Amgen Inc.
American multinational biopharmaceutical company headquartered in Thousand Oaks, California; ranks 18th among biomedical companies by revenue, focused on oncology, cardiovascular, bone health, and autoimmune therapeutic areas.
Clinical Trials
1193
198 active
Approvals
34
Total approvals
Agencies
1
Regulatory bodies
Founded
1980
Not yet recruiting
14
1.2%
No Longer Available
6
0.5%
Terminated
106
8.9%
Recruiting
64
5.4%
Suspended
1
0.1%
Approved For Marketing
4
0.3%
Withdrawn
21
1.8%
Available
2
0.2%
Active, not recruiting
184
15.4%
Unknown
4
0.3%
Completed
787
66.0%
- Amgen reported positive topline results from the Phase 3 OASIZ 301 study of dazodalibep in adults with Sjögren's disease and moderate-to-severe systemic disease activity. - The trial met its primary endpoint with statistically significant and clinically meaningful improvement in ESSDAI score at Week 48, with benefits seen from Week 4. - The most common adverse events were nasopharyngitis, urinary tract infection, hypertension and infusion-related reactions, generally mild to moderate, with no thromboembolic or opportunistic infection imbalance.
- All three anti-AAV antibody-naive patients with relapsed or refractory ALL in the Phase 1/2 SENTRY-CD19 trial achieved MRD-negative complete responses after a single VNX-101 administration. - Responses showed durability, with the first patient remaining MRD-negative through Day 260 and the T-cell engager GP101 still detectable at therapeutic levels beyond nine months. - VNX-101 delivers an AAV vector that transduces hepatocytes to secrete GP101, a CD19xCD3 bispecific T-cell engager, aiming to replace repeated or continuous protein infusions. - CRS and ICANS occurred during dose escalation and resolved with standard of care, and Vironexis will prioritize development in antibody-naive relapsed or refractory ALL.
- Sling Therapeutics raised a $123 million Series C led by Forbion to fund a late-stage trial of its oral thyroid eye disease drug linsitinib. - The global Phase 3 'Orbit' study will enroll about 130 adults with moderate-to-severe active TED, dosed at 150 mg or placebo twice daily for 24 weeks. - An earlier late-stage trial showed a statistically significant 52% response rate at 24 weeks with no drug-related hearing loss or tinnitus reported. - If approved, linsitinib would be the first oral therapy for TED, offering an alternative to injected IGF-1R antibodies Tepezza and Lumvoa.
- Sling Therapeutics has dosed the first patients in the global Phase III ORBIT trial of oral linsitinib in moderate to severe active thyroid eye disease. - ORBIT will randomize approximately 130 adults 1:1 to linsitinib 150 mg or placebo twice daily for 24 weeks, with proptosis response at week 24 as the primary endpoint. - The Phase IIb/III LIDS trial reported positive topline results in January 2025, meeting its primary endpoint with a 52% proptosis responder rate at week 24 (p = 0.01). - Linsitinib is the only oral IGF-1R inhibitor in Phase III TED development, positioned on oral administration and a differentiated safety profile versus infused biologics.
- Bristol Myers Squibb and Ono Pharmaceutical filed suit in Delaware federal court seeking to block Amgen's proposed US biosimilar of the cancer immunotherapy Opdivo. - The complaint alleges Amgen's biosimilar would infringe seven US patents covering Opdivo and asks the court to bar sales while those patents remain in force. - Opdivo generated more than $5.9 billion in US revenue last year, and Bristol Myers expects patent exclusivity over the drug to run until 2028. - Amgen declined to comment on the litigation but said it has applied for FDA approval and remains confident it will be in the first wave of Opdivo biosimilars.
- The FDA approved an update to the IMDELLTRA prescribing information cutting required monitoring for the first two infusions from 22-24 hours to 6-8 hours. - Patients must still receive a follow-up assessment, including vital signs, the day after each of the first two doses on Cycle 1 Days 2 and 9. - Amgen said the change may reduce treatment complexity for community oncology practices, where an estimated 80% to 85% of US cancer patients receive care. - Monitoring recommendations beyond the first two doses remain unchanged, and Amgen recently reported positive topline overall survival data from the Phase 3 DeLLphi-305 study.
- Oncology still accounts for 38.6% of newly identified drug candidates, but the number of cancer drugs in development fell 4.6% for a second consecutive year. - The anti-obesity category grew 30.7% to 588 drugs, and obesity entered the top 10 indications for the first time with 576 candidates. - Rare disease drugs slipped 1.3% to 7,618 candidates yet rose to 33.2% of the overall pipeline, with Novartis leading at 116 candidates. - Lilly's retatrutide delivered 28.3% average weight loss at 80 weeks, while Novo Nordisk's CagriSema missed noninferiority to tirzepatide.
- Novartis's pelacarsen and Novo Nordisk's ziltivekimab both failed to separate from placebo in late-stage cardiovascular outcome trials despite strong genetic support for their targets. - Cardiologist Ethan Weiss said the field can no longer claim that genetics is undefeated in predicting which drugs will work in outcome studies. - Novartis shares fell 14% in a single session and Amgen dropped 9.8% as investors repriced roughly 35,000 patients still enrolled in Lp(a) outcome trials. - Weiss attributed the Lp(a) failure largely to background therapy, arguing the risk signal diminishes in patients already on statins and other powerful medicines.
- The FDA has approved Replimune's oncolytic immunotherapy Tudriqev for unresectable advanced melanoma that has progressed after PD-1 immunotherapy. - Tudriqev, formerly known as RP1, is engineered to selectively target and destroy cancer cells and is the second oncolytic virus approved. - Both approved oncolytic viruses are engineered live attenuated HSV-1 vectors encoding GM-CSF and a fusogenic GALV-GP-R glycoprotein.
- Amgen's phase III DeLLphi-305 trial met its primary overall survival endpoint for tarlatamab plus durvalumab versus durvalumab alone as first-line maintenance in extensive-stage small-cell lung cancer. - The 563-patient randomized study enrolled patients whose disease had not progressed after induction with durvalumab, platinum chemotherapy and etoposide, with PFS and ORR also significantly improved. - No numerical survival data, hazard ratios or safety tables were disclosed, and the full dataset is slated for presentation at an upcoming medical meeting and regulatory submission. - Tarlatamab, a DLL3-directed bispecific T-cell engager already approved in second-line ES-SCLC, could move earlier into the maintenance setting if the benefit is confirmed.
