ASX Health Stocks: Market darling Neuren Pharma jumps 16pc on Acadia worldwide licence
Health & Biotech
Health & Biotech
Market darling Neuren Pharma (ASX:NEU) surged 16% this morning after announcing an expansion of its global partnership with US partner Acadia for trofinetide (sold under the brand DAYBUE in the US).
Under the new agreement, Acadia’s (NASDAQ:ACAD) exclusive licence for trofinetide in North America has now been expanded to a worldwide exclusive licence.
This won’t change existing milestone payments and royalties to Neuren for trofinetide in North America, with the company set to receive US$100 million up-front, plus additional potential milestone payments of up to US$427 million on sales of trofinetide outside North America.
In the meantime, Acadia has today provided very encouraging early insights into the US launch of DAYBUE, expecting net sales of US$21-23 million in Q2 2023 and US$45-55 million in Q3 2023.
Separately, Neuren has also granted to Acadia an exclusive worldwide licence to develop and commercialise NNZ2591 for Rett syndrome and Fragile X syndrome.
This will enable a faster coordinated global development for NNZ2591, replacing the restrictions in the existing agreement on use by Neuren in those two indications.
Potential milestone payments and royalties payable to Neuren for NNZ-2591 in Rett and Fragile X are identical to the trofinetide milestone payments.
Neuren CEO, Jon Pilcher, said the unique knowledge and expertise the Acadia team has built from the successful development of DAYBUE in the US will allow Acadia to succeed in global markets.
“We very much look forward to continuing to collaborate with Acadia as we all strive to make a difference in neurodevelopmental disorders, which have such urgent unmet need,” Pilcher said.
Meanwhile, Neuren will retain worldwide rights to NNZ-2591 in all other indications and is currently conducting Phase 2 clinical trials in each of Phelan-McDermid, Pitt Hopkins, Angelman and Prader-Willi syndromes, with first top-line results expected in December.
Neuren’s share price has more multiplied more than 7x since early 2022 when the company announced that it was close to launching the first ever drug for Rett syndrome to the market.
Results from the Phase 3 Lavender study of trofinetide were positive, and in March this year Neuren announced that it has received “historic” US FDA approval for DAYBUE.
DAYBUE has since been made available to the US market to treat adult and pediatric patients two years of age and older suffering from the disease.
The drug is the first and only approved treatment for Rett syndrome ever in the world.