HALO Announces Janssen Submits Extension Application To European Medicines Agency For Subcutaneous Formulation Of DARZALE...

Friday 19 July 2019


SAN DIEGO, July 19, 2019 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO), a biotechnology company developing novel oncology and drug-delivery therapies, today announced that Janssen-Cilag International NV (Janssen) has submitted an extension application to the European Medicines Agency (EMA) for the subcutaneous delivery of DARZALEX® (daratumumab) for patients with multiple myeloma.

"We are pleased that Janssen's filing follows quickly after its filing last week of a Biologics License Application (BLA) with the U.S. Food and Drug Administration," said Dr. Helen Torley, President and CEO. "We are particularly excited that, pending approval by the EMA, a greater number of patients with multiple myeloma may soon have a new therapeutic option that offers the potential of DARZALEX® with a shorter administration time."

Janssen's submission follows the announcement of positive results from its Phase 3 COLUMBA study, which investigated subcutaneously administered DARZALEX® in comparison to intravenous DARZALEX® in patients with relapsed and refractory multiple myeloma. Subcutaneous DARZALEX®, using ENHANZE® drug delivery technology, was found to be non-inferior to intravenous DARZALEX® with regard to the co-primary endpoints of overall response rate and Maximum Ctrough concentration on day 1 of the third treatment cycle prior to dose.

HALO Announces First Clinical Dosing In argenx's Phase 1 Trial Of Efgartigimod (ARGX-113) With ENHANZE®

Wednesday 17 July 2019

SAN DIEGO, July 17, 2019 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO), a biotechnology company developing novel oncology and drug-delivery therapies, today announced that argenx has dosed the first subject in a phase 1 clinical trial evaluating the safety, pharmacokinetics and pharmacodynamics of efgartigimod (ARGX-113), using Halozyme's proprietary ENHANZE® drug delivery technology.

"Since the signing of our collaboration with argenx earlier this year, we have made strong progress and I am delighted that the first phase 1 trial has been initiated in such a short amount of time," said Dr. Helen Torley, President and CEO of Halozyme. "We look forward to expanding our work with argenx to bring the potential benefits of subcutaneous administration to more patients suffering from severe autoimmune diseases through our ENHANZE® technology."

Initiation of this study triggers a $5 million milestone payment to Halozyme during the current quarter under the global collaboration and license agreement between the two companies.

Agreed. The pegph20 cancer leg is a freebie if it works and won't cause long term grief if it doesn't.

Given the seriousness of the indication one could hope it would get a fast track review. Good news in any event.
-Fritz

If one has been been holding for years through multiple reverse splits one is far from flat. One is in in the House of Pain.

Halozyme analyst at Cantor Fitzgerald Halozyme price target raised to $27 from $24 at Cantor Fitzgerald. Cantor Fitzgerald analyst Charles Duncan raised his price target for Halozyme Therapeutics to $27 from $24 after including potential future royalty revenues from Enhanze-enhanced drugs developed by partner companies. The analyst continues to view the approval and launch of the Enhanze-based products as "fueling sustainable revenue growth" through 2027, with the Darzalex program as the near-term driver. He sees "notable potential" share upside "almost irrespective" of the outcome of the HALO-301 Phase trial in pancreatic cancer later in 2019. Duncan reiterates an Overweight rating on Halozyme.

Read more at:
https://thefly.com/landingPageNews.php?id=2928258

Bruse is too busy printing and selling shares. That's his actual business model. The rest is just props in his theater of lies.

Clearly heading for sub-penny, and not for the first time.

It already is the #1 scam in the USA.

Should be on the Breakdown Board

Down she goes as predicted. Must be those nasty convertibles. Third reverse split on deck!
-Fritz

Agreed lots of good stuff on the horizon but, in retrospect, I think the volume yesterday was prompted by end of Q rebalancing.
Price is going back in the right direction, though.
Stay tuned!
-Fritz

Must have been rebalancing at end of Q. Same huge volume spike occurred with HALO today.
-Fritz

Huge volume spike today.
Good luck,
-Fritz

The article reeks of so many inaccuracies it seems designed to rescue some short sellers.
-Fritz

Halozyme Announces CRADA With National Institute of Allergy and Infectious Diseases For Use Of ENHANZE®

Tuesday 25 June 2019


SAN DIEGO, June 25, 2019 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced a Cooperative Research and Development Agreement (CRADA) with the National Institute of Allergy and Infectious Diseases' Vaccine Research Center (VRC), part of the National Institutes of Health, enabling the VRC's use of Halozyme's ENHANZE® drug delivery technology to develop subcutaneous formulations of broadly neutralizing antibodies (bnAbs) against HIV for HIV treatment.

The two bnAbs selected for the CRADA are VRC07-523LS and N6LS. The VRC will engage in early phase studies in healthy adults investigating the safety, tolerability, dose, and pharmacokinetics of formulating these bnAbs with ENHANZE® for the purpose of optimizing subcutaneous administration of these antibodies.

"We are excited to collaborate with NIAID as they seek to develop new therapies that potentially address a large unmet need in the field of HIV treatment and prevention," said Dr. Helen Torley, President and CEO of Halozyme. "This CRADA is an example of the value ENHANZE® can potentially bring to the treatment of infectious diseases, particularly in the early stages of development."

More like Potemkin Village. LMAO.

Bruce does work hard -he is the most prolific poster on this board.

Actually they's reverse split TWICE before.

In short, yes. The EPA and other regulatory authorities overtly acknowledge that by limiting the number of "acceptable" adverse effects/consequences in humans to a number that is far greater than zero.
-Fritz

Target number of overall survival events reached.

On June 12, 2019, Halozyme Therapeutics, Inc., a Delaware corporation (“Halozyme”), announced that it had reached the target number of 330 overall survival events in its HALO-301clinical trial and that it plans to conduct the final overall survival analysis upon data maturity which will occur when all patients enrolled in the study have been followed for at least 8.5 months. Accordingly, Halozyme projects to achieve data maturity in mid-September 2019. Based on this timing of data maturity, Halozyme expects to announce top line results for the HALO-301clinical trial by December 2019.

The method of causing death to a plant via introduction of chemical toxicity to the plant's environment cannot be limited to a single species. The regulators admit that and only seek to limit damage to the percentage of the human population which they deem acceptable.
-Fritz

The 'new alternative' will likely prove to be equally toxic.
-Fritz

FDA grants priority review to Roche’s Mabthera/Rituxan (rituximab) in children with two rare blood vessel disorders

There are currently no US Food and Drug Administration (FDA) approved treatments for children living with granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA)
The PePRS study is the first global trial of MabThera/Rituxan in paediatric patients with GPA or MPA
MabThera/Rituxan in combination with glucocorticoids is the only FDA-approved therapy for adults with these two rare forms of vasculitis
If approved, this would be the first paediatric indication for MabThera/Rituxan


Basel, 12 June 2019 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the US Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) and granted Priority Review for the use of MabThera®/Rituxan® (rituximab), in combination with glucocorticoids (GCC), for the treatment of granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) in children two years of age and older. GPA and MPA are rare, potentially life-threatening diseases affecting small and medium sized blood vessels.[1]

“We are committed to delivering new treatment options for rare diseases, such as paediatric GPA and MPA, for which there are currently no approved medicines,” said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. “We will continue to work closely with the FDA to bring MabThera/Rituxan to children with these two serious and potentially life-threatening diseases.”

Priority Review Designation is granted to medicines that, if approved, the FDA has determined to have the potential to provide significant improvements in the safety or effectiveness of the treatment of a serious disease.

The sBLA was submitted based on data from the PePRS study, a phase IIa, global, open-label, single-arm study investigating the safety, pharmacodynamics/pharmacokinetics and exploratory efficacy of intravenous MabThera/Rituxan in 25 patients with severe GPA or MPA between six and 17 years of age.[2] Treatment with four weekly infusions of MabThera/Rituxan in combination with a tapering course of oral glucocorticoids was assessed in newly diagnosed or relapsing active GPA or MPA paediatric patients.

MabThera/Rituxan is currently indicated for the treatment of four autoimmune indications. The FDA approved MabThera/Rituxan for rheumatoid arthritis (RA) in 2006, for the treatment of adults with GPA and MPA in 2011, and for adults with pemphigus vulgaris in 2018. Since 2006, more than 900,000 patients have been treated with MabThera/Rituxan for autoimmune conditions worldwide. If approved, this would be the first paediatric indication for MabThera/Rituxan.

About Granulomatosis with Polyangiitis and Microscopic Polyangiitis
Granulomatosis with polyangiitis (GPA) (formerly known as Wegener's Granulomatosis) and microscopic polyangiitis (MPA) are two types of ANCA-associated vasculitis (AAV).[3] AAV is a form of vasculitis, or blood vessel inflammation, that primarily affects small blood vessels.[3] In general, GPA and MPA both affect the small blood vessels of the kidneys, lungs, sinuses, and a variety of other organs, but the diseases may affect each person differently.[1,4] Both GPA and MPA are considered rare diseases, with an estimated prevalence globally of 23 to 160 cases per million in the population.[5] Cases of paediatric onset GPA and MPA are even more rare and are associated with severe, potentially life-threatening symptoms.[6]

About MabThera/Rituxan
MabThera (Rituxan in the US) in combination with methotrexate is indicated for the treatment of adults with severe active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to other disease-modifying anti-rheumatic drugs (DMARD) including one or more tumour necrosis factor (TNF) inhibitor therapies. MabThera/Rituxan, in combination with glucocorticoids, is indicated for the treatment of adults with severe, active granulomatosis with polyangiitis (Wegener’s, GPA) and microscopic polyangiitis (MPA). People with serious infections should not receive MabThera/Rituxan. It is not known if MabThera/Rituxan is safe or effective in children.

About Roche in rheumatology and beyond
For more than 50 years, Roche has followed the science to pioneer medicines for immune-mediated rheumatic diseases. First-in-class anti-IL-6 receptor therapy Actemra®/RoActemra® (tocilizumab) has treated more than one million people with debilitating conditions, such as rheumatoid arthritis (RA), polyarticular and systemic juvenile idiopathic arthritis, giant cell arteritis and chimeric antigen receptor T-cell-induced cytokine release syndrome. Rituxan®/MabThera® (rituximab), which targets CD20, has significant clinical and real-world experience treating rheumatic conditions including RA, granulomatosis with polyangiitis and microscopic polyangiitis. Roche aims to provide solutions for people that need new treatments most, particularly those with severe or life-threatening conditions and limited treatment options. Our pipeline consists of treatments designed to target immune pathways including a glycoengineered type II anti-CD20 antibody in lupus nephritis.

Relentless dilution will have it's effect.

If it were not for liability concerns, companies would ruin many lives.
-Fritz

Excellent, thanks!

I think your analysis is solid.
Good luck,
-Fritz

Interesting that HALO is not a presence at ASCO this year AFAIK.
-Fritz

Goldman has been involved for years and hasn't had any influence on the standard methodology employed by the Capn'.

That is a very long way off, at least for the average investor.
-Fritz

Question: HALO stated yesterday that the targeted number of events in the 301 PEGpH20 study will occur by end of summer. In that event might one expect an announcement that might move the pps at that time or does such a thing pass by unremarked until the statistical study is completed (in this case Q4/19).
Thanks,
-Fritz

It sounds like they know that PEGpH20 is going to succeed.

From the transcript:

Edited Transcript of the Conference Call

https://finance.yahoo.com/news/edited-transcript-halo-earnings-conference-040107005.html?soc_src=hl-viewer&soc_trk=ma

As have I, FWIW.
-Fritz

Dew, do you think the eventual buyer of the Nsetle skin unit will then turn it's attention to Revance?
Thanks,
-Fritz

Dr. Armour is a serious pickup. I am impressed. Bodes well.
Good luck!
-Fritz

Halozyme Names Dr. Alison A. Armour As Senior Vice President Of Research And Development

Halozyme Therapeutics, Inc. (NASDAQ:HALO
Monday 6 May 2019


SAN DIEGO, May 6, 2019 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO), a biotechnology company developing novel oncology and drug-delivery therapies, today announced the appointment of biotechnology and pharmaceutical industry expert Alison A. Armour, M.B. Ch.B., B.Sc., M.Sc., M.D., FRCR, FRCP, as senior vice president, research and development, effective immediately. In this role, she will report to Dr. Helen Torley, president and chief executive officer.

Dr. Armour will lead Halozyme's research, clinical development, regulatory, safety and pharmacovigilance efforts. Alison's immediate focus will be the PEGPH20 regulatory submissions for pancreas cancer in the event of positive data. She will also play a key role in shaping the PEGPH20 new indication development strategy and expanding our oncology portfolio.

"I am delighted to welcome Alison to Halozyme," said Dr. Torley. "She brings a wealth of experience in all stages of oncology drug development, as well as over 15 years of practice as a clinical oncologist. Her experience and strong record of overseeing successful regulatory submissions makes Alison a valuable addition to our leadership team."

Dr. Armour joins Halozyme from Endocyte, where she served as Chief Medical Officer and was responsible for the company's clinical division, including all medical, clinical operations, regulatory, data management and pharmacovigilance activities. In this position, she worked on all aspects of the company's portfolio, including folate and PSMA and CAR-T therapies. She played a key role in Endocyte's successful in-licensing deal of PSMA617 in 2017 and the subsequent development process that resulted in Endocyte's sale to Novartis for $2.1 billion in December 2018.

Prior to joining Endocyte, Dr. Armour served as Vice President of Development and team lead for TYKERB® at GSK and then at Novartis. Earlier in her career, Dr. Armour also served as global medical science director at AstraZeneca, where she led early, late stage, and post-commercial medical development for IRESSA®, obtaining the first EGFRm+ approval in non-small cell lung cancer (NSCLS) for the drug.

"I am excited to join Halozyme and contribute to its efforts to bring innovative new therapies to the market that can improve patients' lives utilizing my experience in drug development and oncology," said Dr. Armour.

Dr. Armour is known in the industry for her research and her leadership in the areas of medical and radiation oncology—she has co-authored two textbooks and more than 60 publications. Dr. Armour earned her B.Sc. in Biochemistry, her M.B., Ch.B., M.Sc., and Doctorate of Medicine from the University of Glasgow; her FRCR at the Royal College of Radiologists London, UK and her FRCP at the Royal College of Physicians in London, UK, for contributions to the field of oncology.

About Halozyme

Halozyme Therapeutics Inc, Inst Holders, 1Q 2019 (HALO)
3:57 am ET April 20, 2019 (Dow Jones) Print

The following table shows the largest shareholders in HALOZYME THERAPEUTICS INC COM (HALO) for the quarter ended March 31, 2019, listed by holding size. The list represents up to 50 of the largest holders in the company.

Note: Unless otherwise mentioned the reporting date is 03/31/2019

Institution... Shares Held... %Held... Last Report

The Vanguard Group Inc. 13,207,753 154,094 9.090 12/31

BlackRock Fund Advisors 9,603,144 (96,106) 6.609 12/31

Iridian Asset Management LLC 9,027,164 (201,235) 6.213 12/31

Bellevue Asset Management AG 8,322,860 75,000 5.728 12/31

SSgA Funds Management Inc. 4,107,501 (235,667) 2.827 12/31

Invesco Advisers Inc. 3,744,719 51,368 2.577 12/31

Pictet Asset Management SA 3,715,808 347,674 2.557 12/31

Thrivent Investment Management 3,562,505 426,775 2.452 12/31

Snyder Capital Management LP 2,833,759 446,409 1.950 12/31

Fidelity Management & Research 2,556,359 176,900 1.759 12/31

First Eagle Investment Managem 2,130,775 (42,314) 1.466 12/31

JPMorgan Investment Management 2,040,243 411,833 1.404 12/31

Artisan Partners LP 2,039,215 (122,657) 1.403 12/31

JPMorgan Asset Management (UK) 1,881,386 132,920 1.295 12/31

Northern Trust Investments In 1,768,452 (53,074) 1.217 12/31

Merian Global Investors (UK) L 1,562,994 369,267 1.076 12/31

Geode Capital Management LLC 1,520,657 76,753 1.047 12/31

Goldman Sachs Asset Management 1,347,389 40,066 0.927 12/31

Dimensional Fund Advisors LP 1,097,080 294,909 0.755 12/31

New York State Common Retireme 1,048,054 29,284 0.721 12/31

Numeric Investors LLC 1,037,698 156,000 0.714 12/31

PanAgora Asset Management Inc 1,000,059 12,192 0.688 12/31

OppenheimerFunds Inc. 1,000,000 0 0.688 12/31

Granite Investment Partners LL 988,939 223,836 0.681 12/31

First Light Asset Management L 938,399 52,876 0.646 12/31

BlackRock Advisors LLC 902,306 23,648 0.621 12/31

Fisher Asset Management LLC 865,919 418,581 0.596 12/31

Elk Creek Partners LLC 740,816 139,123 0.510 12/31

Teachers Advisors LLC 735,938 413,847 0.506 12/31

Charles Schwab Investment Mana 695,083 (245,209) 0.478 03/31

Federated MDTA LLC 622,212 454,491 0.428 12/31

Goldman Sachs & Co. LLC (Priva 558,419 203,366 0.384 12/31

TIAA-CREF Investment Managemen 529,018 (9,662) 0.364 12/31

Macquarie Investment Managemen 500,000 0 0.344 12/31

Invesco Capital Management LLC 469,395 (16,707) 0.323 12/31

Two Sigma Advisers LP 455,020 (281,100) 0.313 12/31

BlackRock Investment Managemen 454,781 10,728 0.313 12/31

BlackRock Investment Managemen 439,958 (40,536) 0.303 12/31

AXA Investment Managers UK Ltd 428,217 0 0.295 12/31

American Century Investment Ma 416,996 217,379 0.287 12/31

D. E. Shaw & Co. LP 402,884 32,721 0.277 12/31

SV Health Managers LLP 398,633 (30,000) 0.274 12/31

SEI Investments Management Cor 376,339 0 0.259 12/31

ALPS Advisors Inc. 361,008 77,631 0.248 12/31

The Bank of New York Mellon Co 353,758 (49,635) 0.243 12/31

Jacobs Levy Equity Management 327,478 (23,500) 0.225 12/31

AllianceBernstein LP 315,610 26,786 0.217 12/31

Renaissance Technologies LLC 304,600 (286,000) 0.210 12/31

Baker Bros. Advisors LP 299,969 (150,000) 0.206 12/31

DWS Investment GmbH 283,916 (861,515) 0.195 12/31

13F data provided by: Factset Research Systems Inc.;

Please send questions to ownership@factset.com.

Copyright, Factset Research Systems, 2019. All Rights Reserved.

(END) Dow Jones Newswires

April 20, 2019 03:57 ET (07:57 GMT)