Chiesi Group has significantly expanded its rare disease portfolio through strategic agreements, culminating in a substantial $1.9 billion deal to acquire KalVista Pharmaceuticals, a biotechnology company whose recently launched medication is seeing robust market adoption following its FDA approval last summer.<\/p>\n
Under the terms disclosed on Wednesday, Chiesi will pay $27 in cash for each share of KalVista, representing a premium of 40.3% over the company\u2019s closing share price from the preceding day. The transaction is expected to be finalized in the third quarter of this year.<\/p>\n
KalVista, headquartered in Cambridge, Massachusetts, is known for its primary asset, Ekterly, an acute treatment for hereditary angioedema (HAE), a rare genetic disorder characterized by sudden, painful swelling episodes in various body parts. These episodes can threaten a patient\u2019s life if they obstruct breathing.<\/p>\n
Ekterly is a small molecule designed to inhibit kallikrein, a protein involved in HAE swelling crises. Currently, acute episodes are treated with injections of a medication from Pharming Group and two from Takeda Pharmaceutical; however, Ekterly has distinguished itself as the first oral on-demand treatment for patients aged 12 and older.<\/p>\n
Following its FDA approval in July, KalVista launched Ekterly and projected a 2025 revenue of $49.1 million. According to a March research note by Joseph Schwartz, an analyst at Leerink Partners, Ekterly’s market entry has been robust, capturing nearly 20% of the market share within just a few quarters. Since the U.S. approval, the treatment has also received market authorization in the European Union, the United Kingdom, Switzerland, Australia, Singapore, and Japan. KalVista is now targeting younger patients, planning to submit to the FDA this year to extend Ekterly’s label to children aged 2 to 11 years.<\/p>\n
Based in Parma, Italy, Chiesi is a family-owned private company operating across three business units: respiratory care, rare diseases, and specialty care. For the fiscal year 2025, Chiesi reported revenues of \u20ac3.6 billion (approximately $4.2 billion), marking an 8.2% increase compared to the prior year.<\/p>\n
The rare disease division of Chiesi, known as Chiesi Global Rare Diseases and based in Boston, accounted for \u20ac906 million of the company\u2019s revenue for the fiscal year 2025\u2014an increase of 22% year-over-year. This unit’s portfolio includes Filsuvez, a treatment for rare skin diseases acquired through the $1.25 billion purchase of Amryt Pharma, and Elfabrio, an enzyme replacement therapy developed in collaboration with Protalix Biotherapeutics. Last year, the division also announced a partnership with Arbor Biotechnologies for its first in vivo gene-editing clinical therapy, marking Chiesi’s entry into genetic medicine.<\/p>\n
In the announcement regarding KalVista’s acquisition, Chiesi noted that Ekterly would play a key role in realizing its goal of achieving \u20ac6 billion (approximately $7 billion) in sales by 2030. Giacomo Chiesi, Executive Vice President of Chiesi Global Rare Diseases, characterized the acquisition of KalVista as a strategic addition to the company\u2019s rare disease portfolio.<\/p>\n
“In the realm of HAE, patients continue to face significant unmet needs, and KalVista’s innovation greatly enhances our presence in the rare immunology space by adding a differentiated on-demand treatment option that can significantly improve disease management,” he stated in a prepared release.<\/p>\n
The market for HAE medications encompasses both prophylactic treatments and on-demand therapies, with both segments witnessing noteworthy developments over the past year. Less than two months after Ekterly’s approval, the FDA also green-lighted Dawnzera from Ionis Pharmaceuticals, an antisense oligonucleotide designed to prevent HAE attacks in patients aged 12 and older.<\/p>\n
BioCryst Pharmaceuticals\u2019 flagship product, Orladeyo, remains the only pill approved for HAE prophylaxis. In October, BioCryst expanded its footprint in HAE by acquiring Astria Therapeutics for $700 million, a company whose leading drug candidate could potentially offer prophylaxis with merely two injections annually. This week, Intellia Therapeutics also shared phase 3 data supporting its plan to seek FDA approval for lonvo-z, an in vivo gene-editing therapy that aims to permanently inactivate a gene responsible for HAE swelling attacks. This therapy offers the promise of being a one-time treatment for this disorder.<\/p>\n
Ekterly will also face direct competition, as Pharvaris’s deucrictibant inhibits a different target in HAE known as the bradykinin B2 receptor. Late last year, Pharvaris reported achieving the primary endpoint in a phase 3 study testing the capsule as an on-demand treatment for HAE patients aged 12 and older and intends to file for a new drug application in the first half of 2026. A long-acting formulation of this medication is also under advanced testing for HAE prophylaxis, with data expected in the third quarter of this year.<\/p>\n
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