President Donald Trump’s recently issued executive order (EO) putting a stop to diversity, equity, and inclusion programs in the U.S. government is sending ripples far and wide, into areas that some might not have anticipated. The FDA has taken down from its website the guidelines regarding action plans related to achieving diversity in clinical trials.
Some favorable and some not-so-great results from separate midstage trials testing the anti-dickkopf homolog 1 antibody sirexatamab in combo regimens for two types of gastrointestinal tumors vexed Leap Therapeutics Inc. (NASDAQ:LPTX), shares of which ended Jan. 28 at 66 cents, down $1.60, or 71%.
As investors look ahead to data shortly from Veru Inc. with enobosarm, the weight-loss space remains hot, with Novo Nordisk A/S reporting favorable top-line results from a phase Ib/IIa trial evaluating amycretin, a unimolecular GLP-1 and amylin receptor agonist for once weekly subcutaneous administration in people overweight or with obesity.
“The [colorectal cancer field is moving, and thankfully it’s moving quickly,” said Marwan Fakih, gastrointestinal specialist at City of Hope, speaking about initial phase II data from Xilio Therapeutics Inc.’s ongoing trial with vilastobart (XTX-101) when paired with PD-L1-blocking antibody Tecentriq (atezolizumab, Roche AG) in metastatic microsatellite stable disease.
Immunoforge Co. Ltd.’s approval of an IND by the Korea Ministry of Food and Drug Safety reminded Wall Street – not that anybody needed reminding – about the marketplace jostle among therapies for chronic myeloid leukemia (CML), where a number of drugs are cleared by the U.S. FDA but significant need remains in terms of efficacy as well as tolerability.
Among the companies to provide updates at the J.P. Morgan Healthcare Conference in San Francisco was Vigil Neuroscience Inc., which has intrigued Wall Street more since the deal signed in December by Muna Therapeutics ApS, of Copenhagen, Denmark, with London-based GSK plc.
Data from two out of three positive studies faced the U.S. FDA’s Anesthetic and Analgesic Drug Products Advisory Committee as members examined the package submitted by Seikagaku Corp., of Tokyo, for SI-6603 (condoliase), a chemonucleolytic drug for radicular leg pain associated with lumbar disc hernia.
Roche AG’s disclosure in December that prasinezumab, partnered with Prothena plc, fell short of its primary phase IIb endpoint put the spotlight on microtubule binding region (MTBR)-targeting therapies in neurological disorders.
The J.P. Morgan (JPM) Healthcare Conference in San Francisco kicked off with a resounding bang as Johnson & Johnson (J&J) disclosed plans to acquire Intra-Cellular Therapies Inc. for $132 per share, which equates to an equity value of about $14.6 billion.
