Pharma Stock Roundup: Regulatory Updates In Focus At PFE, BMY, RHHBY, SNY

In a relatively quiet week with respect to news in the pharma sector, Pfizer’s (NYSE:PFE) regulatory application looking for the approval of rare disease pipeline candidate, tafamidis, was granted priority review by the FDA. While the FDA accepted Roche’s (OTC:RHHBY) label expansion application for approval of a Tecentriq-based cancer combination for first-line lung cancer, the European regulators approved Bristol-Myers’ (NYSE:BMY) Opdivo-based cancer combination for a type of kidney cancer.

Recap of the Week’s Most Important Headlines

FDA Grants Priority Review to Pfizer’s NDA for Tafamidis: The FDA granted to its immuno-oncology combination of Opdivo (3 mg/kg) with Yervoy (1mg/kg) as first-line treatment option for patients with intermediate- and poor-risk advanced renal cell carcinoma, the most common type of kidney cancer. The Opdivo + low-dose Yervoy combination was approved to treat this indication in the United States in April. The approval is based on positive data phase III CheckMate-214 study. Please note that Opdivo + low-dose Yervoy combination is also approved for patients with unresectable or metastatic melanoma in the United States.

FDA Accepts Roche’s sBLA for Tecentriq in First-Line NSCLC: The FDA has accepted Roche’s supplemental biologics license application (sBLA) looking for approval of immunotherapy Tecentriq plus chemotherapy (Abraxane and carboplatin) for the first-line treatment of metastatic non-squamous non-small cell lung cancer. The sBLA is based on data from the phase III IMpower130 study. The FDA’s decision is expected on Sep 2, 2019. The label expansion of the drug will boost sales. In December last year, Tecentriq was approved for use in combination with Avastin plus chemotherapy for first-line metastatic non-squamous NSCLC.

FDA Committee’s Mixed Vote on Sanofi’s Zynquista: An FDA advisory committee gave a mixed vote to Sanofi (NASDAQ:SNY) and partner Lexicon Pharmaceuticals’ diabetes candidate, Zynquista (sotagliflozin), which is under review in the United States for type I diabetes. The Endocrinologic and Metabolic Drugs Advisory Committee voted eight to eight on the question whether the benefits of the SGLT-1 and SGLT-2 inhibitor outweigh the risks to support an approval by the FDA. The FDA is expected to give its decision on Mar 22, 2019. Zynquista is also under review in the EU.

Kitov’s New Data Shows That NT219 has Anti-Cancer Effect: Israel-based small biotech Kitov Pharma Ltd (NASDAQ:KTOV) announced new findings, which demonstrated its anti-tumor resistance drug candidate, NT219’s unique mechanism of action. NT219 is a small molecule that presents a new concept in cancer therapy by targeting two pathways involved in cancer drug resistance. It is being developed to overcome cancer drug resistance and to boost the efficacy of numerous oncology drugs available now. It is being developed for use in combination with other cancer therapies. The data showed that even a short exposure of cancerous cells to NT219 was sufficient to trigger irreversible shutdown of cancer pathways, resulting in a long-term anti-cancer effect.

The NYSE ARCA Pharmaceutical Index rose 0.3% in the last five trading sessions.

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Written By: Zacks Investment Research