The $71 Billion Cancer Shift: Why The FDA Is Speeding Up
VANCOUVER, British Columbia, Feb. 05, 2026 (GLOBE NEWSWIRE) -- Equity-Insider.com News Commentary – The market is waking up to a $71 billion reality[1]. We are seeing a decisive move away from broad chemotherapy and toward precision biologics like mRNA and oncolytic viruses. The FDA is actively accelerating this cycle, having granted multiple breakthrough designations in January 2026 alone for platforms that demonstrate genuine survival durability[2]. This structural realignment positions Oncolytics Biotech Inc. (NASDAQ:ONCY), Moderna (NASDAQ:MRNA), Immunome (NASDAQ:IMNM), Autolus Therapeutics (NASDAQ:AUTL), and Prelude Therapeutics (NASDAQ:PRLD) within the emerging biological innovation cycle.
Smart money is rotating into these late-stage assets for one reason: measurable survival advantages[3]. Institutional capital is prioritizing programs where advanced modalities solve major unmet needs with blockbuster potential[4]. The data confirms that targeting specific molecular variants validates commercial viability, signaling that these biological platforms are poised to outperform traditional approaches in the hardest-to-treat patient segments.
Oncolytics Biotech Inc. (NASDAQ:ONCY) just 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 achieved a 33% response rate in KRAS-mutant microsatellite-stable (MSS) colorectal cancer patients, compared to roughly 10% with chemotherapy alone. 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://equity-insider.com/2025/03/18/is-oncolytics-biotech-the-markets-most-undervalued-cancer-opportunity/
In other recent industry developments and happenings in the market include:
Moderna (NASDAQ:MRNA) announced median five-year follow-up data from the Phase 2b KEYNOTE-942/mRNA-4157-P201 study, demonstrating that intismeran autogene in combination with KEYTRUDA continued to show sustained and clinically meaningful improvement in recurrence-free survival. The therapy reduced the risk of recurrence or death by 49% compared to KEYTRUDA alone in patients with high-risk melanoma following complete resection.
"Now with five years of follow-up data, today's results highlight the potential of a prolonged benefit of the intismeran autogene and KEYTRUDA combination in patients with resected high-risk melanoma," said Kyle Holen, Moderna's Senior Vice President and Head of Development, Oncology and Therapeutics. "We continue to invest in our platform in oncology because of encouraging outcomes like these."
The safety profile of intismeran autogene in combination with KEYTRUDA remains consistent with previous reports. Moderna and Merck have eight Phase 2 and Phase 3 clinical trials underway across multiple tumor types, including melanoma, non-small cell lung cancer, bladder cancer and renal cell carcinoma, with the Phase 3 INTerpath-001 study for adjuvant melanoma now fully enrolled.
Immunome (NASDAQ:IMNM) announced positive topline results from the Phase 3 RINGSIDE trial of varegacestat, an investigational oral once-daily gamma secretase inhibitor, in patients with progressing desmoid tumors. The registrational trial met its primary endpoint, with varegacestat significantly improving progression-free survival versus placebo with an 84% reduction in the risk of disease progression or death.
"RINGSIDE is the largest and most comprehensive clinical trial conducted to date in patients with desmoid tumors, and the topline results represent the highest objective response rate observed in a randomized clinical trial in this patient population," said Clay Siegall, CEO of Immunome. "These findings demonstrate the potential of varegacestat to offer best-in-class results in a convenient, once-daily, oral medicine."
The trial also met all key secondary endpoints, with varegacestat delivering a confirmed objective response rate of 56% versus 9% with placebo. Varegacestat was generally well tolerated with a manageable safety profile consistent with the gamma secretase inhibitor class. Immunome plans to submit a New Drug Application to the FDA in Q2 2026.
Autolus Therapeutics (NASDAQ:AUTL) has delivered preliminary unaudited fourth quarter AUCATZYL net product revenue of approximately $24 million and full year 2025 revenue of approximately $75 million in its first commercial year. The company projects 2026 AUCATZYL revenue between $120 million and $135 million while advancing obe-cel into pediatric B-ALL and lupus nephritis indications, with Phase 2 enrollment for pediatric B-ALL expected to complete in the first half of 2027.
"We had a successful launch of AUCATZYL in the US with full year sales well above expectations and more than 60 centers offering treatment," said Christian Itin, CEO of Autolus Therapeutics. "The real-world data confirmed a high level of clinical activity and a favorable safety profile for AUCATZYL consistent with prior clinical trial results."
The Phase 1 CATULUS trial demonstrated a 95.5% overall response rate in pediatric relapsed or refractory B-ALL patients with low rates of high-grade cytokine release syndrome and neurotoxicity. Autolus Therapeutics expects current cash to fund operations into Q4 2027 while optimizing manufacturing to shift from negative to positive gross margin in 2026.
Prelude Therapeutics (NASDAQ:PRLD) has received FDA clearance of its investigational new drug application for PRT12396, a mutant-selective JAK2V617F inhibitor, with a Phase 1 study in polycythemia vera and myelofibrosis patients anticipated to initiate by Q2 2026. The JAK2V617F mutation drives disease progression in approximately 95% of polycythemia vera patients, 60% of essential thrombocythemia patients and 55% of myelofibrosis patients.
"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," said Kris Vaddi, CEO of Prelude Therapeutics. "This achievement demonstrates our ability to translate high-quality science rapidly into clinical progress."
The company's novel allosteric inhibitors bind into the JAK2 JH2 deep pocket where the V617F mutation resides and demonstrate mutant-specific inhibition in multiple preclinical models. Prelude Therapeutics believes this approach may reduce mutant allele burden and potentially slow or reverse disease progression for myeloproliferative neoplasm patients.
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SOURCES:
- https://www.factmr.com/report/targeted-oncology-biologics-market
- https://www.targetedonc.com/view/fda-oncology-update-january-2026-new-horizons-in-precision-medicine
- https://www.esmoopen.com/article/S2059-7029(24)01859-3/fulltext
- https://www.biospace.com/deals/biotechs-next-chapter-asset-centric-deals-and-shifting-alpha-at-jpm-2026
