RegulationPriority Review (United States), Breakthrough Therapy (United States), Fast Track (United States), Priority Review (Australia), Special Review Project (China)

Structure/Sequence

Molecular FormulaC19H17F2N3NaO5

InChIKeyNOSILXJBCIUPCT-KIUAEZIZSA-N

CAS Registry1051375-13-3

Clinical Trials associated with Cabotegravir sodium

NCT06854029

/ Not yet recruitingPhase 4IIT

Optimizing Long-Acting Pre-Exposure Prophylaxis and Medications for Opioid Use Disorder Interventions in Carceral Settings

The investigators plan to conduct an R61/33 hybrid type 2 implementation-effectiveness trial that includes 1) a one-year exploratory R61 phase that will enable the development of the intervention protocol needed for the R33 trial phase including concrete R61 phase milestones; 2) a four-year R33 phase that will include a concurrent implementation evaluation and a randomized control trial.

Start Date01 Nov 2025

Sponsor / Collaborator

Duke University

[+4]

NCT06336434

/ WithdrawnPhase 1/2IIT

Phase I/II Study of the Pharmacokinetics and Safety of Long-Acting Injectable Cabotegravir and Rilpivirine in Pregnant and Postpartum Adults With HIV-1

This is a Phase I/II, multicenter, open-label, non-randomized study with four groups to characterize the pharmacokinetics and safety of Cabotegravir (CAB) and Rilpivirine (RPV) long-acting injectable (LA) during pregnancy and postpartum among people with HIV-1 viral suppression and their infants.

Start Date01 May 2025

Sponsor / Collaborator

National Institute of Allergy & Infectious Diseases

NCT06970223

/ RecruitingPhase 1

Phase 1, Open-Label, Randomised Crossover Study Assessing the Tolerability and Acceptability of Long Acting Cabotegravir Intramuscular and Lenacapavir Subcutaneous Injections Over Time in Healthy Adults Without HIV

This study will evaluate the tolerability and acceptability of injection site reactions (ISRs) of two long-acting (LA) injectables. Additional characteristics of the ISRs will be investigated and described as well as safety outcomes.

Start Date22 Apr 2025

Sponsor / Collaborator

ViiV Healthcare Ltd.

100 Clinical Results associated with Cabotegravir sodium

100 Translational Medicine associated with Cabotegravir sodium

100 Patents (Medical) associated with Cabotegravir sodium

1,364

Literatures (Medical) associated with Cabotegravir sodium

31 Dec 2025·JOURNAL OF DERMATOLOGICAL TREATMENT

Efficacy and safety of fixed-dose clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% gel in Hispanic participants with moderate-to-severe acne: a pooled analysis

Article

Author: Callender, Valerie D. ; Cook-Bolden, Fran E. ; Alexis, Andrew F. ; Guenin, Eric ; Gold, Linda Stein ; Baldwin, Hilary

INTRODUCTION:

Clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% (CAB) gel is the only fixed-dose, triple-combination approved for acne. In phase 2 and 3 studies, CAB demonstrated superior efficacy to vehicle and component dyads. This post hoc analysis examined efficacy/tolerability of CAB in 147 self-identified Hispanic/Latino participants (referred to as Hispanic).

METHODS:

Data were pooled from one phase 2 (NCT03170388) and two phase 3 (NCT04214652, NCT04214639) double-blind, 12-week studies. Eligible participants aged ≥9 years with moderate to severe acne were randomized to once-daily CAB or vehicle. Endpoints included ≥2-grade reduction from baseline in Evaluator's Global Severity Score with clear/almost clear skin (treatment success) and inflammatory/noninflammatory lesion counts. Treatment-emergent adverse events (TEAEs) were assessed.

RESULTS:

At week 12, 56.2% of CAB-treated participants achieved treatment success vs 18.4% with vehicle (p < 0.001). Reductions in inflammatory/noninflammatory lesions were 77.1%/76.2% with CAB vs 56.4%/45.0% with vehicle, respectively (p < 0.001, all). CAB TEAE rates were similar to overall study populations (27.0% vs 24.6%-36.2%). Baseline hyperpigmentation scores decreased from 0.6 to 0.3 (1 = mild) at week 12 with CAB. CAB gel was efficacious, safe, and well tolerated in Hispanic participants. Limitations include lack of Fitzpatrick skin phototype and short study duration.

CONCLUSIONS:

This study provides support for acne treatment with CAB in ethnically diverse populations.

01 Dec 2025·Current HIV/AIDS Reports

Long-Acting Injectable Antiretroviral Therapy for Treatment of Human Immunodeficiency Virus: A Review

Review

Author: Brotherton, Amy L ; Rossi, Michael R ; Beckwith, Curt G ; Sanchez, Martha C ; Johnson, Jennie E

PURPOSE OF REVIEW:

Long-acting injectable (LAI) antiretroviral therapy (ART) for treatment of HIV-1 are approved both as a complete treatment regimen (cabotegravir/rilpivirine) and as an additional treatment option (lenacapavir) for those with multidrug resistant HIV-1. Here, we review the data supporting these approvals, pharmacokinetics, and additional patient populations that many benefit from LAI ART.

RECENT FINDINGS:

Persons with HIV and adherence challenges as well as those in low-and-middle income countries have high rates of adherence and viral suppression with LAI ART. LAI cabotegravir/rilpivirine (CAB/RPV) offers an alternative treatment approach to daily oral ART for people with HIV-1 infection that is associated with high rates of patient satisfaction when compared to daily oral ART. LAI CAB/RPV is currently only approved in those with HIV-1 viral suppression, however recent data support the use of LAI ART in populations with adherence challenges. Furthermore, given high rates of NNRTI resistance globally, CAB/RPV is not recommended in low-and-middle income countries presently, although this recommendation is likely to change based on recently published data. More research is needed among groups that may benefit from long-acting treatments for HIV-1.

01 Dec 2025·Current HIV/AIDS Reports

Understanding the Drivers of CAB PrEP Uptake and Use among Women in sub-Saharan Africa to Build Demand for New PrEP Methods

Review

Author: Schwartz, Katie ; Donaldson, Emily ; Bishopp, Casey ; Mungai-Barris, Zoe ; Briedenhann, Elmari ; Irungu, Elizabeth

Abstract:

Purpose of Review:

As injectable cabotegravir for pre-exposure prophylaxis (CAB PrEP) is introduced in sub-Saharan Africa, it is important to understand how behavioral drivers may influence women’s decisions around whether or not to use it.

Recent Findings:

Facilitating factors include prior familiarity with injections and the perceived efficacy of CAB PrEP, while barriers include a fear or dislike of needles and negative attitudes held by community members and influencers. Further research is needed to fully understand behavioral factors affecting African women’s CAB PrEP use.

Summary:

HIV prevention policymakers, practitioners, advocates, and clients are optimistic about CAB PrEP, predicting that this long-acting method will be popular among women in sub-Saharan Africa. However, women may also face barriers to use. Knowledge of behavioral facilitators and barriers can enhance the adaptation or development of HIV prevention communication and demand generation strategies that support informed decision-making in a multi-method market.

122

News (Medical) associated with Cabotegravir sodium

18 Jun 2025

·www.fiercepharma.com

FDA signs off on Gilead's landmark long-acting PrEP med, signaling new era in HIV prevention

For many, Gilead Sciences' twice-yearly PrEP injection stands to replace the standard once-daily pills used for HIV prevention. With the FDA’s much-anticipated nod for Gilead Sciences’ long-acting HIV pre-exposure prophylaxis (PrEP) injection Yeztugo (lenacapavir), a new era of HIV prevention has dawned.The approval, which came a day ahead of its June 19 scheduled FDA decision date, marks the first for a twice-yearly PrEP option and fittingly comes just before the 13-year anniversary of the introduction of world’s first PrEP option, Gilead’s daily pill Truvada. “This is a historic day in the decades-long fight against HIV. Yeztugo is one of the most important scientific breakthroughs of our time and offers a very real opportunity to help end the HIV epidemic,” Gilead CEO Daniel O’Day said in a company press release. "Gilead scientists have made it their life’s work to end HIV and now, with the FDA approval of Yeztugo and in collaboration with our many partners, we can help to make that goal a reality.”Along with the convenience factor of the every-six-month injection, Yeztugo also touts competitive efficacy proven through two large phase 3 studies. Gilead has touted its clinical effort as the “most comprehensive and diverse HIV prevention trial program ever conducted."In Gilead’s Purpose 1 trial of cisgender women at sites across South Africa and Uganda, Yeztugo use yielded an unprecedented 100% efficacy rate, with zero HIV infections observed across the treatment group. The drug also demonstrated its superiority when compared to Gilead's own Truvada, the results showed.The Purpose 2 trial, meanwhile, tested the long-acting PrEP drug in a broader population that included cisgender gay and bisexual men, transgender people and nonbinary people at sites across the world. Again, Yeztugo proved to be widely effective at reducing HIV infections; 99.9% of those who took the twice-yearly option did not acquire HIV, with only two cases reported out of more than 2,000 participants. The result showed that Yeztugo is 89% more effective at reducing HIV than once-daily Truvada, the company pointed out. In studying Yeztugo across the Purpose trials, Gilead noted adherence issues with the once-daily comparators Truvada and its newer option, Descovy. With two yearly injections of Yeztugo, PrEP users can “get it and forget it” instead of having to remember to take a daily pill, Jared Baeten, M.D., Ph.D., Gilead’s senior vice president of clinical development and head of virology, explained in a recent interview with Fierce Pharma.It's all part of the company’s plan to “redefine the PrEP market” as a whole, Chief Commercial Officer Johanna Mercier noted on an earnings call last summer. While Gilead already has a hold on the PrEP market with its existing pills, “new options” are needed to work toward the goal of “ending infections in this country and around the world,” Baeten said.Now, with the FDA’s blessing, the company can hit the ground running with the “thoughtful and creative” rollout it’s been plotting (PDF) for months.Global access Gilead has already set up agreements with six drugmakers that were given a royalty-free license to make and supply low-cost versions of the long-acting PrEP option in 120 high-incidence, resource-limited countries. It also is utilizing the European Medicines Agency’s EU-Medicines for all program to allow other drug regulators to leverage Europe’s accelerated review of the drug for their own assessments, potentially speeding up broader global access.“We see the potential for lenacapavir to be a medicine of global impact,” Baeton said. “We’re pushing on all sides to make sure that the impact at the global scale is going to fulfill the promise that lenacapavir holds.”Even so, to deliver on its goal of widening the existing PrEP market, “targeted approaches” will be needed to unlock underpenetrated markets overseas, Citi analysts pointed out in a December note to clients. In the U.S., Gilead looks to expand the 400,000-person PrEP market to more than 1 million people by the mid-2030s and will execute on a Yeztugo access strategy “designed to enable broad uptake and availability for individuals with and without insurance coverage,” it said. Yeztugo marks another feather in Gilead's cap when it comes to the company's leading HIV portfolio. The drug's active ingredient, lenacapavir, was first approved several years ago for adults with multidrug-resistant HIV under the brand name Sunlenca. It’s a “tiny, tiny population,” Baeton said, but one that the company is “so proud” to treat.Despite the company’s work in other treatment areas like oncology and liver disease, Gilead's HIV products continue to make up the majority of its overall sales, driven largely by HIV treatment Biktarvy. Gilead hasn’t yet offered specific sales expectations for Yeztugo, but it expects the current PrEP market to grow “quite rapidly” upon launch considering that many PrEP-naïve people are “hanging in there” until it’s available, Mercier said on an April earnings call. Mizuho analysts previously put lenacapavir's peak annual sales potential at around $4 billion to $5 billion but have since doubled that projection to around $8 billion in peak worldwide sales, the analysts wrote in a recent note to clients. Until now, GSK’s 2021-approved every-two-month Apretude was the longest-acting player in the PrEP market. Considering Yeztugo's launch is “one of the most awaited in the HIV market,” Citi analysts figure Gilead’s PrEP portfolio can secure more than a 60% share of the U.S. PrEP market by the mid-2030s, according to the analytics firms' December note.

Clinical ResultDrug ApprovalPhase 3License out/in

07 May 2025

·www.shionogi.com

Announcement of Agreement on Company Split (Simplified Absorption-Type Split) of Japan Tobacco Inc.'s Pharmaceutical Business and Acquisition of Shares of Akros Pharma Inc. by Shionogi Inc. (Making it a Subsidiary)

OSAKA, Japan, May 7, 2025 - Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.; hereafter "Shionogi" or the “Company”) today announced that at the Board of Directors meeting held on May 7, 2025, it resolved to succeed to the pharmaceutical business of Japan Tobacco Inc. (Headquarters: Minato-ku, Tokyo; President: Masamichi Terabatake; hereinafter referred to as "Japan Tobacco") (hereinafter referred to as "JT Pharmaceutical Business" or the "Business to be Split") through a company split (simplified absorption-type split) (hereinafter referred to as the "Absorption-Type Split") and to acquire all issued shares of Akros Pharma Inc. (a 100% sub-subsidiary of Japan Tobacco, headquartered in New Jersey, USA; hereinafter referred to as "Akros") by Shionogi Inc., a group company of Shionogi in the USA (hereinafter referred to as the "Share Acquisition"), and has entered into an agreement (hereinafter referred to as the "Agreement") regarding the same. In connection with the Agreement, the Company also resolved at the Board of Directors meeting held today to conduct a tender offer (hereinafter referred to as the "Tender Offer") for the common shares of Torii Pharmaceutical Co., Ltd. (hereinafter referred to as "Torii Pharmaceutical"), a consolidated subsidiary of Japan Tobacco, to make Torii Pharmaceutical a wholly-owned subsidiary of the Company (hereinafter referred to as the "Full Ownership"). For details on the Tender Offer, please refer to the "Notice of Commencement of Tender Offer for Shares of Torii Pharmaceutical Co., Ltd. (Securities Code: 4551)" released today. I. Purpose of the Absorption-Type Split and Share Acquisition (hereinafter referred to as the "Transaction") Shionogi's basic policy (SHIONOGI Group Heritage) is to always provide the best medicine (healthcare solutions) necessary to protect people's health. The Company engages in research and development, manufacturing, and sales activities of prescription drugs, over-the-counter drugs, and diagnostic agents. In 2020, the Company set forth the Vision (SHIONOGI Group Vision) that aims to achieve by 2030, "Creating the Future of Healthcare with a New Platform," and formulated the medium-term management plan Shionogi Transformation Strategy 2030 (STS2030) to realize this Vision. The Company is transforming into a Healthcare as a Service (HaaS) company that provides various healthcare services tailored to customer needs, not limited to the provision of prescription drugs, to comprehensively address the problems faced by patients and society worldwide. From fiscal 2020 to fiscal 2022, the Company aimed to contribute to the early end of the COVID-19 pandemic by providing not only therapeutic drugs but also total care solutions for COVID-19, including detection (epidemic prediction), prevention, diagnosis, and mitigation of severe cases. As a result, the Company obtained domestic approval for the COVID-19 therapeutic drug Xocova at an unprecedented speed, advancing its drug discovery capabilities. Additionally, the Company expanded its product and service offerings beyond prescription drugs, including its first vaccine and wastewater epidemiology survey service. Based on the achievements and lessons learned from these efforts, the path to realizing the SHIONOGI Group Vision became clearer, leading to the revision of STS2030 in 2023 and the start of STS2030 Revision. In STS2030 Revision, the three years from fiscal 2023 to fiscal 2025 are positioned as STS Phase 2, with the basic policy of global top-line growth centered on the infectious disease area and fostering growth drivers through aggressive investment, accelerating growth through transformation. In research and development, the Company focuses on high-impact infectious diseases and high-impact QOL diseases as priority areas. In infectious diseases, the Company has developed many innovative new drugs, such as the anti-HIV drugs (dolutegravir and cabotegravir), the for multidrug-resistant Gram-negative bacterial infections (cefiderocol), and the anti-influenza virus drug Xofluza, based on its strong foundation in small molecule drug discovery (creating drugs with molecular weights ranging from tens to hundreds). The Company aims to solve the problems faced by patients and society worldwide by further strengthening and expanding its strong foundation in small molecule drug discovery. On the other hand, JT Pharmaceutical Business has been engaged in research and development of prescription drugs since entering the business in 1987, aiming to create first-in-class small molecule drugs through stable research and development investment. Currently, under the business purpose of "valuing science, technology, and human resources and contributing to patients' health," Japan Tobacco conducts research and development, while Torii Pharmaceutical handles manufacturing, sales, and promotion activities, building an integrated value chain and maximizing synergies within the group. JT Pharmaceutical Business focuses on three priority research and development areas: cardiovascular, renal, and muscle, "immunology and inflammation, and central nervous system, with strengths in rapid clinical development through specialization on research and development in the small molecule drug discovery and collaboration between domestic and international research and development bases. To deliver new drugs created in-house to patients as early as possible, JT Pharmaceutical Business actively engages in out-licensing and partnerships with global mega-pharma companies, in addition to promoting in-house development. Shionogi has been considering collaboration with JT Pharmaceutical Business and Torii Pharmaceutical to realize the Vision of "Creating the Future of Healthcare with a New Platform" in STS2030 Revision. As a result of these considerations, the Company concluded that by adding the capabilities of JT Pharmaceutical Business, which has strengths in small molecule drug discovery and development , it would be possible to accelerate the advancement of promising pipeline projects and increase the responsiveness and efficiency of business operations through collaboration with the Company's pharmaceutical manufacturing functions. The Company proposed to Japan Tobacco the acquisition of JT Pharmaceutical Business and the full ownership of Torii Pharmaceutical, and after subsequent discussions, reached the Agreement. The Company believes that the Transaction will create a leading company that delivers innovative pharmaceuticals from Japan to the world, contributing to the health of patients and people worldwide, and contributing to the realization of a sustainable and healthy society. The Company also believes that the Transaction will provide opportunities for the employees of JT Pharmaceutical Business (including group companies) to continue to thrive with peace of mind. II. Overview of the Absorption-Type Split i. Summary of the Absorption-Type Split (1) Date (1) Date of Board Resolution for Agreement May 7, 2025 (2) Date of Agreement May 7, 2025 (3) Date of Board Resolution for Absorption-Type Split Agreement September, 2025 (planned) (4) Date of Absorption-Type Split Agreement September, 2025 (planned) (5) Effective Date of Absorption-Type Split December, 2025 (planned) (Note 1): The Absorption-Type Split falls under the simplified absorption-type split stipulated in Article 796, Paragraph 2 of the Companies Act for the Company, and Article 784, Paragraph 2 of the Companies Act for Japan Tobacco. Therefore, it will be carried out without the approval resolution of the shareholders' meeting. (Note 2): The schedule may be changed as necessary, considering the need for responses to approvals, registrations, notifications, etc., from relevant authorities, circumstances, and other various factors. (2) Method of Absorption-Type Split The Company will be the succeeding company, and Japan Tobacco will be the splitting company. (3) Allocation of Consideration The Company will pay 5,397 million yen to Japan Tobacco as consideration for the Absorption-Type Split. (4) Handling of Stock Acquisition Rights and Bonds with Stock Acquisition Rights Not applicable. (5) Increase or Decrease in Capital Due to Absorption-Type Split Not applicable. (6) Rights and Obligations to be Succeeded The Company will succeed to the assets, liabilities, and contractual rights and obligations related to the Absorption-Type Split, except for those separately specified in the Absorption-Type Split Agreement. (7) Prospects for Debt Performance The Company believes that there are no issues with performance of the debts that will become due after the effective date of the Absorption-Type Split. ii. Allocation of Consideration and Basis for the Absorption-Type Split (1) Basis and Reason for Allocation of Consideration The allocation of consideration was agreed upon after comprehensive discussions between both companies, taking into account the performance status and future prospects of the business to be split. (2) Matters Related to Calculation The Company has not obtained a valuation report from a valuation institution in connection with the Absorption-Type Split. (3) Prospect of Delisting and Its Reason Since the consideration involves the exchange of money, there is no prospect of delisting. (4) Measures to Ensure Fairness Not applicable. However, the Company has appointed Nishimura & Asahi Law Office as the legal advisor for the Absorption-Type Split and has received legal advice on various procedures, decision-making methods, and processes related to the Absorption-Type Split. Nishimura & Asahi Law Office does not have any significant interests that should be disclosed in relation to the Absorption-Type Split and is not a related party to the Company or Japan Tobacco. (5)Measures to Avoid Conflicts of Interest Not applicable. (Unit: million yen, unless otherwise specified.) i. Overview of JT Pharmaceutical Business (1) Content of JT Pharmaceutical Business Research and development of prescription drugs (2) Business Performance of JT Pharmaceutical Business Fiscal year ended December 2024 Net sales ¥44,942 million (3) Items and Amounts of Assets and Liabilities of the JT Pharmaceutical Business to be Succeeded (as of December 31, 2024) The assets (excluding shares of Torii Pharmaceutical and Akros) and liabilities, as well as other rights and obligations belonging to the JT pharmaceutical business, As stipulated in the absorption-type split agreement will be succeeded by our company. Assets Liabilities field book value field book value Current Assets ¥8,588 million Current Assets ¥5,448 million Fixed Liabilities ¥37,832 million Fixed Liabilities ¥9,875 million Total ¥46,420 million Total ¥15,323 million Note: The above amounts are calculated based on the balance sheet as of December 31, 2024, and the actual amounts to be succeeded will be adjusted for any increases or decreases up to the effective date. ii. Status After the Absorption-Type Split (1) Name of Company Shionogi & Co., Ltd. Japan Tobacco Inc. (2) Location 1-8, Doshomachi 3-chome, Chuo-ku, Osaka 541-0045, Japan 1-1, Toranomon 4-chome, Minato-ku, Tokyo (3) Representative Isao Teshirogi, Ph.D., Representative Director, President and CEO Masamichi Terabatake, President, Chief Executive Officer and Representative Director　 (4) Business Description Research, development, manufacturing and distribution of pharmaceuticals, diagnostic reagents and medical devices, etc. Manufacture, sale, import, etc., of manufactured tobacco (5) Paid-in Capital ¥21,279 million ¥100,000 million (6) Fiscal Year-End March 31 December 31 (7) Net Assets It is not confirmed at this time It is not confirmed at this time (8) Total Assets It is not confirmed at this time It is not confirmed at this time iii. Overview of Accounting Treatment For the accounting treatment related to the Absorption-Type Split, we plan to apply IFRS 3 'Business Combinations' and use the purchase method, with our Company as the acquiring entity. The amount of goodwill generated from this Absorption-Type Split is currently undecided, and we will inform you as soon as it is determined. iv. Future Outlook We are currently assessing the impact of this Absorption-Type Split on our consolidated performance, and will inform you as soon as it is determined. v. Other Noteworthy Matters The Agreement is contingent upon the absence of any factors hindering the execution of the stock acquisition, such as the issuance of a cease and desist order, based on the results of the Japan Fair Trade Commission's review of the notification under Article 10, Paragraph 2 of the Act on Prohibition of Private Monopolization and Maintenance of Fair Trade. II. Overview of this Stock Acquisition i. Overview of Our U.S. Subsidiary (Shionogi Inc.) Acquiring the Shares (1) Name of Company Shionogi Inc. (2) Location 400 Campus Drive, Florham Park, NJ 07932, USA (3) Representative President and Chief Executive Officer Nathan McCutcheon (4) Business Description Development, manufacturing, and sales of pharmaceuticals (5) Paid-in Capital 12 USD (as of March 31, 2024) (6) Date of Founding August 2008 (7) Major Shareholders and Shareholding Ratios Shionogi (100%) ii. Overview of the Subsidiary to be Acquired (1) Name of Company Akros Pharma Inc. (2) Location 302 Carnegie Center, Suite 300, Princeton, NJ 08540 (3) Job Title and Name of Representative President＆CEO Teppei Higuchi (4) Business Description Clinical development, joint research, and exploration of new technology projects overseas (5) Paid-in Capital 1,000 USD (as of December 31, 2024) (6) Date of Founding January 1999 (7) Net Assets 23,776 thousand USD (as of December 31, 2024) (8) Total Assets 32,986 thousand USD (as of December 31, 2024) (9) Major Shareholders and Shareholding Ratios JT AMERICA INC. (100%) ※ JT AMERICA INC. is a wholly owned subsidiary of Japan Tobacco Inc. (10) Relationship between Shionogi and said company Capital Relationship None. Personal Relationship None. Transactional Relationship None. Status as Related Party None. iii. Overview of the Counterparty in the Stock Acquisition (1) Name of Company JT AMERICA INC. (2) Location 112 W. 34th Street, 18th Floors, New York, NY 10120 (3) Job Title and Name of Representative President & CEO Toshimitsu Eguchi (4) Business Description Holding company functions in the U.S. for non-tobacco and non-food businesses (5) Paid-in Capital 51 thousand USD (as of December 31, 2024) (6) Date of Founding May 1988 (7) Net Assets 141,447 thousand USD (as of December 31, 2024) (8) Total Assets 142,125 thousand USD (as of December 31, 2024) (9) Major Shareholders and Ownership Ratios Japan Tobacco Inc.(100％) (10) Relationship between Shionogi and said company Capital Relationship None. Personal Relationship None. Business Relationship None. Related Party Relationship None. iv. Number of Shares to be Acquired, Acquisition Price, and the Status of Shareholding Before and After the Acquisition * The acquisition price has been converted at an exchange rate of 1 USD = 151.55 JPY (based on the average rate over the past six months). v. Date vi. Future Outlook We are currently assessing the impact of this stock acquisition on Shionogi’s consolidated financial results for the fiscal year ending March 2026. If it becomes necessary to revise the performance forecast, Shionogi will promptly disclose the information. For Further Information, Contact: SHIONOGI Website Inquiry Form: https://www.shionogi.com/global/en/contact.html

AcquisitionLicense out/in

06 May 2025

·www.prnewswire.com

HALOZYME RAISES 2025 FINANCIAL GUIDANCE RANGES AND REPORTS STRONG FIRST QUARTER 2025 RESULTS

Announcing New $250M Share Repurchase Total Revenue Increased 35% YOY to $265 million and Royalty Revenue Increased 39% YOY to $168 million Net Income Increased 54% YOY to $118 million; Adjusted EBITDA Increased 40% YOY to $162 million; GAAP Diluted EPS Increased 55% YOY to $0.93; non-GAAP Diluted EPS Increased 41% YOY to $1.111 Raising 2025 Financial Guidance Ranges for Total Revenue to $1,200 - $1,280 million, Representing YOY Growth of 18% - 26%, Adjusted EBITDA to $790 - $840 million, Representing YOY Growth of 25% - 33% and non-GAAP Diluted EPS to $5.30 - $5.70, Representing YOY Growth of 25% - 35%1 SAN DIEGO, May 6, 2025 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme" or the "Company") today reported its financial and operating results for the first quarter ended March 31, 2025, provided an update on its recent corporate activities and raised its 2025 financial guidance. "2025 is off to a strong start with our current three blockbuster brands, Darzalex SC, Phesgo and VYVGART Hytrulo, continuing to demonstrate strong growth in their currently approved indications. Our four recently launched products, Ocrevus Zunovo in U.S. and Europe, Tecentriq Hybreza in U.S. and Europe, Opdivo Qvantig in U.S. and Rybrevant SC in Europe are just beginning their contributions as our partners focus on gaining and expanding coverage and reimbursement. This broadened portfolio is resulting in an unprecedented set of 11 additional growth catalysts that have happened recently or are expected to happen in the coming months. These opportunities include multiple new European and U.S. product approvals, multiple new indication approvals and multiple key reimbursement milestones supporting access for an even greater number of patients, all creating new near and longer-term growth opportunity. As a result of this momentum, I am pleased to announce we are increasing our full year 2025 financial guidance ranges and a new $250 million share buyback," said Dr. Helen Torley, president and chief executive officer, of Halozyme. "In addition, our long-term growth prospects have never been better with additional growth opportunities projected to result from our pipeline, where two products, BMS' nivolumab plus relatlimab SC and Takeda's 20% immune globulin SC, continue in Phase 3 and where ViiV and Acumen announced development progress and data in the quarter. I am also pleased to announce that we have signed our first HVAI development agreement with a current ENHANZE partner and that a different ENHANZE partner is now moving our SVAI into clinical testing," concluded Dr. Torley. First Quarter and Recent Corporate Highlights: On May 6, Halozyme announced a second $250 million share repurchase under the $750 million approved program from February 2024. In April 2025, Halozyme filed a patent infringement lawsuit against Merck Sharp & Dohme Corp. ("Merck") in the U.S. District Court in New Jersey alleging that Merck is using Halozyme's patented MDASE™ subcutaneous drug delivery technology to develop Subcutaneous ("SC") Keytruda. Halozyme is seeking damages and injunctive relief to stop Merck's infringement of Halozyme's MDASE™ intellectual property. In March 2025, Halozyme completed the first $250 million Accelerated Share Repurchase of its common stock under the $750 million approved program from February 2024. First Quarter and Recent Partner Highlights: In April 2025, Roche received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use ("CHMP") recommending an update to the European Union ("EU") label for Phesgo® for human epidermal growth factor receptor 2 ("HER2")-positive breast cancer. Administration of Phesgo® outside of a clinical setting (such as in a person's home) by a healthcare professional will be possible, once safely established in a clinical setting. In April 2025, argenx received a positive opinion from the CHMP recommending European Commission approval of VYVGART® 1000mg (efgartigimod alfa) developed with ENHANZE® for SC injection as a monotherapy for the treatment of adult patients with progressive or relapsing active chronic inflammatory demyelinating polyneuropathy ("CIDP") after prior treatment with corticosteroids or immunoglobulins. In April 2025, argenx received U.S. Food and Drug Administration ("FDA") approval of VYVGART® Hytrulo prefilled syringe for self-injection for the treatment of adult patients with generalized myasthenia gravis who are anti-acetylcholine receptor antibody positive and adult patients with CIDP. In April 2025, Janssen received European Commission marketing authorization of the SC formulation of RYBREVANT® (amivantamab) with ENHANZE®, in combination with LAZCLUZE® (lazertinib), for the first-line treatment of adult patients with advanced non-small cell lung cancer ("NSCLC") with epidermal growth factor receptor ("EGFR") exon 19 deletions or exon 21 L858R substitution mutations. Additionally, RYBREVANT® (amivantamab) is approved as a monotherapy for adult patients with advanced NSCLC with activating EGFR exon 20 insertion mutations after the failure of platinum-based therapy. This represents the 10th partner product with ENHANZE® to be commercialized. In April 2025, Janssen received European Commission approval for an indication extension of DARZALEX® SC in combination with bortezomib, lenalidomide, and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma regardless of transplant eligibility. In March 2025, Bristol Myers Squibb received a positive CHMP opinion recommending approval of Opdivo® (nivolumab) with ENHANZE® across multiple solid tumor indications. In March 2025, Acumen announced top-line results from a Phase 1 study of sabirnetug (ACU193) with ENHANZE® comparing the pharmacokinetics between SC and intravenous administrations in healthy volunteers that demonstrated weekly SC administration of sabirnetug was well-tolerated with systematic exposure supporting further clinical development. In March 2025, ViiV announced results from a Phase 2b study demonstrated N6LS administered every four months SC with ENHANZE® in combination with cabotegravir successfully maintained viral suppression in adults living with HIV who were already stable on treatment. In March 2025, Takeda announced Health Canada expanded the marketing authorization for HYQVIA® to include CIDP as a maintenance therapy after stabilization with intravenous immunoglobulin to prevent relapse of neuromuscular disability and impairment in adults. First Quarter 2025 Financial Highlights: Revenue was $264.9 million, compared to $195.9 million in the first quarter of 2024. The 35% year-over-year increase was primarily driven by royalty revenue growth and an increase in sales of bulk rHuPH20. Revenue for the quarter included $168.2 million in royalties, an increase of 39% compared to $120.6 million in the first quarter of 2024, primarily attributable to increases in revenue of VYVGART® Hytrulo, DARZALEX® SC, and Phesgo®. Cost of sales was $48.4 million, compared to $28.3 million in the first quarter of 2024. The increase in cost of sales was primarily due to an increase in product sales. Amortization of intangibles expense remained flat at $17.8 million, compared to the first quarter of 2024. Research and development expense was $14.8 million, compared to $19.1 million in the first quarter of 2024. The decrease in research and development expense was primarily due to lower compensation expense driven by resource optimization and labor allocation initiatives, and timing of planned investments in ENHANZE® related to the development of our new high-yield rHuPH20 manufacturing process. Selling, general and administrative expense was $42.4 million, compared to $35.1 million in the first quarter of 2024. The increase was primarily due to an increase in consulting and professional service fees and compensation expense. Operating income was $141.5 million, compared to $95.5 million in the first quarter of 2024. Net income was $118.1 million, compared to $76.8 million in the first quarter of 2024. EBITDA and Adjusted EBITDA were $162.0 million, compared to $115.7 million in the first quarter of 2024.1 GAAP diluted earnings per share was $0.93, compared to $0.60 in the first quarter of 2024. Non-GAAP diluted earnings per share was $1.11, compared to $0.79 in the first quarter of 2024.1 Cash, cash equivalents and marketable securities were $747.9 million on March 31, 2025, compared to $596.1 million on December 31, 2024. The increase was primarily a result of cash generated from operations. Financial Outlook for 2025 The Company is raising its financial guidance for 2025. Note that the guidance reflects tariffs that are currently implemented. For the full year 2025, the Company expects: Total revenue of $1,200 million to $1,280 million, representing growth of 18% to 26% over 2024 total revenue, primarily driven by increases in royalty revenue. Revenue from royalties of $750 million to $785 million, representing growth of 31% to 37% over 2024. Adjusted EBITDA of $790 million to $840 million, representing growth of 25% to 33% over 2024. Non-GAAP diluted earnings per share of $5.30 to $5.70, representing growth of 25% to 35% over 2024. The Company's earnings per share guidance does not consider the impact of potential future share repurchases. Webcast and Conference Call Halozyme will host its Quarterly Update Conference Call for the first quarter ended March 31, 2025 today, Tuesday, May 6, 2025, at 1:30 p.m. PT/4:30 p.m. ET. The conference call may be accessed live with pre-registration via link: . The call will also be webcast live through the "Investors" section of Halozyme's corporate website and a recording will be made available following the close of the call. To access the webcast and additional documents related to the call, please visit Halozyme.com. About Halozyme Halozyme is a biopharmaceutical company advancing disruptive solutions to improve patient experiences and outcomes for emerging and established therapies. As the innovators of ENHANZE® drug delivery technology with the proprietary enzyme rHuPH20, Halozyme's commercially-validated solution is used to facilitate the subcutaneous delivery of injected drugs and fluids, with the goal of improving the patient experience with rapid subcutaneous delivery and reduced treatment burden. Having touched one million patient lives in post-marketing use in ten commercialized products in at least one major region and across more than 100 global markets, Halozyme has licensed its ENHANZE® technology to leading pharmaceutical and biotechnology companies including Roche, Takeda, Pfizer, Janssen, AbbVie, Eli Lilly, Bristol-Myers Squibb, argenx, ViiV Healthcare, Chugai Pharmaceutical and Acumen Pharmaceuticals. Halozyme also develops, manufactures and commercializes, for itself or with partners, drug-device combination products using its advanced auto-injector technologies that are designed to provide commercial or functional advantages such as improved convenience, reliability and tolerability, and enhanced patient comfort and adherence. The Company has two commercial proprietary products, Hylenex® and XYOSTED®, partnered commercial products and ongoing product development programs with Teva Pharmaceuticals and McDermott Laboratories Limited, an affiliate of Viatris Inc. Halozyme is headquartered in San Diego, CA and has offices in Ewing, NJ and Minnetonka, MN. Minnetonka is also the site of its operations facility. For more information visit and connect with us on LinkedIn and Twitter. Note Regarding Use of Non-GAAP Financial Measures In addition to disclosing financial measures prepared in accordance with U.S. generally accepted accounting principles ("GAAP"), this press release and the accompanying tables contain certain non-GAAP financial measures. The Company reports earnings before interest, taxes, depreciation, and amortization ("EBITDA"), adjusted EBITDA, Non-GAAP diluted earnings per share, Non-GAAP diluted shares, and guidance with respect to those measures, in addition to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP. The Company calculates non-GAAP diluted earnings per share excluding share-based compensation expense, amortization of debt discounts, intangible asset amortization, one-time changes, if any, such as changes in contingent liabilities, inventory adjustments, impairment charges, and certain adjustments to income tax expense. The Company calculates non-GAAP diluted shares excluding the dilutive impact of convertible notes which is used in calculating non-GAAP diluted earnings. The Company calculates EBITDA excluding interest, taxes, depreciation and amortization. The Company calculates adjusted EBITDA excluding one-time items, if any, such as changes in contingent liabilities, inventory adjustments, impairment charges and transaction costs for business combinations. Reconciliations between GAAP and Non-GAAP financial measures are included at the end of this press release. The Company does not provide reconciliations of forward-looking adjusted measures to GAAP due to the inherent difficulty in forecasting and quantifying certain amounts that are necessary for such reconciliation, including adjustments that could be made for changes in share-based compensation expense and the effects of any discrete income tax items. For the same reasons, the Company is unable to address the probable significance of the unavailable information. The Company provides non-GAAP financial measures that it believes will be achieved; however, it cannot accurately predict all of the components of the adjusted calculations and the U.S. GAAP measures may be materially different than the non-GAAP measures. The Company evaluates other items of income and expense on an individual basis for potential inclusion in the calculation of Non-GAAP financial measures and considers both the quantitative and qualitative aspects of the item, including (i) its size and nature, (ii) whether or not it relates to the Company's ongoing business operations and (iii) whether or not the Company expects it to occur as part of the Company's normal business on a regular basis. Non-GAAP financial measures do not have any standardized meaning and are therefore unlikely to be comparable to similarly titled measures presented by other companies. These non-GAAP financial measures are not meant to be considered in isolation and should be read in conjunction with the Company's consolidated financial statements prepared in accordance with GAAP, and are not prepared under any comprehensive set of accounting rules or principles. In addition, from time to time in the future there may be other items that the Company may exclude for purposes of its non-GAAP financial measures, and the Company may in the future cease to exclude items that it has historically excluded for purposes of its non-GAAP financial measures. The Company considers these non-GAAP financial measures to be important because they provide useful measures of the operating performance of the Company, exclusive of factors that do not directly affect what the Company considers to be its core operating performance, as well as unusual events. The non-GAAP measures also allow investors and analysts to make additional comparisons of the operating activities of the Company's core business over time and with respect to other companies, as well as assessing trends and future expectations. The Company uses non-GAAP financial information in assessing what it believes is a meaningful and comparable set of financial performance measures to evaluate operating trends, as well as in establishing portions of our performance-based incentive compensation programs. Safe Harbor Statement In addition to historical information, the statements set forth in this press release include forward-looking statements including, without limitation, statements concerning the Company's financial performance (including the Company's expected financial outlook for 2025) and expectations for future growth, profitability, total revenue, royalty revenue, EBITDA, Adjusted EBITDA, and non-GAAP diluted earnings-per-share and potential share repurchases under its share repurchase program. Forward-looking statements regarding the Company's ENHANZE® drug delivery technology may include the possible benefits and attributes of ENHANZE®, its potential application to aid in the dispersion and absorption of other injected therapeutic drugs and facilitating more rapid delivery and administration of higher volumes of injectable medications through subcutaneous delivery and the expected expiration date of our ENHANZE® patent in Europe. Forward-looking statements regarding the Company's business may include potential growth and receipt of royalty and milestone payments driven by our partners' development and commercialization efforts, potential new clinical trial study starts and clinical data, regulatory submissions and product launches, the size and growth prospects of our partners' drug franchises, potential new or expanded collaborations (including potential HVAI and SVAI collaborations) and collaborative targets and regulatory review, and potential approvals of new partnered or proprietary products, and the potential timing of these events. These forward-looking statements are typically, but not always, identified through use of the words "expect," "believe," "enable," "may," "will," "could," "intends," "estimate," "anticipate," "plan," "predict," "probable," "potential," "possible," "should," "continue," and other words of similar meaning and involve risk and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. Actual results could differ materially from the expectations contained in these forward-looking statements as a result of several factors, including unexpected levels of revenues, expenditures and costs, unexpected delays in the execution of the Company's share repurchase program, unexpected results or delays in the growth of the Company's business, or in the development, regulatory review or commercialization of the Company's partnered or proprietary products, regulatory approval requirements, uncertainties in tariffs and trade policies, unexpected adverse events or patient outcomes and competitive conditions. In addition, there can be no assurance as to developments related to the litigation referred to in this press release, the outcome of the litigation or any remedies that could be awarded in connection with the litigation. These and other factors that may result in differences are discussed in greater detail in the Company's most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission. Except as required by law, the Company undertakes no duty to update forward-looking statements to reflect events after the date of this release. Contacts: Tram Bui VP, Investor Relations and Corporate Communications 609-333-7668 [email protected] Samantha Gaspar Teneo 212-886-9356 [email protected] Footnotes: 1. Reconciliations between GAAP reported and non-GAAP financial information for actual results are provided at the end. SOURCE Halozyme Therapeutics, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultDrug ApprovalPhase 2Phase 1Financial Statement

100 Deals associated with Cabotegravir sodium

External Link

KEGG	Wiki	ATC	Drug Bank
D10548 D10549	Cabotegravir sodium	J05AR	DB11751

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
HIV Infections	Canada	ViiV Healthcare Ltd.	21 Sep 2020

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
HIV-Associated Lipodystrophy Syndrome	Phase 1	United States	GSK Plc	01 May 2013
Hepatitis	Phase 1	United States	ViiV Healthcare Ltd.	01 Nov 2011
Herpesviridae Infections	Phase 1	-	ViiV Healthcare Ltd.	01 Sep 2010

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04542070 (SOLAR, Pubmed \| J Infect Chemother)	Phase 3	-	670	Long-Acting Cabotegravir + Rilpivirine (CAB+RPV LA)	uexuaavlvd(fwdkkarrya) = upedqxyxqy uzbjzwyvoh (uhnwqyyfyl ) View more	Positive	01 Jul 2025
				Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF)	uexuaavlvd(fwdkkarrya) = ncssnkaxfm uzbjzwyvoh (uhnwqyyfyl ) View more
NCT03635788 (LATITUDE , CTgov)	Phase 3	HIV Infections	456	CAB-LA Maintenance Dose+Oral CAB+RPV-LA Loading Dose (Step 2 Arm A: LA ART)	vngyblrzcj = clculrqcjs gtrfsqhclk (cpjpqwtdju, qijhrryjxs - uasxhqlkkm) View more	-	24 Apr 2025
				Standard of Care (SOC) Oral ART (Step 2 Arm B: SOC)	vngyblrzcj = alyeisykij gtrfsqhclk (cpjpqwtdju, dxejspegzj - hvbejldbjw) View more
NCT04542070 (SOLAR, Pubmed \| J Acquir Immune Defic Syndr)	Phase 3	HIV Infections	687	Cabotegravir + Rilpivirine LA	elqlkfwpme(fcfyvjzybo) = bglhvyzedc tafxpylgdr (uipdfurmjg, -4.50 to 4.00)	Positive	01 Apr 2025
				Bictegravir/Emtricitabine/Tenofovir Alafenamide	iodtxtfiyl(tymjjlxbeo) = eozpdwaigr unybatwvnu (bseuluudhc, -2.30 to +1.95) View more
NCT03497676 (IMPAACT 2017/MOCHA, Pubmed \| Lancet HIV)	Phase 1/2	HIV Infections	139	Long-acting Injectable Cabotegravir 600 mg + Long-acting Injectable Rilpivirine 900 mg	isqitjkkrp(rmmdrdixhd) = 10.8% [95% CI 6.2-17.2] of all 139 participants in the evaluable analysis population had at least one adverse event of grade 3 or above by week 24 ibiumzveso (aibbkvgfrc ) View more	Positive	01 Mar 2025
NCT04692077 (CTgov)	Phase 2	HIV Infections	9	CAB LA+Tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) tablet	vlghvrbyrn(uinjecuhik) = swbuzmrglh vbzuezogze (nbrsurkdwk, 1.3) View more	-	29 Jan 2025
OPERA (BusinessWire) Manual	Not Applicable	HIV Infections	-	Apretude (cabotegravir long-acting (CAB LA))	xetbasyrlt(apxsupmtmp) = djcdolyztm qjdptyxpoo (aghoklohqt )	Positive	16 Oct 2024
NCT04824131 (CTgov)	Phase 2	HIV Infections	55	Cabotegravir (Cabotegravir Long Acting)	tjsgjzagsy = uzzfovluoi ixiukimcch (zwifremian, wwgksltdyl - qyzksycxqx) View more	-	30 Jul 2024
				CAB (Step 1 - CAB LA Oral Phase)	hvnbqfivpv(kagfhkrmxm) = nyrzmdusvk xkxrbyclsm (guvlpaaqgv, xpkmlsejru - lrpplgnvgx) View more
NCT03299049 \| NCT02951052 \| NCT02938520 (Pubmed \| J Infect Dis)	Phase 3	HIV Infections Maintenance	1,245	CAB + RPV LA every 4 week dosing	jrplzlbsfj(qkchctuxez) = pbmaaqspge kwtxcfseol (ppttvbiqju )	Positive	25 Jul 2024
				CAB + RPV LA every 8 week dosing	jrplzlbsfj(qkchctuxez) = syelhkftxo kwtxcfseol (ppttvbiqju )
NCT02720094 (CTgov)	Phase 2/3	HIV Infections	4,570	Cabotegravir (Cabotegravir)	mhmqwejwnf = nxpnwtthdg jpbptsgjts (jhlaqhqcrj, xpqxewgbmy - lkmurirpzj) View more	-	24 Nov 2023
				FTC+TDF (TDF/FTC)	mhmqwejwnf = lxwxkearwb jpbptsgjts (jhlaqhqcrj, czguszjyew - szsromjggr) View more
NCT04399551 (CARISEL, CTgov)	Phase 3	HIV Infections	437	Continuous Quality Improvement (CQI) calls	lwnpxvuuum = afeiniwfvc yegspzxypm (giwrkpsgvh, snrvaadybn - gwyesqqqbs)	-	19 May 2023

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