Recent months have brought a wave of promising developments in clinical research. From respiratory disease to mental health and cancer, data emerging in May 2025 point toward new therapeutic paths and underline the importance of biomarkers, patient stratification, and innovative modalities. Below are some of the most striking findings.

Respiratory and Inflammatory Disease Advances

• TX45 in PH-HFpEF shows early positive signs
  Tectonic Therapeutic presented complete results from Part A of its Phase 1b trial of TX45 in patients with pulmonary hypertension combined with heart failure with preserved ejection fraction (PH-HFpEF). Nineteen subjects took part. The safety profile was acceptable and early efficacy signals met expectations. The trial’s next stage (the APEX Phase 2 global trial) is under way, with topline results expected in 2026.
• Verekitug moving ahead in multiple respiratory indications
  Upstream Bio disclosed that its clinical-stage program targeting inflammatory lung diseases is accelerating. Verekitug is expected to generate Phase 2 data in chronic rhinosinusitis with nasal polyps by Q3 2025. A severe asthma trial is now expected in first half of 2026. Also the planned dosing of patients with COPD (chronic obstructive pulmonary disease) will begin mid-2025. These developments broaden the agent’s potential reach across respiratory conditions.

Oncology and Cancer-Related Breakthroughs

• CAN-2409 shows survival benefit in pancreatic cancer
  Candel Therapeutics reported final survival data from a randomized, controlled Phase 2a study of CAN-2409 in patients with borderline resectable pancreatic ductal adenocarcinoma (PDAC). Patients who received CAN-2409 plus chemoradiotherapy achieved a median overall survival of 31.4 months, compared with 12.5 months in the standard-of-care control arm. This kind of improvement, if validated in larger studies, could shift treatment expectations for PDAC patients.
• Phase 3 for CAN-2409 in prostate cancer proceeds under SPA
  The same molecule, CAN-2409, also reported positive Phase 3 results in intermediate-to-high risk localized prostate cancer. The trial was conducted under a Special Protocol Assessment (SPA) with the U.S. FDA. Because of the favorable topline data, Candel is working toward submission of a biologics license application (BLA) by Q4 2026, assuming continued alignment with regulatory and trial endpoints.

Mental Health and Biomarker-Driven Psychiatry

• Alto Neuroscience advances in precision psychiatry
  Alto Neuroscience released its Q1 2025 report, highlighting progress on several fronts. Among them, its ALTO-203 trial (Phase 2 proof-of-concept in major depressive disorder with high levels of anhedonia) is expected to post topline data in Q2 2025. ALTO-101 in schizophrenia is scheduled for a readout in the second half of 2025. The company continues to lean on biomarker strategies (e.g., EEG-based markers) to stratify patients and enrich trial populations. Strong cash reserves are projected to carry operations and development well into 2028.

What These Data Suggest

These recent results and developments reflect several recurring themes:

• Biomarkers and patient stratification are becoming central, especially in mental health and immunologic disease. Studies that use biomarkers tend to report stronger, more consistent signals.
• Broadening of indication spectrum for promising agents (e.g. respiratory + inflammatory disease) suggests a trend toward multi-use or multi-indication strategies.
• Regulatory pathways and alignment such as SPAs are playing crucial roles in helping companies plan for approval and reduce risk.
• Importance of Phase 1b/2 data: early signals, when positive, are helping to build confidence in later stage trial designs.

These developments do not yet guarantee ultimate success, but they do build a strong foundation for what could be transformative therapies across several disease areas.