Describing Kalobios Pharmaceuticals Inc. as "the little engine that could," Cameron Durrant, chairman and CEO, said the company's emergence from bankruptcy opened a new chapter that repositioned newly acquired asset benznidazole as lead compound in its neglected and rare disease pipeline and provided exit equity financing of $11 million to restart its development engines.
Xcovery Inc. launched the phase III trial of X-396 (ensartinib), its lead ALK inhibitor, as a first-line treatment in patients with ALK+ non-small-cell lung cancer. The global, open-label, randomized eXalt3 study is expected to enroll approximately 400 patients to evaluate the efficacy and safety of X-396 head-to-head against Pfizer Inc.'s Xalkori (crizotinib).
Findings from the phase III NOVA trial of niraparib in women with recurrent ovarian cancer blasted shares of developer Tesaro Inc. to an historic high after the company reported the trial achieved its primary endpoint of statistically significant progression-free survival (PFS) compared to control across germline BRCA mutation (gBRCAmut) carriers and non-gBRCAmut carriers, including those with homologous recombination deficient (HRD) tumors.
Armed with a $44 million series B, Annexon Biosciences Inc. extended the development runway for its still-preclinical lead asset through completion of phase II programs designed to answer key questions about its pursuit of classical complement pathway inhibitors to treat neurodegenerative disorders.
Efforts to improve the treatment of multidrug-resistant bacterial infections begin with the pipeline, and pipelines emerge from scientific prowess and deal-making. Despite public rhetoric about confronting the superbug threat globally, experts contend that the cupboard of innovative treatments to address these pathogens is meager and the supply of scientists needed to restock the shelves is scarce.
Efforts to improve the treatment of multidrug-resistant bacterial infections begin with the pipeline, and pipelines emerge from scientific prowess and dealmaking. Despite public rhetoric about confronting the superbug threat globally, experts contend that the cupboard of innovative treatments to address these pathogens is meager and the supply of scientists needed to restock the shelves is scarce.
After a long development saga that stretched across multiple companies, Rayaldee (calcifediol) was approved by the FDA to treat secondary hyperparathyroidism (SHPT) in adults with stage 3 or 4 chronic kidney disease (CKD) who have serum total 25-hydroxyvitamin D levels lower than 30 ng/mL – a first for the indication, which affects predialysis patients.
Rgenix Inc., a start-up from the Rockefeller University lab of co-founder and scientific advisor Sohail Tavazoie, landed a $33 million series B financing led by Novo A/S and Sofinnova Partners. Existing investors, including the Partnership Fund for New York City, Alexandria Venture Investments and Conegliano Ventures LP, also participated.
SAN FRANCISCO – The global markets track during last week's BIO International Convention drew a number of attendees seeking to hear more about the promising China market and its changing regulations.
Infinity Pharmaceuticals Inc. stunned investors early Tuesday by disclosing disappointing results from the registration-focused DYNAMO study. The phase II trial, which evaluated the efficacy and safety of duvelisib – the oral, dual inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma – as a monotherapy in 129 patients with refractory indolent non-Hodgkin lymphoma (iNHL), met its primary endpoint by demonstrating an overall response rate (ORR) of 46 percent.
