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Biotech Stocks Facing FDA Decision In July 2020

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Acacia Pharma Group
Acacia Pharma Group

The FDA decision on Acacia Pharma Group plc.’s (ACPH.BR) Byfavo is scheduled for July 5, 2020.

Byfavo is an ultra-short-acting and reversible intravenous benzodiazepine sedative/anesthetic designed for use during invasive medical procedures, such as during colonoscopy and bronchoscopy. About 24.5 million such procedures are said to take place annually in the US, of which around 90% use moderate sedation.

Acacia Pharma in-licensed the U.S. commercialization rights to Byfavo from Cosmo Pharmaceuticals N.V. in January 2020.

According to the companies, Byfavo is faster than the available alternatives of the same pharmaceutical class for the same indication (e.g. midazolam) and is safer than other alternatives for the same indication (e.g. propofol). ByFavo can be reversed with flumazenil to rapidly terminate sedation or anesthesia.

If approved, Byfavo is expected to achieve peak sales of $150 million to $200 million by the year 2025 to 2027.

On the Euronext Brussels, ACPH.BR closed Thursday’s (Jun.25, 2020) trading at EUR 3.09, up 2.65%.