Dafinchi AI

LeMaitre Vascular, Inc.

LMAT

Healthcare

1w

International Artegraft Launch Surpasses Expectations

Q2 international Artegraft sales reached $420,000, up from $185,000 in Q1.
Full-year Artegraft sales expected to surpass $2 million.
Approval in multiple regions including U.S., EU, U.K., Australia, New Zealand, South Africa, Israel, Thailand, and Malaysia.
Additional approvals in Canada, Korea, and Singapore are likely in 2026.
European launch success driven by CE Mark and MDR progress, with upcoming approvals in Ireland or Germany.
Opening a RestoreFlow distribution facility in Dublin to support European launches.

Amicus Therapeutics, Inc.

FOLD

Healthcare

2w

Strong and Sustained Revenue Growth in Core Business and New Launch Countries

Amicus reported 17th consecutive quarter of double-digit revenue growth at CER, driven by Pompe and Fabry disease.
Q2 revenue reached $154.7 million, up 22% YoY, with significant contributions from newly launched countries including Italy, Switzerland, Portugal, Czech Republic, Sweden, and the Netherlands.
The company expects continued growth in these markets and plans to launch in up to 10 new countries in 2025.

Apellis Pharmaceuticals, Inc.

APLS

Healthcare

2w

FDA Label Expansion for EMPAVELI in C3G and Primary IC-MPGN

FDA approved a label expansion for EMPAVELI for patients 12 years and older with C3 myelopathy and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN).
This is the company's third FDA approval in 4 years, highlighting scientific strength and regulatory success.
The approval enables treatment with a C3-targeting therapy that achieves outcomes across proteinuria reduction, eGFR stabilization, and C3 deposit clearance.
Launch is underway, expanding into rare nephrology and underserved populations, including pediatric patients and post-transplant recurrence.

AORT

Healthcare

1w

Progress and Market Potential of AMDS Launch

The U.S. launch of AMDS is progressing with positive early demand, including initial stocking orders and hospital approvals.
Approximately 75% of the volume is concentrated in the top 600 centers, with about 1,000 accounts capable of performing AMDS procedures.
Hospitals must complete IRB approval, VAC approval, and surgeon training before implanting AMDS, with ongoing progress in these steps.
Management highlighted the strong physician feedback and the device's potential to tap into a $150 million annual market with limited competition.
Cross-selling opportunities are emerging, with some surgeons adopting On-X valves after training on AMDS, indicating synergistic growth potential.

PTC Therapeutics, Inc.

PTCT

Healthcare

1w

Sephience Approval and Launch Strategy for PKU

Sephience received EU approval in late June and FDA approval in the US for broad labeling for patients aged 1 month and above.
The company expects Sephience to become the standard of care for PKU, with a revenue opportunity exceeding $1 billion in the US.
European launch began in Germany in mid-July, leveraging early access mechanisms in other countries while pricing and reimbursement are being finalized.
Initial US launch is planned within two weeks, targeting 104 PKU centers that treat over 80% of US PKU patients.
The company is engaging payers with positive feedback, minimal restrictions, and plans to expand access in Japan and Brazil before year-end.

SIBN

Healthcare

1w

International Launch of iFuse TORQ in Europe Accelerates Growth Potential

Received regulatory approval in June to launch iFuse TORQ in Europe, with initial cases completed in July.
Early positive reception from surgeons and interventionalists suggests strong future demand.
Expect TORQ to significantly boost international revenue growth in 2026 and beyond, with a slow start in Q4 due to later-than-expected approval.

OrthoPediatrics Corp.

KIDS

Healthcare

1w

Rapid International Clinic Expansion into Ireland and California

First international clinic opened in Ireland, complementing existing implant business and expanding global footprint.
Announced multiple new clinics in the U.S., including California (Los Angeles), Dayton, Ohio, and Denver, Colorado.
International clinics now total over 40, surpassing the goal of 4 expansions in 2025.
International demand remains strong, especially in Europe and the Middle East, with new scoliosis markets abroad.
European EU MDR approval achieved through OP Canada, with more approvals expected in upcoming quarters.

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.

Elanco Animal Health Incorporated

ELAN

Healthcare

1w

Progress and Impact of Credelio Quattro Launch

Credelio Quattro is a best-in-class product in the fastest-growing animal health market, with share capture tracking ahead of expectations.
Approximately 14% dollar share of broad spectrum sales in June, with healthy inventory dynamics and early signs of consumer demand growth.
70% of Quattro's share capture has come from switches or new starts, indicating strong market penetration and competitive displacement.
The product is expanding its presence in over 2,200 clinics, with 500 clinics buying Elanco products for the first time, demonstrating broad adoption.
Elanco is preparing for global expansion with submissions in Australia, Canada, EU, UK, and Japan starting in 2026, indicating significant international growth potential.

EXEL

Healthcare

3w

Strong U.S. Cabozantinib Franchise Growth and Net Launch Momentum

U.S. cabozantinib net product revenues increased 19% YoY to $520 million in Q2 2025.
Growth driven solely by commercial demand with negligible clinical trial sales and gross-to-net headwinds.
Rapid uptake in new indications, including neuroendocrine tumors (NET), contributing approximately 4% of total revenue.
Leading market share in second-line plus NET segment with about 35% new patient share in Q2 2025.
European approval for NET indication received by partner Ipsen, expanding royalty streams.
Continued evaluation of revenue guidance as momentum builds in net launch and additional revenue opportunities.

Gilead Sciences, Inc.

GILD

Healthcare

1w

FDA Approval and Launch of Yeztugo for HIV Prevention

Early launch data shows over 25,000 customer calls and high engagement, with 72% unaided awareness and 95% aided awareness among providers.
The company aims for 75% access within 6 months and 90% within 12 months, with early signs of successful reimbursement and formulary inclusion, including a new J-code coming in October.
Gilead has initiated preparations for European approval and a partnership with the Global Fund to expand access to approximately 2 million people in low-income countries over three years.