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It was a relatively quiet first week for the pharma sector after the holidays. AbbVie (ABBV - Free Report) announced positive data from two phase III studies each, evaluating its relatively new but successful drug, Skyrizi in active psoriatic arthritis and Crohn's disease. AstraZeneca (AZN - Free Report) , Pfizer (PFE - Free Report) and Roche (RHHBY - Free Report) provided FDA updates.
Recap of the Week’s Most Important Stories
AbbVie’s Skyrizi Meets Goal in Label Expansion Studies: AbbVie announced data from two phase III induction studies evaluating Skyrizi in adult patients with moderate-to-severe Crohn's disease. The data showed that a significantly greater proportion of such patients treated with either dose of Skyrizi (600 mg or 1200 mg) met primary endpoints, demonstrating statistically significant results for clinical remission and endoscopic response after 12 weeks of treatment compared to placebo. Skyrizi is presently approved to treat moderate-to-severe plaque psoriasis.
Meanwhile, top-line data from AbbVie’s two phaseIII studies evaluating Skyrizi (risankizumab) for active psoriatic arthritis showed that significantly more patients treated with risankizumab (150 mg) achieved the primary endpoint of ACR20 response at week 24 versus placebo. The candidate also showed significant improvements in skin clearance, physical function and minimal disease activity, which were the studies’ secondary endpoints, at week 24
FDA Grants Priority Review to AstraZeneca’s Farxiga for CKD: The FDA granted priority review to AstraZeneca’s application seeking approval of its diabetes medicine, Farxiga for the treatment of new or worsening chronic kidney disease in adults with and without type-II diabetes (T2D). The FDA’s decision is expected in the second quarter of 2021. Farxiga is presently approved to treat T2D and heart failure with reduced ejection fraction in the United States
Pfizer Begins Dosing in Pivotal DMD Study: Pfizer began dosing in a pivotal phase III study (CIFFREO) evaluating its investigational gene therapy candidate, PF-06939926, to treat Duchenne muscular dystrophy (“DMD”). The study is expected to enroll 99 ambulatory male boys (age 4 to 7) across 15 countries. The primary endpoint of the 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 FDA accepted Pfizer’s biologics license application (“BLA”) for somatrogon its long-acting, once-weekly therapy to treat pediatric patients with growth hormone deficiency. The BLA was granted standard review and the FDA’s decision is expected in October 2021.
FDA’s Breakthrough Tag for Roche’s Immunotherapy Combo: The FDA granted Breakthrough Therapy Designation (“BTD”) to Roche’s novel cancer immunotherapy, tiragolumab in combination with its immuno-oncology drug, Tecentriq (atezolizumab). The BTD status is for the first-line treatment of patients with metastatic non-small cell lung cancer whose tumors have high PD-L1 expression with no EGFR or ALK genomic tumor aberrations.
The NYSE ARCA Pharmaceutical Index rose 0.8% in the last five trading sessions.
Watch out for pipeline and regulatory updates next week.
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.
Image: Bigstock
Pharma Stock Roundup: ABBV's Positive Skyrizi Data, AZN, PFE, RHHBY's FDA Updates
It was a relatively quiet first week for the pharma sector after the holidays. AbbVie (ABBV - Free Report) announced positive data from two phase III studies each, evaluating its relatively new but successful drug, Skyrizi in active psoriatic arthritis and Crohn's disease. AstraZeneca (AZN - Free Report) , Pfizer (PFE - Free Report) and Roche (RHHBY - Free Report) provided FDA updates.
Recap of the Week’s Most Important Stories
AbbVie’s Skyrizi Meets Goal in Label Expansion Studies: AbbVie announced data from two phase III induction studies evaluating Skyrizi in adult patients with moderate-to-severe Crohn's disease. The data showed that a significantly greater proportion of such patients treated with either dose of Skyrizi (600 mg or 1200 mg) met primary endpoints, demonstrating statistically significant results for clinical remission and endoscopic response after 12 weeks of treatment compared to placebo. Skyrizi is presently approved to treat moderate-to-severe plaque psoriasis.
Meanwhile, top-line data from AbbVie’s two phaseIII studies evaluating Skyrizi (risankizumab) for active psoriatic arthritis showed that significantly more patients treated with risankizumab (150 mg) achieved the primary endpoint of ACR20 response at week 24 versus placebo. The candidate also showed significant improvements in skin clearance, physical function and minimal disease activity, which were the studies’ secondary endpoints, at week 24
FDA Grants Priority Review to AstraZeneca’s Farxiga for CKD: The FDA granted priority review to AstraZeneca’s application seeking approval of its diabetes medicine, Farxiga for the treatment of new or worsening chronic kidney disease in adults with and without type-II diabetes (T2D). The FDA’s decision is expected in the second quarter of 2021. Farxiga is presently approved to treat T2D and heart failure with reduced ejection fraction in the United States
Pfizer Begins Dosing in Pivotal DMD Study: Pfizer began dosing in a pivotal phase III study (CIFFREO) evaluating its investigational gene therapy candidate, PF-06939926, to treat Duchenne muscular dystrophy (“DMD”). The study is expected to enroll 99 ambulatory male boys (age 4 to 7) across 15 countries. The primary endpoint of the 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 FDA accepted Pfizer’s biologics license application (“BLA”) for somatrogon its long-acting, once-weekly therapy to treat pediatric patients with growth hormone deficiency. The BLA was granted standard review and the FDA’s decision is expected in October 2021.
FDA’s Breakthrough Tag for Roche’s Immunotherapy Combo: The FDA granted Breakthrough Therapy Designation (“BTD”) to Roche’s novel cancer immunotherapy, tiragolumab in combination with its immuno-oncology drug, Tecentriq (atezolizumab). The BTD status is for the first-line treatment of patients with metastatic non-small cell lung cancer whose tumors have high PD-L1 expression with no EGFR or ALK genomic tumor aberrations.
The NYSE ARCA Pharmaceutical Index rose 0.8% in the last five trading sessions.
Large Cap Pharmaceuticals Industry 5YR % Return
Large Cap Pharmaceuticals Industry 5YR % Return
Here’s how the eight major stocks performed in the last five trading sessions.
Last week, Merck (MRK - Free Report) recorded the maximum gain (2.7%) while Roche declined the most (3.6%).
In the past six months, while J&J (JNJ - Free Report) recorded the maximum rally (12.6%) AstraZeneca declined the most (7%).
(See the last pharma stock roundup here: FDA Emergency Nod to PFE/BNTX COVID-19 Vaccine, AZN to Buy ALXN)
What's Next in the Pharma World?
Watch out for pipeline and regulatory updates next week.
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 >>