What Is Happening With Pulse Biosciences Stock Today?

Pulse Biosciences Inc PLSE shares are tumbling after announcing an update to its recent FDA 510(k) submission to add sebaceous hyperplasia to expand the CellFX System's current labeling.

• The Company received an Additional Information (AI) letter, stating that the Company did not provide sufficient clinical evidence for the expanded use of the system.
• The letter also notes that the Company had not met the primary endpoints of the sebaceous hyperplasia FDA-approved IDE study. 
• The Company anticipates meeting with the FDA to discuss the contents of the AI letter and potential next steps, which may require additional clinical data and potentially a new 510(k) submission. 
• Based on FDA guidance, the Company believes its meeting with the FDA will be in Q1 2022.
• In Europe, the CellFX System is approved for sebaceous hyperplasia, seborrheic keratosis, and non-genital warts. 
• In the U.S., the CellFX System is cleared for dermatologic procedures requiring ablation and resurfacing of the skin and treating benign lesions.
• Price Action: PLSE shares are down 33.3% at $7.24 during the market session on the last check Tuesday.