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Biotech Stock Roundup: FDA Nod for REGN's Eylea in DR, Tie-Ups & Other Updates
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It’s been a pretty ho-hum week for the biotech sector with regulatory and other pipeline updates as well as collaborations. While Regeneron’s leading ophthalmology drug was approved by the FDA for yet another indication, Celgene’s oncology drug was given a Breakthrough Designation for a difficult indication.
Recap of the Week’s Top Stories:
FDA Approves Label Expansion of Regeneron’s Eylea: Regeneron Pharmaceuticals, Inc. (REGN - Free Report) announced that the FDA has approved a label expansion of its lead drug Eylea. The drug has been approved to treat all stages of diabetic retinopathy (DR), thereby reducing the risk of blindness. The approval was based on the results of PANORAMA study, which showed that 20% of untreated patients developed proliferative diabetic eye disease at the end of twelve months and Eylea lowered this risk by 85-88% when administered using an every 16-week or eight-week dosing regimen, respectively. DR is the leading cause of blindness among the working-age American adults.
Celgene’s Pomalyst Gets Breakthrough Designation: Celgene Corporation announced that the FDA has granted Breakthrough Therapy designation to Pomalyst (pomalidomide) for the treatment of patients with human immunodeficiency virus (HIV)-positive Kaposi sarcoma, who previously received systemic chemotherapy as well as patients with HIV-negative Kaposi’s sarcoma. The drug is already approved in combination with dexamethasone for patients with multiple myeloma, who received at least two prior therapies including lenalidomide and a proteasome inhibitor and also demonstrated disease progression in 60 days. The status is intended to expedite the development and review of medicines with an early evidence of potential clinical benefit in serious diseases. Celgene plans to submit a supplemental New Drug Application for Pomalyst pertaining to this indication by the end of 2019.
Gilead Collaborates With Goldfinch Bio on Kidney Disease: Gilead Sciences, Inc. (GILD - Free Report) announced an alliance with the biotechnology company Goldfinch Bio to discover, develop and commercialize a pipeline of innovative therapeutics for the diabetic kidney disease (DKD) and certain orphan kidney diseases. Gilead has exclusive options to license the worldwide rights to certain products directed toward targets emerging from Goldfinch’s proprietary Kidney Genome Atlas (KGA). Per the terms of the collaborative deal, Goldfinch will receive $55 million in upfront payments, including a $5-million equity investment and an additional $54-million fee to support the development of the KGA platform for DKD. The company is also eligible to receive up to $1.95 billion in potential payments for the first five collaboration programs based on the successful achievement of its research, development, regulatory and commercial milestones and tiered royalties on the sales of potential products originating from this collaboration.
Myovant Slumps Despite Positive Data for Lead Drug: Shares of Myovant Sciences, Inc. plunged even though the company posted positive data on its lead drug, relugolix, from a late-stage study. LIBERTY 1, the first of the two phase III studies on once daily relugolix combination therapy met its primary efficacy endpoint and six key secondary endpoints in women with uterine fibroids. The outcomes show that 73.4% of women receiving once daily oral relugolix combination therapy achieved the responder criteria compared with only 18.9% of them receiving placebo. Relugolix combination therapy maintained bone mineral density at levels comparable to placebo over 24 weeks and was generally well tolerated. The company expects findings from LIBERTY 2, the replicate phase III study evaluating once daily relugolix combination therapy in women with uterine fibroids and heavy menstrual bleeding. Assuming the program to be successful, the company plans to submit a New Drug Application (NDA) to the FDA in fourth-quarter 2019.
The NASDAQ Biotechnology index declined 2.8% in the past five trading sessions. Among the major biotech giants, Regeneron lost 5.51% in the period. Over the past six months, shares of Celgene have surged 35.21% whereas the Biogen stock has lost 26.91%. (See the last biotech stock roundup here: Biotech Stock Roundup: BIIB, VRTX, ALXN Q1 Earnings Top & Other Pipeline Updates)
What's Next in Biotech?
Stay tuned for pipeline development news.
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One out of every six people retires a multimillionaire. Get smart tips you can do today to become one of them in a new Special Report, “7 Things You Can Do Now to Retire a Multimillionaire.”
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Biotech Stock Roundup: FDA Nod for REGN's Eylea in DR, Tie-Ups & Other Updates
It’s been a pretty ho-hum week for the biotech sector with regulatory and other pipeline updates as well as collaborations. While Regeneron’s leading ophthalmology drug was approved by the FDA for yet another indication, Celgene’s oncology drug was given a Breakthrough Designation for a difficult indication.
Recap of the Week’s Top Stories:
FDA Approves Label Expansion of Regeneron’s Eylea: Regeneron Pharmaceuticals, Inc. (REGN - Free Report) announced that the FDA has approved a label expansion of its lead drug Eylea. The drug has been approved to treat all stages of diabetic retinopathy (DR), thereby reducing the risk of blindness. The approval was based on the results of PANORAMA study, which showed that 20% of untreated patients developed proliferative diabetic eye disease at the end of twelve months and Eylea lowered this risk by 85-88% when administered using an every 16-week or eight-week dosing regimen, respectively. DR is the leading cause of blindness among the working-age American adults.
Celgene’s Pomalyst Gets Breakthrough Designation: Celgene Corporation announced that the FDA has granted Breakthrough Therapy designation to Pomalyst (pomalidomide) for the treatment of patients with human immunodeficiency virus (HIV)-positive Kaposi sarcoma, who previously received systemic chemotherapy as well as patients with HIV-negative Kaposi’s sarcoma. The drug is already approved in combination with dexamethasone for patients with multiple myeloma, who received at least two prior therapies including lenalidomide and a proteasome inhibitor and also demonstrated disease progression in 60 days. The status is intended to expedite the development and review of medicines with an early evidence of potential clinical benefit in serious diseases. Celgene plans to submit a supplemental New Drug Application for Pomalyst pertaining to this indication by the end of 2019.
Gilead Collaborates With Goldfinch Bio on Kidney Disease: Gilead Sciences, Inc. (GILD - Free Report) announced an alliance with the biotechnology company Goldfinch Bio to discover, develop and commercialize a pipeline of innovative therapeutics for the diabetic kidney disease (DKD) and certain orphan kidney diseases. Gilead has exclusive options to license the worldwide rights to certain products directed toward targets emerging from Goldfinch’s proprietary Kidney Genome Atlas (KGA). Per the terms of the collaborative deal, Goldfinch will receive $55 million in upfront payments, including a $5-million equity investment and an additional $54-million fee to support the development of the KGA platform for DKD. The company is also eligible to receive up to $1.95 billion in potential payments for the first five collaboration programs based on the successful achievement of its research, development, regulatory and commercial milestones and tiered royalties on the sales of potential products originating from this collaboration.
Myovant Slumps Despite Positive Data for Lead Drug: Shares of Myovant Sciences, Inc. plunged even though the company posted positive data on its lead drug, relugolix, from a late-stage study. LIBERTY 1, the first of the two phase III studies on once daily relugolix combination therapy met its primary efficacy endpoint and six key secondary endpoints in women with uterine fibroids. The outcomes show that 73.4% of women receiving once daily oral relugolix combination therapy achieved the responder criteria compared with only 18.9% of them receiving placebo. Relugolix combination therapy maintained bone mineral density at levels comparable to placebo over 24 weeks and was generally well tolerated. The company expects findings from LIBERTY 2, the replicate phase III study evaluating once daily relugolix combination therapy in women with uterine fibroids and heavy menstrual bleeding. Assuming the program to be successful, the company plans to submit a New Drug Application (NDA) to the FDA in fourth-quarter 2019.
Myovant currently carries a Zacks Rank#2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Performance
Medical - Biomedical and Genetics Industry 5YR % Return
Medical - Biomedical and Genetics Industry 5YR % Return
The NASDAQ Biotechnology index declined 2.8% in the past five trading sessions. Among the major biotech giants, Regeneron lost 5.51% in the period. Over the past six months, shares of Celgene have surged 35.21% whereas the Biogen stock has lost 26.91%. (See the last biotech stock roundup here: Biotech Stock Roundup: BIIB, VRTX, ALXN Q1 Earnings Top & Other Pipeline Updates)
What's Next in Biotech?
Stay tuned for pipeline development news.
Will you retire a millionaire?
One out of every six people retires a multimillionaire. Get smart tips you can do today to become one of them in a new Special Report, “7 Things You Can Do Now to Retire a Multimillionaire.”
Click to get it free >>