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Biotech Stock Roundup: Label Expansion of Regeneron's Eylea, Vertex's Kalydeco
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The major regular pipeline and regulatory updates in the biotech sector over the past week includes Regeneron Pharmaceuticals’ (REGN - Free Report) getting an FDA nod for its ophthalmology drug Eylea. The FDA also approved a label expansion of Vertex Pharmaceuticals’ (VRTX - Free Report) Kalydeco.
Recap of the Week’s Most Important Stories:
Regeneron Gets FDA Approval for Label Expansion of Eylea: Regeneron announced that the FDA has approved a supplemental Biologics License Application (sBLA) for its flagship ophthalmology drug, Eylea injection, in patients with wet age-related macular degeneration (wet AMD). The news comes as a surprise as earlier this month, the FDA issued a complete response letter (CRL) to its sBLA because of ongoing labeling discussions. Eylea is already approved to treat wet AMD for every four- or eight-week dosing intervals after three initial monthly doses.
Regeneron and partner Teva Pharmaceutical Industries Ltd. (TEVA - Free Report) also announced positive top-line results from a phase III study on the pipeline candidate, fasinumab. This randomized, double-blind, placebo-controlled study of fasinumab was conducted to treat patients with chronic pain from osteoarthritis (OA) of the knee or hip.
FDA Accepts Alexion’s BLA for ALXN1210: Alexion Pharmaceuticals, Inc. announced that the FDA has granted a priority review to its biologics license application (BLA) for C5 complement inhibitor, ALXN1210. The candidate is being evaluated for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH). The FDA has set an action date of Feb 18, 2019. Since Alexion used a rare disease priority review voucher, the review period is now fixed for eight months instead of the standard 12 months. The application is supported by positive data from two phase III studies on the largest population of patients with PNH.
Vertex's Cystic Fibrosis Drug Gets FDA Nod for Children: The FDA approved Vertex Pharmaceuticals Incorporated’s cystic fibrosis (CF) drug, Kalydeco, for its use in children between 12 and 24 months, who have at least one mutation in their CF transmembrane conductance regulator (CFTR) gene, responsive to Kalydeco based on clinical and/or in vitro assay data. The approval was based on data from an ongoing phase III program, ARRIVAL, evaluating 25 kids, who have one of 10 mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. A similar line-extension application is under review in the EU with a decision expected in the first half of next year. Kalydeco is a key revenue driver for Vertex.
Alnylam Completes Enrolment in Late-Stage Study of Givosiran: Alnylam Pharmaceuticals, Inc. (ALNY - Free Report) announced that it has achieved full-patient accrual in its phase III study, ENVISION, on investigational RNAi therapeutic givosiran for the treatment of acute hepatic porphyrias (AHPs). Enrolment in the study was completed among 94 AHP patients, which crossed the initial target of approximately 75 patients owing to high patient demand. Top-line results of the interim analysis are expected by this September-end in support of a potential accelerated approval. Additional data is expected in early 2019. Alnylam expects to submit an NDA by 2018 end, seeking an accelerated approval.
Performance
Medical - Biomedical and Genetics Industry 5YR % Return
The NASDAQ Biotechnology Index has inched up 1.68% over the last five trading sessions. Among the major biotech stocks, Regeneron has gained 4.61%. Over the past six months, Gilead has lost 7.75% while Biogen has rallied 19.9%. (See the last biotech stock roundup here: Biotech Stock Roundup: Regeneron Shines, BLUE Surges, ONCE Plunges)
What's Next in Biotech?
Stay tuned for regulatory updates and pipeline development news.
More Stock News: This Is Bigger than the iPhone!
It could become the mother of all technological revolutions. Apple sold a mere 1 billion iPhones in 10 years but a new breakthrough is expected to generate more than 27 billion devices in just 3 years, creating a $1.7 trillion market.
Zacks has just released a Special Report that spotlights this fast-emerging phenomenon and 6 tickers for taking advantage of it. If you don't buy now, you may kick yourself in 2020.
Image: Bigstock
Biotech Stock Roundup: Label Expansion of Regeneron's Eylea, Vertex's Kalydeco
The major regular pipeline and regulatory updates in the biotech sector over the past week includes Regeneron Pharmaceuticals’ (REGN - Free Report) getting an FDA nod for its ophthalmology drug Eylea. The FDA also approved a label expansion of Vertex Pharmaceuticals’ (VRTX - Free Report) Kalydeco.
Recap of the Week’s Most Important Stories:
Regeneron Gets FDA Approval for Label Expansion of Eylea: Regeneron announced that the FDA has approved a supplemental Biologics License Application (sBLA) for its flagship ophthalmology drug, Eylea injection, in patients with wet age-related macular degeneration (wet AMD). The news comes as a surprise as earlier this month, the FDA issued a complete response letter (CRL) to its sBLA because of ongoing labeling discussions. Eylea is already approved to treat wet AMD for every four- or eight-week dosing intervals after three initial monthly doses.
Regeneron and partner Teva Pharmaceutical Industries Ltd. (TEVA - Free Report) also announced positive top-line results from a phase III study on the pipeline candidate, fasinumab. This randomized, double-blind, placebo-controlled study of fasinumab was conducted to treat patients with chronic pain from osteoarthritis (OA) of the knee or hip.
Regeneron currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
FDA Accepts Alexion’s BLA for ALXN1210: Alexion Pharmaceuticals, Inc. announced that the FDA has granted a priority review to its biologics license application (BLA) for C5 complement inhibitor, ALXN1210. The candidate is being evaluated for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH). The FDA has set an action date of Feb 18, 2019. Since Alexion used a rare disease priority review voucher, the review period is now fixed for eight months instead of the standard 12 months. The application is supported by positive data from two phase III studies on the largest population of patients with PNH.
Vertex's Cystic Fibrosis Drug Gets FDA Nod for Children: The FDA approved Vertex Pharmaceuticals Incorporated’s cystic fibrosis (CF) drug, Kalydeco, for its use in children between 12 and 24 months, who have at least one mutation in their CF transmembrane conductance regulator (CFTR) gene, responsive to Kalydeco based on clinical and/or in vitro assay data. The approval was based on data from an ongoing phase III program, ARRIVAL, evaluating 25 kids, who have one of 10 mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. A similar line-extension application is under review in the EU with a decision expected in the first half of next year. Kalydeco is a key revenue driver for Vertex.
Alnylam Completes Enrolment in Late-Stage Study of Givosiran: Alnylam Pharmaceuticals, Inc. (ALNY - Free Report) announced that it has achieved full-patient accrual in its phase III study, ENVISION, on investigational RNAi therapeutic givosiran for the treatment of acute hepatic porphyrias (AHPs). Enrolment in the study was completed among 94 AHP patients, which crossed the initial target of approximately 75 patients owing to high patient demand. Top-line results of the interim analysis are expected by this September-end in support of a potential accelerated approval. Additional data is expected in early 2019. Alnylam expects to submit an NDA by 2018 end, seeking an accelerated approval.
Performance
Medical - Biomedical and Genetics Industry 5YR % Return
Medical - Biomedical and Genetics Industry 5YR % Return
The NASDAQ Biotechnology Index has inched up 1.68% over the last five trading sessions. Among the major biotech stocks, Regeneron has gained 4.61%. Over the past six months, Gilead has lost 7.75% while Biogen has rallied 19.9%. (See the last biotech stock roundup here: Biotech Stock Roundup: Regeneron Shines, BLUE Surges, ONCE Plunges)
What's Next in Biotech?
Stay tuned for regulatory updates and pipeline development news.
More Stock News: This Is Bigger than the iPhone!
It could become the mother of all technological revolutions. Apple sold a mere 1 billion iPhones in 10 years but a new breakthrough is expected to generate more than 27 billion devices in just 3 years, creating a $1.7 trillion market.
Zacks has just released a Special Report that spotlights this fast-emerging phenomenon and 6 tickers for taking advantage of it. If you don't buy now, you may kick yourself in 2020.
Click here for the 6 trades >>