Zai Lab Collaborates with Amgen for Clinical Trial
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 13 hours ago
0mins
Should l Buy AMGN?
Source: Newsfilter
- Clinical Collaboration Agreement: Zai Lab has entered into a global clinical trial collaboration with Amgen to evaluate the safety and efficacy of DLL3-targeting antibody-drug conjugate zocilurtatug pelitecan in combination with IMDELLTRA®, marking a strategic move in the treatment of small cell lung cancer.
- Global Study Launch: Amgen will sponsor a global Phase 1b study while Zai Lab retains full ownership of zocilurtatug pelitecan, which is expected to drive the development of new therapies and enhance the company's competitiveness in the oncology market.
- Efficacy Potential: Zocilurtatug pelitecan has demonstrated a high response rate at the EORTC-NCI-AACR and ASCO meetings, particularly showing significant intracranial activity in heavily pretreated small cell lung cancer patients, potentially offering new treatment options for this challenging disease.
- Market Outlook: With poor prognosis for small cell lung cancer patients, and IMDELLTRA® already FDA-approved, the combination of zocilurtatug pelitecan and IMDELLTRA® is poised to further improve efficacy, addressing the urgent market demand for new therapies.
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Analyst Views on AMGN
Wall Street analysts forecast AMGN stock price to rise
24 Analyst Rating
14 Buy
9 Hold
1 Sell
Moderate Buy
Current: 351.850
Low
280.00
Averages
363.10
High
425.00
Current: 351.850
Low
280.00
Averages
363.10
High
425.00
About AMGN
Amgen Inc. is a biotechnology company. It discovers, develops, manufactures and delivers medicines for the toughest diseases. It focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve people’s lives. It operates in the human therapeutics segment. Its marketed products portfolio includes EPOGEN (epoetin alfa); Aranesp (darbepoetin alfa); Parsabiv (etelcalcetide); Neulasta (pegfilgrastim); KANJINTI (trastuzumab-anns); Otezla; BLINCYTO (blinatumomab); ACTIMMUNE (interferon gamma-1b); Neulasta (pegfilgrastim); Sensipar/Mimpara (cinacalcet); Prolia (denosumab); ENBREL; QUINSAIR (levofloxacin); Repatha (evolocumab) and others. It markets ENBREL, a tumor necrosis factor blocker, in the United States and Canada. It markets Otezla, a small molecule that inhibits phosphodiesterase 4, in many countries around the world. It markets Repatha, a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, in many countries around the world.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Zai Lab Partners with Amgen for Global Clinical Trial
- Global Clinical Trial Collaboration: Zai Lab announced a collaboration with Amgen to conduct a global clinical trial studying its antibody-drug conjugate zocilurtatug pelitecan in combination with Amgen's bispecific T-cell engager Imdelltra, marking a strategic move in the small cell lung cancer space.
- Clinical Trial Phase: Amgen will sponsor a global Phase 1b study to evaluate the drug combination in patients with extensive-stage small cell lung cancer, which accounts for about two-thirds of SCLC cases, indicating the potential market size of this collaboration.
- Ownership and Supply of Drug: Zai Lab will retain full ownership of zocilurtatug pelitecan and supply the experimental therapy for the Amgen-led study, ensuring control over the development process while potentially enhancing its market competitiveness.
- Market Outlook for SCLC: Small cell lung cancer accounts for 15% of nearly 2.5 million lung cancer cases diagnosed globally each year, with extensive-stage SCLC having high relapse rates and poor prognosis, highlighting the urgent need for new therapies, and Zai Lab's collaboration aims to address this market gap.
See More
Zai Lab Collaborates with Amgen for Clinical Trial
- Clinical Collaboration Agreement: Zai Lab has entered into a global clinical trial collaboration with Amgen to evaluate the safety and efficacy of DLL3-targeting antibody-drug conjugate zocilurtatug pelitecan in combination with IMDELLTRA®, marking a strategic move in the treatment of small cell lung cancer.
- Global Study Launch: Amgen will sponsor a global Phase 1b study while Zai Lab retains full ownership of zocilurtatug pelitecan, which is expected to drive the development of new therapies and enhance the company's competitiveness in the oncology market.
- Efficacy Potential: Zocilurtatug pelitecan has demonstrated a high response rate at the EORTC-NCI-AACR and ASCO meetings, particularly showing significant intracranial activity in heavily pretreated small cell lung cancer patients, potentially offering new treatment options for this challenging disease.
- Market Outlook: With poor prognosis for small cell lung cancer patients, and IMDELLTRA® already FDA-approved, the combination of zocilurtatug pelitecan and IMDELLTRA® is poised to further improve efficacy, addressing the urgent market demand for new therapies.
See More
Trump's Drug Pricing Policy Affects European Market Launches
- Launch Decline: According to GlobalData, the number of pharmaceutical launches in Europe has decreased by 35% in the first ten months following the implementation of the International Reference Pricing policy, indicating that Trump's Most Favored Nation pricing policy may lead drugmakers to delay or withdraw products, thereby impacting market competitiveness.
- Increased Withdrawals: In the ten months following Trump's executive order, the number of brands with at least one pack withdrawn from the European market rose by 43%, suggesting that drugmakers may face a dilemma between maintaining access in lower-priced EU markets and ensuring U.S. pricing integrity.
- Policy Impact Assessment: While other factors could contribute to changes in drug launches and withdrawals, GlobalData notes that this trend may serve as an early signal of the impact that the introduction of International Reference Pricing in the U.S. may have on European markets, raising concerns about patient access and affordability.
- Case Study: For instance, Amgen recently withdrew its cholesterol therapy Repatha from the Danish market, reflecting the strategic considerations drugmakers must navigate in response to pricing policies, which could influence their market positioning in Europe.
See More
FDA Warns of Liver Injury Risk Linked to Amgen's Tavneos
- Liver Injury Warning: The U.S. FDA has issued a warning regarding the risk of drug-induced liver injury associated with Amgen's Tavneos (avacopan), identifying 76 cases in its adverse events database that show reasonable evidence of a causal association, posing a significant threat to patient health.
- Serious Outcome Statistics: Among the 76 cases, 74 were classified as serious outcomes, including 54 hospitalizations and 8 deaths, indicating an urgent need to reassess the drug's safety to prevent future medical incidents and potential legal liabilities.
- Onset Time Analysis: The median time to onset of liver injury was 46 days (ranging from 22 to 140 days), suggesting that patients may experience severe health issues relatively soon after starting Tavneos, highlighting the need for enhanced monitoring by healthcare providers.
- Monitoring Recommendations: The FDA advises healthcare providers to initiate liver panel testing every two weeks during the first month of treatment, then monthly for the next five months, ensuring timely detection of potential liver damage to mitigate health risks for patients.
See More
Analysis of DGRO ETF's 52-Week Price Range
- Price Range Analysis: DGRO ETF's 52-week low is $54.09 per share, with a high of $74.28, and a last trade at $69.61, indicating stability and investor confidence in the ETF's performance.
- Technical Analysis Tool: Comparing the current share price to the 200-day moving average provides valuable insights for investors, aiding in market trend assessment and potential buying opportunities.
- ETF Unit Trading Mechanism: ETFs trade like stocks, where investors buy and sell 'units' that can be created or destroyed based on demand, impacting liquidity and market performance.
- Inflows and Outflows Monitoring: Weekly monitoring of changes in shares outstanding helps identify ETFs experiencing significant inflows or outflows, allowing investors to stay informed about market dynamics and investment opportunities.
See More
Teva Receives FDA Approval for New Biosimilar Drug
- Biosimilar Approval: Teva Pharmaceutical's Ponlimsi (denosumab-adet) has received FDA approval as a biosimilar to Amgen's Prolia (denosumab), which is projected to generate approximately $4.4 billion in revenue in 2025, indicating Teva's potential in the osteoporosis treatment market.
- Increased Market Competition: As Prolia is Amgen's best-selling drug, Teva's approval may exert competitive pressure, potentially leading to a decline in Prolia's market share, which could adversely affect Amgen's revenue and market position.
- Regulatory Review Progress: Teva also announced that the FDA and the European Medicines Agency have agreed to review its biosimilar applications for Genentech and Novartis' Xolair (omalizumab), which reported sales of approximately $3.8 billion and $1.7 billion in 2025, respectively, showcasing Teva's expansion potential in respiratory disease treatments.
- Optimistic Industry Outlook: With the FDA relaxing testing rules for biosimilars, Teva's applications are likely to receive more support, potentially driving growth for other generic drug suppliers in the industry, thereby enhancing market competition and drug accessibility.
See More
Zai Lab Partners with Amgen for Global Clinical Trial
- Global Clinical Trial Collaboration: Zai Lab announced a collaboration with Amgen to conduct a global clinical trial studying its antibody-drug conjugate zocilurtatug pelitecan in combination with Amgen's bispecific T-cell engager Imdelltra, marking a strategic move in the small cell lung cancer space.
- Clinical Trial Phase: Amgen will sponsor a global Phase 1b study to evaluate the drug combination in patients with extensive-stage small cell lung cancer, which accounts for about two-thirds of SCLC cases, indicating the potential market size of this collaboration.
- Ownership and Supply of Drug: Zai Lab will retain full ownership of zocilurtatug pelitecan and supply the experimental therapy for the Amgen-led study, ensuring control over the development process while potentially enhancing its market competitiveness.
- Market Outlook for SCLC: Small cell lung cancer accounts for 15% of nearly 2.5 million lung cancer cases diagnosed globally each year, with extensive-stage SCLC having high relapse rates and poor prognosis, highlighting the urgent need for new therapies, and Zai Lab's collaboration aims to address this market gap.
See More
Zai Lab Collaborates with Amgen for Clinical Trial
- Clinical Collaboration Agreement: Zai Lab has entered into a global clinical trial collaboration with Amgen to evaluate the safety and efficacy of DLL3-targeting antibody-drug conjugate zocilurtatug pelitecan in combination with IMDELLTRA®, marking a strategic move in the treatment of small cell lung cancer.
- Global Study Launch: Amgen will sponsor a global Phase 1b study while Zai Lab retains full ownership of zocilurtatug pelitecan, which is expected to drive the development of new therapies and enhance the company's competitiveness in the oncology market.
- Efficacy Potential: Zocilurtatug pelitecan has demonstrated a high response rate at the EORTC-NCI-AACR and ASCO meetings, particularly showing significant intracranial activity in heavily pretreated small cell lung cancer patients, potentially offering new treatment options for this challenging disease.
- Market Outlook: With poor prognosis for small cell lung cancer patients, and IMDELLTRA® already FDA-approved, the combination of zocilurtatug pelitecan and IMDELLTRA® is poised to further improve efficacy, addressing the urgent market demand for new therapies.
See More
Trump's Drug Pricing Policy Affects European Market Launches
- Launch Decline: According to GlobalData, the number of pharmaceutical launches in Europe has decreased by 35% in the first ten months following the implementation of the International Reference Pricing policy, indicating that Trump's Most Favored Nation pricing policy may lead drugmakers to delay or withdraw products, thereby impacting market competitiveness.
- Increased Withdrawals: In the ten months following Trump's executive order, the number of brands with at least one pack withdrawn from the European market rose by 43%, suggesting that drugmakers may face a dilemma between maintaining access in lower-priced EU markets and ensuring U.S. pricing integrity.
- Policy Impact Assessment: While other factors could contribute to changes in drug launches and withdrawals, GlobalData notes that this trend may serve as an early signal of the impact that the introduction of International Reference Pricing in the U.S. may have on European markets, raising concerns about patient access and affordability.
- Case Study: For instance, Amgen recently withdrew its cholesterol therapy Repatha from the Danish market, reflecting the strategic considerations drugmakers must navigate in response to pricing policies, which could influence their market positioning in Europe.
See More
FDA Warns of Liver Injury Risk Linked to Amgen's Tavneos
- Liver Injury Warning: The U.S. FDA has issued a warning regarding the risk of drug-induced liver injury associated with Amgen's Tavneos (avacopan), identifying 76 cases in its adverse events database that show reasonable evidence of a causal association, posing a significant threat to patient health.
- Serious Outcome Statistics: Among the 76 cases, 74 were classified as serious outcomes, including 54 hospitalizations and 8 deaths, indicating an urgent need to reassess the drug's safety to prevent future medical incidents and potential legal liabilities.
- Onset Time Analysis: The median time to onset of liver injury was 46 days (ranging from 22 to 140 days), suggesting that patients may experience severe health issues relatively soon after starting Tavneos, highlighting the need for enhanced monitoring by healthcare providers.
- Monitoring Recommendations: The FDA advises healthcare providers to initiate liver panel testing every two weeks during the first month of treatment, then monthly for the next five months, ensuring timely detection of potential liver damage to mitigate health risks for patients.
See More
Analysis of DGRO ETF's 52-Week Price Range
- Price Range Analysis: DGRO ETF's 52-week low is $54.09 per share, with a high of $74.28, and a last trade at $69.61, indicating stability and investor confidence in the ETF's performance.
- Technical Analysis Tool: Comparing the current share price to the 200-day moving average provides valuable insights for investors, aiding in market trend assessment and potential buying opportunities.
- ETF Unit Trading Mechanism: ETFs trade like stocks, where investors buy and sell 'units' that can be created or destroyed based on demand, impacting liquidity and market performance.
- Inflows and Outflows Monitoring: Weekly monitoring of changes in shares outstanding helps identify ETFs experiencing significant inflows or outflows, allowing investors to stay informed about market dynamics and investment opportunities.
See More
Teva Receives FDA Approval for New Biosimilar Drug
- Biosimilar Approval: Teva Pharmaceutical's Ponlimsi (denosumab-adet) has received FDA approval as a biosimilar to Amgen's Prolia (denosumab), which is projected to generate approximately $4.4 billion in revenue in 2025, indicating Teva's potential in the osteoporosis treatment market.
- Increased Market Competition: As Prolia is Amgen's best-selling drug, Teva's approval may exert competitive pressure, potentially leading to a decline in Prolia's market share, which could adversely affect Amgen's revenue and market position.
- Regulatory Review Progress: Teva also announced that the FDA and the European Medicines Agency have agreed to review its biosimilar applications for Genentech and Novartis' Xolair (omalizumab), which reported sales of approximately $3.8 billion and $1.7 billion in 2025, respectively, showcasing Teva's expansion potential in respiratory disease treatments.
- Optimistic Industry Outlook: With the FDA relaxing testing rules for biosimilars, Teva's applications are likely to receive more support, potentially driving growth for other generic drug suppliers in the industry, thereby enhancing market competition and drug accessibility.
See More
