Dafinchi AI

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.

Prestige Consumer Healthcare Inc.

PBH

Healthcare

1w

Strategic Acquisition of Pillar5 to Secure Eye Care Supply Chain

The company announced the acquisition of Pillar5, a Canadian pharma manufacturing site, to address long-term sterile eye care supply constraints.
The purchase price is approximately $100 million, funded from cash on hand, and expected to be neutral to EPS.
This acquisition aims to accelerate capacity expansion, including a new high-speed line expected to start in Q3, to support growth in eye care demand.
Management emphasized that the acquisition is primarily about supply stability and long-term capacity, not immediate profitability impact.
The company has been evaluating sterile eye care capacity options for over a decade, highlighting the strategic importance of this move.
Full supply normalization from the new capacity is expected to occur in the second half of fiscal 2026 and into fiscal 2027.

Cytokinetics, Incorporated

CYTK

Healthcare

1w

Regulatory Review and PDUFA Extension for Aficamten

The FDA extended the PDUFA date for the NDA of aficamten to December 26, 2025, with a late-cycle review meeting moved to September.
Cytokinetics maintains confidence in the approvability of aficamten, citing quality clinical data and ongoing collaborative dialogue with the FDA.
All activities related to the review process, including GCP inspections, have been completed with no observations recorded.
The company has submitted an updated REMS package following the FDA's review, supporting their regulatory position.
Regulatory reviews are also ongoing in Europe and China, with potential approvals expected in H1 2026 in Europe and H2 2025 in China.

PTC Therapeutics, Inc.

PTCT

Healthcare

1w

Financial Performance Summary

Cash, cash equivalents, and marketable securities totaled approximately $1.99 billion as of June 30, 2025, up from $1.14 billion at the end of 2024.
Non-GAAP R&D expense was $104 million, down from $123 million in Q2 2024, excluding stock-based compensation.
Non-GAAP SG&A expense was $76 million, up from $60 million in Q2 2024, excluding stock-based compensation.
PTC received $58 million in royalty revenue from Roche's Evrysdi sales.
PTC Therapeutics reported total revenue of $179 million in Q2 2025, including $96 million from the DMD franchise.
Translarna net product revenue was $59 million and Emflaza net product revenue was $36 million in the quarter.

Crinetics Pharmaceuticals, Inc.

CRNX

Healthcare

1w

FDA Approval and Launch Readiness of Paltusotine (PALSONIFY)

Crinetics' NDA for paltusotine (PALSONIFY) remains on track with an anticipated FDA approval in September 2025.
The company has assembled a highly experienced launch team and is preparing for a transformational market entry.
Engagement with patient communities and advocacy groups has reinforced confidence that PALSONIFY addresses a critical unmet need in acromegaly treatment.
The launch is expected to be gradual, with formulary placement taking 6-9 months post-approval and patient adoption aligning with infrequent endocrinologist visits (2-4 times/year).
Commercial preparations include a dedicated sales force of approximately 30 representatives and ongoing payer discussions emphasizing PALSONIFY's value proposition of rapid disease control and convenience.
Crinetics is actively working on international expansion, targeting a European launch in 2026.

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.

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.

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.

Anika Therapeutics, Inc.

ANIK

Healthcare

2w

Disappointing Phase III Hyalofast Trial Results and Impact on FDA Submission Timeline

The U.S. pivotal Phase III trial for Hyalofast missed its primary endpoints, with statistical significance not achieved on co-primary measures of KOOS Pain and IKDC Function.
The trial faced challenges due to declining use of microfracture, higher dropout rates, missed visits during COVID, and reduced evaluable sample size.
Despite the miss on primary endpoints, secondary endpoints showed statistical significance, and international data with positive 15-year outcomes support the product's value.
The company plans to submit the third and final PMA module in the second half of 2025, extending the review timeline to 2027 to ensure thorough review and dialogue with the FDA.

Pulmonx Corporation

LUNG

Healthcare

2w

International Market Expansion and Growth Strategy

International revenue reached a record $9.1 million in Q2 2025, a 32% increase year-over-year, driven by Europe and Asia.
The company emphasizes the success of foundational investments in education, market development, and pathway creation, which are scaling effectively.
Long-term growth is supported by initiatives like peer-to-peer education, regional multidisciplinary emphysema boards, and physician engagement.
International growth is expected to be more moderate in the second half, with a focus on sustaining momentum in direct markets.