Novartis agrees to take actions aimed at meeting US Administration priorities for drug pricingAdditional Novartis medicines will be made available through direct-to-patient platforms in 2026Company remains committed to investing in markets that value innovation and implement policies that support broad and fast access to medicines Basel, December 19, 2025 – Novartis, a leading global innovative medicines company, today announced it has reached an agreement with the US government that aims to lower the price ...

The Trump administration signed deals with nine pharmaceutical companies on Friday, the latest in a series of pacts designed to lower drug prices in exchange for a reprieve from threatened tariffs on their products https://t.co/ixX5U0KWcJ ...

Core Insights - Viatris Inc. (VTRS) has announced four significant regulatory achievements in its pipeline, highlighting its R&D progress for 2025 and its commitment to advancing its portfolio globally [2][9]. Regulatory Approvals - The FDA has approved Viatris' octreotide acetate for injectable suspension, a generic version of Sandostatin LAR Depot, which is used for treating acromegaly and certain types of diarrhea related to tumors [3][4]. - This approval marks VTRS' first injectable product utilizing microsphere technology and is the fourth injectable approval for the company in 2025, enhancing its generics portfolio with complex, high-value products [4]. - The FDA has accepted VTRS' new drug application (NDA) for a low-dose estrogen weekly contraceptive patch, aimed at women with a BMI below 30 kg/m², with a target action date set for July 30, 2026 [5][6]. - The patch delivers approximately 150 mcg of norelgestromin and 17.5 mcg of ethinyl estradiol daily, representing a new option for women seeking lower estrogen doses [6][7]. - The FDA has cleared an investigational new drug (IND) application for MR-146, a gene therapy candidate for neurotrophic keratopathy, with a phase I/II clinical trial planned for the first half of 2026 [8][9]. - Viatris has also received acceptance for its Japanese NDA for pitolisant in obstructive sleep apnea syndrome (OSAS), with plans to submit a separate NDA for narcolepsy by year-end [10][11]. Company Performance - Viatris has demonstrated strong performance over the past six months, with shares increasing by 34.6%, compared to the industry growth of 6.1% during the same period [12]. - The company's expansion in Emerging Markets and robust growth in Greater China are positively impacting sales, with new drug approvals expected to further enhance its portfolio [13].

Key Takeaways U.S. pharma entered a rebound in 2025, with a $370B domestic investment pledge reshaping the industry. Tariff threats and MFN pricing deals pushed firms like Eli Lilly to expand U.S. manufacturing capacity. ETFs such as IHE offer diversified exposure to pharma's growth while reducing single-stock risks. The U.S. pharmaceutical industry underwent a historic, policy-driven transformation in 2025. After a period of post-pandemic cooling, the industry demonstrated stark improvement, ignited by a ...

Core Viewpoint - Merck & Co. Inc. will not exercise its option for Evaxion A/S's Gonorrhea vaccine candidate EVX-B2, allowing Evaxion to retain global rights and seek another licensing partner [1][2]. Group 1: Company Developments - Evaxion's Gonorrhea vaccine candidate EVX-B2 has shown protective effects against the bacteria in preclinical studies, yet no vaccine has been approved for Gonorrhea despite over 80 million infections annually [2]. - Evaxion's CEO, Helen Tayton-Martin, stated that the decision by Merck does not affect the company's cash runway, which extends to the second half of 2027 [2]. - Merck's option was specifically for the protein-based version of EVX-B2, while Evaxion is also developing an mRNA version in collaboration with Afrigen Biologics [3]. Group 2: Financial Aspects - Evaxion received a cash payment of $7.5 million from Merck and is eligible for future milestone payments of up to $592 million, along with royalties on net sales for the EVX-B3 vaccine [4]. - Merck will take full responsibility for the further development and associated costs of the EVX-B3 vaccine [4]. Group 3: Market Reaction - Following the news, Evaxion's stock (EVAX) experienced a decline of 14.61%, trading at $4.91 [5].

Core Viewpoint - A class action lawsuit has been filed against Telix Pharmaceuticals Ltd. for allegedly misrepresenting the company's development progress and overstating achievements in prostate cancer therapeutics during the Class Period from February 21, 2025, to August 28, 2025 [1][3]. Group 1: Lawsuit Details - The lawsuit is on behalf of investors who purchased Telix securities during the specified Class Period [1]. - Investors have until January 9, 2026, to seek appointment as lead plaintiff representatives of the class [2]. Group 2: Allegations - The complaint alleges that the defendants misrepresented the company's business operations, including the reliability of its supply chain and partners, leading to materially false or misleading statements [3]. - As a result of these misrepresentations, investors experienced significant losses when the truth about the company's business was revealed [3]. Group 3: Company Background - Telix Pharmaceuticals is based in Melbourne, Australia, and focuses on radiopharmaceutical therapies and diagnostics for oncology [2].

U.S. stocks were higher, with the Dow Jones index gaining more than 250 points on Friday.Shares of Carnival PLC (NYSE:CUK) rose sharply during Thursday's session after the company announced better-than-expected fourth-quarter adjusted EPS results and issuedFY26 adjusted EPS guidance above estimates.Carnival shares jumped 16.3% to $30.61 on Friday.Here are some other big stocks recording gains in today’s session.NovaBay Pharmaceuticals Inc (NYSE:NBY) shares jumped 45.1% to $4.28.Intuitive Machines Inc (NASDA ...

Core Insights - Pfizer's stock has declined approximately 3% this week following the announcement of its financial guidance for 2026, which did not meet investor expectations [1] Financial Guidance - Pfizer anticipates total revenues for 2026 to be between $59.5 billion and $62.5 billion, reflecting modest growth from the revised 2025 revenue expectation of around $62 billion, primarily due to lower revenues from COVID products and the impending patent cliff [2] - The company expects adjusted earnings per share in the range of $2.80 to $3.00 for 2026, a decline from the 2025 expected range of $3.00 to $3.15, influenced by the dilutive impact of recent deals and lower COVID revenues [3] Oncology Segment - Pfizer holds a strong position in oncology, with oncology sales accounting for approximately 28% of total revenues, which have increased by 7% in the first nine months of 2025 [4][5] - The company is advancing its oncology pipeline and expects to have eight or more blockbuster oncology medicines by 2030 [5] Product Development and Acquisitions - Pfizer is focusing on expanding its product labels and has in-licensed rights for new oncology treatments, including a dual PD-1 and VEGF inhibitor [6][7] - The company has reduced its dependence on COVID-related revenues, with non-COVID operational revenues improving due to key products and new acquisitions, which are expected to deliver double-digit growth in 2026 [8][9] Challenges and Headwinds - Pfizer is facing a significant revenue impact from the loss of exclusivity for several key products between 2026 and 2030, which is projected to reduce sales by approximately $1.5 billion in 2026 [15] - The company is also experiencing lower sales of COVID products due to decreased vaccination and infection rates, with expected COVID revenues around $5 billion in 2026, down from $6.5 billion in 2025 [12][14] Stock Performance and Valuation - Pfizer's stock has underperformed compared to the industry and the S&P 500, losing 4.9% year-to-date [17] - The stock is currently trading at a price/earnings ratio of 8.04, significantly lower than the industry average of 17.11 and its five-year mean of 10.41, indicating potential attractiveness for investors [20] Future Outlook - Despite current challenges, Pfizer's key drugs and new product launches are expected to help offset losses from patent expirations, with anticipated cost savings of $7.7 billion by the end of 2027 [26] - The company is viewed as a hold in investment portfolios as it rebuilds its pipeline in oncology and obesity, which could drive growth from 2029 onwards [27]

Core Viewpoint - Merck is expected to face significant challenges impacting its long-term growth outlook, primarily due to the impending loss of exclusivity for its leading drug, Keytruda, in 2028, despite recent sales growth [1][11]. Group 1: Keytruda and Revenue Impact - Keytruda, a PD-L1 inhibitor, generated sales of $23.3 billion in the first nine months of 2025, marking an 8% year-over-year increase and accounting for over 50% of Merck's pharmaceutical sales [1][2]. - The intravenous formulation of Keytruda will lose patent exclusivity in 2028, prompting Merck to develop a subcutaneous formulation, Keytruda Qlex, which has its own patents extending beyond 2028 [3]. - The anticipated loss of exclusivity for Keytruda is a major concern for Merck's revenue stability moving forward [11]. Group 2: Declining Sales of Gardasil - Gardasil, Merck's second-largest product, saw sales of $4.20 billion in the first nine months of 2025, reflecting a 40% decline year over year, primarily due to weak demand in China and Japan [4][5]. - Management expects continued weakness in Gardasil sales in these markets as they head into 2026 [5]. Group 3: Regulatory and Competitive Challenges - The redesign of Medicare Part D under the Inflation Reduction Act, effective in 2025, poses additional challenges, with drugs like Januvia and Janumet facing government price setting starting in 2026 and 2027, respectively [6][7]. - Keytruda is also expected to be subject to government price setting in 2027, which could further impact U.S. sales post-2029 [7]. Group 4: Future Growth Prospects - Merck is focusing on new products like the 21-valent pneumococcal conjugate vaccine, Capvaxive, and the pulmonary arterial hypertension drug, Winrevair, to drive revenue growth after Keytruda's exclusivity ends [8]. - The Animal Health business is contributing positively to Merck's growth, and the company aims to achieve $3 billion in annual cost savings by the end of 2027 through optimization initiatives [9]. Group 5: Market Performance and Valuation - Merck's shares have increased by 27.5% over the past six months, outperforming the industry average of 19% [14]. - The company's price/earnings ratio stands at 11.56, which is lower than the industry average of 17.11 and its five-year mean of 12.49, indicating attractive valuation [15]. - The Zacks Consensus Estimate for 2025 earnings per share has risen from $8.92 to $8.98, while the estimate for 2026 has decreased from $9.44 to $8.37 [17].

PresentationThank you for standing by. My name is Jayel, and I will be your conference operator today. At this time, I would like to welcome everyone to the BioMarin business update. [Operator Instructions] I would now like to turn the conference over to Traci McCarthy, Head of Investor Relations. You may begin. Perhaps, your line is on mute, Traci.Traci McCartyGroup Vice President Thank you, Jayel, and good morning, everyone. Thank you for joining us to discuss BioMarin's acquisition of Amicus Therapeutics ...