We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Pharma Stock Roundup: FDA Nod to LLY's Kisunla, SNY's Dupixent Gets EU Nod for COPD
Read MoreHide Full Article
This week, Eli Lilly (LLY - Free Report) won a long-awaited FDA approval for its Alzheimer's disease (AD) drug, donanemab, to be sold under the brand name Kisunla. Sanofi (SNY - Free Report) and partner Regeneron’s blockbuster drug Dupixent was approved for a new indication — chronic obstructive pulmonary disease (COPD) — in Europe. Merck (MRK - Free Report) exercised an option that would give it global exclusive rights to develop and commercialize opevesostat, which was until now being developed in partnership with Orion Corporation.
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) gave a positive opinion recommending the approval of AstraZeneca’s (AZN - Free Report) Imfinzi for endometrial cancer. Roche (RHHBY - Free Report) halted a lung cancer study evaluating pipeline candidate, tiragolumab plus Tecentriq and chemotherapy, due to lack of efficacy.
Recap of the Week’s Most Important Stories
FDA Approves Lilly’s Alzheimer’s Drug: The FDA granted approval to Eli Lilly’s Kisunla (donanemab) for treating early symptomatic Alzheimer's disease. The approval was kind of expected after last month, when an FDA committee assessing the safety and effectiveness of donanemab voted 11-0, unanimously recommending its approval. Kisunla’s BLA was based on data from the TRAILBLAZER-ALZ 2 phase III study.
According to Lilly, Kisunla is the only Aβ targeting therapy that can be discontinued when amyloid plaques clear up, as shown by a PET scan. This will lower treatment costs and burden for patients. Kisunla will be the second drug on the market to treat AD. Biogen and its Japan-based partner Eisai’s Leqembi was approved by the FDA for early Alzheimer’s disease in the United States in July 2023. Kisunla’s label includes a black-box warning for ARIA, similar to Leqembi’s label. The Centers for Medicare & Medicaid Services has also granted broad reimbursement to Aβ targeting therapies like Leqembi and Kisunla under Medicare plans.
Sanofi’s Dupixent Gets EU Approval for COPD: The European Commission granted approval to Sanofi/Regeneron’s Dupixent for treating COPD in patients with raised blood eosinophils. The approval for the COPD indication was based on data from two studies called NOTUS and BOREAS. The EMA is the first regulatory authority in the world to approve Dupixent for COPD patients. In the United States, a supplemental biologics license application (sBLA) seeking approval of Dupixent for COPD is under review with the FDA. The FDA’s decision is expected on Sep 27.
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.
Merck Gets Exclusive Rights to Prostate Cancer Candidate From Partner: Merck and Finnish pharmaceutical company Orion Corporation mutually exercised the option that will provide Merck global exclusive rights to develop and commercialize opevesostat (previously MK-5684), which the companies were, until now, co-developing and co-commercializing, per a collaboration deal signed in 2022. Opevesostat, an investigational CYP11A1 inhibitor, is being developed in two phase III studies for the treatment of certain patients with metastatic castration-resistant prostate cancer. The option exercise will convert the co-exclusive license into an exclusive global license for Merck. Per the deal, Orion will be eligible to receive development, regulatory and sales-based milestone payments of up to $1.63 billion, as well as royalties on sales if the product is approved.
The CHMP gave a positive opinion recommending approval of Merck’s pulmonary arterial hypertension (PAH) drug Winrevair (sotatercept) in Europe. The decision of the European Commission is expected in the third quarter of 2024. If approved by the European Commission, Winrevair will become the first activin signaling inhibitor therapy for PAH in Europe. The CHMP recommendation was based on data from the STELLAR study. Winrevair (sotatercept) was approved for PAH in the United States in March 2024.
CHMP Recommends Approving AstraZeneca’s Imfinzi for Endometrial Cancer: The CHMP recommended approval for AstraZeneca’s Imfinzi (durvalumab) as a treatment for certain patients with primary advanced or recurrent endometrial cancer. The CHMP has recommended approval of Imfinzi plus chemotherapy followed by Imfinzi and Lynparza as a first-line treatment for patients with mismatch repair proficient (pMMR) advanced or recurrent endometrial cancer.
The CHMP’s positive opinion of both regimens was based on data from a prespecified exploratory subgroup analysis by MMR status in the phase III DUO-E study. Imfinzi plus chemotherapy, followed by Imfinzi monotherapy, was approved for treating adult patients with dMMR advanced or recurrent endometrial cancer based on data from the phase III DUO-E study in the United States in June.
AstraZeneca’s marketing authorization application (MAA) seeking approval for sipavibart to prevent COVID-19 has been accepted by the EMA under accelerated assessment. Sipavibart is an investigational long-acting antibody being developed for the prevention of COVID-19 in immunocompromised patients. The accelerated assessment helps in reducing the timeline for the CHMP to review the MAA compared to the standard procedure. The MAA for sipavibart was based on positive data from the phase III SUPERNOVA study.
Roche Halts NSCLC Study on Tiragolumab Combo: Roche’s phase II/III lung cancer study on tiragolumab combination regimen failed to meet the primary endpoints of progression-free survival at primary analysis and overall survival at first interim analysis. The SKYSCRAPER-06 evaluated tiragolumab plus Tecentriq plus chemotherapy for first-line treatment of locally advanced unresectable or metastatic non-squamous non-small cell lung cancer. This combination showed reduced efficacy in both progression free survival and overall survival compared to the comparator arm, as a result of which the company plans to halt the study.
The NYSE ARCA Pharmaceutical Index declined 1.67% in the last five trading sessions.
Here’s how the eight major stocks performed in the last five trading sessions.
Image Source: Zacks Investment Research
In the last five trading sessions, Pfizer rose the most (1.0%), while Merck and AbbVie declined the most (both 4.3%).
In the past six months, Lilly has risen the most (43.5%), while J&J has declined the most (9.8%).
Image: Bigstock
Pharma Stock Roundup: FDA Nod to LLY's Kisunla, SNY's Dupixent Gets EU Nod for COPD
This week, Eli Lilly (LLY - Free Report) won a long-awaited FDA approval for its Alzheimer's disease (AD) drug, donanemab, to be sold under the brand name Kisunla. Sanofi (SNY - Free Report) and partner Regeneron’s blockbuster drug Dupixent was approved for a new indication — chronic obstructive pulmonary disease (COPD) — in Europe. Merck (MRK - Free Report) exercised an option that would give it global exclusive rights to develop and commercialize opevesostat, which was until now being developed in partnership with Orion Corporation.
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) gave a positive opinion recommending the approval of AstraZeneca’s (AZN - Free Report) Imfinzi for endometrial cancer. Roche (RHHBY - Free Report) halted a lung cancer study evaluating pipeline candidate, tiragolumab plus Tecentriq and chemotherapy, due to lack of efficacy.
Recap of the Week’s Most Important Stories
FDA Approves Lilly’s Alzheimer’s Drug: The FDA granted approval to Eli Lilly’s Kisunla (donanemab) for treating early symptomatic Alzheimer's disease. The approval was kind of expected after last month, when an FDA committee assessing the safety and effectiveness of donanemab voted 11-0, unanimously recommending its approval. Kisunla’s BLA was based on data from the TRAILBLAZER-ALZ 2 phase III study.
According to Lilly, Kisunla is the only Aβ targeting therapy that can be discontinued when amyloid plaques clear up, as shown by a PET scan. This will lower treatment costs and burden for patients. Kisunla will be the second drug on the market to treat AD. Biogen and its Japan-based partner Eisai’s Leqembi was approved by the FDA for early Alzheimer’s disease in the United States in July 2023. Kisunla’s label includes a black-box warning for ARIA, similar to Leqembi’s label. The Centers for Medicare & Medicaid Services has also granted broad reimbursement to Aβ targeting therapies like Leqembi and Kisunla under Medicare plans.
Sanofi’s Dupixent Gets EU Approval for COPD: The European Commission granted approval to Sanofi/Regeneron’s Dupixent for treating COPD in patients with raised blood eosinophils. The approval for the COPD indication was based on data from two studies called NOTUS and BOREAS. The EMA is the first regulatory authority in the world to approve Dupixent for COPD patients. In the United States, a supplemental biologics license application (sBLA) seeking approval of Dupixent for COPD is under review with the FDA. The FDA’s decision is expected on Sep 27.
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.
Merck Gets Exclusive Rights to Prostate Cancer Candidate From Partner: Merck and Finnish pharmaceutical company Orion Corporation mutually exercised the option that will provide Merck global exclusive rights to develop and commercialize opevesostat (previously MK-5684), which the companies were, until now, co-developing and co-commercializing, per a collaboration deal signed in 2022. Opevesostat, an investigational CYP11A1 inhibitor, is being developed in two phase III studies for the treatment of certain patients with metastatic castration-resistant prostate cancer. The option exercise will convert the co-exclusive license into an exclusive global license for Merck. Per the deal, Orion will be eligible to receive development, regulatory and sales-based milestone payments of up to $1.63 billion, as well as royalties on sales if the product is approved.
The CHMP gave a positive opinion recommending approval of Merck’s pulmonary arterial hypertension (PAH) drug Winrevair (sotatercept) in Europe. The decision of the European Commission is expected in the third quarter of 2024. If approved by the European Commission, Winrevair will become the first activin signaling inhibitor therapy for PAH in Europe. The CHMP recommendation was based on data from the STELLAR study. Winrevair (sotatercept) was approved for PAH in the United States in March 2024.
CHMP Recommends Approving AstraZeneca’s Imfinzi for Endometrial Cancer: The CHMP recommended approval for AstraZeneca’s Imfinzi (durvalumab) as a treatment for certain patients with primary advanced or recurrent endometrial cancer. The CHMP has recommended approval of Imfinzi plus chemotherapy followed by Imfinzi and Lynparza as a first-line treatment for patients with mismatch repair proficient (pMMR) advanced or recurrent endometrial cancer.
The CHMP’s positive opinion of both regimens was based on data from a prespecified exploratory subgroup analysis by MMR status in the phase III DUO-E study. Imfinzi plus chemotherapy, followed by Imfinzi monotherapy, was approved for treating adult patients with dMMR advanced or recurrent endometrial cancer based on data from the phase III DUO-E study in the United States in June.
AstraZeneca’s marketing authorization application (MAA) seeking approval for sipavibart to prevent COVID-19 has been accepted by the EMA under accelerated assessment. Sipavibart is an investigational long-acting antibody being developed for the prevention of COVID-19 in immunocompromised patients. The accelerated assessment helps in reducing the timeline for the CHMP to review the MAA compared to the standard procedure. The MAA for sipavibart was based on positive data from the phase III SUPERNOVA study.
Roche Halts NSCLC Study on Tiragolumab Combo: Roche’s phase II/III lung cancer study on tiragolumab combination regimen failed to meet the primary endpoints of progression-free survival at primary analysis and overall survival at first interim analysis. The SKYSCRAPER-06 evaluated tiragolumab plus Tecentriq plus chemotherapy for first-line treatment of locally advanced unresectable or metastatic non-squamous non-small cell lung cancer. This combination showed reduced efficacy in both progression free survival and overall survival compared to the comparator arm, as a result of which the company plans to halt the study.
The NYSE ARCA Pharmaceutical Index declined 1.67% in the last five trading sessions.
Here’s how the eight major stocks performed in the last five trading sessions.
Image Source: Zacks Investment Research
In the last five trading sessions, Pfizer rose the most (1.0%), while Merck and AbbVie declined the most (both 4.3%).
In the past six months, Lilly has risen the most (43.5%), while J&J has declined the most (9.8%).
(See the last pharma stock roundup here: FDA’s CRL to MRK & ABBV, Phase III Study Failures for NVO, AZN)
What's Next in the Pharma World?
Watch this space for regular pipeline and regulatory updates next week.
Merck, Sanofi, Roche, Lilly and AstraZeneca have a Zacks Rank #3 (Hold) each. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.