Dafinchi AI

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.

Kura Oncology, Inc.

KURA

Healthcare

1w

FDA Priority Review and Regulatory Progress for Ziftomenib

The FDA has accepted Kura's NDA for ziftomenib in relapsed/refractory NPM1-mutant AML, granting a priority review with a PDUFA date of November 30, 2025.
Management reports ongoing collaborative and constructive interactions with the FDA, emphasizing alignment with the review timeline.
Regulatory milestones include addressing information requests and preparing for pre-approval inspections, with a focus on ensuring a successful review outcome.

Day One Biopharmaceuticals, Inc.

DAWN

Healthcare

1w

OJEMDA 12-Month Revenue Exceeds Expectations

OJEMDA has generated $113.1 million in net revenue over the past 12 months, surpassing initial expectations.
The company reports strong commercial momentum, physician adoption, and patient demand.
Ongoing growth driven by deepening prescriber adoption and payer coverage.

Allogene Therapeutics, Inc.

ALLO

Healthcare

5d

Streamlined ALPHA3 Study Enhances Patient Safety and Enrollment

Allogene has restructured the ALPHA3 trial into a 2-arm randomized study to improve safety and scalability, removing the FCA arm.
The protocol change was made in collaboration with the Data Safety Monitoring Board and FDA guidance, emphasizing agility and patient safety.
Over 50 sites are now active across the U.S. and Canada, with international expansion underway, supporting enrollment growth.
The company remains on track for a futility analysis in the first half of 2026, which will provide early efficacy signals.
Investors should note that the simplification of the study design is expected to boost investigator participation and patient enrollment.

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.

CONMED Corporation

CNMD

Healthcare

2w

Innovative Growth Strategy Focused on Four Key Drivers

Management emphasizes ongoing investments behind four growth drivers: AirSeal, Buffalo Filter, BioBrace, and Foot & Ankle.
Long-term revenue growth target is mid- to high-single digits, supported by these drivers.
Management highlights strategic portfolio optimization towards higher-margin, high-growth opportunities.

Twist Bioscience Corporation

TWST

Healthcare

2w

Strategic Portfolio Expansion in Synthetic Biology with New Product Launches

Twist Bioscience launched gene fragments shipped standard without adapters, enhancing supply chain control and reducing turnaround times.
Modest investment of under $3 million enabled the development of internal primer manufacturing, allowing faster delivery and increased market share.
Upcoming product launches in synthetic biology over the next 12 months aim to unlock new market opportunities and expand share in existing segments.
Focus on continuous innovation and differentiation through R&D, leveraging AI to drive customer demand and product development.

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.

Mersana Therapeutics, Inc.

MRSN

Healthcare

5d

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.

Jazz Pharmaceuticals plc

JAZZ

Healthcare

1w

Upcoming FDA Approval of Dordaviprone for Rare Glioma

FDA PDUFA target date of August 18 for dordaviprone.
Acquisition of Chimerix in April enhanced pipeline.
Potential for patent extension into 2037.
Focus on launching in academic settings for H3 K27M-mutant glioma.
Management confidence in bringing this first-in-class therapy to market.