Acurx Pharmaceuticals' ACX-362E, being developed to treat patients with Clostridium difficile infection, received qualified infectious disease product status from the FDA. The company intends to launch an early-stage clinical trial of the candidate in the fourth quarter.
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The FDA approved the inclusion of new evidence from a late-stage study that Novartis' Cosentyx, or secukinumab, slows progression of joint structural damage at week 24 in patients with active psoriatic arthritis.
CytoDyn submitted to the FDA protocol amendments for a Phase II study of PRO 140 in patients with graft-versus-host disease, which includes switching pretreatment conditioning to reduced intensity conditioning from aggressive myeloablative conditioning. The revision also includes switching to open-label design from a blinded 1-to-1 randomized placebo-controlled design and a 50% increase in the PRO 140 dose.
A regulator in Poland granted Moleculin Biotech approval to begin a Phase I/II clinical trial of its experimental drug Annamycin, indicated for relapsed or refractory acute myeloid leukemia. The approval will allow Moleculin to start patient recruitment, with the study expected to begin later this year.
FDA's Antimicrobial Drugs Advisory Committee will meet Aug. 8 to discuss two new drug applications for Paratek Pharmaceuticals' qualified infectious disease product- and fast-track-tagged omadacycline, in oral and IV formulations, for the treatment of patients with community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections. The candidate achieved the primary endpoints of three late-stage studies for both indications.
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Follow-on funding pulled in $73.1 million for ObsEva, which recently reported that its candidate OBE2109, or linzagolix, met the primary endpoint in the Phase IIb EDELWEISS study for endometriosis-associated pain indication. The company also has Phase III PRIMROSE 1 and 2 trials of the candidate for uterine fibroid-associated heavy menstrual bleeding.
An untranched round of Series B financing pulled in $10 million for Aminex Therapeutics. The company recently dosed the first patient in an early-stage trial of AMXT 1501 as monotherapy or in combination with eflornithine to treat solid tumors.
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TG Therapeutics and Novimmune of Switzerland will collaborate on developing the latter's bispecific antibody TG-1801 to treat hematologic B cell malignancies, with the partners planning to launch clinical testing of their candidate, to be developed and marketed by TG, this year or early next year. In addition to an undisclosed exclusive option, Novimmune will gain $3 million in TG stock upfront plus early clinical development milestones, with additional milestones totaling up to $185 million and royalties if TG exercises its own undisclosed exclusive option.
Editing a section of pigs' DNA left them immune to the virus that causes porcine reproductive and respiratory syndrome, a disease that causes abortion and breathing problems for which there is no effective vaccine or treatment. The technology could improve herd health and reduce the need for antibiotic use, experts said.
A total of $40 million will be awarded by the Energy Department to 31 projects furthering studies on how organisms such as yeast, fungi, cyanobacteria and rare thermophilic microbes can be used to produce bioproducts including biofuels from renewable resources.
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