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The Zacks Analyst Blog Highlights: Flexion Therapeutics, Alexion Pharmaceuticals, PTC Therapeutics, Johnson & Johnson and TESARO
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For Immediate Release
Chicago, IL – October 03, 2017 – Zacks.com announces the list of stocks featured in the Analyst Blog. Every day the Zacks Equity Research analysts discuss the latest news and events impacting stocks and the financial markets. Stocks recently featured in the blog include Flexion Therapeutics (Nasdaq: – Free Report), Alexion Pharmaceuticals (Nasdaq: – Free Report), PTC Therapeutics (Nasdaq:(PTCT - Free Report) – Free Report), Johnson & Johnson (NYSE:(JNJ - Free Report) – Free Report) and TESARO (Nasdaq: – Free Report).
3 Biotech and Pharma Stocks with Key FDA Catalysts This October
The FDA, which approved 22 novel drugs last year, has given its approval to 34 drugs so far in 2017 including three in September. Key approvals this year include Novartis’s Kymriah (the first gene therapy in the United States), Lilly’s Verzenio (advanced or metastatic breast cancer), Gilead’s Vosevi (hepatitis C virus), Puma’s Nerlynx (to reduce the risk of breast cancer returning), J&J’s Tremfya (moderate-to-severe plaque psoriasis), Regeneron/Sanofi’s Kevzara (rheumatoid arthritis), Roche’s multiple sclerosis treatment, Ocrevus, Regeneron and Sanofi’s eczema treatment, Dupixent, Tesaro’s PARP inhibitor, Zejula, and BioMarin’s Brineura (treatment of a specific form of Batten disease) among others. Quite a few of these drugs have blockbuster potential.
With the drug development process being lengthy and time-consuming and requiring the utilization of a lot of funds and resources, key pipeline events including data readouts and regulatory updates are of paramount importance and could act as major catalysts. Here is a look at a few important regulatory events scheduled for the month of October.
Will Flexion Gain Approval for Its First Drug?
Specialty pharma company, Flexion Therapeutics (Nasdaq: – Free Report) is awaiting FDA approval of its first product, Zilretta. The company, which is focused on the development and commercialization of novel, local therapies for the treatment of patients with musculoskeletal conditions, beginning with osteoarthritis (“OA”), expects a decision from the agency on Oct 6, 2017. Flexion is looking to get Zilretta approved for the treatment of OA related knee pain. Zilretta, a non-opioid, could provide OA patients with a new and alternative treatment option on approval. Flexion already has a sales leadership team in place and said that the pre-approval inspection of the Patheon manufacturing facility was concluded without any observations.
Flexion stock has gained 27.1% year to date, substantially outperforming the 3.6% rally of the industry it belongs to.
Alexion’s Soliris Label to Be Expanded Again?
Alexion Pharmaceuticals(Nasdaq: – Free Report) is working on expanding the label of its flagship product, Soliris (eculizumab). Soliris, currently approved in the United States for serious ultra-rare disorders like paroxysmal nocturnal hemoglobinuria (“PNH”) and atypical hemolytic uremic syndrome (aHUS), brought in sales of $1.6 billion in the first half of the year. Alexion has a key catalyst coming up with a decision from the FDA expected by Oct 23, 2017 regarding the approvability of Soliris for refractory generalized myasthenia gravis (gMG). EU approval for this indication came in August making it the first and only complement-based therapy approved for an ultra-rare subset of gMG. The gMG indication represents incremental growth opportunity for Soliris.
PTC Therapeutics(Nasdaq:(PTCT - Free Report) – Free Report) is expecting a decision from the FDA regarding the approval status of Translarna for the treatment of nonsense mutation Duchenne muscular dystrophy (nmDMD). While approved in the EU, Translarna is yet to gain approval in the United States. The company had initially filed a new drug application (“NDA”) in the United States in December 2015. However, in February 2016, the FDA issued a refusal to file (“RTF”) letter saying that the NDA was not sufficiently complete to allow a substantive review. The company was told that both the phase IIb and phase III ACT DMD studies were negative and did not provide sufficient evidence of effectiveness and adequate information about the abuse potential of Translarna. PTC filed a NDA in the first quarter of 2017 and was assigned an FDA action date of Oct 24, 2017.
However, chances of gaining approval seem low considering Translarna failed to gain the support of an FDA advisory panel last week. While the panel found the drug to be effective, they found the submitted data inconclusive and said that more data would be needed to support efficacy. Given this situation, we believe the FDA will issue a complete response letter (“CRL”) and ask for additional data.
PTC’s shares are up 83.4% year to date, compared to the industry’s 3.6% rally.
Apart from the above three companies, quite a few other companies are awaiting decisions from the FDA. Industry bellwether Johnson & Johnson (NYSE:(JNJ - Free Report) – Free Report) is seeking FDA approval for a 10mg dose of Xarelto for reducing the risk of recurrent venous thromboembolism (VTE). With the FDA granting priority review, a response should be out on Oct 28, 2017.
Cancer-focused company, TESARO (Nasdaq: – Free Report) is expecting a decision from the FDA for its intravenous (“IV”) formulation of rolapitant on Oct 25, 2017. The company had received a CRL earlier this year for the IV formulation.
Today's Stocks from Zacks' Hottest Strategies
It's hard to believe, even for us at Zacks. But while the market gained +18.8% from 2016 - Q1 2017, our top stock-picking screens have returned +157.0%, +128.0%, +97.8%, +94.7%, and +90.2% respectively.
And this outperformance has not just been a recent phenomenon. Over the years it has been remarkably consistent. From 2000 - Q1 2017, the composite yearly average gain for these strategies has beaten the market more than 11X over. Maybe even more remarkable is the fact that we're willing to share their latest stocks with you without cost or obligation.
Zacks Equity Research provides the best of quantitative and qualitative analysis to help investors know what stocks to buy and which to sell for the long-term.
Continuous coverage is provided for a universe of 1,150 publicly traded stocks. Our analysts are organized by industry which gives them keen insights to developments that affect company profits and stock performance. Recommendations and target prices are six-month time horizons.
Strong Stocks that Should Be in the News
Many are little publicized and fly under the Wall Street radar. They're virtually unknown to the general public. Yet today's 220 Zacks Rank #1 "Strong Buys" were generated by the stock-picking system that has nearly tripled the market from 1988 through 2015. Its average gain has been a stellar +26% per year.See these high-potential stocks free >>.
Zacks Investment Research is under common control with affiliated entities (including a broker-dealer and an investment adviser), which may engage in transactions involving the foregoing securities for the clients of such affiliates.
Past performance is no guarantee of future results. Inherent in any investment is the potential for loss. This material is being provided for informational purposes only and nothing herein constitutes investment, legal, accounting or tax advice, or a recommendation to buy, sell or hold a security. No recommendation or advice is being given as to whether any investment is suitable for a particular investor. It should not be assumed that any investments in securities, companies, sectors or markets identified and described were or will be profitable. All information is current as of the date of herein and is subject to change without notice. Any views or opinions expressed may not reflect those of the firm as a whole. Zacks Investment Research does not engage in investment banking, market making or asset management activities of any securities. These returns are from hypothetical portfolios consisting of stocks with Zacks Rank = 1 that were rebalanced monthly with zero transaction costs. These are not the returns of actual portfolios of stocks. The S&P 500 is an unmanaged index. Visit https://www.zacks.com/performance for information about the performance numbers displayed in this press release.
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The Zacks Analyst Blog Highlights: Flexion Therapeutics, Alexion Pharmaceuticals, PTC Therapeutics, Johnson & Johnson and TESARO
For Immediate Release
Chicago, IL – October 03, 2017 – Zacks.com announces the list of stocks featured in the Analyst Blog. Every day the Zacks Equity Research analysts discuss the latest news and events impacting stocks and the financial markets. Stocks recently featured in the blog include Flexion Therapeutics (Nasdaq: – Free Report), Alexion Pharmaceuticals (Nasdaq: – Free Report), PTC Therapeutics (Nasdaq:(PTCT - Free Report) – Free Report), Johnson & Johnson (NYSE:(JNJ - Free Report) – Free Report) and TESARO (Nasdaq: – Free Report).
Today, Zacks is promoting its ''Buy'' stock recommendations. Get #1Stock of the Day pick for free.
Here are highlights from Monday’s Analyst Blog:
3 Biotech and Pharma Stocks with Key FDA Catalysts This October
The FDA, which approved 22 novel drugs last year, has given its approval to 34 drugs so far in 2017 including three in September. Key approvals this year include Novartis’s Kymriah (the first gene therapy in the United States), Lilly’s Verzenio (advanced or metastatic breast cancer), Gilead’s Vosevi (hepatitis C virus), Puma’s Nerlynx (to reduce the risk of breast cancer returning), J&J’s Tremfya (moderate-to-severe plaque psoriasis), Regeneron/Sanofi’s Kevzara (rheumatoid arthritis), Roche’s multiple sclerosis treatment, Ocrevus, Regeneron and Sanofi’s eczema treatment, Dupixent, Tesaro’s PARP inhibitor, Zejula, and BioMarin’s Brineura (treatment of a specific form of Batten disease) among others. Quite a few of these drugs have blockbuster potential.
With the drug development process being lengthy and time-consuming and requiring the utilization of a lot of funds and resources, key pipeline events including data readouts and regulatory updates are of paramount importance and could act as major catalysts. Here is a look at a few important regulatory events scheduled for the month of October.
Will Flexion Gain Approval for Its First Drug?
Specialty pharma company, Flexion Therapeutics (Nasdaq: – Free Report) is awaiting FDA approval of its first product, Zilretta. The company, which is focused on the development and commercialization of novel, local therapies for the treatment of patients with musculoskeletal conditions, beginning with osteoarthritis (“OA”), expects a decision from the agency on Oct 6, 2017. Flexion is looking to get Zilretta approved for the treatment of OA related knee pain. Zilretta, a non-opioid, could provide OA patients with a new and alternative treatment option on approval. Flexion already has a sales leadership team in place and said that the pre-approval inspection of the Patheon manufacturing facility was concluded without any observations.
Flexion stock has gained 27.1% year to date, substantially outperforming the 3.6% rally of the industry it belongs to.
Alexion’s Soliris Label to Be Expanded Again?
Alexion Pharmaceuticals(Nasdaq: – Free Report) is working on expanding the label of its flagship product, Soliris (eculizumab). Soliris, currently approved in the United States for serious ultra-rare disorders like paroxysmal nocturnal hemoglobinuria (“PNH”) and atypical hemolytic uremic syndrome (aHUS), brought in sales of $1.6 billion in the first half of the year. Alexion has a key catalyst coming up with a decision from the FDA expected by Oct 23, 2017 regarding the approvability of Soliris for refractory generalized myasthenia gravis (gMG). EU approval for this indication came in August making it the first and only complement-based therapy approved for an ultra-rare subset of gMG. The gMG indication represents incremental growth opportunity for Soliris.
Alexion’s shares are up 14.7% year to date, compared to the industry’s 16.2% rally. Alexion is a Zacks Rank #3 (Hold) stock - you can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
CRL Likely for PTC’s Translarna
PTC Therapeutics(Nasdaq:(PTCT - Free Report) – Free Report) is expecting a decision from the FDA regarding the approval status of Translarna for the treatment of nonsense mutation Duchenne muscular dystrophy (nmDMD). While approved in the EU, Translarna is yet to gain approval in the United States. The company had initially filed a new drug application (“NDA”) in the United States in December 2015. However, in February 2016, the FDA issued a refusal to file (“RTF”) letter saying that the NDA was not sufficiently complete to allow a substantive review. The company was told that both the phase IIb and phase III ACT DMD studies were negative and did not provide sufficient evidence of effectiveness and adequate information about the abuse potential of Translarna. PTC filed a NDA in the first quarter of 2017 and was assigned an FDA action date of Oct 24, 2017.
However, chances of gaining approval seem low considering Translarna failed to gain the support of an FDA advisory panel last week. While the panel found the drug to be effective, they found the submitted data inconclusive and said that more data would be needed to support efficacy. Given this situation, we believe the FDA will issue a complete response letter (“CRL”) and ask for additional data.
PTC’s shares are up 83.4% year to date, compared to the industry’s 3.6% rally.
Apart from the above three companies, quite a few other companies are awaiting decisions from the FDA. Industry bellwether Johnson & Johnson (NYSE:(JNJ - Free Report) – Free Report) is seeking FDA approval for a 10mg dose of Xarelto for reducing the risk of recurrent venous thromboembolism (VTE). With the FDA granting priority review, a response should be out on Oct 28, 2017.
Cancer-focused company, TESARO (Nasdaq: – Free Report) is expecting a decision from the FDA for its intravenous (“IV”) formulation of rolapitant on Oct 25, 2017. The company had received a CRL earlier this year for the IV formulation.
Today's Stocks from Zacks' Hottest Strategies
It's hard to believe, even for us at Zacks. But while the market gained +18.8% from 2016 - Q1 2017, our top stock-picking screens have returned +157.0%, +128.0%, +97.8%, +94.7%, and +90.2% respectively.
And this outperformance has not just been a recent phenomenon. Over the years it has been remarkably consistent. From 2000 - Q1 2017, the composite yearly average gain for these strategies has beaten the market more than 11X over. Maybe even more remarkable is the fact that we're willing to share their latest stocks with you without cost or obligation.
See Them Free>>
Today, Zacks is promoting its ''Buy'' stock recommendations. Get #1 Stock of the Day pick for free.
About Zacks Equity Research
Zacks Equity Research provides the best of quantitative and qualitative analysis to help investors know what stocks to buy and which to sell for the long-term.
Continuous coverage is provided for a universe of 1,150 publicly traded stocks. Our analysts are organized by industry which gives them keen insights to developments that affect company profits and stock performance. Recommendations and target prices are six-month time horizons.
Strong Stocks that Should Be in the News
Many are little publicized and fly under the Wall Street radar. They're virtually unknown to the general public. Yet today's 220 Zacks Rank #1 "Strong Buys" were generated by the stock-picking system that has nearly tripled the market from 1988 through 2015. Its average gain has been a stellar +26% per year.See these high-potential stocks free >>.
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Past performance is no guarantee of future results. Inherent in any investment is the potential for loss. This material is being provided for informational purposes only and nothing herein constitutes investment, legal, accounting or tax advice, or a recommendation to buy, sell or hold a security. No recommendation or advice is being given as to whether any investment is suitable for a particular investor. It should not be assumed that any investments in securities, companies, sectors or markets identified and described were or will be profitable. All information is current as of the date of herein and is subject to change without notice. Any views or opinions expressed may not reflect those of the firm as a whole. Zacks Investment Research does not engage in investment banking, market making or asset management activities of any securities. These returns are from hypothetical portfolios consisting of stocks with Zacks Rank = 1 that were rebalanced monthly with zero transaction costs. These are not the returns of actual portfolios of stocks. The S&P 500 is an unmanaged index. Visit https://www.zacks.com/performance for information about the performance numbers displayed in this press release.