Arrowhead Positioned for Success with FDA Approval of Ionis Pharmaceuticals' Tryngolza, Says H.C. Wainwright

Ionis Pharmaceuticals' FDA approval of Tryngolza has positive read-through for Arrowhead's plozasiran, an RNA interference therapeutic. H.C. Wainwright analyst Patrick Trucchio expects plozasiran to be approved by mid-2025 with a broad label. He believes it has "best-in-class" characteristics and is well-positioned to become standard-of-care in familial chylomicronemia syndrome. The firm reiterates a Buy rating on Arrowhead's shares with an $80 price target.

The recent Food and Drug Administration (FDA) approval of Ionis Pharmaceuticals' Tryngolza (olezarsen) for the treatment of familial chylomicronemia syndrome (FCS) has generated excitement in the biotech industry. This approval marks a significant milestone for Ionis, as it will be the first medicine the company will commercialize independently, having previously licensed the rights of its drugs to development partners [1].

Tryngolza's approval, based on late-stage clinical trial results, demonstrates its efficacy in reducing triglyceride levels and minimizing the risk of pancreatitis, a potentially life-threatening complication in FCS patients [1]. The FDA's decision opens the door for Ionis to launch the drug and capitalize on its potential market.

Moreover, Tryngolza's success has positive implications for other RNA interference therapeutics in development, such as Arrowhead Pharmaceuticals' Plozasiran. H.C. Wainwright analyst Patrick Trucchio anticipates that Plozasiran, an RNA interference therapeutic for familial chylomicronemia syndrome, will secure FDA approval by mid-2025 with a broad label [2]. Trucchio believes that Plozasiran boasts "best-in-class" characteristics and is poised to become the standard-of-care treatment for FCS, further solidifying the potential market for RNA interference therapies.

The approval of Tryngolza not only highlights the potential of RNA interference therapies but also underscores the importance of continued innovation and investment in the development of treatments for rare genetic disorders.

References:
[1] STAT News. (2024, December 19). Ionis Pharmaceuticals' FDA approval of Tryngolza has positive read-through for Arrowhead's Plozasiran. https://www.statnews.com/2024/12/19/ionis-fda-approval-tryngolza-familial-chylomicronemia-syndrome-triglycerides/
[2] Fierce Pharma. (2024, December 19). FDA nod for Tryngolza: Ionis enters new era, commercial stage company. https://www.fiercepharma.com/pharma/fda-nod-tryngolza-ionis-enters-new-era-commercial-stage-company