BLU’s last closing price of $9.67.
“The takeaways from EOP2 further strengthen our confidence in the BLU-5937 program, and we are updating our model accordingly,” Renza said.
If approval of BLU-5937 is accepted, Renza estimates revenue as early as 2026 with peak sales potential of over $1.4 billion.
BLU also said on Tuesday that it plans to start the Phase 3 trial in the fourth quarter and expects data from the CALM-1 trial in the second half of 2024, a timeline that Renza said was in line with expectations.
The RBC Capital Markets outperformance rating compares to an average Wall Street rating of Strong Buy and a Quantitative Hold rating.