Neurocrine expects $20M in revenue milestones under the AbbVie agreement in FY19 Neurocrine (NBIX) announces revenue milestones under the AbbVie (ABBV) agreement for 2019 are expected to be $20M contingent on FDA’s acceptance of the NDA submission of elagolix for uterine fibroids. Ongoing SG&A and R&D expenses for 2019, excluding upfront expenses associated with the recently announced Voyager Therapeutics collaboration, should approximate $550M-$600M. The 2019 anticipated expenses include an estimated $80M of share-based compensation expense. The increase in expenses is largely attributable to the Voyager collaboration’s ongoing program costs, increased investment in INGREZZA patient education, sales and marketing activities, opicapone NDA submission and increased R&D pipeline activities.
https://thefly.com/landingPageNews.php?id=2859439
Tuesday, February 5, 2019
Paratek announces commercial launch of Nuzyra antibiotic in the U.S.
Paratek Pharmaceuticals announced the commercial availability of Nuzyra in the United States. Nuzyra, a modernized tetracycline, is a once-daily intravenous and oral antibiotic for the treatment of adults with community-acquired bacterial pneumonia and acute skin and skin structure infections. Paratek Pharmaceuticals has also partnered with JMI Laboratories to develop a comprehensive initiative called the Keystone that provides access to current antimicrobial surveillance susceptibility data including Nuzyra. Keystone is designed to play an essential role in monitoring the prevalence of antimicrobial resistance in the United States.
https://thefly.com/landingPageNews.php?id=2859511
https://thefly.com/landingPageNews.php?id=2859511
Array BioPharma Gains as Loss Narrower Than Expected
Cancer drugmaker Array BioPharma Inc. (ARRY - Get Report) rose 11% on strong revenue growth and after its loss for its fiscal second quarter was narrower than expectations.
The company -- with several drugs in its development pipeline -- posted a loss for the period ended Dec. 31, of 5 cents a share. The loss was narrower than the Zacks Consensus Estimate of 16 cents and its loss the same quarter the previous year of 17 cents.
Quarterly revenue shot up to $82.5 million, compared with about $42 million the same quarter a year prior.
Thanks largely to research and development expenses, total costs also were up in the quarter, to around $93 million, pulling losses from operations down to around $10.8 million for the year, according to the company.
A boost came from net sales of its melanoma drug combination Braftovi and Mektovi that hit $22.7 million for the quarter, far outpacing the prior quarter that saw $14 million in sales.
Array specializes in developing and bringing to market so-called targeted small molecule drugs for patients with cancer and other diseases, and currently has several drugs in scores of clinical trials, including one in advanced trials for colorectal cancer. The company also has partnerships with AstraZeneca, Genentech, Seattle Genetics and others.
https://www.thestreet.com/markets/array-biopharma-surges-on-narrower-than-expected-loss-14856220
Thanks largely to research and development expenses, total costs also were up in the quarter, to around $93 million, pulling losses from operations down to around $10.8 million for the year, according to the company.
https://www.thestreet.com/markets/array-biopharma-surges-on-narrower-than-expected-loss-14856220
Actinium initiates novel Phase 1/2 trial of Actimab-A and venetoclax
Actinium Pharmaceuticals (ATNM) announced that its novel Phase 1/2 combination trial of Actimab-A and venetoclax has been initiated. Gary Schiller, MD, Professor, Hematology-Oncology and Director, Hematologic Malignancy/Stem Cell Transplant Program at the UCLA Medical Center will serve as Principal Investigator for this study. The Phase 1/2 combination trial will enroll patients with relapsed or refractory AML or Acute Myeloid Leukemia that have been previously treated with venetoclax and patients that have never received venetoclax. Venetoclax is a BCL-2 or B-Cell Lymphoma 2 inhibitor that is jointly developed and marketed by AbbVie (ABBV) and Genentech.
AtriCure enrolls first patient in ICE-AFIB clinical trial
AtriCure announced the first patient was treated in the ICE-AFIB trial. Following Investigational Device Exemption approval by the FDA, the first patient was treated by Dr. Niv Ad, at Washington Adventist Hospital in Takoma Park, Maryland. The trial will evaluate the safety and effectiveness of the cryoICE Ablation System for the treatment of persistent and long-standing persistent atrial fibrillation during concomitant open-chest cardiac surgery.
Pharm-Olam enrolls patients in Zealand Pharma orphan drug study
Pharm-Olam is now enrolling patients in the U.S. and Europe into a pivotal Phase III study within the treatment of short bowel syndrome. Initiated in early October 2018, the study is a placebo-controlled, randomized, parallel-group, double-blind clinical trial with fixed-dose injections. The trial is being conducted at approximately 40 investigational sites in the United States, Canada, and Europe and will ultimately enroll 129 patients with SBS. Because people with SBS often cannot absorb enough nutrients, the trial will help determine if parenteral support volume can be reduced. Zealand Pharma is developing a long-acting GLP-2 analog in an auto-injector with potential for convenient weekly administration, which has been granted orphan status by the U.S. Food and Drug Administration.
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