Curevac B.V. Stock Price, News & Analysis

CureVac N.V. (CVAC) has announced a strategic pivot in its COVID-19 vaccine efforts, prioritizing the development of second-generation mRNA vaccine candidates in partnership with GSK. The company will withdraw its first-generation vaccine candidate, CVnCoV, from regulatory review due to potential overlaps with approval timelines for newer candidates. CureVac expects the second-generation program to enter clinical development soon and aims for market readiness in 2022, with reported pre-clinical data indicating up to 10x higher immunogenicity than CVnCoV.

CureVac has announced a strategic adjustment to its European manufacturing network in response to decreased demand for its COVID-19 vaccine candidate, CVnCoV, currently under review by the EMA. The company is terminating contracts with WACKER and Celonic while maintaining agreements with Rentschler Biopharma and Novartis. This move aims to align manufacturing capacity with actual demand. Vaccine production for the second-generation COVID-19 candidate, CV2CoV, developed with GSK, remains unaffected and is expected to enter clinical trials in Q4 2021.

CureVac (Nasdaq:CVAC) announced groundbreaking findings demonstrating the efficacy of HNF4A mRNA therapeutics in treating liver fibrosis and cirrhosis, published in the Journal of Hepatology. The preclinical study showed that treatment in mouse models significantly restored HNF4A levels, reducing liver injury. This research is a crucial step towards developing effective therapies for a condition that causes millions of deaths annually. Ongoing research will focus on optimizing these mRNA candidates for future clinical applications.

CureVac N.V. reported financial results for Q2 and H1 2021, showing a cash position of €1.36 billion as of June 30. Vaccine candidate CVnCoV has demonstrated 48% efficacy across all age groups, particularly 53% in ages 18-60. A second-generation vaccine, CV2CoV, showed improved immune responses in preclinical studies and is set to enter Phase 1 trials in Q4 2021. However, total revenues decreased by 35% and 14% year-over-year due to a one-time revenue effect in 2020. Operating losses increased to €147.8 million in Q2.

CureVac has announced results from its pivotal Phase 2b/3 HERALD study of COVID-19 vaccine candidate CVnCoV, demonstrating overall vaccine efficacy of 48% against COVID-19 of any severity. The study included 40,000 participants across 10 countries and showed significant efficacy of 53% in participants aged 18 to 60. Notably, CVnCoV provided full protection against hospitalization or death in this age group. CureVac is in ongoing discussions with the European Medicines Agency (EMA) regarding regulatory submission.

CureVac N.V. (NASDAQ:CVAC) announced the appointment of Dr. Malte Greune as Chief Operating Officer effective July 1, 2021. Dr. Greune, with extensive pharmaceutical experience, will lead CureVac's clinical and commercial manufacturing initiatives. Concurrently, Dr. Florian von der Mülbe resigns from the Management Board to focus on The RNA Printer project, enhancing CureVac's mobile RNA vaccine manufacturing capabilities. Dr. Greune's leadership aims to transition CureVac from a science-driven to a commercial pharmaceutical entity, boosting its RNA-based product development.

CureVac N.V. (NASDAQ:CVAC) announced the results of its annual general meeting where shareholders approved most proposals, notably the appointments of Antony Blanc and Klaus Edvardsen as managing directors, and the re-appointment of Pierre Kemula. However, they rejected the authorization for the management board to acquire shares. The company emphasizes its focus on mRNA technology, leveraging over 20 years of expertise to develop innovative therapies across various domains.

CureVac N.V. (NASDAQ:CVAC) announced significant changes to its Supervisory Board. Dr. Ingmar Hoerr has withdrawn his candidacy due to ongoing health issues, while Dr. Timothy M. Wright has resigned to focus on personal endeavors. Both were recognized for their contributions to the company, with Hoerr credited for advancing mRNA technology. CureVac continues to develop transformative mRNA-based medicines and has a diverse clinical pipeline targeting vaccines, cancer therapies, and rare diseases. The company remains committed to its innovative approach in the biopharmaceutical sector.

CureVac (NASDAQ:CVAC) announced its second interim analysis of the HERALD study, which evaluated its COVID-19 vaccine candidate CVnCoV. Conducted across 10 countries with approximately 40,000 participants, the analysis revealed an interim efficacy of 47% against COVID-19; however, it did not meet the statistical success criteria. The safety profile remained favorable. Out of 134 assessed cases, 57% were due to variants of concern. The study is progressing towards a final analysis, with results shared with the European Medicines Agency (EMA). CureVac is also advancing second-generation vaccine candidates.