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US FDA Commissioner Makary says FDA supports mRNA vaccines but US taxpayers should not bear the cost
Reuters· 2026-02-23 20:15
Skip to main content Exclusive news, data and analytics for financial market professionalsLearn more aboutRefinitiv US FDA Commissioner Makary says FDA supports mRNA vaccines but US taxpayers should not bear the cost February 23, 20268:15 PM UTCUpdated ago By Ahmed Aboulenein U.S. Food and Drug Administration Commissioner Marty Makary speaks during a press conference at the Department of Health and Human Services in Washington, D.C., U.S., November 10, 2025.... Purchase Licensing Rights, opens new tab Read ...
Pharmaceutical Contract Development and Manufacturing Organization Forecasts Report 2026: A $374.68 Billion Market by 2031 - One-Stop CDMOs, Rapid AI Platforms, and GLP-1/HPAPI Build-Outs Drive Demand
Globenewswire· 2026-02-03 09:01
Market Overview - The Pharmaceutical Contract Development and Manufacturing Organization (CDMO) market is projected to grow from USD 258.88 billion in 2025 to USD 275.27 billion in 2026, reaching USD 374.68 billion by 2031, with a CAGR of 6.33% from 2026 to 2031 [2]. Market Drivers - There is a robust outsourcing demand for complex biologics, high-potency APIs (HPAPIs), and AI-enabled process-development platforms, which are driving market growth [3]. - Increasing outsourcing volume by large pharmaceutical companies is influenced by escalating R&D costs and pipeline complexity, leading to a preference for asset-light models that leverage CDMO expertise [5]. - The surge in biologics and complex-molecule pipelines is evident, with biological entities dominating new-drug filings, including antibody-drug conjugates and mRNA vaccines [6]. Geographic Insights - North America held a 37.95% revenue share in 2025, supported by premier biologics programs and a deep venture-capital pool [9]. - The Asia-Pacific region is expected to grow at the fastest rate of 7.18% CAGR through 2031, with significant investments in mega-plants for mAbs and oligonucleotides [10]. - Europe is experiencing steady expansion, with Germany and the UK leading in quality and innovation despite Brexit challenges [11]. Market Trends - Consolidation in the industry is evident, as seen in Novo Holdings' USD 16.5 billion acquisition of Catalent, indicating a shift towards end-to-end CDMO providers [4]. - The demand for specialist partners is amplified by the need for compliance with stringent multi-region regulatory requirements, which challenge smaller entrants [8]. Competitive Landscape - Major players in the market include Thermo Fisher Scientific, Lonza Group, Catalent, and Samsung Biologics, among others, with strategic moves and market share analysis highlighting their competitive positioning [17].
This COVID-Era Biotech Favorite Is Surging Once Again On Strong Q4 Guidance: Momentum Score Spikes - Moderna (NASDAQ:MRNA)
Benzinga· 2026-01-16 08:56
Core Viewpoint - Moderna Inc. is experiencing a resurgence in stock momentum after a significant decline since its peak in 2021, driven by improved financial outlook and investor sentiment [1][4]. Group 1: Stock Performance - The stock has seen a 91.87% decline from its all-time high in 2021, but has recently gained 76% from its November 2025 lows [1][3]. - The Momentum score in Benzinga's Edge Stock Rankings has increased from 22.5 to 74.61 in just one week, indicating a strong turnaround in investor sentiment [2][3]. - Shares have climbed 31.7% in the past month and an additional 14.8% over the past week [3]. Group 2: Financial Outlook - Moderna's full-year 2025 revenue is projected at $1.9 billion, exceeding previous estimates by approximately $100 million [4]. - The company has reduced its GAAP operating expense forecast by about $200 million for the year, improving its cost structure [4]. - The projected year-end cash balance has been increased to $8.1 billion, contributing to positive investor sentiment [4]. Group 3: Recent Trading Activity - On a recent trading day, shares of Moderna closed down 3.01% at $39.36 but were up 0.66% overnight [5]. - The stock maintains a favorable price trend across short, medium, and long-term time frames in Benzinga's Edge Stock Rankings [5].
Moderna (MRNA) Rockets 17% on Strong Preliminary FY25 Results
Yahoo Finance· 2026-01-14 12:09
Group 1 - Moderna Inc. reported a strong performance with a 17.02% increase in stock price, closing at $39.60, driven by positive preliminary earnings results for full-year 2025 [1][3] - The company expects revenues of $1.9 billion for full-year 2025, exceeding its previous guidance range of $1.6 billion to $2 billion [2] - Moderna aims for up to 10% revenue growth in 2026 while reducing operating expenses to between $4.2 billion and $4.6 billion, with a goal to break even by 2028 [2][4] Group 2 - CEO Stephane Bancel highlighted the successful launch of a third product and significant cost reductions of approximately $2 billion, surpassing initial financial commitments [3] - The company is focused on building a seasonal vaccine franchise for at-risk populations, which is expected to support revenue growth and fund future innovations in oncology and rare diseases [4] - Official financial results are anticipated to be released in the second week of next month [4]
BioNTech (NasdaqGS:BNTX) 2025 Investor Day Transcript
2025-10-01 14:02
Summary of BioNTech and InstaDeep AI Day Conference Company and Industry Overview - **Company**: BioNTech - **Industry**: Biotechnology, specifically focusing on oncology and infectious diseases Key Points and Arguments 1. **Integration of AI in BioNTech**: AI is fully integrated into BioNTech's business model and development processes, enhancing research and development capabilities across multiple continents [3][4][5] 2. **Focus on Oncology**: BioNTech is a late-stage clinical company with a core focus on oncology, utilizing advanced therapies such as immunotherapy and messenger RNA therapeutics [4][5] 3. **Partnerships for Development**: BioNTech has partnered with Bristol-Myers Squibb to develop bispecific antibodies, particularly BNT327 (pumitamic), targeting multiple cancer indications [8][9] 4. **AI-Driven Personalized Vaccines**: The company is developing personalized vaccines based on individual mutations identified through sequencing, aiming to induce immune responses against various cancer types [10][11][12] 5. **AI in Drug Discovery**: InstaDeep, BioNTech's AI unit, is leveraging AI to optimize drug discovery processes, including the development of a supercomputer (KyberCluster) to enhance computational capabilities [30][34][35] 6. **Nucleotide Transformer v3**: InstaDeep introduced Nucleotide Transformer v3, a state-of-the-art genomics model capable of processing sequences of up to 1 million nucleotides, demonstrating superior performance in genome annotation and experimental data prediction [42][44][58] 7. **Generative Capabilities**: Nucleotide Transformer v3 can generate DNA sequences with specific properties, validated through lab experiments, showcasing its potential in gene therapy applications [55][56][58] 8. **AI's Exponential Growth**: The conference highlighted the exponential growth in data, compute power, and model efficiency in AI, emphasizing the transformative potential of AI in biotechnology [23][25][26] Additional Important Content 1. **Historical Context**: The conference took place at the Science Museum, a location significant for the history of vaccines, linking BioNTech's current innovations to past breakthroughs in medicine [3] 2. **AI's Role in Cancer Treatment**: The discussion included the complexity of cancer treatment and the need for personalized approaches due to the heterogeneity of tumors [9][10][19] 3. **Collaborative Research**: The collaboration between BioNTech and InstaDeep has led to significant advancements in AI applications in biology, evidenced by multiple publications in prestigious journals [31] 4. **Future Vision**: BioNTech envisions a future where AI-driven personalized medicine becomes standard, integrating clinical samples with advanced AI tools to optimize treatment strategies [20][21] This summary encapsulates the core discussions and innovations presented during the AI Day conference, highlighting the strategic direction of BioNTech and its AI unit, InstaDeep, in revolutionizing biotechnology and personalized medicine.
GeoVax Labs (NasdaqCM:GOVX) 2025 Conference Transcript
2025-09-25 20:57
Summary of GeoVax Labs Conference Call Company Overview - **Company**: GeoVax Labs (NasdaqCM:GOVX) - **Industry**: Biotechnology - **Focus**: Development of novel vaccines for infectious diseases and therapies for solid tumor cancers [1] Core Points and Arguments - **Public Health Issue**: The unmet needs of immunocompromised patients, particularly in the context of COVID-19, are significant. Current vaccines are inadequate for these populations [2][3] - **Limitations of Current Vaccines**: Existing mRNA vaccines (Pfizer, Moderna, Novavax) are first-generation and have limited breadth of protection. They require reconfiguration for new variants and have a short efficacy duration of about three to six months [3] - **Target Population**: Over 40 million individuals in the U.S. and over 400 million worldwide are at high risk due to medical conditions that impair their immune response [4] - **GeoVax's Solution**: The GEO-CM04S1 vaccine is designed to address the limitations of current vaccines, providing adequate protection for high-risk groups, including blood cancer patients and those with chronic lymphocytic leukemia [5][6] - **Clinical Trials**: Two active clinical trials are underway, showing promising immune responses that exceed those of mRNA vaccines. The trials focus on blood cancer patients who do not respond to existing vaccines [6][7] Financial Status and Plans - **Funding**: GeoVax raised funds in early July and plans to raise an additional $12 million to $15 million by the end of the year to support ongoing programs [9] - **Market Interest**: The recent acquisition of Bavarian Nordic for $3 billion has generated interest in GeoVax, although the company remains focused on advancing its programs without speculation on potential acquisitions [10] Regulatory Environment - **FDA Interaction**: The company reports minimal impact from the short-staffed FDA, maintaining active communication and progress on current programs [11] Stock Price and Investor Relations - **Stock Valuation**: Analysts suggest the stock could be valued between $5 to $12 per share, indicating it is currently undervalued. GeoVax aims to enhance transparency and communication with investors to boost stock activity and liquidity [12][13][15] Additional Notes - **Upcoming Milestones**: GeoVax has several programs advancing, including a vaccine for mpox/smallpox and therapies for solid tumors, with updates expected in the near future [7][8]
RFK Jr. was ‘never’ briefed by experts on vaccine preventable diseases: CDC official who resigned
NBC News· 2025-08-29 21:30
Concerns Regarding CDC's Integrity - A former CDC official resigned, citing concerns that the CDC is being transformed into a "weaponized organization" driven by ideological goals rather than public health [3] - The resignation was partly due to the perceived loss of a "firewall between ideology and science" at the CDC, particularly with the departure of Susan Manares [4] - There are fears that science at the CDC will be "contaminated by ideology," especially in the vaccine space [5] - The official expressed concern that HHS policies do not reflect scientific reality [5] - The official believes there is an "irresistible force" making it impossible for the CDC to maintain the validity of its science against ideology, especially regarding vaccines [6] - There are concerns about the appointment of individuals lacking scientific experience to positions of influence at the CDC, potentially allowing bias to influence scientific recommendations [8] Vaccine-Related Concerns - The official fears that trust in the CDC, especially in the vaccine space, will erode due to attacks and misinformation [9][10] - The official suggests cross-checking CDC information with clinicians and professional organizations [10][11][12] - Concerns were raised about Secretary Kennedy pushing disputed claims linking vaccines to autism, which has been debunked by science [13] - Secretary Kennedy made inaccurate statements about mRNA vaccines, claiming they "didn't do anything in the pandemic" and are "the most dangerous vaccines known to humanity" [14] - There are concerns about potential retrofitting of data to support conclusions linking vaccines to autism and other diseases [15] - The official mentioned concerns about alum and thimerosal being targeted as harmful vaccine components despite scientific evidence to the contrary [16][17] Lack of Communication and Briefings - Secretary Kennedy has never been briefed by CDC experts on diseases, specifically vaccine-preventable diseases [22] - The official offered briefings on measles, H5N1 (bird flu), and vaccines in general, but these offers were not taken up [20][21] - The official questions who is briefing Secretary Kennedy if not the CDC experts [23] - Secretary Kennedy has made statements about vaccines that contradict the information provided by CDC experts [24] Optimism and Recommendations - The official hopes that the public can still trust the CDC but is concerned, especially regarding vaccines [9] - The official expresses optimism that the acting CDC director, Jim O'Neal, will engage with scientists and support science-based decision-making [27][28][29] - The official hopes that elected officials will take action to protect the health of America rather than focusing on ideologies [31][32]
RFK Jr. challenges Secy. Hegseth to a pull up and push up challenge
MSNBC· 2025-08-19 13:20
Two, three. One, two, three. One, two, three.Hi, I'm Robert F. Jenny Jr. ., your AJ Secretary.I'm here with Secretary Hugs from the Department of Defense. And we had our big big body challenge today. 50 pull-ups, 100 push-ups.You try to get under five minutes. How did you We got close. I was about 525.You were right behind me. Jonathan Lamir asking the appropriate question. Why does uh RFK Jr.. who at 70 let's admit it's jacked. We don't know if it's a Donnie Deutsch H you know like HGH thing you know remem ...
Doctor DEBUNKS RFK Jr.'s claims about mRNA vaccines
MSNBC· 2025-08-17 21:18
I'm sure you've heard that Health Secretary Robert F. Kennedy Jr. . made big news recently by announcing that he's cutting 22 mRNA vaccine development programs and additional federal funding for other mRNA technologies.If mRNA sounds familiar, it's because it is. This was the biotechnology platform that allowed for the innovation that was the COVID vaccine, the life-saving COVID vaccine that saved millions of lives in the thick of the pandemic. To justify these cuts, RFK Jr.. said this. As the pandemic show ...
The Rachel Maddow Show - Aug. 11 | Audio Only
MSNBC· 2025-08-12 05:35
Crime and Justice - A convicted triple murderer, who committed the crimes with an axe and machete in Madrid in June 2016, was freed from prison after being convicted and serving a 30-year sentence [12][8]. - The triple murderer was released as part of a situation involving Donald Trump's El Salvador prison initiative, and is now reportedly free in Orlando [14][13]. - Another individual, previously deported five times and with a history of criminal offenses, including gun crimes, was also released from federal prison by Donald Trump and is set to be fully released in January, with a reported work permit to follow [28][25][26]. - A Department of Justice official, who had previously urged January 6th rioters to "kill cops," was hired by Pam Bondi after being pardoned by Donald Trump [38]. Political Actions and Policies - Donald Trump deployed hundreds of National Guard members to Washington DC, placing the DC police under direct federal control, despite violent crime rates being at a 30-year low [38]. - The Trump administration expanded military zones in Texas, New Mexico, and Arizona, granting active duty troops the authority to stop, search, and arrest Americans on domestic soil [41]. - The Pentagon confirmed the deployment of 700 active duty US Marines and roughly 4,000 National Guardsmen to Los Angeles, over the objections of the city and state [47]. Public Health - The Trump administration decided to cancel half a billion dollars in contracts related to mRNA technology, a decision criticized by public health officials who warn of potential loss of lives [67][68]. - Experts warn that cutting funding for mRNA vaccines could hinder preparedness for future pandemics, potentially costing millions of lives [73]. - A gunman fired more than 180 shots into the headquarters of the Centers for Disease Control (CDC) in Atlanta, killing one police officer, but the incident garnered no response from President Donald Trump [38].