Why Did ACAD Stock Slump 8% After Hours Today?

Acadia Pharmaceuticals said that the Committee for Medicinal Products for Human Use informed it of a negative trend around its application after an oral explanation recently.

• CEO Catherine Owen Adams said that the negative trend vote is “disappointing” and “not what we hoped for.”
• The committee will formally adopt its opinion in February and the company will request a re-examination, Acadia said. 
• Trofinetide is approved by the U.S. Food and Drug Administration to treat Rett syndrome.

Shares of Acadia Pharmaceuticals Inc. (ACAD) fell over 8% after-hours on Monday after the company said that it was informed of a negative trend vote from a European Medicines Agency committee regarding its application for Trofinetide for the treatment of Rett syndrome.

The company said that the Committee for Medicinal Products for Human Use informed it of a negative trend around its application after an oral explanation recently.

The committee will formally adopt its opinion in February and the company will request a re-examination, the company said.

CEO Weighs In

CEO Catherine Owen Adams said that the negative trend vote is “disappointing” and “not what we hoped for.”

“...we believe the strong data that supported the approval of trofinetide for the treatment of Rett syndrome in the United States, Canada, and Israel speak to the meaningful benefits that trofinetide can deliver,” she said.

Timeline And Steps Ahead

As per legislation in the EU, the company can request a re-examination of CHMP’s opinion within 15 days of receiving its formal opinion. The company will then have 60 days to submit reasons for the re-examination request which will then be reviewed by the committee.

Trofinetide is approved by the U.S. Food and Drug Administration to treat Rett syndrome in adults and children.  

Rett syndrome is a rare genetic neurological and developmental disorder that affects the way the brain develops. This disorder causes a progressive loss of motor skills and language and primarily affects females.

This marks the latest hardship for Acadia whose late-stage intranasal Carbetocin trial in Prader-Willi syndrome (PWS) patients failed to achieve a statistically significant improvement in hyperphagia in September.

How Did Stocktwits Users React?

On Stocktwits, retail sentiment around ACAD stock stayed within the ‘neutral’ territory while message volume rose from ‘normal’ to ‘high’ levels.

ACAD stock has gained 41% over the past 12 months. 

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