Novartis Hits 52-Week High on FDA Approval for New Hives Drug
The regulator's green light for Rhapsido, a first-in-class oral treatment for chronic hives, positions the company to challenge injectable rivals.
Shares of Novartis (NVS) surged 2.6% to a new 52-week high of $131.21 after the company received U.S. Food and Drug Administration (FDA) approval for its new oral treatment, Rhapsido (remibrutinib). The drug is a first-in-class therapy for chronic spontaneous urticaria (CSU), a debilitating skin condition commonly known as chronic hives.
The approval marks a significant milestone for both Novartis and patients, offering a convenient, twice-daily pill in a market dominated by injectable treatments. , noting Rhapsido is the first oral Bruton's tyrosine kinase (BTK) inhibitor approved for CSU in adults who have not responded to antihistamines.
CSU affects an estimated 1.7 million people in the United States, causing persistent and unpredictable itchy hives and swelling. For decades, the primary treatment options beyond antihistamines have been injectable biologics, such as Novartis's own Xolair. Rhapsido's oral formulation eliminates the need for injections and frequent lab monitoring, for a more accessible and less burdensome therapy.
The FDA's decision was , which demonstrated that Rhapsido provided rapid and sustained relief from the condition's most disruptive symptoms. Clinical data showed significant improvements in itch and hive activity as early as two weeks after starting treatment.
Wall Street has reacted positively to the news, with analysts forecasting a strong commercial launch. The convenience of an oral pill could capture a significant portion of the CSU market, which is projected to reach nearly $5.5 billion by 2032. Some , defined as generating over $1 billion in annual sales, based on the CSU indication alone.
Novartis is also exploring remibrutinib's potential in treating several other immune-mediated conditions, including hidradenitis suppurativa and food allergies, which could further expand its market potential. The approval strengthens Novartis's immunology portfolio and positions it for continued growth as it prepares to make Rhapsido available to U.S. patients in the coming weeks.