Dafinchi AI

Relmada Therapeutics, Inc.

RLMD

Healthcare

1w

Progress and Milestones for NDV-01 in Bladder Cancer

Relmada reported impressive 6-month follow-up data for NDV-01, with a 91% response rate in high-grade non-muscle invasive bladder cancer (NMIBC).
The 6-month disease-free status was achieved by 90% of evaluable patients, indicating durable efficacy.
NDV-01 is a sustained-release formulation of gemcitabine and docetaxel, designed to improve safety, convenience, and efficacy over traditional therapies.
The company plans to initiate a Phase III trial in the first half of 2026, with preparations underway including FDA interactions and manufacturing scale-up.
The 6-month data showed no treatment-related adverse events greater than grade 3, supporting safety and tolerability.
The focus is on positioning NDV-01 as a potential first-in-class bladder-sparing therapy, especially for BCG-unresponsive patients.

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.

Castle Biosciences, Inc.

CSTL

Healthcare

2w

FDA Breakthrough Designation for DecisionDx-Melanoma and Strategic Path to FDA Approval

Castle Biosciences received FDA Breakthrough Device Designation for DecisionDx-Melanoma, signaling a significant regulatory milestone.
The company is actively progressing towards an FDA submission, with no specific public timeline disclosed.
Management expressed confidence that existing data supports FDA approval, emphasizing the importance of the breakthrough designation in accelerating regulatory pathway.

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.

Syndax Pharmaceuticals, Inc.

SNDX

Healthcare

2w

Revuforj's Rapid Adoption and Early Line Usage Trends

Since launch, over 500 patients have been treated with Revuforj, with approximately 90% of usage in KMT2A patients.
In just 7 months, Revuforj has reached 1/4 of the 2,000 diagnosed relapsed/refractory KMT2A AML patients annually.
Physicians are increasingly using Revuforj in earlier lines of therapy, with emerging claims data showing 70% of use in second and third-line settings.
The company estimates that about 1/3 of KMT2A patients treated with Revuforj have proceeded to transplant, with this percentage expected to grow.
Early indicators suggest a higher transplant rate in the commercial setting compared to pivotal trials, driven by earlier treatment.
Physicians plan to restart Revuforj post-transplant for 1 to 2 years, potentially extending treatment duration and improving outcomes.

Schrödinger, Inc.

SDGR

Healthcare

1w

Progress and Strategic Opportunities for SGR-1505 MALT1 Inhibitor

Initial Phase I data for SGR-1505 showed a well-tolerated profile with responses in heavily pretreated CLL and Waldenstrom's macroglobulinemia patients, with 3 of 17 CLL patients responding and all 5 Waldenstrom's patients responding.
The program has received FDA Fast Track designation, highlighting its potential as a promising therapeutic in refractory hematologic cancers.
Schrodinger is exploring strategic opportunities to accelerate clinical development and maximize the potential of SGR-1505, rather than pursuing independent late-stage trials.
The company plans to provide further updates on dose escalation, translational data, and regulatory feedback later this year.
The emerging profile of SGR-1505 suggests best-in-class potential, with early evidence supporting its use in refractory disease, especially in patients previously exposed to BTK and BCL2 inhibitors.

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.

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.

BioCryst Pharmaceuticals, Inc.

BCRX

Healthcare

2w

Record-Breaking U.S. Launch Performance of ORLADEYO in Year 5

Q2 was the best quarter since approval for ORLADEYO in terms of revenue and new patient demand.
U.S. prescriptions increased over 10% compared to Q1 2021 and over 15% compared to Q1 2025.
Revenue exceeded expectations by over $22 million in Q2, with 45% YoY growth.
Demand driven by increased prescriber confidence, real-world evidence, and expanding patient segments, including normal C1 inhibitor patients.

Revolution Medicines, Inc.

RVMD

Healthcare

1w

Advancement of RAS(ON) Inhibitors and Pipeline Progress

Revolution Medicines has a pipeline of three clinical-stage RAS(ON) inhibitors: daraxonrasib, elironrasib, and zoldonrasib, with recent publications highlighting their innovative chemistry and mechanism of action.
Daraxonrasib received Breakthrough Therapy designation from the FDA for metastatic pancreatic cancer with KRAS G12 mutations, emphasizing its potential to address a large unmet medical need.
The company is progressing towards multiple registrational trials, including a Phase III in second-line pancreatic cancer (RASolute 302), and plans to initiate first-line and adjuvant trials later in 2025.
Elironrasib and zoldonrasib are showing promising clinical data, with elironrasib granted Breakthrough Therapy designation for KRAS G12C NSCLC, and ongoing studies for G12D mutations and combination therapies.

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.