Hospital Universitario La Paz

ORYZON Reports Financial Results and Corporate Update for Quarter Ended March 31, 2023

Retrieved on: 
Wednesday, May 10, 2023

Dr Carlos Buesa, Oryzon’s Chief Executive Officer, said: “Oryzon has made strong clinical progress in the first quarter this year.

Key Points: 
  • Dr Carlos Buesa, Oryzon’s Chief Executive Officer, said: “Oryzon has made strong clinical progress in the first quarter this year.
  • Research and development (R&D) expenses were $4.4 million for the quarter ended March 31, 2023, compared to $4.2million for the quarter ended March 31, 2022.
  • General and administrative expenses were $1.2 million for the first quarter ended March 31, 2023, compared to $1.3 million for the first quarter ended March 31, 2022.
  • Net losses were $1.4 million for the first quarter ended March 31, 2023, compared to $1.7 million for the first quarter ended March 31, 2022.

BioCryst Presents New Data Demonstrating Consistently Low Attack Rates Among HAE Patients After Switching to ORLADEYO® (berotralstat)

Retrieved on: 
Friday, July 1, 2022

The analysis of the attack-free status of patients with HAE who switched from injectable LTP therapy to ORLADEYO in APeX-S builds on previous data that have shown consistently low attack rates in ORLADEYO patients.

Key Points: 
  • The analysis of the attack-free status of patients with HAE who switched from injectable LTP therapy to ORLADEYO in APeX-S builds on previous data that have shown consistently low attack rates in ORLADEYO patients.
  • APeX-S was an open-label, international study that evaluated safety and tolerability of ORLADEYO 110 mg and 150 mg in HAE patients.
  • Consistently low attack rates were observed in these patients, with median attack rates following the switch to ORLADEYO monotherapy of 0.0 throughout 12 months of treatment with ORLADEYO.
  • These data further demonstrate that ORLADEYO is generally well tolerated and an effective prophylactic therapy that reduces attack rates and improves QoL in patients with HAE.

Masimo Announces FDA Clearance of Pediatric Indication for SedLine® Brain Function Monitoring and the SedLine Pediatric EEG Sensor

Retrieved on: 
Monday, February 28, 2022

Masimo (NASDAQ: MASI) announced today the FDA clearance of SedLine brain function monitoring for pediatric patients (1-17 years of age) and the SedLine Pediatric EEG Sensor.

Key Points: 
  • Masimo (NASDAQ: MASI) announced today the FDA clearance of SedLine brain function monitoring for pediatric patients (1-17 years of age) and the SedLine Pediatric EEG Sensor.
  • Equipped with Masimos advanced signal processing technology, SedLine helps clinicians monitor brain activity bilaterally by processing electroencephalogram (EEG) signals from Masimos four-lead SedLine EEG sensors.
  • Joe Kiani, Founder and CEO of Masimo, said, SedLine is achieving for brain function monitoring what Masimo SET did for pulse oximetry.
  • These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo SedLine and the SedLine Pediatric EEG Sensor, as well as their FDA clearane for pediatric patients.

ORYZON to Present New Clinical Data and Corporate Updates at International Conferences in September and October

Retrieved on: 
Wednesday, September 22, 2021

Oryzon will present preliminary data from the ongoing collaboration with INGEMM in Phelan McDermid Syndrome (PMS) at the International Conference on Autism, ICA-2021, which will be held on September 23-24.

Key Points: 
  • Oryzon will present preliminary data from the ongoing collaboration with INGEMM in Phelan McDermid Syndrome (PMS) at the International Conference on Autism, ICA-2021, which will be held on September 23-24.
  • The communication entitled "Phenotype and Psychometric Characterization of Phelan McDermid Syndrome Patients" will be presented by Dr. Carlos Buesa, Oryzons CEO.
  • Executive directors of the company will attend the BIO Spain 2021 event, which will take place September 27-October 1.
  • The company will moderate a KOL panel discussion on precision medicine therapeutic approaches for CNS disorders and the potential of LSD1 inhibitors like vafidemstat.