Core Viewpoint - Bavarian Nordic A/S has entered into an agreement to sell its Priority Review Voucher (PRV) for a total cash consideration of USD 160 million, following the approval of its chikungunya vaccine, VIMKUNYA™ [1] Group 1: Financial Impact - The National Institutes of Health (NIH) will receive 20% of the gross proceeds from the sale of the PRV, which will be recognized as other operating income [2] - The sale proceeds will not impact the guided revenue expectations for 2025, but EBITDA will be positively impacted, with updates on the EBITDA margin of 26-30% for 2025 to be provided upon closing of the transaction [2] Group 2: Transaction Details - The transaction is subject to customary closing conditions, including an anti-trust review expected in the third quarter of 2025 [3] - Jefferies LLC acted as the exclusive financial advisor to Bavarian Nordic for this transaction [3] Group 3: Company Overview - Bavarian Nordic is a global vaccine company focused on improving health through innovative vaccines, with a strong portfolio in mpox and smallpox vaccines, as well as travel vaccines [4]

First children vaccinated in clinical study seeking to expand the target population for the chikungunya vaccine. COPENHAGEN, Denmark, June 12, 2025 – Bavarian Nordic A/S (OMX: BAVA) announced today the initiation of a Phase 3 clinical study of its single-dose, virus-like particle (VLP) chikungunya vaccine, CHIKV VLP in children 2 to 11 years of age. This first trial of CHIKV VLP in a pediatric population aims to expand the target population for the vaccine, currently approved for persons 12 years of age and ...

Goldman Sachs 46th Annual Global Healthcare Conference June 11, 2025 Cautionary Note Regarding Forward-Looking Statements This presentation includes forward-looking statements. These forward-looking statements generally can be identified by the use of words such as "anticipate," "expect," "plan," "could," "may," "will," "believe," "estimate," "forecast," "goal," "project," and other words of similar meaning. These forward-looking statements address various matters including Novavax's corporate strategy and ...

Vaxcyte (PCVX) FY Conference June 10, 2025 01:20 PM ET Speaker0 All right. Great. Let's let's kick off our next session. Very pleased to have the management team of Backside here with us, Grant Pickering, CEO and Andrew Guggenheim, CFO. Grant and Andrew, welcome, and thank you for being here. Thank you for having us, Assad, and great to be here. Great. So I guess maybe we can just start at a very high level. In nutshell, for those who perhaps aren't familiar with the Vaxide story, maybe just give us a quick ...

Investment Rating - The report maintains a "Buy" rating for several healthcare stocks, including Wuxi Apptec and Eyebright, based on their strong growth potential and market positioning [11]. Core Insights - The EU's planned restrictions on Chinese medtech firms' access to public procurements over EUR 5 million are expected to have limited impact on the covered companies, as most do not participate in such procurements and have manageable revenue exposure to the EU market [3]. - The healthcare indices in China showed positive performance, with HSHCI rising by 4.1% and HSHKBIO by 4.5% during the week of June 2-6, 2025, indicating a favorable market trend [2]. - Recent approvals in the drug sector include Akeso's cadonilimab for cervical cancer and Hansoh's aumolertinib for NSCLC in the UK, showcasing ongoing innovation and regulatory progress in the industry [4][5]. Summary by Sections Market Access and Regulatory Environment - The EU's International Procurement Instrument investigation concluded that China has limited EU medical device producers' access to government contracts, leading to the proposed restrictions [3]. - Companies like Mindray and MGI Tech have established local manufacturing facilities, which may help mitigate the impact of these restrictions [3]. Drug Approvals and Developments - Akeso's cadonilimab received approval for treating first-line cervical cancer, while Innovent and Hutchmed's sintilimab + fruquintinib application was accepted for renal cell carcinoma [4]. - Hansoh's aumolertinib has been approved in the UK for specific NSCLC patients, indicating a strong pipeline for innovative therapies [4]. Stock Performance and Recommendations - The report highlights top picks in the healthcare sector, including Wuxi Apptec and Eyebright, based on their expected solid fundamental recovery and market share potential [11]. - The report notes that the chemicals sector outperformed healthcare indices, with a 1.7% increase in A shares and a 3.8% increase in H shares [12].

Vaxart (VXRT) 2025 Conference June 05, 2025 02:00 PM ET Speaker0 Good afternoon, everyone. Thanks for coming for the last day of the Jefferies Healthcare Conference. Last but not least, we have Vexard with us today. Together with me is a CEO, mister Steve Lowe, and also CMO, James Cumming. Alright. So, Steve, I know you have a very unique platform oral vaccine. So maybe we can start with some, like, high level introduction on your platform, and that'll be very helpful. Speaker1 Sure. That's that's great. We ...

Core Insights - Valneva SE announced positive six-month antibody persistence and safety data for its Phase 2 clinical trial of the chikungunya vaccine IXCHIQ in children, supporting the initiation of a pivotal Phase 3 study in early 2026 [1][2][8] Company Overview - Valneva is a specialty vaccine company focused on developing, manufacturing, and commercializing vaccines for infectious diseases, with a strong track record in advancing multiple vaccines from early R&D to approvals [10][11] - The company currently markets three proprietary travel vaccines, including the world's first and only chikungunya vaccine, and has a pipeline that includes candidates for Lyme disease, Shigella, and Zika virus [12] Clinical Trial Results - The Phase 2 trial (VLA1553-221) involved 304 healthy children aged one to eleven years, demonstrating that a full dose of the vaccine elicited a more robust immune response compared to a half dose, with a 96.5% seroresponse rate at Day 180 [2][3][8] - The vaccine was well tolerated across all age groups tested, with no safety concerns identified, supporting the selection of the full dose for the upcoming Phase 3 trial [4][5][8] Market Context - Chikungunya poses a significant health risk, particularly in endemic areas, with Brazil reporting over one million cases from January 2019 to July 2024, and India reporting 370,000 cases during the same period [5][7] - The World Health Organization has identified chikungunya as a major public health problem, with the economic impact expected to grow due to climate change and the geographical spread of mosquito vectors [7]

Saint-Herblain (France), May 26, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that its senior management will present and hold investor meetings at several upcoming investor conferences in the United States and Europe in June 2025. Key topics for discussion include Valneva’s commercial stage vaccines and its differentiated portfolio of vaccine candidates, including VLA15, the world’s leading Lyme disease vaccine candidate. VLA15 is partnered with Pfize ...

Core Viewpoint - Evaxion A/S has initiated a one-year extension of its ongoing phase 2 trial for its personalized cancer vaccine EVX-01, aimed at treating advanced melanoma, leveraging its AI-Immunology™ platform to explore the vaccine's long-term clinical and immune benefits [1][2][4]. Group 1: Trial Details - The first patient has been dosed in the one-year extension of the trial, which will involve two additional doses of EVX-01 as monotherapy [3]. - The initial two years of the trial involved EVX-01 in combination with standard anti-PD-1 therapy, and the extension phase allows for evaluation of EVX-01 as a standalone treatment [4][5]. - The trial extension incurs minimal costs since trial sites are already operational and the vaccine has been produced [2][10]. Group 2: Clinical Data and Results - Interim one-year data presented at the ESMO Congress in September 2024 showed a 69% Overall Response Rate, with tumor target lesions reduced in 15 out of 16 patients [8]. - At the AACR Annual Meeting in April 2025, it was reported that 80% of EVX-01's vaccine targets triggered a targeted immune response, indicating favorable outcomes compared to other treatment approaches [9]. - The completed phase 1/2a clinical trial demonstrated that 67% of metastatic melanoma patients had objective clinical responses, highlighting the predictive power of the AI-Immunology™ platform [12]. Group 3: Product and Technology Overview - EVX-01 is a personalized peptide-based cancer vaccine designed to engage the patient's immune system against tumors, tailored to each individual's unique tumor profile [6][11]. - The AI-Immunology™ platform is central to Evaxion's approach, enabling the development of novel immunotherapies for various diseases, including cancer [13].

Company Urges Stockholders to Vote FOR Reverse Stock Split Proposal at Upcoming Annual Meeting to Avoid Nasdaq Delisting SOUTH SAN FRANCISCO, Calif., May 12, 2025 (GLOBE NEWSWIRE) -- Vaxart, Inc. (Nasdaq: VXRT) today addresses frequently asked stockholder questions regarding a reverse stock split proposal at the Company’s Annual Meeting taking place on Wednesday, May 21, 2025, to regain Nasdaq compliance. 1) Why is Vaxart proposing a reverse stock split? a. Vaxart is at risk of being delisted from Nasdaq si ...