Kyverna accelerates into another FDA fast track following IPO plans

Kyverna has nabbed another FDA fast-track designation for its lead asset, adding further momentum to its IPO roadshow days after declaring plans to go public. 

The fast track tag, this time for refractory progressive multiple sclerosis, announced Friday, gives Kyverna more frequent and accessible communication with U.S. regulators as KYV-101 advances through the clinic. It also enables the company to apply for priority review, which accelerates the FDA approval review period down to six months if and when Kyverna submits a new drug application.

Kyverna’s autologous CD19-targeting cell therapy recently was given the green light to enter a phase 2 open-label trial for patients with multiple sclerosis and secured a fast-track tag for myasthenia gravis last month.

These regulatory speed boosts are arguably more meaningful for this new wave of cell therapies than for Kyverna specifically. The tide has slowly but meaningfully shifted in the past year from cell therapies’ promise resting solely in oncology. Now autologous and off-the-shelf candidates alike are testing the waters in autoimmune diseases like MS and lupus. In addition to KYV-101, Kyverna is working on an allogeneic equivalent, KYV-201. 

The biotech’s recent decision to IPO is meant to fund further development of KYV-101, which in addition to MS and myasthenia gravis is in development to treat lupus. KYV-101 is also being tested in a phase 1, open-label, basket trial for other autoimmune diseases, a study sponsored by the University of Pennsylvania and David Porter, M.D., director of cell therapy and transplant at Penn Medicine. 

Kyverna is among five biotechs, including CG Oncology and Alto Neuroscience, which have so far announced plans this year to go public—already exceeding the two that did so in January 2023.