Acelyrin | MedPath

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

14 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.

Akeso Reports Positive Phase 3 Results for Ivonescimab in Lung Cancer, Building on Recent FDA Approval Success

a month ago

• Akeso announced positive Phase 3 results for ivonescimab, a novel PD-1/VEGF bispecific antibody, demonstrating superior tumor progression control when combined with chemotherapy compared to PD-1 inhibitor plus chemotherapy in lung cancer patients. • The company recently secured FDA approval for penpulimab, its PD-1 monoclonal antibody, for first-line treatment of nasopharyngeal carcinoma, marking significant expansion of Akeso's oncology portfolio. • Akeso and Summit Therapeutics are advancing ivonescimab in a global study against the standard Keytruda-chemotherapy regimen, with results expected in 2027, potentially challenging the current treatment paradigm in lung cancer.

Biotech Deal Landscape: February-March 2025 Sees Surge in Partnerships Across Multiple Therapeutic Areas

3 months ago

• The first quarter of 2025 witnessed significant biotech partnership activity, with Eli Lilly, AstraZeneca, and Novo Nordisk emerging as top collaborators in deals worth billions across small molecules, antibodies, and RNA therapeutics. • February 2025 featured notable acquisitions including Novartis's $2.15 billion buyout of Anthos Therapeutics, while March saw AstraZeneca acquire Belgian biotech EsoBiotec and Bristol Myers Squibb purchase 2seventy bio for $286 million. • Obesity therapeutics gained significant traction in March 2025, with AbbVie entering the field through a $350 million upfront deal with Gubra for an amylin analog, while Roche partnered with Zealand Pharma on petrelintide in a deal worth up to $5.25 billion.

Alumis to Present 52-Week Phase 2 Data for Novel TYK2 Inhibitor in Psoriasis at AAD 2025

3 months ago

• Alumis will showcase long-term safety and efficacy data for ESK-001, their oral TYK2 inhibitor, in moderate-to-severe plaque psoriasis through multiple presentations at the 2025 AAD annual meeting. • The company has accelerated the timeline for their Phase 3 ONWARD program, with topline data now expected in Q1 2026, reflecting strong patient enrollment and investigator interest. • ESK-001 demonstrated sustained PASI score improvements and favorable safety profile in interim 28-week open-label extension data, with most patients achieving PASI 75 at the 40mg twice-daily dose.

TEPEZZA Sales Surge as Thyroid Eye Disease Treatment Market Expands to $2.3 Billion

3 months ago

• TEPEZZA, the first FDA-approved treatment for thyroid eye disease, generated $1.9 billion in sales for 2024, with $460 million in Q4 alone, addressing a critical unmet need for patients with limited treatment alternatives. • The global thyroid eye disease market reached $2.3 billion in 2023 across seven major markets, with continued growth expected through 2034 due to increasing disease awareness and rising prevalence. • Several competitors are developing alternative therapies, including Immunovant's batoclimab and Sling Therapeutics' oral small molecule linsitinib, potentially reshaping the treatment landscape in the coming years.

Alumis and Acelyrin Announce Merger Deal, Suspend Phase III Plans for Lonigutamab

3 months ago

• Alumis and Acelyrin have entered into a merger agreement, marking a significant consolidation in the biotechnology sector. • The companies announced the suspension of the planned Phase III program for lonigutamab following disappointing Phase II results reported in January. • The merger decision includes a strategic reassessment of lonigutamab's development program to evaluate its potential value and future direction.

Alumis and Acelyrin Announce Merger to Create $737M Clinical-Stage Biopharma Company

4 months ago

• Alumis and Acelyrin have agreed to merge in an all-stock transaction, creating a combined entity with $737 million in cash runway extending into 2027. • The merged company will retain the Alumis name and prioritize development of two TYK2 inhibitors targeting conditions including psoriasis, lupus, and multiple sclerosis. • Acelyrin's thyroid eye disease drug lonigutamab is included in the deal but will undergo strategic review to assess its market differentiation potential.

Clinical Trial Industry Faces Complex Challenges in 2025: Adaptive Designs, Political Shifts, and Diversity Requirements

4 months ago

• Clinical trials are becoming increasingly complex and expensive as they target smaller patient populations and face stricter regulations, driving the need for smarter and more efficient trial designs. • Political changes, including Trump's presidency, could lead to significant regulatory shifts in the clinical trial landscape, potentially affecting approval pathways and oversight mechanisms. • New legislation like the Inflation Reduction Act is expected to impact trial initiations and drug development, while diversity guidelines from WHO, FDA, and EMA present both opportunities and challenges for patient recruitment.

Biopharma Industry Faces Continued Layoffs in 2025 Amid Strategic Realignments

5 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.

Promising Phase 1/2 Results for ACELYRIN's Lonigutamab Support Buy Rating

5 months ago

Derek Archila from Wells Fargo maintains a Buy rating on ACELYRIN, INC. due to promising Phase 1/2 trial results for Lonigutamab, indicating potential safety advantages and sufficient activity to advance to Phase 3 trials.

Acelyrin's Lonigutamab Shows Promise in Phase 2 Data for Thyroid Eye Disease

5 months ago

• Acelyrin's lonigutamab demonstrates a potential best-in-class efficacy and safety profile for treating Thyroid Eye Disease (TED), according to updated Phase 2 data. • A virtual investor event on January 6, 2025, will feature clinician perspectives on unmet needs in TED and the design of the Phase 3 LONGITUDE program. • The Phase 3 LONGITUDE program, developed after discussions with the FDA, aims to be the most inclusive registrational program in TED to date. • Lonigutamab, a subcutaneously delivered monoclonal antibody targeting IGF-1R, offers potential for longer-term, convenient dosing, improving clinical response.

Acelyrin's Lonigutamab Shows Promise in Thyroid Eye Disease Phase 2 Data

5 months ago

• Acelyrin will present Phase 2 data for subcutaneous Lonigutamab, indicating a potentially best-in-class efficacy and safety profile for Thyroid Eye Disease (TED). • The company plans to unveil the design for its Phase 3 program following a successful meeting with the FDA. • A virtual investor event is scheduled to reveal the data and Phase 3 design, featuring experts from Stanford and the University of Colorado School of Medicine.

Acelyrin Inc. Faces Market Volatility Amidst Clinical Trial Updates

5 months ago

• Acelyrin Inc. (SLRN) stock reached a 52-week low amidst challenging market conditions, reflecting broader economic pressures and investor concerns. • The Phase 2b/3 study of izokibep for uveitis treatment failed to meet its primary endpoint, showing no statistically significant difference from placebo. • Acelyrin is advancing its clinical pipeline with lonafarnib for thyroid eye disease and plans to initiate a Phase 3 program for lonigutamab in early 2025. • Despite setbacks, Acelyrin maintains a strong liquidity position, with cash runway expected to extend into mid-2027, and is set to acquire global rights to lonigutamab.

Acelyrin's Izokibep Advances in Phase 3 Trials Amidst Analyst Revisions and Institutional Investment

5 months ago

• Acelyrin's lead drug candidate, Izokibep, is currently in Phase 3 clinical trials for Hidradenitis Suppurativa, Psoriatic Arthritis, and uveitis, and Phase 2 trials for Axial Spondyloarthritis. • Institutional investors, including Point72 Asset Management L.P., have increased their positions in Acelyrin, indicating confidence in the company's potential. • Several analysts have adjusted their price targets for Acelyrin, reflecting evolving expectations for the company's performance and the potential of Izokibep. • Acelyrin's stock experienced trading fluctuations, highlighting the dynamic nature of the biopharmaceutical market and investor sentiment towards the company.

Acelyrin's Lonigutamab Shows Promise in Phase 2, Phase 3 Program Design Announced for Thyroid Eye Disease

5 months ago

• Acelyrin's lonigutamab demonstrated clinically meaningful improvements in Thyroid Eye Disease (TED) symptoms, including proptosis, CAS, and diplopia, in Phase 2 trials. • The Phase 3 LONGITUDE program, consisting of two global trials, is set to begin in Q1 2025, evaluating lonigutamab's safety and efficacy with topline data expected in H2 2026. • Lonigutamab, a subcutaneous anti-IGF-1R monoclonal antibody, showed a favorable safety profile with no reported cases of hearing impairment, hyperglycemia, or menstrual disorders. • Acelyrin's strategic focus shifts to lonigutamab after izokibep fails in Phase 2b/3 uveitis trial, with existing cash resources projected to last through mid-2027.