Highest-materiality recent filing
Minerva enters $75M ATM offering; Phase 3 roluperidone relapse phase extended to 52 weeks
Up to $75M in common stock may be sold at-the-market through Leerink Partners; 3% commission.
Minerva Q1 GAAP net loss $125.4M on warrant revaluation; Phase 3 roluperidone trial advances
Confirmatory Phase 3 trial of roluperidone for negative symptoms of schizophrenia initiated; first patient screened March 2026; topline data expected 2H 2027.
Minerva (NERV) Q4 non-GAAP adj loss $7.1M; cash $82.4M; Phase 3 roluperidone on track for Q2 2026
Non-GAAP adjusted net loss for Q4 2025 was $7.1M ($0.64/sh) vs $4.0M ($0.53/sh) in Q4 2024.
Minerva unveils Phase 3 trial design for roluperidone; planned start Q2 2026
Phase 3 trial to enroll 380 patients with negative symptoms of schizophrenia; 1:1 randomization to placebo or 64 mg roluperidone.
Dr. Kaul appointed to Minerva's board (Class II) effective Nov 14, 2025; board size increased to 6.
Minerva Neurosciences raises up to $200M to fund Phase 3 trial of roluperidone
Private placement: $80M upfront Series A preferred; Tranche A warrants for another $80M (cash exercise), Tranche B warrants for $40M contingent on milestone event.
Minerva Neurosciences regains Nasdaq compliance with net income rule
Nasdaq Panel confirmed compliance with Listing Rule 5550(b)(3) (minimum $500K net income from continuing operations).
Nasdaq Panel grants Minerva continued listing subject to equity compliance by March 31, 2025
Company must file disclosure on transactions to meet $2.5M minimum stockholders' equity by 3/31/25.
Minerva Neurosciences receives Nasdaq delisting notice for MVLS non-compliance; to request hearing
Second Nasdaq notice for continued non-compliance with $35M minimum Market Value of Listed Securities; delisting determination unless hearing requested.
Minerva Neurosciences receives Nasdaq delisting notice for low market value
MVLS below $35M minimum for 31 consecutive business days as of April 10, 2024.
FDA issues Complete Response Letter for roluperidone; NDA not approved
FDA cited single positive study insufficient; requires at least one additional positive well-controlled trial.
Minerva Neurosciences raises $20M in PIPE at $10/share for roluperidone launch
Gross proceeds ~$20M from 1,425,000 shares at $10/share and 575,575 pre-funded warrants at $9.99.
Minerva Neurosciences regains Nasdaq compliance on minimum market value requirement
Received Nasdaq Compliance Notice on June 16, 2023, after MVLS exceeded $35M for 10 consecutive business days.
Minerva Neurosciences receives Nasdaq delisting determination; intends to request hearing
Received second Nasdaq notice on May 31 for continued non-compliance with minimum Market Value of Listed Securities ($35M).
Minerva Neurosciences announces FDA files NDA for roluperidone after appeal of refuse-to-file
FDA filed Minerva's NDA for roluperidone on April 27, 2023, to treat negative symptoms in schizophrenia.
FDA upholds refusal to file Minerva's NDA for roluperidone for schizophrenia negative symptoms
FDA confirmed refusal-to-file letter dated Oct 14, 2022 remains in effect after Type A meeting on Nov 30, 2022.
Minerva Neurosciences receives Nasdaq notice for MVLS non-compliance; has until May 30, 2023
Nasdaq notified Minerva on Dec 1, 2022 that MVLS fell below $35M for 30 consecutive business days.
FDA issued Refusal to File letter for NDA of roluperidone for negative symptoms of schizophrenia.
Minerva Neurosciences transfers stock listing to Nasdaq Capital Market to avoid delisting
Transfer from Nasdaq Global Market to Nasdaq Capital Market effective Sept 12, 2022; ticker NERV unchanged.
Minerva submits NDA to FDA for roluperidone (64 mg) to treat negative symptoms of schizophrenia
NDA supported by two late-stage studies (MIN-101C03 and MIN-101C07) in patients with moderate to severe negative symptoms.
FDA says Phase 3 study for roluperidone remains negative; additional data needed
FDA stated the Phase 3 study is negative under the Hochberg procedure; both 32 mg and 64 mg doses must be significant.
Minerva Neurosciences receives Nasdaq delisting notice for equity shortfall
Notice received March 8, 2022: stockholders' equity in 2021 10-K fails Nasdaq Rule 5450(b)(1).
Phase 3 roluperidone results published; primary endpoint missed significance in ITT
Trial published in Schizophrenia Bulletin for roluperidone to treat negative symptoms in schizophrenia.
Minerva Neurosciences receives Nasdaq deficiency notice for bid price below $1.00
Nasdaq letter dated Jan 12, 2022, for closing bid price below $1.00 for 30 consecutive business days.
NSFS (primary) for roluperidone 64mg vs placebo: p≤0.064 (ITT), p≤0.044 (mITT).
FDA denies Minerva's pre-NDA meeting request for roluperidone, recommends Type C meeting
FDA denied pre-NDA meeting for roluperidone (negative symptoms of schizophrenia); recommends Type C guidance meeting instead.
Geoff Race promoted to President effective Oct 11, 2021; he was EVP, CFO, and CBO.
Minerva's roluperidone bioequivalence study meets all PK objectives; pre-NDA meeting planned
Study showed bioequivalence in AUC_inf between Phase 2b, Phase 3, and planned commercial formulations.
Minerva Neurosciences appoints Dr. Kuchibhatla as SVP Head of R&D; Dr. Saoud to advisory role
Dr. Jay Saoud resigns as SVP Head of R&D effective Sept 15, 2021; transitions to consultant through June 2022.
On May 29, 2024, Jeryl Hilleman notified the Board of Directors (the “Board”) of Minerva Neurosciences, Inc. (the “Company”) of her intention to resign as a member of the Board, effective August 6, 2024, including from her role as Chair of the Audit Committee of the Board.
On May 3, 2023, William Doyle notified the Board of Directors (the “Board”) of Minerva Neurosciences, Inc. (the “Company”) of his intention to resign as a member of the Board, effective May 3, 2023, including from his role as Chair of the Compensation Committee of the Board and a member of the Audit Committee of the Board.
On October 11, 2021, Minerva Neurosciences, Inc. (the “Company”) announced the appointment of Geoffrey Race as the Company’s President, effective October 11, 2021.
On October 11, 2021, the Company announced the appointment of Frederick Ahlholm as the Company’s Chief Financial Officer (principal financial officer and principal accounting officer), effective October 11, 2021.
Max materiality 1.00 · Median 0.60 · Most common event other_material