Minerva Neurosci Stock Price, News & Analysis

Minerva Neurosciences (Nasdaq: NERV) announced successful results from a pivotal bioequivalence study for roluperidone, aimed at treating negative symptoms of schizophrenia. The study met all key pharmacokinetic objectives, demonstrating bioequivalence between formulations used in late-stage trials and the planned commercial version. This progress is crucial for the upcoming NDA submission to the FDA. The study involved 48 healthy volunteers, confirming that the formulations can be administered with or without food, addressing FDA observations from a prior meeting.

Minerva Neurosciences announced the retirement of Dr. Jay Saoud, Head of Research & Development, who will transition to an advisory role effective September 16, 2021. He will assist with the preparation for a New Drug Application (NDA) for roluperidone. Dr. Ramana Kuchibhatla has been appointed as the new Senior Vice President and Head of Research & Development. Dr. Kuchibhatla brings over 35 years of experience in the life sciences sector, which is expected to support Minerva’s ongoing efforts in developing treatments for CNS disorders.

Minerva Neurosciences (NERV) reported a net loss of $10.6 million for Q2 2021, significantly down from a net income of $29.5 million in Q2 2020. The loss per share was $0.25, compared to a gain of $0.75 last year. The company is progressing towards a New Drug Application submission for roluperidone, targeting schizophrenia treatment. Cash and equivalents increased to approximately $74.3 million from $25.5 million at year-end 2020. A pivotal bioequivalence study is underway, with topline results expected in Q3 2021.

Minerva Neurosciences (NASDAQ: NERV) announced it will release its financial results and business updates for Q2 2021 on August 2, 2021. A live webcast and conference call will occur at 8:30 a.m. ET to discuss these results. Investors can access the call by dialing (877) 312-5845, or via the company's website for a live and archived broadcast. Minerva is focused on developing treatments for CNS disorders, including its compounds roluperidone for schizophrenia and MIN-301 for Parkinson’s disease.

Minerva Neurosciences, a clinical-stage biopharmaceutical firm, will present at the JMP Securities Life Sciences Conference on June 16, 2021, at 10:00 a.m. Eastern Time. The presentation will be accessible via a live and archived webcast on their investor relations website.

Minerva's key compounds include roluperidone for schizophrenia and MIN-301 for Parkinson’s disease. The company's common stock trades on NASDAQ under the symbol NERV.

Minerva Neurosciences, a clinical-stage biopharmaceutical company focused on CNS disorders, will participate in the Jefferies Virtual Healthcare Conference on June 2, 2021, at 11:00 a.m. ET. The event will be accessible through a live and archived webcast on the company's investor relations website. Minerva's portfolio includes roluperidone (MIN-101), in clinical trials for schizophrenia, and MIN-301, in pre-clinical development for Parkinson's disease. The stock is listed on NASDAQ under the symbol NERV.

Minerva Neurosciences reported significant advancements in its phase 3 trial of roluperidone for negative symptoms of schizophrenia, showcasing continuous symptom improvement over one year. The safety profile remains favorable with few serious side effects. Financially, the company posted a net loss of $8.8 million for Q1 2021, reduced from $12.2 million in Q1 2020. R&D expenses dropped to $3.3 million due to the trial’s completion, while G&A expenses remained steady. The cash position is robust at $80.2 million, supporting ongoing drug development efforts.

Minerva Neurosciences announced positive results from the 40-week open-label extension of its Phase 3 trial for roluperidone, targeting negative symptoms of schizophrenia. Out of 333 participants, improvements were observed in the Negative Symptom Factor Score (6.8 points for 32 mg, 7.5 points for 64 mg) and Personal and Social Performance scores (12.3 points for 32 mg, 14.5 points for 64 mg). The treatment showed a favorable safety profile with few serious adverse events. The company plans to submit a New Drug Application following further studies to address FDA comments raised in 2020.

Minerva Neurosciences (NASDAQ: NERV) will release its financial results for the first quarter of 2021 on May 12, 2021. The company will host a conference call at 8:30 a.m. Eastern Time to discuss these results. Interested parties can access the call by dialing (877) 312-5845 domestically or (765) 507-2618 internationally, using conference ID 8981662. The call will also be available via live webcast on the company’s website, where an archived recording will be accessible for 30 days post-event.