Shares of Protagonist Therapeutics Inc. (NASDAQ:PTGX) climbed 93.9% on Oct. 11 after the FDA removed a full clinical hold on studies of the rusfertide, the company's investigational treatment for the blood disorders polycythemia vera and hereditary hemochromatosis. Triggered by a finding of malignant skin tumors in mice treated with the drug disclosed on Sept. 17, the FDA's three-weeks-ago hold had pushed Protagonist shares down by as much as 72%. Read More
Supernus Pharmaceuticals Inc. CEO Jack Khattar, in disclosing his firm’s plan to acquire Adamas Pharmaceuticals Inc., said the team there has made “significant progress in redirecting” the Parkinson’s disease (PD) drug Gocovri (amantadine), but plenty more potential remains on the table with the oral selective RET kinase inhibitor. Read More
Pacira Biosciences Inc. will add to its core non-opioid-based therapies business by buying Flexion Therapeutics Inc. for $427 million. That brings into the company’s fold Zilretta (triamcinolone acetonide extended-release injectable suspension) for treating osteoarthritis knee pain, an injectable non-opioid that’s already FDA approved in addition to being in a phase II study for treating shoulder osteoarthritis. Read More
DUBLIN – Shares in Idorsia Ltd. were off almost 4% Oct. 11 on news that lucerastat missed the primary endpoint of the Modify phase III trial in Fabry disease. The double-blinded, placebo-controlled study, which recruited 118 adult patients, was designed to evaluate the effect of lucerastat on neuropathic pain. Patients were randomized to drug or placebo in a 2-to-1 ratio. Read More
Cambridge, U.K.-based Astrazeneca plc has new data from its long-acting COVID-19 antibody combination, AZD-7442, which aims to provide longer protection, potentially for up to a year. Latest data show the intramuscularly injected drug achieved a statistically significant reduction in severe COVID-19 or death compared to placebo in non-hospitalized patients with mild to moderate symptomatic disease. Read More
On the last day of this year’s Molecular Targets meeting, an annual joint conference of the American Association for Cancer Research, the National Cancer Institute and the European Organization for the Research and Treatment of Cancer, the final plenary went from molecular to macro in a lively discussion of the biggest roadblock in cancer drug development, and what can be done to improve it. Read More
Nearly two years after confronting an initial complete response letter, Enzyvant Therapeutics Inc. has won FDA approval for a unique treatment for children born without a thymus, an ultra-rare condition leaving them deeply disadvantaged in fighting infections. The product, to be marketed as Rethymic, is the first thymus tissue product approved in the U.S. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Acumen, Argenx, Cyprium, Fortress, Nanoscope, Nkarta. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Allogene, Amgen, Astrazeneca, Beigene, Chemocentryx, Janssen, Takeda. Read More
