Midatech Pharma climbs on FDA’s Fast Track Designation for brain tumor candidate

Jun. 01, 2022 8:12 AM ETMidatech Pharma plc (MTP)By: Dulan Lokuwithana, SA News Editor

Headquarters of US Food and Drug Administration (FDA)

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  • The ADRs of U.K.-based biotech Midatech Pharma (NASDAQ:MTP) added ~50% in the pre-market Wednesday after the company announced that the FDA issued the Fast Track designation for its development program of MTX110 in recurrent glioblastoma ("rGBM").
  • A rapidly growing and aggressive brain tumor, rGBM is characterized by short survival rates and frequent recurrence.
  • MTX110, a water-soluble formulation of Panobinostat, would soon undergo a company-sponsored Phase I study targeting rGBM, Chief Scientific Officer of Midatech (MTP) Dmitry Zamoryakhin said.
  • The FDA offers the Fast Track designation to accelerate the development and review of drugs targeted at serious conditions where there is an unmet medical need.
  • It facilitates developers to conduct frequent communications with the regulator on plans for clinical studies.
  • Read: Midatech (MTP) appointed Zamoryakhin as its CSO in July 2021.