AstraZeneca's Saphnelo Treatment Receives FDA Response
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 4d ago
0mins
Should l Buy AZN?
Source: seekingalpha
- FDA Complete Response Letter: The US FDA issued a Complete Response Letter to AstraZeneca regarding its subcutaneous version of lupus treatment Saphnelo (anifrolumab), indicating that the regulatory review process is ongoing.
- Information Submission: AstraZeneca stated that it has provided the information requested by the FDA in the letter, with a response expected by the end of H1 2023, which will directly impact the drug's market prospects.
- Clinical Trial Progress: The original Biologics License Application (BLA) for the subcutaneous version of Saphnelo included a planned interim analysis of the phase III TULIP-SC trial, which ultimately met its primary endpoint, demonstrating the drug's efficacy.
- EU Approval Context: Notably, the subcutaneous version of Saphnelo was approved in the European Union in December, laying a foundation for AstraZeneca's global marketing efforts and enhancing its competitive position in the lupus treatment market.
Trade with 70% Backtested Accuracy
Stop guessing "Should I Buy AZN?" and start using high-conviction signals backed by rigorous historical data.
Sign up today to access powerful investing tools and make smarter, data-driven decisions.
Analyst Views on AZN
Wall Street analysts forecast AZN stock price to fall over the next 12 months. According to Wall Street analysts, the average 1-year price target for AZN is 102.75 USD with a low forecast of 95.00 USD and a high forecast of 108.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
5 Analyst Rating
5 Buy
0 Hold
0 Sell
Strong Buy
Current: 187.160
Low
95.00
Averages
102.75
High
108.00
Current: 187.160
Low
95.00
Averages
102.75
High
108.00
About AZN
AstraZeneca PLC is a United Kingdom-based science-led biopharmaceutical company. The Company focuses on the discovery, development, and commercialization of prescription medicines. The Company operates across therapy areas, including Oncology; Cardiovascular, Renal and Metabolism (CVRM); Respiratory and Immunology (R&I); Vaccines and Immune Therapies (V&I), and Rare Disease. In the Oncology area, its key products include Tagrisso, Imfinzi, Calquence, Lynparza, and Enhertu. The key products of CVRM area include Farxiga/Forxiga, Brilinta/Brilique, Crestor, and Lokelma. In the R&I area, the key products are Symbicort, Fasenra, Breztri/Trixeo, and Tezspire. In the V&I Therapies area, the products are Beyfortus and FluMist. The products in the Rare Disease area are Ultomiris, Soliris, Strensiq, and Koselugo. It has about 191 projects in its development pipeline, including 19 new molecular entities (NMEs) in the late-stage pipeline. The Company distributes its products in over 125 countries.
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.
Next Week's Market Focus: Super Bowl and Earnings Reports
- Super Bowl Event: This Sunday, the Patriots will face the Seahawks in Super Bowl LX, expected to attract a large audience and boost related advertising revenues, further solidifying the significance of sporting events in the market.
- Earnings Season Arrives: Companies like Coinbase, Ford, McDonald's, and Moderna will report earnings next week, with analysts focusing on McDonald's same-store sales, which are expected to rise due to promotional activities, reflecting consumer demand for value products.
- Economic Data Release: The delayed January jobs report will be released on Wednesday, with economists forecasting the addition of 70,000 jobs in the U.S., providing the market with the latest dynamics on the labor market.
- Inflation Indicator Focus: The Consumer Price Index (CPI) will be released on Friday, with the market closely monitoring this key indicator's impact on future economic outlook and Federal Reserve policy, potentially influencing interest rate decisions.
See More
TrumpRx Launches, But Few Will Reap Its Benefits.
Limited Initial Benefits: Only a small segment of consumers is expected to benefit from the TrumpRx initiative aimed at reducing drug costs.
Expert Opinions: Experts suggest that the initiative may not provide widespread relief for all Americans regarding prescription drug prices.
See More
Market Sentiment Shift Creates Opportunities
- Money Flow Analysis: Early trading shows positive money flows into Microsoft, NVIDIA, and Tesla, while Amazon, Google, and Meta experience outflows, indicating a divergence in market sentiment that could influence investor decisions and market trends.
- Investment Strategy Recommendations: Investors are advised to hold long-term quality assets while establishing protection bands to mitigate market volatility, especially given the current increase in market uncertainty, which helps balance risk and reward.
- Traditional Portfolio Adjustments: For those adhering to a traditional 60/40 stock-bond allocation, focusing on high-quality bonds and those with five-year durations or less is recommended to address inflation risks, ensuring stability and yield in their portfolios.
- High Beta Stocks Focus: When adjusting hedge levels, it is suggested to adopt wider stop-loss strategies for high beta stocks to maintain flexibility amid market fluctuations, which is particularly crucial for investors seeking high returns.
See More
Trump Launches New Website to Lower Drug Prices
- Website Functionality: Trump announced the launch of trumprx.gov at the White House, aimed at helping consumers access more affordable prescription medications, allowing users to search for drugs, view discounted prices, and print coupons to purchase medications at reduced prices from pharmacies or manufacturers' websites.
- Significant Price Reductions: For instance, the monthly costs of Ozempic and Wegovy will decrease from $1,028 and $1,349 to as low as $199, demonstrating the website's direct economic impact on diabetes and obesity patients, which is expected to alleviate their medication burden.
- Collaboration with Drugmakers: The website will feature medications from additional companies that have signed
See More
OAK Family Advisors Fully Exits NICE Position
- Complete Liquidation: OAK Family Advisors fully liquidated its position in NICE during Q4 2026, selling 28,021 shares in a transaction valued at approximately $4 million, indicating a pessimistic outlook on the company's future prospects.
- Poor Market Performance: NICE's stock price has dropped 34.2% over the past year, closing at $109.37 on February 2, 2026, significantly underperforming the S&P 500 by 49.66 percentage points, reflecting market disappointment in its performance.
- Investment Strategy Shift: This liquidation indicates OAK Family Advisors is adjusting its portfolio by reducing its stake in NICE while increasing investments in non-tech sectors like Boeing, Novo Nordisk, and Qualcomm, showing a preference for value stocks.
- Future Investment Plans: Despite OAK's exit, NICE plans to aggressively invest in AI-driven software over the next few years to capture market demand, which may influence investor expectations regarding its future earnings.
See More
AstraZeneca's Saphnelo Treatment Receives FDA Response
- FDA Complete Response Letter: The US FDA issued a Complete Response Letter to AstraZeneca regarding its subcutaneous version of lupus treatment Saphnelo (anifrolumab), indicating that the regulatory review process is ongoing.
- Information Submission: AstraZeneca stated that it has provided the information requested by the FDA in the letter, with a response expected by the end of H1 2023, which will directly impact the drug's market prospects.
- Clinical Trial Progress: The original Biologics License Application (BLA) for the subcutaneous version of Saphnelo included a planned interim analysis of the phase III TULIP-SC trial, which ultimately met its primary endpoint, demonstrating the drug's efficacy.
- EU Approval Context: Notably, the subcutaneous version of Saphnelo was approved in the European Union in December, laying a foundation for AstraZeneca's global marketing efforts and enhancing its competitive position in the lupus treatment market.
See More
Next Week's Market Focus: Super Bowl and Earnings Reports
- Super Bowl Event: This Sunday, the Patriots will face the Seahawks in Super Bowl LX, expected to attract a large audience and boost related advertising revenues, further solidifying the significance of sporting events in the market.
- Earnings Season Arrives: Companies like Coinbase, Ford, McDonald's, and Moderna will report earnings next week, with analysts focusing on McDonald's same-store sales, which are expected to rise due to promotional activities, reflecting consumer demand for value products.
- Economic Data Release: The delayed January jobs report will be released on Wednesday, with economists forecasting the addition of 70,000 jobs in the U.S., providing the market with the latest dynamics on the labor market.
- Inflation Indicator Focus: The Consumer Price Index (CPI) will be released on Friday, with the market closely monitoring this key indicator's impact on future economic outlook and Federal Reserve policy, potentially influencing interest rate decisions.
See More
TrumpRx Launches, But Few Will Reap Its Benefits.
Limited Initial Benefits: Only a small segment of consumers is expected to benefit from the TrumpRx initiative aimed at reducing drug costs.
Expert Opinions: Experts suggest that the initiative may not provide widespread relief for all Americans regarding prescription drug prices.
See More
Market Sentiment Shift Creates Opportunities
- Money Flow Analysis: Early trading shows positive money flows into Microsoft, NVIDIA, and Tesla, while Amazon, Google, and Meta experience outflows, indicating a divergence in market sentiment that could influence investor decisions and market trends.
- Investment Strategy Recommendations: Investors are advised to hold long-term quality assets while establishing protection bands to mitigate market volatility, especially given the current increase in market uncertainty, which helps balance risk and reward.
- Traditional Portfolio Adjustments: For those adhering to a traditional 60/40 stock-bond allocation, focusing on high-quality bonds and those with five-year durations or less is recommended to address inflation risks, ensuring stability and yield in their portfolios.
- High Beta Stocks Focus: When adjusting hedge levels, it is suggested to adopt wider stop-loss strategies for high beta stocks to maintain flexibility amid market fluctuations, which is particularly crucial for investors seeking high returns.
See More
Trump Launches New Website to Lower Drug Prices
- Website Functionality: Trump announced the launch of trumprx.gov at the White House, aimed at helping consumers access more affordable prescription medications, allowing users to search for drugs, view discounted prices, and print coupons to purchase medications at reduced prices from pharmacies or manufacturers' websites.
- Significant Price Reductions: For instance, the monthly costs of Ozempic and Wegovy will decrease from $1,028 and $1,349 to as low as $199, demonstrating the website's direct economic impact on diabetes and obesity patients, which is expected to alleviate their medication burden.
- Collaboration with Drugmakers: The website will feature medications from additional companies that have signed
See More
OAK Family Advisors Fully Exits NICE Position
- Complete Liquidation: OAK Family Advisors fully liquidated its position in NICE during Q4 2026, selling 28,021 shares in a transaction valued at approximately $4 million, indicating a pessimistic outlook on the company's future prospects.
- Poor Market Performance: NICE's stock price has dropped 34.2% over the past year, closing at $109.37 on February 2, 2026, significantly underperforming the S&P 500 by 49.66 percentage points, reflecting market disappointment in its performance.
- Investment Strategy Shift: This liquidation indicates OAK Family Advisors is adjusting its portfolio by reducing its stake in NICE while increasing investments in non-tech sectors like Boeing, Novo Nordisk, and Qualcomm, showing a preference for value stocks.
- Future Investment Plans: Despite OAK's exit, NICE plans to aggressively invest in AI-driven software over the next few years to capture market demand, which may influence investor expectations regarding its future earnings.
See More
AstraZeneca's Saphnelo Treatment Receives FDA Response
- FDA Complete Response Letter: The US FDA issued a Complete Response Letter to AstraZeneca regarding its subcutaneous version of lupus treatment Saphnelo (anifrolumab), indicating that the regulatory review process is ongoing.
- Information Submission: AstraZeneca stated that it has provided the information requested by the FDA in the letter, with a response expected by the end of H1 2023, which will directly impact the drug's market prospects.
- Clinical Trial Progress: The original Biologics License Application (BLA) for the subcutaneous version of Saphnelo included a planned interim analysis of the phase III TULIP-SC trial, which ultimately met its primary endpoint, demonstrating the drug's efficacy.
- EU Approval Context: Notably, the subcutaneous version of Saphnelo was approved in the European Union in December, laying a foundation for AstraZeneca's global marketing efforts and enhancing its competitive position in the lupus treatment market.
See More
