Minerva Neurosci Stock Price, News & Analysis

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.

Minerva Neurosciences, Inc. (NASDAQ: NERV) reported financial results for 2020, achieving a net income of $1.9 million, reversing a loss of $72.2 million in 2019. The fourth quarter loss decreased significantly to $7.3 million from $29.9 million. Cash and equivalents totaled $25.5 million as of December 31, 2020. Major developments include completing the Phase 3 open-label extension for roluperidone, with data expected in H1 2021, and a $60 million upfront payment from Royalty Pharma for the royalty interest in seltorexant, potentially rising to $95 million with milestones.

Minerva Neurosciences (NASDAQ: NERV) announced it will release its fourth quarter and fiscal year financial results for the period ending December 31, 2020 on March 8, 2021. A conference call will be held at 8:30 a.m. EST to discuss these results along with additional business updates. Investors can participate by calling (877) 312-5845 for domestic or (765) 507-2618 for international access, using conference ID 5663077. The webcast will also be available on Minerva's website, with an archived version accessible for 30 days after the event.

Minerva Neurosciences (Nasdaq: NERV) has entered an agreement with Royalty Pharma (Nasdaq: RPRX) to sell its royalty interest in seltorexant for $60 million upfront and up to $95 million in milestone payments. Seltorexant is in Phase 3 development targeting major depressive disorder with insomnia. The funds will support Minerva's lead compound, roluperidone, also in Phase 3 for schizophrenia. Minerva will earn mid-single digit royalties on seltorexant's net sales, enhancing its financial position.

Minerva Neurosciences (NASDAQ: NERV) announced it received meeting minutes from the FDA regarding its investigation of roluperidone for negative symptoms in schizophrenia. The FDA raised concerns about the Phase 2b and Phase 3 studies, indicating that the data may not support an NDA submission due to insufficient evidence of effectiveness and the lack of adequate trials. However, Minerva intends to bridge the data gap with additional studies and is optimistic about addressing FDA concerns, continuing its development efforts.

Minerva Neurosciences (NASDAQ: NERV) announced its participation in the Jefferies Virtual London Healthcare Conference on November 17, 2020, at 12:55 p.m. GMT (7:55 a.m. EST). The presentation will be available as a live webcast and can be accessed through the company’s investor relations website. Minerva focuses on developing innovative therapies for CNS disorders, with key compounds including roluperidone for schizophrenia and MIN-301 for Parkinson’s disease. For further details, visit the company's website.

Minerva Neurosciences (NASDAQ: NERV) reported its Q3 2020 financial results, revealing a net loss of $8.1 million, significantly improved from a loss of $14.0 million in Q3 2019. Collaborative revenue surged to $41.2 million, attributed to the termination of a licensing agreement with Janssen. R&D expenses dropped to $4.6 million, while G&A expenses decreased to $3.5 million. The FDA has granted a Type C meeting for roluperidone on November 10, 2020, to discuss clinical data and potential NDA submission. An update is expected in December 2020.