Approvals
Lisraya carries a boxed warning typical of JAK inhibitors, but otherwise has a broad label that allows use in all adults with the rare autoimmune disease, setting up the drug for blockbuster status in a few years, according to Leerink.
A future expansion of Rasonque into first-line pancreatic ductal adenocarcinoma could set Revolution Medicines up to hit $2.3 billion in sales by 2028, according to Truist Securities.
The FDA granted the approval of Revolution Medicines’ daraxonrasib, now to be known as Rasonque, in pancreatic adenocarcinoma 6.5 months ahead of deadline.
Gastroesophageal adenocarcinoma presents the biggest market opportunity for Jazz Pharmaceuticals’ Ziihera, according to Truist Securities, which forecasts peak sales of the drug to reach $2.5 billion.
Regeneron’s Pasatru is the second fibrodysplasia ossificans progressiva drug approved in the U.S., following the 2023 approval of Ipsen’s Sohonos.
The accelerated greenlight for Ultragenyx’s gene therapy for glycogen storage disease has raised analyst expectations for approval of UX111, which the FDA rejected last summer and is currently reviewing for a second time. A decision is expected by mid-September.
The FDA approves Zenbexus just as copycat competitors depress sales of Bristol Myers Squibb’s multiple myeloma drugs Pomalyst and Revlimid, which crashed 71% and 49% year-on-year, respectively, in the second quarter.
Analysts expect Replimune’s newly approved Tudriqev to reach $1.3 billion in peak sales in 2035.
Replimune’s immunotherapy for advanced melanoma faced a perilous regulatory road with two previous rejections, but the drug—to be marketed as Tudriqev—prevailed with strong support from oncologists and a 10-3 advisory committee vote in its favor.
Orzeyful is the first orexin agonist cleared by the FDA, and is the first narcolepsy therapy that addresses the full host of disease symptoms. It is “likely to reshape the treatment paradigm” for the condition, Jefferies told investors.
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