Minerva Neurosciences

Minerva Neurosciences, Inc. is a clinical-stage biopharmaceutical company, which engages in the development and commercialization of a portfolio of product candidates to treat central nervous system diseases. It develops Roluperidone for the treatment of negative symptoms in patients with schizophrenia and MIN-301 for the treatment of Parkinson’s disease. The company was founded by Rogerio Vivaldi Coelho and Goeffrey Robin Race on April 23, 2007 and is headquartered in Waltham, MA.

Earnings data Q3 2023

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Minerva Neurosciences, Inc. is a clinical-stage biopharmaceutical company, which engages in the development and commercialization of a portfolio of product candidates to treat central nervous system diseases. It develops Roluperidone for the treatment of negative symptoms in patients with schizophrenia and MIN-301 for the treatment of Parkinson’s disease. The company was founded by Rogerio Vivaldi Coelho and Goeffrey Robin Race on April 23, 2007 and is headquartered in Burlington, MA.

Minerva Neurosciences has raised $20M through a private placement at a premium to market prices. Boehringer Ingelheim participated in the private placement. Boehringer is itself developing a drug for schizophrenia, albeit for cognitive impairments associated with schizophrenia. NERV has six months until the PDUFA goal date for its roluperidone application but used only $4M in cash in operating activities in Q2, so cash isn't currently a concern.

Minerva Neurosciences: There's Probably Time For One More Rally

BURLINGTON, Mass., Aug. 01, 2023 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (Nasdaq: NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system disorders, today reported business updates and financial results for the second quarter ended June 30, 2023.

Minerva Neurosciences Reports 2023 Second Quarter Financial Results and Business Updates

BURLINGTON, Mass., June 28, 2023 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (Nasdaq: NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system disorders, today announced that it has agreed to sell an aggregate of 1,425,000 shares of its common stock at a purchase price of $10 per share and pre-funded warrants to purchase an aggregate of 575,575 shares of its common stock at a purchase price of $9.99 per pre-funded warrant, to Boehringer Ingelheim, a global biopharmaceutical company with a growing mental health pipeline that includes schizophrenia, and Federated Hermes Kaufmann Funds in a private investment in public equity (the “PIPE”) financing. Minerva expects that the gross proceeds from the PIPE will be approximately $20 million, before deducting PIPE-related expenses payable by Minerva. Minerva intends to use the net proceeds from the PIPE to support potential regulatory approval in the U.S., commercialization activities and market launch of roluperidone, which is being developed for the treatment of negative symptoms in schizophrenia.

Minerva Neurosciences Announces $20 Million in Private Placement Priced at a Premium to Market

Minerva Neurosciences (NERV) appears to have found support after losing some value lately, as indicated by the formation of a hammer chart. In addition to this technical chart pattern, strong agreement among Wall Street analysts in revising earnings estimates higher enhances the stock's potential for a turnaround in the near term.

Here's Why Minerva Neurosciences (NERV) Is a Great 'Buy the Bottom' Stock Now

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NERV has once again run on the submission of an NDA for roluperidone for the treatment of negative symptoms in schizophrenia. There will be no Refusal to File letter this time, with NERV using a dispute resolution process to its advantage.

Minerva Neurosciences: Up About 250 Percent Since April With An FDA Catalyst Ahead

Minerva Neurosciences (NERV) has been upgraded to a Zacks Rank #2 (Buy), reflecting growing optimism about the company's earnings prospects. This might drive the stock higher in the near term.

What Makes Minerva Neurosciences (NERV) a New Buy Stock

Minerva Neurosciences, Inc. (NASDAQ:NERV ) Q1 2023 Earnings Conference Call May 15, 2023 8:30 AM ET Company Participants Geoff Race - President Dr. Remy Luthringer - Executive Chairman and CEO Fred Ahlholm - Senior Vice President and CFO Conference Call Participants Andrew Tsai - Jefferies Douglas Tsao - H.C. Wainwright Operator Welcome to the Minerva Neurosciences First Quarter 2023 Conference Call.

Minerva Neurosciences, Inc. (NERV) Q1 2023 Earnings Call Transcript

BURLINGTON, Mass., May 15, 2023 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (Nasdaq: NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system disorders, today reported business updates and financial results for the first quarter ended March 31, 2023.

Minerva Neurosciences Reports 2023 First Quarter Financial Results and Business Updates

FDA confirms acceptance of the filing of the NDA for roluperidone Application has been granted a standard review FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of February 26, 2024 BURLINGTON, Mass., May 10, 2023 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (Nasdaq: NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system (CNS) disorders, today announced that on May 8, 2023, it received confirmation from the U.S. Food and Drug Administration (FDA) that the Company's New Drug Application (NDA) for roluperidone for the treatment of negative symptoms in patients with schizophrenia has been filed in accordance with the recent Appeal Granted letter dated April 27, 2023 and assigned a standard review classification.

Minerva Neurosciences Announces Update on its New Drug Application (NDA) for Roluperidone for the Treatment of Negative Symptoms in Schizophrenia

BURLINGTON, Mass., May 08, 2023 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (Nasdaq: NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system (CNS) disorders, today announced that it will release first quarter 2023 financial results and business updates on Monday, May 15, 2023.

Minerva Neurosciences to Report First Quarter 2023 Financial Results and Business Updates on May 15, 2023

Minerva Neurosciences, Inc. (NASDAQ:NERV ) Q4 2022 Earnings Conference Call March 8, 2023 8:30 AM ET Company Participants Geoff Race - President Remy Luthringer - CEO Fred Ahlholm - CFO Conference Call Participants Andrew Tsai - Jefferies Douglas Tsao - H.C. Wainwright Operator Good day, and thank you for standing by.

Minerva Neurosciences, Inc. (NERV) Q4 2022 Earnings Call Transcript

Company to Host Conference Call Today at 8:30 a.m. ET Company to Host Conference Call Today at 8:30 a.m. ET

Minerva Neurosciences Reports Fiscal Year 2022 Fourth Quarter And Year End Financial Results And Business Updates

Management to Host Conference Call Management to Host Conference Call

Minerva Neurosciences to Report Fiscal Year 2022 Financial Results and Business Updates on March 8, 2023

Minerva (NERV) confirmed that the FDA's refuse-to-file letter on its regulatory filing, seeking approval for roluperidone, to treat symptoms of schizophrenia remains in effect.

Minerva (NERV) Down; FDA Denies Review Schizophrenia Drug NDA

Minerva Neurosciences, Inc. (NASDAQ:NERV ) Q3 2022 Earnings Conference Call November 9, 2022 8:30 AM ET Company Participants Geoff Race - President Remy Luthringer - CEO Frederick Ahlholm - CFO Conference Call Participants Andrew Tsai - Jefferies Douglas Tsao - H.C. Wainwright Myles Minter - William Blair Operator Thank you for standing by.

Minerva Neurosciences, Inc. (NERV) Q3 2022 Earnings Call Transcript

Company To Host Live Webcast Today at 8:30 a.m. ET Company To Host Live Webcast Today at 8:30 a.m. ET

Minerva Neurosciences Reports Third Quarter 2022 Financial Results and Business Updates

BURLINGTON, Mass., Nov. 02, 2022 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (Nasdaq: NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system (CNS) disorders, today announced that it will release financial results and business updates for the third quarter of 2022 on Wednesday, November 9, 2022. The Company will host a webcast that day at 8:30 a.m. Eastern Time to discuss the results and updates.

Minerva Neurosciences to Report Third Quarter 2022 Financial Results and Business Updates on November 9, 2022

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Minerva Neurosciences Inc. NERV, +7.61% said Monday that it received a refusal to file letter from the Food and Drug Administration for its application for roluperidone as a treatment for patients with schizophrenia. "The company intends to request a Type A meeting and looks forward to continued discussions with the FDA," Minerva CEO said in a news release.

Minerva Neurosciences to request meeting with FDA about schizophrenia drug

BURLINGTON, Mass., Oct. 17, 2022 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (Nasdaq: NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system (CNS) disorders, today announced that the company has received a refusal to file letter from the U.S. Food and Drug Administration (FDA) regarding the company's New Drug Application (NDA) for roluperidone for the treatment of negative symptoms in patients with schizophrenia. The FDA has indicated that the company can request a Type A meeting to discuss the content of the refusal to file letter.

Minerva Neurosciences Receives Refusal to File Letter from FDA for its New Drug Application for Roluperidone for the Treatment of Negative Symptoms in Schizophrenia

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