Latest news with #BARDA
CBS News
6 days ago
- Health
- CBS News
Trump administration yanks Moderna's bird flu vaccine research funding even as company reports promising test results
Scientists warn what future bird flu mutations could mean for people | 60 Minutes The Trump administration has canceled $766 million awarded to drugmaker Moderna Inc. to develop a vaccine against potential pandemic influenza viruses, including the H5N1 bird flu. The company said it was notified Wednesday that the Health and Human Services Department had withdrawn funds awarded in July 2024 and in January to pay for development and purchase of its investigational vaccine. The funds were awarded through the Biomedical Advanced Research and Development Authority, or BARDA, a program that focuses on medical treatments for potential pandemics. The new vaccine, called mRNA-1018, used the same technology that allowed development and rollout of vaccines to fight COVID-19 in record time. Health Secretary Robert F. Kennedy Jr. has expressed deep skepticism regarding mRNA vaccines, despite real-world evidence that the vaccines are safe and saved millions of lives. The cancelation came as Moderna announced positive interim results from an early-stage trial of the vaccine that targeted H5 bird flu virus, tested in 300 healthy adults. "While the termination of funding from HHS adds uncertainty, we are pleased by the robust immune response and safety profile observed in this interim analysis," CEO Stephane Bancel said in a statement. He added that Moderna would "explore alternatives" for funding the development and manufacturing of the vaccine, according to French news agency AFP. "These clinical data in pandemic influenza underscore the critical role mRNA technology has played as a countermeasure to emerging health threats," AFP cited Bancel as saying. In a statement in March, Moderna told CBS News medical contributor and editor-at-large for public health at KFF Health News Dr. Céline Gounder that, "Researchers have been exploring mRNA's potential in medicine for over 30 years, leading to the rapid deployment of mRNA-based COVID-19 vaccines that transformed the course of the pandemic. With more than a billion doses distributed worldwide and an unprecedented amount of real-world safety and efficacy data, the benefits of mRNA vaccination ... are well established." Dr. Ashish Jha, a public health expert who served as former President Joe Biden's COVID-19 response coordinator, remarked about the funding withdrawal on X, saying, "This move puts the lives of Americans at risk. The attack on mRNA vaccines is beyond absurd. It was President Trump's Operation Warp Speed that gave us mRNA vaccines. ... If Bird Flu starts spreading from people to people, we will come to regret this as the day we decided to put the lives of the American people at grave risk. " H5N1 bird flu viruses spilled from wild bird into cattle in the U.S. last year, infecting hundreds of animals in several states. At least 70 people in the U.S. have been sickened by bird flu infections, mostly mild. One person died. Scientists fear that continued mutation of the virus could enable it to become more virulent or more easily spread in people, with the possibility that it could trigger a pandemic. Moderna received $176 million in July 2024 and $590 million in January. The January award would have supported a late-stage clinical trial that could have determined the vaccine's efficacy against pandemic viruses, including bird flu, a company spokesman said.
Associated Press
6 days ago
- Health
- Associated Press
Trump administration cancels $766 million Moderna contract to fight pandemic flu
The Trump administration has canceled $766 million awarded to drugmaker Moderna Inc. to develop a vaccine against potential pandemic influenza viruses, including the H5N1 bird flu. The company said it was notified Wednesday that the Health and Human Services Department had withdrawn funds awarded in July 2024 and in January to pay for development and purchase of its investigational vaccine. The funds were awarded through the Biomedical Advanced Research and Development Authority, or BARDA, a program that focuses on medical treatments for potential pandemics. The new vaccine, called mRNA-1018, used the same technology that allowed development and rollout of vaccines to fight Covid-19 in record time. Health Secretary Robert F. Kennedy Jr. has expressed deep skepticism regarding the safety of mRNA vaccines. The cancelation came as Moderna announced positive interim results from an early-stage trial of the vaccine that targeted H5 bird flu virus, tested in 300 healthy adults. 'While the termination of funding from HHS adds uncertainty, we are pleased by the robust immune response and safety profile observed in this interim analysis,' the company said in a statement. H5N1 bird flu viruses spilled from wild bird into cattle in the U.S. last year, infecting hundreds in several states. At least 70 people in the U.S. have been sickened by bird flu infections, mostly mild. One person died. Scientists fear that continued mutation of the virus could allow it to become more virulent or more easily spread in people, with the possibility that it could trigger a pandemic. Moderna received $176 million in July 2024 and $590 million in January. The January award would have supported a late-stage clinical trial that could have determined the vaccine's efficacy against pandemic viruses, including bird flu, a company spokesman said. — The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute's Science and Educational Media Group and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.
Yahoo
14-05-2025
- Business
- Yahoo
Spectral AI Inc (MDAI) Q1 2025 Earnings Call Highlights: Strong Financial Performance and ...
Research and Development Revenue: Increased by 6% to $6.7 million from $6.3 million in Q1 2024. Gross Margin: Improved to 47.2% from 46.6% in Q1 2024. General and Administrative Expenses: Reduced to $4.1 million from $5.1 million in Q1 2024. Operating Loss: Decreased to $896,000 from a net loss of $2.1 million in Q1 2024. Net Income: Reported at $2.9 million compared to a net loss of $3.2 million in Q1 2024. Cash and Cash Equivalents: Totaled $14.1 million as of March 31, 2025, up from $5.2 million on December 31, 2024. Shares Outstanding: 25,588,121 shares as of March 31, 2025. Revenue Guidance for 2025: Approximately $21.5 million, excluding potential sales from the UK and Australia. Warning! GuruFocus has detected 2 Warning Signs with MDAI. Release Date: May 13, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Spectral AI Inc (NASDAQ:MDAI) reported a strong start to 2025 with significant accomplishments in product advancement and operating efficiencies. The company is on track for its FDA de novo classification submission by the end of the second quarter of 2025. The burn validation study results demonstrated the superior performance of the DeepView technology, which will support the FDA submission. Spectral AI Inc (NASDAQ:MDAI) successfully completed a debt financing agreement with Avenue Capital, securing up to $15 million in funding. Research and development revenue for the first quarter rose 6% to $6.7 million, reflecting increased activity under the BARDA Project BioShield contract. The company anticipates less revenue from the BARDA contract in the second half of the year as it focuses on further developments of the DeepView system. General and administrative expenses, although reduced, still represent a significant cost, with a focus on operational efficiencies needed to maintain a long cash runway. The FDA submission process involves known and unknown risks, and the outcome is not guaranteed despite efforts to de-risk the submission. The commercialization of the DeepView system outside the BARDA environment is still in early stages, with efforts needed to expand beyond the initial contract. The development of the DeepView SnapShot M for military use is ongoing, with no guarantee of meeting the 2027 timeline for availability. Q: On the guidance, you're calling for $21.5 million just from BARDA revenue. You're tracking ahead of that, so any pull forward there in terms of what you saw in the first quarter? A: Vincent Capone, CFO: We had a strong start to the year, reflecting our focus on the FDA submission by the end of the second quarter. The second half of the year may see less revenue from the BARDA contract as we work on further developments of the DeepView system. We are confident in the $21.5 million revenue guidance, but may restate it if we continue to outperform. Q: You're going to submit to the FDA by the end of the second quarter. How are you preparing for that submission, and what interactions have you had with the FDA? A: Vincent Capone, CFO: We have a 12-year relationship with BARDA, which has been very helpful. We've had over 10 pre-sub meetings with the FDA and are working hard to get the submission ready. The burn validation study results support our submission, and we've identified key metrics the FDA will consider. We feel confident but acknowledge we don't control the outcome. Q: With respect to the 10 pre-sub meetings with the FDA, have there been any additional requests or deliverables? A: Vincent Capone, CFO: We have been working through the submission process with the FDA. While I won't get into specifics, our rigorous analysis and burn validation study results are benchmarks the FDA will consider. We are excited to submit and have tried to de-risk the process as much as possible. Q: General and administrative expenses seemed lower than expected in the first quarter. How do you see that for the rest of the year? A: Vincent Capone, CFO: We've focused on operational efficiencies, resulting in lower expenses. We anticipate general and administrative expenses to remain consistent with the first-quarter results, which helps us maintain a long runway with our cash on hand. Q: Regarding the SnapShot M device, you mentioned prototypes are ready. Is there a chance it will be available for military use before 2027? A: Vincent Capone, CFO: While I can't confirm an earlier timeline, we are focused on the FDA submission for the DeepView system and continue to work on the MTEC contract. SnapShot M is a promising second indication of our technology, and we are committed to supporting the US military with this device. For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus.
Yahoo
14-05-2025
- Business
- Yahoo
Vaxart Inc (VXRT) Q1 2025 Earnings Call Highlights: Strategic Progress Amidst Challenges
Release Date: May 13, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Vaxart Inc (NASDAQ:VXRT) successfully lifted the stop work order on their 10,000 participant COVID-19 Phase 2B vaccine trial, indicating progress in their clinical development. The company completed enrollment in their Phase 1 norovirus vaccine trial, showing efficiency in advancing their clinical programs. Vaxart Inc (NASDAQ:VXRT) reported a significant increase in revenue for Q1 2025, primarily due to their BARDA contract, indicating strong financial performance. The company is actively pursuing strategic partnerships, which could provide non-dilutive funding and further advance their vaccine programs. Vaxart Inc (NASDAQ:VXRT) has a new CFO, Jerome Grossman, who brings over 20 years of experience in biotech, potentially strengthening their financial leadership. Vaxart Inc (NASDAQ:VXRT) faced a stop work order on their COVID-19 trial, which caused delays in their clinical timeline. The company had to implement workforce reductions to manage costs, indicating financial constraints. Vaxart Inc (NASDAQ:VXRT) is at risk of being delisted from NASDAQ due to not meeting the $1 minimum bid price requirement, which could impact their stock liquidity and investor interest. The resignation of their CFO, Phil Lee, for personal reasons, may cause transitional challenges in their financial management. The company is considering a reverse stock split as a last resort to maintain NASDAQ listing, which could affect shareholder value. Warning! GuruFocus has detected 5 Warning Signs with VXRT. Q: For the COVID-19 program, what are the gating factors to start patient dosing, and how fast do you expect to complete the enrollment of the 10,000 participants in the Phase 2B study? A: Stephen Lowe, CEO: We are pleased that the stop work order was lifted, and we are now moving forward with screening patients. We hope to start dosing soon. James Cummings, Chief Medical Officer, added that the enrollment is expected to take approximately 5 to 6 months, but this will be adjusted based on initial enrollment rates. Q: Regarding the norovirus program, what are the expectations for the Phase 1 results, and how would you define a positive study? A: Sean Tucker, Chief Scientific Officer: Success would be indicated by the new constructs trending better than the old ones on key immunogenicity endpoints. James Cummings added that the study is based on compelling preclinical data, and they look forward to reporting topline data this year. Q: Have there been any learnings from the Sentinel cohort that are informative to the discussions with BARDA regarding the COVID-19 program? A: James Cummings, Chief Medical Officer: We are engaging with BARDA to determine if an interim analysis of the Sentinel cohort would be beneficial. The study is double-blinded, and we are currently unable to provide further details. Q: What impact did the stop work order have on the expected timeline for the COVID-19 study, and where is the study being conducted? A: Stephen Lowe, CEO: The stop work order was lifted sooner than expected, which was positive. James Cummings added that the 10,000 participant cohort was impacted, but the 400 participant Sentinel study continued. Enrollment for the larger cohort is projected to take about 6 months once dosing begins. Q: Are there any active partnership discussions for the norovirus program, and what is the market opportunity? A: Stephen Lowe, CEO: Norovirus presents a significant market opportunity, and there is interest from various companies, including large multinationals. Discussions are ongoing, and they are expected to accelerate following the release of topline results. For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
06-05-2025
- Health
- Yahoo
US government exercises $144m option for smallpox
Amid a US measles outbreak the US government has placed a $143.6m order for Bavarian Nordic's smallpox/mpox jab Jynneos to bolster its infectious disease preparedness. The order is part of a ten-year contract awarded to vaccine-developer Bavarian Nordic by the US government's Biomedical Advanced Research and Development Authority (BARDA). The agreement between the pair includes options valued at $299m for the fill and finish of freeze-dried vaccines. Deliveries under the new contract options are planned for 2026. The additional options exercised by BARDA support the manufacturing and supply of freeze-dried Jynneos by conversion of bulk vaccine, as well as supplemental payments for all doses procured under the freeze-dried contract. The latter was triggered after the freeze-dried formulation's extended shelf life was demonstrated. The freeze-dried formulation of Jynneos provides greater flexibility in stockpiling. The US Food and Drug Administration (FDA) approved this version in March 2025 after Bavarian Nordic demonstrated comparability to the older liquid formulation in terms of immune responses. Bavarian Nordic has supplied a liquid-frozen formulation of its vaccine to the US government for stockpiling since 2010 and ramped up production in response to the mpox outbreak in 2022-2023. Liquid-frozen formulations require a temperature-controlled supply chain that keeps them frozen between production up until being used on a patient. Freeze-dried formulations have fewer supply chain limitations, conferring advantages such as easier transportation, storage conditions, and extended shelf life. Freeze drying is a dehydration process to extend its shelf life and molecular stability. Bavarian Nordic's CEO Paul Chaplin said: 'The freeze-dried vaccine, with its improved shelf life, provides a significant contribution to securing the long-term availability of countermeasures to protect US citizens against life-threatening diseases.' The ten-year contract for the freeze-dried version came amid calls to stockpile vaccines with longer shelf-lives. With the $144m order, Bavarian Nordic stated that $284m of the $299m has been exercised to-date. For a time, Jynneos was the only FDA-approved vaccine for the prevention of mpox. Emergent BioSolutions' ACAM2000 then became the second vaccine for the infectious disease, winning FDA approval to prevent mpox in those at high risk of infection in August 2024. Bavarian Nordic's product, also known as MVA-BN and Imvanex in other regions, has been a key pillar of fighting the ongoing mpox outbreak in Africa. The biotech has sent more than a million doses of the vaccine to countries experiencing outbreaks and promised further ramp-ups in vaccine production.
