Kyverna and ElevateBio sign commercial supply deal for miv-cel
The new agreement replaces a prior development pact and covers manufacturing for Kyverna's CAR T-cell therapy as it nears a possible U.S. approval in stiff person syndrome.
Kyverna Therapeutics and ElevateBio announced on July 27, 2026 that they had entered into a manufacturing agreement covering both U.S. commercial and global clinical supply of miv-cel, mivocabtagene autoleucel, Kyverna's autologous CD19-directed CAR T-cell therapy.1
According to the companies, the arrangement is meant to give Kyverna flexible, scalable supply capacity as it prepares for potential launches in stiff person syndrome (SPS) and generalized myasthenia gravis (gMG), as well as other ongoing clinical studies.1
The underlying corporate filing shows this deal formally supersedes an earlier arrangement. Kyverna disclosed that it had entered a Development and Manufacturing Services Agreement with ElevateBio Basecamp on July 22, 2023, under which ElevateBio provided cell manufacturing, release and testing services for miv-cel.1 That agreement has now been replaced: on July 23, 2026, the companies signed a Clinical and Commercial Supply Agreement that replaces the prior agreement entirely, under which ElevateBio will handle development and manufacturing for both clinical and commercial supply of the product, with details to be set out in future statements of work.1
Under the new contract, Kyverna committed to order minimum quantities of the product in certain years and/or after regulatory approval, including from the FDA.1 Pricing terms will adjust annually based on inflation, capped by a formula tied to the Producer Price Index for Pharmaceutical Preparation Manufacturing.1 The agreement runs for an initial five-year term, renewing automatically in one-year increments unless terminated under specified conditions.1
Kyverna said it remains on schedule with regulatory plans, noting it expects to complete its rolling BLA submission for miv-cel in SPS during the fourth quarter of 2026.1 The company said that, if cleared, miv-cel could become the first CAR T-cell therapy approved by the FDA for an autoimmune disease and the first approved treatment for people with SPS.1 The full agreement text is expected to be filed with Kyverna's 10-Q for the quarter ending September 30, 2026.
Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.