HONG KONG – Chinese biopharmaceutical firm Beigene Ltd. filed with the Hong Kong Stock Exchange (HKEX) for a monster IPO that could raise more than $1 billion. It is the second biotech firm to seek an HKEX listing after Hangzhou-based Ascletis Pharma Inc. priced a nearly $400 million offering earlier this month. Read More
Shares of Redhill Biopharma Ltd. (NASDAQ:RDHL) took a 14 percent bounce early Monday after the Tel Aviv, Israel-based company reported that the first phase III study of RHB-104 to test its hypothesis on Mycobacterium avium paratuberculosis (MAP) infection in Crohn's disease met its primary and key secondary endpoints. But those gains eroded, with shares closing at $8.75 for a loss of 68 cents, or 7.2 percent, after unanswered questions about the data, which remain under analysis, and the design of a follow-on phase III that company officials deemed likely once they have a chance to meet with the FDA. Read More
Two pivotal trials testing the ability of a topical suspension of silver particles to improve the efficacy of laser therapy for acne have both failed to surface additional benefit from the candidate, SNA-001, sending shares of the regimen's developer, Sienna Biopharmaceuticals Inc. (NASDAQ:SNNA) down as far as $12.77 before ending the day at $15 Monday, down 70 cents. The probability of success in a soon-to-finish third pivotal trial with a different laser now seems lower, Sienna's president and CEO, Frederick Beddingfield, said. Read More
LONDON – The EMA has again diverged from the FDA on its view of risk vs. benefit, giving a second negative opinion for Portola Pharmaceuticals Inc.'s Bevyxxa (betrixaban) for the prevention of venous thromboembolism and for Radius Health Inc.'s Tymlos (abaloparatide) for osteoporosis, both of which received U.S. approval last year. Read More
HONG KONG – Sinovant Sciences Ltd., of Shanghai, has joined hands with U.S. firm Renexxion LLC to develop naronapride, an investigational gastrointestinal prokinetic for treating irritable bowel syndrome with constipation (IBS-C). Read More
The scrum between Ariosa Diagnostics Inc. and Illumina Inc. over patents pertaining to noninvasive prenatal tests has several years of history behind it, but the two companies may not be done with each other just yet. Ariosa petitioned the U.S. Supreme Court to review the question of what constitutes the date of prior art, an important policy question the court could answer in a manner that invalidates a large number of patents. Read More
Overturning a split decision from one of its own three-judge panels, the U.S. Court of Appeals for the Federal Circuit ruled 7-4 in an en banc decision Friday that the Patent and Trademark Office (PTO) has to pay its own attorneys' fees, win or lose. Read More
Veracyte Inc., of South San Francisco, closed its public offering of 5.75 million shares, including 750,000 shares sold upon full exercise of the underwriters' overallotment, priced at $10.25 per share. Net proceeds totaled about $55.1 million. Leerink Partners and William Blair acted as joint book-running managers and BTIG acted as lead manager. Read More
4D Pharma plc, of Leeds, U.K., said data published in PLOS One showed that specific single bacterial strains from the human gut microbiota have the potential to serve as therapeutic inhibitors of HDAC, which is particularly relevant for disease areas involving host epigenetic aberrations. Read More
