Workflow
Saphnelo (anifrolumab)
icon
Search documents
FDA Rejects AZN's Saphnelo SubQ Formulation, Priority Tag to Datroway
ZACKS· 2026-02-04 16:16
Key Takeaways FDA granted priority review to AZN's Datroway sBLA for unresectable or metastatic TNBC, with a Q2 2026 target.AZN's Datroway already has approvals in breast and lung cancer and is being studied across multiple cancers.The FDA issued a CRL for AZN's Saphnelo SC. AZN has resubmitted data and expects a U.S. decision in H1 2026.AstraZeneca (AZN) and its Japan-based partner Daiichi Sankyo announced that the FDA has accepted and granted priority review to their supplemental biologics license applica ...
AstraZeneca PLC (AZN) Gains After Successful Saphnelo Trial
Yahoo Finance· 2026-01-20 09:58
Group 1: Investment Potential - AstraZeneca PLC is ranked fourth in a list of the Top 10 Oncology Stocks to Buy Now, indicating strong investment interest in the company [1] - Barclays analyst James Gordon raised the price target for AstraZeneca from 14,000 GBp to 16,500 GBp, maintaining an Overweight rating on the shares, suggesting positive market sentiment [1] Group 2: Clinical Developments - AstraZeneca announced significant results from its Phase III TULIP‑SC trial of Saphnelo (anifrolumab) for systemic lupus erythematosus (SLE), with 56.2% of patients showing improvement compared to 37.1% in the placebo group, highlighting the drug's potential as a therapy for SLE [2] - The company is advancing cancer care through a robust late-stage oncology pipeline and innovative therapies, aiming to improve patient outcomes across various tumor types globally [3]
AstraZeneca’s Subcutaneous Saphnelo Shows Significant Disease Reduction in Landmark Lupus Trial
Yahoo Finance· 2026-01-19 12:49
Group 1 - AstraZeneca is considered one of the best long-term stocks to buy, with Barclays analyst James Gordon raising the price target from 14,000 GBp to 16,500 GBp while maintaining an Overweight rating [1] - AstraZeneca published positive results from the Phase III TULIP-SC trial, showing that subcutaneous administration of Saphnelo significantly reduces disease activity in systemic lupus erythematosus patients, which is crucial for the 3.4 million people globally affected by this condition [2] - The trial demonstrated that weekly 120 mg subcutaneous doses of Saphnelo were well tolerated, with a safety profile similar to the intravenous version, and the new formulation is currently under regulatory review in the US and Japan [3] Group 2 - AstraZeneca is a biopharmaceutical company involved in the discovery, development, manufacturing, and commercialization of prescription medicines [4]
12 Best Future Stocks to Buy For the Long Term
Insider Monkey· 2026-01-16 20:25
Group 1: Tech Market Outlook - The tech bull market is expected to continue, with Nvidia's CEO Jensen Huang being recognized as a pivotal figure in the AI revolution, shifting focus from hardware to robotics and autonomous technology [1] - AI-related stocks have recently surged following strong earnings from Micron, indicating robust demand for memory chips, although there is a bipolar market environment where stocks react strongly to news [2] - The S&P tech sector is trading at a lower forward P/E ratio compared to the beginning of the year, suggesting that fears of an AI bubble are keeping valuations in check [2] Group 2: Future Market Predictions - Looking ahead to 2026, market vulnerability is anticipated, with the Federal Reserve identified as a primary threat to the bull market rather than valuation concerns [3] - A washout is deemed necessary to reset bullish sentiment, similar to how surprise tariffs in early 2025 prepared the market for a subsequent run [3] Group 3: Stock Recommendations - CleanSpark Inc. (NASDAQ:CLSK) is highlighted as a top future stock, with an average upside potential of 74.16% and 34 hedge fund holders, focusing on Bitcoin mining and expanding into AI data centers [8][9] - AstraZeneca (NASDAQ:AZN) is also recommended, with a 9.65% average upside potential and 54 hedge fund holders, bolstered by positive trial results for Saphnelo, which offers a new self-administered treatment option for systemic lupus erythematosus [12][13][14]
Berenberg Bank Remains Bullish on AstraZeneca PLC (AZN) – Here’s Why
Yahoo Finance· 2026-01-10 19:57
Group 1 - AstraZeneca PLC (NASDAQ:AZN) is recognized as one of the best performing pharmaceutical stocks in 2025, with a Buy rating reiterated by Berenberg Bank and a price target of $95 [1] - The company announced positive full results from the Phase III TULIP-SC trial, showing that 56.2% of patients receiving Saphnelo (anifrolumab) experienced a reduction in disease activity at Week 52 compared to 37.1% in the placebo group [2] - The safety profile observed in the TULIP-SC trial was consistent with Saphnelo's known clinical profile, confirming the findings from the interim analysis as statistically significant [3] Group 2 - AstraZeneca PLC is a biopharmaceutical company engaged in the exploration, development, manufacturing, and commercialization of prescription medicines, supplying products to specialty and primary care physicians [4]
AstraZeneca's Fasenra Falls Short In Smoker's Lung Trial
Benzinga· 2025-09-17 17:20
Group 1 - AstraZeneca Plc released topline data from the RESOLUTE Phase 3 trial of Fasenra (benralizumab), which showed numerical improvement but did not achieve statistical significance in the primary endpoint for patients with chronic obstructive pulmonary disease (COPD) [1] - The safety and tolerability profile for Fasenra in the trial was consistent with the known profile of the medicine [1] - Fasenra is currently approved as an add-on maintenance treatment for severe eosinophilic asthma (SEA) in over 80 countries, including the US, Japan, the EU, and China [2] Group 2 - Fasenra has also been approved in more than 60 countries for the treatment of eosinophilic granulomatosis with polyangiitis and is under regulatory review for hypereosinophilic syndrome [3] - AstraZeneca shared high-level results from a pre-specified interim analysis of the Phase 3 TULIP-SC trial in patients with systemic lupus erythematosus (SLE), showing a statistically significant reduction in disease activity compared to placebo [4][5] - The TULIP-SC interim results are currently under regulatory review, and Saphnelo IV infusion is approved for moderate to severe SLE in over 70 countries [6]