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. develops and commercializes drug-delivery technologies for subcutaneous administration of biologics and other injectable therapies. News about HALO commonly covers ENHANZE licensing agreements, Hypercon and Surf Bio hyperconcentration collaborations, partner product regulatory approvals, royalty-based revenue updates, and financial guidance.
The company also reports developments tied to its proprietary products Hylenex and XYOSTED, drug-device combination products using auto-injector technologies, and collaborations with pharmaceutical and biotechnology companies in oncology, inflammatory disease and other therapeutic areas.
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.
Halozyme (NASDAQ: HALO) has provided an update on its non-binding proposal to acquire Evotec SE for €11.00 per share in cash, valuing the company at €2.0 billion. The proposed combination would create a leading global innovative pharma services company with projected annual revenue of $2 billion in 2025. The acquisition would combine Evotec's drug discovery and biologics manufacturing capabilities with Halozyme's ENHANZE® drug delivery technology. The all-cash transaction would be funded through cash reserves and new debt, with projected net leverage less than 2x within two years post-close. Halozyme expects to have over $800 million in cash by year-end 2024, maintaining a 15-20%+ revenue CAGR through 2023-2028 and achieving 45-50% adjusted EBITDA margin by 2026.
Halozyme (NASDAQ: HALO) has submitted a non-binding proposal to acquire Evotec SE (NASDAQ: EVO) for €11.00 per share in cash, valuing the company at €2.0 billion. The offer represents a 109% premium to Evotec's share price on October 15, 2024, and a 77% premium to its three-month volume weighted average price.
The proposed combination aims to create a global innovative services company, integrating Evotec's drug discovery platform and Just – Evotec Biologics manufacturing capabilities with Halozyme's ENHANZE® technology. The merger would diversify and extend Halozyme's revenue and EBITDA growth well into the next decade, with no financing contingency required for the transaction.
Halozyme (HALO) reported strong Q3 2024 financial results with total revenue increasing 34% YOY to $290.1 million, driven by 36% growth in royalty revenue to $155.1 million. Net income rose 67% to $137 million, while adjusted EBITDA grew 60% to $184 million. The company raised its 2024 guidance, now expecting total revenue of $970-$1,020 million (17-23% YOY growth) and adjusted EBITDA of $595-$625 million (40-47% YOY growth). Key highlights include FDA approvals for Roche's TECENTRIQ HYBREZA and OCREVUS ZUNOVO with ENHANZE technology, plus expanded partnerships with argenx and ViiV Healthcare.
Halozyme Therapeutics (NASDAQ: HALO) announced that the European Patent Office (EPO) revoked one of Janssen's co-formulation patents for DARZALEX® SC. The company affirms this decision will not impact its 2024 royalty revenue guidance of $520-555 million or its projection to exceed $1 billion in royalty revenues by 2027. The company maintains that U.S. and European royalty revenues from DARZALEX FASPRO® and SC will remain unaffected through 2032. The decision does not affect Halozyme's composition of matter patents for ENHANZE® or other licensees' ability to obtain co-formulation patents.
Halozyme Therapeutics (NASDAQ: HALO) has announced it will release its third quarter 2024 financial and operating results on Thursday, October 31, 2024, 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 company's investor relations website.