Rapid point-of-care diagnostics company Lumos Diagnostics Inc. saw its stock shoot up 327% on the news that it finally gained U.S. FDA 510(k) clearance for its Febridx rapid, point-of-care test for bacterial infections. Febridx is a finger prick blood test that can indicate if a person has a bacterial or viral acute respiratory infection within 10 minutes.
Haemalogix Ltd.’s monoclonal antibody Kappamab met all primary endpoints in a phase IIb trial that combined the MAb with lenalidomide and dexamethasone in kappa-type multiple myeloma patients who had relapsed or become refractory to other treatments.
Precision diagnostics company Inoviq Ltd.’s stock soared 44% on the news that its breast cancer diagnostic, SubB2M/CA15-3, detected all stages of breast cancer with 87% accuracy, 81% sensitivity and 93% specificity. The clinical validation study that included 483 samples outperformed the standard of care CAS15-3 test, demonstrating an area under the curve (AUC) of .93 compared to .70.
Enveric Biosciences Inc. is gearing up to begin clinical trials in generalized anxiety disorder with lead candidate, EB-373, a psilocin prodrug. Trials are expected to begin in the fourth quarter of 2023.
Telix Pharmaceuticals Ltd. will acquire Lightpoint Medical Ltd. in a $35 million deal that will expand its urology pipeline and bring in house a new surgery-focused unit. Under the terms of the deal, Telix of Melbourne, Australia, will pay Lightpoint $20 million up front and a further $15 million on achievement of certain development milestones. The up-front payment will be paid in equity, and the additional milestones will be payable in cash or equity, at Telix’s election.
Enveric Biosciences Inc. is gearing up to begin clinical trials in generalized anxiety disorder with lead candidate, EB-373, a psilocin prodrug. Trials are expected to begin in the fourth quarter of 2023.
Telix Pharmaceuticals Ltd. will acquire Lightpoint Medical Ltd. in a $35 million deal that will expand its urology pipeline and bring in house a new surgery-focused unit. Under the terms of the deal, Telix of Melbourne, Australia, will pay Lightpoint $20 million up front and a further $15 million on achievement of certain development milestones. The up-front payment will be paid in equity, and the additional milestones will be payable in cash or equity, at Telix’s election.
The EU’s In Vitro Diagnostic Regulation (IVDR) has not yet been fully implemented, but Australia’s Therapeutic Goods Authority (TGA) is wasting no time attempting to harmonize with the IVDR.
In its second approval this month from the U.S. FDA, Avita Medical Inc.’s Recell system received premarket approval for the repigmentation of stable depigmented vitiligo lesions. The approval marks the first therapeutic device offering a one-time treatment for vitiligo at the point of care. Using the device, a clinician prepares and delivers autologous skin cells from pigmented skin to stable depigmented areas.
After raising AU$4 million (US$2.6 million), Argenica Therapeutics Pty. Ltd. is gearing up to begin phase II trials in ischemic stroke for ARG-007, a glutamate receptor modulator that is believed to reduce brain tissue death after stroke.
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