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Regeneron, Teva Announce Positive Data on Osteoarthritis Drug
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Regeneron Pharmaceuticals, Inc. (REGN - Free Report) and partner Teva Pharmaceutical Industries Ltd. (TEVA - Free Report) announced positive top-line results from a phase III study on pipeline candidate, fasinumab.
The randomized, double-blind, placebo-controlled study of fasinumab was conducted to treat patients with chronic pain from osteoarthritis (OA) of the knee or hip.
The study met both co-primary endpoints and all key secondary endpoints at week 16 as the data showed that fasinumab-treated patients experienced significantly less pain and significantly improved functional ability from baseline compared to placebo.
We note that this phase III study is a sub-study of a larger, long-term trial that involves 52 weeks of active treatment, designed to determine the safety and tolerability of fasinumab including adverse events (AEs), in patients with pain due to radiographically-confirmed OA of the knee or hip.
Patients will continue on therapy for an additional 36 weeks, followed by a subsequent 20-week off the drug to assess its safety. The primary efficacy data were assessed at 16 weeks. The primary safety analysis of the larger, long-term trial will take place at 72 weeks (52-week active treatment and 20-week follow-up periods).
Both the companies plan to present detailed results at an upcoming medical congress. We remind investors that Regeneron and Teva entered into a global collaboration in September 2016 and are jointly developing fasinumab under the same. Mitsubishi Tanabe Pharma Corporation holds exclusive development and commercial rights for fasinumab in Japan and 10 other Asian countries.
The companies plan to advance fasinumab in a phase III study in patients with OA of the knee or hip who currently have very limited therapeutic choices to treat their chronic pain, other than with non-steroidal anti-inflammatory drugs or opioids.
In April 2018, an independent Data Monitoring Committee (DMC), monitoring the ongoing safety and efficacy of the fasinumab clinical trials, recommended that the two higher dose-regimens (3 mg every four weeks and 6 mg every eight weeks) be discontinued based on the risk benefit assessment but the program may continue with the lower dose-regimens of fasinumab.
Regeneron’s stock has lost 1.1% in the year so far compared with the industry’s 5.3% decline.
Regeneron’s efforts to expand the label of its approved drugs and concurrently develop its pipeline are encouraging as well. However, the company suffered a setback when the FDA issued a complete response letter (CRL) to its supplemental Biologics License Application (sBLA) for flagship drug Eylea injection due to ongoing labeling discussions.
Regeneron’s second-quarter results were impressive as the company comfortably beat both earnings and sales estimates on the back of growth in Dupixent’s sales. Regeneron and partner Sanofi (SNY - Free Report) are also working to expand Dupixent’s label.
Gilead’s earnings per share estimates have increased from $6.10 to $6.57 for 2018 in the past 60 days. Estimates for 2019 are also up by 14 cents.
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Regeneron, Teva Announce Positive Data on Osteoarthritis Drug
Regeneron Pharmaceuticals, Inc. (REGN - Free Report) and partner Teva Pharmaceutical Industries Ltd. (TEVA - Free Report) announced positive top-line results from a phase III study on pipeline candidate, fasinumab.
The randomized, double-blind, placebo-controlled study of fasinumab was conducted to treat patients with chronic pain from osteoarthritis (OA) of the knee or hip.
The study met both co-primary endpoints and all key secondary endpoints at week 16 as the data showed that fasinumab-treated patients experienced significantly less pain and significantly improved functional ability from baseline compared to placebo.
We note that this phase III study is a sub-study of a larger, long-term trial that involves 52 weeks of active treatment, designed to determine the safety and tolerability of fasinumab including adverse events (AEs), in patients with pain due to radiographically-confirmed OA of the knee or hip.
Patients will continue on therapy for an additional 36 weeks, followed by a subsequent 20-week off the drug to assess its safety. The primary efficacy data were assessed at 16 weeks. The primary safety analysis of the larger, long-term trial will take place at 72 weeks (52-week active treatment and 20-week follow-up periods).
Both the companies plan to present detailed results at an upcoming medical congress. We remind investors that Regeneron and Teva entered into a global collaboration in September 2016 and are jointly developing fasinumab under the same. Mitsubishi Tanabe Pharma Corporation holds exclusive development and commercial rights for fasinumab in Japan and 10 other Asian countries.
The companies plan to advance fasinumab in a phase III study in patients with OA of the knee or hip who currently have very limited therapeutic choices to treat their chronic pain, other than with non-steroidal anti-inflammatory drugs or opioids.
In April 2018, an independent Data Monitoring Committee (DMC), monitoring the ongoing safety and efficacy of the fasinumab clinical trials, recommended that the two higher dose-regimens (3 mg every four weeks and 6 mg every eight weeks) be discontinued based on the risk benefit assessment but the program may continue with the lower dose-regimens of fasinumab.
Regeneron’s stock has lost 1.1% in the year so far compared with the industry’s 5.3% decline.
Regeneron’s efforts to expand the label of its approved drugs and concurrently develop its pipeline are encouraging as well. However, the company suffered a setback when the FDA issued a complete response letter (CRL) to its supplemental Biologics License Application (sBLA) for flagship drug Eylea injection due to ongoing labeling discussions.
Regeneron’s second-quarter results were impressive as the company comfortably beat both earnings and sales estimates on the back of growth in Dupixent’s sales. Regeneron and partner Sanofi (SNY - Free Report) are also working to expand Dupixent’s label.
Zacks Rank and Other Stock to Consider
Regeneron currently carries a Zacks Rank #2 (Buy). Another top-ranked stock in the healthcare sector is Gilead Sciences, Inc. (GILD - Free Report) , which sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Gilead’s earnings per share estimates have increased from $6.10 to $6.57 for 2018 in the past 60 days. Estimates for 2019 are also up by 14 cents.
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Here's another stock idea to consider. Much like petroleum 150 years ago, lithium power may soon shake the world, creating millionaires and reshaping geo-politics. Soon electric vehicles (EVs) may be cheaper than gas guzzlers. Some are already reaching 265 miles on a single charge.
With battery prices plummeting and charging stations set to multiply, one company stands out as the #1 stock to buy according to Zacks research.
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