Halozyme Therapeutics Halozyme Therapeutics (HALO) 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 authorization for a subcutaneous (SC) formulation of RYBREVANT® (amivantamab) in combination with LAZCLUZE® (lazertinib) for . . . This content is for paid subscribers. Please click here …

Halozyme Therapeutics Today, January 8, 2025 /PRNewswire/ - Halozyme Therapeutics, Inc. (HALO) provided a financial update, reiterating full year 2024 financial guidance and raising full year 2025 and multi-year financial guidance. The Company has also announced that. it has recently entered into . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Halozyme Therapeutics in the NEWS Halozyme Therapeutics, Inc. (HALO) announced that Roche received U.S. Food and Drug Administration (FDA) approval for Tecentriq Hybreza™ (atezolizumab and hyaluronidase-tqjs) with Halozyme's ENHANZE® drug delivery technology. Tecentriq Hybreza™ can be injected subcutaneously in approximately 7 minutes compared to 30-60 minutes for standard intravenous (IV) infusion of . . . This content is for paid subscribers. Please click here to subscribe …

Halozyme Therapeutics in the NEWS Halozyme Therapeutics (HALO) announced today that the Medicines and Healthcare Products Regulatory Agency (MHRA) in Great Britain has approved Roche's (

The way drugs are being delivered into patients’ bodies have become more than ever considered important with regard to the safety and efficacy of the treatments. We consider Halozyme Biopharmaceutical is a leader in bringing disruptive solutions to significantly improve patient experiences and outcomes for emerging and established therapies. As the innovators of the ENHANZE® technology with the proprietary enzyme rHuPH20, Halozyme's commercially-validated solution is used …

Our Most Pressing Need Our current, most pressing need is news that makes sense. Stock Market investors are waiting for comprehensive news regarding inflation in the U.S., the rest of the world's economy and the price of crude oil. Indeed, we are all waiting to hear confirmed news promising the end of Russia's invasion into Ukraine. All the news we have been hearing up til …

Halozyme Therapeutics Announced US FDA Approval for Janssen Biotech's DARZALEX FASPRO® Halozyme Therapeutics (HALO) announced that Janssen Biotech, Inc. (Janssen) received U.S. FDA approval of DARZALEX FASPRO® (daratumumab + hyaluronidase-fihj) in combination with pomalidomide and dexamethasone (Pd) for adult patients with multiple myeloma who have received at least one prior line of therapy, including . . . This content is for paid subscribers. Please click here to …

Halozyme Therapeutics Approvals for DARZALEX®SC Halozyme Therapeutics (HALO) announced that the European Commission (EC) has granted Janssen Pharmaceutical Companies of Johnson & Johnson two marketing authorizations for the subcutaneous formulation of daratumumab, known as DARZALEX® SC in the European Union.  The first authorization relates to the use of DARZALEX® SC in combination with bortezomib . . . This content is for paid subscribers. Please click here to …

Halozyme and PTC Therapeutics: Near-Term Game-Changing PDUFAS Some of the Prohost Portfolio selected companies are having near term PDUFAS which we believe will have a positive outcome. Indeed the FDA approvals are expected to tremendously boost these firms' values. Today we present two selected Biotech firms from the Prohost Portfolio.   Halozyme Halozyme (HALO) has two upcoming important

Halozyme Therapeutics is Focusing on ENHANZE® Technology Halozyme Therapeutics (HALO) decides to focus on its ENHANZE® drug delivery technology, halt the development activities for PEGPH20 and close its oncology operations. These decisions were made after the failure of HALO-301 Phase 3 clinical study evaluating PEGPH20 as a first-line therapy for patients with metastatic pancreas cancer to reach the primary endpoint of overall survival. The PEGPH20 failure …

Halozyme and argenx Collaboration argenx (ARGX) dosed the first subject in phase 1 clinical trial for the safety, pharmacokinetics, and pharmacodynamics of its product efgartigimod plus Halozyme’s (HALO) drug delivery technology ENHANZE®. The drug aims at treating severe autoimmune diseases including myasthenia gravis (MG), immune thrombocytopenia (ITP)and skin blistering diseases.    We find it good news that this first clinical trial has been initiated in a …

Halozyme Therapeutics (HALO) and argenx (ARGX) announced a global collaboration and license agreement offering argenx the right to use Halozyme's ENHANZE® drug delivery technology to develop multiple subcutaneous product formulations for current or future argenx product candidates. The agreement provides argenx exclusive access to ENHANZE® for any product targeting the human neonatal Fc receptor, FcRn, including argenx's lead asset efgartigimod (ARGX-113) and up to two additional targets, potentially shortening …

The Week in Review #13 From the Prohost Portfolio - 1. Betting on the technology - HALOZYME - As expected, the pulse of fat agreements with HALO is accelerating . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Halozyme Therapeutics (HALO) announced that it will present nonclinical data at the 32nd Annual Meeting of the Society for Immunotherapy of Cancer (SITC) which demonstrate the potential for PEGPH20, Halozyme's pegylated recombinant human hyaluronidase, to increase the infiltration of immune cells into the tumor microenvironment and enhance the efficacy of immuno-oncology drugs in an HA-accumulating murine colon tumor model. The study shows that degradation of hyaluronan (HA) …

The Week in Review #4 AMAZING STOCK REBOUNDING - We have already witnessed and wrote about the fierce rebounding of some of our selected stocks comprising: Exelixis (EXEL), Sangamo (SGMO), Array (ARRY), ImmunoGen (IMGN) and others . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Following the announcement of two new licensing agreements for its ENHANZE® drug-delivery technology, Halozyme Therapeutics (HALO) raised financial guidance for 2017 as follows: - Net revenue of $245 million to $260 million, an increase of $130 million from the prior range of $115 million to $130 million, reflecting the portion of upfront payments from the new agreements expected to be recorded as revenue in 2017; - Operating expenses of $240 million …

On June 22, 2017, the U.S. Food and Drug Administration (FDA) has approved Genentech’s Rituxan Hycela™. This product is a combination of Genentech’s drug rituximab and Halozyme's hyaluronidase enzyme through Halozymes’s proprietary human ENHANZE® technology. The aim of the combination is changing Rituxan from an intravenously administered product into a subcutaneous (under the skin) injection. The new version Rituxan Hycela is expected to reduce the …

Prohost Letter #411 SOME STOCK RALLYING NEWS - Under normal conditions, some good news should rally the stocks of the firms that the news belong to them. During the past six months, Amgen (AMGN) announced a series of good news that seem to have fallen on deaf ears. Yesterday Amgen announced some positive results from three approved and one experimental products – all the news …

Prohost Letter #410 JUNE PDUFA DAYS This month, the FDA will decide on the approvals of drugs belonging to companies that Prohost has picked for investment. Usually, granting approvals rallies the stocks of the drugs’ developing firms. Sending Complete Response Letters for demands that might delay approvals would cut a substantial percentage of the stocks’ values, while rejections would cause the stocks to falter. Let’s …

Extremely important, not just exciting, were the results of Halozyme Therapeutics’s (HALO) Phase 2 randomized, multi-center clinical trial of its PEGPH20 in combination with ABRAXANE® (nab-paclitaxel) and gemcitabine in stage IV pancreas cancer. The results demonstrated a statistically significant increase in progression-free survival (PFS) in patients with high levels of hyaluronan (HA-High) treated with PEGPH20 plus ABRAXANE and gemcitabine when compared to HA-High patients receiving …