The FDA has refused to accept an application from Moderna to review its first mRNA seasonal flu vaccine, the company said. https://t.co/mBu4Up1Lh5 ...

The FDA has refused to accept an application from Moderna to review its first mRNA seasonal flu vaccine, the company said. https://t.co/9wBbuFdMc1 ...

Core Insights - Ascletis Pharma Inc. has selected ASC36, an oral amylin receptor peptide agonist, for clinical development targeting obesity, with an Investigational New Drug Application (IND) submission to the FDA expected in Q2 2026 [1] Group 1: Drug Development and Efficacy - ASC36 oral tablets achieved absolute oral bioavailability of 6% to 8% in non-human primate studies, with a long elimination half-life of 116 to 167 hours, supporting once-daily dosing [1] - In non-human primates, ASC36 reduced mean body weight by up to 13.2% from baseline after 7 days of once-daily dosing and significantly reduced food intake [1] - In a diet-induced obese rat model, ASC36 demonstrated approximately 32% and 91% greater relative body weight reduction compared to eloralintide and petrelintide, respectively [1] Group 2: Technological Advancements - ASC36 was developed using Ascletis' proprietary Peptide Oral Transport Enhancement Technology (POTENT) and Artificial Intelligence-assisted Structure-Based Drug Discovery (AISBDD) [1] - The expected lower dosing of ASC36 compared to recently FDA-approved oral GLP-1R peptide agonists may provide scalability advantages in manufacturing [1] Group 3: Company Overview - Ascletis Pharma Inc. is a fully integrated biotechnology company focused on developing therapeutics for metabolic diseases, utilizing multiple proprietary technology platforms [1] - The company has a diverse pipeline portfolio, including ASC30, a small molecule GLP-1R agonist, and other peptide agonists for chronic weight management [1]

Financial Data and Key Metrics Changes - For Q4 2025, total revenues were approximately $599 million, including cabozantinib franchise net product revenues of $546.6 million [13] - Full year 2025 US CABO franchise net product revenues grew 17% to approximately $2.12 billion compared to 2024 [7] - GAAP net income for Q4 2025 was approximately $244.5 million, or $0.92 per share basic [16] - Non-GAAP net income for Q4 2025 was approximately $259.5 million, or $0.97 per share basic [17] - Cash and marketable securities at the end of 2025 were approximately $1.66 billion [17] Business Line Data and Key Metrics Changes - CABOMETYX maintained its position as the leading TKI for renal cell carcinoma (RCC) and neuroendocrine tumors, with Q4 2025 TRX volume growing 15% compared to Q4 2024 [19][20] - CABOMETYX's gross-to-net for Q4 2025 was 28.5%, lower than the previous quarter due to lower PHS and 340B volume [13] - Zanzalintinib is positioned as the next potential oncology franchise, with seven ongoing pivotal trials [10][24] Market Data and Key Metrics Changes - CABOMETYX's market share in the oral TKI segment grew from 43% to 46% from Q4 2024 to Q4 2025 [19] - The market basket growth rate for oral TKIs was 7% during the same period, indicating CABOMETYX outpaced the market [20] - The neuroendocrine tumor indication for CABOMETYX exceeded $100 million in revenue for 2025 [21] Company Strategy and Development Direction - The company aims to build a multi-franchise business in solid tumor oncology, focusing on cabozantinib and zanzalintinib [5][6] - The strategy includes expanding leadership in gastrointestinal (GI) indications while maintaining a strong position in genitourinary (GU) oncology [5] - Business development activities are focused on late-stage assets in GU and GI spaces, with a priority on pay-for-success transactions [11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in building on the momentum from 2025 into 2026, with expectations for continued strong performance from the cabozantinib business [5] - The company is preparing for the potential launch of zanzalintinib, with a PDUFA date set for later in the year [22] - Management highlighted the significant unmet medical need in the third-line plus colorectal cancer setting, which zanzalintinib aims to address [22][26] Other Important Information - The company repurchased $954 million of its common stock in 2025, retiring approximately 24 million shares [17] - The remaining balance under the stock repurchase plan is approximately $590 million [18] Q&A Session Summary Question: How long will the company benefit from the small manufacturer discount for Zanza? - Management indicated that the small manufacturer exemptions are tied to having a single product as the majority revenue source, which is expected to remain the case for the foreseeable future [34][35] Question: Can you comment on recent 340B purchasing behavior? - Management noted variability in 340B purchasing behavior throughout 2025 and expects continued variability in 2026, which could impact gross-to-net [39][40] Question: What is the expected population size for STELLAR-316? - The estimated population for STELLAR-316 is around 20,000-25,000 patients who are MRD positive after definitive therapy [42][43] Question: What is the growth expectation for NET revenues? - Management expressed optimism about the growth potential in the neuroendocrine tumor segment, emphasizing the need to expand outreach in the community setting [45][47] Question: How does the company anticipate positive data impacting commercial strategy? - Positive data from ongoing trials is expected to enhance communication with physicians and clarify the benefits of the treatment for patients [56][58]

Core Viewpoint - Gilead Sciences Inc. reported strong fourth-quarter earnings but provided weak guidance for fiscal 2026, leading to a decline in stock price during extended trading [1][3]. Financial Performance - Gilead reported quarterly earnings of $1.86 per share, surpassing the consensus estimate of $1.81 [2]. - Quarterly revenue reached $7.93 billion, exceeding the Street estimate of $7.69 billion [2]. Product Launch and Growth - The company highlighted the successful U.S. launch of Yeztugo, the world's first twice-yearly HIV prevention therapy, along with continued growth for Biktarvy and Descovy [2]. Future Outlook - For fiscal 2026, Gilead expects adjusted EPS in the range of $8.45 to $8.85, compared to the analyst estimate of $8.74 [3]. - Revenue guidance for fiscal 2026 is projected between $29.6 billion and $30 billion, below the analyst estimate of $30.22 billion [3]. Stock Performance - Following the earnings report, Gilead's stock price fell by 2.87% to $143 in extended trading [3].

Financial Data and Key Metrics Changes - Gilead reported total product sales of $28.9 billion for 2025, a 1% increase from 2024, exceeding guidance due to strong HIV sales growth despite a $1.1 billion headwind from Medicare Part D redesign and a $900 million decline in Veklury revenue [33][34] - The base business revenue, excluding Veklury, was $28 billion, up 4% from 2024, also surpassing guidance [33] - Non-GAAP diluted EPS for 2025 was $8.15, in line with guidance, reflecting lower R&D expenses and higher revenues [36] Business Line Data and Key Metrics Changes - The HIV business grew 6% year-over-year to $20.8 billion, driven by strong demand for Biktarvy and Descovy, with Biktarvy sales reaching $14.3 billion, up 7% [34][11] - The liver business also grew 6% to $3.2 billion, primarily due to the strong performance of Livdelzi [34][17] - Oncology product Trodelvy saw a 6% increase in sales to $1.4 billion, driven by demand in metastatic breast cancer treatment [34][18] - Cell therapy sales declined 7% year-over-year to $1.8 billion, reflecting competitive pressures [34][20] Market Data and Key Metrics Changes - The HIV prevention portfolio, including Yes2Go, grew significantly, with fourth-quarter sales of Yes2Go at $96 million and full-year sales at $150 million [13][15] - The U.S. market for HIV prevention is expanding, with Descovy achieving over 45% market share [13] - Livdelzi's market share in the U.S. for second-line primary biliary cholangitis exceeded 50% [17] Company Strategy and Development Direction - Gilead is targeting four commercial launches in 2026, including Trodelvy for first-line metastatic triple-negative breast cancer and a new daily oral combination for HIV treatment [6][22] - The company aims to maintain expense discipline while investing in new product launches and expanding its pipeline, with up to 10 ongoing and potential new launches through 2027 [7][8] - Gilead's strategy focuses on diversifying its portfolio and enhancing its clinical pipeline, which is considered the strongest in its history [6][7] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in entering 2026 with a strong position, citing no major product losses expected until 2036 and a commitment to returning capital to shareholders [8][43] - The company anticipates a 2% headwind to growth in 2026 due to drug pricing agreements and changes to the Affordable Care Act, but expects underlying growth of 6% absent these factors [41][42] - Management highlighted the importance of ongoing clinical trials and product launches in driving future growth [24][32] Other Important Information - Gilead returned $5.9 billion to shareholders in 2025, including $1.9 billion in share repurchases [42] - The company plans to invest approximately $1 billion annually in early-stage pipeline development and partnerships [43] Q&A Session Summary Question: Can you elaborate on the assumptions driving the $800 million guidance for Yes2Go? - Management highlighted strong access with 90% payer coverage and ongoing direct-to-consumer campaigns to increase awareness and drive growth [45][48] Question: What type of share gains do you expect for Anito-cel in the fourth-line setting? - Management expects modest contributions in 2026 post-launch, with a goal to become the market leader over time due to its efficacy and safety profile [52][56] Question: Are you expecting cannibalization of Descovy PrEP sales by Yes2Go? - Management anticipates that while Yes2Go will grow, Descovy will also continue to perform well in 2026, with both products benefiting from increased awareness in HIV prevention [58][60] Question: Can you discuss the profile of the long-acting 6-month treatment drug GS-3242? - Management expressed excitement about GS-3242's potential, emphasizing its differentiated profile and the importance of its combination with lenacapavir [63][66] Question: What do you need to show in the PURPOSE 365 study for lenacapavir for PrEP? - The study aims to demonstrate effective prevention through pharmacokinetics and safety, with potential market expansion opportunities if successful [69][73]

Core Viewpoint - PharmAla Biotech Holdings Inc. announces changes to its Board of Directors, including the resignation of Dr. Malik Slassi and the appointment of Mr. Lennie Ryer, aiming to enhance the board's expertise as the company progresses in its development [1][2][3]. Company Overview - PharmAla Biotech Holdings Inc. is focused on the research, development, and manufacturing of MDXX class molecules, including MDMA, with a dual focus on alleviating the backlog of clinical-grade MDMA for trials and commercial sales, as well as developing novel drugs [4]. - The company is currently the only provider of clinical-grade MDMA for patient treatments outside of clinical trials and has completed proof-of-concept research into several intellectual property families, including its lead drug candidate ALA-002 [4]. Board Changes - Dr. Malik Slassi has resigned from the board effective February 9, 2026, after four years of support and insight during the company's early stages [2][3]. - Mr. Lennie Ryer, a seasoned financial executive with extensive experience in corporate finance and governance, has been appointed to the board, bringing valuable expertise as the company enters a new phase of development [3].

Q425 & FY25 Financial Results 1 0 D e c e m b e r 2 0 2 4 F e b r u a r y 1 0 , 2 0 2 6 Forward-Looking Statements Statements included in this document that are not historical in nature are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Gilead cautions readers that forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include those relating to: Gilea ...

LOS ANGELES, CALIFORNIA / ACCESS Newswire / February 10, 2026 / Today, eXoZymes Inc. (NASDAQ:EXOZ) ("eXoZymes") - a pioneer of AI-enhanced enzymes transforming abundant feedstock into valuable nutraceuticals and new medicines - announced the launch of a redesigned corporate website and updated visual identity, reflecting the company's refined strategic focus on pharmaceutical and nutraceutical markets. The update follows the company's previously communicated decision to sharpen its commercial scope toward s ...

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