Interim results from Kalytera Therapeutics Inc.'s phase II open-label study of multiple doses of cannabidiol (CBD) in preventing acute graft-vs.-host disease (GVHD) were positive enough to persuade the company to skip enrolling the high-dose cohort and move directly to a phase III registration study.
What began a year and a half ago as a takeover of Impact Biomedicines Inc. ended Friday with FDA approval for the wholly owned Celgene Corp. subsidiary's rare bone marrow disorders drug, Inrebic (fedratinib).
The as-much-as-$15 million follow-on public offering proposed by Honolulu-based Cardax Inc. won't move the company off the island but it's designed to move it from the OCTQB to Nasdaq.
Phase III results for evinacumab from Regeneron Pharmaceuticals Inc. released Wednesday show a 49% LDL cholesterol reduction in patients with homozygous familial hypercholesterolemia (HoFH) when compared to lipid-reducing therapies alone.
The multiple months that typically separate a successful round of fundraising and entering the clinic are being brushed aside by Landos Biopharma Inc. as the company races toward two phase II trials following its just completed $60 million series B financing.
A choppy year for Amgen Inc. may be smoothing out after the U.S. District Court of New Jersey ruled that patents for Sandoz Inc.'s biosimilar, Erelzi (etanercept-szzs), a potential competitor to Amgen's highly lucrative arthritis treatment Enbrel (etanercept), should never have been granted.
The advisory committee meeting (adcom) that slowed progress for Amarin Corp. and its pending supplemental new drug application (sNDA) for expanding the labeling of Vascepa (icosapent ethyl) was a shock not only to the company but to investors, too, as the stock (NASDAQ:AMRN) took a battering Friday.
A successful $55 million series D fundraising allowed Oric Pharmaceuticals Inc.'s CEO to lean upon on a truism that's often easily waved away in business fundamentals as he overhauled the company management.
With a $33 million series B round now under his belt, Glycomine Inc.'s CEO said serendipity is a large part of what brought the company to study glycosylation disorders, a rare disease that affects about 1,000 people.
Neoleukin Therapeutics Inc. and Aquinox Pharmaceuticals Inc. agreed to a merger in which Aquinox acquires Neoleukin, and Neoleukin becomes the official company name. The combined company plans to develop and commercialize computationally designed protein therapeutics for unmet needs in immuno-oncology, inflammation and autoimmunity.
