Health and Healthcare

Why Minerva's Incredible Move May Be Justified

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Minerva Neurosciences Inc. (NASDAQ: NERV) saw its shares make absolutely massive gains on Thursday following the release of positive results from a couple mid-stage clinical trials. Specifically the company announced positive results for its Phase 2A trial of MIN-117 in major depressive disorder (MDD) and Phase 2B trial of MIN-101 monotherapy in schizophrenia.

However, after the dust has settled, a couple analysts weighed in and gave their opinion on where Minerva stands to go from here. We have provided highlights from both trials as well.

In the MDD trial, both doses of MIN-117 demonstrated a favorable tolerability profile, and the incidence and types of side effects did not differ significantly between the MIN-117 group and the placebo group. There were no unexpected adverse events were reported. Preliminary analysis showed that treatment with MIN-117 is not associated with cognitive impairment, sexual dysfunction, suicidal ideation or weight gain.

Pharmacodynamic measurements based on sleep recordings show that MIN-117 preserved sleep continuity and architecture and therefore is not expected to have detrimental effects on rapid eye movement (REM) sleep distribution and duration unlike most marketed antidepressants.

In the schizophrenia trial, the study successfully achieved its primary endpoint, demonstrating the statistically significant benefit of MIN-101 over placebo in improving negative symptoms. MIN-101 was generally reported to be well tolerated, and the incidence and types of side effects did not differ significantly between the MIN-101 group and the placebo group.

Dr. Remy Luthringer, president and CEO of Minerva, commented on the schizophrenia trial:

We also observed consistent improvements in multiple secondary endpoints. This broad impact underscores the potential of MIN-101, a molecule that combines sigma2 antagonism and 5-HT2a antagonism, as a promising differentiated treatment for a debilitating disease affecting large numbers of underserved patients worldwide.  Because negative symptoms are not only present in schizophrenia but also in brain degenerative disorders and other mental illnesses, we believe that MIN-101 may be a candidate for the potential treatment of other indications.

Jefferies reiterated a Buy rating and raised its price target to $17 from $10. The firm’s key takeaway was that shares are attractively valued for the opportunities that these drug candidates present. Positive data from these trials will allow the company to secure partnerships as well as additional capital.

JMP Securities reiterated its Market Outperform rating for Minerva and raised its price target to $17 from $10. The firm further commented in its report:

This morning, Minerva announced positive results from a Phase 2b trial for MIN-101 in schizophrenia patients and a Phase 2a trial for MIN-117 in patients with major depressive disorder. The Phase 2b trial for MIN-101 met its primary and key secondary endpoints and, in our view, the magnitude of the effect sizes and statistical significance provide confidence that the results are robust. We view these results as highly positive and expect the company to provide additional details on the magnitude and time-course of benefit, as well as safety, at a competitor conference next week. Additionally, we believe the Phase 2a results for MIN-117 establish clinical proof of concept for a potentially differentiated treatment option in MDD with a novel mechanism of action. We are increasing our price target from $10 to $17 which reflects an increase in probability of success for MIN-101 from 45% to 65% and we now include MIN-117 with an NPV of ~$3/share. Our price target is derived through a sum-of-the parts NPV analysis of MIN-101, MIN-202, and MIN-117, with MIN-301 representing upside potential to our valuation.

Shares of Minerva closed Thursday up 233% at $11.80, with a consensus analyst price target of $13.50 and a 52-week trading range of $3.45 to $13.22. In early trading indications Friday, the stock is down nearly 8% at $10.89.

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