Welcome to our dedicated page for Halozyme Thrp news (Ticker: HALO), a resource for investors and traders seeking the latest updates and insights on Halozyme Thrp stock.
Halozyme Therapeutics, Inc. (HALO) delivers innovative drug delivery solutions through its proprietary ENHANZE® technology, transforming subcutaneous administration of biologics. This dedicated news hub provides investors and healthcare professionals with essential updates on clinical developments, strategic partnerships, and regulatory milestones.
Access timely press releases covering earnings reports, ENHANZE® licensing agreements, and oncology pipeline advancements. Our curated collection features updates on FDA submissions, collaboration expansions with global pharmaceutical leaders, and technology applications across autoimmune disorders and cancer treatments.
Key updates include partnership announcements with industry leaders, clinical trial progress for subcutaneous therapies, and financial performance insights. The resource serves investors tracking royalty revenue models and analysts monitoring competitive positioning in biopharmaceutical delivery systems.
Bookmark this page for direct access to verified corporate communications and objective reporting on Halozyme's mission to enhance treatment experiences through advanced drug delivery platforms. Regularly updated to reflect the company's latest achievements in patient-centric biotechnology innovation.
Halozyme (HALO) reported strong financial results for Q4 and full year 2024, achieving record revenue of $1.015 billion. Q4 total revenue increased 30% YOY to $298 million, with royalty revenue up 40% to $170.4 million. Full year net income rose 58% to $444.1 million.
The company's growth was driven by strong performance of DARZALEX SC, Phesgo, and VYVGART Hytrulo. Four additional ENHANZE regulatory product approvals were secured in the U.S. and EU in 2024. The company maintains its 2025 guidance, projecting total revenue of $1,150-1,225 million (13-21% growth) and royalty revenue of $725-750 million (27-31% growth).
In December 2024, Halozyme entered an Accelerated Share Repurchase agreement for $250 million under its $750 million approved program. The company's cash position strengthened to $596.1 million by year-end 2024, up from $336.0 million in 2023.
Halozyme Therapeutics (NASDAQ: HALO) has announced it will release its fourth quarter and full year 2024 financial and operating results on Tuesday, February 18, 2025, after market close. The company will host a conference call the same day at 1:30 p.m. PT/4:30 p.m. ET to discuss the results. Investors can access the call through pre-registration and view a live webcast through the investor section of Halozyme's website.
Halozyme Therapeutics (NASDAQ: HALO) announced that Janssen-Cilag International NV received a positive CHMP opinion recommending marketing authorization for a subcutaneous formulation of RYBREVANT® (amivantamab) in Europe. The recommendation covers two treatments: combination therapy with LAZCLUZE® for first-line treatment of advanced NSCLC with specific EGFR mutations, and monotherapy for advanced NSCLC with EGFR exon 20 insertion mutations after platinum-based therapy failure.
The subcutaneous formulation, developed using Halozyme's ENHANZE® technology, demonstrates significant advantages with an approximate five-minute administration time and a five-fold reduction in infusion-related reactions. The recommendation is supported by positive results from the Phase 3 PALOMA-3 study.
Halozyme (NASDAQ: HALO) has reiterated its 2024 financial guidance and raised its 2025 and multi-year financial outlook. The company projects 2025 total revenue of $1,150-$1,225 million (16-23% YoY growth), adjusted EBITDA of $755-$805 million (24-32% growth), and non-GAAP diluted EPS of $4.95-$5.35 (21-30% growth).
The growth is primarily driven by VYVGART Hytrulo's strong acceptance in generalized myasthenia gravis and CIDP, along with continued growth of Darzalex SC and Phesgo. Three additional products - Ocrevus Zunovo, Tecentriq Hybreza, and Opdivo Qvantig - are expected to contribute modestly in 2025 with meaningful growth from 2026.
The company has also announced a new $250 million accelerated share repurchase program under its previously announced $750 million share repurchase program.
Halozyme Therapeutics (NASDAQ: HALO) has announced an upcoming Investor Conference Call scheduled for Wednesday, January 8, 2025, at 5:30 a.m. PT / 8:30 a.m. ET. During this call, Dr. Helen Torley, President and CEO, and Nicole LaBrosse, CFO, will present preliminary unaudited results for the full year 2024 and provide updated financial guidance for 2025 and beyond.
Investors can pre-register for the live call through a provided registration link. The presentation will also be accessible via webcast through the 'Investors' section of Halozyme's website, with presentation materials becoming available 15 minutes before the call. A recording of the call will be made available afterward.
Halozyme Therapeutics (NASDAQ: HALO) announced that Takeda received regulatory approval from Japan's MHLW for HYQVIA®, a combination therapy using Halozyme's ENHANZE® technology, for patients with agammaglobulinemia or hypogammaglobulinemia.
HYQVIA® is Japan's first plasma-derived subcutaneous therapy combining Immunoglobulin 10% with Recombinant Human Hyaluronidase PH20. The therapy allows for reduced dosing frequency (every 3-4 weeks) compared to conventional treatments (weekly/bi-weekly).
The approval is based on two Phase 3 studies in Japan involving 16 patients aged 2+ years. The trials showed maintained IgG trough levels of 9.494g/L, comparable to traditional treatments. Main adverse reactions included pyrexia (31.3%) and various injection site reactions (12.5%).
Halozyme Therapeutics (NASDAQ: HALO) announced that argenx's VYVDURA, co-formulated with Halozyme's ENHANZE® drug delivery technology, received regulatory approval in Japan for treating chronic inflammatory demyelinating polyneuropathy (CIDP) in adults. The treatment, administered as a weekly 30-90 second subcutaneous injection, is the first FcRn blocker approved for CIDP.
The approval is based on the ADHERE Study, which showed 69% of patients demonstrated clinical improvement, with a 61% reduction in relapse risk versus placebo. VYVDURA was previously approved in Japan for generalized myasthenia gravis (gMG) in January 2024 and received Orphan Drug designation for CIDP in March 2024.
Halozyme (NASDAQ: HALO) announces FDA approval of Bristol Myers Squibb's Opdivo Qvantig™, the first and only subcutaneously administered PD-1 inhibitor co-formulated with ENHANZE® technology. The approval covers most previously approved adult solid tumor Opdivo® indications. The key advantage is faster administration time (3-5 minutes vs. 30 minutes for IV Opdivo).
The approval is based on the Phase 3 CheckMate-67T trial, which demonstrated noninferiority to IV Opdivo. The overall response rate was 24% for Opdivo Qvantig compared to 18% for IV Opdivo. The safety profile was comparable to IV Opdivo, with serious adverse reactions occurring in 28% of patients.
Halozyme Therapeutics (NASDAQ: HALO) has announced its executive leadership team's upcoming presentations at two major investor conferences on December 4, 2024. Chief Financial Officer Nicole LaBrosse will present at the Piper Sandler 36th Annual Healthcare Conference in New York at 10:30am PT, while President and CEO Helen Torley will speak at the 7th Annual Evercore ISI HealthCONx Conference in Miami at 9:30am PT.
Both events will feature fireside chats and one-on-one meetings. Live audio webcasts will be available on the company's Investor Relations website, with replays accessible for 90 days after the conferences.
Halozyme Therapeutics (NASDAQ: HALO) has withdrawn its non-binding proposal to acquire Evotec SE (NASDAQ: EVO) for €11.00 per share in cash, which valued Evotec at €2.0 billion. The withdrawal comes after Evotec's unwillingness to engage in discussions about the potential combination. Despite Halozyme's attempts to engage with Evotec's leadership, including informal discussions with a Supervisory Board member, their requests were not accepted. Halozyme maintains its 2024 guidance with revenue of $970-$1,020 million and adjusted EBITDA of $595-$625 million, and projects 10 approved products with ENHANZE® by 2025 and $1 billion in royalty revenue by 2027.
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