Roche Holdings AG RHHBY and Spark Therapeutics, Inc. ONCE have received a request for additional information and documentary material from the U.S. Federal Trade Commission (FTC).
The request is in connection with the FTC’s review of the company’s pending acquisition of Spark, which was announced in February 2019.
The request is issued as part of the regulatory review process under Hart-Scott-Rodino Act.
The waiting period will be extended by 10 days after Roche substantially complies with the Second Request, unless the waiting period is terminated earlier by the FTC or the parties enter into a timing agreement with it.
Roche has also extended the period of its previously announced tender offer to purchase all the outstanding shares of common stock of Spark at $114.50 per share till Jul 31, 2019.
We note that the company is looking to diversify its strong oncology portfolio through deals and acquisitions.
The delay in approval by regulatory authorities is disappointing. Spark's shares are trading down on the news.
The impending acquisition will enable Roche to have a foothold in the promising gene-therapy space. Spark Therapeutics is a leader in the field of gene therapy.
Spark Therapeutics’ lead drug, Luxturna, was approved by the FDA for the treatment of patients with viable retinal cells and confirmed biallelic RPE65 mutation-associated retinal dystrophy, a genetic blinding condition caused by mutations in the RPE65 gene. Per the company, Luxturna is the first FDA-approved gene therapy for a genetic disease, the first and only pharmacological treatment for an inherited retinal disease (IRD), and the first adeno-associated virus (AAV) vector gene therapy approved in the United States. The company has a collaboration agreement with Novartis Pharma AG NVS.
The stock has gained 10.1% in the year so far compared with the industry's 1.7% growth.
The addition of Luxturna will bolster Roche’s broad portfolio, as it faces stiff competition from biosimilars for key drugs such as Avastin, Rituxan and Herceptin from Novartis and Amgen AMGN.
Roche currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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