Sellas Life Sciences Group Inc SLS shares are on solid footing Friday following the announcement of Fast Track designation for its multiple myeloma candidate.
At the time of writing, the shares were rallying 10.67 percent to $1.66 on about 28 times their average volume.
What Happened
Sellas said the FDA has granted Fast Track designation to its lead product candidate galinpepimut-S, or GPS, a cancer vaccine that's being evaluated for multiple myeloma.
The candidate targets the Wilms Tumor 1 protein present in an array of tumor types.
Why It's Important
The Fast Track program is meant to incentivize the development of drugs for treating serious conditions that have the potential to address unmet medical needs.
Greater access to the FDA is among the advantages of the designation, which is granted with the intention of expediting the development, review and potential approval of a candidate.
It allows submission of the BLA on a rolling basis, with the FDA considering sections of the BLA before the complete application is submitted.
What's Next
In March, Sellas presented Phase 2 clinical and immunological data for GPS in treating high-risk multiple myeloma, which showed improved median progression-free survival of 23.6 months relative to immunomodulatory drug or proteasome inhibitor post-ASCT maintenance.
GPS also has Orphan Drug status for multiple myeloma as well as two other indications: acute myeloid leukemia and malignant plural mesothelioma.
The company has planned Phase 3 trials of GPS in both AML and MPM.
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