Arrowhead hits 52-week high as late-stage trial win marks derisking event

Arrowhead Pharmaceuticals (ARWR) reached a new 52-week high on Wednesday after the company announced a late-stage trial win for a lipid-lowering agent, which Cantor Fitzgerald identified as “a meaningful derisking event.”

Shares of the California-based biotech added more than 20% as plozasiran, its siRNA treatment, hit the main goals in two late-stage trials for severe hypertriglyceridemia, causing up to 81% of median triglyceride reductions over twelve months as an injectable.

Developed using the company’s TRiM platform, plozasiran is already available in the U.S. as Redemplo for familial chylomicronemia syndrome, the most severe form of sHTG.

“This is a meaningful derisking event, which will likely bring back many investors who did not want to take the binary risk, and ARWR could continue to grind higher from here," Cantor analyst Prakhar Agrawal wrote with an Overweight rating.

Agrawal compared data from the SHASTA-3 and SHASTA-4 trials with results for olezarsen, a rival sHTG drug from Ionis Pharmaceuticals (IONS) marketed as Tryngolza following its FDA approval in June.

“Efficacy is at least comparable to olezarsen, safety at a high-level looks clean, and plozasiran already has a meaningful differentiation on dosing frequency," the analyst added, according to Bloomberg News.

“REDEMPLO will compete well with TRYNGOLZA based on a similar price, greater TG-lowering efficacy, and less frequent quarterly dosing,” wrote Piper Sandler’s Edward Tenthoff. With an Overweight rating on ARWR, the analyst noted the company’s plans to submit a supplemental new drug application before the year-end seeking a “potential blockbuster label expansion” for plozasiran in sHTG.

However, Barclays analyst Eliana Merle highlighted Ionis’ (IONS) first-mover advantage and added that while SHASTA-3 and SHASTA-4 results appeared “competitive with IONS," called sHTG “a large market able to support multiple players.” Merle has an Overweight rating on ARWR.

Seeking Alpha analyst Larry Hall argued that the SHASTA-3 and SHASTA-4 trials, which demonstrated median triglyceride reductions of 79% and 81%, respectively, represented the commercial validation of plozasiran.

“Biotech investors should take a serious look" at Arrowhead (ARWR), he said, adding that the company "is now proving the intrinsic strengths and validity of its TRiM platform, based on innovative gene knockdown therapies.”