Complaint filed in New Jersey alleges Merck uses Halozyme's patented MDASE technology to develop SC Keytruda

Halozyme is seeking damages and injunctive relief to stop the infringement

SAN DIEGO, April 24, 2025 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) (Halozyme), a biotechnology company that pioneered the use of human hyaluronidase for subcutaneous drug delivery, today filed a patent infringement lawsuit against Merck Sharp & Dohme Corp. (Merck) in U.S. District Court in New Jersey.

SAN DIEGO, April 10, 2025 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) (Halozyme) today announced that argenx has received U.S. Food and Drug Administration (FDA) approval of VYVGART® Hytrulo prefilled syringe for self-injection (efgartigimod alfa and hyaluronidase-qvfc) for the treatment of adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive and adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP).

Subcutaneous DARZALEX® is co-formulated with Halozyme's ENHANZE® drug delivery technology

SAN DIEGO, April 9, 2025 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) (Halozyme) today announced that Janssen-Cilag International NV, a Johnson & Johnson company, received European Commission (EC) approval for an indication extension of DARZALEX® (daratumumab) subcutaneous (SC) co-formulated with ENHANZE® in the frontline setting. The approval is for daratumumab SC in combination with bortezomib, lenalidomide, and dexamethasone (daratumumab-VRd) for the treatment of adult patients with newly diagnosed multiple myeloma.1

SAN DIEGO, April 7, 2025 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) (Halozyme) today announced that Janssen-Cilag International NV, a Johnson & Johnson company, has received European Commission (EC) marketing authorization of the subcutaneous (SC) formulation of RYBREVANT® (amivantamab), 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, it 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.

A decision on the European marketing authorization extension for the subcutaneous formulation of Opdivo is expected by June 2, 2025

SAN DIEGO, March 31, 2025 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) (Halozyme) today announced that Bristol Myers Squibb received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency, recommending approval of a new Opdivo® (nivolumab) subcutaneous formulation developed with ENHANZE®, Halozyme's proprietary recombinant human hyaluronidase enzyme (rHuPH20), across multiple previously approved adult solid tumors as monotherapy, monotherapy maintenance following completion of nivolumab plus Yervoy® (ipilimumab) combination therapy, or in combination with chemotherapy or cabozantinib.

SAN DIEGO, Feb. 26, 2025 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme") today announced that Dr. Helen Torley, president and chief executive officer, will present and host investor meetings at the TD Cowen 45th Annual Healthcare Conference.

The presentation is scheduled for Wednesday, March 5 at 8:50am PT / 11:50am ET.

A live audio webcast will be available on the Investor Relations section of the Company's website. Replays of the audio webcasts will be available for 90 days following the conference.

Fourth Quarter Total Revenue Increased 30% YOY to $298 million and Royalty Revenue Increased 40% YOY to $170 million

Fourth Quarter Net Income Increased 60% YOY to $137 million; Adjusted EBITDA Increased 61% YOY to $196 million; GAAP EPS Increased 63% YOY to $1.06; non-GAAP EPS Increased 54% YOY to $1.261

Record Full Year 2024 Total Revenue Increased 22% YOY to $1,015 million and Record Royalty Revenue Exceeded Guidance Increasing 27% YOY to $571 million

Full Year 2024 Net Income Increased 58% YOY to $444 million; GAAP EPS Increased 63% YOY to $3.43; Adjusted EBITDA Increased 48% YOY to $632 million and non-GAAP EPS Increased 53% YOY to $4.231, Both Exceeding Guidance 

SAN DIEGO, Feb. 4, 2025 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme") today announced it will release its fourth quarter and full year 2024 financial and operating results on Tuesday, February 18, 2025, following the close of trading.

Halozyme will host a conference call on Tuesday, February 18, 2025 at 1:30 p.m. PT/4:30 p.m. ET to discuss the results. The conference call may be accessed live with pre-registration via this link: https://registrations.events/direct/Q4I7813760.

SAN DIEGO, Feb. 3, 2025 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) (Halozyme) today announced that Janssen-Cilag International NV, a Johnson & Johnson company, received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency recommending an extension of marketing authorisation for a subcutaneous (SC) formulation of RYBREVANT® (amivantamab) 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, and as a monotherapy for the treatment of adult patients with advanced NSCLC with activating EGFR exon 20 insertion mutations after failure of platinum-based therapy.

Reports Preliminary 2024 Unaudited Estimated Ranges Consistent with Previous Financial Guidance 

Raises 2025 Financial Guidance Ranges for Total Revenue to $1,150 - $1,225 million, Representing YoY Growth of 16% - 23%, Adjusted EBITDA of $755 - $805 million, Representing YoY Growth of 24% - 32%, and non-GAAP Diluted EPS of $4.95 - $5.35, Representing YoY Growth of 21% - 30%1,2

Announces New $250 million Accelerated Share Repurchase

Conference Call Scheduled Today at 5:30am PT/8:30am ET

SAN DIEGO, Jan. 8, 2025 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme" or the "Company") today provided a financial update, reiterating full year 2024 financial guidance and raising full year 2025 and multi-year financial guidance. The Company also announced it has recently entered into a new $250 million accelerated share repurchase (ASR) program under its previously announced $750 million share repurchase program.