EMA's CHMP Reaffirms Decision to Deny Change in Marketing Authorization for Hetlioz (Tasimelteon)
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 3 days ago
0mins
Should l Buy AMGN?
Source: moomoo
EMA's Recommendation: The European Medicines Agency (EMA) has confirmed its recommendation to reuse a specific change in the marketing authorization process.
Marketing Authorization: This recommendation pertains to the marketing authorization for a product associated with the organization Hetlioz, which is linked to the treatment of certain conditions.
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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: 348.770
Low
280.00
Averages
363.10
High
425.00
Current: 348.770
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.
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- Significant LDL-C Level Reduction: After 96 weeks of treatment, the median LDL-C level in the Repatha group was 44 mg/dL compared to 105 mg/dL in the placebo group, demonstrating Repatha's superior efficacy in cholesterol reduction, potentially offering better cardiovascular protection for patients.
- Strategic Importance of Early Intervention: The findings emphasize the importance of early and intensive LDL-C lowering strategies in high-risk patients without known atherosclerosis, which may effectively reduce the risk before cardiovascular disease onset.
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