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J&J (JNJ) Seeks Expanded Use of Tremfya for Crohn's Disease
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Johnson & Johnson (JNJ - Free Report) announced that it has submitted a supplemental biologics license application (sBLA) seeking approval of its immunology drug, Tremfya, for a new indication — moderately to severely active Crohn’s disease (CD). This marks the second label expansion filing for Tremfya in three months, following the sBLA in active ulcerative colitis (UC) indication that was filed in March.
Tremfya is currently approved to treat certain patients with plaque psoriasis and active psoriatic arthritis in several countries, including the United States and the EU.
The latest sBLA for the Crohn’s disease indication was based on data from the GALAXI 2 and 3 phase III studies as well as the phase III GRAVITI study.
Concurrently, JNJ also released data from the GRAVITI study, which evaluated the Tremfya subcutaneous (SC) induction therapy in adult patients with moderately to severely active Crohn’s disease. The study met both co-primary endpoints.
Data from the GRAVITI study showed that treatment with Tremfya led to statistically significant and clinically meaningful outcomes for clinical remission as well as endoscopic response at week 12. All other remaining multiplicity-controlled endpoints were statistically significant versus placebo at week 12, week 24 and week 48.
Shares of Johnson & Johnson have declined 5.8% so far this year against the industry’s rally of 20.3%.
Image Source: Zacks Investment Research
The GRAVITI study with the SC induction therapy of Tremfya showed a clinical benefit similar to the one previously seen with the intravenous (IV) induction in the GALAXI studies.
The GALAXY head-to-head studies showed the superiority of Tremfya over J&J’s blockbuster drug Stelara in key endoscopic endpoints in Crohn’s disease.
Data from the GALAXI and GRAVITI underlines the potential of Tremfya to become the only IL-23 inhibitor to offer both SC or IV induction treatment options for patients with Crohn’s disease.
Tremfya is an important drug in J&J’s immunology drug portfolio and a key driver of top-line growth. The drug generated sales of $808 million in the first quarter of 2024, up 26.3% year over year, driven by strong market growth and share gains. J&J expects Tremfya to be a $5 billion product with potential approvals in the inflammatory bowel disease (IBD) indications, CD and UC.
In recent years, there has been a surge in CD and UC cases due to genetic factors, environmental factors and lifestyle changes. In addition, immune system irregularities, higher diagnosis rates, increased focus on early diagnosis and favorable reimbursement policies in developed countries are driving demand for IBD treatments.
Earlier this week, the FDA approved AbbVie’s (ABBV - Free Report) blockbuster drug Skyrizi to treat adults with moderately to severely active UC in the United States. Skyrizi is already approved in the United States and the EU for treating three other immune-mediated inflammatory diseases — plaque psoriasis, psoriatic arthritis and CD.
ABBV’s Skyrizi has now become the first IL-23 antagonist approved for UC and CD.
Zacks Rank & Stocks to Consider
Johnson & Johnson currently carries a Zacks Rank #3 (Hold).
In the past 60 days, estimates for Aligos Therapeutics’ 2024 loss per share have narrowed from 84 cents to 73 cents, while loss per share estimates for 2025 have narrowed from 82 cents to 71 cents. Year to date, shares of ALGS have declined 37.3%.
Aligos Therapeutics’ earnings beat estimates in three of the trailing four quarters and missed the same on the remaining occasion, the average surprise being 7.83%.
In the past 60 days, estimates for RAPT Therapeutics’ 2024 loss per share have narrowed from $3.19 to $2.93. Loss per share estimates for 2025 have narrowed from $2.40 to $2.05. Year to date, shares of RAPT have plunged 87.6%.
RAPT’s earnings beat estimates in two of the trailing four quarters while missing the same on the remaining two occasions, the average surprise being 3.19%.
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J&J (JNJ) Seeks Expanded Use of Tremfya for Crohn's Disease
Johnson & Johnson (JNJ - Free Report) announced that it has submitted a supplemental biologics license application (sBLA) seeking approval of its immunology drug, Tremfya, for a new indication — moderately to severely active Crohn’s disease (CD). This marks the second label expansion filing for Tremfya in three months, following the sBLA in active ulcerative colitis (UC) indication that was filed in March.
Tremfya is currently approved to treat certain patients with plaque psoriasis and active psoriatic arthritis in several countries, including the United States and the EU.
The latest sBLA for the Crohn’s disease indication was based on data from the GALAXI 2 and 3 phase III studies as well as the phase III GRAVITI study.
Concurrently, JNJ also released data from the GRAVITI study, which evaluated the Tremfya subcutaneous (SC) induction therapy in adult patients with moderately to severely active Crohn’s disease. The study met both co-primary endpoints.
Data from the GRAVITI study showed that treatment with Tremfya led to statistically significant and clinically meaningful outcomes for clinical remission as well as endoscopic response at week 12. All other remaining multiplicity-controlled endpoints were statistically significant versus placebo at week 12, week 24 and week 48.
Shares of Johnson & Johnson have declined 5.8% so far this year against the industry’s rally of 20.3%.
Image Source: Zacks Investment Research
The GRAVITI study with the SC induction therapy of Tremfya showed a clinical benefit similar to the one previously seen with the intravenous (IV) induction in the GALAXI studies.
The GALAXY head-to-head studies showed the superiority of Tremfya over J&J’s blockbuster drug Stelara in key endoscopic endpoints in Crohn’s disease.
Data from the GALAXI and GRAVITI underlines the potential of Tremfya to become the only IL-23 inhibitor to offer both SC or IV induction treatment options for patients with Crohn’s disease.
Tremfya is an important drug in J&J’s immunology drug portfolio and a key driver of top-line growth. The drug generated sales of $808 million in the first quarter of 2024, up 26.3% year over year, driven by strong market growth and share gains. J&J expects Tremfya to be a $5 billion product with potential approvals in the inflammatory bowel disease (IBD) indications, CD and UC.
In recent years, there has been a surge in CD and UC cases due to genetic factors, environmental factors and lifestyle changes. In addition, immune system irregularities, higher diagnosis rates, increased focus on early diagnosis and favorable reimbursement policies in developed countries are driving demand for IBD treatments.
Earlier this week, the FDA approved AbbVie’s (ABBV - Free Report) blockbuster drug Skyrizi to treat adults with moderately to severely active UC in the United States. Skyrizi is already approved in the United States and the EU for treating three other immune-mediated inflammatory diseases — plaque psoriasis, psoriatic arthritis and CD.
ABBV’s Skyrizi has now become the first IL-23 antagonist approved for UC and CD.
Zacks Rank & Stocks to Consider
Johnson & Johnson currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the healthcare sector are Aligos Therapeutics, Inc. (ALGS - Free Report) and RAPT Therapeutics, Inc. (RAPT - Free Report) , each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 60 days, estimates for Aligos Therapeutics’ 2024 loss per share have narrowed from 84 cents to 73 cents, while loss per share estimates for 2025 have narrowed from 82 cents to 71 cents. Year to date, shares of ALGS have declined 37.3%.
Aligos Therapeutics’ earnings beat estimates in three of the trailing four quarters and missed the same on the remaining occasion, the average surprise being 7.83%.
In the past 60 days, estimates for RAPT Therapeutics’ 2024 loss per share have narrowed from $3.19 to $2.93. Loss per share estimates for 2025 have narrowed from $2.40 to $2.05. Year to date, shares of RAPT have plunged 87.6%.
RAPT’s earnings beat estimates in two of the trailing four quarters while missing the same on the remaining two occasions, the average surprise being 3.19%.