Halozyme Therapeutics, Inc.NASDAQ
Mon, Nov. 21, 9:22 AM
- Halozyme Therapeutics (NASDAQ:HALO) eases 10% premarket on light volume in response to its announcement that collaboration partner AbbVie (NYSE:ABBV) has terminated a development program involving Halozyme's ENHANZE platform and the tumor necrosis factor alpha (TNF-alpha). It decided to nix development after a failed Phase 1 study.
- Other work will continue under the companies' 2015 Global Collaboration and Licensing Agreement. TNF-alpha was the first nominated target of nine included in the agreement.
Thu, Nov. 10, 10:00 AM
- Halozyme Therapeutics (HALO +11.9%) and Roche's (OTCQX:RHHBY -1.3%) Genentech will collaborate in clinical trials assessing the combination of Tecentriq (atezolizumab) and Halozyme's PEGPH20 in up to eight tumor types beginning next year.
- The first study will be an open-label Phase 1b/2 led by Genentech that will evaluate the combination in six tumor types, with an initial focus on gastrointestinal malignancies, including pancreatic and gastric cancers, some of whom will have high levels of hyaluronan (HA). Halozyme's role will be supplying product.
- Halozyme will lead the second study, an open-label Phase 1b assessing the combination along with chemo in patients with advanced/metastatic biliary and gallbladder cancers. Only patients with high HA levels will be enrolled.
- PEGPH20 is an investigational drug administered intravenously that temporarily degrades HA, a chain of natural sugars that builds up around cancer cells inhibiting the effectiveness of cancer-killing therapies.
- Atezolizumab is a PD-L1 antagonist that is designed to block inhibitory T-cell checkpoints thereby allowing cytotoxic T cells to reach the tumor.
Mon, Nov. 7, 4:18 PM
Sun, Nov. 6, 5:35 PM
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Fri, Nov. 4, 7:42 AM
- Theravance Biopharma (NASDAQ:TBPH) initiated with Overweight rating and $42 (71% upside) price target by Piper Jaffray.
- Viveve Medial (Pending:VIVE) initiated with Buy rating and $8 (59% upside) price target by B. Riley.
- Alexion Pharmaceuticals (NASDAQ:ALXN) initiated with Buy rating and $164 (29% upside) price target by Deutsche Bank.
- Halozyme Therapeutics (NASDAQ:HALO) initiated with Buy rating and $12 (42% upside) price target by Deutsche Bank.
- Cynosure (NASDAQ:CYNO) initiated with Buy rating and $60 (47% upside) price target by Aegis Capital.
- ARIAD Pharmaceuticals (NASDAQ:ARIA) initiated with Hold rating and $9.50 (10% upside) price target by Deutsche Bank.
- Aurinia Pharmaceuticals (NASDAQ:AUPH) initiated with Speculative Buy rating and $8 (214% upside) price target by Mackie Research Capital.
- Achaogen (NASDAQ:AKAO) initiated with Buy rating and $10 (166% upside) price target by Aegis Capital.
- Kindred Biosciences (NASDAQ:KIN) initiated with Buy rating and $7.50 (46% upside) price target by Ladenburg Thalmann.
- Global Blood Therapeutics (NASDAQ:GBT) initiated with Buy rating and $47 (210% upside) price target by Roth Capital.
- Obalon Therapeutics (Pending:OBLN) initiated with Buy rating and $28 (207% upside) price target by Canaccord Genuity. Initiated with Buy rating and $18 (97% upside) price target by Stifel Nicolaus.
Thu, Nov. 3, 9:05 AM
- The FDA accepts for review Genentech's (OTCQX:RHHBY) Biologics License Application (BLA) seeking approval of a subcutaneous formulation of rituximab in a range of blood cancer indications. It is a co-formulation with Halozyme's (NASDAQ:HALO) ENHANZE platform, marketed ex-U.S. as MabThera SC.
- ENHANZE is based on a proprietary recombinant hyaluronidase enzyme (rHuPH20) that temporarily degrades a natural chain of sugars in the body called hyaluronan. This helps in the dispersion and absorption of injected drugs which enables subcutaneous administration of medicines that are currently restricted to the intravenous route.
Tue, Aug. 9, 5:35 PM
Tue, Aug. 9, 4:18 PM
Mon, Aug. 8, 5:35 PM
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Wed, Jun. 8, 9:28 AM
- Halozyme (NASDAQ:HALO) inks a new financing agreement with Oxford Finance LLC and Silicon Valley Bank under which it borrowed $55M at 8.25% to refinance existing long-term debt. The new facility allows interest-only payments for the first 18 months, followed by principal and interest payments until maturity on January 1, 2021.
- The deal should increase the company's cash balance by $22M both this year and in 2017. The company has the option to borrow an additional $15M in Q2 2017 at prime + 4.75%.
- As of March 31, Halozyme's quick assets totaled ~$239M.
- Shares are up 2% premarket on light volume.
Sun, Jun. 5, 8:54 PM
- A Phase 2 clinical trial evaluating Halozyme Therapeutics' (NASDAQ:HALO) lead product candidate, PEGPH20, in combination with Celgene's (NASDAQ:CELG) Abraxane (nab-paclitaxel) and the chemo agent gemcitabine (PAG arm), compared to Abraxane and gemcitabine alone (AG arm) showed a significant treatment effect in 135 subjects with metastatic pancreatic cancer treated in Stage One of the study. The data were presented yesterday at ASCO16 in Chicago.
- Median progression-free survival (PFS) in the PAG arm was 9.2 months compared to 6.0 months in the AG arm. The overall response rate also favored the PAG arm, 50% versus 33% as did the median duration of response: 8.1 months versus 3.7 months. Median overall survival (OS) was similar: 11.8 months for the PAG arm compared to 10.9 for the AG arm.
- On the negative side, the rate of thromboembolic (blood clot) events was higher in the PAG arm (43%) compared to the AG arm (25%) but the incidence rates were reduced to 9% and 6%, respectively, with the use of the blood thinner heparin on a preventative basis.
- PEGPH20 is an investigational drug administered intravenously that temporarily degrades hyaluronan, a chain of natural sugars that builds up around cancer cells inhibiting the effectiveness of cancer-killing therapies.
- A Phase 3 study assessing PEGPH20 in pancreatic cancer commenced in March. According to clinicaltrials.gov, the estimated final data collection date for the primary endpoints, PFS and OS, is October 2018. The estimated study completion date is December 2019.
Mon, May 9, 5:40 PM
Mon, May 9, 4:21 PM
- Halozyme Therapeutics (NASDAQ:HALO): Q1 EPS of -$0.16 beats by $0.04.
- Revenue of $42.5M (+127.6% Y/Y) beats by $12.85M.
Sun, May 8, 5:35 PM
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Mon, Apr. 18, 4:43 PM
- Complementing its development program for lead product candidate PEGPH20, Halozyme Therapeutics (NASDAQ:HALO) adds two new candidates to its pipeline: PEG-ADA2 (PEGylated adenosine deaminase 2), an immune checkpoint inhibitor and HTI-1511, a novel anti-EGFR ADC (antibody-drug conjugate) to treat solid tumors.
- PEG-ADA2 is designed to decrease the concentration of adenosine in the tumor microenvironment. PEGylation prolongs its circulation in the body. The accumulation of adenosine its believed to contribute to a suppressed immune response to certain cancers. The final decision to advance it to the clinic should be made by year end.
- HTI-1511 is engineered to bind to EGFR at the low pH of the tumor microenvironment while decreasing the binding at the neutral pH of the skin. The ADC delivers a potent cytotoxin, monomethyl auristatin E, to treat EGFR-positive tumors, including those with KRAS and BRAF mutations. It has shown potential efficacy in colon cancer, lung cancer and cholangiocarcinoma models. The company is preparing for an IND submission to the FDA with clinical studies planned to commence in 2018.
Sat, Apr. 2, 5:10 PM