Positive efficacy results led to Praxis Precision Medicines Inc.’s phase II Embold study in developmental and epileptic encephalopathies (DEEs) being halted early, propelling the company’s shares dramatically upward.
Success by nearly all measures with Praxis Precision Medicines Inc.’s essential tremor phase III candidate, ulixacaltamide, drove the company’s stock up significantly and provided solid data for an NDA filing planned for early 2026.
Essential tremor is a movement disorder marked by involuntary, rhythmic shaking in the hands but sometimes affecting the head, voice and other areas. Its exact cause is still unknown. Recent research suggests that dysfunction in the neurotransmitter systems, particularly involving γ-aminobutyric acid (GABA), contributes significantly to the disorder.
Cala Health Inc.’s KIQ wearable device delivers transcutaneous afferent patterned stimulation through nerves at the wrist that modulate neural activity in the brain and reduces hand tremors in individuals with essential tremor, two recent studies show.
An advisory committee for the U.S. Centers for Medicare & Medicaid Services endorsed a series of patient- and clinician-reported outcomes that might not be reflected in the evidentiary bases for currently available technologies. This development suggests some manufacturers will have to conduct new studies of their devices in order to sustain Medicare coverage.
Rebrain SAS's Optimmri platform received European Medical Device Regulation CE mark certification to enable surgeons to identify areas of interest in the brain during deep brain stimulation procedures for Parkinson's disease and essential tremor.
After Study 1’s independent data monitoring committee said the experiment will likely fall short of its primary endpoint with ulixacaltamide in essential tremor, Praxis Precision Medicines Inc. plans to wait for full data from Study 1 as well as Study 2 in the Essential 3 phase III program before deciding on regulatory moves.
A series of disappointments that drove Sage Therapeutics Inc.’s stock down by 85% since August of 2023 has evolved into an unsolicited takeout offer by partner Biogen Inc., followed by a lawsuit filed by Sage a week later. The two parties, both of Cambridge, Mass., first partnered in a $1.52 billion deal in 2020, primarily to develop Zurzuvae (zuranolone) for depression. The deal included Biogen taking a 10.2% equity stake in Sage, paying $104.14 per share, or $650 million total.
In the wake of Sage Therapeutics Inc.’s recent phase II fizzle with SAGE-324 in essential tremor, Wall Street is waiting for better news in the indication, which has racked up failures across several developers. Among those finding favor lately is Praxis Precision Medicines Inc. with Nav-targeting ulixacaltamide, also known as PRAX-628, which Oppenheimer analyst Francois Brisebois said “warrants particular attention.”
A phase II failure with SAGE-324 in essential tremor (ET) had Wall Street speculating about the fate of Sage Therapeutics Inc.’s partnership with Biogen Inc. Shares of Cambridge, Mass.-based Sage (NASDAQ:SAGE) ended July 24 at $10.38, down $2.70, or 20.6%, after the firm disclosed top-line results from the phase II Kinetic 2 dose-ranging study of oral SAGE-324 (also known as BIIB-124) for ET. The trial did not show a statistically significant dose-response relationship based on the primary endpoint, the Essential Tremor Rating Assessment Scale (TETRAS) Performance Subscale Item 4 (upper limb) total score.
