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.
Dublin-based Jazz Pharmaceuticals plc's buyout of Cavion Inc. via merger with a subsidiary had some on Wall Street scratching their chins, as the takeover undoubtedly adds to the central nervous system (CNS) pipeline but with lingering development risks.
Analysts had questions aplenty for Nektar Therapeutics Inc. about cancer drug candidate bempegaldesleukin ("bempeg," NKTR-214) after the firm made known some apparent manufacturing problems with the compound, a CD122-preferential interleukin-2 pathway agonist designed to stimulate the patient's own immune system and fight various cancer types.
As expected, Rhythm Pharmaceuticals Inc. rolled out positive top-line results from two pivotal, phase III trials evaluating setmelanotide, the company's melanocortin-4 receptor (MCR4R) agonist, for the treatment of pro-opiomelanocortin (POMC) and leptin receptor (LEPR) deficiency obesities.
Leap Therapeutics Inc. said its anti-Dickkopf-1 (DKK1) antibody, DKN-01, in combination with the anti-PD-1 antibody Keytruda (pembrolizumab, Merck & Co. Inc.), turned up higher survival and objective response outcomes in patients with advanced gastroesophageal junction and gastric cancer (GEJ/GC) whose tumors expressed high levels of DKK1 (DKK1-high).
