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Y-mAbs Flags Potential Delay In Pre-BLA Meeting, Sticks To Regulatory Filing Timeline

Y-mAbs Flags Potential Delay In Pre-BLA Meeting, Sticks To Regulatory Filing Timeline

Y-mAbs Therapeutics, Inc (NASDAQ: YMAB), a thinly traded small-cap oncology-focused biopharma company, said in a Friday SEC  filing that its omburtamab pre-BLA meeting with the FDA may now be delayed.

What Happened

Y-mAbs develops novel antibody therapeutics for oncology targets based on technology licensed from Memorial Sloan Kettering Cancer Center.

The company said in the SEC filing that it received an email notification from the FDA Thursday stating that, upon reviewing the omburtamab pre-BLA meeting submission, the regulatory body deemed that the pre-BLA meeting originally scheduled for November will now be converted into a general guidance meeting,

The New York-based company said the FDA did not indicate a reason for the change.

Why It's Important

Omburtamab is an antibody that is broadly reactive with human solid tumors. It is being evaluated for multiple indications, with CNS/leptomeningeal metastases from neuroblastoma in pediatric patients in the most advanced stage of development.

Y-mAbs said its rolling submission for omburtamab, which was originally planned to commence in December, may not take place in 2019. It could now be rescheduled to the first quarter of 2020, the company said. 

"We remain confident in the contents of our pre-BLA meeting submission and do not believe that this change in the timing of the pre-BLA meeting with the FDA will impact our previously disclosed and anticipated timing for our complete omburtamab BLA submission, which we still expect to complete by the end of the first quarter of 2020," Y-mAbs said. 

The company said it hopes to have flexibility to file the BLA, either via a rolling submission or a single submission.

The commercialization timeline is unaffected, according to Y-mAbs. 

On Oct 26, the company presented updated data for omburtamab at the International Society of Pediatric Oncology Annual Congress in Lyon, France that showed an improvement in median survival from 47.1 months at the prior readout to 50.8 months.

Price Action 

Y-mAbs shares were down 0.48% at $31 at the time of publication. 

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Posted-In: Biotech News FDA Trading Ideas Best of Benzinga


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