Biotech Catalysts to Watch: Key Developments for 2026 and Beyond

Four biotech catalysts in 2026 could reshape the market. Focus on drugs like TLSA's Foralumab and CLDI's CLD-401, as investors gear up for important updates this year. These catalysts will roll out between August and December, offering critical insights into their progress.

The full biotech catalysts to watch

TLSA's Foralumab: A Unique Approach to Multiple Sclerosis

TLSA's intranasal foralumab is in a Phase 2a trial for non-active secondary progressive multiple sclerosis (na-SPMS), with top-line data due in October 2026. The drug's probability of approval (PoA) is 20%, a nod to promising early results and the inherent risks of early-stage trials. Foralumab, an intranasal fully human anti-CD3 monoclonal antibody, has shown stabilization in Expanded Disability Status Scale (EDSS) scores among patients previously treated with B-cell therapies. In an open-label study of 10 patients, 75% reported improvement, with notable reductions in fatigue. Challenges persist in the na-SPMS field, with biologics' success rates historically around 15-25%. The absence of regulatory designations like Fast Track or Breakthrough Therapy adds to the uncertainty, especially without pivotal efficacy data and the high placebo response risk in smaller trials. The innovative intranasal delivery method could offer a new immunomodulatory approach distinct from therapies like ocrelizumab, though the lack of comparator trials raises questions about its effectiveness. Investors should watch the October 2026 data release, which could either confirm the preliminary findings or reveal the drug's limitations.

CLDI's CLD-401: Navigating the Pre-Clinical Landscape

Calidi Biotherapeutics is advancing CLD-401, an oncolytic virus targeting metastatic non-small cell lung cancer (NSCLC) and head and neck cancer. Currently in IND-enabling pre-clinical studies, CLD-401's PoA is pegged at 13%, reflecting high attrition rates typical of first-in-human oncology candidates. The Phase I study plans to start in Q1 2027, focusing on safety, pharmacodynamics, and efficacy, though no human data is available yet. The drug uses a genetically modified vaccinia virus for systemic delivery, a leap over traditional local administration methods. The global market for its target indications is about $28.5 billion, showing a significant unmet need for patients with resistant or refractory disease. The anticipated IND submission by the end of 2026 and first patient dosing in early 2027 will be pivotal for investors. With no regulatory designations and challenges of systemic toxicity, upcoming data releases should be closely monitored to assess the drug's tolerability and anti-tumor activity.

CLDI's CLD-401: Moving Toward IND Submission

CLDI is also preparing for an IND submission for CLD-401, targeting non-small cell lung cancer, head and neck cancer, and triple-negative breast cancer. Submission is expected by December 31, 2026, with a low PoA of 5%. The Phase I basket study will explore the drug's safety and efficacy, designed to express an IL-15 superagonist within the tumor microenvironment. Although preclinical results look promising, the lack of critical efficacy metrics is concerning. Oncolytic viruses typically face low Phase I success rates of about 5-10%, adding uncertainty to CLD-401's future. The systemic IL-15 delivery approach is unprecedented, complicating regulatory evaluations. Investors should remain cautious, as the absence of human data and defined trial endpoints could slow progress. The market opportunity is substantial, making it crucial to monitor the IND submission and subsequent trial developments.

CNTX's CT-95: A First-in-Class T Cell Engager

CNTX is pushing forward with its first-in-human bispecific antibody, CT-95 (MSLN x CD3), now in Phase 1a trials for solid tumors. The PoA is estimated at 19%, targeting MSLN-expressing malignancies, which present a significant unmet clinical need. The global market for these cancers is estimated at $15 billion, underscoring CT-95's potential to fill a critical treatment gap. The ongoing Phase 1a trial aims to assess safety and tolerability, with initial data expected in September 2026. However, the absence of efficacy data is concerning. CT-95 has not received any regulatory designations, and the risks associated with early-stage immunotherapy development are significant. The drug's first-in-class mechanism could offer a competitive edge, but it faces challenges from high attrition rates in early-phase trials. Investors should focus on the upcoming initial data release, as it will be crucial in determining CT-95's path in oncology.

Upcoming Catalysts: What to Watch in Late 2026

Several biotech catalysts stand out in the latter part of 2026. OTLK's ONS-5010/LYTENAVA™ is set to deliver results for neovascular age-related macular degeneration (nAMD) on August 30, 2026. This candidate has a high PoA, highlighting its potential market impact. NMRA's NMRA-215 for obesity is also set for an August release, and PYXS's MICVO is scheduled for October 1, targeting first-line recurrent/metastatic head and neck squamous cell carcinoma. These upcoming catalysts, alongside developments for Foralumab and CLD-401, are key data points that could shift market dynamics. Investors should weigh the implications of each announcement, considering the competitive landscape and existing treatment options. Late 2026 is packed with potential, making it a crucial time for stakeholders to stay informed and agile.

The bottom line

Biotech catalysts offer both opportunities and risks. Staying informed is crucial for investors aiming to capitalize on these developments.