A phase III trial testing Astellas Pharma Inc.'s acute myeloid leukemia (AML) candidate, gilteritinib, as a maintenance therapy after hematopoietic stem cell transplant (HCT) has dosed its first patient. It's the fourth late-stage trial testing the FLT3/Axl kinase inhibitor in an active landscape of increasingly tailored AML therapies. If successful, the study could help the Tokyo-based company establish a basis for a potentially broad label for the orphan-designated medicine.
Atyr Pharma Inc. is raising $45.8 million in equity financing through a private placement expected to help it advance both its pulmonary disease-focused iMod.Fc program and the preclinical Project Orca, an immuno-oncology program from which it plans to identify the project’s first candidate.
Xoma Corp. is licensing to Novartis AG global commercial rights to its interleukin-1 (IL-1) beta antibody gevokizumab in the wake of Les Laboratories Servier’s decision last year to quit the asset.
Boehringer Ingelheim GmbH (BI) has started a phase IIa trial in nonalcoholic steatohepatitis (NASH) seeking insight on four different doses of BI-1467335, an anti-inflammatory drug it acquired from Sydney-based Pharmaxis Ltd. The kick-off triggered an €18 million (US$21.3 million) milestone payment for Pharmaxis. A €10 million (US$11.8 million) milestone tied to the launch of another phase II study in a second soon-to-be disclosed indication is expected later this year.
Krystal Biotech Inc., a company developing gene therapies for rare skin disorders, has filed to raise up to $34.5 million in an IPO. Its two preclinical programs, KB-103 for dystrophic epidermolysis bullosa (DEB) and KB-104 for Netherton syndrome, employ an engineered viral vector based on herpes simplex virus 1 and skin-optimized gene transfer.
A phase III trial testing Astellas Pharma Inc.’s acute myeloid leukemia (AML) candidate, gilteritinib, as a maintenance therapy after hematopoietic stem cell transplant (HCT) has dosed its first patient. It’s the fourth late-stage trial testing the FLT3/Axl kinase inhibitor in an active landscape of increasingly tailored AML therapies. If successful, the study could help the company establish a basis for a potentially broad label for the orphan-designated medicine.
Productos Medix S.A. de C.V., a Mexican weight loss specialist leading the most advanced effort to date to get Danish drug developer Saniona AB's first product to market, started a phase III trial of the drug, tesofensine, in obesity. The Medix-funded study is due to finish within two years and could potentially support approval of the triple monoamine reuptake inhibitor as a monotherapy in Mexico, where it's estimated that more than 70 percent of people are overweight and more than 30 percent are clinically obese.
Alzeca Biosciences Inc., a small developer of imaging agents intended to aid early diagnosis of Alzheimer's disease and other neurodegenerative disorders, has closed an $11 million series A financing backed by private investors.
A combination of the Bristol-Myers Squibb Co. checkpoint inhibitors Opdivo (nivolumab) and Yervoy (ipilimumab) diminished the size of previously untreated renal cell carcinomas (RCC) for more people than Pfizer Inc.'s Sutent (sunitinib) during a closely watched phase III trial.
