Austin-based XBiotech Inc. is launching its first Phase III trial, for its antibody Xilonix (MABp1), after announcing Wednesday that the monoclonal antibody received fast-track designation by the FDA. Read More

In a potential sign the initial public offering (IPO) waters may become more treacherous for biotechs during this year's presidential election season, Regulus Therapeutics Inc. slashed the price of its IPO to $4 per share – less than half of the proposed price range of $10 to $12 – while more than doubling the number of shares, from a proposed 4.5 million to 11.3 million. Read More

Aragon Pharmaceuticals Inc. parlayed its successful Phase II results in prostate cancer to a new financing round worth $50 million supported by existing investors and led by new investor venBio. The funds will support advancement of ARN-509 in castration-resistant prostate cancer (CRPC). Read More

Flush with $27 million from a Series A in August, Aerpio Therapeutics Inc. is moving full speed ahead into its clinical development program for AKB-9778, a first-in-class human protein tyrosine phosphatase-beta (HPTP-beta) inhibitor, with dosing of the first patients in a Phase Ib/IIa study in diabetic macular edema (DME). Read More

• Sigma-Tau Pharmaceuticals Inc., of Gaithersburg, Md., said the FDA approved Cystaran (cysteamine ophthalmic solution) 0.44 percent, a topical ophthalmic therapeutic developed in partnership with the National Institutes of Health, for the treatment of corneal cysteine crystal accumulation as a result of cystinosis. Cystaran is designated an orphan drug in the U.S. Read More

• Pfizer Inc., of New York, reported top-line data assessing the immunogenicity, tolerability and safety of Prevenar 13 (Pneumococcal polysaccharide conjugate vaccine [13-valent, absorbed]) in adults 18 to 49 years of age. The study's primary objective was to demonstrate that the immune response to Prevenar 13 in the 18- to 49-year-old age group is noninferior to the compound's immune response in the 60- to 64-year-old age group as measured by serotype-specific opsonophagocytic assay titers one month after vaccination. Read More

• Circassia Ltd., of Oxford, UK, started a pivotal, large-scale Phase III study of its ToleroMune cat allergy treatment for rhinoconjunctivitis. The study will test safety and efficacy of the ToleroMune treatment in approximately 1,200 subjects from the U.S., Canada and Europe. Read More