Oyster Point Pharma (NASDAQ:OYST): Q3 GAAP EPS of -$8.10.
Cash and cash equivalents of $72.28M.
Tuesday, December 3, 2019
Aerie Pharma files Roclanda application in Europe
Aerie Pharmaceuticals (NASDAQ:AERI) has submitted its marketing application in Europe seeking approval of Roclanda (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005% for the reduction of intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
The product was approved in the U.S. in March under the brand name Rocklatan.
Axsome’s AXS-12 achieves primary endpoint in mid-stage narcolepsy study
Axsome Therapeutics (NASDAQ:AXSM) announces that AXS-12 (reboxetine) met the prespecified primary endpoint and significantly reduced the number of cataplexy attacks as compared to placebo in patients with narcolepsy in the CONCERT Phase 2 trial.
AXS-12 also significantly reduced excessive daytime sleepiness and improved cognitive function, sleep quality and sleep-related symptoms.
At Week 2, AXS-12 demonstrated a mean reduction of 14.6 cataplexy attacks per week compared to a reduction of 2.6 attacks per week for placebo, representing mean reductions of 48.8% and 8.6% from baseline, respectively.
The proportion of patients achieving a 50% or greater reduction in the weekly number of cataplexy attacks was 76.2% for AXS-12 compared to 30.0% for placebo at Week 2.
Axsome intends to initiate Phase 3 trials of AXS-12 in 2020.
Shares are up 6% premarket.
Radiology Study Looks at Motorized Scooter Injuries
More than half of people who received X-rays or CT scans after electric scooter accidents were found to have injuries, most commonly to the upper extremities, according to a new study presented today at the annual meeting of the Radiological Society of North America (RSNA). Researchers said the findings underscore the need for more public education on the use of these scooters.
Dockless electric motorized rental scooters, also known as e-scooters, have exploded in popularity in recent years. E-scooters are familiar sights in urban areas and on college campuses, where users value them as an inexpensive, convenient and less strenuous alternative to bicycles.
The rapid growth of rental e-scooters in cities across the U.S. has sparked concerns, as hospital emergency departments have reported a growing number of injuries associated with the vehicles. Earlier this year, the Centers for Disease Control and Prevention (CDC), in association with Austin Public Health, released a study assessing the potential public health impact of e-scooter use.
“E-scooters have a narrow platform, can travel up to 15 to 20 miles per hour and require a level of coordination and skill that is often not native to many users,” said study co-author Aiza Ashraf, M.D., diagnostic radiology resident at the Indiana University School of Medicine in Indianapolis. “Whereas physical effort is required to get a bicycle up to speed, e-scooters are self-powering.”
Imaging exams for e-scooter accidents spiked at Indiana University Health System after the scooters were legalized in Indianapolis in September 2018. To find out more about this trend, Dr. Ashraf, Mohsin Mukhtar, M.D., and colleagues at Indiana University School of Medicine, studied electronic medical records and radiology archives of people ages 18 and older who had exams ordered for scooter-related injuries over a five-year period.
The researchers identified 69 exams performed on 36 unique Emergency Department patients with involvement of an e-scooter. There were 19 males and 17 females included in the study, and two-thirds were in the 18-30 age range. X-rays of the extremities and CT of the head, face and cervical spine were the most common exams ordered.
Nineteen of the 36 patients were found to have a radiographically apparent injury. The most common injuries involved the upper extremities, particularly the wrist. There were six cases of distal radial fractures, or fracture of the forearm bone close to the wrist, making it the most common injury in the study group. Soft tissue injuries of the head, face, wrist and ankle, were present in five cases.
“We believe that many users are not fully aware of the potential significant injuries that may occur with e-scooter use,” Dr. Mukhtar said. “Raising awareness and doing further research on this topic could inform future policy.”
The study findings highlight the importance of protective equipment such as helmets and hand/wrist guards, researchers said, along with the potential dangers of riding while under the influence of intoxicating substances. In addition, the study suggests that communities should consider imposing speed limits on e-scooter users.
“Limiting e-scooter speed could reduce the overall incidence and severity of injuries in the event of a fall or collision,” Dr. Ashraf said. “And since these e-scooters could be viewed as a potential public health hazard, we would recommend public education on the use of these devices.”
The study also found a lack of adequate and specific documentation of scooter type in the emergency medical records. More than 200 instances found in the search may have been e-scooter-related, but lack of documentation in the records prevented the researchers from making a definitive link.
“A robust ability for more systematic data collection and analysis, for example, performed as a multi-institutional public health study, may be of benefit,” Dr. Mukhtar said.
Co-authors are Mark S. Frank, M.D., and Scott D. Steenburg, M.D.
Mission-AbbVie Alzheimer’s, Parkinson’s Collaboration Reaches Milestone
Mission Therapeutics (“Mission”), a drug discovery and development company focused on selectively inhibiting deubiquitylating enzymes (DUBs), and AbbVie (“AbbVie”)(NYSE: ABBV), a global, research-driven biopharmaceutical company, today announced the identification of several DUBs as potential drug targets in their Alzheimer’s and Parkinson’s R&D collaboration.
AbbVie has nominated the panel of DUBs that will be progressed for further characterization and screening activities. This is the first major milestone of the Companies’ DUB research and preclinical development collaboration in neurodegenerative diseases.
Under the terms of the collaboration, announced in November 2018, Mission and AbbVie are working together to identify specific DUBs and discover suitable inhibitor compounds for the treatment of Alzheimer’s and Parkinson’s diseases. AbbVie then has the option to gain exclusive rights to develop and commercialize DUB inhibitors against up to four selected targets. Mission is eligible to receive success-based milestone payments and royalty payments for each commercialized product.
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