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Regulatory

EVOK

Evoke Pharma, Inc. announced that its new patent for GIMOTI nasal spray is now listed in the FDA's Orange Book, extending patent protection to 2029. This listing adds to the existing three patents for GIMOTI and reinforces the company's IP portfolio. The Orange Book listing aids in monitoring potential generic competition.

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November 27, 2023 | 1:32 pm

MULN

Mullen Automotive Inc. (NASDAQ:MULN) and Rapid Response Defense Systems (RRDS) have filed responses for a U.S. Customs and Border Protection application regarding Mullen's Class 1 EV cargo van. The application details the substantial transformation of the vehicle to meet U.S. standards, which could classify it as a U.S.-made product. The assembly process occurs in Mullen's Mississippi facility, employing 103 individuals, with the company employing around 400 nationwide. Mullen sources globally but is adding domestic suppliers to its supply chain. A successful ruling, expected within 45 days, would affirm Mullen's commitment to the U.S. EV market. Mullen and RRDS will showcase the Mullen ONE EV cargo van at the Fed Fleet conference in Washington, D.C. in January 2024.

Portfolio Pulse from Benzinga Newsdesk

November 27, 2023 | 1:31 pm

BIMI

BIMI International Medical Inc. received a notification from Nasdaq for non-compliance with Listing Rule 5250(c)(1) due to not filing its Q3 Form 10-Q. The company had previously been granted an extension to file its Q2 Form 10-Q, which it has now filed. BIMI must submit an updated plan to regain compliance, with a deadline of February 20, 2024, to file all delinquent reports.

Portfolio Pulse from Benzinga Newsdesk

November 27, 2023 | 1:25 pm

AZUL

SRFM

Surf Air Mobility Inc. (NYSE:SRFM) and Azul S.A. (NYSE:AZUL) have entered into an agreement to incorporate electric powertrains into Azul's Cessna Caravan fleet. The collaboration aims to develop Surf Air Mobility's proprietary electric powertrain technology in Brazil, with a focus on meeting regulatory requirements and achieving certification by 2026. Azul's goal is to reach net-zero carbon emissions by 2045, and the electrification of its fleet is a step towards this. The partnership is expected to reduce operating costs by 50% and eliminate carbon emissions for the aircraft, potentially improving the economics of Azul's routes and enabling new routes.

Portfolio Pulse from Benzinga Newsdesk

November 27, 2023 | 1:21 pm

VINE

Fresh Vine Wine, Inc. (NYSE:VINE) received an Acceptance Letter from NYSE American confirming the acceptance of its compliance plan. The company was previously notified of non-compliance with the stockholders' equity requirement of Section 1003(a)(ii) of the NYSE American Company Guide, having reported stockholders' equity below $4 million and losses in recent fiscal years. Fresh Vine Wine reported $2.4 million in equity as of June 30, 2023, and $1.1 million as of September 30, 2023. The company has until March 8, 2025, to regain compliance with Sections 1003(a)(i) and (ii), during which it will be subject to periodic reviews and risk of delisting if it fails to comply. Its stock will continue to trade under the symbol 'VINE' with a '.BC' indicator signaling noncompliance.

Portfolio Pulse from Benzinga Newsdesk

November 27, 2023 | 1:19 pm

VEON

VEON Ltd. (NASDAQ:VEON) has introduced a new Clawback Policy and updated its incentive plans to align with Nasdaq listing standards and enhance corporate governance. The policy allows for the recovery of erroneously awarded compensation in case of accounting restatements and aims to align executive remuneration with shareholder interests. The changes reflect VEON's commitment to ethical practices and financial integrity.

Portfolio Pulse from Benzinga Newsdesk

November 27, 2023 | 1:14 pm

IPA

ImmunoPrecise Antibodies Ltd. (NASDAQ:IPA) has announced key appointments to its Board of Directors, including Mitch Levine as the new Chairman of the Board. Levine brings extensive experience in the life sciences industry and financial strategy, particularly with Nasdaq market operations. Chris Buyse has been appointed as Chairman of the Remuneration and Nomination Committee, and Dirk Witters as the new Chairman of the Audit Committee. These appointments are expected to guide IPA's growth in biotechnology. Additionally, IPA will host a conference call on December 14, 2023, to discuss its Q2 fiscal year 2024 financial results.

Portfolio Pulse from Benzinga Newsdesk

November 27, 2023 | 1:13 pm

TAK

Takeda (NYSE:TAK) will present 17 company-sponsored and nine collaborative abstracts at the 65th American Society of Hematology Annual Meeting. The presentations will include data supporting the recent FDA approval of ADZYNMA for cTTP treatment, Phase 1 data for TAK-755 in sickle cell disease, and a meta-analysis for hemophilia A. Oncology presentations will cover ICLUSIG in Ph+ ALL and ADCETRIS in Hodgkin lymphoma. The research aims to improve treatment for hematologic diseases with high unmet patient need.

Portfolio Pulse from Benzinga Newsdesk

November 27, 2023 | 1:11 pm

OTLK

Outlook Therapeutics has received the minutes from a Type A meeting with the FDA regarding ONS-5010, reaffirming its regulatory path forward. The company remains committed to advancing ONS-5010, an investigational ophthalmic formulation of bevacizumab, towards a potential Biologics License Application (BLA) submission.

Portfolio Pulse from Benzinga Newsdesk

November 27, 2023 | 1:07 pm

ICAD

iCAD, Inc. (NASDAQ:ICAD) presented new research at the RSNA annual meeting, showcasing its ProFound Breast Health Suite's ability to predict breast cancer risk and detect heart disease. The AI-powered suite can assess calcium deposits in breast arteries, indicating cardiovascular disease. Studies confirmed the suite's effectiveness in cancer detection and standardizing breast arterial calcifications (BAC) reporting. Dr. Emily Conant and other researchers highlighted the potential of iCAD's 4th generation Breast AI in improving patient outcomes. The company's solutions are at various stages of regulatory approval, with some pending FDA clearance.

Portfolio Pulse from Benzinga Newsdesk

November 27, 2023 | 1:07 pm