The FDA Cleared 50 Oncology Approvals in 2025 and the Pipeline Keeps Accelerating

Issued on behalf of Oncolytics Biotech Inc.

VANCOUVER – Baystreet.ca News Commentary – The FDA issued more than 50 oncology approvals in 2025, with most of those concentrated in immunotherapy and targeted therapy, and January 2026 extended that pace with Breakthrough Therapy designations for agents spanning RAS inhibitors, alpha-emitting radiopharmaceuticals, and allogeneic cell therapies^[1]. Global spending on cancer medicines reached $252 billion in 2024, a $29 billion increase year-over-year, with projections now pointing toward $441 billion by 2029 as precision modalities displace legacy chemotherapy regimens across solid and hematologic indications^[2]. Oncolytics Biotech Inc. (NASDAQ: ONCY), Citius Oncology, Inc. (NASDAQ: CTOR), Prelude Therapeutics Incorporated (NASDAQ: PRLD), ALX Oncology Holdings Inc. (NASDAQ: ALXO), and Protara Therapeutics, Inc. (NASDAQ: TARA) are each advancing distinct mechanisms through clinical and commercial milestones in underserved patient populations.

That regulatory productivity coincides with a structural shift in clinical development: ADCs, bispecific antibodies, and protein degradation technologies are redefining the oncology pipeline, with over 5,000 active oncology trials underway in North America alone and oncology protocols accounting for 41% of all global clinical trials started in 2025^[3]. Meanwhile, leading oncology researchers expect 2026 to bring further advances in cellular therapies, precision oncology, and biomarker-driven patient selection, with novel chemistry platforms including PROTACs and molecular glues beginning to enter clinical development^[4]. The convergence of multimodal phenotyping with modality-specific delivery is compressing timelines from proof-of-concept to registrational readout, favoring companies positioned at that intersection.

Oncolytics Biotech Inc. (NASDAQ: ONCY) recently received Fast Track Designation from the FDA for its cancer treatment pelareorep in second-line microsatellite-stable metastatic colorectal cancer patients with KRAS mutations. This regulatory status can enable more frequent FDA meetings and faster potential approval timelines, and it only gets granted when a treatment shows meaningful advantages over existing options.

The designation is based on clinical data showing pelareorep combined with standard chemotherapy and Avastin^® achieved a 33% response rate in KRAS-mutant microsatellite-stable (MSS) colorectal cancer patients, compared to roughly 10% with chemotherapy and Avastin^®. More importantly, patients lived a median 27 months versus 11.2 months with standard treatment, and their cancer stayed stable for 16.6 months compared to 5.7 months. Response rate measures the percentage of patients whose tumors shrink significantly or disappear.

This matters because KRAS-mutant MSS colorectal cancer represents one of the hardest-to-treat cancer populations, with limited options after first-line treatment fails and minimal benefit from immune therapies. The global market for second-line treatment in this patient group runs between $3 billion and $5 billion annually.

"Adding pelareorep to the standard-of-care in this underserved segment of colorectal cancer patients results in a doubling or tripling of critical clinical endpoints, including overall survival, progression-free survival, and objective response rate," said Jared Kelly, CEO of Oncolytics Biotech.

The company plans to launch a controlled study comparing standard-of-care versus standard-of-care plus pelareorep, with the first clinical site activating in March and interim data expected by year-end 2026. This marks pelareorep's second Fast Track Designation in gastrointestinal cancers, following an earlier designation for pancreatic cancer.

Oncolytics is building out its leadership team to handle these expanding programs. The company recently announced two critical hires: John McAdory as Executive Vice President of Strategy and Operations, who ran late-stage clinical trials at CG Oncology, and Yujun Wu as Vice President, Head of Biostatistics, who led statistics at Morphic Therapeutic through its sale to Eli Lilly. Kelly and Chief Business Officer Andrew Aromando both joined from Ambrx Biopharma, which sold to Johnson & Johnson for $2 billion in 2024.

Pelareorep is also showing strong results in anal cancer, where third-line patients achieved a 29% response rate with responses lasting around 17 months in a setting with no FDA-approved treatments. In second-line anal cancer patients, the 30% response rate more than doubled the benchmark for available immunotherapy.

CONTINUED… Read this and more news for Oncolytics Biotech at: https://usanewsgroup.com/2023/10/02/the-most-undervalued-oncolytics-company-on-the-nasdaq/

In other recent industry developments and happenings in the market include:

Citius Oncology, Inc. (NASDAQ: CTOR), the oncology-focused subsidiary of Citius Pharmaceuticals (NASDAQ: CTXR), entered an exclusive distribution agreement with Uniphar to expand access to LYMPHIR (denileukin diftitox-cxdl) across Western and Eastern Europe through country-specific managed access programs. The deal marks Citius Oncology's third international distribution partnership, following arrangements covering Southern Europe, the Balkans, Turkey, and the Middle East. LYMPHIR, a targeted IL-2 receptor-directed fusion protein for relapsed or refractory cutaneous T-cell lymphoma, launched commercially in the United States in December 2025.

"This agreement with Uniphar builds on the momentum of our international expansion efforts and reflects our commitment to partnering with experienced organizations that have deep regional expertise and proven execution capabilities," said Leonard Mazur, Chairman and Chief Executive Officer of Citius Oncology and Citius Pharmaceuticals. "As our third international distribution agreement, this partnership further strengthens our ability to responsibly expand access to LYMPHIR for patients with limited treatment options."

Citius Oncology will supply finished product while Uniphar manages market access and distribution in the designated territories. LYMPHIR is not approved for commercial use outside the United States, and access in the covered regions will be provided solely through managed access programs.

Prelude Therapeutics Incorporated (NASDAQ: PRLD) received FDA clearance of its Investigational New Drug application for PRT12396, a mutant-selective JAK2V617F inhibitor designed for polycythemia vera and myelofibrosis. The IND clearance allows Prelude to proceed with a Phase 1 open-label, multi-center study evaluating safety, efficacy, and pharmacokinetics in patients with high-risk polycythemia vera and intermediate- to high-risk myelofibrosis, with first patient dosing anticipated by Q2 2026. The JAK2V617F mutation drives disease progression in approximately 95% of polycythemia vera patients and 55% to 60% of those with myelofibrosis.

"The FDA's clearance of our IND for PRT12396 marks a pivotal first milestone in the strategic transformation and development focus on our JAK2 and KAT6 programs that we outlined last quarter," stated Kris Vaddi, Chief Executive Officer of Prelude. "This achievement demonstrates our ability to translate high-quality science rapidly into clinical progress."

The JAK2V617F inhibitor program is subject to an exclusive option agreement with Incyte announced in November 2025. Prelude's novel allosteric inhibitors bind into the JAK2 JH2 "deep pocket" where the V617F mutation resides, an approach the company believes may reduce mutant allele burden and potentially slow or reverse disease progression.

ALX Oncology Holdings Inc. (NASDAQ: ALXO) reported new data demonstrating that CD47 expression levels predict response to its investigational CD47-inhibitor evorpacept in combination with Jazz Pharmaceuticals' Ziihera (zanidatamab-hrii) in heavily pretreated HER2-positive metastatic breast cancer. In the Phase 1b/2 trial, previously reported results showed a 56% confirmed objective response rate and median progression-free survival of 7.4 months among nine patients with centrally confirmed HER2-positive disease who had received a median of six prior therapies. The new exploratory analysis found that responses were largely restricted to patients with higher CD47 expression, reinforcing findings from the separate ASPEN-06 trial in HER2-positive gastric cancer.

"These new findings support a CD47-dependent, HER2-driven biology for evorpacept," said Barbara Klencke, M.D., Chief Medical Officer at ALX Oncology. "Going forward, we believe that a biomarker-driven approach incorporating CD47 expression may optimize patient selection for evorpacept combinations with HER2-targeted agents."

The full biomarker analysis has been submitted for presentation at an upcoming scientific congress. ALX Oncology is also advancing ASPEN-09-Breast, a Phase 2 trial of evorpacept in breast cancer, and ALX2004, a novel EGFR-targeted antibody-drug conjugate currently in Phase 1 dose escalation.

Protara Therapeutics, Inc. (NASDAQ: TARA) announced it will present updated interim data from the Phase 2 ADVANCED-2 trial of TARA-002 in BCG-Unresponsive non-muscle invasive bladder cancer patients at the ASCO Genitourinary Cancers Symposium on February 27, 2026. The poster will include safety and efficacy data from approximately 25 six-month evaluable patients in the BCG-Unresponsive cohort, which is targeting enrollment of 75 to 100 patients. TARA-002 is a first-in-class TLR2/NOD2 agonist derived from inactivated Streptococcus pyogenes that activates innate and adaptive immune pathways within the bladder wall.

Bladder cancer is the sixth most common cancer in the United States, with non-muscle invasive disease representing approximately 80% of diagnoses and roughly 65,000 new NMIBC cases per year. Protara is also evaluating TARA-002 in a separate Phase 2 trial for pediatric patients with lymphatic malformations and developing IV Choline Chloride for patients on parenteral nutrition.

Source: https://usanewsgroup.com/2024/09/21/is-oncolytics-biotech-the-markets-most-undervalued-cancer-opportunity/

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