Genentech
Search documents
Novartis, Genentech file suit alleging illegal importation of prescription drug
CNBC· 2026-02-26 20:44
A sign of Swiss pharmaceutical giant Novartis is seen on the top of a building at Novartis Campus in Basel on Sept. 9, 2025.Novartis, one of the world's largest pharmaceutical companies, and Genentech, a major biotech firm, say they've uncovered a "dangerous scheme" to import their allergy medication from Canada into the U.S. in violation of U.S. Food and Drug Administration regulations.Both are suing SHARx — a so-called alternative funding program — and a Canadian pharmacy over the importation of Xolair, a ...
Recursion(RXRX) - 2025 Q4 - Earnings Call Transcript
2026-02-25 14:02
Recursion Pharmaceuticals (NasdaqGS:RXRX) Q4 2025 Earnings call February 25, 2026 08:00 AM ET Company ParticipantsBen Taylor - CFO and President of Recursion UKDave Hallett - Chief Scientific OfficerNajat Khan - CEO and PresidentNajat KhanGood morning, everyone, thank you so much for joining us. I want to start by briefly framing where Recursion is today in its journey and evolution. Over the past decade, Recursion has built something truly special, a differentiated platform, pioneering the integration of l ...
Genprex Strengthens Intellectual Property Portfolio with Japanese and EU Patents for Reqorsa® Gene Therapy in Combination with Immunotherapies to Treat Cancer
Prnewswire· 2026-02-23 13:00
Private Securities Litigation Reform Act of 1995. These forward-looking statements are made on the basis of the current beliefs, expectations and assumptions of management, are not guarantees of performance and are subject to significant risks and uncertainty. These forward-looking statements should, therefore, be considered in light of various important factors, including those set forth in Genprex's reports that it files from time to time with the Securities and Exchange Commission and which you should re ...
Here are all the tariffs staying in place after Supreme Court ruling
New York Post· 2026-02-20 22:33
Core Points - The Supreme Court ruled that tariffs imposed under the International Emergency Economic Powers Act (IEEPA) exceeded President Trump's authority, leading to the removal of a significant batch of tariffs [1][6] - Tariffs enacted under Section 232 of the Trade Expansion Act of 1962, aimed at protecting U.S. national security, remain in effect [2] Automotive Industry - Foreign vehicles and auto parts are still subject to a 25% tariff, which was implemented to encourage U.S. manufacturing [4] - Automakers are facing substantial financial impacts due to these tariffs, with Mercedes-Benz reporting a $1.2 billion hit to earnings in 2025 [5] - Ford anticipates a tariff bill similar to last year's $2 billion, while General Motors expects a $3.1 billion charge in 2025 and an additional $3 billion to $4 billion in 2026 [7] Furniture Industry - The furniture sector is affected by a 25% tariff on upholstered couches, kitchen cabinets, and vanities, which is set to increase to 50% in 2027 [11] - This industry is particularly sensitive to tariffs due to the high volume of imported goods [11] Steel and Aluminum Industry - Steel and aluminum imports continue to face a 50% tariff, impacting companies in home appliances, electronics, and beverage industries [13] Semiconductor Industry - A 25% tariff on certain semiconductors and chipmaking equipment remains in place, which took effect last month [14] Pharmaceutical Industry - While tariffs as high as 250% on pharmaceuticals have been avoided, there is potential for future tariffs under Section 232 if agreements with drugmakers are reversed [15][16] - Major pharmaceutical companies have agreed to lower drug prices to avoid tariffs for at least three years [16]
FDA Approves Genentech's Venclexta® Plus Acalabrutinib Combination Regimen for Previously Untreated Chronic Lymphocytic Leukemia
Businesswire· 2026-02-20 07:00
Core Viewpoint - The FDA has approved the combination of Venclexta® (venetoclax) and acalabrutinib for treating previously untreated adults with chronic lymphocytic leukemia (CLL), marking a significant advancement for newly diagnosed patients [1] Company Summary - Genentech, part of the Roche Group, announced the FDA approval based on the Phase III AMPLIFY study results [1]
FDA Accepts New Drug Application for Genentech's Giredestrant in ESR1-Mutated, ER-Positive Advanced Breast Cancer
Businesswire· 2026-02-20 06:05
Core Viewpoint - Genentech, a member of the Roche Group, has received FDA acceptance for its New Drug Application for giredestrant, an investigational oral therapy for specific breast cancer patients [1] Group 1: Drug Development - The New Drug Application is for giredestrant, which is intended to be used in combination with everolimus [1] - The target patient population includes adult patients with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2-negative, ESR1-mutated locally advanced or metastatic breast cancer [1]
EyePoint Appoints Michael Campbell as Chief Commercial Officer
Globenewswire· 2026-02-18 12:00
Core Viewpoint - EyePoint, Inc. has appointed Michael Campbell as Chief Commercial Officer to lead the commercial strategy and launch readiness for DURAVYU, an investigational treatment for retinal diseases currently in Phase 3 development [1][2] Company Overview - EyePoint, Inc. is a clinical-stage biopharmaceutical company focused on developing innovative therapeutics for serious retinal diseases, with its lead product candidate DURAVYU expected to provide significant commercial potential [8][9] - The company is headquartered in Watertown, Massachusetts, and has a commercial manufacturing facility in Northbridge, Massachusetts [9] Leadership Appointment - Michael Campbell brings over 30 years of commercial leadership experience, having successfully launched several ophthalmology products, including Lucentis and Xiidra [1][3][4] - His previous roles include Chief Commercial Officer at Opthea and Senior Vice President at Viatris Eye Care, where he led the launch of Tyrvaya [3][4] Product Development - DURAVYU is currently in Phase 3 pivotal trials for wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME), with topline data expected in mid-2026 [8][10] - The product is designed as a sustained delivery treatment combining vorolanib, a selective tyrosine kinase inhibitor, and is positioned to potentially be the first sustained release TKI to market [2][8] Commercial Strategy - The company aims to leverage Campbell's expertise to position DURAVYU for a successful U.S. launch, emphasizing a patient-centric approach and robust clinical data [2][8] - DURAVYU is expected to address both VEGF-mediated vascular leakage and IL-6 mediated inflammatory drivers of DME, enhancing its potential market impact [10]
Genentech Announces Positive Phase III Results for Gazyva in Primary Membranous Nephropathy, Marking a Significant Milestone in This Autoimmune Disease
Businesswire· 2026-02-16 06:00
Core Insights - Genentech, a member of the Roche Group, announced that the Phase III MAJESTY study for Gazyva® (obinutuzumab) in adults with primary membranous nephropathy met its primary endpoint, demonstrating statistically significant and clinically meaningful results [1] Study Results - The study showed that significantly more patients achieved complete remission at two years (104 weeks) with Gazyva compared to tacrolimus [1] - Safety profile of Gazyva was consistent with previously characterized data [1]
Genentech's Fenebrutinib Is the First Investigational Medicine in Over a Decade That Reduces Disability Progression in Primary Progressive Multiple Sclerosis (PPMS)
Businesswire· 2026-02-07 20:40
Core Insights - Genentech, a member of the Roche Group, announced that its investigational BTK inhibitor fenebrutinib met the primary endpoint of non-inferiority compared to Ocrevus in reducing disability progression in patients with primary progressive multiple sclerosis [1] Group 1 - The Phase III FENtrepid study demonstrated a 12% reduction in the risk of disability progression with fenebrutinib compared to Ocrevus [1]
Adaptive Biotechnologies Reports Fourth Quarter and Full Year 2025 Financial Results
Globenewswire· 2026-02-05 21:05
Core Insights - Adaptive Biotechnologies reported strong financial performance in 2025, achieving 46% revenue growth and profitability in its Minimal Residual Disease (MRD) business [2][10] - The company is well-positioned for continued growth in 2026, with a focus on disciplined capital allocation and expanding margins [2] Financial Performance - Fourth quarter 2025 revenue reached $71.7 million, a 51% increase year-over-year; excluding Genentech Agreement revenue, the increase was 63% [4][10] - MRD revenue for Q4 2025 was $61.9 million, up 54% from Q4 2024; Immune Medicine revenue was $9.8 million, a 34% increase [4][10] - For the full year 2025, total revenue was $277.0 million, a 55% increase from 2024; MRD revenue was $212.3 million (46% increase), and Immune Medicine revenue was $64.6 million (93% increase) [10][12] Operating Expenses and Profitability - Operating expenses for Q4 2025 were $84.5 million, a 4% increase from the previous year; for the full year, operating expenses decreased by 2% to $334.1 million [5][11] - The net loss for Q4 2025 was $13.6 million, significantly reduced from $33.7 million in Q4 2024; for the full year, the net loss was $59.5 million, down from $159.6 million in 2024 [6][12] - Adjusted EBITDA for Q4 2025 was $4.1 million, a turnaround from a loss of $16.4 million in Q4 2024; for the full year, Adjusted EBITDA was $12.2 million compared to a loss of $80.4 million in 2024 [7][13] Business Segments and Developments - The MRD business achieved positive Adjusted EBITDA and cash flow, contributing 86% of Q4 revenue and 77% of full-year revenue [9][10] - The clonoSEQ test volume increased by 43% in Q4 2025, with 30,038 tests delivered, and a total of 105,587 tests for the year, up 39% [10] - The company signed two non-exclusive immune receptor data licensing agreements with Pfizer Inc. and received expanded Medicare coverage for clonoSEQ [9][10] 2026 Financial Guidance - The company expects MRD revenue for 2026 to be between $255 million and $265 million, with total operating expenses projected between $350 million and $360 million [14]