Merus N.V.'s second-quarter earnings report included an important update on phase I MCLA-117, which Jefferies analyst Maury Raycroft said could be a best-in-class "game-changer" for the treatment of acute myeloid leukemia (AML) – a candidate that "alone is a reason to own the stock," in his view.
Newark, Calif.-based Protagonist Therapeutics Inc.'s third-quarter earnings call included an update on hepcidin mimetic PTG-300 in beta-thalassemia, but other prospects in the pipeline are starting to excite investors as well.
Kidney-disease player Chinook Therapeutics Inc. CEO Eric Dobmeier told BioWorld that the company's $65 million series A round provides "a few years of money at the current pace. I'm hopeful we're going to make progress, have really good use of proceeds, and be out there raising money again to advance the company, because there's just such a huge unmet need right now."
The FDA cleared Rozlytrek (entrectinib) for the treatment of adults with ROS1-positive, metastatic non-small-cell lung cancer, also granting accelerated approval to the tyrosine kinase inhibitor for adult and pediatric patients (12 and older) with solid tumors that have a NTRK gene fusion.
Chief Commercial and Strategy Officer Elizabeth Jeffords told BioWorld that the endpoints in Alkahest Inc.'s just-begun phase II trial with human plasma fraction GRF-6021 will not only test how well patients bounce back from hip or knee arthroplasty but "could absolutely support the work in cognitive and neurodegenerative indications as well," where data rolled out earlier this month.
Monopar Therapeutics Inc., another company looking to attack the bane of many cancer patients – severe oral mucositis (SOM) – has filed for a $40.2 million IPO that will help advance into phase III its mucobuccal tablet of the adrenergic alpha2 agonist clonidine, branded Validive.
Although two heavy hitters' drugs have been approved in the marginal zone lymphoma (MZL) setting where New York-based TG Therapeutics Inc. is due to report important data during the fourth quarter, the company just might have an edge with its oral PI3K-delta inhibitor, umbralisib.
The FDA cleared Rozlytrek (entrectinib) for the treatment of adults with ROS1-positive, metastatic non-small-cell lung cancer, also granting accelerated approval to the tyrosine kinase inhibitor for adult and pediatric patients (12 and older) with solid tumors that have a NTRK gene fusion.
During its recent conference call on earnings, Fate Therapeutics Inc. gave out what one analyst called "a wake-up call for the entire industry" with regard to cost of goods, just as more are starting to awaken regarding the company's potential therapeutically.
The FDA cleared oral pretomanid, developed by the non-profit TB Alliance, under the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD) as part of a three-drug, six-month, all-oral regimen for the treatment of tuberculosis (TB) in people with extensively drug-resistant disease (XDR-TB) or multidrug-resistant TB (MDR-TB) who are treatment-intolerant or non-responsive.
