Retrieved on:
Tuesday, February 7, 2023
United Kingdom,
CFIUS,
Security (finance),
Pacific Time Zone,
Competition and Markets Authority,
Acquisition,
Indivior,
Foreign investment,
Committee on Foreign Investment in the United States,
HSR,
Agreement,
LSE,
Completion,
Hart–Scott–Rodino Antitrust Improvements Act,
Internet,
Competition,
Shareholder,
Committee,
CVR College of Engineering,
Defense,
Holding company Additionally, the Competition and Markets Authority in the United Kingdom has elected to take no action with regard to the proposed merger.
Key Points:
- Additionally, the Competition and Markets Authority in the United Kingdom has elected to take no action with regard to the proposed merger.
- The proposed merger remains subject to approval by Opiant stockholders.
- Indivior and Opiant continue to anticipate completing the Agreement in the first quarter of 2023.
- The Opiant Board of Directors unanimously recommends that stockholders vote “FOR” the approval and adoption of the Agreement and the approval of the acquisition.
FTC,
Security (finance),
Pacific Time Zone,
Acquisition,
Indivior,
HSR,
DOJ,
Justice minister,
Agreement,
LSE,
Hart–Scott–Rodino Antitrust Improvements Act,
Internet,
Federal Trade Commission,
CVR College of Engineering,
Holding company The waiting period expired on February 2, 2023, without any action taken by the Federal Trade Commission (FTC).
Key Points:
- The waiting period expired on February 2, 2023, without any action taken by the Federal Trade Commission (FTC).
- Completion of the transaction is subject to the satisfaction of the remaining customary closing conditions, including approval by Opiant stockholders and the receipt of remaining applicable regulatory approvals.
- Indivior and Opiant continue to anticipate completing the merger agreement in the first quarter of 2023.
- The Opiant Board of Directors unanimously recommends that stockholders vote “FOR” the approval and adoption of the Agreement and the approval of the acquisition.
Retrieved on:
Thursday, January 19, 2023
New Drug Application,
Regulation of tobacco by the U.S. Food and Drug Administration,
Priority review,
Safety,
FDA,
United,
Mental disability,
Centers for Disease Control and Prevention,
NDA,
Diagnosis,
Food,
File,
Opioid overdose,
PDUFA,
Pharmaceutical industry The NDA was granted a Priority Review designation and has been given a Prescription Drug User Fee Act (PDUFA) action date of May 22, 2023, accelerating the review time from ten months to six months from the date of filing.
Key Points:
- The NDA was granted a Priority Review designation and has been given a Prescription Drug User Fee Act (PDUFA) action date of May 22, 2023, accelerating the review time from ten months to six months from the date of filing.
- “We are delighted to announce that the FDA has accepted Opiant’s NDA for OPNT003 for filing and designated it priority review status,” said Roger Crystal, M.D., President and CEO of Opiant.
- We believe the data supporting this NDA indicates that OPNT003 can potentially offer first responders and communities an important treatment option in tackling the very serious opioid overdose crisis.
- About 90% – approximately 73,000 – of opioid overdose deaths were linked to potent synthetic opioids, driven by illicit fentanyl.
Retrieved on:
Tuesday, November 22, 2022
ASPR,
Opioid overdose,
United,
Drug overdose,
HHS,
Biomedical Advanced Research and Development Authority,
Food,
Regulation of tobacco by the U.S. Food and Drug Administration,
File,
BARDA,
NDA,
Mental disability,
United States Department of Health and Human Services,
Risk,
Development,
New Drug Application,
Media,
FDA,
Pharmaceutical industry,
Risk management SANTA MONICA, Calif., Nov. 22, 2022 (GLOBE NEWSWIRE) -- Opiant Pharmaceuticals, Inc.(Opiant) (NASDAQ: OPNT) today announced it has completed submission of its rolling New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for OPNT003, nasal nalmefene, for the treatment of opioid overdose.
Key Points:
- SANTA MONICA, Calif., Nov. 22, 2022 (GLOBE NEWSWIRE) -- Opiant Pharmaceuticals, Inc.(Opiant) (NASDAQ: OPNT) today announced it has completed submission of its rolling New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for OPNT003, nasal nalmefene, for the treatment of opioid overdose.
- We are very pleased to submit our NDA for OPNT003, saidRoger Crystal, M.D., President and Chief Executive Officer of Opiant.
- We believe the data supporting this NDA indicate OPNT003 can potentially offer first responders and communities an important treatment option in tackling the very serious opioid overdose crisis in the United States.
- Opiant Pharmaceuticals, Inc., is building a leadingfranchiseof new medicines to combat addictions and drug overdose.
Retrieved on:
Monday, November 14, 2022
Olive,
LON,
Committee,
Opioid overdose,
Fast track (FDA),
Committee on Foreign Investment in the United States,
Security (finance),
Person,
CVR,
Sumathi Best Television Current Reporting Award,
Risk,
Drug overdose,
Death,
Nature,
The Annual Report,
Hypoventilation,
FDA,
Failure,
File,
Annual report,
CVR College of Engineering,
Latham & Watkins,
CFIUS,
Media,
Foreign investment,
Patient,
Bank,
Pharmaceutical industry,
Risk management,
Cryptocurrency,
Indivior This transaction provides Opiant shareholders with immediate value in addition to the potential future upside from the CVRs.
Key Points:
- This transaction provides Opiant shareholders with immediate value in addition to the potential future upside from the CVRs.
- The members of the Board of Directors of Opiant, who hold approximately 4.5% of the outstanding Opiant shares, have entered into a voting agreement with Indivior and agreed to vote their shares in favor of the transaction.
- Lazard Frres & Co. LLC is serving as financial advisor to Opiant and Latham & Watkins LLP is serving as legal advisor to Opiant.
- Opiant Pharmaceuticals, Inc., is building a leadingfranchiseof new medicines to combat addictions and drug overdose.
Regulation of tobacco by the U.S. Food and Drug Administration,
Drug overdose,
Emergency,
Media,
Risk,
FDA,
GLOBE,
Fast track (FDA),
Administration,
NASDAQ,
NDA,
AptarGroup,
Terminology,
Pharmaceutical industry,
Renewable energy,
Risk management SANTA MONICA, Calif., June 08, 2022 (GLOBE NEWSWIRE) -- Opiant Pharmaceuticals, Inc.(Opiant) (NASDAQ: OPNT) today announced a capacity investment agreement with Aptar Pharma (Aptar), a leading provider of drug delivery systems,to expand production of Aptars nasal Unidose device, which will be used in the production of commercial supply of OPNT003, nasal nalmefene.
Key Points:
- SANTA MONICA, Calif., June 08, 2022 (GLOBE NEWSWIRE) -- Opiant Pharmaceuticals, Inc.(Opiant) (NASDAQ: OPNT) today announced a capacity investment agreement with Aptar Pharma (Aptar), a leading provider of drug delivery systems,to expand production of Aptars nasal Unidose device, which will be used in the production of commercial supply of OPNT003, nasal nalmefene.
- This capacity investment with Aptar demonstrates Opiants commitment to ensure adequate supply of OPNT003, nasal nalmefene, to communities and emergency responders as quickly as possible, if approved, saidRoger Crystal, M.D., President and Chief Executive Officer of Opiant.
- Opiant has initiated rolling submission of a New Drug Application to the U.S Food and Drug Administration (FDA), for OPNT003, nasal nalmefene, for the treatment of opioid overdose, using the 505(b)(2) pathway.
- Opiant Pharmaceuticals, Inc., the company that developed NARCAN Nasal Spray, is building a leadingfranchiseof new medicines to combat addictions and drug overdose.
National Center for Health Research,
New Drug Application,
NCHS,
Drug overdose,
NIDA,
Death,
United States Department of Health and Human Services,
Office of the Assistant Secretary for Preparedness and Response,
Biomedical Advanced Research and Development Authority,
Food,
National Institute on Drug Abuse,
Opioid overdose,
Media,
CDC,
Hypoventilation,
Risk,
FDA,
Development,
GLOBE,
Assistant,
Review,
BARDA,
Fentanyl,
NASDAQ,
MD,
Department,
NDA,
PD,
National Center for Health Statistics,
National Institute,
Regulation of tobacco by the U.S. Food and Drug Administration,
Terminology,
Medical statistics,
Pharmaceutical industry,
Medical device,
Company The module was submitted pursuant to a rolling submission, as agreed with the U.S. Food and Drug Administration (FDA) during a pre-NDA meeting.
Key Points:
- The module was submitted pursuant to a rolling submission, as agreed with the U.S. Food and Drug Administration (FDA) during a pre-NDA meeting.
- As communicated previously, the Company expects to complete the submission of the NDA using the 505(b)(2) pathway in the second half of 2022.
- We look forward to working with the FDA to complete this rolling submission for OPNT003, nasal nalmefene, and we will provide an update when the NDA is completed.
- Opiant Pharmaceuticals, Inc., the company that developed NARCAN Nasal Spray, is building a leadingfranchiseof new medicines to combat addictions and drug overdose.
Annual general meeting,
Drug overdose,
NASDAQ,
Health,
Review,
Shareholder,
COVID-19,
Investor,
Method,
Safety,
Eastern Time Zone,
Internet access,
GLOBE,
Auction,
Holding company,
Security (finance) The meeting will be held online only and will begin at 09:00 AM PDT on June 14, 2022, as previously scheduled.
Key Points:
- The meeting will be held online only and will begin at 09:00 AM PDT on June 14, 2022, as previously scheduled.
- The matters to be voted on at the 2022 Annual Meeting, remain unchanged.
- A list of shareholders entitled to vote at the 2022 Annual Meeting will be available for review by interested shareholders.
- Opiant Pharmaceuticals, Inc., the company that developed NARCAN Nasal Spray, is building a leadingfranchiseof new medicines to combat addictions and drug overdose.
Well,
D,
NASDAQ,
GLOBE,
Development,
Human services,
Emergent BioSolutions,
PD,
NDA,
EBS,
Drug overdose,
Remifentanil,
Two-phase electric power,
Federal,
Research,
Centers for Disease Control and Prevention,
CDC,
Commercial,
Biomedical Advanced Research and Development Authority,
Ventilation,
FDA,
End-user license agreement,
Preparedness,
License,
Emergent,
Center,
Contract research organization,
Financial result,
Marketing,
Sale,
Opioid overdose,
Pharmaceutical industry,
Cryptocurrency,
Medical device,
Fine chemical,
Online gambling,
Life insurance SANTA MONICA, Calif., May 10, 2022 (GLOBE NEWSWIRE) -- Opiant Pharmaceuticals, Inc.(Opiant) (NASDAQ: OPNT), a specialty pharmaceutical company developing medicines to treat addictions and drug overdose, today reported financial results for the three months ended March 31, 2022, and provided a corporate update.
Key Points:
- SANTA MONICA, Calif., May 10, 2022 (GLOBE NEWSWIRE) -- Opiant Pharmaceuticals, Inc.(Opiant) (NASDAQ: OPNT), a specialty pharmaceutical company developing medicines to treat addictions and drug overdose, today reported financial results for the three months ended March 31, 2022, and provided a corporate update.
- Financial Results for the First Quarter EndedMarch 31, 2022
For the three months endedMarch 31, 2022, Opiant recorded approximately$4.5 millionin revenue, compared to approximately$6.4 millionduring the corresponding period of 2021.
- First quarter 2022 sales of NARCAN Nasal Spray were approximately$93.1 million, as reported by EBS.
- As ofMarch 31, 2022, Opiant had approximately$50.8 millionin cash, cash equivalents, and marketable securities.
SANTA MONICA, Calif., May 03, 2022 (GLOBE NEWSWIRE) -- Opiant Pharmaceuticals, Inc.(Opiant) (NASDAQ: OPNT), a specialty pharmaceutical company developing medicines to treat addictions and drug overdose, will report its financial results for the first quarter ended March 31, 2022, after the financial markets close onTuesday, May 10, 2022.
Key Points:
- SANTA MONICA, Calif., May 03, 2022 (GLOBE NEWSWIRE) -- Opiant Pharmaceuticals, Inc.(Opiant) (NASDAQ: OPNT), a specialty pharmaceutical company developing medicines to treat addictions and drug overdose, will report its financial results for the first quarter ended March 31, 2022, after the financial markets close onTuesday, May 10, 2022.
- The Companys management team is scheduled to host a conference call and webcast with slides at4:30 p.m. ETonTuesday, May 10, 2022.
- To access the call, please dial 1-877-407-0792 in theU.S.or 1-201-689-8263 outside theU.S.and provide the conference ID number: 13728852.
- Following the live webcast, an archived version of the call will be available on the website.
