ZENEO®

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CROSSJECT announces a successful capital increase of €5.7 million following full exercise of the extension clause
Globenewswire· 2025-06-24 17:00
Press release CROSSJECT announces a successful capital increase of €5.7 million following full exercise of the extension clause Dijon, France June 24, 2025 (7.00 PM CET) -- CROSSJECT (ISIN: FR0011716265; Euronext: ALCJ), the specialty pharmaceutical company in late-stage clinical and regulatory development of ZEPIZURE®, its emergency treatment for the management of epileptic seizures based on the award-winning ZENEO® needle-free auto- injector, announces the successful completion of its capital increase wit ...
CROSSJECT advances on the development of ZEPIZURE® Junior, its solution for epilepsy crises in children
Globenewswire· 2025-06-11 05:30
Core Insights - CROSSJECT is advancing the development of ZEPIZURE® Junior, a solution for managing epilepsy crises in children, while also progressing with ZEPIZURE® for adults [2][6]. Company Development - CROSSJECT has completed a clinical echography study involving 90 adults and children aged 2-18 to assess anatomical characteristics relevant to the ZENEO® device's drug delivery system [4]. - The company has successfully calibrated the ZENEO® device for pediatric use, confirming its effectiveness in delivering the drug solution at the appropriate penetration depth [4][9]. - Previous studies indicated that children over 8 years old can effectively use the ZENEO® autoinjector [5]. Market Context - According to the CDC, approximately 456,000 children in the U.S. are diagnosed with active epilepsy, highlighting a significant market need for effective treatment solutions [3]. - CROSSJECT aims to establish ZEPIZURE® as the standard of care for pediatric epilepsy, indicating a strategic focus on this demographic [6]. Financial and Regulatory Aspects - CROSSJECT has a $60 million contract with BARDA to support the development of ZEPIZURE®, which underscores the financial backing for its pediatric initiatives [7][8].
Launch of a capital increase with preferential subscription rights for nearly 5 million euros
Globenewswire· 2025-06-04 18:22
Group 1 - CROSSJECT is launching a capital increase with preferential subscription rights for an initial total amount of approximately €4.98 million, which may increase to €5.73 million if the extension clause is exercised [3][4][9] - The company aims to use around 60% of the net proceeds for the final development phases of ZEPIZURE® and the initial production stages, while approximately 40% will be allocated to R&D for other projects and general expenses [5][6] - CROSSJECT is on track to submit an Emergency Use Authorization (EUA) application to the FDA and expects to finalize production of validation batches in June 2025 [4][7] Group 2 - The subscription price for the new shares is set at €1.40, representing a 22.6% discount to the closing price on June 3, 2025 [9][16] - Existing shareholders and Vatel Capital have committed to subscribe for approximately €3.7 million, representing 76.4% of the transaction [9][36] - The subscription period is from June 12, 2025, to June 20, 2025, with preferential subscription rights detached on June 10, 2025 [18][24][30] Group 3 - The capital increase will involve the issuance of approximately 3,556,199 new shares, which may increase to 4,089,628 shares if the extension clause is fully exercised [13][15] - The company estimates that the net working capital will be sufficient to meet obligations until the end of 2025, assuming first payments from its American partner [7] - CROSSJECT's share capital currently comprises 46,230,596 fully subscribed shares, with a par value of €0.1 each [12]
Maxim Group initiates the coverage of the CROSSJECT share with a BUY recommendation and a target price of €4.00
Globenewswire· 2025-06-03 05:30
Group 1 - Maxim Group has initiated coverage of CROSSJECT with a BUY recommendation and a target price of €4.00 [2] - The CROSSJECT share price was €1.77 on the date of the research report issuance, May 29, 2025 [3] - CROSSJECT is in advanced regulatory development for ZEPIZURE®, an epileptic rescue therapy, supported by a $60 million contract with BARDA [5][6] Group 2 - CROSSJECT specializes in developing emergency medicines using its needle-free auto-injector ZENEO® platform [5] - The company aims to provide solutions for allergic shocks, adrenal insufficiencies, and other emergency indications [5] - Patrick Alexandre, CEO of CROSSJECT, expressed excitement about the endorsement from Maxim Group and the potential for further developments in the North American market [4]
CROSSJECT prepares for the launch of a capital increase with preferential subscription rights of around 5 million euros in preparation for commercial and production activities linked to EUA approval
Globenewswire· 2025-05-20 05:30
Core Points - CROSSJECT plans to launch a capital increase of approximately 5 million euros, potentially increasing to 5.8 million euros, to support commercial and production activities related to the EUA approval of ZEPIZURE® [2][3][8] - The capital increase aims to provide financial resources for the final development phases of ZEPIZURE® and to initiate production steps, with a significant portion allocated to R&D for other projects [8][10] Offer Details - The capital increase will be executed through the issuance of new shares with preferential subscription rights, as authorized by the Supervisory Board and the Annual General Meeting [4][5] - The net proceeds will be allocated approximately 60% to ZEPIZURE® development and production, and 40% to R&D for other projects, repayment of financial creditors, and general expenses [8][9] Financial Strategy - If the Offer is limited to 75% of the issue, around 3.8 million euros, the allocation will be on a pro rata basis, prioritizing ZEPIZURE® activities [9] - The company estimates that the net working capital from the Offer will be sufficient to meet obligations until the end of 2025, assuming first payments from the US partner [10] Shareholder Support - Gemmes Venture, a 26% reference shareholder, intends to guarantee the Offer in cash up to 75% of the initial amount [11] - Heights Capital Management has indicated its intention to subscribe to the capital increase by offsetting its claim of around 0.5 million euros [12] Company Overview - CROSSJECT is a specialty pharmaceuticals company developing emergency medicines, with ZEPIZURE® in advanced regulatory development and a $60 million contract with BARDA [15][16] - The company utilizes its ZENEO® platform for easy delivery of emergency drugs via intramuscular injection [15]
CROSSJECT’s ZENEO® needle-free autoinjector consistently matches depth of traditional intramuscular injections and exceeds the standards needle length of currently utilized auto-injectors
Globenewswire· 2025-05-15 05:30
Press Release CROSSJECT’s ZENEO® needle-free auto-injector consistently matches depth of traditional intramuscular injections and exceeds the standards needle length of currently utilized auto-injectors Injection depth with ZENEO® matches that of 30-mm conventional intramuscular needles, out-performs length of needles imbedded in commercially available needle-based auto-injectors.ZENEO® further demonstrates commercial adoption potential by eliminating usage errors and mimicking traditional intramuscular inj ...
CROSSJECT provides updates on the EUA filing of ZEPIZURE®
Globenewswire· 2025-05-07 05:30
Press Release CROSSJECT provides updates on the EUA filing of ZEPIZURE® CROSSJECT and its EUROFINS CDMO partner successfully completed the aseptic filling of all ZEPIZURE® registration batches and anticipate the delivery of the last manufacturing data needed for U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) submission in June 2025.CROSSJECT started the final regulatory activities for the ZEPIZURE® dossier submission under EUA.CROSSJECT began manufacturing EUA batches, intended as ...
Eton Pharmaceuticals to Report First Quarter 2025 Financial Results on Tuesday, May 13, 2025
Globenewswire· 2025-05-01 20:30
Core Viewpoint - Eton Pharmaceuticals, Inc. will report its first quarter 2025 financial results on May 13, 2025, and will host a conference call to discuss these results [1]. Company Overview - Eton Pharmaceuticals is focused on developing and commercializing treatments for rare diseases, currently offering seven commercial products: INCRELEX®, ALKINDI SPRINKLE®, GALZIN®, PKU GOLIKE®, Carglumic Acid, Betaine Anhydrous, and Nitisinone [3]. - The company has six additional product candidates in late-stage development: ET-400, ET-600, Amglidia®, ET-700, ET-800, and ZENEO® hydrocortisone autoinjector [3]. Investor Relations - Investors can submit questions via email to investorrelations@etonpharma.com during the conference call [1]. - The live webcast of the conference call will be accessible on Eton's website, with an archived version available for 30 days post-event [2].
Mise à disposition du rapport financier annuel 2024
Globenewswire· 2025-04-30 15:45
Group 1 - The core announcement is that CROSSJECT has made its 2024 annual financial report available to the public and filed it with the French Financial Markets Authority [2][5] - CROSSJECT is a pharmaceutical company specializing in the advanced development and registration of ZEPIZURE®, an emergency solution for managing epilepsy crises [2][3] - The company has secured a $60 million contract from the U.S. Biomedical Advanced Research and Development Authority (BARDA) for the research and development of ZEPIZURE® [3][4] Group 2 - ZEPIZURE® utilizes the award-winning needle-free auto-injector ZENEO®, allowing untrained patients and caregivers to perform intramuscular injections easily and instantly in emergency situations [3] - CROSSJECT is also developing additional products for emergency treatment of allergic shocks, adrenal insufficiencies, opioid overdoses, and asthma attacks [3]