BioAtla stock is trading higher today: Here’s why

BioAtla (NASDAQ: BCAB) shares are trading higher after the company announced it was granted Fast Track Designation from the FDA to ozuriftamab vedotin.

Ozuriftamab vedotin is the company’s conditionally and reversibly active ROR2 antibody drug conjugate directed for the treatment of patients with recurrent or metastatic SCCHN with disease progression on or after platinum-based chemotherapy and anti-PD-1/L1 antibody therapy.

“The FDA’s decision is an important recognition of the potential of our CAB-ROR2-ADC, ozuriftamab vedotin. There remains a significant unmet need in refractory head and neck cancer where previous treatments have failed and current outcomes are suboptimal with low response rates,” said Jay M. Short, Ph.D., Chairman, Chief Executive Officer and co-founder of BioAtla.

The company is on track to meet with the FDA for guidance on a potentially registrational trial in 2H 2024

“To date, ozuriftamab vedotin has shown promising clinical activity in treatment-refractory SCCHN patients who had a median of 3 prior lines of therapy. In addition, ozuriftamab vedotin continues to have a manageable safety profile with no new safety signals. We look forward to discussing with the FDA plans for a potential registrational trial in the second half of this year.”

What is Fast Track Designation: Fast Track Designation applies to a drug that is intended to treat a serious or life-threatening disease or condition and where the drug has demonstrated the potential to address unmet medical need. It could lead to actions to expedite development and review of the drug, including opportunities for frequent interactions with the FDA review team and potential priority review if supported by the clinical data at the time of a BLA submission.

BioAtla shares are trading 11.5% higher to $1.94 at the time of writing. The stock has a 52-week high of $4.02 and a 52-week low of $1.14.