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Opiant Pharmaceuticals (NASDAQ: OPNT) announced a Notice of Allowance from the USPTO for OPNT004 (drinabant), aimed at treating cannabinoid hyperemesis syndrome (CHS). This significant step indicates that the patent for a parenteral formulation of drinabant will likely be granted soon, anticipated to expire no earlier than 2040. The company believes that the rising use of cannabis due to legalization may increase CHS cases, thereby creating a market for OPNT004, which is expected to enter Phase I studies in 2023.
Mind Medicine (MindMed) Inc. (NASDAQ: MNMD) announced the appointment of Dr. Suzanne Bruhn and Dr. Roger Crystal as independent members of its Board of Directors, effective August 11, 2022. Their extensive experience in life sciences and product development is expected to aid MindMed in advancing its product candidates aimed at treating brain health disorders. Dr. Bruhn, formerly of Tiaki Therapeutics, and Dr. Crystal, CEO of Opiant Pharmaceuticals, bring significant expertise to the board. The company also announced Dr. Halperin Wernli's retirement from the board while continuing her role as President.
Opiant Pharmaceuticals (NASDAQ: OPNT) reported Q2 2022 revenues of $3.9 million, a decline from $11.3 million in Q2 2021, attributing $2.3 million to NARCAN® sales through Emergent BioSolutions (EBS). Opiant issued a default notice to EBS for underpayment of royalties, claiming $9.1 million is owed. R&D expenses surged to $7.9 million, up from $3.1 million year-over-year. The net loss for Q2 2022 was approximately $11.8 million, marking a substantial decline from a net income in Q2 2021. Opiant maintains a strong financial position with $40.2 million in cash as of June 30, 2022, and continues development of OPNT003 for opioid overdose.
Opiant Pharmaceuticals announced a $2.1 million grant from BARDA to support the development of OPNT003, a nasal nalmefene treatment for opioid overdose. This funding focuses on preparing a New Drug Application (NDA) for FDA submission. The opioid crisis remains severe, with over 80,000 deaths linked to overdoses in the U.S. from February 2021 to February 2022. OPNT003 has demonstrated promising results in clinical trials, showing rapid absorption and superior effectiveness compared to nasal naloxone. Opiant aims to complete the NDA filing in the latter half of 2022.
Opiant Pharmaceuticals announced a Notice of Allowance from the USPTO for U.S. Patent Application No. 16/461,354 related to OPNT003, an investigational treatment for opioid overdose. This patent protects the formulation and methods involving nalmefene and Intravail® in a nasal delivery system, extending patent protection until 2037. The company is also in the process of submitting a New Drug Application to the FDA for OPNT003, aiming for completion in H2 2022. This follows OPNT003's Fast Track Designation from the FDA in November 2021.
Opiant Pharmaceuticals, Inc. (NASDAQ: OPNT) will report its financial results for Q2 2022 on August 11, 2022, after market close. A conference call with management is scheduled for the same day at 4:30 p.m. ET, accessible via U.S. and international lines. Opiant, known for its NARCAN® Nasal Spray, focuses on developing treatments for addiction and drug overdose. For further details, visit www.opiant.com.
Opiant Pharmaceuticals, Inc. (NASDAQ: OPNT) announced the grant of 25,900 restricted stock units (RSUs) to seven new employees as part of its 2022 Inducement Equity Incentive Plan. The RSUs serve as material inducements for employment, in accordance with Nasdaq Listing Rule 5635(c)(4). Each RSU will vest over four years, with the first 25% vesting on the one-year anniversary of the grant date. Opiant, known for developing NARCAN® Nasal Spray, focuses on creating medicines to combat addictions and drug overdoses.
Opiant Pharmaceuticals (NASDAQ: OPNT) has entered a long-term agreement with Aptar Pharma to expand production of the nasal Unidose device for OPNT003, an opioid overdose treatment. The agreement includes a €2 million (approx. $2.1 million) investment from Opiant to support increased production capacity. Opiant is in the process of submitting a New Drug Application (NDA) to the FDA, utilizing the 505(b)(2) pathway, with plans to complete it in the second half of 2022. This move aims to ensure rapid supply of OPNT003 to communities if approved.
Opiant Pharmaceuticals (NASDAQ: OPNT) filed the first module of its New Drug Application (NDA) for OPNT003, a nasal nalmefene aimed at treating opioid overdose. This submission follows a previous agreement with the FDA and is part of a rolling submission process, expected to complete by late 2022. The opioid crisis is worsening, with over 80,000 deaths reported in 2021, prompting urgent need for new treatments. OPNT003 has shown promising results in pharmacokinetic studies, demonstrating rapid and sustained effects against opioid overdose.
Opiant Pharmaceuticals, Inc. (NASDAQ: OPNT) announced a virtual-only format for its 2022 Annual Meeting of Shareholders due to rising COVID-19 cases. The meeting will take place on June 14, 2022, at 9:00 AM PDT. Shareholders of record as of April 18, 2021, will participate and need their control number to vote. Opiant encourages early voting and will provide the proxy statement on its website. Those without a control number can attend as guests but cannot vote. Further information is available on Opiant’s website.
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