Top Analyst sagt kaufen William Blair analyst Myles Minter reiterated a Buy rating on Minerva Neurosciences (NERV ? Research Report) on February 5. The company?s shares closed last Monday at $8.48, close to its 52-week high of $9.23.
According to TipRanks.com, Minter is a 5-star analyst with an average return of 136.9% and a 100.0% success rate. Minter covers the Healthcare sector, focusing on stocks such as Ionis Pharmaceuticals, Axsome Therapeutics, and Karuna Therapeutics.
Minerva Neurosciences has an analyst consensus of Strong Buy, with a price target consensus of $19.00.
Phase 3 Studie of Roluperidone (MIN-101) verfehlt primären Endpunkt
"Minerva said the 64 milligram and 32 milligram doses "were not statistically significantly different from placebo" at week 2 on the primary endpoint. "Even though this studydidn't achieve its primary and key secondary endpoints, primarily due to a larger than expected placebo effect at Week 12, [...]"
Obwohl die FDA kommuniziert hat, dass die eingereichten Daten (MIN-101) nicht ausreichen um eine Zulassung zu erteilen, plant Minerva einen Zulassungsantrag einzureichen. Für diesen Fall wäre ein Ablehnungsschreiben seitens der FDA sehr wahrscheinlich.
" Following the completion of the open-label portion of the Phase 3 trial with roluperidone in schizophrenia and the Type C meeting with the U.S. Food and Drug Administration (FDA), the Company continues to work towards the submission of a New Drug Application (NDA) in the first half of 2022. On June 29, 2021, the Company completed the enrollment of 48 subjects in a pivotal bioequivalence study with roluperidone in healthy volunteers. The objective of this study is to compare the formulations employed in the Phase 2b and Phase 3 trials with roluperidone, as well as at least one new formulation designed in conjunction with the Company?s commercial supplier to facilitate large scale manufacturing. Top line results from this study are expected in the third quarter of 2021."