MEDINCELL Aktie

 

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PETAH TIKVA (dpa-AFX) - Teva Pharmaceuticals, the U.S. affiliate of Teva Pharmaceutical Industries Ltd. (TEVA), together with Medincell, announced that the U.S. Food and Drug Administration (FDA) ......

PARSIPPANY, N.J. and TEL AVIV, Israel and PARIS, Feb. 20, 2026 (GLOBE NEWSWIRE) -- Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), and Medincell (Euronext: MEDCL), announced today that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for olanzapine extended-release injectable suspension (TEV-'749) for the treatment of schizophrenia in adults. TEV-'749 is designed to improve real-world treatment adherence and help patients maintain long-term stability, with the goal of addressing a critical treatment gap for people living with schizophrenia....

Medincell's overall ESG rating has been upgraded from C+ to B by ISS, a leading global provider of sustainability ratings Medincell is ranked in the first decile of the Pharmaceuticals & Biotechnology sector Medincell's ESG disclosure is classified at a very high transparency levelMONTPELLIER, France--(BUSINESS WIRE)--Regulatory News: Medincell (Euronext Paris: MEDCL), a commercial- and clinical-stage biopharmaceutical licensing company developing long-acting injectable treatments, today announces that ISS has upgraded the company's ESG rating from C+ to B. Medincell is ranked within the first decile of the Pharmaceuticals & Biotechnology sector, benefits from ISS ESG Prime Status, and achieves a very high level of ESG disclosure transparency. This updated rating is based on ISS ESG's independent assessment of multiple extra‑financial criteria, including: Social factors and product responsibility, Governance and business ethics requirements as defined within the ISS ESG methodology, and Selected env...

OLANZAPINE LAI: EU Submission Expected in Q2 2026MONTPELLIER, France--(BUSINESS WIRE)--Regulatory News: Medincell's (Paris:MEDCL) partner, Teva Pharmaceuticals, today shared the following information in connection with the publication of its Q4 and full‑year 2025 results: About UZEDY® 2025 net sales reached $191 million, including $55 million in the fourth quarter Teva's initial 2026 net sales outlook is in the range of $250 - $280 million Medincell receives mid‑to high‑single-digit royalties on UZEDY® net sales and is eligible for up to $105 million in commercial milestone payments, subject to the achievement of annual sales thresholds. About OLANZAPINE LAI Olanzapine Long-Acting Injectable (LAI) has the potential to offer the efficacy of olanzapine in a once-monthly, subcutaneous formulation for a broad population of patients living with schizophrenia.1 Submission of Olanzapine LAI in the European Union for the treatment of schizophrenia in adults is expected in Q2 2026 Following submission to...

MONTPELLIER, France--(BUSINESS WIRE)--Regulatory News: Medincell (Paris:MEDCL): Event Date Annual results 2025-2026 (April 2025-March 2026) Tuesday, June 16, 2026 General Meeting Thursday, September 10, 2026 Half-Year results 2026-2027 (April-September 2026) Tuesday, December 8, 2026 About Medincell Medincell is a clinical- and commercial-stage biopharmaceutical licensing company developing long-acting injectable treatments across multiple therapeutic areas. Our innovative treatments are designed to ensure adherence to medical prescriptions, enhance the effectiveness and accessibility of medicines, and reduce their environmental impact. These treatments combine active pharmaceutical ingredients with our proprietary BEPO® / BEPO® Star technologies, which enables controlled drug delivery at therapeutic levels for several days, weeks, or months following a subcutaneous or local injection of a small, fully bioresorbable deposit. Risperidone LAI was the first treatment based on BEPO® technology to receive F...

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(April 1st, 2025 - September 30, 2025) MONTPELLIER, France--(BUSINESS WIRE)--Regulatory News: Christophe Douat, CEO of Medincell (Paris:MEDCL): “We are pleased with the company's growth and momentum. We have entered the most transformative years in Medincell's history. UZEDY delivers strong performance and the expected launch of olanzapine LAI next year is poised to be a major catalyst for Medincell's growth. We keep advancing the third engine of our Shift to Growth strategy, with our first program in partnership with AbbVie leading the way, while further expanding and diversifying our pipeline and collaborations with leading pharmaceutical partners.” Stéphane Postic, CFO of Medincell: “Revenues are growing and are expected to accelerate in the coming years with Olanzapine LAI. We have refined our investment plan to allocate resources strategically, with discipline and ambition. This approach is designed to create sustainable value and position Medincell for long-term success.” Consolidated fi...

MONTPELLIER, France--(BUSINESS WIRE)--Regulatory News: Medincell (Paris:MEDCL) will hold a videoconference on Tuesday December 9, 2025 to present the half-year financial results (April 2025-September 2025) > Meeting in French, 6:00 pm (CET): https://www.medincell.com/fr/live-fr/ > Meeting in English, 7:00 pm (CET): https://www.medincell.com/live-en/ Shareholders are invited to send their questions to communication@medincell.com, or through the chat system during the videoconference. About Medincell Medincell is a clinical- and commercial-stage biopharmaceutical licensing company developing long-acting injectable treatments across multiple therapeutic areas. Our innovative treatments are designed to ensure adherence to medical prescriptions, enhance the effectiveness and accessibility of medicines, and reduce their environmental impact. These treatments combine active pharmaceutical ingredients with our proprietary BEPO® technology, which enables controlled drug delivery at therapeutic levels for several ...

MONTPELLIER, France--(BUSINESS WIRE)--Medincell, a clinical-stage pharmaceutical company pioneering long-acting injectable therapies, today announced the expanded role of Dr Grace Kim, Chief Strategy Officer, U.S. Finance. Over the past two years, Grace has played a key and successful role within the Medincell team, with the initial and decisive shaping of the company's US capital growth strategy and advancing cross-border initiatives. As Medincell enters a pivotal growth phase, Dr. Kim will build on this foundation to lead and execute the next stages of company's U.S. capital growth strategy, driving long-term value for patients, partners, and investors. About Dr Grace Kim Dr Grace Kim serves as Medincell's Chief Strategy Officer, U.S. Finance, acting as an execution partner for the company's U.S. capital strategy and global expansion. Dr Grace Kim has two decades' experience in Capital Markets, Corporate Strategy, and Investment Banking. Grace previously served as Chief Strategy Officer of Molecula...

PETAH TIKVA (dpa-AFX) - Teva Pharmaceuticals, the U.S. affiliate of Teva Pharmaceutical Industries Ltd. (TEVA), in collaboration with Medincell (MEDCL.PA), announced that the U.S. Food and Drug Ad......

PARSIPPANY, N.J. and TEL AVIV, Israel and PARIS, Oct. 10, 2025 (GLOBE NEWSWIRE) -- Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), and Medincell (Euronext: MEDCL), announced today that the U.S. Food and Drug Administration (FDA) has approved UZEDY® (risperidone) as a once-monthly extended-release injectable suspension as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar I disorder (BD-I) in adults. The approval is based on existing clinical data for UZEDY, coupled with Model-Informed Drug Development (MIDD) methodologies that leverage previous findings on the safety and efficacy of risperidone formulations already approved for BD-I....

PETAH TIKVA (dpa-AFX) - Medincell SA (MEDCL.PA) reported that new long-term safety data from the completed Phase 3 SOLARIS trial support the potential of Olanzapine LAI (TEV-749) as the first long......

MONTPELLIER, France--(BUSINESS WIRE)--Regulatory News: Medincell (Paris:MEDCL) General Assembly held on September 11, 2025, has approved the appointments of three new independent board members: Dr Sharon Mates, Dr. Charles Kunsch, and Dr. Pascal Touchon. Dr. Sharon Mates, PhD, is the co-founder and former Chair and CEO of Intra-Cellular Therapies, a CNS-focused biotech that developed the successful drug CAPLYTA®, acquired by Johnson & Johnson for $14.6 billion in April 2025. Dr. Charles Kunsch, PhD, is a seasoned life sciences executive with over 30 years of experience, including as former Managing Director at AbbVie Ventures, where he led investments in pioneering biotech companies. Dr. Pascal Touchon, DVM, has over 40 years of international leadership in the biopharmaceutical industry, including key roles at Novartis Oncology and Atara Biotherapeutics and current board positions at Ipsen, CDR-Life, RoslinCT, Catalym and Xylocor. Philippe Guy, Chairman of Medincell's Board, said: “With the election o...

MONTPELLIER, France--(BUSINESS WIRE)--Regulatory News: Medincell's (Paris:MEDCL) combined annual general meeting (ordinary and extraordinary) will be held on September 11, 2025, at 6pm at the Company's headquarters. The notice was published in the “BALO” (French): https://www.journal-officiel.gouv.fr/telechargements/BALO/pdf/2025/0804/202508042503963.pdf The resolutions proposed for voting at the General Assembly include: Approval of the parent company and consolidated financial statements for the 2024-2025 fiscal year and allocation of the result; Election of new independent board members, seasoned professionals in the pharmaceutical field: Ms. Sharon Mates, Mr. Charles Kunsch, and Mr. Pascal Touchon; Approval of existing related-party agreements; Approval of executive compensation elements, including the budget allocated to Board of Directors' remuneration, which has been revised this year to reflect: - The transition from a governance structure based on a Supervisory Board and Management Board t...

MONTPELLIER, France--(BUSINESS WIRE)--Regulatory News: Medincell (Paris:MEDCL): Sharon Mates, PhD, is the co-founder and former Chair and CEO of Intra-Cellular Therapies, a CNS-focused biotech that developed the successful drug CAPLYTA®, acquired by Johnson & Johnson for $14.6 billion in April 2025. Dr. Mates said: "Medincell is entering a new era and I'm excited to help shape its future. Its vision and achievements closely align with my passion for advancing medical innovation and delivering meaningful solutions for patients." Charles Kunsch, PhD, is a seasoned life sciences executive with over 30 years of experience, including as former Managing Director at AbbVie Ventures, where he led investments in pioneering biotech companies. Dr. Kunsch said: “Throughout my career, I've seen how innovation and collaboration can transform bold ideas into meaningful impact. These values are deeply rooted at Medincell. They've already taken the company far and laid a strong foundation for a new phase o...

(April 1st, 2024 - March 31st, 2025) Consolidated financial statements for the year 2024-25 (IFRS standards) Revenues: €25.4 million, multiplied by 2.8x compared to previous year → Other income: €2.3 million, bringing total income to €27.7 million Operating expenses: €38.5 million, a 17% increase compared to previous year Operating result: €(10.8) million, a 48% year-over-year improvement Net result: €(18.4) million, a 26% year-over-year improvement Cash, cash equivalents and low-risk financial investments at the closing: €71.9 million → Composed of €59.0 million in cash and cash equivalent and €12.9 million in low-risk financial investments MONTPELLIER, France--(BUSINESS WIRE)--Regulatory News: Medincell (Paris:MEDCL): Christophe Douat, CEO of Medincell: “2024 marked the beginning of a new era for Medincell with the surge in our revenues notably fueled by the strong performance of UZEDY. Looking ahead, we anticipate further revenue acceleration with the expected 2026 approval and ...

MONTPELLIER, France--(BUSINESS WIRE)--Regulatory News: Medincell (Paris:MEDCL) will host two live videoconferences on Tuesday, June 17, 2025, to present its financial results for the fiscal year ending March 31, 2025. The results will be published earlier that day following the closing of the Paris stock exchange. The presentations will be held in both French and English to accommodate a broad audience of investors, analysts, and stakeholders: French session: 6:00pm CEST / 12:00pm ET > https://www.medincell.com/fr/live-fr/ English session: 7:00pm CEST / 1:00pm ET > https://www.medincell.com/live-en/ During each session, Medincell's management team will provide an overview of the company's performance and strategic outlook and will respond to questions from shareholders. Questions may be submitted in advance via email to communication@medincell.com or asked live during the videoconferences. About Medincell Medincell is a clinical- and commercial-stage biopharmaceutical licensing company developing long-...

PARSIPPANY, N.J. and TEL AVIV, Israel and PARIS, Feb. 25, 2025 (GLOBE NEWSWIRE) -- Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), and Medincell (Euronext: MEDCL) announced today that the supplemental New Drug Application (sNDA) for UZEDY extended-release injectable suspension for the maintenance treatment of BP-I in adults has been accepted for filing by the U.S. Food and Drug Administration (FDA)....

Success of the operation with €42.9 million raised. Participation of US and European Healthcare specialist investors, as well as historical shareholders, in the transaction. Funds raised will enable Medincell to strengthen licensing opportunities by expanding BEPO® technology's reach into new molecules and indications, and by potentially considering complementary technologies. Additionally, funds raised will improve the shareholder structure and reinforce the company's balance sheet, enhancing financial flexibility to drive additional long-term value creation. MONTPELLIER, France--(BUSINESS WIRE)--Regulatory News: Medincell (Paris:MEDCL): This press release is not being made in and copies of it may not be distributed or sent, directly or indirectly, into the United States, Australia, South Africa, Canada or Japan Medincell, a commercial-stage pharmaceutical technology company developing a portfolio of long-acting injectable products in various therapeutic areas (the "Company"), announced to...