Welcome to our dedicated page for Amgen news (Ticker: AMGN), a resource for investors and traders seeking the latest updates and insights on Amgen stock.
News about Amgen Inc. (AMGN) centers on its biotechnology medicines, clinical milestones, corporate transactions and investor communications. The company describes itself as discovering, developing, manufacturing and delivering medicines for cancer, heart disease, osteoporosis, inflammatory diseases and rare diseases, and its news flow reflects activity across these therapeutic areas.
Investors following AMGN news can see updates on regulatory decisions and clinical data for key products. Recent announcements include U.S. Food and Drug Administration approvals and label expansions, such as full approval for IMDELLTRA (tarlatamab-dlle) in extensive stage small cell lung cancer after progression on platinum-based chemotherapy, and approval of UPLIZNA (inebilizumab-cdon) for adults with generalized myasthenia gravis who are anti-acetylcholine receptor and anti-MuSK antibody positive. Amgen has also reported landmark cardiovascular outcomes data for Repatha (evolocumab) from the VESALIUS-CV trial.
Corporate development and pipeline news are another focus. Amgen has announced the acquisition of Dark Blue Therapeutics, a biotechnology company developing targeted protein degraders for oncology, adding an investigational MLLT1/3-targeting molecule for acute myeloid leukemia to its portfolio. The company also issues releases on capital allocation decisions, such as dividend declarations, and on participation in major healthcare investment conferences where management discusses business developments.
This AMGN news page allows readers to track company press releases and related coverage, including clinical trial readouts, FDA decisions, acquisitions, pricing and access initiatives, and presentations at scientific and investor meetings. Users interested in biotechnology, oncology innovation, cardiovascular outcomes and large-cap healthcare equities can monitor these updates as part of their ongoing research on Amgen stock.
Amgen's Otezla® (apremilast) showed significant improvements in adults with mild-to-moderate plaque psoriasis in the Phase 3 ADVANCE trial, presented at the American Academy of Dermatology Meeting. The trial reported a 21.6% response in static Physician's Global Assessment at week 16, compared to 4.1% for placebo (p<0.0001), with improvements in secondary endpoints as well. Common adverse events included diarrhea (14.3%) and headache (12.9%). Amgen aims to expand Otezla's access for this condition following a supplemental New Drug Application to the FDA.
Amgen (NASDAQ:AMGN) is set to report its first quarter financial results on April 27, 2021, after market close. A conference call will follow at 2:00 p.m. PT, featuring CEO Robert A. Bradway and senior management. The call will be available via live audio on Amgen's website, with a replay option for 90 days. Amgen is committed to addressing serious illnesses through innovative therapeutics, leveraging advanced genetics to understand diseases and improve health outcomes.
Amgen announced that the FDA granted Breakthrough Therapy Designation for bemarituzumab as a first-line therapy for patients with FGFR2b overexpressing gastric and gastroesophageal adenocarcinoma. The designation follows promising results from the FIGHT trial, showing significant improvements in progression-free survival and overall survival in patients with at least 10% FGFR2b+ tumor cells. This marks Amgen's second Breakthrough Designation in six months, highlighting its commitment to advancing oncology treatments.
Amgen has launched Biomarker Assist™, a program designed to increase access to biomarker testing for patients with metastatic non-small cell lung cancer (NSCLC). This initiative, supported by professional clinical guidelines, aims to address the issue that many patients are not tested despite the critical role of biomarkers in treatment decisions. The program includes two components: the Next Generation Sequencing (NGS) Affordability Program and the KRAS Single Gene Test Program.
Amgen has completed its acquisition of Five Prime Therapeutics for $1.9 billion, paying $38.00 per share. The merger integrates Five Prime's immuno-oncology assets into Amgen's oncology portfolio, notably the bemarituzumab program for gastric cancer. This adds to Amgen's capabilities in treating cancers prevalent in regions like Japan and Latin America. Amgen accepted 87.8% of Five Prime's shares, leading to its delisting from NASDAQ. The acquisition aims to enhance patient solutions and align with Amgen's growth strategy in oncology.
Amgen has announced an agreement to acquire Rodeo Therapeutics Corporation for an upfront payment of $55 million and potential milestone payments up to $666 million. Rodeo specializes in small-molecule therapies for tissue regeneration, particularly focusing on the 15-PGDH program, which aligns with Amgen's inflammation portfolio. The acquisition is expected to enhance Amgen's capabilities in developing novel therapies for inflammatory diseases. Both companies' boards have approved the transaction, which positions Amgen to leverage Rodeo's promising preclinical data.
Amgen (NASDAQ:AMGN) will present at the virtual Oppenheimer 31st Annual Healthcare Conference on March 16, 2021, at 2:30 p.m. ET. David M. Reese, M.D., Amgen's executive vice president of Research and Development, will lead the presentation. Interested parties can access the live audio broadcast via Amgen's website along with other investor and medical conference presentations. The event's webcast will be archived for 90 days. Amgen focuses on developing innovative therapeutics to address serious medical needs, utilizing advanced human genetics to enhance health outcomes.
Amgen and Five Prime Therapeutics announced an acquisition agreement where Amgen will acquire Five Prime for $38.00 per share, totaling an equity value of approximately $1.9 billion. This strategic acquisition aims to enhance Amgen's oncology portfolio with Five Prime's innovative therapies, particularly the bemarituzumab antibody, which shows promise in treating advanced gastric cancer. The transaction is projected to close by the end of Q2 2021, subject to customary conditions.
Amgen (NASDAQ:AMGN) declared a $1.76 per share dividend for Q2 2021, set to be paid on June 8, 2021, to stockholders of record by May 17, 2021. The company highlights its commitment to developing innovative therapies focusing on high unmet medical needs. Amgen's legacy in biotechnology since 1980 has positioned it among leading independent biotech firms, striving for improved health outcomes globally.
Amgen announced that data from a Phase 3 study published in JAMA highlights the efficacy of BLINCYTO (blinatumomab) in pediatric patients with high-risk B-cell precursor acute lymphoblastic leukemia (B-ALL). After a median follow-up of 22.4 months, 69% of patients treated with BLINCYTO were alive and event-free, compared to 43% with chemotherapy. The 36-month overall survival rate was 81.1% for BLINCYTO versus 55.8% for chemotherapy. Serious adverse events were significantly lower in the BLINCYTO group (24.1% vs. 43.1%). These results suggest BLINCYTO may be a new standard of care for this aggressive disease.
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