PASADENA, Calif.--(BUSINESS WIRE)---- $arwr--Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that as an inducement to entering into employment with the Company, on December 12, 2025, the Company's Board of Directors approved "inducement†grants to 78 new employees under Rule 5635(c)(4) of the NASDAQ Listing Rules. The grants entitle employees, in aggregate, to receive up to 141,310 restricted stock units. The grants are outside the Company's stockholder-approved equity incentive plans and. ...

To ensure this doesn’t happen in the future, please enable Javascript and cookies in your browser.If you have an ad-blocker enabled you may be blocked from proceeding. Please disable your ad-blocker and refresh. ...

TRiM BBB Platform Overview - The TRiM BBB platform facilitates subcutaneous administration for delivering siRNA to the central nervous system by crossing the blood-brain barrier[20] - The platform utilizes a TfR-targeting ligand conjugated to siRNA through a stable, non-reversible covalent linkage, ensuring stability in circulation[20] - The conjugation process is economical, using equimolar amounts of ligand and oligo, achieving a 75-80% yield consistently[26] - Cryo-EM structure shows the TRiM BBB ligand binds to the apical domain of TfR1 without interfering with endogenous Tf binding[28] Efficacy and Target Engagement - In transgenic mice expressing human Transferrin receptor, siRNA quantitation shows over 50x difference between Tg and control group, demonstrating BBB crossing[31] - Two doses of 1.5 mpk achieved ≥75% knockdown across CNS regions in mice, including deep brain[39] - In NHP, therapeutically relevant siRNA accumulation in the brain was achieved, with 0.5-1.5 µg/g across the brain on day 29[42] - ARO-MAPT achieved 70-80% MAPT mRNA reduction across all brain regions in NHP at 3 x 3 mpk, including brain stem and deep brain, with up to 85% knockdown in some cortex regions[53] Durability and Dosing - ARO-MAPT maintains ≥50% knockdown over 3 months in CNS regions in NHP, including deep brain[63] - Tau protein reduction was maintained at 50-60% up to 5 months with single 3 mpk monthly dose in NHP[67] - PK/PD modeling projects quarterly dosing of ARO-MAPT to maintain 50-70% knockdown[70]

Group 1 - U.S. stocks experienced a decline, with the Dow Jones falling over 200 points on Monday [1] - Paramount Skydance Corporation launched an all-cash tender offer to acquire Warner Bros. Discovery, Inc. for $30 per share, valuing the company at $108.4 billion [1] - Paramount aims to create a scaled Hollywood leader by merging with Warner Bros. [1] Group 2 - Paramount Skydance shares increased by 9.8% to $14.68 on Monday [2] - Other notable stocks that gained include Wave Life Sciences Ltd., which rose 129.1% to $17.16 after positive interim Phase 1 data for its obesity drug [4] - Structure Therapeutics Inc. saw a gain of 100.5% to $69.30 following the announcement of topline data from its clinical program for obesity treatment [4] Group 3 - Fulcrum Therapeutics, Inc. shares rose 62.3% to $14.44 after reporting initial results from its Phase 1b trial for sickle cell disease [4] - Kymera Therapeutics, Inc. gained 51.2% to $100.75 after reporting successful trial results for its KT-621 drug [4] - Confluent, Inc. shares increased by 29.2% to $29.89 after IBM agreed to acquire the company for $31 per share [4]

PASADENA, Calif.--(BUSINESS WIRE)---- $arwr--Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that it has dosed the first subjects in a Phase 1/2a clinical trial of ARO-MAPT, the company's investigational RNA interference (RNAi) therapeutic being developed as a potential treatment for tauopathies including Alzheimer's disease, a progressive neurodegenerative disease characterized by cognitive and functional decline. Alzheimer's disease is the most common cause of dementia, affecting an esti. ...

Summary of Arrowhead Pharmaceuticals FY Conference Call (December 04, 2025) Company Overview - **Company**: Arrowhead Pharmaceuticals (NasdaqGS:ARWR) - **Key Event**: Discussion on the company's accomplishments and future plans during the FY Conference Call Key Accomplishments - **Drug Launch**: The launch of Redemplo (Plozasiran) is highlighted as the most significant achievement, marking the company's first independent drug launch after nearly two decades of development [3][4] - **Market Position**: Arrowhead is positioned to become a large-cap biotech company, with a pipeline of nearly 20 drugs and multiple candidates in phase three studies [3] Product Details - **Redemplo (Plozasiran)**: Approved for treating familial chylomicronemia syndrome (FCS) and reducing triglycerides in patients with genetic or clinical FCS. It is the only drug studied in both populations, expanding commercial opportunities [4] - **Ongoing Studies**: Phase three studies (SHASTA 3, SHASTA 4, SHASTA 5, and MUIR 3) are ongoing, with results expected in Q3 2026. An SNDA filing is anticipated by the end of 2026 for SHTG launch in 2027 [5][4] Competitive Landscape - **Market Dynamics**: The company acknowledges competition from Ionis Pharmaceuticals but emphasizes a collaborative approach to grow the market for triglyceride-lowering drugs, particularly in underserved areas [7][8] - **Market Potential**: There is a significant unmet need in the high triglycerides (TG) market, especially for patients at risk of acute pancreatitis [7] Clinical Study Insights - **SHASTA Studies**: SHASTA 3 and SHASTA 4 are placebo-controlled studies with 750 patients, focusing on triglyceride lowering and safety in high-risk populations [10][11] - **Patient Demographics**: Approximately 37% of patients had triglycerides over 880 mg/dL, indicating a severe risk for acute pancreatitis [11] Future Pipeline and Innovations - **Dual PCSK9, ApoC3 Candidate**: A new program aimed at addressing mixed hyperlipidemia is set to begin phase 1/2 studies in early 2026, with initial data expected in Q3 2026 [13][14] - **Inhibin E and ALK7**: Phase 1/2 studies are ongoing, focusing on weight loss and fat reduction mechanisms. The regulatory pathway remains unclear due to evolving FDA guidelines [20][25] Upcoming Milestones - **Key Data Releases**: - Initial obesity data for Inhibin E and ALK7 in January 2026 - Readout for SHASTA 3 and 4 studies in Q3 2026 - Dimer data and MAPT program updates for Alzheimer's expected around the same time [28][29] Conclusion - **Strategic Focus**: Arrowhead Pharmaceuticals is poised for significant growth with multiple product launches and a robust pipeline. The company aims to address unmet medical needs in cardiometabolic diseases and expand its market presence in the biotech sector [27][30]

Arrowhead Pharmaceuticals FY Conference Summary Company Overview - **Company**: Arrowhead Pharmaceuticals (NasdaqGS:ARWR) - **Event**: FY Conference held on December 03, 2025 Key Industry Insights - **Market Opportunity**: Arrowhead's first drug, Plozasiran, has been approved, targeting familial chylomicronemia syndrome (FCS) and severe hypertriglyceridemia (SHTG) [3][4] - **Patient Need**: Approximately 10,000 patients with FCS require treatment to prevent severe pancreatitis, which can be fatal [4] - **Phase Three Data**: Plozasiran demonstrated an 80% reduction in triglycerides and a numerical risk reduction in pancreatitis [5] Competitive Landscape - **Pricing Strategy**: Plozasiran is priced lower than competitors like Tryngolza, which is priced at $595,000 per year per patient. Arrowhead aims to establish value in the SHTG market by initially targeting high-risk patients [6][7] - **Health Economics**: The cost of treating pancreatitis can exceed $60,000 per event, making Plozasiran's pricing compelling from both economic and human perspectives [8][9] Pipeline Developments - **New Candidates**: Arrowhead is developing a dual dimer targeting PCSK9 and ApoC3, which aims to lower LDL and remnant cholesterol [11][12] - **Obesity Programs**: Two programs, ARO-INHBE and ARO-ALK7, are in phase 1/2 studies, focusing on increasing lipolysis without affecting appetite [15][16] - **CNS Delivery**: ARO-MAPT targets tau tangles in Alzheimer's and tauopathies, with expectations for significant knockdown in cerebrospinal fluid (CSF) [22][24] Financial Position - **Cash Reserves**: Ended the fiscal year with $782 million, with additional capital from Sarepta and Novartis bringing total cash close to $1.2 billion [32] - **Funding Strategy**: The capital allows Arrowhead to advance core programs and aims for profitability by 2028, while reducing reliance on capital markets [32][33] Partnerships - **Sarepta Collaboration**: A significant partnership with Sarepta, valued at $800 million upfront and potential $10 billion in milestones, focuses on skeletal muscle programs [26][28] - **Novartis Partnership**: A $200 million upfront deal with Novartis for a preclinical Parkinson's disease drug, with potential for $2 billion in milestone payments [30][31] Conclusion - Arrowhead Pharmaceuticals is positioned for growth with a strong pipeline, strategic pricing, and significant partnerships, aiming to address critical health needs in cardiometabolic diseases and CNS disorders while maintaining a robust financial outlook.

Overview of Arrowhead Pharmaceuticals - Arrowhead Pharmaceuticals has made significant recent progress and accomplishments, particularly highlighted by the update on the Sarepta partnership [2] Future Expectations - Investors should anticipate further developments from Arrowhead as the company approaches the end of the year and into 2026 [2]

Core Insights - Arrowhead Pharmaceuticals, Inc. (NASDAQ:ARWR) has achieved a new three-year high following strong earnings and FDA approval for its treatment for familial chylomicronemia syndrome (FCS) [1][3]. Financial Performance - The company reported a significant reduction in its attributable net loss, narrowing it by 99.7% to $1.63 million from $599.49 million the previous year [3]. - Revenues surged by 23,585% to $829.4 million, up from $3.5 million year-on-year [3]. FDA Approval and Product Launch - Arrowhead Pharmaceuticals received FDA approval for its drug redemplo, which is the first and only approved siRNA medicine aimed at reducing triglycerides in adults with FCS [4]. - The company plans to start selling redemplo before the end of the year [4]. Market Context - The FCS disease is rare, affecting approximately 6,500 individuals in the US, characterized by triglyceride levels that can be 10 to 100 times higher than normal, increasing the risk of severe pancreatitis [5].

Core Insights - Arrowhead Pharmaceuticals has achieved its first FDA approval for Redemplo, a treatment for familial chylomicronemia syndrome (FCS), marking a significant milestone for the company [3] - Following the earnings release, Arrowhead's stock surged by over 23%, reflecting investor optimism [1][5] - The company's revenue for fiscal 2025 reached over $829 million, a substantial increase from $3.6 million in 2024, driven by licensing and collaboration funds [2] Financial Performance - Arrowhead reported a narrowed attributable net loss of $1.6 million for the fiscal year, compared to a loss of $599 million the previous year [3] - The company's gross margin stands at an impressive 96.06% [4] - The market capitalization of Arrowhead Pharmaceuticals is currently $6 billion [4] Market Activity - The stock price of Arrowhead Pharmaceuticals increased to $10.92, with a daily range between $45.09 and $59.15 [4] - The trading volume was reported at 7.1 million, significantly higher than the average volume of 2.3 million [4] Future Prospects - The approval of Redemplo is expected to create a new revenue stream for Arrowhead, enhancing its financial outlook [5] - Ongoing collaborations are anticipated to continue generating funds as the company prepares for the commercialization of Redemplo [5]