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neuren p2 topline results
January 4th, 2024

Impressive Results from Neuren's NNZ-2591 Phase II Clinical Trial in Phelan- McDermid Syndrome

Last month, Neuren Pharmaceuticals (NEU; $24.65) announced impressive top-line data from its Phase II trial of NNZ-2591 conducted in 18 patients with Phelan-McDermid Syndrome (PMS).

December 12th, 2023

Investor Interest Starts Return to Biotech Sector (Neuren)

Over the last two months, there have been some strong price movements in several major and minor biotech stocks. Following a downturn that has lasted almost two years, has the Australian sector finally bottomed?

We reviewed Clinuvel Pharmaceuticals, Dimerix, Imugene, and Neuren.

November 20th, 2023

Neuren Completes First of Four Phase II Studies

In additional to the lucrative royalty stream and milestone payments Neuren Pharmaceuticals (NEU: $14.68) is receiving from its first drug DAYBUE, the company is also conducting four clinical studies in four separate neurodevelopmental disorders with its next drug candidate, NNZ-2591.

November 3rd, 2023

Neuren Pharmaceuticals – Strong DAYBUE Sales in September Quarter at US$67 million

–3 November 2023–

Neuren  Pharmaceuticals' (NEU: $11.29) partner Acadia Pharmaceuticals has reported a strong second quarter of sales of its drug DAYBUE for Rett syndrome after having been launched in the US in April this year.

July 21st, 2023

Neuren Pharmaceuticals Moves to Worldwide License for Trofinetide and NNZ-2591 with Acadia

Neuren Pharmaceuticals (NEU: $14.20) announced this week a significant expansion of its partnership with US biopharmaceutical company Acadia Pharmaceuticals (NASDAQ: ACAD). The agreement not only sees Acadia's exclusive licence for trofinetide in North America expand to a worldwide licence, but also Acadia's acquisition of the exclusive worldwide licence for NNZ-2591 in Rett Syndrome and Fragile X Syndrome.

March 17th, 2023

From Benchtop to the Clinic - Stunning Success for Neuren Pharmaceuticals

Terms: Trofinetide brand name is DAYBUE in North America.

A book was written in 1994 about US biotech company Vertex Pharmaceuticals called The Billion Dollar Molecule. Last week Neuren Pharmaceuticals (NEU: $13.23) may have been successful in achieving that quest - with approval in the US, through its partner Acadia Pharmaceuticals, of the drug which has been renamed DAYBUE (formerly trofinetide) for the treatment of Retts syndrome.

February 24th, 2023

Neuren Pharmaceuticals - FDA Decision on Trofinetide Approaching

Arguably the most significant event for the Australian biotech sector is approaching with a decision expected from the FDA on the approval of trofinetide, developed by Neuren Pharmaceuticals (NEU: $7.16), on 12 March.

August 5th, 2022

Neuren Pharmaceuticals - Partner Files Trofinetide for US Approval

Neuren Pharmaceuticals (NEU: $5.45) has some very clear objectives set for the next 17 months. The most significant of these is gaining US approval of its lead drug candidate, trofinetide, which is being commercialised in North America under license from Neuren by Acadia Pharmaceuticals for the treatment of Rett syndrome in children and adults.

Acadia filed trofinetide for approval last month. The next stage is notice from the FDA that the application is in order and has been accepted (in September), which will trigger a US$10 million payment to Neuren from Acadia.