J&J (JNJ - Free Report) announced the submission of a new drug application (NDA) to the FDA for the approval of its once-daily single tablet, constituting macitentan 10mg and tadalafil 40mg (M/T STCT), for the long-term treatment of pulmonary arterial hypertension (PAH) in adult patients with World Health Organization’s functional class II-III.
The NDA is based on positive data from J&J’s phase III A DUE study, evaluating the efficacy and safety of investigational M/T STCT versus macitentan and tadalafil monotherapies in patients with PAH. The study met its primary endpoint, demonstrating statistically significant improvement in pulmonary hemodynamics (blood flow through pulmonary blood vessels) upon treatment with M/T STCT compared with macitentan and tadalafil monotherapies in the above-mentioned PAH patient population.
In the year so far, shares of J&J have decreased 12.6% compared with the industry’s brisk 0.8% decline.
In the phase III A DUE study, the safety profile of M/T STCT was consistent with the safety profile of the individual components, macitentan and tadalafil. The open-label arm of the A DUE study is currently ongoing.
Management claims that treatment with M/T STCT has the potential to improve patient convenience by reducing their pill burden. PAH patients are often prescribed numerous medicines to manage their condition. Subject to approval, M/T STCT could become a single tablet combination of two guideline-recommended therapies, decreasing the pill burden of patients along with improving patient treatment experience and clinical outcomes.
JNJ currently markets macitentan 10mg under the brand name Opsumit as monotherapy or in combination, which is indicated for the long-term treatment of PAH. Opsumit generated revenues worth $440 million worldwide in the first quarter of 2023.
PAH is a rare and progressive cardiovascular disorder that causes the arteries, lungs and right side of the heart to get narrowed, blocked or destroyed, eventually leading to right heart failure.
Zacks Rank and Stocks to Consider
J&J currently has a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Allogene Therapeutics (ALLO - Free Report) , Akero Therapeutics (AKRO - Free Report) and ADMA Biologics, Inc. (ADMA - 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 90 days, the Zacks Consensus Estimate for Allogene Therapeutics’ 2023 loss per share has narrowed from $2.61 to $2.31. In the year so far, shares of Allogene Therapeutics have fallen by 17.5%.
ALLO beat estimates in three of the trailing four quarters, missing the mark on one occasion, delivering an average earnings surprise of 5.08%.
In the past 90 days, the Zacks Consensus Estimate for Akero Therapeutics’ 2023 loss per share has narrowed from $3.46 to $2.78. In the year so far, shares of Akero Therapeutics have fallen by 19.9%.
AKRO beat estimates in three of the trailing four quarters, missing the mark on one occasion, delivering an average earnings surprise of 7.96%.
In the past 90 days, the Zacks Consensus Estimate for ADMA Biologics’ 2023 loss per share has narrowed from 19 cents to 9 cents. In the year so far, shares of ADMA Biologics have gained by 4.1%.
ADMA beat estimates in each of the trailing four quarters, delivering an average earnings surprise of 19.13%.
Where Will Stocks Go…
If Biden Wins? If Trump Wins?
The answers may surprise you.
Since 1950, even after negative midterm years, the market has never had a lower presidential election year. With voters energized and engaged, the market has been almost unrelentingly bullish no matter which party wins!
Now is the time to download Zacks' free Special Report with 5 stocks that offer extreme upside for both Democrats and Republicans…
1. Medical manufacturer has gained +11,000% in the last 15 years.
2. Rental company is absolutely crushing its sector.
3. Energy powerhouse plans to grow its already large dividend by 25%.
4. Aerospace and defense standout just landed a potentially $80 billion contract.
5. Giant Chipmaker is building huge plants in the U.S.
Hurry, Download Special Report FREE >>
J&J (JNJ - Free Report) announced the submission of a new drug application (NDA) to the FDA for the approval of its once-daily single tablet, constituting macitentan 10mg and tadalafil 40mg (M/T STCT), for the long-term treatment of pulmonary arterial hypertension (PAH) in adult patients with World Health Organization’s functional class II-III.
The NDA is based on positive data from J&J’s phase III A DUE study, evaluating the efficacy and safety of investigational M/T STCT versus macitentan and tadalafil monotherapies in patients with PAH. The study met its primary endpoint, demonstrating statistically significant improvement in pulmonary hemodynamics (blood flow through pulmonary blood vessels) upon treatment with M/T STCT compared with macitentan and tadalafil monotherapies in the above-mentioned PAH patient population.
In the year so far, shares of J&J have decreased 12.6% compared with the industry’s brisk 0.8% decline.
In the phase III A DUE study, the safety profile of M/T STCT was consistent with the safety profile of the individual components, macitentan and tadalafil. The open-label arm of the A DUE study is currently ongoing.
Management claims that treatment with M/T STCT has the potential to improve patient convenience by reducing their pill burden. PAH patients are often prescribed numerous medicines to manage their condition. Subject to approval, M/T STCT could become a single tablet combination of two guideline-recommended therapies, decreasing the pill burden of patients along with improving patient treatment experience and clinical outcomes.
JNJ currently markets macitentan 10mg under the brand name Opsumit as monotherapy or in combination, which is indicated for the long-term treatment of PAH. Opsumit generated revenues worth $440 million worldwide in the first quarter of 2023.
PAH is a rare and progressive cardiovascular disorder that causes the arteries, lungs and right side of the heart to get narrowed, blocked or destroyed, eventually leading to right heart failure.
Zacks Rank and Stocks to Consider
J&J currently has a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Allogene Therapeutics (ALLO - Free Report) , Akero Therapeutics (AKRO - Free Report) and ADMA Biologics, Inc. (ADMA - 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 90 days, the Zacks Consensus Estimate for Allogene Therapeutics’ 2023 loss per share has narrowed from $2.61 to $2.31. In the year so far, shares of Allogene Therapeutics have fallen by 17.5%.
ALLO beat estimates in three of the trailing four quarters, missing the mark on one occasion, delivering an average earnings surprise of 5.08%.
In the past 90 days, the Zacks Consensus Estimate for Akero Therapeutics’ 2023 loss per share has narrowed from $3.46 to $2.78. In the year so far, shares of Akero Therapeutics have fallen by 19.9%.
AKRO beat estimates in three of the trailing four quarters, missing the mark on one occasion, delivering an average earnings surprise of 7.96%.
In the past 90 days, the Zacks Consensus Estimate for ADMA Biologics’ 2023 loss per share has narrowed from 19 cents to 9 cents. In the year so far, shares of ADMA Biologics have gained by 4.1%.
ADMA beat estimates in each of the trailing four quarters, delivering an average earnings surprise of 19.13%.
Where Will Stocks Go…
If Biden Wins? If Trump Wins?
The answers may surprise you.
Since 1950, even after negative midterm years, the market has never had a lower presidential election year. With voters energized and engaged, the market has been almost unrelentingly bullish no matter which party wins!
Now is the time to download Zacks' free Special Report with 5 stocks that offer extreme upside for both Democrats and Republicans…
1. Medical manufacturer has gained +11,000% in the last 15 years.
2. Rental company is absolutely crushing its sector.
3. Energy powerhouse plans to grow its already large dividend by 25%.
4. Aerospace and defense standout just landed a potentially $80 billion contract.
5. Giant Chipmaker is building huge plants in the U.S.
Hurry, Download Special Report FREE >>
Get the latest research report on JNJ - FREE
Get the latest research report on ADMA - FREE
Get the latest research report on ALLO - FREE
Get the latest research report on AKRO - FREE