Dafinchi AI

AbCellera Biologics Inc.

ABCL

Healthcare

1w

Transition to Clinical-Stage Biotech with First Clinical Trials

AbCellera achieved a major milestone by receiving Health Canada authorization to initiate its first two clinical trials for ABCL635 and ABCL575.
Dosing has begun in the Phase I trial for ABCL635, targeting moderate to severe vasomotor symptoms, marking a shift from platform to clinical-stage biotech.
A second Phase I trial for ABCL575 was also initiated, with dosing expected to start shortly, expanding the company's clinical pipeline.
The company added a third program, ABCL688, into IND-enabling studies, indicating ongoing pipeline expansion and transition into more advanced clinical development.

Liquidia Corporation

LQDA

Healthcare

1w

Successful Launch and Early Adoption of YUTREPIA in 11 Weeks

Liquidia's new inhaled prostacyclin, YUTREPIA, achieved over 900 prescriptions and 550 patient starts within just 11 weeks of launch, indicating an unprecedented market response.
The launch was executed with high precision and purpose, leading to rapid adoption across both specialty centers and community practices.
The product's ease of use, tolerability, and dose escalation capabilities have been highly praised by physicians and patients, surpassing initial expectations.
Market access strategies, including co-pay assistance and free vouchers, contributed to a 75% script-to-start conversion rate in the first six weeks.
The early momentum was achieved despite typical market entry barriers, suggesting strong unmet needs and product differentiation.

Adaptive Biotechnologies Corporation

ADPT

Healthcare

1w

MRD Business Achieves Profitability and Outperforms Expectations

MRD business delivered approximately $2 million in positive adjusted EBITDA, surpassing expectations.
MRD revenue grew 42% year-over-year to $49.9 million, driven by increased clinical volume.
Test volume increased 37% YoY to over 25,300 tests, with multiple myeloma being the largest contributor at 41%.
Blood-based testing now accounts for 44% of MRD tests, up 40% YoY.
The company integrated clonoSEQ into Flatiron's OncoEMR, expanding access in community settings.
Total sequencing gross margin improved by 14 percentage points to 64%.
Cash burn was approximately $11 million, a 36% improvement YoY, with a cash position of $222 million.
Full-year guidance was raised for MRD revenue to $190-$200 million, with expectations of continued volume growth.
The company expects positive adjusted EBITDA to continue into the second half of the year.

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.

ACADIA Pharmaceuticals Inc.

ACAD

Healthcare

1w

ACADIA's Pipeline Milestones and Upcoming Data Readouts

ACADIA showcased nine disclosed pipeline programs during its R&D Day, with five Phase II or III data readouts expected through 2027.
Key upcoming milestones include initiating a Phase II study of ACP-204 in Lewy body dementia psychosis in Q3 2025 and top-line results from the COMPASS PWS Phase III study in Q4 2025.
The company plans to start a Phase III study of trofinetide in Rett syndrome in Japan in Q3 2025 and a first-in-human study of ACP-271 before year-end.
Progress in the pipeline underscores ACADIA's strategic focus on expanding indications and leveraging novel biology, with multiple data readouts potentially transforming its market position.

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.

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.

Seres Therapeutics, Inc.

MCRB

Healthcare

1w

Advancement and Clinical Development of SER-155

Seres has advanced preparation for the next stage of SER-155 development, including a Phase II protocol submission to the FDA.
The Phase Ib study showed a 77% relative risk reduction in bloodstream infections in allo-HSCT patients, supporting further development.
The upcoming Phase II study is designed to enroll approximately 248 patients with an adaptive design and interim analysis, with results expected within 12 months of initiation.
Positive interactions with the FDA and breakthrough therapy designation facilitate the study design and potential approval pathway.
The company aims to use interim data to inform next steps, including potential engagement with the FDA for a registrational study.

VXRT

Healthcare

5d

Impact of Second Stop Work Order on COVID-19 Trial Progress

Vaxart received a second stop work order from ATI, funded by BARDA, surprising the company with no prior notice.
The order was issued when approximately 5,000 participants had already been enrolled in the Phase IIb COVID-19 trial.
Despite the order, enrollment was allowed to continue for those already enrolled, maintaining trial momentum.
Management remains optimistic about the potential of the oral COVID-19 vaccine despite the disruption.
The company is awaiting further details from BARDA and ATI to determine next steps for the trial.
The trial's design includes a head-to-head efficacy comparison with an mRNA vaccine, aiming for data in 2026.

Inovio Pharmaceuticals, Inc.

INO

Healthcare

5d

Regulatory Progress and BLA Submission Strategy for INO-3107

Inovio remains on track to submit its BLA for INO-3107 in the second half of 2025, with a goal of file acceptance by year-end.
The company has completed the design verification testing of the CELLECTRA 5PSP device, a key regulatory milestone.
Inovio has requested a rolling submission of its BLA under breakthrough therapy designation, aiming for a 6-month review period and a potential PDUFA date around mid-2026.
The company successfully completed an FDA inspection of its clinical trial operations, an important step in regulatory compliance.
Differences in trial design and technology, such as DNA medicine versus viral vectors, distinguish INO-3107 from competitors' programs.

ABBV

Healthcare

2w

Progress and Pipeline Advancements with Notable Regulatory Approvals

AbbVie received FDA approval for EMRELIS in non-squamous non-small cell lung cancer and Rinvoq for GCA, marking significant milestones in oncology and rheumatology.
The company announced positive Phase III results for Rinvoq in alopecia areata, demonstrating superior efficacy with 54% of patients reaching 80% scalp coverage at 24 weeks.
Regulatory submission of TrenibotE, a first-in-class short-acting toxin for aesthetics, is underway, with potential to expand AbbVie's aesthetic portfolio.