Dafinchi AI

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.

Syndax Pharmaceuticals, Inc.

SNDX

Healthcare

2w

Financial Performance Summary

Niktimvo margin contribution is expected to be 20% to 30% of net sales in the near term, improving as sales grow.
Niktimvo net revenue was $36.2 million in Q2 2025, with Syndax's 50% share of product contribution amounting to $9.4 million, making it profitable in its first full quarter.
Operating expenses are expected to remain stable over the next few years while fully funding strategic priorities.
Operating expenses increased due to commercialization and ongoing trials, with R&D at $62.2 million and SG&A at $43.8 million in Q2 2025.
Revuforj net revenue increased 43% quarter-over-quarter to $28.6 million in Q2 2025.
Syndax maintains a strong balance sheet with $518 million in cash, equivalents, and investments as of June 30, 2025.
Syndax reported combined net product sales of nearly $100 million for Revuforj and Niktimvo in the first half of 2025, significantly exceeding expectations.

Pacira BioSciences, Inc.

PCRX

Healthcare

1w

Strategic Partnership with Johnson & Johnson MedTech for ZILRETTA Expansion

Pacira announced a transformative collaboration with Johnson & Johnson MedTech specifically for ZILRETTA, aiming to significantly expand its reach and patient access.
This partnership doubles the sales calls for ZILRETTA, leveraging J&J's extensive customer base and sales force.
The collaboration is expected to be beneficial starting in 2026, with strategic alignment on expanding treatment options for osteoarthritis pain.
Unlike the previous EXPAREL partnership, this new agreement focuses on a different product and market dynamics, reflecting a strategic pivot post-COVID.
Management highlighted the complementary nature of J&J's portfolio and the potential to reach new physician segments such as sports medicine and rheumatology.
The partnership underscores Pacira's focus on non-opioid, opioid-sparing pain therapies and its emphasis on personalized treatment approaches.

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.

Nektar Therapeutics

NKTR

Healthcare

1w

Innovative Treg Mechanism in Dermatology

Nektar reported highly compelling initial data for rezpegaldesleukin (REZPEG) in atopic dermatitis, establishing it as a potential first-in-class T regulatory cell (Treg) therapy.
The company is pursuing a novel approach to stimulate Tregs via the IL-2 pathway, using native IL-2 with PEGylation, differentiating from competitors focusing on muteins.
Fast Track designation from FDA for both atopic dermatitis and alopecia areata underscores the unmet need and regulatory support for this mechanism.
REZPEG's mechanism aims to restore immune homeostasis by balancing T effector and Treg cells, addressing autoimmune and inflammatory disorders.
The company plans to enter Phase III in 2026, with a broad label targeting both biologic-naive and experienced patients, aiming to capture a significant market share.

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.

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.

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.

Karyopharm Therapeutics Inc.

KPTI

Healthcare

1w

Strategic Focus on Phase III Readouts and Clinical Progress

The company is actively progressing towards multiple pivotal Phase III trials, including in myelofibrosis and endometrial cancer, with top-line data expected in 2026.
There is a strong emphasis on the potential of selinexor in combination with ruxolitinib to redefine the standard of care for myelofibrosis, with an estimated peak revenue potential of up to $1 billion annually in the U.S.
Management highlighted the significance of recent enrollment milestones, such as closing new patient screening for the SENTRY trial in myelofibrosis, which is a key step in their clinical development strategy.
The company is leveraging its clinical data to support regulatory and commercial ambitions, emphasizing the potential for selinexor to address unmet needs in diseases with limited treatment options.

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.

Regeneron Pharmaceuticals, Inc.

REGN

Healthcare

2w

Impact of FDA Inspection Delay on EYLEA HD and BLA for Odronextamab

EYLEA HD regulatory application delays caused by FDA site inspection at Catalent Indiana LLC, which was not specific to EYLEA HD.
Novo Nordisk expects to file a comprehensive response next week, anticipating an expeditious resolution.
BLA for odronextamab, a bispecific antibody for follicular lymphoma, was impacted by the same site inspection, resulting in a Complete Response Letter (CRL) issued earlier this week.
Management remains optimistic about resolving these issues quickly based on Novo's communication and progress with third-party fillers.