Selecta Biosciences Says FDA Puts Clinical Hold on SEL-302 Trial, Shares Lower

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by Stephen Nacrosis

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Shares of biotechnology company Selecta Biosciences Inc. were trading lower in late Wednesday’s session after the company said the US Food and Drug Administration has completed its phase 1/2 clinical trial of SEL-302 to treat patients with methylmalonic acidemia. A clinical hold has been put on the test.

The company said that the SEL-302 includes MMA-101 plus ImmTOR.

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Selecta Biosciences also said on November 23 that it had received a letter from the FDA “issuing a clinical ‘hold to obtain additional information on the chemistry, formulation, and control’ relating to the MMA-101 product candidate.”

“Patient safety is our primary concern, and we are committed to addressing FDA’s questions about CMC as quickly as possible,” said Carsten Brun, President and Chief Executive Officer.

At 5:35 p.m. ET, shares of Selecta Biosciences were trading down 13.2% at $2.76 per share. Volume topped 150,000 shares at the time.

Write to Stephen Necrosis at [email protected]

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