Biotech Stocks Awaiting FDA Verdict in October 2025
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Sep 28 2025
0mins
Should l Buy AMGN?
Source: NASDAQ.COM
FDA Approvals: The FDA authorized Essilor Stellest eyeglass lenses on September 25, marking the first approval aimed at slowing myopia progression in children aged 6 to 12, and granted accelerated approval to Stealth Biotherapeutics' Forzinity as the first treatment for Barth syndrome.
Acetaminophen Scrutiny: The FDA is updating acetaminophen (Tylenol) labeling to warn about potential risks of autism and ADHD in children associated with its use during pregnancy, following renewed scrutiny on this commonly used analgesic.
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Analyst Views on AMGN
Wall Street analysts forecast AMGN stock price to fall
24 Analyst Rating
14 Buy
9 Hold
1 Sell
Moderate Buy
Current: 366.200
Low
280.00
Averages
363.10
High
425.00
Current: 366.200
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.
AMGEN INC: SUBMITS SEC FILING FOR COMMON STOCK OFFERING BY SELLING SECURITYHOLDERS
- Company Filing: AMGEN has filed for offering common stock by selling security holders.
- Purpose of Offering: The offering is intended to provide liquidity for the selling security holders.
See More
AMGEN INC: SUBMITS MIXED SHELF OFFERING; SIZE UNREVEALED - SEC FILING
Company Filing: AMGEN has filed for a mixed shelf offering, allowing it to raise capital through various securities.
Size Disclosure: The specific size of the offering has not been disclosed in the filing.
See More
UPLIZNA Approved for Adult gMG Treatment in Europe
- New Therapy Approval: UPLIZNA (Inebilizumab) has been approved by the European Commission as an adjunct treatment for adults with anti-AChR+ and anti-MuSK+ generalized Myasthenia Gravis (gMG), marking a significant advancement in this field.
- Long-term Disease Control: The therapy demonstrates potential for sustained disease control in gMG patients through a biannual maintenance dose following two initial infusions, which may reduce the need for long-term steroid use.
- Clinical Research Support: The approval is based on data from the MINT study, the largest Phase 3 trial for gMG, involving 238 patients, where 87.4% of UPLIZNA patients successfully reduced their steroid dosage to 5mg or less per day by week 26.
- Market Impact: The approval of UPLIZNA provides a new treatment option for gMG patients, expected to enhance patient quality of life while bolstering Amgen's market position in the rare disease sector.
See More
Amgen to Present at 2026 Oncology Leadership Summit
- Event Schedule: Amgen will participate in Citi's 2026 Virtual Oncology Leadership Summit on February 18, 2026, at 12:15 p.m. PT, where Jean-Charles Soria, Senior Vice President of Oncology, will present the company's latest advancements in oncology.
- Webcast Availability: The presentation will be broadcast live over the internet, accessible to media, investors, and the public, ensuring broad dissemination of information, and will be archived on Amgen's website for at least 90 days for later viewing.
- Company Background: Founded over 45 years ago, Amgen is dedicated to discovering, developing, and manufacturing innovative medicines targeting cancer, heart disease, inflammatory conditions, rare diseases, and obesity, continuously pushing the boundaries of the biotechnology industry and showcasing strong market competitiveness.
- Industry Recognition: Amgen has been recognized for its innovation and workplace culture by Fast Company and Forbes, and is a constituent of the Dow Jones Industrial Average and Nasdaq-100 Index, highlighting its leadership and influence in the biopharmaceutical sector.
See More
Amgen to Present at Citi's 2026 Virtual Oncology Leadership Summit
- Event Schedule: Amgen will participate in Citi's Virtual Oncology Leadership Summit on February 18, 2026, at 12:15 PM PT, featuring a presentation by Jean-Charles Soria, Senior Vice President of Oncology, highlighting the company's advancements in oncology.
- Webcast Availability: The presentation will be broadcast live over the internet, accessible to media, investors, and the general public, ensuring broad audience engagement and enhancing the company's transparency and public involvement.
- Replay Feature: Following the live event, the presentation will be archived and available for replay for at least 90 days, allowing investors and the public who missed the live session to access the information, thereby improving information accessibility and dissemination.
- Company Background: With over 45 years of experience, Amgen focuses on developing innovative medicines to tackle major diseases globally, leveraging its leadership in biotechnology to advance treatments for cancer, heart disease, and more, showcasing strong market competitiveness and innovation capabilities.
See More
UPLIZNA Approved by EU for Myasthenia Gravis Treatment
- New Therapy Approval: Amgen's UPLIZNA (inebilizumab) has received EU approval as a new treatment option for adults with generalized myasthenia gravis (gMG), particularly for patients who are positive for AChR+ and MuSK+ antibodies, marking a significant advancement in the treatment landscape.
- Hope for Patients: With a dosing regimen of twice a year following two initial doses, UPLIZNA offers the potential for long-term disease control, which could significantly improve patients' quality of life and reduce reliance on steroids.
- Clinical Trial Support: The approval is supported by results from the MINT trial, the largest Phase 3 clinical trial for gMG, which demonstrated that 87.4% of UPLIZNA patients reduced their steroid dosage to 5mg or less daily by week 26, showcasing the drug's efficacy.
- Broad Market Potential: The approval of UPLIZNA not only provides a new treatment option for gMG patients but also has the potential to drive market share growth for Amgen in the rare disease sector, further solidifying its leadership position in the biopharmaceutical industry.
See More
AMGEN INC: SUBMITS SEC FILING FOR COMMON STOCK OFFERING BY SELLING SECURITYHOLDERS
- Company Filing: AMGEN has filed for offering common stock by selling security holders.
- Purpose of Offering: The offering is intended to provide liquidity for the selling security holders.
See More
AMGEN INC: SUBMITS MIXED SHELF OFFERING; SIZE UNREVEALED - SEC FILING
Company Filing: AMGEN has filed for a mixed shelf offering, allowing it to raise capital through various securities.
Size Disclosure: The specific size of the offering has not been disclosed in the filing.
See More
UPLIZNA Approved for Adult gMG Treatment in Europe
- New Therapy Approval: UPLIZNA (Inebilizumab) has been approved by the European Commission as an adjunct treatment for adults with anti-AChR+ and anti-MuSK+ generalized Myasthenia Gravis (gMG), marking a significant advancement in this field.
- Long-term Disease Control: The therapy demonstrates potential for sustained disease control in gMG patients through a biannual maintenance dose following two initial infusions, which may reduce the need for long-term steroid use.
- Clinical Research Support: The approval is based on data from the MINT study, the largest Phase 3 trial for gMG, involving 238 patients, where 87.4% of UPLIZNA patients successfully reduced their steroid dosage to 5mg or less per day by week 26.
- Market Impact: The approval of UPLIZNA provides a new treatment option for gMG patients, expected to enhance patient quality of life while bolstering Amgen's market position in the rare disease sector.
See More
Amgen to Present at 2026 Oncology Leadership Summit
- Event Schedule: Amgen will participate in Citi's 2026 Virtual Oncology Leadership Summit on February 18, 2026, at 12:15 p.m. PT, where Jean-Charles Soria, Senior Vice President of Oncology, will present the company's latest advancements in oncology.
- Webcast Availability: The presentation will be broadcast live over the internet, accessible to media, investors, and the public, ensuring broad dissemination of information, and will be archived on Amgen's website for at least 90 days for later viewing.
- Company Background: Founded over 45 years ago, Amgen is dedicated to discovering, developing, and manufacturing innovative medicines targeting cancer, heart disease, inflammatory conditions, rare diseases, and obesity, continuously pushing the boundaries of the biotechnology industry and showcasing strong market competitiveness.
- Industry Recognition: Amgen has been recognized for its innovation and workplace culture by Fast Company and Forbes, and is a constituent of the Dow Jones Industrial Average and Nasdaq-100 Index, highlighting its leadership and influence in the biopharmaceutical sector.
See More
Amgen to Present at Citi's 2026 Virtual Oncology Leadership Summit
- Event Schedule: Amgen will participate in Citi's Virtual Oncology Leadership Summit on February 18, 2026, at 12:15 PM PT, featuring a presentation by Jean-Charles Soria, Senior Vice President of Oncology, highlighting the company's advancements in oncology.
- Webcast Availability: The presentation will be broadcast live over the internet, accessible to media, investors, and the general public, ensuring broad audience engagement and enhancing the company's transparency and public involvement.
- Replay Feature: Following the live event, the presentation will be archived and available for replay for at least 90 days, allowing investors and the public who missed the live session to access the information, thereby improving information accessibility and dissemination.
- Company Background: With over 45 years of experience, Amgen focuses on developing innovative medicines to tackle major diseases globally, leveraging its leadership in biotechnology to advance treatments for cancer, heart disease, and more, showcasing strong market competitiveness and innovation capabilities.
See More
UPLIZNA Approved by EU for Myasthenia Gravis Treatment
- New Therapy Approval: Amgen's UPLIZNA (inebilizumab) has received EU approval as a new treatment option for adults with generalized myasthenia gravis (gMG), particularly for patients who are positive for AChR+ and MuSK+ antibodies, marking a significant advancement in the treatment landscape.
- Hope for Patients: With a dosing regimen of twice a year following two initial doses, UPLIZNA offers the potential for long-term disease control, which could significantly improve patients' quality of life and reduce reliance on steroids.
- Clinical Trial Support: The approval is supported by results from the MINT trial, the largest Phase 3 clinical trial for gMG, which demonstrated that 87.4% of UPLIZNA patients reduced their steroid dosage to 5mg or less daily by week 26, showcasing the drug's efficacy.
- Broad Market Potential: The approval of UPLIZNA not only provides a new treatment option for gMG patients but also has the potential to drive market share growth for Amgen in the rare disease sector, further solidifying its leadership position in the biopharmaceutical industry.
See More
