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Biotech Stock Roundup: Regeneron Down on Eylea Data, Biogen-Alkermes in MS Deal
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It was a relatively slow week given the Thanksgiving break. Key developments this week include Biogen’s (BIIB - Free Report) deal with Alkermes (ALKS - Free Report) and Regeneron’s (REGN - Free Report) disappointing data on Eylea.
Recap of the Week’s Most Important Stories
Biogen Inks Deal with Alkermes for MS Drug: Biogen, a key player in the multiple sclerosis (“MS”) market, has signed up with Alkermes for the worldwide development and commercialization of ALKS 8700. ALKS 8700, a novel, oral, monomethyl fumarate (“MMF”) small drug molecule, is currently in late-stage development for the treatment of relapsing forms of MS.
Under the terms of the deal, Alkermes will receive 50% of the costs it incurred in 2017 related to the development of ALKS8700 (an upfront payment of $28 million) as well as royalties in the mid-teens rate on worldwide net sales. Alkermes could also receive up to $200 million on the achievement of certain milestones with the first payment of $50 million to be recorded in 2017.
With this collaboration, Biogen is basically looking to protect the sales of its blockbuster oral MS drug, Tecfidera (dimethyl fumarate). A new drug application (“NDA”) for ALKS8700 will be filed in 2018 under the 505(b)(2) regulatory pathway referencing Tecfidera. ALKS8700, which has been associated with a differentiated gastrointestinal (“GI”) tolerability profile, is also in a head-to-head study with Tecfidera evaluating the GI profile (Read more: Biogen Acquires Worldwide License for Alkermes' MS Candidate). Alkermes’s shares were up 1.6% on the agreement while Biogen was up 1.7%.
Biogen’s shares are up 11.8% year to date, compared to the 1.1% gain recorded by the industry it belongs to.
Eylea Combination Falls Short in Mid-Stage Studies: Regeneron provided a disappointing update related to its plans for expanding the label of its flagship eye drug, Eylea. The company said that a combination of Eylea and nesvacumab, an Ang2 antibody, evaluated in a couple of mid-stage studies, did not show sufficient differentiation compared to Eylea alone to justify advancement into late-stage development.
While one study was in patients with diabetic macular edema (“DME”), the other was in patients with wet age-related macular degeneration (wet AMD). This is not the first time that Regeneron has faced a setback in its efforts to co-formulate the blockbuster drug. Last year, the company had announced that a mid-stage study evaluating Eylea in combination with rinucumab, an anti-PDGFR-beta antibody, failed to show improvement over Eylea alone in patients with neovascular age-related macular degeneration (wet AMD).
Next up is data from a late-stage study evaluating Eylea in diabetic retinopathy, a growing patient population with significant need – these results should be out in the first half of 2018 (Read more: Regeneron's Stock Falls as Mid-Stage Eye Disease Studies Fail).
Catalyst Drug Positive in Second Phase III Study: Catalyst Pharmaceuticals’s (CPRX - Free Report) shares were up 10.3% on positive top-line results from a second late-stage study on Firdapse for the symptomatic treatment of Lambert-Eaton myasthenic syndrome (“LEMS”), a rare autoimmune disorder. The company said that it remains on track to file for FDA approval in the first quarter of 2018. Firdapse has breakthrough designation in the United States (Read more: Catalyst Reports Positive Phase III Data on Firdapse).
CytomX to get $10 Million Milestone Payment from Bristol-Myers: CytomX Therapeutics (CTMX - Free Report) will be receiving a $10 million milestone payment from partner, Bristol-Myers Squibb, with the FDA accepting the investigational new drug application (“IND”) for a CTLA-4-directed Probody therapeutic.
The companies are collaborating for the discovery, development and commercialization of novel therapies using CytomX‘s proprietary Probody platform. Bristol-Myers has the option to select up to ten oncology targets and two non-oncology targets. Including CTLA-4, Bristol-Myers has selected five oncology targets until now.
Performance
Medical - Biomedical and Genetics Industry 5YR % Return
The NASDAQ Biotechnology Index was up 0.2% over the last four trading sessions. Among major biotech stocks, Biogen was up 2.6% while Regeneron declined 4.8% reflecting investor disappointment about the Eylea pipeline setback. Over the last six months, Biogen was up 26.5% while Regeneron lost 19.6% (See the last biotech stock roundup here: RARE drug Gets FDA Nod, Acorda, Cytokinetics Hit by Pipeline Setbacks).
What's Next in the Biotech World?
Watch out for the usual pipeline and regulatory updates. Amgen (AMGN - Free Report) should get a response from the FDA on December 2 regarding its supplemental Biologics License Application (sBLA) for the inclusion of risk reduction of major cardiovascular events based on data from the large Repatha cardiovascular outcomes study. Repatha is Amgen’s PCSK9 inhibitor.
Investor Alert: Breakthroughs Pending
A medical advance is now at the flashpoint between theory and realization. Billions of dollars in research have poured into it. Companies are already generating substantial revenue, and even more wondrous products are in the pipeline.
Cures for a variety of deadly diseases are in sight, and so are big potential profits for early investors. Zacks names 5 stocks to buy now.
Image: Bigstock
Biotech Stock Roundup: Regeneron Down on Eylea Data, Biogen-Alkermes in MS Deal
It was a relatively slow week given the Thanksgiving break. Key developments this week include Biogen’s (BIIB - Free Report) deal with Alkermes (ALKS - Free Report) and Regeneron’s (REGN - Free Report) disappointing data on Eylea.
Recap of the Week’s Most Important Stories
Biogen Inks Deal with Alkermes for MS Drug: Biogen, a key player in the multiple sclerosis (“MS”) market, has signed up with Alkermes for the worldwide development and commercialization of ALKS 8700. ALKS 8700, a novel, oral, monomethyl fumarate (“MMF”) small drug molecule, is currently in late-stage development for the treatment of relapsing forms of MS.
Under the terms of the deal, Alkermes will receive 50% of the costs it incurred in 2017 related to the development of ALKS8700 (an upfront payment of $28 million) as well as royalties in the mid-teens rate on worldwide net sales. Alkermes could also receive up to $200 million on the achievement of certain milestones with the first payment of $50 million to be recorded in 2017.
With this collaboration, Biogen is basically looking to protect the sales of its blockbuster oral MS drug, Tecfidera (dimethyl fumarate). A new drug application (“NDA”) for ALKS8700 will be filed in 2018 under the 505(b)(2) regulatory pathway referencing Tecfidera. ALKS8700, which has been associated with a differentiated gastrointestinal (“GI”) tolerability profile, is also in a head-to-head study with Tecfidera evaluating the GI profile (Read more: Biogen Acquires Worldwide License for Alkermes' MS Candidate). Alkermes’s shares were up 1.6% on the agreement while Biogen was up 1.7%.
Biogen’s shares are up 11.8% year to date, compared to the 1.1% gain recorded by the industry it belongs to.
Eylea Combination Falls Short in Mid-Stage Studies: Regeneron provided a disappointing update related to its plans for expanding the label of its flagship eye drug, Eylea. The company said that a combination of Eylea and nesvacumab, an Ang2 antibody, evaluated in a couple of mid-stage studies, did not show sufficient differentiation compared to Eylea alone to justify advancement into late-stage development.
While one study was in patients with diabetic macular edema (“DME”), the other was in patients with wet age-related macular degeneration (wet AMD). This is not the first time that Regeneron has faced a setback in its efforts to co-formulate the blockbuster drug. Last year, the company had announced that a mid-stage study evaluating Eylea in combination with rinucumab, an anti-PDGFR-beta antibody, failed to show improvement over Eylea alone in patients with neovascular age-related macular degeneration (wet AMD).
Next up is data from a late-stage study evaluating Eylea in diabetic retinopathy, a growing patient population with significant need – these results should be out in the first half of 2018 (Read more: Regeneron's Stock Falls as Mid-Stage Eye Disease Studies Fail).
Catalyst Drug Positive in Second Phase III Study: Catalyst Pharmaceuticals’s (CPRX - Free Report) shares were up 10.3% on positive top-line results from a second late-stage study on Firdapse for the symptomatic treatment of Lambert-Eaton myasthenic syndrome (“LEMS”), a rare autoimmune disorder. The company said that it remains on track to file for FDA approval in the first quarter of 2018. Firdapse has breakthrough designation in the United States (Read more: Catalyst Reports Positive Phase III Data on Firdapse).
Catalyst is a Zacks Rank #3 (Hold) stock. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
CytomX to get $10 Million Milestone Payment from Bristol-Myers: CytomX Therapeutics (CTMX - Free Report) will be receiving a $10 million milestone payment from partner, Bristol-Myers Squibb, with the FDA accepting the investigational new drug application (“IND”) for a CTLA-4-directed Probody therapeutic.
The companies are collaborating for the discovery, development and commercialization of novel therapies using CytomX‘s proprietary Probody platform. Bristol-Myers has the option to select up to ten oncology targets and two non-oncology targets. Including CTLA-4, Bristol-Myers has selected five oncology targets until now.
Performance
Medical - Biomedical and Genetics Industry 5YR % Return
Medical - Biomedical and Genetics Industry 5YR % Return
The NASDAQ Biotechnology Index was up 0.2% over the last four trading sessions. Among major biotech stocks, Biogen was up 2.6% while Regeneron declined 4.8% reflecting investor disappointment about the Eylea pipeline setback. Over the last six months, Biogen was up 26.5% while Regeneron lost 19.6% (See the last biotech stock roundup here: RARE drug Gets FDA Nod, Acorda, Cytokinetics Hit by Pipeline Setbacks).
What's Next in the Biotech World?
Watch out for the usual pipeline and regulatory updates. Amgen (AMGN - Free Report) should get a response from the FDA on December 2 regarding its supplemental Biologics License Application (sBLA) for the inclusion of risk reduction of major cardiovascular events based on data from the large Repatha cardiovascular outcomes study. Repatha is Amgen’s PCSK9 inhibitor.
Investor Alert: Breakthroughs Pending
A medical advance is now at the flashpoint between theory and realization. Billions of dollars in research have poured into it. Companies are already generating substantial revenue, and even more wondrous products are in the pipeline.
Cures for a variety of deadly diseases are in sight, and so are big potential profits for early investors. Zacks names 5 stocks to buy now.
Click here to see them >>