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JMP Securities initiated coverage on BeiGene Ltd , noting the Chinese biotech firm as a ‘unique investment opportunity.’
The company’s flagship drug, Brukinsa (zanubrutinib), is among the more recent BTK inhibitors to break into a global market projected to hit $12.2 billion by 2031. Three major players dominate this sector, with Johnson & Johnson‘s Imbruvica leading the charge, peaking at $8.7 billion in sales in 2021.
However, competition intensified when AstraZeneca Plc‘s Calquence and Brukinsa entered the market in 2017 and 2019, respectively.
Analyst Reni Benjamin’s confidence in Brukinsa emerging as a market leader is bolstered by an exclusive survey of 37 doctors, indicating that 80% plan to boost their use of Brukinsa due to its perceived safety and long-term effectiveness advantages.
As Imbruvica’s popularity declines, Calquence and Brukinsa will capture a larger market share. By 2031, Brukinsa is expected to command 55% of the market, potentially generating global sales of $5.4 billion, the analyst adds.
Benjamin says Brukinsa is on track to generate over $2 billion for the company in 2024, with total revenues to reach $3.7 billion.
The analyst has initiated the coverage with a Market Perform rating and a price target of $288.
China ranks as the third-largest healthcare market globally, behind the U.S. and the EU, with expenditures reaching $1.2 trillion.
BeiGene, which offers 14 products in China through various U.S. partners, holds a significant position in this market. Despite limited visibility into China’s regulatory and commercial environment, BeiGene’s sales force has driven annual revenues from China to $1.1 billion.
However, JMP writes that the numbers can drop to $178 million by 2031 due to patent expirations unless additional therapeutics are licensed.
Price Action: BGNE stock is up 1.05% at $199.59 at last check Wednesday.
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Photo: Shutterstock
Latest Ratings for BGNE
Date | Firm | Action | From | To |
---|---|---|---|---|
Feb 2022 | Morgan Stanley | Maintains | Overweight | |
Feb 2022 | SVB Leerink | Maintains | Outperform | |
Jan 2022 | Morgan Stanley | Maintains | Overweight |
View More Analyst Ratings for BGNE
View the Latest Analyst Ratings
© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Merck MRK announced that a phase study evaluating its Daiichi Sankyo-partnered HER3-directed DXd antibody drug conjugate (ADC), patritumab deruxtecan, for treating EGFR-mutated non-small cell lung cancer (NSCLC), met its primary endpoint of progression-free survival (PFS).
The HERTHENA-Lung02 evaluated the efficacy and safety of patritumab deruxtecan versus pemetrexed and platinum chemotherapy for treating locally advanced or metastatic EGFR-mutated NSCLC in patients who had received prior EGFR tyrosine kinase inhibitor treatment. In the study, patritumab deruxtecan demonstrated a statistically significant improvement in PFS — the study’s primary endpoint — versus platinum plus pemetrexed induction chemotherapy.
As regards overall survival, a key secondary endpoint of the study, the data were immature at the time of the analysis. The study will continue to further assess overall survival.
Patients with metastatic EGFR-mutated NSCLC who are initially treated with an EGFR TKI sometimes experience disease progression. This creates a need for therapies like patritumab deruxtecan as treatment options for this type of lung cancer in the second-line setting are limited.
Merck plans to discuss the data with regulatory authorities to decide the next steps.
Merck’s stock has risen 8.5% so far this year compared with an increase of 25.9% for the industry.
More on MRK’s Patritumab Deruxtecan
A biologics license application (BLA) seeking accelerated approval for patritumab deruxtecan for previously-treated EGFR-mutated NSCLC is already under review in the United States supported by data from the HERTHENA-Lung01 pivotal phase II study.
In June, the FDA issued a complete response letter to the BLA based on observations made after the inspection of a third-party manufacturing facility. The FDA has not requested any additional efficacy/safety studies, nor has it identified any issues related to the safety and efficacy of the candidate. Merck is working closely with the FDA and the third-party manufacturer to resolve the issue.
Merck’s Deal With Daiichi Sankyo
Merck acquired global co-development and co-commercialization rights to patritumab deruxtecan/MK-1022 and two other ADCs, raludotatug deruxtecan/MK-5909 and ifinatamab deruxtecan/MK-2400 from Japan’s Daiichi Sankyo in October last year for a total potential consideration of up to $22 billion. While raludotatug deruxtecan is being developed in phase II/III study for ovarian cancer, ifinatamab deruxtecan is being studied for small-cell lung cancer in phase III and colorectal, bladder, endometrial and head and neck cancers in phase II.
Daiichi Sankyo has retained exclusive rights for the development of the candidates in Japan. In August this year, Merck expanded its deal with Daiichi to co-develop and co-commercialize MK-6070, an investigational T-cell engager targeting delta-like ligand 3, which it obtained from its acquisition of Harpoon Therapeutics.
Other Companies Making ADC Products
ADCs are being considered a disruptive innovation in the pharmaceutical industry as these will enable better treatment of cancer by harnessing the targeting power of antibodies to deliver cytotoxic molecule drugs to tumors.
Daiichi Sankyo has six ADCs in clinical development across multiple types of cancer, being developed utilizing its DXd ADC technology. It markets Enhertu, a HER2-directed ADC for HER2-mutated breast, lung and gastric cancers, in partnership with AstraZeneca AZN. Daiichi Sankyo and AstraZeneca have also developed datopotamab deruxtecan (Dato-DXd), a TROP2-directed ADC. Dato-DXd is under FDA review for advanced nonsquamous NSCLC as well as previously treated metastatic HR-positive, HER2-negative breast cancer. The sixth ADC candidate is DS-3939, a TA-MUC1-directed ADC, which Daiichi Sankyo is developing on its own.
Pfizer PFE also has a strong portfolio of ADC drugs, which were added with last year’s acquisition of Seagen. The December 2023 acquisition of Seagen added four ADCs — Adcetris, Padcev, Tukysa and Tivdak — to Pfizer’s portfolio. Adcetris, Padcev, Tukysa and Tivdak contributed $279 million, $394 million, $121 million and $33 million, respectively, to Pfizer’s oncology revenues in the second quarter. Pfizer is particularly witnessing strong demand for Padcev.
MRK’s Rank and Stock to Consider
Merck has a Zacks Rank #4 (Sell) currently.
Merck & Co., Inc. Stock Price and Consensus
Merck & Co., Inc. price-consensus-chart | Merck & Co., Inc. Quote
A top-ranked large drugmaker is Eli Lilly LLY, carrying a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Earnings estimates for 2024 have risen from $13.71 to $16.49 per share over the past 60 days. For 2025, earnings estimates have risen from $19.42 to $23.97 per share over the same timeframe. LLY’s stock is up 55.5% year to date.
Lilly beat estimates in each of the last four quarters, delivering a four-quarter average earnings surprise of 69.07%.
Zacks Investment Research
The FDA approved on Wednesday AstraZeneca Plc’s Fasenra (benralizumab) for eosinophilic granulomatosis with polyangiitis (EGPA), a rare, immune-mediated vasculitis (inflammation of the blood vessels) that can result in damage to multiple organs.
The approval was based on data from the MANDARA Phase 3 trial published in The New England Journal of Medicine, which compared the efficacy and safety of Fasenra to the only approved EGPA treatment, GSK Plc’s Nucala (mepolizumab).
Also Read: AstraZeneca CEO Pascal Soriot Updates On Chinese Compliance Probe And Lung Cancer Drug Trial Results
MANDARA was the first head-to-head non-inferiority trial of biologics in patients with EGPA.
In the trial, nearly 60% of Fasenra-treated patients achieved remission, comparable to mepolizumab-treated patients.
Data also showed 41% of Fasenra-treated patients fully tapered off oral corticosteroids (OCS) (vs. 26% in the mepolizumab arm).
The safety and tolerability profile for Fasenra in the MANDARA trial was consistent with the known profile of the medicine.
Approximately half of patients with EGPA have adult-onset severe eosinophilic asthma and often have sinus and nasal symptoms. Fasenra is the second biologic approved to treat this disease.
Fasenra is currently approved as an add-on maintenance treatment for severe eosinophilic asthma in over 80 countries.
It is also approved in children and adolescents ages six and above in the U.S. and Japan.
Last month, the FDA approved AstraZeneca’s Imfinzi (durvalumab) in combination with chemotherapy for adult patients with resectable early-stage non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor mutations or anaplastic lymphoma kinase rearrangements.
AZN Price Action: AstraZeneca stock is down 0.16% at $78.41 at publication Wednesday.
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Photo: Shutterstock
© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
AstraZeneca AZN announced that the FDA has approved its marketed asthma drug, Fasenra (benralizumab) for a new indication. The regulatory body has now approved Fasenra for treating adult patients with eosinophilic granulomatosis with polyangiitis (“EGPA”).
EGPA is a rare autoimmune disease that can cause damage to multiple organs and tissues and is the second approved indication for Fasenra.
Fasenra is already approved as an add-on maintenance treatment for severe eosinophilic asthma (SEA).
Shares of AstraZeneca have increased 16.6% so far this year compared with the industry’s rise of 25.9%.
Latest Approval for AZN’s Fasenra Based on MANDARA Study
The FDA nod for Fasenra in EGPA was based on data from the phase III MANDARA study.
The MANDARA head-to-head study compared a single monthly injection of Fasenra to three injections per month of GSK’s GSK blockbuster drug, Nucala (mepolizumab), which until now was the only approved drug for EGPA.
Data from the study showed that nearly 60% of patients who were treated with Fasenra achieved remission, which was comparable to GSK’s Nucala-treated patients.
Also, 41% of patients who were treated with Fasenra fully stopped taking oral corticosteroids compared to 26% of patients in the Nucala arm.
The latest approval of Fasenra is likely to offer a convenient single monthly subcutaneous injection to patients living with EGPA.
AZN’s Fasenra a Key Revenue Driver
Fasenra is currently approved in more than 80 countries across the world, including the United States, European Union and Japan for SEA. Several label expansion studies are going on for Fasenra for eosinophil-driven diseases beyond severe asthma, like chronic obstructive pulmonary disease, chronic rhinosinusitis with nasal polyps and hypereosinophilic syndrome.
Fasenra generated sales worth $781 million in the first half of 2024, reflecting an increase of 6% year over year at a constant exchange rate. Sales of the drug have been rising, driven by strong demand growth and market share.
Continued label expansion for Fasenra into additional indications and patient populations should boost drug sales in the days ahead.
Other Players in the Respiratory Diseases Market
Apart from GSK’s Nucala, Sanofi SNY and Regeneron’s REGN Dupixent (dupilumab), an IL-4 and IL-13 inhibitor, is also 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.
REGN and SNY are jointly marketing Dupixent under a global collaboration agreement. Sanofi records global net product sales of Dupixent, while Regeneron records its share of profits/losses in connection with the drug’s global sales. The companies are also studying the drug in late-stage studies in a broad range of diseases driven by type II inflammation, like bullous pemphigoid and chronic pruritus of unknown origin.
Zacks Rank
AstraZeneca currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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