Orexo (STO:ORX) touted results today from a 20-person pharmacokinetic study of its OX124-001 naloxone nasal spray. The company’s product is designed to reverse opioid overdoses. In the PK study, Orexo compared its drug to Narcan – the market-leading naloxone rescue medication. Sweden-based Orexo reported that all formulations of OX124 were well-tolerated by study participants and showed […]
Clinical Trials
Frequency Therapeutics raises $42m for hearing regeneration drug
Frequency Therapeutics said today that it closed a $42 million Series B round to support the clinical development of its hearing regeneration drug, FX-322. The company is slated to publish top-line data from an ongoing Phase I/II study of FX-322 in the first half of the year. The Series B round was led by Taiwania […]
Senseonics touts first U.S. trial implant of 180-day CGM
Senseonics (NYSE:SENS) said yesterday that its Eversense XL 180-day continuous glucose sensor was implanted into the first participant of a trial designed to support a pre-market application to the FDA. The company’s 180-patient Promise trial is slated to study the safety and efficacy of the Eversense device in people with diabetes over 180 days. Senseonics also […]
Investigators hit pause on trials following concerns over paclitaxel-coated devices
A meta-analysis published in the Journal of the American Heart Association last week suggested that patients treated with paclitaxel-coated balloons and stents for peripheral artery disease could be at a higher risk for late death compared to people treated with uncoated balloons. The results of the study prompted investigators for two trials to stop their studies. […]
Intersect ENT launches trial of drug-coated sinus balloon
Intersect ENT (NSDQ:XENT) said today that it enrolled the first patient in a trial of its Ascend drug-coated sinus balloon. The Menlo Park, Calif.-based company’s device is designed to deliver mometasone furoate directly to a person’s sinuses at the time of dilation. The 70-person study is slated to explore whether the Ascend device can reduce inflammation […]
Novocure touts analysis of pivotal glioblastoma trial results
Novocure (NSDQ:NVCR) today touted the results of a retrospective sub-group analysis of its EF-14 Phase III pivotal trial in patients with newly diagnosed glioblastoma. The analysis, which was published in the Journal of Neuro-Oncology, demonstrated that more time on Novocure’s Optune device predicted increased survival in people who received Optune plus temozolomide compared to those who received […]
Eyenovia kicks off second Ph3 trial for pupil dilation tech
Eyenovia (NSDQ:EYEN) said this week that it finished patient enrollment in its Phase III Mist-1 trial and enrolled the first patient in its second Phase III trial for the company’s combination eye solution delivered as a micro-dose using its Optejet device. The company is studying the therapy for pharmacologic mydriasis – pupil dilation for eye exams. […]
Statistical error reverses noninferiority finding in head-to-head trial of DES, bioresorbable scaffold
In a reversal, investigators for a trial comparing Biotronik‘s bioresorbable, drug-eluting Orsiro stent and Biosensors‘ BioFreedom drug-eluting stent reported this week that Biosensors’ device did not meet the criteria for noninferiority. The researchers said that while preparing the study for publication in a journal, they discovered a statistical error that ultimately changed the trial’s conclusion. […]
Pulmatrix raises $3m in offering
Pulmatrix (NSDQ:PULM) said this week that it inked a deal with an institutional investor to sell 9,375,000 shares of common stock at 32¢ apiece. The Lexington, Mass.-based company expects to reel in $3 million in total gross proceeds from the offering. Pulmatrix also agreed to issue unregistered warrants to the same investor in a private placement […]
Eyenovia touts publication of intraocular pressure data for micro-dose tech
Eyenovia (NSDQ:EYEN) said this week that the results of its Phase II PG21 study were published in the Nov. issue of the journal Clinical Ophthalmology. The New York-based company’s Phase II study evaluated the effect of self-administered micro-dose latanoprost on intraocular pressure. In the trial, participants successfully self-administered using Eyenovia’s device 88% of the time after limited […]