After rolling out positive, preliminary phase I CAR natural killer cell data, Nkarta Inc. saw its stock (NASDAQ:NKTX) soar to $18.72, up $10.95, or 140.9%, as Wall Street made known its pleasure in results from the small, independent dose-finding studies with Nkarta’s two off-the-shelf lead candidates, NKX-101 and NKX-019, in two groups of blood cancer patients: those with relapsed/refractory (r/r) acute myeloid leukemia (AML) and with r/r non-Hodgkin lymphoma (NHL), respectively. Read More
Shares of Eliem Therapeutics Inc. fell 56% on the company’s announcement that it would end development of its non-opioid palmitoylethanolamide prodrug, ETX-810, in diabetic peripheral neuropathic pain following a phase IIa failure. It was part of a double dose of bad news reported by Seattle-based Eliem, which also is delaying phase II development of depression candidate ETX-155 to resolve issues of lower-than-expected drug exposure in a phase I study of the neuroactive steroid GABAA receptor positive allosteric modulator in photosensitive epilepsy. Read More
Shares in Valneva SE fell sharply after the company said European regulators came back with further queries, including on antibody efficacy data, instead of a recommendation during a rolling review of its delayed COVID-19 vaccine. The company had expected a positive opinion on the vaccine, known as VLA-2001, following the April meeting of the European Medicines Agency’s CHMP committee. Read More
Cambridge Innovation Capital (CIC) has closed its oversubscribed Fund II at £225 million (US$287 million) and is moving from its previous model of open-ended investing to a traditional fixed-term venture capital fund. The money will be dedicated to spinouts from Cambridge University, with CIC investing in series A rounds, but also following on as companies mature and their capital requirements increase. Read More
Epitopea Ltd. raised $13.6 million in seed financing to take forward a new cancer immunotherapy platform based on the identification of a new class of tumor-specific antigens encoded by non-canonical genomic sequences. Read More
Forcefield Therapeutics Ltd. has arrived on the scene with £5.5 million (US$7 million) in funding to advance development of naturally occurring proteins that have been shown to arrest the loss of cardiomyocytes in the immediate aftermath of myocardial infarction. Read More
More than a quarter of all clinical data reported this year are targeting cancer indications, as pandemic news dips and overall activity drops by 12.5%. Read More
There may be no COVID-19 vaccines authorized yet in the U.S. for the youngest children, but there’s now an approved treatment for some children who are already sick with an infection. Read More
Recognizing that patient views about the tradeoffs of using one drug over another may differ from those of doctors, the U.S. FDA’s Office of Prescription Drug Promotion is proposing to examine those tradeoffs in an analysis involving fictitious prescription drugs for type 2 diabetes and psoriasis. Read More
Links to electronic information may become a more common feature in Canadian prescription drug labeling, but electronic labeling is not expected to replace paper labels anytime soon. Read More
New hires and promotions in the biopharma industry, including: Affyimmune, Biomunex, Biotheryx, Evonetix, Generate, Iecure, Inhibrx, Rayzebio, Xalud. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Faron, Isofol, Novavax, Roche, Scynexis, Takeda. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Acelrx, Assembly, Arrowhead, Astellas, Biotest, Grifols, Medigene, Nektar, Portage, Porton, Sinorda, Stimunity, Tiancheng, Turnstone, Visirna, Wave and Xbiome. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bayer, Biogen, Direct, Incyte, Lynk, Medac, Medexus, Novartis, Revance. Read More
