Amicus execs get back up smiling after being scuffed again by latest setback

Amicus $FOLD is continuing its series of painful pratfalls as the biotech repeatedly trips its way toward what executive chairman John Crowley continues to see as an easy layup at the FDA.

Under the light cloak of a Friday evening news drop, Amicus revealed that the FDA had yet again delayed an approval decision needed for AT-GAA — their treatment for Pompe disease — after they were unable to complete a manufacturing inspection in China. Covid lockdowns have been playing hell with inspections in the massive Asian market.

Amicus had already notified investors of a likely roadblock about six weeks ago when the company noted that regulators had yet to schedule a trip to WuXi due to the travel disruptions.

This latest snag follows a series of painful mishaps at Amicus, including its Phase III failure for AT-GAA on the primary endpoint compared to the standard treatment and the self-destruction of a SPAC play as the market came undone.

Amicus gets hit with an 'unexpected' setback on a gene therapy tapped to lead $600M SPAC spinout

Crowley and company, though, have always viewed every setback as an opportunity to voice their confidence of ultimate success. And they didn’t disappoint on Friday evening.

Preview

来源: Endpts

Bradley Campbell

“We continue to believe this is a question of ‘when’ not ‘if’ AT-GAA will be approved and we will continue to work with great urgency to support the FDA’s completion of the final plant inspection necessary for approval so that this important new treatment option is made available for people living with Pompe disease in the United States,” said CEO Bradley Campbell.

SVB’s Joseph Schwartz offered a thumbs-up on the sentiment.

At this juncture we view the ultimate US approval decision timeframe as a black box given China’s continued lockdowns/travel restrictions in commitment to their zero-Covid policy — we spoke with mgmt. after the announcement who noted they expect the US approval in 2023.

The EMA, though, could move faster.

The market approval rests on two decisions: one on a BLA needed for the biologic part of the drug, and the other an NDA required for the second part. Amicus expects them to come together — barring some other problem.

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