15-Jan-2025: 1:30pm: NEU down as much as -9.17% today (closed @ $12 yesterday and down to an intraday low of $10.90 so far today) with a couple of hours to go. So much for being close to the bottom of their downtrend.
I'm not seeing negatives in today's announcement - Trofinetide-marketing-application-submitted-in-Europe.PDF - but clearly it's below some market participants' expectations. Perhaps it's the pace of the DAYBUE™ (trofinetide) roll-out globally that has some punters thinking that while the growth is there it might take longer to play out than previously expected.
I guess that's the trick. How do you accurately manage market expectations when the market is often irrational and many people are simply following trends or charts without too much understanding of what the business does and the environment in which the business operates?
Pharma is well outside of my wheelhouse, but I know enough to know that trofinetide has been derisked and is going to be rolled out globally, and it's already selling in the US and Canada, and the FDA in the US is regarded by most people to be one of the hardest nuts to crack for pharmaceuticals. And the global roll-out will take time, i.e. years - it won't happen overnight.
I'm bemused, but otherwise unphased. I was obviously back in too early with NEU (in December) and I guess that tends to happen to me more often with companies that operate within sectors that I have less overall knowledge about and experience in (outside my sphere of competency), however when I bought back into NEU in December, it was in my SMSF only, and I'm back to being comfortable with 5 year plus timeframes there now - after my TPD claim got approved and paid in October so my prior need to make shorter term profits is no longer there. I'm back to being a medium-term value investor - mostly - who also likes to make a buck here and there on shorter term opportunities. All good.
Today's Announcement:
Disclosure: I hold NEU both here and in my SMSF.
10-March-2022: (USA Time): U.S. FDA approves Acadia's genetic Rett syndrome drug | Reuters
Plain Text Link: https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-approves-acadias-genetic-rett-syndrome-drug-2023-03-11/
Excerpt:
March 10 (Reuters) - The U.S. Food and Drug Administration [FDA] approved Acadia Pharmaceuticals Inc's (ACAD.O) drug for the treatment of Rett syndrome, a genetic brain disorder, the company said on Friday, making it the first approved drug for the condition.
The U.S. health regulator's decision allows use of the trofinetide, to be sold under the brand name Daybue, in adult and pediatric patients two years of age and older and comes with a warning of diarrhea and weight loss.
The approval comes months after the FDA declined to approve expanded use of Acadia's drug Nuplazid to treat psychosis related to Alzheimer's disease. Analysts have said approval of Daybue would help drive growth for the company in the near term.
"We have put a lot of planning into potential commercialization of trofinetide, including resources for patients to access the drug," said Acadia senior executive Kathie Bishop ahead of the approval.
Acadia said it plans to make the drug available to patients by the end of April. It did not disclose details of the price.
Before the approval, David Hoang SMBC Nikko Securities analyst estimated a list price at launch of $450,000 annually. He forecast peak U.S. trofinetide sales of $487.2 million by 2035. RBC Capital Markets analyst Gregory Renza, also writing before the approval, predicted peak U.S. sales to exceed $500 million by 2032 and an average annual launch price of about $425,000.
Acadia forecasts sales of Nuplazid - its only drug on the market - of between $520 and $550 million this year, above analysts' median expectations of $532.8 million, according to Refinitiv data. With the drugmaker facing a loss of exclusivity for Nuplazid in 2028, investors have pinned their hopes on a successful trofinetide launch.
After the FDA declined to approve the expanded use of Nuplazid, Acadia said it would not pursue that indication for Nuplazid further. The drugmaker plans to focus its resources on late-stage development of Nuplazid to treat symptoms of schizophrenia and early-stage development of another candidate, ACP-204, for Alzheimer's-related psychosis.
Rett's syndrome is a rare neurodevelopmental condition that occurs primarily in girls. According to government estimates, it affects fewer than 50,000 people in the U.S.
Shares of the California-based company closed 0.68% lower on Friday.
Acadia's drug acts as an artificial form of the insulin-like growth factor IGF-1 and helps reduces inflammation in the nervous tissue as well as aid in the transmission of nerve impulses.
Acadia's application for marketing approval was based on data from a late-stage study in which treatment with the drug showed improvement in core symptoms of the disease compared to a placebo. Improvement of symptoms was measured according to the assessment scales Rett Syndrome Behaviour Questionnaire and the Clinical Global Impression of Improvement.
The company had licensed the drug for $10 million up front payment from Australian drugmaker Neuron Pharmaceuticals (NEU.AX) for development and sale in North America in 2018.
--- end of excerpt ---
Source: Reuters.com: Reporting by Bhanvi Satija, Nandhini Srinivasan and Anirudh Saligrama in Bengaluru; Editing by Shailesh Kuber and William Mallard
Watch for an announcement from NEU on Monday or Tuesday morning. Share price expected to move, by how much I do not know. Not holding.
It's a public holiday on Monday in SA (Adelaide Cup Day), the ACT (Canberra Day), Victoria (Labour Day) and Tasmania (Eight Hours Day), but importantly not in WA, Qld, the NT or NSW (where the ASX is HQ'd). It is however a public holiday in NZ (Taranaki Anniversary Day) and the two head office addresses I have found for Neuren are (1) in Auckland, New Zealand (according to the ASX and Commsec) and in Camberwell, Victoria (according to Neuren's own website), so that's why I said Monday or Tuesday morning, seeing as it's a public holiday in NZ and Victoria on Monday. Hopefully, somebody can work-from-home or drop into the office anyway to email a short letter through to the ASX announcements platform.
Regardless of whether the announcement comes through on Monday or Tuesday, expect some SP action on Monday.