Roche's Esbriet Gets FDA Breakthrough Tag For New Indication
Zacks Investment Research | Mar 02, 2020 09:53PM ET
Roche Holding (SIX:ROG) AG’s (OTC:RHHBY) member, Genentech, announced that the FDA has granted Breakthrough Therapy designation to Esbriet (pirfenidone) for the treatment of adults with unclassifiable interstitial lung disease (uILD). ILD broadly describes a diverse group of more than 200 types of rare pulmonary diseases. The study represents the first randomized controlled trial to exclusively enroll patients with progressive fibrosing uILD.
FDA’s Breakthrough Therapy designation is granted to speed up the development and review of drugs that target serious or life-threatening conditions. The designation also indicates that Esbriet is eligible for accelerated approval and priority review depending upon certain criteria. The designation was granted on the basis of a phase II study, which assessed the efficacy and safety of Esbriet in uILD. The data showed that the drug slowed disease progression and supported its efficacy on a number of lung function parameters, including forced vital capacity (FVC), in people with uILD at 24 weeks.
We remind investors that Esbriet is an oral medicine approved for the treatment of idiopathic pulmonary fibrosis (IPF), which is available in more than 60 countries worldwide. The drug generated sales of CHF1.1 billion in 2019.
Shares of the company have rallied 20.8% in the past year compared with the industry ’s 6.3% growth.
A potential approval of Esbriet for the treatment of uILD will further boost sales for the company.
Notably, aTyr Pharma, Inc. (NASDAQ:LIFE) is also developing ATYR1923 for interstitial lung diseases (ILDs) in Japan. aTyr is currently enrolling in a proof-of-concept phase Ib/IIa study evaluating ATYR1923 in patients with pulmonary sarcoidosis. This is a multi-ascending dose, placebo-controlled, first-in-patient study that has been designed to evaluate the safety, tolerability, steroid-sparing effect, immunogenicity and pharmacokinetics profile of multiple doses of ATYR1923.
Roche Holding AG Price
the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here .
Novartis’ earnings per share estimates have increased from $5.67 to $5.74 for 2020 in the past 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters by 6.25%, on average.
Pfizer’s earnings per share estimates have increased from $2.67 to $2.80 for 2020 in the past 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters by 7.46%, on average.
Breakout Biotech Stocks with Triple-Digit Profit Potential
The biotech sector is projected to surge beyond $775 billion by 2024 as scientists develop treatments for thousands of diseases. They’re also finding ways to edit the human genome to literally erase our vulnerability to these diseases. Zacks has just released Century of Biology: 7 Biotech Stocks to Buy Right Now to help investors profit from 7 stocks poised for outperformance. Our recent biotech recommendations have produced gains of +50%, +83% and +164% in as little as 2 months. The stocks in this report could perform even better.
Get The News You Want
Zacks Investment Research
Trading in financial instruments and/or cryptocurrencies involves high risks including the risk of losing some, or all, of your investment amount, and may not be suitable for all investors. Prices of cryptocurrencies are extremely volatile and may be affected by external factors such as financial, regulatory or political events. Trading on margin increases the financial risks.
Before deciding to trade in financial instrument or cryptocurrencies you should be fully informed of the risks and costs associated with trading the financial markets, carefully consider your investment objectives, level of experience, and risk appetite, and seek professional advice where needed.
Fusion Media would like to remind you that the data contained in this website is not necessarily real-time nor accurate. The data and prices on the website are not necessarily provided by any market or exchange, but may be provided by market makers, and so prices may not be accurate and may differ from the actual price at any given market, meaning prices are indicative and not appropriate for trading purposes. Fusion Media and any provider of the data contained in this website will not accept liability for any loss or damage as a result of your trading, or your reliance on the information contained within this website.
It is prohibited to use, store, reproduce, display, modify, transmit or distribute the data contained in this website without the explicit prior written permission of Fusion Media and/or the data provider. All intellectual property rights are reserved by the providers and/or the exchange providing the data contained in this website.
Fusion Media may be compensated by the advertisers that appear on the website, based on your interaction with the advertisements or advertisers.