Amgen Inc - AMGN STOCK NEWS

Amgen announced the FDA's acceptance of a supplemental New Drug Application (sNDA) for Otezla® (apremilast) aimed at treating adults with mild-to-moderate plaque psoriasis. The PDUFA action date is set for December 19, 2021. Positive results from the Phase 3 ADVANCE trial indicate that Otezla significantly improved psoriasis symptoms compared to placebo. The treatment has a consistent safety profile, with common adverse events including diarrhea and headache. Since its 2014 approval, over 250,000 patients have been treated with Otezla in the U.S.

Amgen announced a collaboration with the FDA to conduct a multi-center clinical trial comparing the safety and efficacy of LUMAKRAS™ at 960 mg once daily versus a lower dose of 240 mg. This trial, part of the ongoing development program, is expected to yield results by late 2022. Amgen states there will be no impact on the ongoing priority review timelines for LUMAKRAS™. Forward-looking statements caution that actual results may differ due to numerous risks and uncertainties, particularly regarding clinical trials and regulatory approvals.

Amgen reported Q1 2021 financial results with total revenues of $5.9 billion, a 4% decline from Q1 2020, attributed to lower net selling prices but partially offset by volume growth. GAAP EPS decreased 8% to $2.83, and non-GAAP EPS fell 12% to $3.70. Operating income also saw a decline of 10%. The company reaffirmed its total revenue guidance for 2021 at $25.8-$26.6 billion, but revised GAAP EPS guidance down to $9.11-$10.71 from $12.12-$13.17. Despite challenges from COVID-19, Amgen is optimistic about future growth, especially in newer products.

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.