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21st Austria weekly - Valneva S Immo 03/06/2021 [pic1]Valneva: Austrian/French specialty vaccine company Valneva announced that it has completed recruitment for the pivotal Phase 3 trial of its inactivated adjuvanted COVID-19 candidate VLA2001. Over 4 000 volunteers in United Kingdom have been randomized “Cov-Compare” VLA2001-301 which compares Valneva’s SARS-CoV-2 VLA2001 against AstraZeneca’s conditionally approved vaccine Vaxzevria. ....
21st Austria weekly - Valneva beaconsmind Lenzing 10/05/2021 [pic1]Valneva: Valneva SE a French/Austrian specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need announced today that underwriters its global offering an aggregate 7 082 762 new ordinary shares consisting public 2 318 881 American Depositary Shares each representing two concurrent private placement 2 445 000 shares in Europe other countries outside United States have exercised full their option to purchase up 1 062 414 additional form 531 207 ADSs. The ADSs will be delivered concurrently closing Global Offering. As ....
21st Austria weekly - Valneva S&T Strabag 06/04/2021 [pic1]Valneva: an Austrian/French specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need today announced positive data Part A Phase 1/2 clinical trial its inactivated adjuvanted COVID-19 candidate VLA2001. Based this data Company plans to commence a 3 by end April 2021 subject regulatory approval. In study VLA2001-201 three dose levels VLA2001 low medium high based schedule two doses vaccinations weeks apart were evaluated in 153 healthy adults aged 18 55 years.Valneva: performance: 14.77% S&T: ....
14.03.2021 Valneva: Valneva, a specialty vaccine company focused on prevention of diseases with major unmet needs, and Pfizer today announced initiation of study VLA15-221. The VLA15-221 study builds on previous positive Phase 2 studies, incorporates new dose regimens and is anticipated to be the final Phase 2 study readout before a decision to progress into pivotal Phase 3 studies. As announced in December 2020, VLA15-221 is a randomized, observer-blind, placebo-controlled Phase 2 study. It will be the first VLA15 study to include a pediatric population (aged 5-17 years). Overall, the study will enroll approximately 600 healthy participants (aged 5-65 years) who will receive VLA15 or placebo. It will compare the three-dose vaccination schedule (Month 0-2-6) with a two-dose schedule (Month 0-6). Juan Carlos Jaramillo, Chief Medical Officer of Valneva commented, “This trial initiation marks an important step in the development of VLA15 toward a potential licensure. Includin ....
17.01.2021 Valneva: Valneva, an Austrian/French specialty vaccine company focused on prevention against diseases with major unmet needs, today announced an amendment to the terms of its existing debt facility with US-based healthcare investment firms Deerfield Management Company and OrbiMed. Noting the COVID-19 pandemic impact on the travel industry, and following a temporary waiver of the revenue covenant for the second half of 2020, Valneva, Deerfield and OrbiMed have agreed to modify this covenant for 2021 and 2022, replacing the twelve month rolling Euro 115 mn with quarterly minimum revenues representing an annual total of Euro 64 mn in 2021 and an annual total of Euro 103.75 mn in 2022. The parties have also agreed to modify the minimum cash requirement to Euro 50 mn for 2021 and 2023 and to Euro 35 mn for the following years. ....