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Pharma Stock Roundup: FDA Approves J&J's Tremfya for Ulcerative Colitis & More
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This week, the FDA approved J&J’s (JNJ - Free Report) Tremfya for treating an inflammatory bowel disease condition (“IBD”), ulcerative colitis. Novo Nordisk’s (NVO - Free Report) oral obesity pill, amycretin, showed faster weight loss than its blockbuster weekly injection, Wegovy (semaglutide), per full data presented from a 12-week phase I study at the European Association for the Study of Diabetes (“EASD”) meeting in Madrid. Regeneron (REGN - Free Report) and Sanofi’s (SNY - Free Report) blockbuster medicine, Dupixent, showed significant improvements in disease remission and symptoms in a bullous pemphigoid pivotal study.
Recap of the Week’s Most Important Stories
FDA Approves J&J’s Tremfya for Ulcerative Colitis
The FDA granted approval to J&J’s IL-23 inhibitor Tremfya for its first IBD condition, moderately to severely active ulcerative colitis. The approval for the UC indication was based on data from the phase IIb/III QUASAR study. Tremfya is also under review in the EU for UC.
Tremfya, an IL-23 inhibitor, is presently approved to treat certain patients with plaque psoriasis and active psoriatic arthritis in several countries, including the United States and the EU. Tremfya is under review in the United States and EU for the other IBD condition, Crohn’s disease. J&J expects Tremfya to be a $5 billion product with potential approvals in other IBD conditions.
Novo Nordisk’s Amycretin Outperforms Wegovy in Phase I Study
Novo Nordisk’s full data from the phase I study demonstrated that amycretin led to faster weight loss than Wegovy. The data showed that patients who took the highest dose of amycretin lost around 13.1% of body weight after 12 weeks, while those who took the lower dose of the medicine lost around 10.4%. In comparison, Wegovy showed a weight loss of around 6% after 12 weeks and around 15% after 68 weeks in clinical studies. In the study, amycretin was associated with some mild-to-moderate side effects, which were in line with those of Novo Nordisk’s semaglutide drugs,
In March, Novo Nordisk presented initial data from the same study. Back then, the company said that treatment with amycretin resulted in a 13.1% weight reduction after 12 weeks compared with a decrease of 1.1% in the placebo arm.
A phase III pivotal study evaluating Dupixent for treating bullous pemphigoid (BP)met the primary and all key secondary endpoints. In the study, five times more patients treated with Dupixent achieved sustained disease remission, the study’s primary endpoint, compared to placebo. Among the patients,20% were treated with Dupixent and experienced sustained disease remission at 36 weeks compared to 4% for placebo.
Dupixent is currently approved in several countries, including the United States and EU, for five type II inflammatory diseases, namely severe chronic rhinosinusitis with nasal polyposis, severe asthma, moderate-to-severe atopic dermatitis, eosinophilic esophagitis and prurigo nodularis. If approved for BP, Dupixent will become the first medicine approved for this chronic and relapsing skin disease in the United States and the European Union.
Sanofi/Regeneron also announced data from a second pivotal phase III study, LIBERTY-CUPID Study C, evaluating Dupixent for treating chronic spontaneous urticaria (CSU), a chronic inflammatory skin disease, in patients who do not respond to standard-of-care antihistamines. The study met primary and key secondary endpoints, showing treatment with Dupixent led to a nearly 50% reduction in itch and urticaria activity scores compared to placebo.
In October last year, the FDA issued a complete response letter (CRL) for a supplemental biologics license application (sBLA) seeking approval of Dupixent for CSU. The sBLA was based on data from the first phase III study of Dupixent for CSU called CUPID-A. Sanofi/Regeneron will file the additional efficacy data from CUPID Study C to the FDA to meet the request made in the CRL.
The NYSE ARCA Pharmaceutical Index rose 0.43% in the last five trading sessions.
Image: Bigstock
Pharma Stock Roundup: FDA Approves J&J's Tremfya for Ulcerative Colitis & More
This week, the FDA approved J&J’s (JNJ - Free Report) Tremfya for treating an inflammatory bowel disease condition (“IBD”), ulcerative colitis. Novo Nordisk’s (NVO - Free Report) oral obesity pill, amycretin, showed faster weight loss than its blockbuster weekly injection, Wegovy (semaglutide), per full data presented from a 12-week phase I study at the European Association for the Study of Diabetes (“EASD”) meeting in Madrid. Regeneron (REGN - Free Report) and Sanofi’s (SNY - Free Report) blockbuster medicine, Dupixent, showed significant improvements in disease remission and symptoms in a bullous pemphigoid pivotal study.
Recap of the Week’s Most Important Stories
FDA Approves J&J’s Tremfya for Ulcerative Colitis
The FDA granted approval to J&J’s IL-23 inhibitor Tremfya for its first IBD condition, moderately to severely active ulcerative colitis. The approval for the UC indication was based on data from the phase IIb/III QUASAR study. Tremfya is also under review in the EU for UC.
Tremfya, an IL-23 inhibitor, is presently approved to treat certain patients with plaque psoriasis and active psoriatic arthritis in several countries, including the United States and the EU. Tremfya is under review in the United States and EU for the other IBD condition, Crohn’s disease. J&J expects Tremfya to be a $5 billion product with potential approvals in other IBD conditions.
Novo Nordisk’s Amycretin Outperforms Wegovy in Phase I Study
Novo Nordisk’s full data from the phase I study demonstrated that amycretin led to faster weight loss than Wegovy. The data showed that patients who took the highest dose of amycretin lost around 13.1% of body weight after 12 weeks, while those who took the lower dose of the medicine lost around 10.4%. In comparison, Wegovy showed a weight loss of around 6% after 12 weeks and around 15% after 68 weeks in clinical studies. In the study, amycretin was associated with some mild-to-moderate side effects, which were in line with those of Novo Nordisk’s semaglutide drugs,
In March, Novo Nordisk presented initial data from the same study. Back then, the company said that treatment with amycretin resulted in a 13.1% weight reduction after 12 weeks compared with a decrease of 1.1% in the placebo arm.
Sanofi/Regeneron’s Dupixent Studies Meet Primary Goals
A phase III pivotal study evaluating Dupixent for treating bullous pemphigoid (BP)met the primary and all key secondary endpoints. In the study, five times more patients treated with Dupixent achieved sustained disease remission, the study’s primary endpoint, compared to placebo. Among the patients,20% were treated with Dupixent and experienced sustained disease remission at 36 weeks compared to 4% for placebo.
Dupixent is currently approved in several countries, including the United States and EU, for five type II inflammatory diseases, namely severe chronic rhinosinusitis with nasal polyposis, severe asthma, moderate-to-severe atopic dermatitis, eosinophilic esophagitis and prurigo nodularis. If approved for BP, Dupixent will become the first medicine approved for this chronic and relapsing skin disease in the United States and the European Union.
Sanofi/Regeneron also announced data from a second pivotal phase III study, LIBERTY-CUPID Study C, evaluating Dupixent for treating chronic spontaneous urticaria (CSU), a chronic inflammatory skin disease, in patients who do not respond to standard-of-care antihistamines. The study met primary and key secondary endpoints, showing treatment with Dupixent led to a nearly 50% reduction in itch and urticaria activity scores compared to placebo.
In October last year, the FDA issued a complete response letter (CRL) for a supplemental biologics license application (sBLA) seeking approval of Dupixent for CSU. The sBLA was based on data from the first phase III study of Dupixent for CSU called CUPID-A. Sanofi/Regeneron will file the additional efficacy data from CUPID Study C to the FDA to meet the request made in the CRL.
The NYSE ARCA Pharmaceutical Index rose 0.43% 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.
In the last five trading sessions, Novo Nordisk rose the most (4.4%), while AstraZeneca declined the most (4.9%).
Image Source: Zacks Investment Research
In the past six months, while Lilly rose the most (22.9%), Merck declined the most (4.4%).
(See the last pharma stock roundup here: EU Nod for Expanded Use of MRK’s Keytruda & More)
What's Next in the Pharma World?
Watch this space for regular pipeline and regulatory updates next week.
Novo Nordisk, Sanofi and J&J have a Zacks Rank #3 (Hold) each. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.