Company Overview - Valneva SE is a specialty vaccine company focused on developing, manufacturing, and commercializing prophylactic vaccines for infectious diseases, addressing unmet medical needs [6] - The company has a strong track record of advancing multiple vaccines from early R&D to approvals and currently markets three proprietary travel vaccines [6] - Valneva's vaccine pipeline includes candidates for Lyme disease, Zika virus, and other global public health threats, with revenues from its commercial business supporting ongoing development [6] Chikungunya Vaccine Update - The UK’s Commission on Human Medicines (CHM) has updated its recommendations for Valneva's single-dose chikungunya vaccine, IXCHIQ, following a review of its benefits and risks [1] - The updated prescribing information includes restrictions for individuals over 60 years of age and those with specified health conditions, as well as guidelines on vaccination timing prior to travel [2] - The benefit-risk profile of IXCHIQ remains favorable for individuals aged 18 to 59 years who are at risk of chikungunya infection without contraindicated medical conditions [2][3] Safety Monitoring and Regulatory Actions - The update follows a temporary suspension of IXCHIQ's use in older individuals due to reports of serious adverse events primarily among elderly patients with significant underlying health conditions during a vaccination campaign [3] - Valneva is committed to maintaining high safety standards and will continue to monitor post-marketing safety data for IXCHIQ, collaborating with relevant authorities for potential updates to recommendations [4] Chikungunya Virus Context - Chikungunya virus (CHIKV) is a mosquito-borne disease causing severe joint pain, fever, and other symptoms, with significant global outbreaks since 2004 [5] - Over 3.7 million cases were reported in the Americas between 2013 and 2023, with the economic impact considered substantial, expected to grow due to climate change affecting mosquito distribution [5] - The World Health Organization (WHO) has identified chikungunya as a major public health problem, highlighting the need for effective vaccine solutions [5]

Market Overview - U.S. stock futures are lower, with Dow futures dropping approximately 700 points [1] Company-Specific Developments - Valneva SE has withdrawn its IXCHIQ Chikungunya vaccine BLA and IND in the U.S. following an FDA suspension and a review of new serious adverse events, leading to a 7.7% decline in shares to $9.29 in pre-market trading [1] - Rezolve AI PLC shares fell 15% to $3.92 in pre-market trading [2] - POET Technologies Inc experienced an 11.2% decline to $7.37 in pre-market trading [2] - Forward Industries Inc shares decreased by 10.5% to $7.70 after a previous gain of 4% on Friday [2] - Babcock & Wilcox Enterprises Inc shares dipped 9.9% to $7.59 in pre-market trading [2] - Bakkt Holdings Inc fell 9.5% to $19.38 after a 10% increase on Friday [2] - Applovin Corp shares decreased by 9.5% to $515.03 after a 6% decline on Friday [2] - ALT5 Sigma Corp shares fell 8.9% to $2.36 after gaining 7% on Friday, despite regaining Nasdaq compliance [2] - HIVE Digital Technologies Ltd shares dropped 7.7% to $3.20 in pre-market trading [2] - Aeva Technologies Inc shares declined 6.8% to $18.01 in pre-market trading [2] - Bitdeer Technologies Group fell 6.8% to $14.75 in pre-market trading [2] - Terrestrial Energy Inc shares decreased by 6.3% to $10.95 in pre-market trading [2] - Tesla Inc shares fell 2.7% to $425.75, with CEO Elon Musk confirming that vehicles equipped with the AI4 (HW4) chip will achieve unsupervised autonomous driving without upgrades [2] - NVIDIA Corp shares declined 2.4% to $181.77 in pre-market trading [2]

Core Viewpoint - Valneva SE has voluntarily withdrawn its biologics license application and Investigational New Drug application for its chikungunya vaccine, IXCHIQ, in the United States due to regulatory challenges and safety investigations [1][2]. Regulatory Actions - The U.S. FDA suspended the vaccine's license in August 2025, leading Valneva to await further guidance on its response [2]. - The FDA has placed the IND on clinical hold pending an investigation into a newly reported foreign Serious Adverse Event (SAE) [2]. Clinical Studies and Safety - Currently, no clinical studies involving IXCHIQ are actively vaccinating participants [3]. - Valneva intends to proceed with planned post-marketing clinical activities, subject to discussions with regulatory authorities [3]. Serious Adverse Event Investigation - The SAE under investigation occurred outside the U.S. and involved a younger adult who received three concomitant vaccines, including IXCHIQ [4]. - The case may be plausibly related to IXCHIQ vaccination, although causality has not been determined [4]. - The company is actively seeking additional details to further characterize the case [4]. Commitment to Safety - Valneva emphasizes its commitment to the highest safety standards and continues to engage proactively with authorities in all territories where IXCHIQ is licensed, including Europe, Canada, the United Kingdom, and Brazil [5]. Vaccine Target and Profile - IXCHIQ is targeted at travelers to regions where the chikungunya virus is endemic, such as tropical and subtropical areas in Asia, Africa, and the Americas [6]. - Valneva maintains that IXCHIQ's benefit-risk profile remains favorable for individuals living in endemic and outbreak settings, highlighting its unique positioning as a highly durable single-shot vaccine [6].

Core Viewpoint - Valneva SE has voluntarily withdrawn its biologics license application (BLA) and Investigational New Drug (IND) application for its chikungunya vaccine, IXCHIQ, in the U.S. following a suspension by the FDA due to safety concerns related to a Serious Adverse Event (SAE) [1][3][11] Company Summary - Valneva SE is a specialty vaccine company focused on developing, manufacturing, and commercializing vaccines for infectious diseases, addressing unmet medical needs [7] - The company has a strong track record of advancing multiple vaccines from early R&D to approvals and currently markets three proprietary travel vaccines [8] - Revenues from its commercial business support the advancement of its vaccine pipeline, which includes candidates for Lyme disease and Shigella, among others [9] Industry Context - Chikungunya virus (CHIKV) is a mosquito-borne disease that has caused significant outbreaks globally, with over 3.7 million cases reported in the Americas between 2013 and 2023 [6] - The World Health Organization (WHO) has identified chikungunya as a major public health problem, with the economic impact expected to grow due to climate change affecting the spread of mosquito vectors [6]

Core Viewpoint - Valneva has reported its share capital and voting rights as of December 31, 2025, indicating changes in the number of shares and voting rights due to various corporate actions [2]. Group 1: Share Capital and Voting Rights - The total number of shares composing the share capital of Valneva is 173,539,745 ordinary shares with a par value of €0.15 each [2]. - The total number of voting rights, including suspended voting rights, is 189,428,384 [2]. - The total number of voting rights excluding suspended voting rights is 189,304,062 [2]. Group 2: Changes in Voting Rights - Double voting rights were granted on 3,412 ordinary shares [2]. - A transfer into bearer form of 4,895 shares with double voting rights occurred [2]. - The exercise of stock options resulted in the issuance of 429,317 new ordinary shares [2]. - The definitive attribution of 255,218 free ordinary shares took place on December 15, 2025 [2].

Group 1: Market Overview - U.S. stocks experienced an upward trend, with the Dow Jones index increasing by over 100 points on Tuesday [1] - Microchip Technology Inc's shares rose significantly after the company revised its fiscal third-quarter revenue expectations upward [1] Group 2: Microchip Technology Inc - Microchip now anticipates third-quarter fiscal 2026 net sales of approximately $1.185 billion, surpassing its previous guidance range of $1.109 billion to $1.149 billion [2] - The stock price of Microchip Technology increased by 8.1%, reaching $72.47 on Tuesday following the announcement [2] Group 3: Other Notable Stock Movements - Alumis Inc saw a remarkable 129% increase in its stock price to $19.04 after positive trial results for envudeucitinib [3] - Aeva Technologies Inc's stock rose by 31.5% to $17.21 due to its technology being selected for NVIDIA's autonomous vehicle platform [3] - Terrestrial Energy Inc's shares increased by 26.9% to $8.87 after securing an agreement with the U.S. Department of Energy [3] - Bright Minds Biosciences Inc gained 25% to $100.00 following successful Phase 2 trial results [3] - OneStream Inc's stock rose by 25.1% to $23.00 amid reports of a potential buyout [3] - Other companies such as SanDisk Corp, Beam Therapeutics Inc, and Albemarle Corp also recorded significant stock price increases [3]

Core Insights - Valneva SE and Serum Institute of India have mutually agreed to discontinue their license agreement for Valneva's single-shot chikungunya vaccine, allowing Valneva to regain full rights and control over its supply chain and commercialization efforts in endemic high-risk countries [1][2] Group 1: Company Overview - Valneva SE is a specialty vaccine company focused on developing, manufacturing, and commercializing prophylactic vaccines for infectious diseases, addressing unmet medical needs [5] - The company has advanced multiple vaccines from early R&D to approvals and currently markets three proprietary travel vaccines [6] - Valneva's revenue from its growing commercial business supports the advancement of its vaccine pipeline, which includes a Lyme disease vaccine candidate partnered with Pfizer and a Shigella vaccine candidate [7] Group 2: Chikungunya Vaccine Context - Chikungunya virus (CHIKV) is a mosquito-borne disease causing severe joint pain, fever, and other symptoms, with significant economic and medical burdens expected to grow due to climate change [3][4] - Since 2004, chikungunya has spread to over 110 countries, with more than 3.7 million cases reported in the Americas between 2013 and 2023, highlighting the disease as a major public health problem according to the WHO [4] Group 3: Strategic Partnerships and Funding - Valneva's strategic intent to regain rights to the chikungunya vaccine aligns with its commitment to support access in low-and-middle-income countries, as outlined in a funding agreement with the Coalition for Epidemic Preparedness Innovations (CEPI) [2] - CEPI aims to accelerate vaccine development and ensure equitable access, having supported over 70 vaccine candidates against high-risk pathogens [8] Group 4: Serum Institute of India Overview - Serum Institute of India is a global leader in vaccine manufacturing, with an annual capacity of 4 billion doses and a presence in over 170 countries [10][11] - The company focuses on producing affordable vaccines and has played a significant role in reducing the prices of essential vaccines, including those for Diphtheria, Tetanus, and COVID-19 [11]

Group 1: Market Overview - Several high-volatility healthcare and cannabis stocks experienced sharp after-hours gains despite a quiet news day, driven by recent catalysts and technical momentum [1] Group 2: Tilray Brands, Inc. (TLRY) - Tilray's stock rose by 11.36% after hours, reaching $13.53, following a one-for-ten reverse stock split effective December 1, and had already increased by 44.13% during the day [2] Group 3: Valneva SE (VALN) - Valneva's shares increased by 7.22% after hours to $9.31, recovering from a 3.45% decline earlier in the day, supported by positive data from its Phase 2 chikungunya vaccine trial [3] Group 4: Chemomab Therapeutics Ltd. (CMMB) - Chemomab's stock rose by 7.66% after hours to $2.39, reacting to results from its Phase 2 SPRING trial published in the American Journal of Gastroenterology [4] Group 5: Genenta Science S.p.A. (GNTA) - Genenta's shares climbed by 12.06% after hours to $1.58, rebounding from a 14.5% drop, following updated data from its TEM-GBM study in glioblastoma patients [5] Group 6: Kazia Therapeutics Limited (KZIA) - Kazia's stock increased by 10.93% after hours to $11.57, recovering from a 20% decline, after presenting new evidence for its PI3K/mTOR inhibitor at the 2025 SABCS [6] Group 7: Traws Pharma, Inc. (TRAW) - Traws Pharma's shares edged up by 8.81% after hours to $2.54, maintaining active trading momentum despite no new developments [7]

Core Insights - Valneva SE announced positive final antibody persistence and safety data for its Phase 2 clinical trial of the chikungunya vaccine IXCHIQ, showing promising results in 304 children twelve months post-vaccination [1][2][3] Vaccine Efficacy and Safety - The full dose of IXCHIQ elicited a 94.7% seroresponse rate in chikungunya virus-naïve children at Day 360, indicating a strong immune response [3][4] - The vaccine was well tolerated across all age groups tested, with no safety concerns identified [3][4][9] - The trial results align with previous data reported in January and June 2025, confirming the robustness of the immune response and safety profile [2][5] Future Development Plans - The company plans to initiate a Phase 3 study in children after gathering additional real-world experience in the adolescent population, emphasizing the importance of safety [5][9] - The selection of the full dose for future trials is supported by the favorable immune response and safety data observed [4][9] Chikungunya Context - Chikungunya has seen a significant rise in cases globally, with Brazil reporting over one million cases from January 2019 to July 2024, highlighting the urgent need for effective vaccination [5][7] - The World Health Organization has identified chikungunya as a major public health problem, with the disease affecting over 110 countries since its re-emergence [6][7] Trial Details - The Phase 2 trial (VLA1553-221) was a multi-center, randomized, observer-blinded study involving 304 healthy children aged one to eleven years, conducted in the Dominican Republic and Honduras [8][10] - Participants were randomized to receive either a full dose, a half dose, or an active control, with the primary focus on evaluating safety and immunogenicity [8][10]

Core Insights - Valneva SE has released final immunogenicity and safety data from the Phase 2 study of its Lyme disease vaccine candidate, VLA15, indicating a strong immune response and favorable safety profile six months after a third booster dose [1][2][4] Vaccine Efficacy and Safety - The study demonstrated a robust anamnestic immune response across all age groups, confirming the vaccine's compatibility with the expected benefits of annual vaccination before Lyme season [2][4] - Antibody levels remained significantly higher with a three-dose primary vaccination schedule compared to a two-dose schedule, with geometric mean fold rises (GMFRs) ranging from 9.5-fold for Serotype 1 (ST1) to 15.6-fold for Serotype 2 (ST2) [5][6] - The highest GMFRs were observed in the 5 to 11-year-old age group, with levels ranging from 15.5-fold (ST1) to 28.5-fold (ST2), further validating the three-dose schedule and yearly booster [6] Regulatory Pathway - Pfizer aims to submit a Biologics License Application to the U.S. FDA and a Marketing Authorization Application to the European Medicines Agency in 2026, contingent on positive Phase 3 data [4] Operational Strategy - Valneva announced a strategic initiative to optimize its organizational footprint in France, planning to consolidate operations at its Lyon location and close the Nantes site [7] Market Reaction - Following the announcement, Valneva shares increased by 7.65%, reaching $9.19 [8]