Bavarian Nordic Awarded Contract Options from the U.S. Government for Production and Supply of Freeze-dried Smallpox/Mpox Vaccines
Exercised options total USD 143.6 million
Secures manufacturing and supply of freeze-dried JYNNEOS® to the U.S. in 2026
COPENHAGEN, Denmark, May 6, 2025 – Bavarian Nordic A/S (OMX: BAVA) announced today that the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services (HHS), has exercised additional options valued at USD 143.6 million under the existing contract to supply a freeze-dried formulation of JYNNEOS® smallpox vaccine.
The options support the manufacturing and supply of freeze-dried JYNNEOS by conversion of bulk vaccine, previously manufactured under other contract options, as well as supplemental payments for all doses procured under the freeze-dried contract, triggered by the demonstration of an extended shelf-life. The supplemental payments will be invoiced pro rata with deliveries of the freeze-dried vaccines. Deliveries under the new contract options are planned for 2026.
Bavarian Nordic's financial guidance for 2025 remains unchanged at total revenues of DKK 5,700-6,700 million and an EBITDA margin of 26-30%. From the Public Preparedness business, revenue of DKK 3,000-4,000 million is still expected, of which DKK 2,650 million has been secured, which is an increase of DKK 150 million following exercise of the options.
Paul Chaplin, President & CEO of Bavarian Nordic, said: 'Following the recent FDA approval of the freeze-dried formulation of our smallpox/mpox vaccine, we applaud the U.S. government's steadfast commitment to improving national health security through the exercise of these options. The freeze-dried vaccine, with its improved shelf life, provides a significant contribution to securing the long-term availability of countermeasures to protect U.S citizens against life-threatening diseases.'
About our contracts with the U.S. government
Since 2003, Bavarian Nordic has worked with the U.S. government on the development, manufacturing and supply of a non-replicating smallpox vaccine to ensure all populations can be protected from smallpox and mpox, including people with weakened immune systems who are at high risk of adverse reactions to traditional smallpox vaccines, which are based on replicating vaccinia virus strains.
Approved by the FDA in 2019, JYNNEOS was the first smallpox vaccine successfully developed under Project BioShield, a program created by the U.S. Congress in 2004 to accelerate the research, development, procurement, and availability of medical countermeasures against biological, chemical, radiological, and nuclear (CBRN) threats through public-private partnerships.
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Business Wire
4 minutes ago
- Business Wire
Align Technology President and CEO Joe Hogan Personally Purchases $1 Million of Align's Common Stock
TEMPE, Ariz.--(BUSINESS WIRE)--Align Technology, Inc. ('Align') (Nasdaq: ALGN) a leading global medical device company that designs, manufactures, and sells the Invisalign ® System of clear aligners, iTero™ intraoral scanners, and exocad™ CAD/CAM software for digital orthodontics and restorative dentistry, today announced that Joe Hogan, Align Technology president and CEO, has personally purchased approximately $1 million of Align's common stock. Since his last sale of Align common stock in 2021, Mr. Hogan has purchased approximately $8 million of Align common stock 1. 'This purchase reflects my continuing confidence in the long-term value of Align and our commitment to increasing shareholder value by balancing investments to drive growth and continuing to invest with discipline in the areas that will define our future,' said Joe Hogan, president and CEO. 'We are excited about our next-generation technologies and treatment platforms that meet today's patient expectations for fast, effective, and personalized treatment while also providing value and growth opportunities for our doctor customers. We believe that these innovations are not only improving outcomes in Invisalign practices but also expanding our addressable market and strengthening our competitive differentiation.' Continued Hogan, 'While we believe that the macroeconomic uncertainty will likely persist into the near future, we are confident in our ability to adapt and lead. Our long-term strategic initiatives and opportunities remain intact, as does our commitment to focused execution on transforming treatment for doctors and patients.' 1 Valued based on the purchase price of Align common stock at the time of each purchase. About Align Technology Align Technology designs and manufactures the Invisalign ® System, the most advanced clear aligner system in the world, iTero™ intraoral scanners and services, and exocad™ CAD/CAM software. These technology building blocks enable enhanced digital orthodontic and restorative workflows to improve patient outcomes and practice efficiencies for over 286.4 thousand doctor customers and are key to accessing Align's 600 million consumer market opportunity worldwide. Over the past 28 years, Align has helped doctors treat over 20.8 million patients with the Invisalign System and is driving the evolution in digital dentistry through the Align™ Digital Platform, our integrated suite of unique, proprietary technologies and services delivered as a seamless, end-to-end solution for patients and consumers, orthodontists and GP dentists, and lab/partners. Visit for more information. For additional information about the Invisalign System or to find an Invisalign doctor in your area, please visit For additional information about the iTero digital scanning system, please visit For additional information about exocad dental CAD/CAM offerings and a list of exocad reseller partners, please visit Invisalign, iTero, exocad, Align, Align Digital Platform, and iTero Lumina are trademarks of Align Technology, Inc.
Yahoo
an hour ago
- Yahoo
Regeneron cancer bispecific rejected again; Allogene discloses trial death
This story was originally published on BioPharma Dive. To receive daily news and insights, subscribe to our free daily BioPharma Dive newsletter. Today, a brief rundown of news involving Regeneron Pharmaceuticals and Allogene Therapeutics, as well as updates from Bristol Myers Squibb, Biogen, and Argenx that you may have missed. Regeneron said two more of its new drugs hit regulatory setbacks because of Food and Drug Administration inspection issues at a third-party manufacturing plant. The company received a complete response letter for its bispecific cancer antibody odronextamab in lymphoma on July 30, due to issues at an Indiana factory that Novo Nordisk recently acquired from Catalent. In addition, the FDA will delay a decision on an application for high-dose Eylea processed at that plant. The odronextamab setback will require Regeneron to refile its application. The FDA previously rejected another Regeneron bispecific antibody, now approved as Lynozyfic, in multiple myeloma because of third-party manufacturing issues. — Jonathan Gardner Allogene Therapeutics is stopping use of an experimental immunosuppresive antibody called ALLO-647 following the death of a study participant, the company said Friday. ALLO-647 is part of a regimen meant to prepare patients for treatment with Allogene's donor-derived cell therapy for blood cancer, . But the antibody has been associated in rare cases with severe viral infections and, in this instance, was deemed related to an adenovirus infection that triggered liver failure in a participant in Allogene's pivotal trial. Allogene has closed the study arm with ALLO-647 and won't use it in future trials. It will move forward with a standard two-drug immunosuppressive regimen often used in cancer cell therapy. Results from the pivotal trial are still expected next year, the company said. — Ben Fidler Bristol Myers Squibb boosted its revenue outlook for 2025 by $700 million, driven by higher-than-expected sales of its off-patent cancer drug Revlimid. The company now expects full-year sales to be between $46.5 and $47.5 billion, although that may not flow through to the bottom line because of the $1.5 billion it has spent this year to license a BioNTech cancer drug. The unexpectedly high $838 million in Revlimid sales in the second quarter were part of a broader overperformance by the company, which beat Wall Street consensus for both its old and new drug business lines. Sales of Eliquis, Opdivo and Reblozyl were higher than expected, although cell therapy Abecma and new psoriasis drug Sotyktu were below, according to Leerink Partners analyst David Risinger. — Jonathan Gardner Biogen shares rose as much as 7% Thursday after the biotechnology company's latest earnings report surpassed Wall Street expectations. The company recorded $2.6 billion in revenue from April through the end of June, with $160 million coming from Leqembi, its closely watched drug for Alzheimer's disease. Biogen also raised its forecasts for 2025 revenue and earnings per share. To Brian Abrahams, an analyst at the investment bank RBC Capital Markets, the results were indicative that Biogen's efforts to turn around the business are starting to show. 'We see considerable room for upside,' he wrote in a note to clients. — Jacob Bell Shares of Argenx climbed by double digits following quarterly sales numbers for its autoimmune drug Vyvgart that handily topped investor expectations. According to Argenx, the company's multiple Vyvgart formulations combined to generate nearly $949 million in revenue between April and June, beating consensus estimates by more than $80 million. The 'blowout' performance included 'impressive' numbers across Vyvgart's approved indications and different versions, wrote William Blair analyst Myles Minter on Thursday. Leerink Partners' Thomas Smith now projects more than $9 billion in combined peak yearly sales. Argenx's market value rose past $40 billion on the news. — Ben Fidler Recommended Reading Eli Lilly's Julie Gilmore on finding up-and-coming companies and backing small biotechs 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
2 hours ago
- Yahoo
S&P 500 Gains & Losses Today: Amazon Stock Drops; Monolithic Power Surges
Key Takeaways The S&P 500 dropped 1.6% on Friday, Aug. 1, 2025, after the July jobs report revealed an unanticipated level of pressure on the U.S. labor market. Shares of Eastman Chemical plummeted after the maker of specialty chemicals reported year-over-year sales and profit declines. Tech giant Amazon's stock also dropped Friday. Monolithic Power released strong quarterly results, with growth across numerous end markets, and shares of the power management chipmaker U.S. equities indexes tumbled on the final day of the trading week and the first day of the new month after the latest Bureau of Labor Statistics report showed a lower-than-expected pace of hiring in July. The data also showed an uptick in the unemployment rate, along with sharp downward revisions to jobs numbers from May and June. The unexpectedly weak numbers suggest that pressure on the labor market could be more intense than previously believed. That could encourage the Federal Reserve to lower interest rates at its upcoming meetings. The S&P 500 fell 1.6% on Friday, suffering its fourth straight down day as the benchmark index extended its retreat from the record closing high set at the beginning of the week. The Dow ended 1.2% lower, while the Nasdaq dropped 2.2%. Read Investopedia's full daily markets roundup here. Shares of Eastman Chemical (EMN) plunged 19%, experiencing the heaviest decline of any S&P 500 stock. The provider of specialty chemicals reported second-quarter sales and profits that declined year-over and fell short of analysts' expectations. Coinbase Global (COIN), operator of the largest U.S. cryptocurrency exchange, posted second-quarter revenue and adjusted earnings before interest, taxes, depreciation, and amortization that fell short of estimates. Transactions revenue as well as subscriptions and services revenue fell from the previous quarter. Coinbase stock, which fell about 17% on Friday. Although Amazon (AMZN) topped revenue and net income estimates with its second-quarter results, shares of the e-commerce giant slipped 8.3%. Jefferies analysts said growth from the Amazon Web Services cloud computing business was disappointing compared with blowout growth figures from competitor Microsoft (MSFT) and its Azure cloud platform. Other research firms suggested that the pullback in Amazon stock could represent a buying opportunity. The top daily performance in the S&P 500 belonged to shares of Monolithic Power Systems (MPWR), which surged more than 10%. The power management chipmaker reported sales and adjusted profits for the second quarter that surpassed analysts' expectations, boosted by a strong performance in its storage and computing, automotive, and communication markets. Shares of Align Technology (ALGN) advanced 5.8% on Friday, clawing back a portion of the losses posted in the prior session. In quarterly results released Wednesday afternoon, the maker of transparent teeth straighteners and other technological dentistry products reported lower-than-expected sales and profits and announced restructuring measures including workforce cuts. First Solar (FSLR) reported stronger-than-expected sales and profits for the second quarter, and shares of the panel manufacturer jumped 5.3%. The company also increased its full-year sales forecast, and CEO Mark Widmar said shifts in trade policy have strengthened First Solar's position in the industry. Read the original article on Investopedia Error while retrieving data Sign in to access your portfolio Error while retrieving data Error while retrieving data Error while retrieving data Error while retrieving data
