RNAi Crucial Aspects and Innovations in the RNAi Technology Market
A growing prevalence of genetic disorders, rising need for therapies that target cancer, growing emphasis on neurological disorders, growing RNA interference usage in viral and infectious disease treatments, increased research and development and innovation in delivery technologies regarding RNAi technology market. Developmental regulators occur naturally as hormones or proteins which foster cellular differentiation, development, proliferation, and healing. These cells are essential for immune system control, tissue repair, and development.
Key Growth Drivers and Opportunities
Genetic Disorder Cases Spike: As genetic disorders become more prevalent, there is increasing demand for enhanced and specialized treatments. One of the most promising methods in this area is RNA interference (RNAi) technology. With given factors the RNAi technology will possibly be surged, generating investments, research and development and end-up with more extensive use for genetic disorder treatment.
Advancement in Delivery Methods: Delivery method advancements include nanotechnology-based delivery systems and non-transgenic delivery technologies, and are estimated to mitigate delivery issues of RNAi therapeutics. Ongoing research is focusing on studying the mechanisms OD siRNA delivery and catalytic RNA vehicle development to make RNAi based cancer gene therapy having more impact.
Challenges
The Off-target implications which result when RNAi treatments accidently alter genes other than the intended target, restrict growth in markets. Off target effects or phenotypic results are caused by an RNAi reagent's elimination of unintended genes rather that the gene of interest. Accidental gene suppression is often referred to as an off-target effect. It develops when the RNAi molecule attaches itself to something that is not intended.
Innovation and Expansion
F FDA Approves Qfitlia (fitusiran), the First siRNA (RNAi Therapeutic) for the Treatment of Hemophilia A or B
In March 2025, Alnylam Pharmaceuticals, Inc., the leading RNAi therapeutics company, highlighted the significance of the U.S. Food and Drug Administration's (FDA) approval of Qfitlia (fitusiran), the sixth Alnylam-discovered RNAi therapeutic approved in the U.S., and the first and only therapeutic to lower antithrombin (AT), a protein that inhibits blood clotting, with the goal of promoting thrombin generation to rebalance hemostasis and prevent bleeds.
Alnylam's vutrisiran shows positive Phase 3 results in ATTR cardiomyopathy
In June 2024, RNAi drug vutrisiran was announced by Alnylam that reduces mortality and recurrent cardiovascular events by up to 33% in patients with transthyretin amyloidosis–related cardiomyopathy, clearing the way for an upcoming NDA submission.
RNAi Therapies emerge for Hereditary Transthyretin Amyloidosis (ATTR)
In April 2025, The Yuzu Matcha Martini has become a new ready-to-drink bottle that was introduced by world-renowned bartender Hidetsugu Ueno in collaboration with On the Rocks Cocktails and The House of Suntory. The bottle is matched with the Japanese Boulevardier, a traditional whiskey cocktail with an Eastern touch, so it's not simply a matcha martini to add to the family's bar.
Four RNAi drugs show >80% Reduction in Lipoprotein (a)
In August 2024, Early-phase trials of four RNAi-based therapeutics have managed to lower plasma Lp(a) by more than 80%, and Phase 3 studies are now being conducted to assess their impact on cardiovascular outcomes.
Combination mRNA+RNAi Nanoparticle Therapy for Complex Diseases
In December 2024, Codedeliry of mRNA and siRNA via nanoparticles can simultaneously boost positive gene expression and mute detrimental genes, revealed to research from the University of Ottawa. This opens up fresh therapies for a range of ailments, notably cancer and heart disorders.
Inventive Sparks, Expanding Markets
Companies' actives in Rnai technology market includes Alnylam Pharmaceuticals, Inc., ARROWHEAD PHARMACEUTICALS, INC., Silence Therapeutics, Thermo Fisher Scientific Inc., Revvity Discovery Limited, Company, and among others. Companies for RNAi technology aim on developing safe, precise, and efficient gene-silencing therapies for broad range of rare and genetic diseases. Their goals involve getting regulatory clearances for additional indications, refining delivery methods, minimizing off-target effects, and expanding the application of RNA interference beyond liver-targeted therapies.
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GAAP net income for the quarter ended June 30, 2025 was $184.8 million, or $0.68 per share, basic and $0.65 per share, diluted, as compared to GAAP net income of $226.1 million, or $0.78 per share, basic and $0.77 per share diluted, for the comparable period in 2024. GAAP net income per share for the quarter ended June 30, 2025 was favorably impacted by lower weighted-average common shares outstanding for the quarter ended June 30, 2025, as compared to the comparable period in 2024, as a result of the stock repurchase programs. Non-GAAP net income for the quarter ended June 30, 2025 was $212.6 million, or $0.78 per share, basic and $0.75 per share, diluted, as compared to non-GAAP net income of $245.6 million, or $0.85 per share, basic and $0.84 per share diluted, for the comparable period in 2024. Non-GAAP Financial Measures To supplement Exelixis' financial results presented in accordance with U.S. Generally Accepted Accounting Principles (GAAP), Exelixis presents non-GAAP net income (and the related per share measures), which excludes from GAAP net income (and the related per share measures) stock-based compensation, adjusted for the related income tax effect for all periods presented. Exelixis believes that the presentation of these non-GAAP financial measures provides useful supplementary information to, and facilitates additional analysis by, investors. In particular, Exelixis believes that these non-GAAP financial measures, when considered together with its financial information prepared in accordance with GAAP, can enhance investors' and analysts' ability to meaningfully compare Exelixis' results from period to period, and to identify operating trends in Exelixis' business. 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In August 2024, Exelixis' Board of Directors authorized a stock repurchase program to acquire up to $500 million of the company's common stock before December 31, 2025. In February 2025, the Board of Directors authorized the repurchase of up to an additional $500 million of the company's common stock before December 31, 2025. Under these programs, as of June 30, 2025, Exelixis has repurchased $796.3 million of the company's common stock, at an average price of $36.69 per share. Since the approval of the first stock repurchase program in March 2023, the weighted-average diluted common shares outstanding has decreased from 326.3 million shares to 284.4 million shares as of June 30, 2025. Stock repurchases under these programs may be made from time to time through a variety of methods, which may include open market purchases, in block trades, accelerated share repurchase transactions, exchange transactions, or any combination of such methods. The timing and amount of any stock repurchases under the stock repurchase programs will be based on a variety of factors, including ongoing assessments of the capital needs of the business, alternative investment opportunities, the market price of our common stock and general market conditions. Basis of Presentation Exelixis has adopted a 52- or 53-week fiscal year that generally ends on the Friday closest to December 31. For convenience, references in this press release as of and for the fiscal periods ended July 4, 2025 and June 28, 2024, are indicated as being as of and for the periods ended June 30, 2025 and June 30, 2024. Conference Call and Webcast Exelixis management will discuss the company's financial results for the second quarter 2025 and provide a general business update during a conference call beginning at 5:00 p.m. ET / 2:00 p.m. PT today, Monday, July 28, 2025. To access the conference call, please register using this link. Upon registration, a dial-in number and unique PIN will be provided to join the call. To access the live webcast link, log onto and proceed to the Event Calendar page under the Investors & News heading. A webcast replay of the conference call will also be archived on for one year. About Exelixis Exelixis is a globally ambitious oncology company innovating next-generation medicines and regimens at the forefront of cancer care. Powered by drug discovery and development excellence, we are rapidly evolving our product portfolio to target an expanding range of tumor types and indications with our clinically differentiated pipeline of small molecules, antibody-drug conjugates and other biotherapeutics. This comprehensive approach harnesses decades of robust investment in our science and partnerships to advance our investigational programs and extend the impact of our flagship commercial product, CABOMETYX ® (cabozantinib). Exelixis is driven by a bold scientific pursuit to create transformational treatments that give more patients hope for the future. For information about the company and its mission to help cancer patients recover stronger and live longer, visit follow @ExelixisInc on X (Twitter), like Exelixis, Inc. on Facebook and follow Exelixis on LinkedIn. Forward-Looking Statements This press release contains forward-looking statements, including, without limitation, statements related to: Exelixis' plans to discuss the results of STELLAR-303 with regulators and intention of filing for approval in this indication as soon as possible; anticipated timing for zanzalintinib pivotal data milestones with respect to the STELLAR-304 and STELLAR-311 trials and plans to announce additional zanzalintinib pivotal trials; Exelixis' assessment of other potential commercial growth opportunities; Exelixis' plans to present data from STELLAR-303 at a future medical meeting; Exelixis' plans to initiate the phase 1 study for XB371 in the coming months; the terms of Exelixis' settlement agreement with Biocon Pharma Limited which is subject to FDA approval and subject to conditions and exceptions common to agreements of this type; and Exelixis' scientific pursuit to create transformational treatments that give more patients hope for the future. Any statements that refer to expectations, projections or other characterizations of future events or circumstances are forward-looking statements and are based upon Exelixis' current plans, assumptions, beliefs, expectations, estimates and projections. Forward-looking statements involve risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in the forward-looking statements as a result of these risks and uncertainties, which include, without limitation: the degree of market acceptance of CABOMETYX and other Exelixis products in the indications for which they are approved and in the territories where they are approved, and Exelixis' and its partners' ability to obtain or maintain coverage and reimbursement for these products; the effectiveness of CABOMETYX and other Exelixis products in comparison to competing products; the level of costs associated with Exelixis' commercialization, research and development, in-licensing or acquisition of product candidates, and other activities; Exelixis' ability to maintain and scale adequate sales, marketing, market access and product distribution capabilities for its products or to enter into and maintain agreements with third parties to do so; the availability of data at the referenced times; the potential failure of cabozantinib, zanzalintinib and other Exelixis product candidates, both alone and in combination with other therapies, to demonstrate safety and/or efficacy in clinical testing; uncertainties inherent in the drug discovery and product development process; Exelixis' dependence on its relationships with its collaboration partners, including their pursuit of regulatory approvals for partnered compounds in new indications, their adherence to their obligations under relevant collaboration agreements and the level of their investment in the resources necessary to complete clinical trials or successfully commercialize partnered compounds in the territories where they are approved; complexities and the unpredictability of the regulatory review and approval processes in the U.S. and elsewhere; Exelixis' continuing compliance with applicable legal and regulatory requirements; unexpected concerns that may arise as a result of the occurrence of adverse safety events or additional data analyses of clinical trials evaluating cabozantinib, zanzalintinib and other Exelixis product candidates; Exelixis' dependence on third-party vendors for the development, manufacture and supply of its products and product candidates; Exelixis' ability to protect its intellectual property rights; market competition, including the potential for competitors to obtain approval for generic versions of Exelixis' marketed products; changes in economic and business conditions, including as a result of changing trade policies and tariffs and the related uncertainty thereof; and other factors detailed from time to time under the caption 'Risk Factors' in Exelixis' most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q, and in Exelixis' other future filings with the Securities and Exchange Commission. All forward-looking statements in this press release are based on information available to Exelixis as of the date of this press release, and Exelixis undertakes no obligation to update or revise any forward-looking statements contained herein, except as required by law. Exelixis, the Exelixis logo, CABOMETYX and COMETRIQ are registered trademarks of Exelixis, Inc. Opdivo ® is a registered trademark of Bristol Myers Squibb. Opdualag ™ is a trademark of Bristol Myers Squibb. ____________________ (1) Non-cash stock-based compensation used for GAAP reporting in accordance with Accounting Standards Codification Topic 718, Compensation—Stock Compensation. Expand
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