Neuren enters trading halt, downgrades Daybue guidance
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The news: Neuren Pharmaceuticals has entered a trading halt on the ASX pending the publication of top line results of its Phase 2 clinical trial of drug candidate NNZ-2581 for patients with Angelman syndrome.
It followed the release of the company's June quarter results, which included a downgrade to full-year guidance for sales of its Rett syndrome drug trofinetide that sent shares in its US partner Acadia Pharmaceuticals plunging on the Nasdaq earlier this morning.
The numbers: Neuren reported quarterly royalties of $13 million, a 12.1% rise compared to the March quarter.
Earlier today, Acadia — Neuren's US licencee for trofinetide under the brand name Daybue — recorded Q2 sales of USD84.6 million ($129.53 million), an 11% rise quarter on quarter.
However, Acadia lowered its Daybue guidance for FY24 to USD340 million to USD370 million, representing an 11% downgrade at the midpoint of USD370 million to USD420 million.
Neuren said that assuming Acadia's new guidance is met, the Melbourne-based group would earn royalties of $55 million to $61 million, compared to the previous estimate of $61 million to $70 million.
Acadia shares fell 14% in after-hours trading in New York after rising 2.39% during the day.
The context: Neuren noted that momentum in Q2 was "encouraging", but the net rate of patient additions was "slower than expected" during the quarter.
Wilsons Advisory analysts said that new patient starts have been the driver of growth in Daybue. However, Q1 represented a weak seasonal period for new patient starts, while lower new patient additions compared to expectations drove Acadia's guidance revision, the analysts said.
Meanwhile, Neuren noted that it is progressing approvals for its Rett syndrome drug in Europe and Japan, after Acadia had a new drug submission accepted by Canada's health department in April.
Neuren also recorded "positive top-line results" from Phase 2 clinical trials of NNZ-2591 in children with Pitt Hopkins syndrome and Phelan-McDermin syndrome. Following a trading halt, the company is also due to release top line results of NNZ-2591 for patients with Angelman syndrome.
The sources: ASX announcement, Wilsons Advisory research, ASX announcement
