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Johnson & Johnson Tops Q2 Estimates
The Motley Fool· 2025-07-16 18:10
Johnson & Johnson (JNJ 5.68%), a global healthcare leader best known for its pharmaceutical, MedTech, and medical device portfolio, reported earnings for Q2 2025 on Wednesday, July 16, 2025, that topped analysts' consensus estimates. The company exceeded market expectations for both adjusted earnings and revenue, even as some non-GAAP profitability measures dipped from the prior year. Revenue was $23.7 billion, topping the analyst estimate of $22.85 billion, while adjusted EPS came in at $2.77 versus an est ...
Celcuity Announces Issuance of New Patent for Gedatolisib that Extends Patent Exclusivity into 2042
Globenewswire· 2025-07-14 11:05
Core Insights - Celcuity Inc. has been granted U.S. Patent No. 12,350,276 for the clinical dosing regimen of its lead drug candidate, gedatolisib, in ER+/HER2- breast cancer patients, extending patent exclusivity until 2042 [1][2] - The company has a robust patent portfolio for gedatolisib, including 13 granted patents in the U.S. and 290 patents in foreign jurisdictions [2] - Celcuity plans to announce topline data for the PIK3CA wild-type cohort of the VIKTORIA-1 clinical trial in Q3 2025 and for the PIK3CA mutant cohort in Q4 2025 [3] Company Overview - Celcuity is a clinical-stage biotechnology company focused on developing targeted therapies for various solid tumor indications, with gedatolisib as its lead candidate [4] - Gedatolisib is a potent pan-PI3K and mTORC1/2 inhibitor that targets the PI3K/AKT/mTOR pathway, differentiating it from other therapies [4] - The company is currently conducting multiple clinical trials, including the Phase 3 VIKTORIA-1 trial for HR+/HER2- advanced breast cancer and the Phase 1/2 CELC-G-201 trial for metastatic castration-resistant prostate cancer [4]
Evoke Pharma Receives Notice of Allowance for U.S. Patent Application for GIMOTI Extending Orange Book listings to 2036
Globenewswire· 2025-07-09 12:16
Core Insights - Evoke Pharma, Inc. has received a Notice of Allowance from the USPTO for a patent application related to GIMOTI® nasal spray, extending patent exclusivity by an additional 6 years, expected to expire in December 2036 [1][2] Company Overview - Evoke Pharma is a specialty pharmaceutical company focused on developing treatments for gastrointestinal diseases, particularly through its product GIMOTI®, a nasal spray formulation of metoclopramide [6] - GIMOTI® is the only FDA-approved non-oral, self-administered formulation of metoclopramide, indicated for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in adults [5][7] Product Significance - The new patent allowance enhances the GIMOTI® franchise by providing additional protection for its use in patients with moderate to severe symptoms of gastroparesis, a condition that complicates the absorption of oral medications [2][3] - GIMOTI® addresses a significant need in the market as gastroparesis affects millions globally, leading to serious gastrointestinal symptoms and complications [7] Market Commitment - The company is committed to supporting the gastroparesis community and will participate in Gastroparesis Awareness Month to improve treatment options and disease awareness [4]
Pfizer Q1 Earnings Beat Estimates, Several Headwinds Hurt Sales
ZACKS· 2025-04-29 16:35
Core Viewpoint - Pfizer reported mixed first-quarter results for 2025, with adjusted earnings per share of 92 cents exceeding estimates but revenues of $13.72 billion falling short of expectations, reflecting a year-over-year decline of 8% [1][2][15]. Revenue Performance - Total revenues were $13.72 billion, down 8% year-over-year, missing the Zacks Consensus Estimate of $13.89 billion, with operationally a decrease of 6% and a negative currency impact of 2% [2]. - International revenues increased by 4% operationally to $5.34 billion, while U.S. revenues declined by 12% to $8.37 billion [3]. Product Segment Analysis - Primary Care segment sales fell 20% operationally to $5.7 billion, with Eliquis sales declining 4% to $1.92 billion due to pricing pressures from the Inflation Reduction Act [4][5]. - Specialty Care sales rose 6% to $4.0 billion, driven by Vyndaqel family revenues increasing by 33% to $1.49 billion [4][10]. - Oncology sales increased by 7% to $3.76 billion, with Padcev sales rising 25% to $426 million, while Ibrance revenues declined by 6% to $977 million [4][12][13]. Key Product Performance - Paxlovid revenues dropped 75% year-over-year to $491 million, missing estimates [8]. - Comirnaty sales rose 62% year-over-year to $565 million, exceeding expectations [7]. - The RSV vaccine, Abrysvo, recorded sales of $131 million, down 6% year-over-year, missing estimates [9]. Cost Management - Adjusted selling, informational, and administrative expenses decreased by 12% to $3.01 billion, while adjusted R&D expenses also fell by 12% to $2.17 billion [3]. 2025 Guidance - Pfizer reaffirmed its 2025 guidance, projecting total revenues between $61.0 billion and $64.0 billion, with adjusted earnings per share expected in the range of $2.80 to $3.00 [14][16]. Market Context - Pfizer's stock has declined 11.7% year-to-date, contrasting with a 1.5% increase in the industry [16]. - The company faces challenges from declining COVID-19 product sales and potential patent expirations impacting key products from 2026 to 2030 [17]. Strategic Outlook - Pfizer anticipates that non-COVID drug sales and new product contributions will drive revenue growth in 2025, alongside cost-cutting measures expected to yield savings of $7.7 billion by the end of 2027 [20].