San Diego, CA, United States

Halozyme Therapeutics

www.halozyme.com
San Diego, CA, United States

Halozyme Therapeutics, based in San Diego, California, is a biopharmaceutical company developing and commercializing products targeting the extracellular matrix for the endocrinology, oncology, dermatology and drug delivery markets. http://www.halozyme.com Wikipedia.


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News Article | May 9, 2017
Site: www.prnewswire.com

"At the same time, the outlook for our ENHANZE® technology has never been stronger following the unanimous FDA advisory committee in March supporting rituximab SC. Our pipeline of active partner discussions has continued to expand, and while the timing for new ENHANZE® collaboration agreements is unpredictable, it remains our goal to sign another agreement in 2017." For 2017, the company reiterated its financial guidance of: Halozyme will webcast its Quarterly Update Conference Call for the first quarter of 2017 today, Tuesday, May 9 at 4:30 p.m. ET/1:30 p.m. PT. Dr. Helen Torley, president and chief executive officer, will lead the call. The call will be webcast live through the "Investors" section of Halozyme's corporate website and a recording will be made available following the close of the call. To access the webcast and additional documents related to the call, please visit http://www.halozyme.com approximately fifteen minutes prior to the call to register, download and install any necessary audio software. The call may also be accessed at (877) 410-5657 (domestic callers) (334) 323-7224 (international callers) using passcode 769890. A telephone replay will be available after the call by dialing (877) 919-4059 (domestic callers) or (334) 323-0140 (international callers) using replay ID number 22142823. Halozyme Therapeutics is a biotechnology company focused on developing and commercializing novel oncology therapies that target the tumor microenvironment. Halozyme's lead proprietary program, investigational drug PEGPH20, applies a unique approach to targeting solid tumors, allowing increased access of co-administered cancer drug therapies to the tumor in animal models. PEGPH20 is currently in development for metastatic pancreatic cancer, non-small cell lung cancer, gastric cancer, metastatic breast cancer and has potential across additional cancers in combination with different types of cancer therapies. In addition to its proprietary product portfolio, Halozyme has established value-driving partnerships with leading pharmaceutical companies including Roche, Baxalta, Pfizer, Janssen, AbbVie and Lilly for its ENHANZE® drug delivery technology. Halozyme is headquartered in San Diego. For more information visit . In addition to historical information, the statements set forth above include forward-looking statements (including, without limitation, statements concerning the Company's future expectations and plans for growth in 2017, the development and commercialization of product candidates, including clinical trial patient enrollment projections and future development activities of our collaboration partners, the potential benefits and attributes of such product candidates and expected financial outlook for 2017) that involve risk and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. The forward-looking statements are typically, but not always, identified through use of the words "believe," "enable," "may," "will," "could," "intends," "estimate," "anticipate," "plan," "predict," "probable," "potential," "possible," "should," "continue," and other words of similar meaning. Actual results could differ materially from the expectations contained in forward-looking statements as a result of several factors, including unexpected expenditures and costs, unexpected fluctuations or changes in revenues, including revenues from collaborators, unexpected results or delays in development of product candidates, including delays in clinical trial patient enrollment and development activities of our collaboration partners, and regulatory review, regulatory approval requirements, unexpected adverse events and competitive conditions. These and other factors that may result in differences are discussed in greater detail in the Company's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 9, 2017. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/halozyme-reports-first-quarter-2017-financial-results-300454540.html


News Article | May 8, 2017
Site: www.biosciencetechnology.com

Helen Torley, M.B, Ch.B., came across an interesting statistic last year. Out of the 44 publicly traded biotech companies in the thriving life science hub of San Diego, there was only one female CEO: her. The report, released in 2016 by UK-based executive recruitment firm Liftstream, found that only 2 percent of biotech companies in San Diego have a female CEO, while the national average is between 7 and 9 percent. Since taking the reins as CEO of Halozyme Therapeutics three years ago, Torley knew from first-hand experience that the gender balance was skewed, as she was often one of only a few women among 50 men at CEO networking events. However to find out that the numbers were quite so low was “certainly a surprise,” she told Bioscience Technology. That trend in biotech is not exclusive to the CEO role, though. A new study this year from Liftstream of 177 biotechs that went public from 2012 through 2015 found that women held only 10 percent of board positions. One positive note was that nearly 58 percent of the studied boards had a woman on them, which is up from 48 percent reported in Lifstream’s 2014 survey. The new report also found that gender diversity at the leadership level is associated with business advantages. Companies that had at least one female board member saw an average share price increase of 19 percent, while those with all-male board members showed a 9 percent decrease. So why are women being underrepresented in the top levels of biotech organizations? Torley, who has become more interested in and vocal about this topic since seeing recent statistics, broke this question down into three parts: When it comes to the first factor, Torley does not think it is a matter of under training. “If you look at the graduates of all the major business schools, 40 percent of Columbia, Harvard, MIT are women,” she said. “So certainly we’re getting business-trained women.” The same goes for the percentage of women graduating with STEM degrees, which is rising all the time, Torley, who first started out as a physician training in rheumatology, said. As for the pipeline of women, Torley referenced a 2016 McKinsey & Company study about the state of women in corporate America. “What we see is that women, in general, are less likely to be promoted, less likely to get developmental opportunities, and less likely to have meaningful interactions with senior management or have a sponsor for their career,” she said. The concept of sponsorship, which will be discussed later, is very important to Torley. Women drop off at every promotional level, according the McKinsey report, with the percentage getting lower and lower at each higher rung of the corporate ladder. For first time CEO’s, the majority come from what in biotech is called a line function position, where they’re in a role such as the head or VP of a business unit, Torley said. At senior levels, studies show that women often shift from line to staff roles, such as in human resources or finance. By the time they reach the SVP level, women hold only 20 percent of line roles, which hurts their chances of getting a CEO position, the McKinsey report found. “So women are not moving up the chain and being given the types of jobs you need to have to prepare you to be a CEO,” Torley said. While Torley said women are obviously making progress in getting to higher levels, she noted there is certainly data to suggest an unconscious bias can be at play during the selection process where companies don’t develop a diverse candidate pool or choose a male over a female. Also, from her own experience, though not while at Halozyme, she said she has seen unconscious bias at play and been in “plenty of discussions” where a promotion is on the table and people in the room discussing candidates would say things like ‘well she won’t be able to move she’s got young children’ or ‘I know her husband and he’s got a great job so they won’t move,’ or even worry that a female candidate could become pregnant. It’s very important that filters aren’t on, and companies should understand that in today’s world work life balance issues are just as important for males as females, she noted. The good news, Torley said, is that all of these issues can be addressed with attention and effort. “It’s a multifactorial situation, and there’s room for improvement at every step.” One important aspect of career development that many women lack is a sponsor.  Women tend to have mentors, which are great and can give advice and guidance, but as a general rule, Torley said, mentors are not in a position to specifically advance a woman’s career. In contrast, men tend to have a network that includes sponsorship—a person who is actively engaged in helping them find jobs and provide opportunities. It is only in retrospect that Torley realized how important sponsors were to her success and advancement, and that she was extremely fortunate to have numerous ones as her career progressed. For example, when she was up for a big promotion early in her career as a rheumatologist, she admits she may not have been the most scientifically qualified but the head consultant sponsored her to be the person he wanted in that role. Then, when she moved to Novartis to head up ongoing phase 3 studies, she wanted to switch from the medical side of the company to marketing and business. She tried for a year, but no one listened to her until a new head of marketing came in. When Torley asked to be moved, he decided to take a chance on her and the next day she found herself heading up a launch. Later, Torley had the same experience at Amgen, where she was working on the rheumatoid arthritis drug Enbrel. The head of sales and marketing came into her office and asked if she wanted to head up a business unit, and that opportunity helped her make the difficult transition to enter into a line leadership function that helped prepare her for her future as a CEO. Torley credits having these sponsors who were willing to take a chance on her. “I was probably at 80 percent of the qualifications, but they said ‘I think she’s got the potential, let me sponsor her in this role, support her and help her to be successful.” Unfortunately, women don’t have sponsors as often as men.


News Article | May 18, 2017
Site: www.prnewswire.com

Halozyme intends to use the net proceeds from this offering to fund continued development of its PEGPH20 oncology program and for other general corporate purposes. An automatic shelf registration statement on Form S-3 relating to the public offering of the shares of common stock described above was filed with the Securities and Exchange Commission (the "SEC") and is effective. A preliminary prospectus supplement relating to the offering has been filed with the SEC. Copies of the preliminary prospectus supplement and accompanying prospectus may be obtained, when available, from Wells Fargo Securities, LLC, Attention: Equity Syndicate Department, 375 Park Avenue, New York, New York, 10152, or by telephone at (800) 326-5897 or email to cmclientsupport@wellsfargo.com; or Deutsche Bank Securities Inc., Attention: Prospectus Group, 60 Wall Street, New York, NY 10005, or by telephone at (800) 503-4611 or email to prospectus.cpdg@db.com. This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction. About Halozyme Halozyme Therapeutics is a biotechnology company focused on developing and commercializing novel oncology therapies that target the tumor microenvironment. Safe Harbor Statement All of the statements in this press release that are not statements of historical facts constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Examples of such statements include future product development and regulatory events and goals, our business intentions and financial estimates and results as well as the statements regarding the completion, timing and size of the offering. These statements are based upon management's current plans and expectations and are subject to a number of risks and uncertainties which could cause actual results to differ materially from such statements. A discussion of the risks and uncertainties that can affect these statements is set forth in Halozyme's preliminary prospectus supplement and the accompanying prospectus filed with the SEC on May 18, 2017, together with the information incorporated by reference, under the heading "Risk Factors."  Halozyme disclaims any intention or obligation to revise or update any forward-looking statements, whether as a result of new information, future events, or otherwise. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/halozyme-therapeutics-announces-public-offering-of-common-stock-300460374.html


News Article | May 19, 2017
Site: www.prnewswire.com

Halozyme intends to use the net proceeds from this offering to fund continued development of its PEGPH20 oncology program and for other general corporate purposes. An automatic shelf registration statement on Form S-3 relating to the public offering of the shares of common stock described above was filed with the Securities and Exchange Commission (the "SEC") and is effective. A preliminary prospectus supplement relating to the offering has been filed with the SEC and a final prospectus supplement relating to the offering will be filed with the SEC. Copies of the final prospectus supplement and accompanying prospectus may be obtained, when available, from Wells Fargo Securities, LLC, Attention: Equity Syndicate Department, 375 Park Avenue, New York, New York 10152, or by telephone at (800) 326-5897 or email to cmclientsupport@wellsfargo.com; or Deutsche Bank Securities Inc., Attention: Prospectus Group, 60 Wall Street, New York, NY 10005, or by telephone at (800) 503-4611 or email to prospectus.cpdg@db.com. This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction. Halozyme Therapeutics is a biotechnology company focused on developing and commercializing novel oncology therapies that target the tumor microenvironment. Safe Harbor Statement All of the statements in this press release that are not statements of historical facts constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Examples of such statements include Halozyme's expectations regarding its fundraising efforts, including the closing of the public offering, the underwriters' exercise of their option to purchase additional shares and Halozyme's intended use of proceeds. These statements are based upon management's current plans and expectations and are subject to a number of risks and uncertainties which could cause actual results to differ materially from such statements. A discussion of the risks and uncertainties that can affect these statements is set forth in Halozyme's preliminary prospectus supplement and the accompanying prospectus filed with the SEC on May 18, 2017, together with the information incorporated by reference, under the heading "Risk Factors."  Halozyme disclaims any intention or obligation to revise or update any forward-looking statements, whether as a result of new information, future events, or otherwise. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/halozyme-therapeutics-prices-public-offering-of-common-stock-300460532.html


LONDON, UK / ACCESSWIRE / May 18, 2017 / Active Wall St. blog coverage looks at the headline from Omeros Corp. (NASDAQ: OMER) as the Company announced on May 17, 2017, the completion of the IgA nephropathy cohort and also reported additional positive results from the first stage of the Company's Phase 2 clinical trial of OMS721 for the treatment of serious kidney disorders. Register with us now for your free membership and blog access at: One of Omeros' competitors within the Biotechnology space, Halozyme Therapeutics, Inc. (NASDAQ: HALO), reported on May 09, 2017, its financial results and recent highlights for Q1 ended March 31, 2017. AWS will be initiating a research report on Halozyme Therapeutics in the coming days. Today, AWS is promoting its blog coverage on OMER; touching on HALO. Get all of our free blog coverage and more by clicking on the link below: OMS721 is Omeros' lead human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2), the effector enzyme of the complement system's lectin pathway. The additional Phase 2 results in IgA nephropathy patients demonstrated statistically significant improvement in urine protein levels (proteinuria), which is associated with slowing progression of kidney functional loss, and progressively better prognoses. The first stage in this Phase 2 trial includes four different types of complement-associated kidney diseases: IgA nephropathy, membranous nephropathy, lupus nephritis, and complement component 3 (C3) glomerulopathy. Patients of the IgA nephropathy cohort were treated open-label with OMS721 for a total of 12 weeks and then followed post-treatment for six weeks. All IgA nephropathy patients had stage 3B chronic kidney disease and three of the four patients had nephrotic range proteinuria. All patients demonstrated marked improvement in urine albumin-to-creatinine ratio (uACR) and in 24-hour urine protein excretion while concurrently tapering corticosteroid treatment. The mean baseline uACR in these patients was 1,457 mg/g and reached 332 mg/g at the end of the follow-up period. Results of 24-hour urine protein excretion were highly consistent with the uACR results, with a reduction from a mean of 3,935 mg/day at baseline to a mean of 1,067 mg/day at the end of the follow-up period. All patients achieved partial remission based on proteinuria and one patient with nephrotic range proteinuria achieved a 95% reduction. "We are pleased with the continued consistency of the results seen in these patients treated with OMS721," stated Gregory A. Demopulos, M.D., Chairman and Chief Executive Officer of Omeros, "Despite being an orphan disease, IgA nephropathy is the most common primary glomerular disease worldwide, and we are keenly focused on this indication for OMS721. We are aggressively advancing to our Phase 3 clinical trial and look forward to beginning patient enrollment as soon as possible." Currently, there are no treatments approved for IgA nephropathy. As per the press release, it is estimated that 1 in 1,400 persons in the US will develop IgA nephropathy in his or her lifetime, and approximately 40% of them may develop end-stage renal disease. Apart from preparing for the Phase 3 clinical trial in IgA nephropathy, Omeros is continuing to conduct the second stage of its ongoing Phase 2 clinical trial in which OMS721 is evaluated in non-steroid-treated patients with IgA nephropathy. Furthermore, following discussions with both the FDA and the European Medicines Agency, a Phase 3 program for OMS721 in atypical hemolytic uremic syndrome (aHUS) is also in progress The Company also has two Phase 2 trials in progress, one evaluating OMS721 in glomerulonephropathies, which has generated positive data in patients with immunoglobulin A (IgA) nephropathy and with lupus nephritis, the second trial has reported positive data both in patients with hematopoietic stem cell transplant-associated thrombotic microangiopathy (TMA) and in those with aHUS. In addition to potential intravenous administration, Omeros plans to commercialize OMS721 for one or more therapeutic indications as a subcutaneous injection and is also developing small-molecule inhibitors of MASP-2. The FDA has granted OMS721 both orphan drug status for the prevention (inhibition) of complement-mediated TMAs and fast track designation for the treatment of patients with aHUS. On Wednesday, May 17, 2017, following the announcement, the stock closed the trading session at $16.25, jumping 8.70% from its previous closing price of $14.95. A total volume of 1.97 million shares have exchanged hands, which was higher than the 3-month average volume of 639.47 thousand shares. Omeros' stock price soared 40.33% in the last three months, 20.73% in the past six months, and 52.58% in the previous twelve months. Furthermore, since the start of the year, shares of the Company have skyrocketed 63.81%. At Wednesday's closing price, the stock's net capitalization stands at $710.13 million. Active Wall Street (AWS) produces regular sponsored and non-sponsored reports, articles, stock market blogs, and popular investment newsletters covering equities listed on NYSE and NASDAQ and micro-cap stocks. AWS has two distinct and independent departments. One department produces non-sponsored analyst certified content generally in the form of press releases, articles and reports covering equities listed on NYSE and NASDAQ and the other produces sponsored content (in most cases not reviewed by a registered analyst), which typically consists of compensated investment newsletters, articles and reports covering listed stocks and micro-caps. Such sponsored content is outside the scope of procedures detailed below. AWS has not been compensated; directly or indirectly; for producing or publishing this document. The non-sponsored content contained herein has been prepared by a writer (the "Author") and is fact checked and reviewed by a third party research service company (the "Reviewer") represented by a credentialed financial analyst, for further information on analyst credentials, please email info@activewallst.com. Rohit Tuli, a CFA® charterholder (the "Sponsor"), provides necessary guidance in preparing the document templates. The Reviewer has reviewed and revised the content, as necessary, based on publicly available information which is believed to be reliable. Content is researched, written and reviewed on a reasonable-effort basis. The Reviewer has not performed any independent investigations or forensic audits to validate the information herein. The Reviewer has only independently reviewed the information provided by the Author according to the procedures outlined by AWS. AWS is not entitled to veto or interfere in the application of such procedures by the third-party research service company to the articles, documents or reports, as the case may be. Unless otherwise noted, any content outside of this document has no association with the Author or the Reviewer in any way. AWS, the Author, and the Reviewer are not responsible for any error which may be occasioned at the time of printing of this document or any error, mistake or shortcoming. No liability is accepted whatsoever for any direct, indirect or consequential loss arising from the use of this document. AWS, the Author, and the Reviewer expressly disclaim any fiduciary responsibility or liability for any consequences, financial or otherwise arising from any reliance placed on the information in this document. Additionally, AWS, the Author, and the Reviewer do not (1) guarantee the accuracy, timeliness, completeness or correct sequencing of the information, or (2) warrant any results from use of the information. The included information is subject to change without notice. This document is not intended as an offering, recommendation, or a solicitation of an offer to buy or sell the securities mentioned or discussed, and is to be used for informational purposes only. Please read all associated disclosures and disclaimers in full before investing. Neither AWS nor any party affiliated with us is a registered investment adviser or broker-dealer with any agency or in any jurisdiction whatsoever. To download our report(s), read our disclosures, or for more information, visit http://www.activewallst.com/disclaimer/. For any questions, inquiries, or comments reach out to us directly. If you're a company we are covering and wish to no longer feature on our coverage list contact us via email and/or phone between 09:30 EDT to 16:00 EDT from Monday to Friday at: CFA® and Chartered Financial Analyst® are registered trademarks owned by CFA Institute. LONDON, UK / ACCESSWIRE / May 18, 2017 / Active Wall St. blog coverage looks at the headline from Omeros Corp. (NASDAQ: OMER) as the Company announced on May 17, 2017, the completion of the IgA nephropathy cohort and also reported additional positive results from the first stage of the Company's Phase 2 clinical trial of OMS721 for the treatment of serious kidney disorders. Register with us now for your free membership and blog access at: One of Omeros' competitors within the Biotechnology space, Halozyme Therapeutics, Inc. (NASDAQ: HALO), reported on May 09, 2017, its financial results and recent highlights for Q1 ended March 31, 2017. AWS will be initiating a research report on Halozyme Therapeutics in the coming days. Today, AWS is promoting its blog coverage on OMER; touching on HALO. Get all of our free blog coverage and more by clicking on the link below: OMS721 is Omeros' lead human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2), the effector enzyme of the complement system's lectin pathway. The additional Phase 2 results in IgA nephropathy patients demonstrated statistically significant improvement in urine protein levels (proteinuria), which is associated with slowing progression of kidney functional loss, and progressively better prognoses. The first stage in this Phase 2 trial includes four different types of complement-associated kidney diseases: IgA nephropathy, membranous nephropathy, lupus nephritis, and complement component 3 (C3) glomerulopathy. Patients of the IgA nephropathy cohort were treated open-label with OMS721 for a total of 12 weeks and then followed post-treatment for six weeks. All IgA nephropathy patients had stage 3B chronic kidney disease and three of the four patients had nephrotic range proteinuria. All patients demonstrated marked improvement in urine albumin-to-creatinine ratio (uACR) and in 24-hour urine protein excretion while concurrently tapering corticosteroid treatment. The mean baseline uACR in these patients was 1,457 mg/g and reached 332 mg/g at the end of the follow-up period. Results of 24-hour urine protein excretion were highly consistent with the uACR results, with a reduction from a mean of 3,935 mg/day at baseline to a mean of 1,067 mg/day at the end of the follow-up period. All patients achieved partial remission based on proteinuria and one patient with nephrotic range proteinuria achieved a 95% reduction. "We are pleased with the continued consistency of the results seen in these patients treated with OMS721," stated Gregory A. Demopulos, M.D., Chairman and Chief Executive Officer of Omeros, "Despite being an orphan disease, IgA nephropathy is the most common primary glomerular disease worldwide, and we are keenly focused on this indication for OMS721. We are aggressively advancing to our Phase 3 clinical trial and look forward to beginning patient enrollment as soon as possible." Currently, there are no treatments approved for IgA nephropathy. As per the press release, it is estimated that 1 in 1,400 persons in the US will develop IgA nephropathy in his or her lifetime, and approximately 40% of them may develop end-stage renal disease. Apart from preparing for the Phase 3 clinical trial in IgA nephropathy, Omeros is continuing to conduct the second stage of its ongoing Phase 2 clinical trial in which OMS721 is evaluated in non-steroid-treated patients with IgA nephropathy. Furthermore, following discussions with both the FDA and the European Medicines Agency, a Phase 3 program for OMS721 in atypical hemolytic uremic syndrome (aHUS) is also in progress The Company also has two Phase 2 trials in progress, one evaluating OMS721 in glomerulonephropathies, which has generated positive data in patients with immunoglobulin A (IgA) nephropathy and with lupus nephritis, the second trial has reported positive data both in patients with hematopoietic stem cell transplant-associated thrombotic microangiopathy (TMA) and in those with aHUS. In addition to potential intravenous administration, Omeros plans to commercialize OMS721 for one or more therapeutic indications as a subcutaneous injection and is also developing small-molecule inhibitors of MASP-2. The FDA has granted OMS721 both orphan drug status for the prevention (inhibition) of complement-mediated TMAs and fast track designation for the treatment of patients with aHUS. On Wednesday, May 17, 2017, following the announcement, the stock closed the trading session at $16.25, jumping 8.70% from its previous closing price of $14.95. A total volume of 1.97 million shares have exchanged hands, which was higher than the 3-month average volume of 639.47 thousand shares. Omeros' stock price soared 40.33% in the last three months, 20.73% in the past six months, and 52.58% in the previous twelve months. Furthermore, since the start of the year, shares of the Company have skyrocketed 63.81%. At Wednesday's closing price, the stock's net capitalization stands at $710.13 million. Active Wall Street (AWS) produces regular sponsored and non-sponsored reports, articles, stock market blogs, and popular investment newsletters covering equities listed on NYSE and NASDAQ and micro-cap stocks. AWS has two distinct and independent departments. One department produces non-sponsored analyst certified content generally in the form of press releases, articles and reports covering equities listed on NYSE and NASDAQ and the other produces sponsored content (in most cases not reviewed by a registered analyst), which typically consists of compensated investment newsletters, articles and reports covering listed stocks and micro-caps. Such sponsored content is outside the scope of procedures detailed below. AWS has not been compensated; directly or indirectly; for producing or publishing this document. The non-sponsored content contained herein has been prepared by a writer (the "Author") and is fact checked and reviewed by a third party research service company (the "Reviewer") represented by a credentialed financial analyst, for further information on analyst credentials, please email info@activewallst.com. Rohit Tuli, a CFA® charterholder (the "Sponsor"), provides necessary guidance in preparing the document templates. The Reviewer has reviewed and revised the content, as necessary, based on publicly available information which is believed to be reliable. Content is researched, written and reviewed on a reasonable-effort basis. The Reviewer has not performed any independent investigations or forensic audits to validate the information herein. The Reviewer has only independently reviewed the information provided by the Author according to the procedures outlined by AWS. AWS is not entitled to veto or interfere in the application of such procedures by the third-party research service company to the articles, documents or reports, as the case may be. Unless otherwise noted, any content outside of this document has no association with the Author or the Reviewer in any way. AWS, the Author, and the Reviewer are not responsible for any error which may be occasioned at the time of printing of this document or any error, mistake or shortcoming. No liability is accepted whatsoever for any direct, indirect or consequential loss arising from the use of this document. AWS, the Author, and the Reviewer expressly disclaim any fiduciary responsibility or liability for any consequences, financial or otherwise arising from any reliance placed on the information in this document. Additionally, AWS, the Author, and the Reviewer do not (1) guarantee the accuracy, timeliness, completeness or correct sequencing of the information, or (2) warrant any results from use of the information. The included information is subject to change without notice. This document is not intended as an offering, recommendation, or a solicitation of an offer to buy or sell the securities mentioned or discussed, and is to be used for informational purposes only. Please read all associated disclosures and disclaimers in full before investing. Neither AWS nor any party affiliated with us is a registered investment adviser or broker-dealer with any agency or in any jurisdiction whatsoever. To download our report(s), read our disclosures, or for more information, visit http://www.activewallst.com/disclaimer/. For any questions, inquiries, or comments reach out to us directly. If you're a company we are covering and wish to no longer feature on our coverage list contact us via email and/or phone between 09:30 EDT to 16:00 EDT from Monday to Friday at: CFA® and Chartered Financial Analyst® are registered trademarks owned by CFA Institute.


"The HALO-202 data confirm for the first time in a randomized Phase 2 trial using the current standard of care that a biopsy-based biomarker for hyaluronan content can potentially identify patients who will have a meaningfully greater response when PEGPH20 is added to their treatment," said Dr. Hingorani. "The analysis suggests statistically significant and clinically important progress in this very difficult to treat cancer. The median PFS is a notable increase over the current standard of care and supports ongoing exploration in the current Phase 3 study." The study demonstrated that PEGPH20 plus standard chemotherapy of ABRAXANE® (nab-paclitaxel) and gemcitabine improved median progression-free survival (mPFS) by 77 percent over chemotherapy alone in stage IV pancreas cancer patients with high levels of hyaluronan (HA-High). Halozyme is currently enrolling HA-High patients in a global Phase 3 clinical trial. In a subanalysis of patients who received uninterrupted therapy with PEGPH20 plus chemotherapy (Stage 2 patients), a 91 percent improvement in mPFS and a 4-month benefit in overall survival were observed. Dr. Helen Torley, president and chief executive officer of Halozyme said, "The results in the HA-High patient cohort are particularly encouraging given that we are using this biomarker and recruiting this specific patient population in our ongoing global Phase 3 study, HALO-301. We believe that HALO-301 is the first targeted or biomarker driven Phase 3 study to date in this highly lethal cancer type." Pancreas cancer is the third-leading cause of cancer related death in the United States, and more than 65,000 people in the U.S. and top five European countries are diagnosed annually with advanced cases of the disease. About HALO-301 and HALO-202 HALO-301 is a phase 3 global, randomized, double-blind placebo controlled clinical trial evaluating investigational new drug PEGPH20 as a first-line therapy for potential treatment of patients with metastatic pancreas cancer. The trial will be conducted at approximately 200 sites with two primary endpoints, progression free survival and overall survival in patients receiving investigational new drug PEGPH20 in combination with gemcitabine and ABRAXANE (nab-paclitaxel) compared to gemcitabine and nab-paclitaxel alone. Secondary endpoints also include objective response rate and overall survival. More information may be found at clinicaltrials.gov (search HALO 301 or trial identifier NCT02715804) or www.HALO301.com. HALO-202 (Halo 109-202) is a phase 2 multi-center, randomized clinical trial evaluating investigational new drug PEGPH20 as a first-line therapy for potential treatment of patients with metastatic pancreas cancer. The primary outcome of the trial is to measure improvement in progression-free survival in patients receiving investigational new drug PEGPH20 in combination with gemcitabine and nab-paclitaxel compared to gemcitabine and nab-paclitaxel alone. A second primary endpoint assesses the thromboembolic event rate in the PEGPH20 treatment arm. Secondary endpoints also include objective response rate and overall survival. About PEGPH20 PEGPH20 is an investigational PEGylated form of Halozyme's proprietary recombinant human hyaluronidase under clinical development for the potential systemic treatment of tumors that accumulate hyaluronan. PEGPH20 is an enzyme that temporarily degrades HA, a dense component of the tumor microenvironment that can accumulate in higher concentrations around certain cancer cells, potentially constricting blood vessels and impeding the access of other therapies. FDA granted orphan drug designation to PEGPH20 for treatment of pancreas cancer and fast track designation for PEGPH20 in combination with gemcitabine and nab-paclitaxel for the treatment of metastatic pancreas cancer. Additionally, the European Commission, acting on the recommendation from the Committee for Orphan Medicinal Products of the European Medicines Agency, designated investigational drug PEGPH20 an orphan medicinal product for the treatment of pancreas cancer. About Halozyme Halozyme Therapeutics is a biotechnology company focused on developing and commercializing novel oncology therapies that target the tumor microenvironment. Halozyme's lead proprietary program, investigational drug PEGPH20, applies a unique approach to targeting solid tumors, allowing increased access of co-administered cancer drug therapies to the tumor in animal models. PEGPH20 is currently in development for metastatic pancreas cancer, non-small cell lung cancer, gastric cancer, metastatic breast cancer and has potential across additional cancers in combination with different types of cancer therapies. In addition to its proprietary product portfolio, Halozyme has established value-driving partnerships with leading pharmaceutical companies including Roche, Baxalta, Pfizer, Janssen, AbbVie and Lilly for its ENHANZE® drug delivery technology. Halozyme is headquartered in San Diego. For more information visit . Safe Harbor Statement In addition to historical information, the statements set forth above include forward-looking statements (including, without limitation, statements concerning the possible activity, benefits and attributes of PEGPH20, the possible method of action of PEGPH20, its potential application to improve cancer therapies and statements concerning future actions relating to the development of PEGPH20) that involve risk and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. The forward-looking statements are typically, but not always, identified through use of the words "believe," "enable," "may," "will," "could," "intends," "estimate," "anticipate," "plan," "predict," "probable," "potential," "possible," "should," "continue," and other words of similar meaning. Actual results could differ materially from the expectations contained in forward-looking statements as a result of several factors, including unexpected expenditures and costs, unexpected results or delays in development and regulatory review, regulatory approval requirements, unexpected adverse events and competitive conditions. These and other factors that may result in differences are discussed in greater detail in the Company's most recent Annual and Quarterly Reports filed with the Securities and Exchange Commission. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/halozyme-phase-2-data-in-advanced-pancreas-cancer-to-be-featured-in-an-oral-presentation-at-asco-300459642.html


LONDON, UK / ACCESSWIRE / May 18, 2017 / Active Wall St. blog coverage looks at the headline from Omeros Corp. (NASDAQ: OMER) as the Company announced on May 17, 2017, the completion of the IgA nephropathy cohort and also reported additional positive results from the first stage of the Company's Phase 2 clinical trial of OMS721 for the treatment of serious kidney disorders. Register with us now for your free membership and blog access at: One of Omeros' competitors within the Biotechnology space, Halozyme Therapeutics, Inc. (NASDAQ: HALO), reported on May 09, 2017, its financial results and recent highlights for Q1 ended March 31, 2017. AWS will be initiating a research report on Halozyme Therapeutics in the coming days. Today, AWS is promoting its blog coverage on OMER; touching on HALO. Get all of our free blog coverage and more by clicking on the link below: OMS721 is Omeros' lead human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2), the effector enzyme of the complement system's lectin pathway. The additional Phase 2 results in IgA nephropathy patients demonstrated statistically significant improvement in urine protein levels (proteinuria), which is associated with slowing progression of kidney functional loss, and progressively better prognoses. The first stage in this Phase 2 trial includes four different types of complement-associated kidney diseases: IgA nephropathy, membranous nephropathy, lupus nephritis, and complement component 3 (C3) glomerulopathy. Patients of the IgA nephropathy cohort were treated open-label with OMS721 for a total of 12 weeks and then followed post-treatment for six weeks. All IgA nephropathy patients had stage 3B chronic kidney disease and three of the four patients had nephrotic range proteinuria. All patients demonstrated marked improvement in urine albumin-to-creatinine ratio (uACR) and in 24-hour urine protein excretion while concurrently tapering corticosteroid treatment. The mean baseline uACR in these patients was 1,457 mg/g and reached 332 mg/g at the end of the follow-up period. Results of 24-hour urine protein excretion were highly consistent with the uACR results, with a reduction from a mean of 3,935 mg/day at baseline to a mean of 1,067 mg/day at the end of the follow-up period. All patients achieved partial remission based on proteinuria and one patient with nephrotic range proteinuria achieved a 95% reduction. "We are pleased with the continued consistency of the results seen in these patients treated with OMS721," stated Gregory A. Demopulos, M.D., Chairman and Chief Executive Officer of Omeros, "Despite being an orphan disease, IgA nephropathy is the most common primary glomerular disease worldwide, and we are keenly focused on this indication for OMS721. We are aggressively advancing to our Phase 3 clinical trial and look forward to beginning patient enrollment as soon as possible." Currently, there are no treatments approved for IgA nephropathy. As per the press release, it is estimated that 1 in 1,400 persons in the US will develop IgA nephropathy in his or her lifetime, and approximately 40% of them may develop end-stage renal disease. Apart from preparing for the Phase 3 clinical trial in IgA nephropathy, Omeros is continuing to conduct the second stage of its ongoing Phase 2 clinical trial in which OMS721 is evaluated in non-steroid-treated patients with IgA nephropathy. Furthermore, following discussions with both the FDA and the European Medicines Agency, a Phase 3 program for OMS721 in atypical hemolytic uremic syndrome (aHUS) is also in progress The Company also has two Phase 2 trials in progress, one evaluating OMS721 in glomerulonephropathies, which has generated positive data in patients with immunoglobulin A (IgA) nephropathy and with lupus nephritis, the second trial has reported positive data both in patients with hematopoietic stem cell transplant-associated thrombotic microangiopathy (TMA) and in those with aHUS. In addition to potential intravenous administration, Omeros plans to commercialize OMS721 for one or more therapeutic indications as a subcutaneous injection and is also developing small-molecule inhibitors of MASP-2. The FDA has granted OMS721 both orphan drug status for the prevention (inhibition) of complement-mediated TMAs and fast track designation for the treatment of patients with aHUS. On Wednesday, May 17, 2017, following the announcement, the stock closed the trading session at $16.25, jumping 8.70% from its previous closing price of $14.95. A total volume of 1.97 million shares have exchanged hands, which was higher than the 3-month average volume of 639.47 thousand shares. Omeros' stock price soared 40.33% in the last three months, 20.73% in the past six months, and 52.58% in the previous twelve months. Furthermore, since the start of the year, shares of the Company have skyrocketed 63.81%. At Wednesday's closing price, the stock's net capitalization stands at $710.13 million. Active Wall Street (AWS) produces regular sponsored and non-sponsored reports, articles, stock market blogs, and popular investment newsletters covering equities listed on NYSE and NASDAQ and micro-cap stocks. AWS has two distinct and independent departments. 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Wells Fargo Securities, LLC and Deutsche Bank Securities acted as joint book-running managers for the offering. Barclays and JMP Securities acted as co-managers for the offering. An automatic shelf registration statement on Form S-3 relating to the public offering of the shares of common stock described above was filed with the Securities and Exchange Commission (the "SEC") and is effective. A final prospectus supplement and accompanying prospectus relating to this offering have been filed with the SEC. Copies of the final prospectus supplement and accompanying prospectus may be obtained from Wells Fargo Securities, LLC, Attention: Equity Syndicate Department, 375 Park Avenue, New York, New York 10152, or by telephone at (800) 326-5897 or email to cmclientsupport@wellsfargo.com; or Deutsche Bank Securities Inc., Attention: Prospectus Group, 60 Wall Street, New York, NY 10005, or by telephone at (800) 503-4611 or email to prospectus.cpdg@db.com. Electronic copies of the final prospectus supplement and accompanying prospectus are also available on the website of the SEC at www.sec.gov. This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction. About Halozyme Halozyme Therapeutics is a biotechnology company focused on developing and commercializing novel oncology therapies that target the tumor microenvironment. Safe Harbor Statement All of the statements in this press release that are not statements of historical facts constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Examples of such statements include Halozyme's intended use of proceeds. These statements are based upon management's current plans and expectations and are subject to a number of risks and uncertainties which could cause actual results to differ materially from such statements. A discussion of the risks and uncertainties that can affect these statements is set forth in Halozyme's prospectus supplement and the accompanying prospectus filed with the SEC on May 19, 2017, together with the information incorporated by reference, under the heading "Risk Factors."  Halozyme disclaims any intention or obligation to revise or update any forward-looking statements, whether as a result of new information, future events, or otherwise. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/halozyme-therapeutics-announces-completion-of-public-offering-and-full-exercise-of-underwriters-option-to-purchase-additional-shares-300463472.html


News Article | May 25, 2017
Site: www.prnewswire.com

On Tuesday, June 13, Dr. Helen Torley, president and chief executive officer will present at the Goldman Sachs 38th Annual Global Healthcare Conference in Rancho Palos Verdes at 5:00 p.m. ET / 2:00 p.m. PT. Webcasts for the presentations can be accessed through the "Investors" section of www.halozyme.com, and a recording will be made available for 90 days following each event. To access a live webcast, please visit Halozyme's website approximately 15 minutes prior to the presentation to register and download any necessary audio software. About Halozyme Halozyme Therapeutics is a biotechnology company focused on developing and commercializing novel oncology therapies that target the tumor microenvironment. Halozyme's lead proprietary program, investigational drug PEGPH20, applies a unique approach to targeting solid tumors, allowing increased access of co-administered cancer drug therapies to the tumor in animal models. PEGPH20 is currently in development for metastatic pancreatic cancer, non-small cell lung cancer, gastric cancer, metastatic breast cancer and has potential across additional cancers in combination with different types of cancer therapies. In addition to its proprietary product portfolio, Halozyme has established value-driving partnerships with leading pharmaceutical companies including Roche, Baxalta, Pfizer, Janssen, AbbVie and Lilly for its ENHANZE® drug-delivery technology. Halozyme is headquartered in San Diego. For more information visit . To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/halozyme-therapeutics-to-present-at-upcoming-healthcare-conferences-300464185.html


"We are pleased that RITUXAN HYCELA will now provide another treatment option for U.S. patients," said Dr. Helen Torley, president and chief executive officer. "RITUXAN HYCELA has the potential to reduce the treatment burden and administration time, and is an option preferred by many patients." RITUXAN HYCELA has been approved for patients with follicular lymphoma, diffuse large B-cell lymphoma and chronic lymphocytic leukemia, and is expected to be available within one to two weeks. Including all approved indications, Roche reported total 2016 sales of rituximab in the United States of approximately $3.9 billion. Across all of its global collaboration and licensing agreements, Halozyme earns on average a mid-single-digit royalty on sales of products using the ENHANZE technology. Today's approval was preceded by an FDA Oncologic Drug Advisory Committee in March that voted 11 to 0 in favor of the benefit/risk profile for rituximab/human hyaluronidase subcutaneous (under the skin) injection for patients in the proposed indications of follicular lymphoma, diffuse large B-cell lymphoma and chronic lymphocytic leukemia. Halozyme Therapeutics is a biotechnology company focused on developing and commercializing novel oncology therapies that target the tumor microenvironment. Halozyme's lead proprietary program, investigational drug PEGPH20, applies a unique approach to targeting solid tumors, allowing increased access of co-administered cancer drug therapies to the tumor in animal models. PEGPH20 is currently in development for metastatic pancreatic cancer, non-small cell lung cancer, gastric cancer, metastatic breast cancer and has potential across additional cancers in combination with different types of cancer therapies. In addition to its proprietary product portfolio, Halozyme has established value-driving partnerships with leading pharmaceutical companies including Roche, Baxalta, Pfizer, Janssen, AbbVie and Lilly for its ENHANZE™ drug delivery technology. Halozyme is headquartered in San Diego. For more information visit www.halozyme.com. In addition to historical information, the statements set forth above include forward-looking statements including, without limitation, statements concerning the possible activity, benefits and attributes of ENHANZE, the possible method of action of ENHANZE, its potential application to aid in the dispersion and absorption of other injected therapeutic drugs, potential royalties to be received on sales using ENHANZE technology formulation, the number of collaborative targets actually chosen, whether such products are ultimately developed or commercialized, whether milestones triggering milestone payments will be achieved and statements concerning facilitating more rapid delivery of injectable medications through subcutaneous delivery that involve risk and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. The forward-looking statements are typically, but not always, identified through use of the words "believe," "enable," "may," "will," "could," "intends," "estimate," "anticipate," "plan," "predict," "probable," "potential," "possible," "should," "continue," and other words of similar meaning. Actual results could differ materially from the expectations contained in forward-looking statements as a result of several factors, including unexpected expenditures and costs, unexpected results or delays in development, regulatory review and commercialization, regulatory approval requirements, unexpected adverse events and competitive conditions. These and other factors that may result in differences are discussed in greater detail in the Company's most recently filed Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/fda-approves-genentechs-rituxan-hycela-a-subcutaneous-rituximab-coformulated-with-halozyme-enhanze-technology-300478601.html

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