Sangamo Touts Additional Positive Data For Fabry Gene Therapy Candidate

 

• Sangamo Therapeutics Inc 
  SGMO-0.74%+ Free Alerts
   has announced updated preliminary results from the Phase 1/2 STAAR study evaluating isaralgagene civaparvovec (ST-920), a gene therapy candidate for Fabry disease. 
• Recently, Sangamo and Pfizer Inc 
  PFE+1.93%+ Free Alerts
   reopened enrollment in phase 3 AFFINE study hemophilia A gene therapy trial after pausing it due to some patients experiencing blood clotting protein factor VIII activity greater than 150%. 
• These latest data show that all nine patients treated in the dose escalation phase across the four dose cohorts sustained elevated α-Gal A activity ranging from nearly 2-fold to 30-fold of mean normal at the last measurement date.
• The gene therapy was generally well tolerated. All treatment-related adverse events were mild except for one instance of moderate pyrexia. No treatment-related serious adverse events were reported. 
• Four patients were withdrawn from enzyme replacement therapy (ERT) and demonstrated significantly elevated levels of α-Gal A activity up to 28 weeks post-withdrawal.
• Since the cutoff date, one additional patient was withdrawn from ERT.
• The Phase 1/2 STAAR study has progressed into the expansion phase, with four patients dosed. Sangamo is currently planning for a potential Phase 3 clinical trial.

https://www.benzinga.com/general/biotech/22/10/29234106/sangamo-touts-additional-positive-data-for-fabry-gene-therapy-candidate

Owens & Minor Shares Plummet On Reduced Annual Forecasts

 

• Owens & Minor Inc 
  OMI-22.9%+ Free Alerts
   expects Q3 GAAP EPS of $0.15 - $0.17 and adjusted EPS of $0.39 - $0.41, below the consensus of $0.51.
• The company has also updated its FY22 adjusted EPS guidance of $2.50 - $2.60, down from the previous guidance of $2.85 - $3.15.
• OMI expects adjusted EBITDA of $527-$537 million, compared to the earlier forecast of $570-$610 million.
• The company said the Patient Direct segment continues to perform well. The Products & Healthcare Services segment is facing more pressures than previously expected, with unfavorable macroeconomic conditions that show no signs of abating, elevated customer stocking levels, and continued lower-than-expected hospital procedure volume. 
• The company also appointed Andrew Long as EVP, CEO of the Products & Healthcare Services segment, replacing Jeffrey Jochims, who will leave the company. 
• Long has served as the Company's EVP and CFO since joining the Company in November 2019. In addition, Alexander Bruni has been promoted to EVP and CFO, replacing Long.
• Alex Bruni joined Owens & Minor in April 2020 and has served as SVP of Finance, first leading corporate FP&A, then progressing to become the finance leader of the Products & Healthcare Services segment and, most recently, the Patient Direct segment.

https://www.benzinga.com/news/earnings/22/10/29235716/owens-minor-shares-plummet-on-reduced-annual-forecasts

Tiziana Plans to Submit IND for Phase 1 Trial of Intranasal Foralumab in Alzheimer's

 Tiziana Life Sciences Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies via novel routes of drug delivery, today announced that it plans to submit an Investigational New Drug Application (IND) for a Phase 1 Trial of intranasal foralumab in Alzheimer's disease patients after receiving an affirmative written response from the FDA on a Pre-Investigational New Drug Application (PIND). Tiziana plans on filing the IND for Alzheimer’s disease by the third quarter of 2023 upon the completion of requested toxicology studies, then starting its Phase 1 program by the end of 2023.

https://finance.yahoo.com/news/tiziana-life-sciences-plans-submit-110000916.html