As the world awaits pivotal US data on Novavax’s Covid-19 jab, plenty of other players are still trying to get in on the second wave of vaccines. French speciality vaccine company Valneva has completed recruitment for a Phase I/II study of its inactivated, adjuvanted COVID-19 vaccine, with the first results expected in April 2021. Valneva and Pfizer will finalize the dosage analysis and prepare for the next development steps in the coming months. Valneva has reported positive initial results for two Phase 2 clinical trials of VLA15 in over 800 healthy adults. Valneva expects to report topline data in ⦠... Based on these encouraging results, Phase 3 ⦠June 3, 2021, 1:15 PM EDT SHARE THIS ARTICLE. Antibody titers were sustained after 12 months. Saint-Herblain (France), April 21, 2021 â Valneva SE, a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need, today announced it has initiated a pivotal Phase 3 clinical trial for its inactivated, adjuvanted COVID-19 vaccine candidate, VLA2001. This was mainly driven by investments in Valneva’s COVID-19 vaccine VLA2001 as well as Phase 3 clinical study costs for Valneva’s chikungunya vaccine program VLA1553. In parallel to finishing recruitment for the study, Valneva has also started production of the vaccine candidate, known as VLA2001, with the aim of optimising the timeline for potential deliveries of the jab. The initiation of the Cov-Compare trial follows the announcement of initial results from Valneva’s Phase 1/2 clinical trial, which demonstrated that the safety profile and immunogenicity were supportive of further development. As reported by Bloomberg, Phase 3 trials of the vaccine have just begun. share: Share on Facebook Tweet on Twitter Post to Reddit. VALNEVA: Valneva Initiates Phase 3 Clinical Lot Consistency Study for its Single-Shot Chikungunya Vaccine Candidate. Saint-Herblain (France), June 3, 2021 âValneva SE, a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need, today announced that it has completed recruitment for the pivotal Phase 3 trial of its inactivated, adjuvanted COVID-19 vaccine candidate, VLA2001. Saint-Herblain, 09.06.2021: Valneva Completes Phase 3 Trial Recruitment for its Inactivated COVID-19 Vaccine Candidate - Valneva SE, a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need, today announced that it has completed recruitment for the pivotal Phase 3 trial … PRESS RELEASE GlobeNewswire . Financial Information (unaudited results, consolidated under IFRS) € in million3 months ending March 31 20212020Total revenues23.235.2Product sales16.132.7Net profit/(loss)(27.7)(1.2)EBITDA(28.3) 2.4Cash 235.9 80.8 Saint Herblain (France), May 20, 2021 – Valneva SE (“Valneva” or “the Company”), a specialty vaccine company focused on the development … Despite phase 3 clinical trials only just starting, the UK government has pre-ordered more than 100 million doses of the vaccine from Valneva, with the option of buying more down the track. In the Phase 1 clinical trial of VLA1553, Valneva observed development of antibodies to chikungunya virus resulting in 100% seroconversion of the 120 healthy participants. Valneva announced a collaboration with Pfizer for late phase development and, if approved, commercialization of VLA15 3. The virus, which causes a disease named COVID-19, has never before been found in humans. Subject to successful Phase 3 data, Valneva aims to make regulatory submissions for initial approval in the autumn of 2021. In the Phase 1 clinical trial of VLA1553, Valneva observed development of antibodies to chikungunya virus resulting in 100% seroconversion of the 120 healthy participants. EMERYVILLE, Calif., April 6, 2021-- Dynavax Technologies Corporation (Nasdaq: DVAX), a biopharmaceutical company focused on developing and … 4 juin 2021 dans Actualités: VALNEVA : résultats de la Phase 3 sur le Vaccin COVID19 d’ici Septembre 4 juin 2021 dans Actualités: Performance stable pour les Biotechs françaises en 2021 Accueil » Actualités » ABIVAX : Phase 2b positive avec ABX464 dans la RCH. Researchers will then determine … In the Phase 1 clinical trial of VLA1553, Valneva observed development of antibodies to chikungunya virus resulting in 100% seroconversion of the 120 healthy participants. Valneva announced yesterday that a phase 3 trial will compare its COVID-19 vaccine candidate to AstraZeneca’s jab, which is conditionally approved in the EU under the brand name Vaxzevria. Saint-Herblain (France), April 21, 2021 – Valneva SE, a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need, today announced it has initiated a pivotal Phase 3 clinical trial for its inactivated, adjuvanted COVID-19 vaccine candidate, VLA2001. VALNEVA: Valneva Completes Phase 3 Trial Recruitment for its Inactivated COVID-19 Vaccine Candidate. First Chikungunya Vaccine Candidate to Enter Phase 3 Clinical Development Saint-Herblain , September 8, 2020 â Valneva SE a specialty vaccine company focused on prevention of diseases... | May 12, 2021 Based on these results and Valneva's discussions with regulators, VLA1553 has advanced into Phase 3 … Based on these results and Valneva's discussions with regulators, VLA1553 has advanced directly into Phase 3 clinical development. Antibody titers were sustained after 12 months. Valneva has previously reported the successful outcome of its End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) and is now preparing to initiate Phase 3 clinical studies in the USA later this year. Saint-Herblain, 03.11.2002: Valneva Reports Nine Month Results Marked by Further Major Corporate Achievements - Q3 milestones included: - Major COVID-19 vaccine partnership with U.K. government - Pre-clinical and industrialization activities on track - Positive top-line results for Lyme Phase 2 studies - First company to initiate Phase 3 study for chikungunya vaccine; EMA PRIME … Valneva announced a collaboration with Pfizer for late phase development and, if approved, commercialization of VLA15 3. Subject to successful Phase 3 data, Valneva intends to make a regulatory submission in the autumn of 2021 for initial approval. October 20, 2020- Valneva SE announced positive initial results for its second Phase 2 study (VLA15-202) of Lyme disease vaccine candidate VLA15, which investigated a vaccination schedule of Month 0-2-6 based on matching doses. VALNEVA: Valneva Initiates Phase 3 Clinical Lot Consistency Study for its Single-Shot Chikungunya Vaccine Candidate . (CercleFinance.com) - Valneva annonce avoir finalisé le recrutement de l'étude de phase 3 visant à évaluer l'homogénéité des lots cliniques de son VLA1553 à injection unique contre le chikungunya, seul candidat vaccin contre cette maladie actuellement en phase 3 dans le monde.
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