-
1 week ago | 
bioworld.com | Lee Landenberger
Early stage cardio data from Verve bump the stockPositive early stage data for Verve Therapeutics Inc.’s base editing therapy points to a range of development options, including bringing partner Eli Lilly and Co. in a little closer. The new data helped ease the company’s pain from the April 2 enrollment pause of a similarly designed therapy from Verve. BioWorld Clinical Cardiovascular Gene therapy
-
1 week ago | 
bioworld.com | Lee Landenberger
Biopharma exempt from US reciprocal tariffs, but not untouchedAt first glance, it appears that biopharmaceuticals dodged the latest U.S. tariff bullet; med-tech, not so much. According to the executive order President Donald...
-
1 week ago | 
bioworld.com | Lee Landenberger
FDA wants a shift away from animal testing In a roadmap to change animal testing requirements for INDs, the U.S. FDA said its new approach will improve drug safety, hasten the evaluation process, and lower costs for companies and patients. It’s another step in a process of changing rules put in place decades ago. BioWorld Regulatory Monoclonal antibody U.S. FDA
-
2 weeks ago | 
bioworld.com | Lee Landenberger
Alzheon’s lead candidate misses a phase III in early Alzheimer’sAlzheon Inc.’s oral treatment for people in the early stages of Alzheimer’s disease missed its phase III primary endpoint, adding yet another therapy to a long list by many developers that can’t beat dementia. The study also received grant money, which is in increasingly short supply. BioWorld Clinical Neurology/psychiatric Small molecule
-
2 weeks ago | 
bioworld.com | Lee Landenberger
More Lexeo data in Friedreich ataxia sees stock slumpLexeo Therapeutics Inc. produced more positive interim data from early stage studies of its gene therapy to treat Friedreich’s ataxia cardiomyopathy. The results have prompted the company to continue their ongoing dialogue with U.S. FDA regulators to finalize a registrational study protocol and launch that study by early 2026 with data the following year. BioWorld Clinical Cardiovascular Gene therapy FDA
-
2 weeks ago | 
bioworld.com | Lee Landenberger
Neurona closes a $102M financingNeurona Therapeutics Inc. has completed an upsized, oversubscribed $102 million financing round, the third company to do so in a month that’s only four days old. The privately held company’s lead asset is NRTX-1001, a regenerative cell therapy derived from human pluripotent stem cells. It is in an ongoing phase I/II study for treating drug-resistant mesial temporal lobe epilepsy and another in drug-resistant bilateral mesial temporal lobe epilepsy.
-
3 weeks ago | 
bioworld.com | Lee Landenberger
IgAN again: Novartis gets second approval in rare kidney diseaseThe U.S. FDA’s accelerated approval of Vanrafia (atrasentan) from Novartis AG for primary immunoglobulin A nephropathy (IgAN) is the company’s second approval for the indication in the past year and a half. The nod also came without a required safety program through a black box warning. BioWorld Regulatory Genitourinary/sexual function Small molecule U.S. FDA
-
3 weeks ago | 
bioworld.com | Lee Landenberger
Edgewise down on atrial fibrillation; cardiomyopathy data positiveTop-line data from the second and third parts of Edgewise Therapeutics Inc.’s four-part phase II Cirrus-HCM study in hypertrophic cardiomyopathy (HCM) has produced more positive data. There was however less enthusiasm for the results than there had been in September for the first batch of data. BioWorld Clinical Cardiovascular Small molecule
-
3 weeks ago | 
bioworld.com | Lee Landenberger
As companies continually search for next-generation obesity prospects, one of the leaders in the disease space, Novo Nordisk A/S, has obtained an exclusive...
-
3 weeks ago | 
bioworld.com | Lee Landenberger
Corcept looks to NDA following strong phase III ovarian cancer dataRelacorilant, a cortisol modulator from Corcept Therapeutics Inc., produced new and strong phase III results in treating platinum-resistant ovarian cancer. The company also has relacorilant in studies that could eventually lead to approval in other indications. In the near term, though, the positive data led to the company’s stock (NASDAQ:CORT) closing 109% higher at $114.22 per share on March 31.
