2025 Q3 -tulosraportti
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Datan lähde: FactSet, Quartr| Seuraava tapahtuma | |
|---|---|
| 2025 Q4 -tulosraportti | 19.3. |
| Menneet tapahtumat | ||
|---|---|---|
| 2025 Q3 -tulosraportti | 20.11.2025 | |
| 2025 Q2 -tulosraportti | 12.8.2025 | |
| 2025 Q1 -tulosraportti | 7.5.2025 | |
| 2024 Q4 -tulosraportti | 20.3.2025 | |
| 2024 Q3 -tulosraportti | 7.11.2024 |
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- ·4.1.Quick summary:: Valneva terminates cooperation with Serum Institute to take full control over the chikungunya vaccine, with the goal of faster access in at-risk countries, supported by international funding. This is a strategic realignment – not a discontinuation. What does this mean? Valneva and Serum Institute of India are parting ways regarding the production and distribution of the chikungunya vaccine. Serum Institute will no longer have a license to produce or sell the vaccine. Valneva reclaims all rights to the vaccine: Production Deliveries Sales and distribution This gives Valneva greater flexibility and control, especially in countries where the disease is most prevalent. Focus on high-risk areas and developing countries Valneva will prioritize: - Endemic areas (where the disease is common) - Low‑ and middle‑income countries This is financially supported through CEPI and the EU, which reduces Valneva's financial risk. Not a halt in vaccine development, not a defeat for the vaccine, nor a sign that the vaccine is cancelled. On the contrary, the message signals that Valneva desires faster and more direct commercialization. For investors, this could mean: More control, but also more responsibility for Valneva Potentially higher margins in the long term Short-term uncertainty regarding production and distribution Full news:: Valneva and Serum Institute of India terminate license agreement for chikungunya vaccine 31 December 2025 Valneva SE, a specialized vaccine company, and Serum Institute of India (SII), part of the Cyrus Poonawalla Group, announced today that they have jointly agreed to terminate the license agreement for Valneva's single-dose vaccine against chikungunya. Valneva's strategic goal in regaining full rights is to take direct control over the supply chain and commercialization in endemic high-risk areas, thereby accelerating access to the vaccine in the regions hardest hit by the disease. Ensuring access to the vaccine in low‑ and middle‑income countries is part of the funding agreement Valneva entered into with the Coalition for Epidemic Preparedness Innovations (CEPI) in July 2024, with co-financing from the EU. About chikungunya Chikungunya is a viral infection transmitted by mosquitoes and can cause fever, severe joint‑ and muscle pain, headache, nausea, fatigue, and rash. The joint pain can be very debilitating and last for weeks or years. The disease spread rapidly from 2004 and has since been detected in over 110 countries. Between 2013 and 2023, more than 3.7 million cases were reported in the Americas alone. The World Health Organization (WHO) has classified chikungunya as a serious global public health problem. (Other sections describe Valneva, CEPI, Horizon Europe, and Serum Institute of India.) https://www.nordnet.no/market/news/f5ec0ccc-d202-43fe-b747-dfc82ccf274e
- ·11.12.2025Valneva reports positive final Phase 2 results for antibody persistence and safety in children for its Chikungunya vaccine IXCHIQ® Saint-Herblain (France), December 10, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced positive final antibody persistence and safety data from its Phase 2 study evaluating the safety and immunogenicity of two different dose levels of its single-shot Chikungunya vaccine IXCHIQ® in 304 children, twelve months after vaccination. The study is partly funded by the Coalition for Epidemic Preparedness Innovations (CEPI), with support from the EU. The results support further development in Phase 3 in children, which the company plans to initiate after gathering more experience from the adolescent population. The final results from VLA1553-221 were consistent with the initial data and six-month results previously reported in January and June 2025. The full dose (the licensed IXCHIQ® formulation) provided a stronger immune response in children aged 1–11 years at Day 360 post-vaccination compared to the half dose. The immunological response was consistent with what has previously been observed in adults and adolescents. The strong immune response was confirmed in children without prior CHIKV infection, with a seroresponse rate of 94.7 % (full dose) at Day 360. The vaccine was well tolerated in children regardless of dose level or prior infection, and no safety concerns were identified. The comparability between the doses in terms of safety and tolerability, combined with the more pronounced immune response at the full dose, continues to support the selection of the full dose for use in this population. Statement from Valneva: Juan Carlos Jaramillo, Chief Medical Officer at Valneva, said: “The twelve-month persistence and safety data in children are consistent with the robust antibody response and favorable safety profile previously observed in adolescents after a single vaccination. As safety is of utmost importance, especially as we move forward to a Phase 3 study in children, we have decided – in line with regulatory authorities – to gather more experience from the adolescent population before initiating our planned Phase 3 study in children.” “We are convinced that it is crucial to ensure access to a vaccine that can offer long-lasting protection with a single dose, especially in low- and middle-income countries where access to vaccines is often limited.” Global context - Brazil has reported over 1 million cases of chikungunya between January 2019 and July 2024. - India has had 370,000 cases in the same period. - In 2025, outbreaks have been reported in six countries: Bangladesh, Cuba, China, Kenya, Madagascar, Somalia, and Sri Lanka. About chikungunya - Chikungunya virus (CHIKV) is spread via bites from infected Aedes mosquitoes. - Symptoms: fever, severe joint and muscle pain, headache, nausea, fatigue, and rash. - Joint pain can be debilitating and last for weeks to years. - Since 2004, the virus has spread rapidly and is now identified in over 110 countries. - Between 2013 and 2023, more than 3.7 million cases were reported in the Americas. - WHO has highlighted chikungunya as a major global public health problem. About the Phase 2 study VLA1553-221 - Multicenter, randomized, observer-blinded dose-response study. - 304 healthy children aged 1–11 years. - Conducted at three clinical sites in the Dominican Republic and Honduras. - Participants were randomized to full dose, half dose, or active control (Nimenrix). About Valneva SE - Specialty vaccine company focused on infectious diseases with unmet needs. - Has taken several vaccines from early R&D to approval. - Markets three proprietary travel vaccines. - Pipeline includes: - The only Lyme vaccine candidate in advanced clinical development (partnered with Pfizer). - The world's most advanced Shigella vaccine candidate. - Several other vaccines against global health challenges. In short: Valneva confirms that the full dose of IXCHIQ® provides the best and most durable immune response in children, without safety concerns, and plans Phase 3 studies after more experience from adolescents. https://www.nordnet.no/market/news/366eadcc-bbc9-4729-b9e5-072ab629369c
- ·4.12.2025First Berlin Equity Research maintains its buy recommendation on Valneva SE and raises the price target to 6.80 euro, with an upside potential of around 82 %. Key points from the analysis Currently, there are no approved human vaccines against Lyme disease. Valneva and partner Pfizer are developing the vaccine VLA15, which is furthest along in clinical development. All vaccinations in the pivotal phase 3 study have been completed. Results are expected in the first half of 2026. If the results are positive, Pfizer plans to seek regulatory approval in both Europe and the USA in 2026. The vaccine could be launched in autumn 2027, in time for the 2028 tick season. Financial outlook The commercialization of VLA15 will trigger milestone payments to Valneva of 143 million USD from Pfizer in 2027. In addition, Valneva may receive 100 million USD in sales-based milestones, as well as royalties of 14–22 %. Pfizer and Valneva estimate the global market for a Lyme vaccine to be over 1 billion USD, but First Berlin considers this conservative. Based on population figures in endemic areas (approx. 70 million in the USA and 178 million in the EU), an average price of 72 USD per dose and 10 % market share, the market is estimated at over 2 billion USD. Competitive situation Moderna is the main competitor but has paused its Lyme program in phase 2 to prioritize other projects. According to Bloomberg estimates, Moderna will not generate positive EBITDA before 2029. First Berlin now assumes that a potential Moderna vaccine could be launched no earlier than 2034 (previously assumed 2030). Other factors Downward adjustments in the forecasts for Valneva's other products (Ixiaro, Dukoral and Ixchiq) are due to, among other things, a change of distributor in Germany and an FDA suspension of the product license for Ixchiq. The increased valuation of VLA15 outweighs these downward adjustments.
- ·4.12.2025OPERATIONAL UPDATE Valneva to further consolidate its operations in France • French operations to be concentrated at the company's Lyon facility • Final consolidation of R&D in Vienna Saint-Herblain (France), November 26, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) today announced a strategic initiative to optimize its organizational footprint in France as part of the company's ongoing efforts to increase operational efficiency and position Valneva for long-term success. The Company plans to concentrate its French operations at its Lyon facility and close its Nantes facility, which currently includes operational activities as well as certain preclinical R&D activities. This consolidation will streamline operations and improve efficiency in France, while centralizing all R&D at the company's Vienna facility. Valneva plans to move its registered office back to Lyon, where it was originally established, and maintain its listing on Euronext Paris. The city of Lyon in France is internationally recognized as a leading vaccine hub, home to major players such as Sanofi Vaccins and the Mérieux Group, making it an ideal location for Valneva to concentrate its French operations. Valneva is committed to supporting employees through this transition and offering assistance to ensure a smooth process for all affected employees. Valneva – Forward-Looking Statements: This press release contains certain forward-looking statements relating to Valneva’s business, including with respect to the progress, timing, results and completion of research, development and clinical trials for product candidates, to regulatory approval of product candidates and review of existing products, as well as financial guidance including expected product sales, total revenues and total R&D investments. Even if the actual results or developments of Valneva are consistent with the forward-looking statements contained in this press release, these results or developments of Valneva may not be sustainable in the future. In some cases, you can identify forward-looking statements by words such as “may,” “should,” “will,” “expect,” “anticipate,” “believe,” “intend,” “estimate,” “aim,” “target,” or similar words. These forward-looking statements are largely based on Valneva’s current expectations as of the date of this press release and are subject to a number of known and unknown risks and uncertainties as well as other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by these forward-looking statements. In particular, Valneva’s expectations could be affected by, among other things, uncertainties and delays involved in the development and manufacture of vaccines, unexpected clinical trial results, unexpected regulatory actions or delays, general competition, currency fluctuations, the impact of the global and European credit crisis, and the ability to obtain or maintain patents or other intellectual property protection. Success in preclinical studies or earlier clinical trials is not necessarily indicative of results in future clinical trials. In light of these risks and uncertainties, there can be no assurance that the forward-looking statements made in this press release will in fact be realized. Valneva provides this information as of the date of this press release and disclaims any intention or obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. https://valneva.com/wp-content/uploads/2025/11/2025_11_26_Operational-Update_PR_EN_FINAL-2.pdf
- ·4.12.2025Valneva announces positive final Phase 2 results for Lyme vaccine candidate November 26, 2025 .Antibody levels remained well above baseline across all six serotypes and age groups six months after the third annual booster dose. No safety concerns were observed in any age group by an independent Data Monitoring Committee (DMC). The results confirm the benefits of annual vaccination before each Lyme season. Saint-Herblain (France), 26. November 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) today announced positive final immunogenicity and safety data from the Phase 2 study, VLA15-221, of its Lyme vaccine candidate VLA15. The results showed a strong anamnestic immune response and a favorable safety profile six months after a third booster dose (month 48) in all age groups, confirming compatibility with the expected benefits of annual vaccination before each Lyme season. Pfizer and Valneva entered into a collaboration agreement in April 2020 for the development and commercialization of VLA15 by Pfizer. For those who want to read the full report (English) here is the link to the PDF file: https://valneva.com/wp-content/uploads/2025/11/2025_11_26_VLA15_221_Phase-2_Results-1.pdf
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2025 Q3 -tulosraportti
54 päivää sitten41 min
Uutiset
Tämän sivun uutiset ja/tai sijoitussuositukset tai otteet niistä sekä niihin liittyvät linkit ovat mainitun tahon tuottamia ja toimittamia. Nordnet ei ole osallistunut materiaalin laatimiseen, eikä ole tarkistanut sen sisältöä tai tehnyt sisältöön muutoksia. Lue lisää sijoitussuosituksista.
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- ·4.1.Quick summary:: Valneva terminates cooperation with Serum Institute to take full control over the chikungunya vaccine, with the goal of faster access in at-risk countries, supported by international funding. This is a strategic realignment – not a discontinuation. What does this mean? Valneva and Serum Institute of India are parting ways regarding the production and distribution of the chikungunya vaccine. Serum Institute will no longer have a license to produce or sell the vaccine. Valneva reclaims all rights to the vaccine: Production Deliveries Sales and distribution This gives Valneva greater flexibility and control, especially in countries where the disease is most prevalent. Focus on high-risk areas and developing countries Valneva will prioritize: - Endemic areas (where the disease is common) - Low‑ and middle‑income countries This is financially supported through CEPI and the EU, which reduces Valneva's financial risk. Not a halt in vaccine development, not a defeat for the vaccine, nor a sign that the vaccine is cancelled. On the contrary, the message signals that Valneva desires faster and more direct commercialization. For investors, this could mean: More control, but also more responsibility for Valneva Potentially higher margins in the long term Short-term uncertainty regarding production and distribution Full news:: Valneva and Serum Institute of India terminate license agreement for chikungunya vaccine 31 December 2025 Valneva SE, a specialized vaccine company, and Serum Institute of India (SII), part of the Cyrus Poonawalla Group, announced today that they have jointly agreed to terminate the license agreement for Valneva's single-dose vaccine against chikungunya. Valneva's strategic goal in regaining full rights is to take direct control over the supply chain and commercialization in endemic high-risk areas, thereby accelerating access to the vaccine in the regions hardest hit by the disease. Ensuring access to the vaccine in low‑ and middle‑income countries is part of the funding agreement Valneva entered into with the Coalition for Epidemic Preparedness Innovations (CEPI) in July 2024, with co-financing from the EU. About chikungunya Chikungunya is a viral infection transmitted by mosquitoes and can cause fever, severe joint‑ and muscle pain, headache, nausea, fatigue, and rash. The joint pain can be very debilitating and last for weeks or years. The disease spread rapidly from 2004 and has since been detected in over 110 countries. Between 2013 and 2023, more than 3.7 million cases were reported in the Americas alone. The World Health Organization (WHO) has classified chikungunya as a serious global public health problem. (Other sections describe Valneva, CEPI, Horizon Europe, and Serum Institute of India.) https://www.nordnet.no/market/news/f5ec0ccc-d202-43fe-b747-dfc82ccf274e
- ·11.12.2025Valneva reports positive final Phase 2 results for antibody persistence and safety in children for its Chikungunya vaccine IXCHIQ® Saint-Herblain (France), December 10, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced positive final antibody persistence and safety data from its Phase 2 study evaluating the safety and immunogenicity of two different dose levels of its single-shot Chikungunya vaccine IXCHIQ® in 304 children, twelve months after vaccination. The study is partly funded by the Coalition for Epidemic Preparedness Innovations (CEPI), with support from the EU. The results support further development in Phase 3 in children, which the company plans to initiate after gathering more experience from the adolescent population. The final results from VLA1553-221 were consistent with the initial data and six-month results previously reported in January and June 2025. The full dose (the licensed IXCHIQ® formulation) provided a stronger immune response in children aged 1–11 years at Day 360 post-vaccination compared to the half dose. The immunological response was consistent with what has previously been observed in adults and adolescents. The strong immune response was confirmed in children without prior CHIKV infection, with a seroresponse rate of 94.7 % (full dose) at Day 360. The vaccine was well tolerated in children regardless of dose level or prior infection, and no safety concerns were identified. The comparability between the doses in terms of safety and tolerability, combined with the more pronounced immune response at the full dose, continues to support the selection of the full dose for use in this population. Statement from Valneva: Juan Carlos Jaramillo, Chief Medical Officer at Valneva, said: “The twelve-month persistence and safety data in children are consistent with the robust antibody response and favorable safety profile previously observed in adolescents after a single vaccination. As safety is of utmost importance, especially as we move forward to a Phase 3 study in children, we have decided – in line with regulatory authorities – to gather more experience from the adolescent population before initiating our planned Phase 3 study in children.” “We are convinced that it is crucial to ensure access to a vaccine that can offer long-lasting protection with a single dose, especially in low- and middle-income countries where access to vaccines is often limited.” Global context - Brazil has reported over 1 million cases of chikungunya between January 2019 and July 2024. - India has had 370,000 cases in the same period. - In 2025, outbreaks have been reported in six countries: Bangladesh, Cuba, China, Kenya, Madagascar, Somalia, and Sri Lanka. About chikungunya - Chikungunya virus (CHIKV) is spread via bites from infected Aedes mosquitoes. - Symptoms: fever, severe joint and muscle pain, headache, nausea, fatigue, and rash. - Joint pain can be debilitating and last for weeks to years. - Since 2004, the virus has spread rapidly and is now identified in over 110 countries. - Between 2013 and 2023, more than 3.7 million cases were reported in the Americas. - WHO has highlighted chikungunya as a major global public health problem. About the Phase 2 study VLA1553-221 - Multicenter, randomized, observer-blinded dose-response study. - 304 healthy children aged 1–11 years. - Conducted at three clinical sites in the Dominican Republic and Honduras. - Participants were randomized to full dose, half dose, or active control (Nimenrix). About Valneva SE - Specialty vaccine company focused on infectious diseases with unmet needs. - Has taken several vaccines from early R&D to approval. - Markets three proprietary travel vaccines. - Pipeline includes: - The only Lyme vaccine candidate in advanced clinical development (partnered with Pfizer). - The world's most advanced Shigella vaccine candidate. - Several other vaccines against global health challenges. In short: Valneva confirms that the full dose of IXCHIQ® provides the best and most durable immune response in children, without safety concerns, and plans Phase 3 studies after more experience from adolescents. https://www.nordnet.no/market/news/366eadcc-bbc9-4729-b9e5-072ab629369c
- ·4.12.2025First Berlin Equity Research maintains its buy recommendation on Valneva SE and raises the price target to 6.80 euro, with an upside potential of around 82 %. Key points from the analysis Currently, there are no approved human vaccines against Lyme disease. Valneva and partner Pfizer are developing the vaccine VLA15, which is furthest along in clinical development. All vaccinations in the pivotal phase 3 study have been completed. Results are expected in the first half of 2026. If the results are positive, Pfizer plans to seek regulatory approval in both Europe and the USA in 2026. The vaccine could be launched in autumn 2027, in time for the 2028 tick season. Financial outlook The commercialization of VLA15 will trigger milestone payments to Valneva of 143 million USD from Pfizer in 2027. In addition, Valneva may receive 100 million USD in sales-based milestones, as well as royalties of 14–22 %. Pfizer and Valneva estimate the global market for a Lyme vaccine to be over 1 billion USD, but First Berlin considers this conservative. Based on population figures in endemic areas (approx. 70 million in the USA and 178 million in the EU), an average price of 72 USD per dose and 10 % market share, the market is estimated at over 2 billion USD. Competitive situation Moderna is the main competitor but has paused its Lyme program in phase 2 to prioritize other projects. According to Bloomberg estimates, Moderna will not generate positive EBITDA before 2029. First Berlin now assumes that a potential Moderna vaccine could be launched no earlier than 2034 (previously assumed 2030). Other factors Downward adjustments in the forecasts for Valneva's other products (Ixiaro, Dukoral and Ixchiq) are due to, among other things, a change of distributor in Germany and an FDA suspension of the product license for Ixchiq. The increased valuation of VLA15 outweighs these downward adjustments.
- ·4.12.2025OPERATIONAL UPDATE Valneva to further consolidate its operations in France • French operations to be concentrated at the company's Lyon facility • Final consolidation of R&D in Vienna Saint-Herblain (France), November 26, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) today announced a strategic initiative to optimize its organizational footprint in France as part of the company's ongoing efforts to increase operational efficiency and position Valneva for long-term success. The Company plans to concentrate its French operations at its Lyon facility and close its Nantes facility, which currently includes operational activities as well as certain preclinical R&D activities. This consolidation will streamline operations and improve efficiency in France, while centralizing all R&D at the company's Vienna facility. Valneva plans to move its registered office back to Lyon, where it was originally established, and maintain its listing on Euronext Paris. The city of Lyon in France is internationally recognized as a leading vaccine hub, home to major players such as Sanofi Vaccins and the Mérieux Group, making it an ideal location for Valneva to concentrate its French operations. Valneva is committed to supporting employees through this transition and offering assistance to ensure a smooth process for all affected employees. Valneva – Forward-Looking Statements: This press release contains certain forward-looking statements relating to Valneva’s business, including with respect to the progress, timing, results and completion of research, development and clinical trials for product candidates, to regulatory approval of product candidates and review of existing products, as well as financial guidance including expected product sales, total revenues and total R&D investments. Even if the actual results or developments of Valneva are consistent with the forward-looking statements contained in this press release, these results or developments of Valneva may not be sustainable in the future. In some cases, you can identify forward-looking statements by words such as “may,” “should,” “will,” “expect,” “anticipate,” “believe,” “intend,” “estimate,” “aim,” “target,” or similar words. These forward-looking statements are largely based on Valneva’s current expectations as of the date of this press release and are subject to a number of known and unknown risks and uncertainties as well as other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by these forward-looking statements. In particular, Valneva’s expectations could be affected by, among other things, uncertainties and delays involved in the development and manufacture of vaccines, unexpected clinical trial results, unexpected regulatory actions or delays, general competition, currency fluctuations, the impact of the global and European credit crisis, and the ability to obtain or maintain patents or other intellectual property protection. Success in preclinical studies or earlier clinical trials is not necessarily indicative of results in future clinical trials. In light of these risks and uncertainties, there can be no assurance that the forward-looking statements made in this press release will in fact be realized. Valneva provides this information as of the date of this press release and disclaims any intention or obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. https://valneva.com/wp-content/uploads/2025/11/2025_11_26_Operational-Update_PR_EN_FINAL-2.pdf
- ·4.12.2025Valneva announces positive final Phase 2 results for Lyme vaccine candidate November 26, 2025 .Antibody levels remained well above baseline across all six serotypes and age groups six months after the third annual booster dose. No safety concerns were observed in any age group by an independent Data Monitoring Committee (DMC). The results confirm the benefits of annual vaccination before each Lyme season. Saint-Herblain (France), 26. November 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) today announced positive final immunogenicity and safety data from the Phase 2 study, VLA15-221, of its Lyme vaccine candidate VLA15. The results showed a strong anamnestic immune response and a favorable safety profile six months after a third booster dose (month 48) in all age groups, confirming compatibility with the expected benefits of annual vaccination before each Lyme season. Pfizer and Valneva entered into a collaboration agreement in April 2020 for the development and commercialization of VLA15 by Pfizer. For those who want to read the full report (English) here is the link to the PDF file: https://valneva.com/wp-content/uploads/2025/11/2025_11_26_VLA15_221_Phase-2_Results-1.pdf
Yllä olevat kommentit ovat peräisin Nordnetin sosiaalisen verkoston Sharevillen käyttäjiltä, eikä niitä ole muokattu eikä Nordnet ole tarkastanut niitä etukäteen. Ne eivät tarkoita, että Nordnet tarjoaisi sijoitusneuvoja tai sijoitussuosituksia. Nordnet ei ota vastuuta kommenteista.
Tarjoustasot
Euronext Paris
Määrä
Osto
0
Myynti
Määrä
0
Viimeisimmät kaupat
| Aika | Hinta | Määrä | Ostaja | Myyjä |
|---|---|---|---|---|
| - | - | - | - |
Ylin
4,346VWAP
Alin
4,212VaihtoMäärä
2,6 618 429
VWAP
Ylin
4,346Alin
4,212VaihtoMäärä
2,6 618 429
Välittäjätilasto
Dataa ei löytynyt
Asiakkaat katsoivat myös
Yhtiötapahtumat
Datan lähde: FactSet, Quartr| Seuraava tapahtuma | |
|---|---|
| 2025 Q4 -tulosraportti | 19.3. |
| Menneet tapahtumat | ||
|---|---|---|
| 2025 Q3 -tulosraportti | 20.11.2025 | |
| 2025 Q2 -tulosraportti | 12.8.2025 | |
| 2025 Q1 -tulosraportti | 7.5.2025 | |
| 2024 Q4 -tulosraportti | 20.3.2025 | |
| 2024 Q3 -tulosraportti | 7.11.2024 |
2025 Q3 -tulosraportti
54 päivää sitten41 min
Uutiset
Tämän sivun uutiset ja/tai sijoitussuositukset tai otteet niistä sekä niihin liittyvät linkit ovat mainitun tahon tuottamia ja toimittamia. Nordnet ei ole osallistunut materiaalin laatimiseen, eikä ole tarkistanut sen sisältöä tai tehnyt sisältöön muutoksia. Lue lisää sijoitussuosituksista.
Yhtiötapahtumat
Datan lähde: FactSet, Quartr| Seuraava tapahtuma | |
|---|---|
| 2025 Q4 -tulosraportti | 19.3. |
| Menneet tapahtumat | ||
|---|---|---|
| 2025 Q3 -tulosraportti | 20.11.2025 | |
| 2025 Q2 -tulosraportti | 12.8.2025 | |
| 2025 Q1 -tulosraportti | 7.5.2025 | |
| 2024 Q4 -tulosraportti | 20.3.2025 | |
| 2024 Q3 -tulosraportti | 7.11.2024 |
Shareville
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- ·4.1.Quick summary:: Valneva terminates cooperation with Serum Institute to take full control over the chikungunya vaccine, with the goal of faster access in at-risk countries, supported by international funding. This is a strategic realignment – not a discontinuation. What does this mean? Valneva and Serum Institute of India are parting ways regarding the production and distribution of the chikungunya vaccine. Serum Institute will no longer have a license to produce or sell the vaccine. Valneva reclaims all rights to the vaccine: Production Deliveries Sales and distribution This gives Valneva greater flexibility and control, especially in countries where the disease is most prevalent. Focus on high-risk areas and developing countries Valneva will prioritize: - Endemic areas (where the disease is common) - Low‑ and middle‑income countries This is financially supported through CEPI and the EU, which reduces Valneva's financial risk. Not a halt in vaccine development, not a defeat for the vaccine, nor a sign that the vaccine is cancelled. On the contrary, the message signals that Valneva desires faster and more direct commercialization. For investors, this could mean: More control, but also more responsibility for Valneva Potentially higher margins in the long term Short-term uncertainty regarding production and distribution Full news:: Valneva and Serum Institute of India terminate license agreement for chikungunya vaccine 31 December 2025 Valneva SE, a specialized vaccine company, and Serum Institute of India (SII), part of the Cyrus Poonawalla Group, announced today that they have jointly agreed to terminate the license agreement for Valneva's single-dose vaccine against chikungunya. Valneva's strategic goal in regaining full rights is to take direct control over the supply chain and commercialization in endemic high-risk areas, thereby accelerating access to the vaccine in the regions hardest hit by the disease. Ensuring access to the vaccine in low‑ and middle‑income countries is part of the funding agreement Valneva entered into with the Coalition for Epidemic Preparedness Innovations (CEPI) in July 2024, with co-financing from the EU. About chikungunya Chikungunya is a viral infection transmitted by mosquitoes and can cause fever, severe joint‑ and muscle pain, headache, nausea, fatigue, and rash. The joint pain can be very debilitating and last for weeks or years. The disease spread rapidly from 2004 and has since been detected in over 110 countries. Between 2013 and 2023, more than 3.7 million cases were reported in the Americas alone. The World Health Organization (WHO) has classified chikungunya as a serious global public health problem. (Other sections describe Valneva, CEPI, Horizon Europe, and Serum Institute of India.) https://www.nordnet.no/market/news/f5ec0ccc-d202-43fe-b747-dfc82ccf274e
- ·11.12.2025Valneva reports positive final Phase 2 results for antibody persistence and safety in children for its Chikungunya vaccine IXCHIQ® Saint-Herblain (France), December 10, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced positive final antibody persistence and safety data from its Phase 2 study evaluating the safety and immunogenicity of two different dose levels of its single-shot Chikungunya vaccine IXCHIQ® in 304 children, twelve months after vaccination. The study is partly funded by the Coalition for Epidemic Preparedness Innovations (CEPI), with support from the EU. The results support further development in Phase 3 in children, which the company plans to initiate after gathering more experience from the adolescent population. The final results from VLA1553-221 were consistent with the initial data and six-month results previously reported in January and June 2025. The full dose (the licensed IXCHIQ® formulation) provided a stronger immune response in children aged 1–11 years at Day 360 post-vaccination compared to the half dose. The immunological response was consistent with what has previously been observed in adults and adolescents. The strong immune response was confirmed in children without prior CHIKV infection, with a seroresponse rate of 94.7 % (full dose) at Day 360. The vaccine was well tolerated in children regardless of dose level or prior infection, and no safety concerns were identified. The comparability between the doses in terms of safety and tolerability, combined with the more pronounced immune response at the full dose, continues to support the selection of the full dose for use in this population. Statement from Valneva: Juan Carlos Jaramillo, Chief Medical Officer at Valneva, said: “The twelve-month persistence and safety data in children are consistent with the robust antibody response and favorable safety profile previously observed in adolescents after a single vaccination. As safety is of utmost importance, especially as we move forward to a Phase 3 study in children, we have decided – in line with regulatory authorities – to gather more experience from the adolescent population before initiating our planned Phase 3 study in children.” “We are convinced that it is crucial to ensure access to a vaccine that can offer long-lasting protection with a single dose, especially in low- and middle-income countries where access to vaccines is often limited.” Global context - Brazil has reported over 1 million cases of chikungunya between January 2019 and July 2024. - India has had 370,000 cases in the same period. - In 2025, outbreaks have been reported in six countries: Bangladesh, Cuba, China, Kenya, Madagascar, Somalia, and Sri Lanka. About chikungunya - Chikungunya virus (CHIKV) is spread via bites from infected Aedes mosquitoes. - Symptoms: fever, severe joint and muscle pain, headache, nausea, fatigue, and rash. - Joint pain can be debilitating and last for weeks to years. - Since 2004, the virus has spread rapidly and is now identified in over 110 countries. - Between 2013 and 2023, more than 3.7 million cases were reported in the Americas. - WHO has highlighted chikungunya as a major global public health problem. About the Phase 2 study VLA1553-221 - Multicenter, randomized, observer-blinded dose-response study. - 304 healthy children aged 1–11 years. - Conducted at three clinical sites in the Dominican Republic and Honduras. - Participants were randomized to full dose, half dose, or active control (Nimenrix). About Valneva SE - Specialty vaccine company focused on infectious diseases with unmet needs. - Has taken several vaccines from early R&D to approval. - Markets three proprietary travel vaccines. - Pipeline includes: - The only Lyme vaccine candidate in advanced clinical development (partnered with Pfizer). - The world's most advanced Shigella vaccine candidate. - Several other vaccines against global health challenges. In short: Valneva confirms that the full dose of IXCHIQ® provides the best and most durable immune response in children, without safety concerns, and plans Phase 3 studies after more experience from adolescents. https://www.nordnet.no/market/news/366eadcc-bbc9-4729-b9e5-072ab629369c
- ·4.12.2025First Berlin Equity Research maintains its buy recommendation on Valneva SE and raises the price target to 6.80 euro, with an upside potential of around 82 %. Key points from the analysis Currently, there are no approved human vaccines against Lyme disease. Valneva and partner Pfizer are developing the vaccine VLA15, which is furthest along in clinical development. All vaccinations in the pivotal phase 3 study have been completed. Results are expected in the first half of 2026. If the results are positive, Pfizer plans to seek regulatory approval in both Europe and the USA in 2026. The vaccine could be launched in autumn 2027, in time for the 2028 tick season. Financial outlook The commercialization of VLA15 will trigger milestone payments to Valneva of 143 million USD from Pfizer in 2027. In addition, Valneva may receive 100 million USD in sales-based milestones, as well as royalties of 14–22 %. Pfizer and Valneva estimate the global market for a Lyme vaccine to be over 1 billion USD, but First Berlin considers this conservative. Based on population figures in endemic areas (approx. 70 million in the USA and 178 million in the EU), an average price of 72 USD per dose and 10 % market share, the market is estimated at over 2 billion USD. Competitive situation Moderna is the main competitor but has paused its Lyme program in phase 2 to prioritize other projects. According to Bloomberg estimates, Moderna will not generate positive EBITDA before 2029. First Berlin now assumes that a potential Moderna vaccine could be launched no earlier than 2034 (previously assumed 2030). Other factors Downward adjustments in the forecasts for Valneva's other products (Ixiaro, Dukoral and Ixchiq) are due to, among other things, a change of distributor in Germany and an FDA suspension of the product license for Ixchiq. The increased valuation of VLA15 outweighs these downward adjustments.
- ·4.12.2025OPERATIONAL UPDATE Valneva to further consolidate its operations in France • French operations to be concentrated at the company's Lyon facility • Final consolidation of R&D in Vienna Saint-Herblain (France), November 26, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) today announced a strategic initiative to optimize its organizational footprint in France as part of the company's ongoing efforts to increase operational efficiency and position Valneva for long-term success. The Company plans to concentrate its French operations at its Lyon facility and close its Nantes facility, which currently includes operational activities as well as certain preclinical R&D activities. This consolidation will streamline operations and improve efficiency in France, while centralizing all R&D at the company's Vienna facility. Valneva plans to move its registered office back to Lyon, where it was originally established, and maintain its listing on Euronext Paris. The city of Lyon in France is internationally recognized as a leading vaccine hub, home to major players such as Sanofi Vaccins and the Mérieux Group, making it an ideal location for Valneva to concentrate its French operations. Valneva is committed to supporting employees through this transition and offering assistance to ensure a smooth process for all affected employees. Valneva – Forward-Looking Statements: This press release contains certain forward-looking statements relating to Valneva’s business, including with respect to the progress, timing, results and completion of research, development and clinical trials for product candidates, to regulatory approval of product candidates and review of existing products, as well as financial guidance including expected product sales, total revenues and total R&D investments. Even if the actual results or developments of Valneva are consistent with the forward-looking statements contained in this press release, these results or developments of Valneva may not be sustainable in the future. In some cases, you can identify forward-looking statements by words such as “may,” “should,” “will,” “expect,” “anticipate,” “believe,” “intend,” “estimate,” “aim,” “target,” or similar words. These forward-looking statements are largely based on Valneva’s current expectations as of the date of this press release and are subject to a number of known and unknown risks and uncertainties as well as other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by these forward-looking statements. In particular, Valneva’s expectations could be affected by, among other things, uncertainties and delays involved in the development and manufacture of vaccines, unexpected clinical trial results, unexpected regulatory actions or delays, general competition, currency fluctuations, the impact of the global and European credit crisis, and the ability to obtain or maintain patents or other intellectual property protection. Success in preclinical studies or earlier clinical trials is not necessarily indicative of results in future clinical trials. In light of these risks and uncertainties, there can be no assurance that the forward-looking statements made in this press release will in fact be realized. Valneva provides this information as of the date of this press release and disclaims any intention or obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. https://valneva.com/wp-content/uploads/2025/11/2025_11_26_Operational-Update_PR_EN_FINAL-2.pdf
- ·4.12.2025Valneva announces positive final Phase 2 results for Lyme vaccine candidate November 26, 2025 .Antibody levels remained well above baseline across all six serotypes and age groups six months after the third annual booster dose. No safety concerns were observed in any age group by an independent Data Monitoring Committee (DMC). The results confirm the benefits of annual vaccination before each Lyme season. Saint-Herblain (France), 26. November 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) today announced positive final immunogenicity and safety data from the Phase 2 study, VLA15-221, of its Lyme vaccine candidate VLA15. The results showed a strong anamnestic immune response and a favorable safety profile six months after a third booster dose (month 48) in all age groups, confirming compatibility with the expected benefits of annual vaccination before each Lyme season. Pfizer and Valneva entered into a collaboration agreement in April 2020 for the development and commercialization of VLA15 by Pfizer. For those who want to read the full report (English) here is the link to the PDF file: https://valneva.com/wp-content/uploads/2025/11/2025_11_26_VLA15_221_Phase-2_Results-1.pdf
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