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ORTX

Orchard Therapeutics

$13.33 /

+0.28 (+2.15%)

07:09
01/29/20
01/29
07:09
01/29/20
07:09

Orchard Therapeutics granted Orphan Drug Designation for OTL-102

Orchard Therapeutics announced that it has received orphan drug designation from the U.S. Food and Drug Administration for OTL-102, the company's ex vivo autologous hematopoietic stem cell gene therapy being investigated for the treatment of X-linked chronic granulomatous disease. The FDA may grant orphan designation to drugs and biologics intended to treat a rare disease or condition affecting fewer than 200,000 persons in the U.S. Early academic clinical trial data for OTL-102 that was recently published in Nature Medicine demonstrates that ex vivo autologous HSC gene therapy may be a promising approach for the treatment of X-CGD. The letter, which was led by researchers at the University of California, Los Angeles - including Donald B. Kohn, M.D., one of the study's lead investigators and professor of microbiology, immunology and molecular genetics at UCLA - and Great Ormond Street Hospital, provides an analysis of safety and efficacy outcomes in nine severely affected patients with X-CGD. At 12 months post-treatment, six of seven surviving patients, all of whom were adults or late adolescents, exceeded the minimum threshold hypothesized in published literature to demonstrate potential clinical benefit, defined as 10% functioning, oxidase-positive neutrophils in circulation and have discontinued preventive antibiotics. As previously reported, two pediatric patients died within three months of treatment from complications deemed by the investigators and independent data and safety monitoring board to be related to pre-existing comorbidities due to advanced disease progression and unrelated to OTL-102. Investigators are planning to enroll additional pediatric patients in 2020 to assess outcomes in this patient population. In addition, there is work underway to improve the efficiency of the drug product manufacturing process prior to initiating a registrational study.

ORTX Orchard Therapeutics
$13.33 /

+0.28 (+2.15%)

09/17/19
Fly Intel: Top five analyst initiations
09/17/19
Guggenheim bullish on Orchard Therapeutics, initiates with a Buy
09/17/19 Guggenheim
Orchard Therapeutics initiated with a Buy at Guggenheim
09/05/19 Barclays
Orchard Therapeutics initiated with an Overweight at Barclays

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