Chiesi's Commercial Hopes In US Hit By FDA Letter
Protalix-Partnered Fabry Drug Turned Down By Agency
Shares in Protalix sank more than 30% after the company received a complete response letter from US regulators for pegunigalsidase alfa for Fabry disease. No inspection of the company's manufacturing plant in Israel appears to be the main sticking point.
You may also be interested in...
Keeping Track: US FDA Says Yes To AZ’s Farxiga In CKD And ADC’s Zynlonta, But No To Leo’s Tralokinumab, Chiesi’s Pegunigalsidase
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
The Italian group has got the green light in Europe for Lamzede, the first disease-modifying therapy for alpha mannosidosis and believes the drug, along with Procysbi and an investigational Fabry disease being developed with Protalix, constitute a strong portfolio in the rare metabolic disease area.
The UK-headquartered life sciences investment firm has comfortably exceeded its target of $350m for a fund dedicated to taking on late-stage products, incurring all the clinical and regulatory risk and receiving a pre-negotiated return once the drug is approved.