In a relatively quiet week with respect to news in the pharma sector, Pfizer’s ( PFE – Free Report ) 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 ( RHHBY – Free Report ) label expansion application for approval of a Tecentriq-based cancer combination for first-line lung cancer, the European regulators approved Bristol-Myers’ ( BMY – Free Report ) 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 priority review to Pfizer’s new drug application (NDA) looking for approval of pipeline candidate tafamidis, which has been developed to treat transthyretin amyloid cardiomyopathy (ATTR-CM), a rare and fatal illness associated with progressive heart failure.
Pfizer filed two NDAs for tafamidis, one for the meglumine form (20 mg capsule) and the other for a free acid form (61 mg capsule). The priority review designation is for the meglumine form with the FDA’s decision on this NDA expected in July this year. The FDA decision for the NDA for the free acid form is expected in November with the filing getting a standard review period. The NDA filings are based on data from a phase III study, ATTR-ACT.
EU Nod for Bristol-Myers’ Cancer Combo for Kidney Cancer: Bristol-Myers announced that the European Commission has given approval 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 ( SNY – Free Report ) 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 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.
Here is how the seven major stocks performed in the last five trading sessions: It was a mixed performance in the last five trading sessions with Bristol-Myers recording the maximum gain (3.9%) and AstraZeneca ( AZN – Free Report ) declining the most (7.1%) in the same period.
In the past six months, Lilly ( LLY – Free Report ) has been the biggest gainer (33.2%) while Bristol-Myers declined the most (12.3%).
(See the last pharma stock roundup here: Lilly to Buy Loxo for $8B, M&A in Focus at JP Morgan Meet)
What’s Next in the Pharma World?
Watch out for J&J’s fourth-quarter and full year 2018 earnings results and pipeline and regulatory updates next week.
Looking for Stocks with Skyrocketing Upside?
Zacks has just released a Special Report on the booming investment opportunities of legal marijuana.
Ignited by new referendums and legislation, this industry is expected to blast from an already robust $6.7 billion to $20.2 billion in 2021. Early investors stand to make a killing, but you have to be ready to act and know just where to look.
Click here to view original web page at Pharma Stock Roundup: Regulatory Updates in Focus at PFE, BMY, RHHBY, SNY