Arca Biopharma Inc., of Westminster, Colo., said the data and safety monitoring board for the GENETIC-AF trial completed its pre-specified phase IIb interim analysis and recommended completion of the trial with no changes. GENETIC-AF is evaluating beta-blocker Gencaro (bucindolol hydrochloride) as a potential treatment for atrial fibrillation. Top-line results are expected late in the first quarter of 2018. The Gencaro development program has been granted fast track designation by the FDA.
Roivant Sciences Inc., an umbrella for five biopharma companies and a new tech-focused venture, has secured biopharma's biggest-ever private financing, a $1.1 billion equity investment led by Softbank Vision Fund. The investment is expected to accelerate its launch of new subsidiaries within and beyond drug development, starting with the newco Datavant. CEO Vivek Ramaswamy told BioWorld that the new venture aspires to apply artificial intelligence and machine learning to "shelved data sets" in hopes of yielding insights that can speed drug development.
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.
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.
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.
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.
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.
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.
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.
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