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Biotech Stock Roundup: Alexion Reports 4Q Results, Celgene MS Drug Looks Promising
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Key updates in the biotech sector include a mixed quarter from Alexion and promising data on Celgene’s investigational multiple sclerosis (MS) treatment.
Recap of the Week’s Most Important Stories
Mixed Results from Alexion: Alexion’s fourth quarter results were mixed with the company reporting in-line earnings while revenues were just shy of expectations (Read more: Alexion Q4 Earnings In-Line, Sales Rise Y/Y). Alexion’s guidance for 2017 also fell short of expectations. Although flagship drug, Soliris, is expected to continue benefiting from a steady number of new patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic-uremic syndrome (aHUS) across the world, sales will nevertheless be impacted by patient recruitment for the company’s ongoing and planned ALXN1210 studies as well as other studies -- this will impact Soliris revenues by $70 million to $110 million during the year. Moreover, access challenges in Latin America will remain an issue. Within the metabolics franchise, growth will remain moderate with Strensiq revenue per patient expected to be less compared to 2016 as younger patients start treatment.
Celgene’s MS Drug Scores in Late-Stage Study: Celgene’s experimental MS disease drug, ozanimod, met the primary endpoints in a phase III study compared to Biogen’s Avonex. The candidate’s safety and tolerability were consistent with that observed in mid-stage studies. The next step for the company is to report data from a confirmatory study in the second quarter. If all goes well, the company should be in a position to submit regulatory filings by year end.
While MS affects about 400,000 people in the U.S. and approximately 2.5 million people across the world, several treatments like Tysabri, Tecfidera, Gilenya and Aubagio are available. A favorable safety profile could help ozanimod pick share once launched and the drug could bring in sales of more than a billion dollars. Ozanimod has potential not just in MS but also in other lucrative disease areas like ulcerative colitis and Crohn's disease. Celgene is a Zacks Rank #2 (Buy) stock. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Cidara Slumps on CD101 Results: Cidara’s shares plunged 38.5% on disappointing mid-stage data on CD101 topical which was being evaluated for acute vulvovaginal candidiasis (VVC). The company has decided to stop further development of the topical formulation for VVC and will instead focus its resources towards the development of the IV formulation of CD101, as well as the expansion and acceleration of the Cloudbreak immunotherapy platform. CD101 IV is currently in a mid-stage study for candidemia with results expected in the fourth quarter.
Sarepta to Sell Priority Review Voucher to Gilead: Sarepta (SRPT - Free Report) , which was in the news last year for gaining FDA approval for Exondys 51, the first drug approved to treat patients with Duchenne muscular dystrophy (DMD), said that it has entered into a deal with biotech giant Gilead (GILD - Free Report) to sell off its Rare Pediatric Disease Priority Review Voucher (PRV). Sarepta had received the PRV at the time of gaining approval for Exondys 51. Once the deal closes, Gilead will make a payment of $125 million.
While the sale of the PRV will provide Sarepta with a non-dilutive source of funds which the company intends to use to advance the development of its follow on exon skipping candidates and next generation RNA targeted antisense platform, the price tag has given rise to concerns regarding the declining value of PRVs. Earlier, companies like United Therapeutics have sold PRVs for as much as $350 million.
Priority Review for The Medicines Co.’s Carbavance: The FDA has granted priority review to The Medicines Co.’s experimental IV antibiotic, Carbavance. The company is looking to get the antibiotic approved for the treatment of complicated urinary tract infections (cUTIs). At present, the agency does not plan to hold an advisory panel meeting for the drug. Meanwhile, results from an ongoing late-stage study are expected in the third quarter. Carbavance has fast track status in the U.S. for the cUTI indication and is also a Qualified Infectious Disease Product (QIDP) under the GAIN Act.
Over the last one year, The Medicines Co. has significantly outperformed the Zacks-categorized Medical-Biomedical/Genetics industry with shares shooting up 58.1% compared to the industry decline of 3.3%.
EU Nod for New Dosing Option for Amgen’s Repatha: Amgen (AMGN - Free Report) gained EU approval for its single dose administration option for its PCSK9 inhibitor, Repatha. This makes Repatha the first PCSK9 inhibitor in Europe to offer a monthly single-dose delivery option. This dosing option was approved in the U.S. last year in July.
Performance
Medical - Biomedical and Genetics Industry 5YR % Return
The NASDAQ Biotechnology Index was up 1% over the last five trading sessions. Among major biotech stocks, Amgen was up 3% while Vertex declined 2.7%. Over the last six months, Gilead was down 14.4%, while Celgene was up 4.6% (See the last biotech stock roundup here: Regeneron's Praluent to Remain on Market for Now, GILD Presents HIV Data).
What's Next in the Biotech World?
Watch out for the usual pipeline and regulatory updates and earnings updates from companies like BioMarin (BMRN - Free Report) , Exelixis and others. Celgene is also awaiting a decision from the FDA regarding the label expansion of its key revenue generator Revlimid for use in newly diagnosed multiple myeloma (NDMM) patients after an autologous stem-cell transplant (ASCT). Label expansion into this indication will be a significant driver of Revlimid sales. Lexicon Pharmaceuticals also has a big day coming up with the FDA expected to decide on the approval status of telotristat ethyl for the treatment of carcinoid syndrome on Feb 28.
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Biotech Stock Roundup: Alexion Reports 4Q Results, Celgene MS Drug Looks Promising
Key updates in the biotech sector include a mixed quarter from Alexion and promising data on Celgene’s investigational multiple sclerosis (MS) treatment.
Recap of the Week’s Most Important Stories
Mixed Results from Alexion: Alexion’s fourth quarter results were mixed with the company reporting in-line earnings while revenues were just shy of expectations (Read more: Alexion Q4 Earnings In-Line, Sales Rise Y/Y). Alexion’s guidance for 2017 also fell short of expectations. Although flagship drug, Soliris, is expected to continue benefiting from a steady number of new patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic-uremic syndrome (aHUS) across the world, sales will nevertheless be impacted by patient recruitment for the company’s ongoing and planned ALXN1210 studies as well as other studies -- this will impact Soliris revenues by $70 million to $110 million during the year. Moreover, access challenges in Latin America will remain an issue. Within the metabolics franchise, growth will remain moderate with Strensiq revenue per patient expected to be less compared to 2016 as younger patients start treatment.
Celgene’s MS Drug Scores in Late-Stage Study: Celgene’s experimental MS disease drug, ozanimod, met the primary endpoints in a phase III study compared to Biogen’s Avonex. The candidate’s safety and tolerability were consistent with that observed in mid-stage studies. The next step for the company is to report data from a confirmatory study in the second quarter. If all goes well, the company should be in a position to submit regulatory filings by year end.
While MS affects about 400,000 people in the U.S. and approximately 2.5 million people across the world, several treatments like Tysabri, Tecfidera, Gilenya and Aubagio are available. A favorable safety profile could help ozanimod pick share once launched and the drug could bring in sales of more than a billion dollars. Ozanimod has potential not just in MS but also in other lucrative disease areas like ulcerative colitis and Crohn's disease. Celgene is a Zacks Rank #2 (Buy) stock. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Cidara Slumps on CD101 Results: Cidara’s shares plunged 38.5% on disappointing mid-stage data on CD101 topical which was being evaluated for acute vulvovaginal candidiasis (VVC). The company has decided to stop further development of the topical formulation for VVC and will instead focus its resources towards the development of the IV formulation of CD101, as well as the expansion and acceleration of the Cloudbreak immunotherapy platform. CD101 IV is currently in a mid-stage study for candidemia with results expected in the fourth quarter.
Sarepta to Sell Priority Review Voucher to Gilead: Sarepta (SRPT - Free Report) , which was in the news last year for gaining FDA approval for Exondys 51, the first drug approved to treat patients with Duchenne muscular dystrophy (DMD), said that it has entered into a deal with biotech giant Gilead (GILD - Free Report) to sell off its Rare Pediatric Disease Priority Review Voucher (PRV). Sarepta had received the PRV at the time of gaining approval for Exondys 51. Once the deal closes, Gilead will make a payment of $125 million.
While the sale of the PRV will provide Sarepta with a non-dilutive source of funds which the company intends to use to advance the development of its follow on exon skipping candidates and next generation RNA targeted antisense platform, the price tag has given rise to concerns regarding the declining value of PRVs. Earlier, companies like United Therapeutics have sold PRVs for as much as $350 million.
Priority Review for The Medicines Co.’s Carbavance: The FDA has granted priority review to The Medicines Co.’s experimental IV antibiotic, Carbavance. The company is looking to get the antibiotic approved for the treatment of complicated urinary tract infections (cUTIs). At present, the agency does not plan to hold an advisory panel meeting for the drug. Meanwhile, results from an ongoing late-stage study are expected in the third quarter. Carbavance has fast track status in the U.S. for the cUTI indication and is also a Qualified Infectious Disease Product (QIDP) under the GAIN Act.
Over the last one year, The Medicines Co. has significantly outperformed the Zacks-categorized Medical-Biomedical/Genetics industry with shares shooting up 58.1% compared to the industry decline of 3.3%.
EU Nod for New Dosing Option for Amgen’s Repatha: Amgen (AMGN - Free Report) gained EU approval for its single dose administration option for its PCSK9 inhibitor, Repatha. This makes Repatha the first PCSK9 inhibitor in Europe to offer a monthly single-dose delivery option. This dosing option was approved in the U.S. last year in July.
Performance
Medical - Biomedical and Genetics Industry 5YR % Return
Medical - Biomedical and Genetics Industry 5YR % Return
The NASDAQ Biotechnology Index was up 1% over the last five trading sessions. Among major biotech stocks, Amgen was up 3% while Vertex declined 2.7%. Over the last six months, Gilead was down 14.4%, while Celgene was up 4.6% (See the last biotech stock roundup here: Regeneron's Praluent to Remain on Market for Now, GILD Presents HIV Data).
What's Next in the Biotech World?
Watch out for the usual pipeline and regulatory updates and earnings updates from companies like BioMarin (BMRN - Free Report) , Exelixis and others. Celgene is also awaiting a decision from the FDA regarding the label expansion of its key revenue generator Revlimid for use in newly diagnosed multiple myeloma (NDMM) patients after an autologous stem-cell transplant (ASCT). Label expansion into this indication will be a significant driver of Revlimid sales. Lexicon Pharmaceuticals also has a big day coming up with the FDA expected to decide on the approval status of telotristat ethyl for the treatment of carcinoid syndrome on Feb 28.
Just Released – Driverless Cars: Your Roadmap to Mega-Profits Today
In this latest Special Report, Zacks’ Aggressive Growth Strategist Brian Bolan explores a full-blown technological breakthrough in the making – autonomous cars. He also spotlights 8 stocks with tremendous gain potential to feed off this phenomenon. Click to see the stocks right now >>