Amgen, Inc. | MedPath

Sanofi to Acquire Vigil Neuroscience for Up to $600 Million, Expanding Alzheimer's Disease Pipeline

12 hours ago

• Sanofi has entered into a definitive merger agreement to acquire Vigil Neuroscience for $8.00 per share in cash upfront, with an additional $2.00 per share contingent value right tied to VG-3927's first commercial sale. • The acquisition strengthens Sanofi's neurology pipeline with VG-3927, a Phase 2-ready oral small molecule TREM2 agonist being developed for Alzheimer's disease, targeting microglial dysfunction in neurodegenerative disorders. • The transaction, valued at approximately $600 million including the potential CVR payment, is expected to close in the third quarter of 2025, with Vigil's monoclonal antibody program iluzanebart not included in the acquisition.

VERAXA Biotech Appoints Oncology Veteran Rick Austin as Chief Scientific Officer to Advance Novel Cancer Therapies

2 days ago

• Dr. Rick Austin, with over 25 years of oncology drug development experience, joins VERAXA Biotech as Chief Scientific Officer to advance the company's BiTAC platform and clinical-stage pipeline. • Austin brings extensive expertise from leadership roles at Harpoon Therapeutics, Amgen, and Tularik, where he led tumor immunology projects and enabled numerous IND filings and first-in-human studies. • VERAXA, an emerging leader in novel cancer therapies and proposed acquisition target of Voyager Acquisition Corp., aims to leverage Austin's expertise to expand therapeutic windows for antibody drug conjugates and T-cell engagers.

Eli Lilly Considers $5.9 Billion Biomanufacturing Facility in Houston

3 days ago

• Pharmaceutical giant Eli Lilly is exploring a $5.9 billion biomanufacturing plant at McCord Development's Generation Park in Northeast Houston, potentially creating 600 permanent jobs and 2,000 construction positions. • The proposed 236-acre facility would be part of Eli Lilly's broader $50 billion U.S. manufacturing expansion since 2020, aimed at increasing production capacity for medicines including Mounjaro and Zepbound. • If approved, the project would deliver an estimated $2.5 billion economic impact over 10 years and strengthen Houston's emerging life sciences sector, supported by local biotech workforce development initiatives.

Robust Pipeline of 50+ Therapies Reshaping Moderate to Severe Atopic Dermatitis Treatment Landscape

3 days ago

• The moderate to severe atopic dermatitis market is experiencing significant growth with 45+ companies developing over 50 pipeline therapies, driven by rising global prevalence and increased awareness of the condition. • Recent advancements include promising biologics like rezpegaldesleukin (granted FDA fast-track designation), JAK inhibitors such as VC005 and QY201, and novel mechanisms targeting IL-4/IL-13 pathways, offering new hope for patients with inadequate response to current treatments. • Key players including Nektar Therapeutics, Corvus Pharmaceuticals, and Apogee Therapeutics are advancing clinical trials with significant milestones expected in late 2025, potentially transforming the therapeutic landscape for this chronic inflammatory skin condition.

CytomX Doses First Patient in Combination Trial of CX-801 with Keytruda for Metastatic Melanoma

3 days ago

• CytomX Therapeutics has dosed the first patient in a Phase 1 trial combining its masked interferon alpha-2b (CX-801) with Merck's Keytruda in patients with metastatic melanoma. • The novel combination aims to address the high unmet need in PD-1 refractory melanoma by localizing interferon's potent immune-stimulating effects to tumors while minimizing systemic toxicities. • Initial Phase 1a translational and biomarker data from this study are expected in the second half of 2025, potentially advancing a new approach in combination immuno-oncology therapy.

VESALIUS-REAL Study Reveals Critical Gaps in Cardiovascular Care Despite Available Treatments

3 days ago

• The VESALIUS-REAL study of 278,000 high-risk patients found 70% did not receive lipid-lowering therapy after heart attacks or strokes, and 88% had no treatment intensification within a year. • Half of cardiovascular event patients never received follow-up LDL-C testing, and among those tested, 82% failed to achieve guideline-recommended cholesterol goals despite available treatments. • Amgen is working to address these care gaps through initiatives including free LDL-C testing at CVS MinuteClinics, partnerships with cardiology organizations, and the LATTICE Consortium to accelerate implementation science.

ROSALINE Trial: Neoadjuvant Letrozole/Entrectinib Shows Limited Efficacy in Invasive Lobular Breast Cancer

6 days ago

• The phase 2 ROSALINE trial found that combining entrectinib with letrozole failed to meet its primary endpoint, with no efficacy-evaluable patients achieving residual cancer burden (RCB) of 0 or 1 in invasive lobular breast cancer. • Despite the primary endpoint failure, the treatment showed a 49% objective response rate by MRI assessment, with 10% complete responses and 39% partial responses among the 41 evaluable patients. • ROSALINE represents the first neoadjuvant endocrine therapy trial dedicated exclusively to invasive lobular breast cancer, demonstrating the feasibility of subtype-specific trials while researchers continue biomarker analyses.

Neurogene Unveils Protocol to Reverse HLH Syndrome Associated with High-Dose AAV Gene Therapy

6 days ago

• Neurogene has developed a monitoring and treatment algorithm designed to reverse hemophagocytic lymphohistiocytosis (HLH), a rare hyperinflammatory syndrome linked to high-dose AAV gene therapy. • The protocol focuses on daily monitoring of the "three Fs" - elevated ferritin levels, fever, and falling blood counts - with high-dose corticosteroids as first-line treatment and anakinra as second-line therapy. • Despite using a lower dose (E13 vg/kg range) in its Phase 1/2 trial of NGN-401 for Rett syndrome, Neurogene has incorporated this protocol as a precautionary measure, as HLH has not been reported at this dose level.

UPC Issues Landmark Ruling on Second Medical Use Patents in Cholesterol Drug Dispute

7 days ago

• The Unified Patent Court's Düsseldorf Local Division has issued its first-ever ruling on second medical use patent infringement in a dispute between Sanofi/Regeneron and Amgen over PCSK9 inhibitor drugs. • The court established a two-part test for infringement: the product must be marketed in a way that leads to the patented use, and the alleged infringer must know or should have known about such use. • While upholding the validity of Sanofi/Regeneron's patent for using PCSK9 inhibitors to reduce lipoprotein(a) levels, the court ruled Amgen's Repatha did not infringe as there was insufficient evidence of it being prescribed for this purpose.

GSK and iTeos Terminate TIGIT Cancer Drug Development After Phase 2 Failure

9 days ago

• GSK and iTeos Therapeutics have discontinued development of belrestotug, their TIGIT-targeting immunotherapy, after it failed to significantly delay tumor progression in non-small cell lung cancer patients. • The companies are terminating all ongoing trials, including a Phase 3 study, ending their four-year collaboration that began with GSK's $625 million upfront payment and potential $1.45 billion in milestone payments. • iTeos is now conducting a strategic review to preserve capital, as the failure eliminates its most advanced drug candidate and represents another setback for TIGIT-targeting therapies in oncology.

Leap Therapeutics Halves Workforce and Refocuses Cancer Drug Development Amid Market Challenges

13 days ago

• Leap Therapeutics has announced a significant restructuring, reducing its workforce by approximately 50% and narrowing the development focus of its lead cancer drug candidate in response to challenging market conditions. • The strategic pivot aims to extend the company's cash runway while concentrating resources on the most promising clinical applications of its lead oncology asset, potentially improving its chances for regulatory success. • This move follows similar restructuring trends across the biotech sector, with companies like Arcturus, NGM Bio, and Erasca all recently announcing staff reductions and pipeline reprioritizations to navigate the difficult funding environment.

Robust Pipeline of 80+ Therapies Advancing in Psoriasis Treatment Landscape

a month ago

• DelveInsight's 2025 Psoriasis Pipeline Report reveals over 80 companies developing 80+ pipeline therapies, highlighting significant R&D investment in this therapeutic area. • Promising treatments in development include topical roflumilast (Arcutis Biotherapeutics) in Phase III trials and GSK2982772 (GlaxoSmithKline), a novel RIPK1 inhibitor in Phase I development. • Alumis Inc. has initiated a long-term extension study for ESK-001 in moderate to severe plaque psoriasis patients, evaluating safety, efficacy, and durability of response over 24 weeks.

Roche and Zealand Pharma Forge $5.3 Billion Partnership to Develop Novel Obesity Treatments

2 months ago

• Roche has entered into a $5.3 billion collaboration with Zealand Pharma to co-develop petrelintide, a promising amylin analog for obesity treatment, both as monotherapy and in combination with Roche's incretin asset CT-388. • The partnership includes upfront payments of $1.65 billion to Zealand Pharma, with profits and losses to be shared 50/50 in the US and Europe, while Roche gains exclusive commercialization rights for the rest of the world. • Clinical data suggests petrelintide could deliver weight loss comparable to GLP-1 receptor agonists but with improved tolerability, potentially addressing unmet needs in the obesity market that is projected to affect 4 billion people globally by 2035.

Novo Nordisk Launches Home Delivery Service for Wegovy at $499 Monthly for Cash-Paying Patients

3 months ago

• Novo Nordisk introduces NovoCare Pharmacy, a direct-to-patient delivery service offering all Wegovy dose strengths at $499 per month for cash-paying and eligible commercially insured patients without coverage. • The launch comes as Wegovy supply stabilizes, with FDA confirming Novo Nordisk can now meet market demand following previous shortages that limited new prescriptions since 2022. • Currently, over 55 million Americans have coverage for weight management medicines, with 90% of insured Wegovy patients paying $0-$25 monthly for their prescriptions.

FDA Grants Priority Review to Dupixent for Bullous Pemphigoid Treatment

3 months ago

• The FDA has accepted Dupixent's supplemental biologics license application for priority review in treating bullous pemphigoid, with a decision expected by June 20, 2025. • Pivotal trial results showed five times more patients achieving sustained disease remission with Dupixent compared to placebo, demonstrating significant improvements in disease severity and itch reduction. • Approximately 27,000 adults in the US suffer from bullous pemphigoid uncontrolled by systemic corticosteroids, representing a significant unmet medical need in this elderly population.

Linsitinib Shows Promise in Reducing Proptosis in Thyroid Eye Disease

4 months ago

• Linsitinib, an oral small molecule, significantly reduced proptosis in patients with active, moderate to severe thyroid eye disease (TED) in a Phase 2b/3 trial. • The LIDS trial met its primary endpoint, demonstrating a statistically significant proptosis responder rate of 52% (p = 0.01) at Week 24 with the 150mg BID dose. • Linsitinib exhibited a favorable safety profile, with no drug-related hearing impairment, tinnitus, or menstrual cycle changes reported in the trial. • Sling Therapeutics plans to initiate a confirmatory Phase 3 trial in 2025, aiming to provide a convenient oral treatment option for TED patients.

Kailera's HRS9531 Shows Strong Phase II Weight Loss, Pfizer Cautious on Danuglipron

4 months ago

• Kailera Therapeutics' HRS9531, a dual GLP-1/GIP receptor agonist, demonstrated a 21.1% placebo-adjusted weight reduction in Phase II trials over 36 weeks. • Pfizer CEO Albert Bourla expressed caution regarding their oral obesity candidate, danuglipron, despite plans for late-stage studies of the once-daily formulation. • Kailera reported that 59% of patients on HRS9531 achieved at least 20% body weight loss, with no plateau observed, suggesting potential for greater efficacy with longer use. • Pfizer abandoned a twice-daily danuglipron formulation due to toxicities, focusing on a once-daily version, but analysts remain divided on its prospects in the competitive obesity market.

Biopharma Industry Faces Continued Layoffs in 2025 Amid Strategic Realignments

4 months ago

• Biopharma companies continue to announce layoffs in 2025, driven by strategic realignments, pipeline reprioritizations, and challenging financial conditions. • Several companies, including Intellia Therapeutics and IGM Biosciences, are cutting a significant portion of their workforce to focus on key programs and extend cash runways. • These workforce reductions are often accompanied by discontinuation of certain drug development programs and a shift in strategic focus towards core assets. • The layoffs reflect a broader trend in the industry as companies adapt to evolving market dynamics and prioritize efficiency and long-term sustainability.

Cytokinetics Halts ALS Drug Trial and Faces FDA Rejection for Heart Failure Treatment

5 months ago

• Cytokinetics stopped the Phase 3 COURAGE-ALS trial of resedemtiv for amyotrophic lateral sclerosis (ALS) after a futility analysis showed no benefit over placebo. • The FDA rejected Cytokinetics' omecamtiv mecarbil for heart failure, citing insufficient efficacy data, increasing the likelihood that the company will shelve the drug. • Cytokinetics is now focusing on aficamten, a cardiac myosin inhibitor in Phase 3 development for hypertrophic cardiomyopathy (HCM), with results expected later in 2023.

Viridian's Veligrotug Shows Promise in Phase 3 Trial for Chronic Thyroid Eye Disease

5 months ago

• Viridian Therapeutics' veligrotug met all primary and secondary endpoints in the THRIVE-2 Phase 3 trial for chronic thyroid eye disease (TED). • The trial demonstrated statistically significant improvements in proptosis, diplopia, and clinical activity scores (CAS) after five infusions of veligrotug. • A Biologics License Application (BLA) submission for veligrotug is on track for the second half of 2025, potentially transforming TED treatment. • Viridian is advancing VRDN-003, a subcutaneous anti-IGF-1R antibody, with topline data expected in the first half of 2026.