Dynavax Technologies Corp., of Berkeley, Calif., said it intends to offer $125 million of shares of its common stock, subject to market and other conditions, in an underwritten public offering. The company also expects to grant the underwriters a 30-day option to purchase up to an additional $18.75 million of shares of its common stock to cover overallotments, if any. Net proceeds from the proposed offering will support activities associated with preparing for their anticipated U.S. commercial launch of Heplisav-B if it gains FDA approval. Also the funds will support continuing the clinical development of lead investigational cancer immunotherapeutic product candidates, SD-101 and DV-281. Read More
Can-Fite Biopharma Ltd., of Petach Tikva, Israel, said the phase II liver cancer trial testing namodenoson (CF-102) has enrolled and randomized all 78 patients. The study, which enrolled patients with advanced hepatocellular carcinoma (HCC), is measuring overall survival as the primary endpoint. Secondary endpoints include progression-free survival, safety and the relationship between outcomes and A3AR expression. Namodenoson is an oral, small molecule designed to bind to the A3 adenosine receptor and has orphan status in the U.S. and Europe and fast track status in the U.S. for second-line HCC. Read More
As part of its commitment under the PDUFA V agreement, the FDA will hold a public meeting Sept. 18 for a discussion on the structured assessment of benefits and risks in the drug regulatory process. The meeting will focus on regulatory and industry experiences with approaches to structured benefit-risk assessments, ways to incorporate patient perspectives into the assessments and methods to advance the assessments. The sessions will look at the entire drug development life cycle, including premarket drug review and postmarket safety surveillance, according to a notice published in Wednesday's Federal Register. Registration is due by Sept. 11. Read More
Ardelyx Inc., of Fremont, Calif., said it is reducing workforce to focus on the first-in-class drug candidate, tenapanor, in phase III development for irritable bowel syndrome with constipation and hyperphosphatemia, and RDX7675, a binder for the treatment of hyperkalemia, which is also in phase III development. The company is cutting the workforce by 28 percent, leaving 76 employees. The company said that this move along with other cost-saving activities should extend the operating runway to the end of 2018, excluding any revenues gained through partnerships. Ardelyx will incur about $0.8 million in one-time, cash-related restructuring expenses, which will be recorded predominantly in the third quarter of this year. Read More
LONDON – The EMA has opened a public consultation on the development of drugs for use by older people who are at the greatest risk of encountering usability problems that can lead to poor adherence, medication errors and reduced quality of life. Read More
HONG KONG – After collecting $57 million in a series B round, Hangzhou Just Biotherapeutics Ltd. venture is now looking to build on the technology platform provided by its U.S.-based parent to focus on completing a new manufacturing plant in China designed to lower the cost of biosimilars and new biologics. Read More
A phase I immunotherapy trial of a therapeutic vaccine for type I diabetes showed that the treatment did not aggravate the disease, researchers from King's College London reported in the Aug. 9, 2017, issue of Science Translational Medicine. Read More
Privately held Melinta Therapeutics Inc. had "been interested in this transaction for quite some time," Lyn Baranowski, vice president of corporate development and strategy, told BioWorld, speaking about the all-stock transaction whereby her firm will merge with a subsidiary of Cempra Inc. to create a stand-alone firm specializing in anti-infectives and trading on the NASDAQ exchange. Read More
As the first PARP inhibitor approved for maintenance therapy in ovarian cancer, Tesaro Inc.'s Zejula (niraparib) blasted past consensus estimates for the second quarter, recording U.S. sales of $25.9 million following its April launch, well above the $11 million predicted by analysts. Read More
