On Wednesday, Arrowhead Pharmaceuticals Corp (NASDAQ:ARWR) shares received a reiterated Buy rating from a TD Cowen analyst following the release of comprehensive Phase 3 PALISADE trial data for their drug candidate.
The study, which focuses on patients with familial chylomicronemia syndrome (FCS), demonstrated an 83% reduction in the risk of acute pancreatitis. This significant finding was observed with only two events in two patients treated with the drug ploza, compared to seven events in five patients on placebo.
The analyst highlighted the drug's ApoC3 and triglyceride-lowering efficacy, which aligns with the top-line data released in June. The complete dataset is considered to be solidly competitive with IONS's olezarsen, despite slight differences in patient populations and study designs. The robustness of the data suggests that ploza could become a key standard of care for FCS treatment.
Further bolstering the positive outlook for Arrowhead Pharma, the analyst anticipates that a New Drug Application (NDA) will be submitted by the end of 2024. With a potential product launch the following year, expectations are set for ploza to make a significant impact on the market for FCS therapies.
The trial's results and the subsequent analyst endorsement come at a crucial time for Arrowhead as they prepare for regulatory steps and commercial strategy. The company's progress and the analyst's reaffirmed confidence in the stock underscore the potential for ploza to benefit patients with FCS, a rare and potentially life-threatening disorder.
In other recent news, Arrowhead Pharmaceuticals has seen significant strides in its clinical trials. The company's Phase 3 trial for plozasiran, a treatment for familial chylomicronemia syndrome (FCS), achieved its primary and all secondary endpoints, a development that is expected to bolster the upcoming New Drug Application (NDA) filing with the FDA. Arrowhead also plans to submit the NDA for plozasiran by the end of this year, with potential approval anticipated in 2025.
The company reported a net loss of $170.8 million for its fiscal 2024 third-quarter performance, with cash and investments totaling $436.7 million. To support its pipeline development, Arrowhead secured a $400 million loan from Sixth Street.
In terms of analyst ratings, H.C. Wainwright maintained a Buy rating on Arrowhead shares, while Citi and Piper Sandler reiterated their Neutral and Overweight ratings respectively.
In other developments, Arrowhead is advancing two RNA interference candidates, ARO-INHBE and ARO-ALK7, into the final stages of preclinical development for obesity and metabolic disease treatment, with plans to file clinical trial applications by the end of 2024. These are the latest developments in Arrowhead's ongoing efforts to advance its portfolio and improve patient outcomes.
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