Minerva Initiates Phase III Study On Schizophrenia Candidate

Minerva Neurosciences, Inc. (NASDAQ:NERV) announced that it has initiated a phase III study, MIN-101C07, to evaluate its lead pipeline candidate as monotherapy for the treatment of negative symptoms in patients diagnosed with schizophrenia.

Minerva’s share price has declined 51.9% so far this year, while the industry witnessed a gain of 7.5%.

The phase III study design is a 12-week, placebo-controlled, monotherapy study testing two doses of MIN-101 — 32 mg and 64 mg — in schizophrenia patients with negative symptoms. The patients are required to have moderate to severe negative and stable positive symptoms over six months prior to enrollment The patients are also required to have a specified minimum threshold baseline score (>20) on the Positive and Negative Syndrome Scale (“PANSS”) negative sub-scale in order to be eligible for the study.

The primary endpoint of the study is to achieve an improvement in PANSS score. Top-line data from the study is expected in the first half of 2019.

The 12-week study will be followed by an open-label extension study for period of 40 weeks.

The design of the phase III study is similar to the successfully completed phase IIb study. The phase IIb study showed improvement in schizophrenic patients with negative symptoms treated with MIN-101 compared to placebo.

With no approved products in its portfolio, Minerva is dependent on the progress of its pipeline. Moreover, with no major collaboration agreements the company doesn’t have a source of funds while it continues to burn cash for the research and development process. The company expects to incur operating losses going forward. The cash available is expected to fund operations for the next 12 months only.

Any setback in the development of MIN-101 will adversely impact Minerva’s shares.

Meanwhile, Minerva has a license agreement with Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson (NYSE:JNJ) , for co-development of orexin-2 receptor antagonist, MIN-202, for treating schizophrenia.

Zacks Rank & Stocks to Consider

Minerva Neurosciences carries a Zacks Rank #3 (Hold).

A couple of better-ranked stocks in the pharma sector include Celldex Therapeutics, Inc. (NASDAQ:CLDX) and ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD) . Both the stocks carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Celldex’s loss estimates narrowed from $1.03 to 93 cents for 2017 and from 96 cents to 90 cents over the last 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters with an average beat of 15.36%.

ACADIA’s loss estimates narrowed from $2.42 to $2.41 for 2017 and from $1.62 to $1.59 over the last 30 days. The company came up with a positive earnings surprise in three of the trailing four quarters with an average beat of 9.95%.

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