ZEPIZURE®

Search documents
CROSSJECT remains engaged during the summer break
Globenewswire· 2025-08-04 15:35
Press Release CROSSJECT remains engaged during the summer break Dijon, France, August 4, 2025 (5:30 p.m. CET) -- CROSSJECT (ISIN: FR0011716265; Euronext: ALCJ), the specialty pharmaceutical company developing emergency products based on its proprietary ZENEO® needle-free auto-injector technology, remains fully engaged to submitting the ZEPIZURE® dossier for Emergency Use Authorization (EUA). During the summer break, maintenance operations are being carried out at Crossject's three production sites. These wi ...
CROSSJECT announces a successful capital increase of €5.7 million following full exercise of the extension clause
Globenewswire· 2025-06-24 17:00
Core Viewpoint - CROSSJECT successfully completed a capital increase of €5.7 million, which will support the final registration phases of ZEPIZURE®, its emergency treatment for epileptic seizures [2][3][18] Financing Details - The capital increase was achieved through a preferential subscription rights offering, with a gross amount of €5,725,479.20 and a net amount of approximately €5,458,093.69 [2][3] - The subscription price was set at €1.40, reflecting a 22.6% discount to the closing price on June 3, 2025 [3] - Total demand for the offering reached €9.2 million, resulting in an oversubscription rate of 1.84 times the initial offering [9][18] Use of Proceeds - Approximately 60% of the net proceeds will be allocated to the final development phases of ZEPIZURE® and initial production stages [6] - The remaining 40% will finance R&D for other projects, including ZENEO® Adrenaline and ZENEO® Hydrocortisone, and cover general administrative expenses [6] Development Timeline - CROSSJECT is on track for the EUA submission to the FDA and anticipates a confirmation of receipt within one month after submission [5] - The company is also preparing for a second NDA filing for ZEPIZURE® in the second quarter of 2026 [6] Shareholder Impact - Following the capital increase, the company's share capital will amount to €5,032,022.40, comprising 50,320,224 shares [11] - Gemmes Venture, a significant shareholder, subscribed €62,460, reducing its stake from 24.7% to approximately 22.0% post-transaction [12] Legal and Regulatory Framework - The capital increase was authorized by the Supervisory Board and executed in accordance with the resolutions from the Combined General Meeting [8] - The new shares will be listed on Euronext Growth and will be fully assimilated to existing shares upon issuance [26][27]
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
Core Insights - CROSSJECT's ZENEO® needle-free auto-injector demonstrates comparable injection depth to traditional 30-mm needles and exceeds the length of many existing auto-injectors, indicating strong clinical and commercial potential [2][3][4] Company Overview - CROSSJECT is a specialty pharmaceuticals company focused on developing emergency medications, particularly through its ZENEO® needle-free auto-injector platform [6] - The company is advancing the regulatory development of ZEPIZURE®, an emergency injectable for epilepsy management, supported by a $60 million contract with BARDA [6][7] Product Performance - In a recent MRI study with 50 healthy subjects, the ZENEO® auto-injector achieved a mean injection depth of 34 mm (±7.5 mm) on bare skin and 28 mm (±8.4 mm) through clothing, both within the intended range for intramuscular injections [4] - The ZENEO® device's performance surpasses that of conventional needle-based auto-injectors, which typically have needle lengths between 11 mm and 25 mm, ensuring rapid and complete dose delivery [4][8] Clinical Validation - The study results align with previous clinical findings, confirming that midazolam injected with ZENEO® is bioequivalent to injections using a 30-mm needle [5] - Local reactions to the treatment were transient and well-tolerated, similar to those experienced with traditional intramuscular injections [5]
CROSSJECT provides updates on the EUA filing of ZEPIZURE®
Globenewswire· 2025-05-07 05:30
Core Insights - CROSSJECT is advancing the Emergency Use Authorization (EUA) filing process for ZEPIZURE®, an injectable treatment for epilepsy crises, in collaboration with BARDA [3][5][6] - The company has successfully completed critical aseptic filling steps for ZEPIZURE® and is on track with final assembly and packaging [4][9] - Initial feedback from the FDA is anticipated within one month of the submission, with the final manufacturing data expected to be delivered by June 2025 [5][9] Company Overview - CROSSJECT is a specialty pharmaceuticals company focused on developing emergency medications using its needle-free auto-injector ZENEO® platform [7] - The company has a $60 million contract with BARDA to support the development of ZEPIZURE® [7][8] - Other products in development include solutions for allergic shocks and adrenal insufficiencies, as well as various emergency therapies [7]
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]