Emi-Le Clinical Data Highlights and Tumor Response Rates
Mersana reported a 31% objective response rate (ORR) in evaluable patients with B7-H4 high tumor expression at ASCO 2025, with doses ranging from 38 to 67 mg/m².
In adenoid cystic carcinoma type 1 (ACC1), 4 confirmed responses and 1 unconfirmed response were observed among 9 evaluable patients, with a confirmed ORR of 56% after data cutoff.
The company emphasized Emi-Le's potential to address unmet needs in triple-negative breast cancer (TNBC) patients previously treated with topoisomerase 1 inhibitors, highlighting poor outcomes with current standard of care.
Data from the TNBC expansion cohort showed a 29% ORR in B7-H4 high patients, with median PFS of 16 weeks, suggesting promising efficacy beyond standard chemotherapy.
Mersana is progressing with dose expansion in TNBC, enrolling over 45 patients across two dosing regimens, with initial data expected in the second half of 2025.
The company believes the post-topo-1 TNBC opportunity is sizable, with Trodelvy expected to generate about $1 billion in 2025, and Emi-Le could serve as a subsequent line of therapy, especially as treatment landscapes evolve.
Strategic Focus on Phase III Readouts and Clinical Progress
The company is actively progressing towards multiple pivotal Phase III trials, including in myelofibrosis and endometrial cancer, with top-line data expected in 2026.
There is a strong emphasis on the potential of selinexor in combination with ruxolitinib to redefine the standard of care for myelofibrosis, with an estimated peak revenue potential of up to $1 billion annually in the U.S.
Management highlighted the significance of recent enrollment milestones, such as closing new patient screening for the SENTRY trial in myelofibrosis, which is a key step in their clinical development strategy.
The company is leveraging its clinical data to support regulatory and commercial ambitions, emphasizing the potential for selinexor to address unmet needs in diseases with limited treatment options.
Adjusted EBITDA was $14.5 million, a 24% increase year-over-year, with adjusted EPS of $0.05 for the quarter.
Adjusted gross margin improved by 140 basis points to 71.5%, reflecting operational efficiencies and favorable test mix.
Average revenue per test grew 2% year-over-year, driven by favorable test mix, sales targeting, revenue cycle projects, and expanding payer coverage.
GeneSight revenue declined 12% year-over-year due to UnitedHealthcare coverage changes but volume growth rebounded to 5% in Q2.
Hereditary cancer testing revenue grew 9% year-over-year, with oncology channel volume up 14%.
Myriad Genetics reported Q2 2025 revenue of $213 million, a 5% increase year-over-year excluding impacts from UnitedHealthcare's GeneSight coverage decision and the divested European EndoPredict business.
Prenatal revenue grew 7% year-over-year despite a 7% volume decline due to order management system issues, which have since been resolved.
Prolaris revenue grew 4% year-over-year, with volume up 6% sequentially from Q1 2025.
The company recognized a noncash goodwill and intangible impairment charge of $317 million due to market capitalization decline, excluded from non-GAAP EPS.
Myriad's Strategic Shift to Cancer Care Continuum Focus
Myriad is updating its long-range strategy to focus on the Cancer Care Continuum (CCC).
The new strategy aims to drive accelerated growth and profitability through three pillars: expanding in cancer diagnostics, growing prenatal and mental health markets, and maintaining financial discipline.
The company plans to leverage its leadership in hereditary cancer testing and expand into therapy selection, genomic profiling, immuno-oncology, and MRD testing.
Partnerships, such as with PATHOMIQ for AI-enabled prostate cancer testing, will play a key role in this expansion.
Management emphasizes increased urgency, disciplined execution, and strategic partnerships to achieve growth targets.
U.S. Launch Growth and Real-World Data for Amtagvi
Iovance has surpassed 100 patients treated in a single quarter for the first time with Amtagvi, indicating strong adoption.
Real-world data shows a nearly 49% response rate overall and approximately 61% in patients treated in earlier lines, reinforcing the therapy's durability.
The company plans to onboard large community practices in Q4, targeting earlier treatment settings and potentially higher response rates.
Demand is driven by increased field activities, new centers, and strategic distribution channels like specialty pharmacies, expanding access in community settings.
Management emphasizes the potential for peak U.S. sales of $1 billion or more, with international markets offering additional growth opportunities.
The focus on earlier treatment settings and community oncology networks aims to position Amtagvi as a preferred option for appropriate patients.
Veracyte delivered approximately 25,500 Decipher tests in Q2, on track to exceed 100,000 tests annually, marking a significant milestone.
Decipher volume grew 28% year-over-year, with 13 consecutive quarters of over 25% growth, driven by strong execution and expanding clinical utility.
The metastatic prostate cancer test launch in June has generated increased physician interest, especially in high-risk NCCN patients, contributing to halo effects and future growth potential.
The company expects Decipher to maintain double-digit growth driven by market share gains, incidence growth, and expanding clinical evidence, including ongoing prospective trials and guideline updates.
FIRDAPSE generated $84.8 million in net product revenue in Q2 2025, up $7.5 million from Q2 2024, with a reaffirmed full-year guidance of $355-$360 million.
The growth was impacted in 2024 by the Change Healthcare cybersecurity breach, which shifted volume from Q1 to Q2, but the impact was fully resolved by June 2024.
Year-to-date, FIRDAPSE revenue increased 16.9% over the first half of 2024, indicating strong underlying demand and market durability.
Management emphasizes high prescription approval rates above 90% and low discontinuation rates below 20%, supporting sustained performance.
The company is actively expanding education efforts supported by updated NCCN guidelines, targeting undiagnosed cancer-associated LEMS patients, with an opportunity to reach a high-potential underserved population.
Advancement of RAS(ON) Inhibitors and Pipeline Progress
Revolution Medicines has a pipeline of three clinical-stage RAS(ON) inhibitors: daraxonrasib, elironrasib, and zoldonrasib, with recent publications highlighting their innovative chemistry and mechanism of action.
Daraxonrasib received Breakthrough Therapy designation from the FDA for metastatic pancreatic cancer with KRAS G12 mutations, emphasizing its potential to address a large unmet medical need.
The company is progressing towards multiple registrational trials, including a Phase III in second-line pancreatic cancer (RASolute 302), and plans to initiate first-line and adjuvant trials later in 2025.
Elironrasib and zoldonrasib are showing promising clinical data, with elironrasib granted Breakthrough Therapy designation for KRAS G12C NSCLC, and ongoing studies for G12D mutations and combination therapies.
Strategic Partnership with BioNTech for PD-L1 VEGF Bispecific BNT327
BMS entered into a global strategic partnership with BioNTech to co-develop and commercialize BNT327, a potentially transformative PD-L1 VEGF bispecific therapy.
The collaboration aims to accelerate clinical trials, expedite time to market, and expand indications, with the goal of positioning BNT327 as a first or second to market in its class.
The partnership leverages BMS' expertise in immuno-oncology and BioNTech's innovation, with a focus on speed to market and broadening indications.
Initial clinical development is underway in small cell lung cancer, non-small cell lung cancer, and triple-negative breast cancer.