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Neuropharm
| Date | Reports available | Download |
|---|---|---|
| Oct 06 2008 |
Key data inflection point The result of the Phase III SOFIA (Study Of Fluoxetine In Autism) study for Neuropharm’s lead project NPL-2008, due in Q109, represents a key near-term valuation inflection point. If successful, this could add significantly to our valuation as it increases the probability that NPL 2008 will become the first drug specifically indicated to treat autism. Neuropharm has completed recruitment of SOFIA and begun a rolling US NDA. Approval and launch of the drug are possible in 2010, along with the associated build-up of a small, in-house US sales force. Research type: Review - Preliminary results |
Log in to download 8 page note available |
| Jul 24 2008 |
Fragile X trial data Results of two early-stage open-label Phase II studies of Neuropharm’s programmes for Fragile X syndrome were released earlier this week, ahead of its presentation at the International Fragile X Conference starting today. Results of both studies were positive and highlight Neuropharm’s broader R&D base, although the investment case still relies on NPL-2008 for autism. Neuropharm has confirmed recruitment for the SOFIA trial is on track and should complete the clinical phase by the year end. Completion of filing of the rolling NDA is due in Q209. Research type: Update - Trial update |
Log in to download 5 page note available |
| Jul 10 2008 |
Fragile X results soon Results of Phase II studies of Neuropharm’s programmes for Fragile X syndrome are due to be presented at a scientific meeting later this month. Recruitment into the SOFIA trial of NPL-2008 for autism is going well, with clinical phase expected to complete around the year-end. A potential rolling NDA filing of NPL-2008 could start in early Q4, which would complete with the submission of the clinical data. NPL-2008 could become the first drug approved for treating a core symptom of autism and, with potential for fast-track review, this is possible by Q4 2009. Research type: Update - Trial update |
Log in to download 8 page note available |
| Mar 03 2008 |
Autism speaks out Neuropharm’s investment case centres squarely on its NPL-2008 novel formulation of fluoxetine for the treatment of autism, which is currently in a Phase III study. The product could be launched in the US in Q4 2009 and has the potential for peak sales approaching $700m/year. The company is well financed and unusually has sufficient resources to evolve into a speciality pharmaceutical firm focused on CNS conditions, capturing a significant proportion of end-market sales. Research type: Outlook - Initiation of coverage |
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