We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
OPKO's (OPK) NGENLA to Offer GHD Treatment in European Union
Read MoreHide Full Article
OPKO Health, Inc. (OPK - Free Report) and Pfizer Inc. (PFE - Free Report) recently gained marketing authorization from the European Commission for the next-generation long-acting recombinant human growth hormone NGENLA (somatrogon). The European Union (EU) marketing authorization is valid in all EU Member States along with Iceland, Norway and Liechtenstein.
In 2014, Pfizer and OPKO signed a worldwide agreement to develop and commercialize NGENLA to treat growth hormone deficiency (GHD). Under the terms of the deal, Pfizer is responsible for registering and commercializing NGENLA for GHD, whereas OPKO is responsible for conducting the clinical program.
Management at OPKO is optimistic that NGENLA can improve the quality of life for children affected by GHD and their families while promoting treatment adherence. The company anticipates the EU marketing authorization to allow more children with GHD to benefit from the once-weekly treatment.
Prior to the EU marketing authorization, NGENLA was approved in Canada, Australia, and Japan to treat pediatric GHD.
Few Words on NGENLA
NGENLA is a once-weekly injection used to treat children and adolescents aged three years and above experiencing growth disturbance due to insufficient growth hormone secretion. NGENLA provides a novel treatment option for GHD that lowers the frequency of required injections from once daily to once weekly. It is a synthetic growth hormone that compensates for the lack of growth hormone in the body. When compared to the growth hormone GENOTROPIN (somatropin), its action in the body lasts longer, allowing for weekly rather than daily injections.
Image Source: Zacks Investment Research
Per Pfizer’s management, NGENLA offers a new, longer-acting option that significantly reduces the treatment burden from once-daily to once-weekly injections.
EU Approval Background
The EU marketing authorization of NGENLA was backed by findings of a global, randomized, open-label, active-controlled Phase 3 study that assessed the safety and efficacy of once-weekly NGENLA against the once-daily GENOTROPIN. The study’s primary endpoint of non-inferiority of the NGENLA compared to GENOTROPIN was met after 12 months, as determined by annual height velocity. In the study, NGENLA was usually well tolerated and had a safety profile similar to GENOTROPIN.
Industry Prospects
Per a report published in Mordor Intelligence, the human growth hormone market is expected to see a CAGR of 8.61% during 2021-2026. Factors such as development of recombinant human growth hormone drugs, surge in pituitary dysfunction cases and growing off-label use of human growth hormones are fuelling market growth.
Given the market prospects, the EU marketing authorization for NGENLA comes at an opportune time.
Other Notable Developments
In February 2022, OPKO’s health’s licensee Vifor Fresenius Medical Care Renal Pharma (VFMCRP) began the commercial launch of RAYALDEE (extended release calcifediol) in Germany. This marks RAYALDEE’s first launch outside the United States. VFMCRP has gained marketing authorizations for RAYALDEE in 11 European countries, and plans to launch in more markets later this year.
In December 2021, OPKO received the FDA approval for its 4Kscore Test. The 4Kscore test has been given the nod for use in men, aged 45 and above, who have not had a prostate biopsy previously or are biopsy negative and have an age-specific abnormal total PSA and/or abnormal digital rectal exam. This approval is likely to provide a boost to OPKO’s Diagnostics business.
Share Price Performance
The stock has underperformed its industry over the past year. It has lost 41% compared with the industry’s fall of 11%.
Owens & Minor has a long-term earnings growth rate of 23.6%. Owens & Minor’s earnings surpassed estimates in the trailing four quarters, delivering a surprise of 32.4%, on average.
Owens & Minor has outperformed the industry over the past year. OMI has gained 59.6% against an 19.1% industry decline in the said period.
HealthEquity has a long-term earnings growth rate of 16.5%. HealthEquity’s earnings surpassed estimates in the trailing four quarters, delivering an average surprise of 9.8%.
HealthEquity has declined 28.5% against the industry’s 59.3% slump over the past year.
See More Zacks Research for These Tickers
Normally $25 each - click below to receive one report FREE:
Image: Bigstock
OPKO's (OPK) NGENLA to Offer GHD Treatment in European Union
OPKO Health, Inc. (OPK - Free Report) and Pfizer Inc. (PFE - Free Report) recently gained marketing authorization from the European Commission for the next-generation long-acting recombinant human growth hormone NGENLA (somatrogon). The European Union (EU) marketing authorization is valid in all EU Member States along with Iceland, Norway and Liechtenstein.
In 2014, Pfizer and OPKO signed a worldwide agreement to develop and commercialize NGENLA to treat growth hormone deficiency (GHD). Under the terms of the deal, Pfizer is responsible for registering and commercializing NGENLA for GHD, whereas OPKO is responsible for conducting the clinical program.
Management at OPKO is optimistic that NGENLA can improve the quality of life for children affected by GHD and their families while promoting treatment adherence. The company anticipates the EU marketing authorization to allow more children with GHD to benefit from the once-weekly treatment.
Prior to the EU marketing authorization, NGENLA was approved in Canada, Australia, and Japan to treat pediatric GHD.
Few Words on NGENLA
NGENLA is a once-weekly injection used to treat children and adolescents aged three years and above experiencing growth disturbance due to insufficient growth hormone secretion. NGENLA provides a novel treatment option for GHD that lowers the frequency of required injections from once daily to once weekly. It is a synthetic growth hormone that compensates for the lack of growth hormone in the body. When compared to the growth hormone GENOTROPIN (somatropin), its action in the body lasts longer, allowing for weekly rather than daily injections.
Image Source: Zacks Investment Research
Per Pfizer’s management, NGENLA offers a new, longer-acting option that significantly reduces the treatment burden from once-daily to once-weekly injections.
EU Approval Background
The EU marketing authorization of NGENLA was backed by findings of a global, randomized, open-label, active-controlled Phase 3 study that assessed the safety and efficacy of once-weekly NGENLA against the once-daily GENOTROPIN. The study’s primary endpoint of non-inferiority of the NGENLA compared to GENOTROPIN was met after 12 months, as determined by annual height velocity. In the study, NGENLA was usually well tolerated and had a safety profile similar to GENOTROPIN.
Industry Prospects
Per a report published in Mordor Intelligence, the human growth hormone market is expected to see a CAGR of 8.61% during 2021-2026. Factors such as development of recombinant human growth hormone drugs, surge in pituitary dysfunction cases and growing off-label use of human growth hormones are fuelling market growth.
Given the market prospects, the EU marketing authorization for NGENLA comes at an opportune time.
Other Notable Developments
In February 2022, OPKO’s health’s licensee Vifor Fresenius Medical Care Renal Pharma (VFMCRP) began the commercial launch of RAYALDEE (extended release calcifediol) in Germany. This marks RAYALDEE’s first launch outside the United States. VFMCRP has gained marketing authorizations for RAYALDEE in 11 European countries, and plans to launch in more markets later this year.
In December 2021, OPKO received the FDA approval for its 4Kscore Test. The 4Kscore test has been given the nod for use in men, aged 45 and above, who have not had a prostate biopsy previously or are biopsy negative and have an age-specific abnormal total PSA and/or abnormal digital rectal exam. This approval is likely to provide a boost to OPKO’s Diagnostics business.
Share Price Performance
The stock has underperformed its industry over the past year. It has lost 41% compared with the industry’s fall of 11%.
Zacks Rank and Key Picks
Currently, OPKO carries a Zacks Rank #3 (Hold).
A few better-ranked stocks in the broader medical space are Owens & Minor, Inc. (OMI - Free Report) and HealthEquity, Inc. (HQY - Free Report) , each currently carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Owens & Minor has a long-term earnings growth rate of 23.6%. Owens & Minor’s earnings surpassed estimates in the trailing four quarters, delivering a surprise of 32.4%, on average.
Owens & Minor has outperformed the industry over the past year. OMI has gained 59.6% against an 19.1% industry decline in the said period.
HealthEquity has a long-term earnings growth rate of 16.5%. HealthEquity’s earnings surpassed estimates in the trailing four quarters, delivering an average surprise of 9.8%.
HealthEquity has declined 28.5% against the industry’s 59.3% slump over the past year.