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Minerva (NERV) Submits NDA for Schizophrenia Candidate, Stock Up

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Minerva Neurosciences (NERV - Free Report) submitted a new drug application (“NDA”) to the FDA seeking approval of roluperidone to treat negative symptoms in patients with schizophrenia. Minerva is seeking approval for the 64 mg dosage of roluperidone.

Schizophrenia is a chronic mental illness characterized by hallucinations, distorted perceptions, emotions, behavior and sense of self and others. Per the World Health Organization, schizophrenia affects 20 million people worldwide.

The company has been in talks with the FDA regarding the NDA evaluation of roluperidone, since its Type C meeting with the regulatory body in March 2022.

The NDA is based on the results of two late-stage studies, namely MIN-101C03 (24-week study) evaluating a 32 mg dosage of roluperidone and MIN-101C07 (40-week study) evaluating a 64 mg dosage of roluperidone in patients with moderate to severe negative symptoms and stable positive symptoms of schizophrenia.

The studies provide long-term data regarding the safety and efficacy of roluperidone as well as the efficacy based on the blinded doses of roluperidone. The data aims to exhibit the improvement in negative symptoms and the low rate of worsening positive symptoms in schizophrenic patients, following the designated time periods, 24 weeks and 40 weeks, respectively.

Shares of Minerva declined 28.4% in the year-to-date period, compared to the industry’s decline of 21.3%.

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Minerva is a clinical-stage biopharma company specializing in developing product candidates for treating diseases related to the central nervous system (CNS).

Apart from roluperidone (MIN-101), the company also has MIN-301 as its candidate to treat Parkinson’s disease.

Additionally, the company has also developed seltorexant, in collaboration with Jannsen Pharmaceuticals, a wholly-owned subsidiary of Johnson & Johnson (JNJ - Free Report) , for the treatment of insomnia and as an adjunctive treatment of major depressive disorder (MDD).

In 2020, Minerva opted out of the collaboration with JNJ’s Jannsen Pharmaceuticals. Minerva was entitled to receive mid to single-digit royalties from the potential worldwide sales of seltorexant in certain indications, even after the opt-out.

However, in June 2021, Minerva sold its royalty interests in seltorexant to Royalty Pharma (RPRX - Free Report) for an upfront payment of $60 million. The fund from Royalty Pharma was used by Minerva to continue with the development of roluperidone to treat negative schizophrenic symptoms, which was at that time in the late stage of development.

 

Zacks Rank and A Key Pick

Minerva currently holds a Zacks Rank #2 (Buy).

A similar-ranked stock in the same sector is Aerie Pharmaceutical , carrying a Zacks Rank #2. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Aerie’s loss estimates for 2022 have narrowed down from $2.01 per share to $1.83 over the past 30 days. Earnings of Aerie beat estimates in three of the last four quarters while missing the same on one occasion. AERI reported a negative earnings surprise of 70.27%, on average.


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