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Bluebird Bio (BLUE) said on Monday that the Food and Drug Administration had suspended one of its gene therapy studies due to safety concerns and that BLUE’s stock had collapsed.
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The drug is not approved in the United States, but is sold in Europe under the name Skysona. It treats a rare metabolic disorder known as cerebral adrenoleukodystrophy, or CALD.
The biotech company also reported larger-than-expected loss and revenue in the second quarter, below analysts’ expectations. The company recorded a loss per share of $ 3.58 and revenue of $ 7.5 million. The losses have grown year on year and sales have plummeted.
In today’s stock market, BLUE stock fell 27.5% to 18.16.
BLUE stock collapses on clinical standby
A patient who received Skysona gene therapy – also known as Lenti-D – was later diagnosed with a form of cancer called myelodysplastic syndrome.
Bluebird uses what is called a viral vector to insert gene therapy into patients. A viral vector is an “empty”, non-harmful virus. Evidence suggests that the design of the viral vector contributed to the patient’s cancer, Bluebird said in a press release.
“Based on what we know, we remain convinced that (Lenti-D) can offer hope to patients and families affected by this devastating disease who have very few treatment options,” said the CEO Nick Leschly in a written statement.
The company said it plans to resolve the clinical suspension “as soon as possible.” But the BLUE stock has fallen massively.
Bluebird to leave Europe
Meanwhile, Bluebird has confirmed its intention to split into two separate biotech companies: Bluebird and 2Seventy Bio. The separation will take place in the fourth quarter.
Next, Bluebird said it also plans to pull out of Europe. In addition to Skysona gene therapy for CALD, Bluebird also sells Zynteglo, a treatment for beta thalassemia, in Europe. Bluebird says it plans to focus on the United States But the United States is behind Europe in terms of gene therapy approvals.
“While European regulators have been innovative partners in supporting accelerated regulatory pathways for these therapies, European payers have yet to evolve their approach to gene therapy in a way that can recognize innovation and benefits. lifetime expected from these products, ”Andrew Obenshain, Bluebird’s president of serious genetic diseases, said in a written statement.
The company said it hopes to find a potential partner in Europe to license its gene therapies.
Monday’s news took BLUE stock to its lowest level in seven years.
Follow Allison Gatlin on Twitter at @IBD_AGatlin.
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