Advanced Accelerator Applications S.A. announced that the FDA has accepted and considered complete the resubmission of the New Drug Application (NDA) for its investigational drug lutetium Lu 177 dotatate (Lutathera). The FDA has set an action date of Jan 26, 2018.
Advanced Accelerator is looking to get Lutathera approved for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in adults.
Advanced Accelerator’s shares have outperformed the industry year to date. The stock rallied 82.5% as against the industry’s decline of 1.2%, over the same time frame.
We remind investors that Advanced Accelerator received a complete response letter (CRL) from the FDA for the NDA for Lutathera in December last year. The FDA showed concerns about issues related with format, traceability, uniformity, and completeness relating to the NETTER-1 (phase III study that compared treatment using lutetium Lu 177 oxodotreotide with a double dose of Octreotide LAR) and Erasmus (Phase I/II study conducted in patients with a wide range of NET indications) clinical datasets.
Further, the CRL requested subgroup analyses for gender, age and racial subgroups, as well as other stratification factors and important disease characteristics. The CRL also noted that that any observations made during inspections of manufacturing facilities supporting the NDA need to be resolved prior to approval of the NDA. However, the FDA did not request for additional studies.
The company resubmitted the application in July 2017 after taking into consideration the concerns expressed by the FDA. As part of this process, the company sent a test dataset to the FDA to confirm that the data and format were compatible and able to be analyzed. Further, the company also engaged a team of consultants experienced in FDA reviews to perform a rigorous critique of both the datasets and the major clinical sections of the dossier prior to resubmitting.
Last month, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion recommending the marketing authorization of lutetium for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in adults.
Zacks Rank & Stocks to Consider
Advanced Accelerator currently holds a Zacks Rank #3 (Hold). Better-ranked stocks in health care sector include Alexion Pharmaceuticals, Inc. (ALXN - Free Report) , Regeneron Pharmaceuticals, Inc. (REGN - Free Report) and Aduro BioTech, Inc. (ADRO - Free Report) . While Alexion and Regeneron sport a Zacks Rank #1 (Strong Buy), Aduro carries Zacks Rank#2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Alexion Pharmaceuticals’ earnings per share estimates have moved up from $5.57 to $5.61 for 2017 and from $6.90 to $6.92 for 2018 over the last 30 days. The company delivered positive earnings surprises in all the trailing four quarters, with an average beat of 11.12%. The share price of the company has increased 13.7% year to date.
Regeneron’s earnings per share estimates have increased from $12.84 to $14.78 for 2017 and from $15.32 to $16.21 for 2018 over the last 30 days. The company pulled off positive earnings surprises in two of the trailing four quarters, with an average beat of 10.11%. The share price of the company has increased 30.5% year to date.
Aduro’s loss estimates per share have narrowed from $1.46 to $1.32 for 2017 and from $1.41 to $1.24 for 2018 over last 30 days. The company came up with positive earnings surprises in two of the trailing four quarters, with an average beat of 2.53%.
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