Halozyme Announces Janssen Receives FDA Approval Of DARZALEX FASPRO® (Daratumumab And Hyaluronidase-fihj) As Treatment For Newly Diagnosed Patients With Light Chain (AL) Amyloidosis
, /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced that Janssen Biotech, Inc. (Janssen) has received U.S. Food and Drug Administration (FDA) approval of DARZALEX (daratumumab and hyaluronidase-fihj) in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd) for the treatment of adult patients with newly diagnosed light chain (AL) amyloidosis. DARZALEX is the first and only FDA-approved treatment for patients with this rare and serious blood disorder associated with the production of an abnormal protein which leads to the deterioration of vital organs, most notably the heart, kidneys and liver. This indication is approved under accelerated approval and is based on the combination's hematologic complete response rate (hemCR) measure. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.  DARZALEX is not indicated and is not recommended for the treatment of patients with light chain (AL) amyloidosis who have NYHA Class IIIB or Class IV cardiac disease or Mayo Stage IIIB outside of controlled clinical trials.
PR Newswire - PRF · 11h ago
Halo Labs Provides Updates on Bophelo Bioscience and MedCan Partnership
CNW Group - CND · 12h ago
Dow Jones Weakens Following JPMorgan Earnings; Nasdaq Falls Less, But Some Growth Stocks Power Higher
Investor's Business Daily · 18h ago
Novartis' (NVS) Ligelizumab Gets Breakthrough Therapy Status
Zacks · 19h ago
Lexicon (LXRX) Soars on FDA Permission for Sotagliflozin NDA
Lexicon (LXRX) announces that data from two late-stage studies on its type II diabetes candidate, sotagliflozin, can support a regulatory approval application.
Zacks · 20h ago
The Daily Biotech Pulse: DBV's Positive FDA Feedback, Pfizer's Cancer Drug Gets Label Expansion, Applied DNA COVID Testing Volume Surges
Here's a roundup of top developments in the biotech space over the last 24 hours. Scaling The Peaks (Biotech Stocks Hitting 52-week Highs Jan. 14)
Benzinga · 21h ago
Marinus (MRNS) Gets Positive FDA Response for Ganaxolone Study
Marinus (MRNS) gets positive FDA response for phase III Marigold study on oral ganaxolone in children and young adults with CDKL5 deficiency disorder that appears sufficient to support the NDA filing.
Zacks · 1d ago
The Daily Biotech Pulse: Alexion Pauses COVID-19 Study, NantKwest Readout, Organogenesis Jumps On Guidance, Trial Updates
Here's a roundup of top developments in the biotech space over the last 24 hours: Scaling The Peaks (Biotech Stocks Hitting 52-week Highs Jan. 13)
Benzinga · 1d ago
Halo Labs Announces December Record Sales
CNW Group - CND · 2d ago
Regeneron (REGN), U.S. Government Ink Deal for COVID-19 Treatment
Zacks · 2d ago
Editas (EDIT) Gets FDA Nod to Begin Safety Study on EDIT-301
The FDA clears the initiation of the safety phase of Editas' (EDIT) early-stage study on investigational gene-editing therapy EDIT-301 for treating sickle cell disease. Shares down.
Zacks · 3d ago
bluebird (BLUE) to Spin Off Oncology Unit Into Separate Entity
bluebird (BLUE) to separate its severe genetic disease and oncology businesses into different and independent publicly traded companies. Shares up.
Zacks · 3d ago
Horizon (HZNP) Provides Preliminary 2020 Financial Results
Horizon (HZNP) provides 2020 preliminary financial results and updates on its key drugs.
Zacks · 3d ago
Ultragenyx (RARE) Presents Preliminary 2020 Revenues & Guidance
Ultragenyx (RARE) provides preliminary 2020 Crysvita revenues and 2021 revenue guidance for the same.
Zacks · 3d ago
Sarepta (SRPT) Looks Good: Stock Adds 9.1% in Session
Sarepta (SRPT) saw a big move last session, as its shares jumped more than 9% on the day, amid huge volumes.
Zacks · 3d ago
Halo Labs Announces Record Retail Sales Growth in Oregon Cannabis Market for November 2020
CNW Group - CND · 4d ago
Halozyme Therape Has Returned 50.3% Since SmarTrend Recommendation (HALO)
SmarTrend identified an Uptrend for Halozyme Therape (NASDAQ:HALO) on October 16th, 2020 at $28.81. In approximately 3 months, Halozyme Therape has returned 50.27% as of today's recent price of $43.30.
Comtex SmarTrend(R) · 4d ago
Infrastructure and Energy Alternatives, Carrols Restaurant, Moderna, Blueprint Medicines and Halozyme Therapeutics highlighted as Zacks Bull and Bear of the Day
Zacks · 4d ago
Halozyme Therapeutics releases FY21 outlook ahead of JMP healthcare conference, stock -6%
Halozyme Therapeutics ([[HALO]] -5.7%) expects its FY21 revenue to range between $375-$395M (+40% to +45% Y/Y), shy of market consensus of $401.22M.The company expects a doubling in revenue from royalties, a
Seekingalpha · 4d ago
DJ Halozyme Therapeutics Sees 2021 Revenue $375M to $395M
Dow Jones · 4d ago
Webull provides a variety of real-time HALO stock news. You can receive the latest news about Halozyme through multiple platforms. This information may help you make smarter investment decisions.
About HALO
Halozyme Therapeutics, Inc. is a biotechnology company focused on developing and commercializing oncology therapies. The Company operates in research, development and commercialization of human enzymes and other drug candidates. The Company's segment also includes research and development activities and product sales of Hylenex recombinant. The Company's development pipeline consists of clinical-stage product candidates in oncology. Its lead oncology program is PEGPH20 (polyethylene glycol (PEG)ylated recombinant human hyaluronidase), a molecular entity being developed for the systemic treatment of tumors, which accumulate HA. It is in Phase II and Phase III clinical testing for PEGPH20 in stage IV pancreatic ductal adenocarcinoma (Studies 109-202 and 109-301); Phase Ib clinical testing in non-small cell lung cancer (Study 107-201), and in Phase Ib clinical testing in non-small cell lung cancer and gastric cancer (Study 107-101).