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Pfizer (PFE) Begins Dosing in DMD Study With Gene Therapy
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Pfizer Inc. (PFE - Free Report) announced that it has dosed the first participant in the phase III CIFFREO study, evaluating the safety and efficacy of its investigational gene therapy candidate, PF-06939926, for treating boys with Duchenne muscular dystrophy (“DMD”), a progressive muscular weakness.
The primary endpoint of the double-blind, placebo-controlled, CIFFREO study is the change from baseline in the North Star Ambulatory Assessment (“NSAA”), a 17-item test, at year one. The NSAA test measures gross motor function in boys with DMD.
The first patient was dosed on Dec 29, 2020 at a site in Spain. The above study will enroll 99 ambulatory male patients aged between four to seven years, across 55 clinical sites in 15 countries.
Notably, the CIFFREO study is Pfizer’s first phase III study on a gene therapy for DMD that has begun enrolling patients. Per the company, currently there are no approved disease-modifying treatment options available for all genetic forms of DMD.
The FDA had granted a Fast Track designation to PF-06939926 for DMD in October 2020. The regulatory body also granted an Orphan Drug and Rare Pediatric Disease designations to PF-06939926 for the given indication.
Shares of Pfizer have declined 4.7% in the past year against the industry’s increase of 3.6%.
We note that DMD is a rare genetic disorder, which primarily affects boys and is the most common type of muscular dystrophy. Several companies are engaged in developing gene therapies for treating DMD as the market holds promise.
One such company – Sarepta Therapeutics (SRPT - Free Report) is developing gene therapies for treating muscular dystrophies including DMD. Its lead gene therapy candidate, SRP-9001, is being evaluated in mid-stage studies for treating DMD.
Another company, Solid Biosciences (SLDB - Free Report) is also making gene therapies for treating DMD and successful development of the same might induce acute competition for Pfizer in the long run.
Merck’s earnings estimates have been revised 1.5% upward for 2021 over the past 90 days. The stock has rallied 9.5% in the past six months.
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 2021.
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Pfizer (PFE) Begins Dosing in DMD Study With Gene Therapy
Pfizer Inc. (PFE - Free Report) announced that it has dosed the first participant in the phase III CIFFREO study, evaluating the safety and efficacy of its investigational gene therapy candidate, PF-06939926, for treating boys with Duchenne muscular dystrophy (“DMD”), a progressive muscular weakness.
The primary endpoint of the double-blind, placebo-controlled, CIFFREO study is the change from baseline in the North Star Ambulatory Assessment (“NSAA”), a 17-item test, at year one. The NSAA test measures gross motor function in boys with DMD.
The first patient was dosed on Dec 29, 2020 at a site in Spain. The above study will enroll 99 ambulatory male patients aged between four to seven years, across 55 clinical sites in 15 countries.
Notably, the CIFFREO study is Pfizer’s first phase III study on a gene therapy for DMD that has begun enrolling patients. Per the company, currently there are no approved disease-modifying treatment options available for all genetic forms of DMD.
The FDA had granted a Fast Track designation to PF-06939926 for DMD in October 2020. The regulatory body also granted an Orphan Drug and Rare Pediatric Disease designations to PF-06939926 for the given indication.
Shares of Pfizer have declined 4.7% in the past year against the industry’s increase of 3.6%.
We note that DMD is a rare genetic disorder, which primarily affects boys and is the most common type of muscular dystrophy. Several companies are engaged in developing gene therapies for treating DMD as the market holds promise.
One such company – Sarepta Therapeutics (SRPT - Free Report) is developing gene therapies for treating muscular dystrophies including DMD. Its lead gene therapy candidate, SRP-9001, is being evaluated in mid-stage studies for treating DMD.
Another company, Solid Biosciences (SLDB - Free Report) is also making gene therapies for treating DMD and successful development of the same might induce acute competition for Pfizer in the long run.
Zacks Rank & Stock to Consider
Pfizer currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the large-cap pharma sector is Merck & Co., Inc. (MRK - Free Report) , which has a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Merck’s earnings estimates have been revised 1.5% upward for 2021 over the past 90 days. The stock has rallied 9.5% in the past six months.
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 2021.
Click here for the 6 trades >>