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Pharma Stock Roundup: EU Nod to RHHBY, MRK Drugs, FDA and Pipeline Updates
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This week, the European Commission approved Roche’s (RHHBY - Free Report) Enspryng for a rare, autoimmune disorder and allowed expanded use of Merck’s (MRK - Free Report) Keytruda for first-line esophageal cancer. The FDA granted emergency approval to Roche’s rheumatoid arthritis (RA) drug,Actemra to treat patientshospitalized for COVID-19 and informed AbbVie (ABBV - Free Report) that it will not meet its action dates for two applications seeking approval of its RA drug, Rinvoq for two new indications.
Recap of the Week’s Most Important Stories
FDA Approves Roche’s Actemra for COVID-19: The FDA granted Emergency Use Authorization to Roche’s Actemra/RoActemra for the treatment of COVID-19 in hospitalized adult and pediatric patients. The EUA was based on data from four studies,which were conducted on more than 5,500 hospitalized patients.
Meanwhile the European Commission approved Roche’s Enspryng for both adults and adolescents in the EU living with anti-aquaporin-4 (AQP4) antibody positive neuromyelitis optica spectrum disorder (NMOSD). NMOSD is a rare, lifelong and debilitating autoimmune disorder of the central nervous system. The drug is already approved in the United States, Canada, Japan and Switzerland.
European Approval for Merck’s Keytruda for Esophageal Cancer: The European Commission granted approval to Merck’s PD-L1 inhibitor, Keytruda in Europe as a first-line treatment in combination with chemotherapy for certain patients with esophageal cancer or HER2-negative gastroesophageal junction (GEJ) adenocarcinoma in patients whose tumors express PD-L1 (Combined Positive Score [CPS] ≥10).. The European approval was based on results from the pivotal phase III KEYNOTE-590 study. Keytruda was approved for a similar indication by the FDA in March.
Meanwhile, Merck announced plans tovoluntarily withdraw the U.S. accelerated approval indication for Keytruda for the third-line gastric cancer. The decision was made in consultation with the FDA because Merck failed to meet its post-marketing requirement of demonstrating an overall survival benefit in a phase III study. Merck said that it will begin the withdrawal in six months. The decision to withdraw this third-line gastric cancer indication for Keytruda as a monotherapy does not affect the other accelerated approvals in certain patients with gastric cancer
FDA Will Miss Action Dates on AbbVie’s Rinvoq sNDAs: The FDA informed AbbVie that it will not meet its action dates for supplemental new drug applications (sNDAs) for AbbVie’s JAK inhibitor drug, Rinvoq (upadacitinib), for active psoriatic arthritis and active ankylosing spondylitis in adults. Rinvoq is presently approved for treating moderate-to-severe rheumatoid arthritis. The FDA has not taken any formal action like delaying the PDUFA date. However, it is currently reviewing Pfizer’s (PFE - Free Report) post-marketing study, ORAL Surveillance, on marketed JAK inhibitor, Xeljanz (tofacitinib), in patients with rheumatoid arthritis, which it cited as the reason for the delay.
AbbVie announced that Rinvoq met the primary endpoint of clinical remission at one year in a phase III maintenance ulcerative colitis (UC) study. In the study, 42% of patients given Rinvoq 15 mg once daily and 52% of patients given Rinvoq 30 mg once daily dose achieved clinical remission at week 52 compared to 12% in the placebo group.
Meanwhile, all ranked secondary endpoints of the study,including the achievement of endoscopic improvement, histologic-endoscopic mucosal improvement (HEMI) and corticosteroid-free clinical remission at week 52, were met. Data from two phase III induction studies on Rinvoq in the UC indication. U-ACHIEVE and U-ACCOMPLISH, were announced in December 2020 and February 2021, respectively. Rinvoq is presently approved to treat moderate-to-severe rheumatoid arthritis (RA).
AstraZeneca/Sanofi RSV Vaccine Shows Favorable Safety/Tolerability Profile:AstraZeneca (AZN - Free Report) /Sanofi (SNY - Free Report) announced data from the phase II/III MEDLEY study on their vaccine candidate, nirsevimab given to infants at high risk of respiratory syncytial virus (RSV) entering their first RSV season. The infants at high risk are those with chronic lung disease (CLD), congenital heart disease (CHD) and/or prematurity. In the study, nirsevimab demonstrated favourable safety and tolerability profile compared to Synagis, which is the only therapy available against lower respiratory tract infections caused by RSV for preterm infants and those with health conditions.
Meanwhile, AstraZeneca also initiated a phase II/III study,which will evaluate safety and immunogenicity of a new COVID-19 variant vaccine AZD281 in both previously vaccinated and unvaccinated adults. The first participants in the study, which expects to recruit 2,250 participants across UK, South Africa, Brazil and Poland, were vaccinated. AZD281 has been developed using same adenoviral vector platform as AstraZeneca’s marketed COVID-19 vaccine called Vaxzevria in EU.
Sanofi announced that it is divesting 16 of its Consumer Healthcare brands in Europe to Stada in a bid to streamline its Consumer Healthcare product portfolio in the country. The transaction is expected to close in the third quarter.
CHMP Approvals: The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) gave a positive opinion,recommending approval of Rinvoq for adults and adolescents with moderate to severe AD.
The CHMP also recommended approving AstraZeneca’s Forxiga (dapagliflozin) for the treatment of chronic kidney disease (CKD) in adults with and without type-II diabetes (T2D). The FDA had approved Farxiga (Forxiga’s name in U.S. market) for the CKD indication in April this year.
J&J Agrees to Pay $263M to Settle Opioid Case: J&J (JNJ - Free Report) announced a settlement agreement in an opioid litigation case with the New York state. J&J is one of the several companies whose opioid-based drugs like Duragesic have been held responsible for fueling the state’s opioid epidemic. Per the settlement agreement,J&J agreed to pay $263 million in funding to address opioid related issues. The settlement means it will no longer be part of the jury trial,which began this week. J&J also said it would no longer manufacture and sell opioids nationwide
The NYSE ARCA Pharmaceutical Index rose 1.3% in the last five trading sessions.
Watch out for regular pipeline and regulatory updates next week.
Zacks' Top Picks to Cash in on Artificial Intelligence
In 2021, this world-changing technology is projected to generate $327.5 billion in revenue. Now Shark Tank star and billionaire investor Mark Cuban says AI will create ""the world's first trillionaires."" Zacks' urgent special report reveals 3 AI picks investors need to know about today.
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Pharma Stock Roundup: EU Nod to RHHBY, MRK Drugs, FDA and Pipeline Updates
This week, the European Commission approved Roche’s (RHHBY - Free Report) Enspryng for a rare, autoimmune disorder and allowed expanded use of Merck’s (MRK - Free Report) Keytruda for first-line esophageal cancer. The FDA granted emergency approval to Roche’s rheumatoid arthritis (RA) drug,Actemra to treat patientshospitalized for COVID-19 and informed AbbVie (ABBV - Free Report) that it will not meet its action dates for two applications seeking approval of its RA drug, Rinvoq for two new indications.
Recap of the Week’s Most Important Stories
FDA Approves Roche’s Actemra for COVID-19: The FDA granted Emergency Use Authorization to Roche’s Actemra/RoActemra for the treatment of COVID-19 in hospitalized adult and pediatric patients. The EUA was based on data from four studies,which were conducted on more than 5,500 hospitalized patients.
Meanwhile the European Commission approved Roche’s Enspryng for both adults and adolescents in the EU living with anti-aquaporin-4 (AQP4) antibody positive neuromyelitis optica spectrum disorder (NMOSD). NMOSD is a rare, lifelong and debilitating autoimmune disorder of the central nervous system. The drug is already approved in the United States, Canada, Japan and Switzerland.
European Approval for Merck’s Keytruda for Esophageal Cancer: The European Commission granted approval to Merck’s PD-L1 inhibitor, Keytruda in Europe as a first-line treatment in combination with chemotherapy for certain patients with esophageal cancer or HER2-negative gastroesophageal junction (GEJ) adenocarcinoma in patients whose tumors express PD-L1 (Combined Positive Score [CPS] ≥10).. The European approval was based on results from the pivotal phase III KEYNOTE-590 study. Keytruda was approved for a similar indication by the FDA in March.
Meanwhile, Merck announced plans tovoluntarily withdraw the U.S. accelerated approval indication for Keytruda for the third-line gastric cancer. The decision was made in consultation with the FDA because Merck failed to meet its post-marketing requirement of demonstrating an overall survival benefit in a phase III study. Merck said that it will begin the withdrawal in six months. The decision to withdraw this third-line gastric cancer indication for Keytruda as a monotherapy does not affect the other accelerated approvals in certain patients with gastric cancer
FDA Will Miss Action Dates on AbbVie’s Rinvoq sNDAs: The FDA informed AbbVie that it will not meet its action dates for supplemental new drug applications (sNDAs) for AbbVie’s JAK inhibitor drug, Rinvoq (upadacitinib), for active psoriatic arthritis and active ankylosing spondylitis in adults. Rinvoq is presently approved for treating moderate-to-severe rheumatoid arthritis. The FDA has not taken any formal action like delaying the PDUFA date. However, it is currently reviewing Pfizer’s (PFE - Free Report) post-marketing study, ORAL Surveillance, on marketed JAK inhibitor, Xeljanz (tofacitinib), in patients with rheumatoid arthritis, which it cited as the reason for the delay.
AbbVie announced that Rinvoq met the primary endpoint of clinical remission at one year in a phase III maintenance ulcerative colitis (UC) study. In the study, 42% of patients given Rinvoq 15 mg once daily and 52% of patients given Rinvoq 30 mg once daily dose achieved clinical remission at week 52 compared to 12% in the placebo group.
Meanwhile, all ranked secondary endpoints of the study,including the achievement of endoscopic improvement, histologic-endoscopic mucosal improvement (HEMI) and corticosteroid-free clinical remission at week 52, were met. Data from two phase III induction studies on Rinvoq in the UC indication. U-ACHIEVE and U-ACCOMPLISH, were announced in December 2020 and February 2021, respectively. Rinvoq is presently approved to treat moderate-to-severe rheumatoid arthritis (RA).
AstraZeneca/Sanofi RSV Vaccine Shows Favorable Safety/Tolerability Profile: AstraZeneca (AZN - Free Report) /Sanofi (SNY - Free Report) announced data from the phase II/III MEDLEY study on their vaccine candidate, nirsevimab given to infants at high risk of respiratory syncytial virus (RSV) entering their first RSV season. The infants at high risk are those with chronic lung disease (CLD), congenital heart disease (CHD) and/or prematurity. In the study, nirsevimab demonstrated favourable safety and tolerability profile compared to Synagis, which is the only therapy available against lower respiratory tract infections caused by RSV for preterm infants and those with health conditions.
Meanwhile, AstraZeneca also initiated a phase II/III study,which will evaluate safety and immunogenicity of a new COVID-19 variant vaccine AZD281 in both previously vaccinated and unvaccinated adults. The first participants in the study, which expects to recruit 2,250 participants across UK, South Africa, Brazil and Poland, were vaccinated. AZD281 has been developed using same adenoviral vector platform as AstraZeneca’s marketed COVID-19 vaccine called Vaxzevria in EU.
Sanofi announced that it is divesting 16 of its Consumer Healthcare brands in Europe to Stada in a bid to streamline its Consumer Healthcare product portfolio in the country. The transaction is expected to close in the third quarter.
CHMP Approvals: The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) gave a positive opinion,recommending approval of Rinvoq for adults and adolescents with moderate to severe AD.
The CHMP also recommended approving AstraZeneca’s Forxiga (dapagliflozin) for the treatment of chronic kidney disease (CKD) in adults with and without type-II diabetes (T2D). The FDA had approved Farxiga (Forxiga’s name in U.S. market) for the CKD indication in April this year.
J&J Agrees to Pay $263M to Settle Opioid Case: J&J (JNJ - Free Report) announced a settlement agreement in an opioid litigation case with the New York state. J&J is one of the several companies whose opioid-based drugs like Duragesic have been held responsible for fueling the state’s opioid epidemic. Per the settlement agreement,J&J agreed to pay $263 million in funding to address opioid related issues. The settlement means it will no longer be part of the jury trial,which began this week. J&J also said it would no longer manufacture and sell opioids nationwide
The NYSE ARCA Pharmaceutical Index rose 1.3% 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, AstraZeneca rose the most (3.3%) while Novartis recorded the maximum decline (0.8%).
In the past six months, Lilly has recorded the maximum gain (39.7%) while Merck declined the most (3.6%)
(See the last pharma stock roundup here: EU Nod to AZN, SNY, JNJ Drugs, Glaxo’s New COVID-19 Drug Data)
What's Next in the Pharma World?
Watch out for regular pipeline and regulatory updates next week.
Zacks' Top Picks to Cash in on Artificial Intelligence
In 2021, this world-changing technology is projected to generate $327.5 billion in revenue. Now Shark Tank star and billionaire investor Mark Cuban says AI will create ""the world's first trillionaires."" Zacks' urgent special report reveals 3 AI picks investors need to know about today.
See 3 Artificial Intelligence Stocks With Extreme Upside Potential>>