- Revenue of $56.9 Million Compared to $30.9 Million in Prior-year Period -
- ENHANZE® Partner Receives FDA Approval for Subcutaneous Formulation of Herceptin® -
- Positive Phase 3 Trial Results Announced for Subcutaneous Formulation of DARZALEX® -
- On Track for Pivotal Phase 3 Trial Results from HALO-301 in second half 2019 -
SAN DIEGO, May 7, 2019 - Halozyme Therapeutics, Inc. (NASDAQ: HALO), a biotechnology company developing novel oncology and drug-delivery therapies, today reported financial results for the first quarter ended March 31, 2019 and provided an update on recent corporate activities.
“We enjoyed a strong start to 2019 as our first quarter included a new ENHANZE® collaboration with argenx, positive phase III data from Janssen’s COLUMBA study evaluating a subcutaneous formulation of DARZALEX®, and FDA approval of Herceptin Hylecta™,” said Dr. Helen Torley, president and chief executive officer. “Looking ahead in 2019, we expect this momentum to continue. On ENHANZE® we anticipate regulatory submissions by ENHANZE® partner Janssen for the subcutaneous formulation of DARZALEX®, a new phase 3 trial initiation by one of our ENHANZE® partners and multiple Phase 1 trial initiations. On PEGPH20, we project the announcement of topline results from our HALO-301 pivotal phase 3 trial in pancreas cancer in the second half of the year.”
First Quarter 2019 and Recent Highlights Include:
In February 2019, we announced that Genentech, a member of the Roche Group, received approval from the FDA for Herceptin Hylecta™, a co-formulation of trastuzumab and rHuPH20. Herceptin Hylecta™ is approved for the treatment of certain people with HER2-positive early breast cancer. Herceptin Hylecta™ is a ready-to-use formulation that can be administered in two to five minutes, compared to 30 to 90 minutes for intravenous trastuzumab. In April 2019, Roche made Herceptin Hylecta™ available in the U.S.
The following information was filed by Halozyme Therapeutics Inc (HALO) on Tuesday, May 7, 2019 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.
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Form Type: 10-Q Quarterly Report Accession Number: 0001159036-19-000027 Submitted to the SEC: Tue May 07 2019 12:08:53 PM EST Accepted by the SEC: Tue May 07 2019 Period: Sunday, March 31, 2019 Industry: Biological Products No Disgnostic Substances