TESARO, Inc. TSRO announced that it has received a Complete Response Letter (CRL) from the FDA regarding its New Drug Application (NDA) for Varubi IV (rolapitant IV). The company was seeking approval of rolapitant IV for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic chemotherapy.
The company’s shares were down 0.9% immediately after the announcement. Over the two following trading session, TESARO’s shares were down 0.2%.
A look at TESARO’s share price movement in the past one year shows that the company has outperformed the Medical Drugs industry, with the stock skyrocketing almost 295%, while the industry registered a decline of 11.9%.
Coming back to the latest news, in the letter, the FDA has asked for additional information regarding the in vitro method utilized to demonstrate the comparability of the product manufactured at the two proposed commercial manufacturers that were included in the application.
In its press release, TESARO noted that it is working hard to address the requested information and intends to respond to the CRL as soon as possible. The company anticipates an approval in the first half of 2017.
However, the FDA did not raise any concerns regarding the safety or efficacy of rolapitant IV, which is encouraging. Also, no concern was raised regarding the active pharmaceutical ingredient, which is also used in Varubi oral product.
We remind investors that Varubi was approved in the U.S. in Sep 2015, in combination with other antiemetic agents, for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy in adults, including, but not limited to, highly emetogenic chemotherapy.
A potential approval of the intravenous formulation of Varubi will be able to address a market with significant unmet need. More than half the patients treated with emetogenic chemotherapy experience the debilitating side effect of chemotherapy induced nausea and vomiting.
Going forward, we expect investors to remain focus on further updates by the company on the regulatory front related to Varubi IV.
TESARO currently carries a Zacks Rank #3 (Hold).
Key Picks in the Sector
Some better-ranked stocks in this industry include Sucampo Pharmaceuticals, Inc. SCMP, Intra-Cellular Therapies, Inc. ITCI, and Kite Pharma, Inc. KITE. While Sucampo sports a Zacks Rank #1 (Strong Buy), Intra-Cellular and Kite Pharma carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Sucmapo’s earnings estimates were stable at $1.22 for 2016 but have increased from $1.30 to $1.74 for 2017 over the last 60 days. The company posted a positive earnings surprise in all of the four trailing quarters with an average beat of 35.5%.
Intra-Cellular’s loss estimates have narrowed 6.6% for 2016 over the last 60 days. The company posted a positive surprise in each of the four trailing quarters, with an average beat of 15.43%.
Kite Pharma’s loss estimates narrowed 2.1% and 0.2% for 2016 and 2017, respectively, over the last 60 days. The company posted a positive surprise twice in the four trailing quarters with an average beat of 7.89%.
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