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BWXT Medical Submits Tc-99m Generator New Drug Application To FDA

BWX Technologies, Inc. (NYSE:BWXT) announced today that subsidiary BWXT Medical Ltd. has submitted a new drug application to the U.S. Food and Drug Administration (FDA) to request approval of its technetium-99m (Tc-99m)

Benzinga · 09/13/2022 16:06

BWX Technologies, Inc. (NYSE:BWXT) announced today that subsidiary BWXT Medical Ltd. has submitted a new drug application to the U.S. Food and Drug Administration (FDA) to request approval of its technetium-99m (Tc-99m) generator for diagnostic imaging.

Once approved for commercial production by regulatory bodies, BWXT Medical’s new proprietary manufacturing technology will be used to irradiate molybdenum targets at an Ontario Power Generation reactor, process Mo-99 (the parent isotope of Tc-99m) and subsequently incorporate material into Tc-99m generators at BWXT Medical’s Kanata, Ontario facility for delivery to radiopharmacies and hospitals across the United States and Canada.

Tc-99m is used in over 40 million diagnostic procedures annually, and is the daughter isotope of molybdenum-99 (Mo-99). Historically Mo-99 has been produced within research reactors using uranium as a starting material. Alternatively, the BWXT Tc-99m generator will be produced from natural molybdenum targets irradiated at a commercial power reactor, greatly reducing complex waste by-products. These targets are processed into the finished active pharmaceutical ingredient and then loaded into generators that have the function and form of generators already used at radiopharmacies and hospitals today.

“We are excited to reach this key milestone for BWXT Medical, putting us one step closer toward our aspiration of global leadership in nuclear medicine manufacturing,” said Rex D. Geveden, BWXT’s president and chief executive officer. “Our Tc-99m generator product is a lower cost, more reliable, drop-in replacement to current generators, and we see it as a key component of our medical portfolio.”

“BWXT’s multi-year, comprehensive R&D campaign is resulting in not only a foundational product line for the business, but also in the delivery of a crucial diagnostic drug product that supports the health of millions of people,” said Dr. Jonathan Cirtain, president and chief executive officer of BWXT Medical. “Beyond Tc-99m, I am excited to lead BWXT Medical through a compelling set of growth opportunities including early success indications driven by breakthroughs in therapeutic nuclear medicine.”

“Our multi-faceted growth strategy is focused on commercializing our Tc-99m generator, expanding our base business of cGMP-quality isotopes and finished drug products, and providing new therapeutic radioisotopes and sterile drug products to address significant growing demand for these innovative therapies,” said Dr. Cirtain.

BWXT has published a presentation on the Investor Relations section of its website about BWXT Medical. The presentation highlights the subsidiary’s Tc-99m generator strategy, its growing nuclear medicine product portfolio and exciting future opportunities in therapeutic radioisotopes. The presentation can be found here.