Dafinchi AI

Exact Sciences Corporation

EXAS

Healthcare

1w

Freenome Blood-Based CRC Test Licensing and Strategic Implications

Exact Sciences licensed exclusive rights to Freenome's blood-based colorectal cancer screening tests, including current and future versions, subject to regulatory approval.
The licensing agreement allows for potential deployment of improved next-generation blood tests, with the possibility to exit if performance thresholds are not met.
Management views the Freenome technology as a strategic addition that accelerates time to market and broadens the company's portfolio beyond stool-based tests.
The company emphasizes the importance of the blood test in reaching patients who refuse traditional screening methods, targeting a niche market with high unmet need.
Freenome's initial test showed 73% sensitivity for colon cancer, but management expressed disappointment with the results, indicating ongoing internal testing and evaluation.
The agreement includes a flexible structure with a 10% royalty, providing strategic optionality without full acquisition, balancing risk and investment.

Bio-Techne Corporation

TECH

Healthcare

1w

Strategic divestiture of Exosome Diagnostics to MDxHealth

Bio-Techne announced the divestiture of Exosome Diagnostics, including the ExoDx prostate test and clinical lab to MDxHealth.
Expected close in the first quarter of fiscal 2026.
Retains access to proprietary exosome technology used in ESR1 mutation kit for breast cancer recurrence.
Repositioning of portfolio to focus on core growth pillars and improve operating margin.

TransMedics Group, Inc.

TMDX

Healthcare

2w

FDA Conditional Approval for Next-Gen OCS Lung Program

TransMedics received FDA conditional approval for the OCS Lung IDE in July 2025, marking a significant regulatory milestone.
The company is actively engaging with FDA leadership to address final questions and plans to initiate trial activities after summer.
The next-gen OCS Lung trial will be the largest in lung preservation history, with over 450 lungs to be randomized.
Management is confident that successful trial results will establish the platform as the new standard of care in lung transplantation.
This clinical program is expected to be a major growth catalyst in 2026, though it will not impact 2025 financials.
The trial aims to demonstrate superior clinical outcomes over traditional cold storage, addressing longstanding market perceptions.

Edwards Lifesciences Corporation

EW

Healthcare

3w

Impact of Early TAVR Data and Asymptomatic Indication Approvals on Market Dynamics

Management highlighted the renewed clinical focus on TAVR driven by early trial data and recent approvals for asymptomatic severe AS, which enable treatment regardless of symptoms.
The approvals are expected to catalyze multiyear growth, with potential guideline and policy changes, including a new U.S. NCD.
Clinical studies such as the Optum real-world study and 10-year PARTNER II outcomes reinforce the value of early intervention and long-term durability, positioning Edwards as a leader in TAVR.
Management emphasized the strategic importance of evidence generation and guideline evolution in expanding TAVR adoption.

NovoCure Limited

NVCR

Healthcare

3w

Financial Performance Summary

Cash and investments totaled $912 million at quarter-end; $560 million in convertible notes due later this year will be retired with cash on hand.
General and administrative expenses rose 17% to $44 million, driven by higher share-based compensation and personnel costs supporting the lung cancer launch and company build-out.
Gross margin was 74%, down from 77% in Q2 2024, mainly due to rollout costs of the HFE array and non-small cell lung cancer launch prior to broad reimbursement.
Net loss was $40 million with a loss per share of $0.36; adjusted EBITDA was negative $10 million.
Net revenues were $159 million, a 6% increase from Q2 2024, driven primarily by 7% active patient growth in the GBM franchise and double-digit growth in international markets.
Research and development expenses were $56 million, up 2% year-over-year, with no expected material step-up this year due to shifting trial spend.
Sales and marketing expenses were $57 million, a 1% increase, reflecting incremental launch costs for non-small cell lung cancer mostly offset by lower stock-based compensation.
The company plans to draw $100 million from its credit facility in September as part of a four-tranche agreement, with the first two tranches obligated to be drawn.

VCYT

Healthcare

1w

Decipher Market Penetration and Growth Drivers

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.

Regeneron Pharmaceuticals, Inc.

REGN

Healthcare

2w

Impact of FDA Inspection Delay on EYLEA HD and BLA for Odronextamab

EYLEA HD regulatory application delays caused by FDA site inspection at Catalent Indiana LLC, which was not specific to EYLEA HD.
Novo Nordisk expects to file a comprehensive response next week, anticipating an expeditious resolution.
BLA for odronextamab, a bispecific antibody for follicular lymphoma, was impacted by the same site inspection, resulting in a Complete Response Letter (CRL) issued earlier this week.
Management remains optimistic about resolving these issues quickly based on Novo's communication and progress with third-party fillers.

OPKO Health, Inc.

OPK

Healthcare

2w

Strategic Asset Sale and Focused Business Model for BioReference Health

OPKO is streamlining BioReference Health by preparing to sell its oncology and related clinical testing assets to Labcorp for $225 million, with $192.5 million payable at closing and an earn-out of up to $32.5 million based on performance.
The sale aims to monetize assets, sharpen focus on core testing operations, and improve financial profile.
Post-transaction, BioReference will retain core clinical testing in NY and NJ, including proprietary tests like 4Kscore, and expand into direct-to-consumer and employer-based testing.
Management emphasizes that this strategic move is expected to enhance margins and position BioReference for profitability.

Myriad Genetics, Inc.

MYGN

Healthcare

1w

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.

Myriad Genetics, Inc.

MYGN

Healthcare

1w

Financial Performance Summary

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.

NeoGenomics, Inc.

NEO

Healthcare

3w

Financial Performance Summary

Adjusted EBITDA was $10.7 million, down 2% from prior year, impacted by Pathline acquisition ramp; excluding Pathline, adjusted EBITDA grew 13%.
Adjusted gross profit improved by $4.6 million or 6% over prior year.
Cash flow from operations was positive $20 million, up 44% year-over-year, with cash and marketable securities ending at $164 million.
Clinical revenue grew 16% year-over-year with organic clinical revenue up 13%, driven by a 10% increase in test volumes and a 3% increase in average unit price (AUP).
NeoGenomics reported Q2 2025 revenue of $181 million, representing 10% year-over-year growth but slightly below guidance.
NGS testing accounted for 32% of total clinical revenue and grew 23%, slightly below the 25% target but above market growth rates.
Nonclinical revenue declined 26% year-over-year due to weakness in pharma and biotech customer demand.
The company retired $201 million of convertible notes in Q2, significantly reducing debt.