Registration Momentum Builds Across the Oncology Pipeline
VANCOUVER, British Columbia, Feb. 17, 2026 (GLOBE NEWSWIRE) -- USANewsGroup.com News Commentary – The FDA's accelerated approval framework continues to deliver measurable population health gains, with a January 2026 analysis in Cancer Research Communications confirming that drugs cleared through the program improved real-world progression-free survival in 65% of solid tumor indications studied, with none performing worse than the existing standard of care[1]. That track record is fueling a concentrated push among clinical-stage oncology companies toward registration-directed study designs in high-unmet-need tumor types, as demonstrated by Oncolytics Biotech Inc. (NASDAQ:ONCY), Incyte (NASDAQ:INCY), Erasca, Inc. (NASDAQ:ERAS), Karyopharm Therapeutics Inc. (NASDAQ:KPTI), and Acrivon Therapeutics, Inc. (NASDAQ:ACRV).
The regulatory signal extends well beyond single approvals. In January 2026 alone, the FDA granted orphan drug designations for agents targeting gastrointestinal cancers and myelofibrosis, as well as breakthrough therapy designations across several rare oncology indications including NSCLC, ovarian cancer, and T-cell malignancies[2]. For companies already positioned along these expedited pathways, the structural advantage compounds through more frequent agency meetings, smaller pivotal trial populations, and shorter review timelines.
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:
Incyte (NASDAQ:INCY) received a positive opinion from the CHMP of the European Medicines Agency recommending approval of Zynyz (retifanlimab) in combination with carboplatin and paclitaxel for the first-line treatment of advanced squamous cell carcinoma of the anal canal (SCAC). The recommendation was based on the Phase 3 POD1UM-303/InterAACT2 trial, published in The Lancet, which demonstrated a statistically significant 37% reduction in the risk of progression or death (P=0.0006), with median progression-free survival of 9.3 months versus 7.4 months for chemotherapy alone. If approved by the European Commission, Zynyz would become the first PD-1 immunotherapy for advanced SCAC in Europe.
"Today's positive CHMP opinion is an important step towards addressing the urgent need for new treatment options for patients in Europe with advanced SCAC, a disease which has seen limited innovation for decades," said Lee Heeson, Executive Vice President and Head of Incyte International. "If approved, Zynyz in combination with platinum-based chemotherapy has the potential to become a new standard-of-care for patients living with this rare and difficult-to-treat cancer."
Zynyz is already approved in the U.S. and Japan for first-line SCAC in combination with platinum-based chemotherapy, as well as in the U.S. for second-line SCAC and Merkel cell carcinoma. Incyte reported full-year 2025 total revenue growth of 21%, guided 2026 net product revenue up to $4.94 billion, and has 14 pivotal trials underway.
Erasca, Inc. (NASDAQ:ERAS) reported early clinical activity for ERAS-0015, its potential best-in-class pan-RAS molecular glue, including confirmed partial responses across multiple tumor types and RAS mutations during dose escalation of the AURORAS-1 Phase 1 trial. Notably, the company observed first clinical responses at approximately one-tenth the dose at which competitor RMC-6236 produced initial responses, consistent with preclinical data showing 8 to 21 times greater binding affinity for ERAS-0015. Safety and tolerability have been favorable, with no dose-limiting toxicities and well-behaved linear pharmacokinetics across all dose levels evaluated through the January 7, 2026, data cutoff.
"During dose escalation, ERAS-0015 has already demonstrated promising early clinical activity with multiple ongoing confirmed and unconfirmed responses achieved, along with encouraging safety and tolerability data and well-behaved PK," said Jonathan E. Lim, M.D., Erasca's chairman, CEO, and co-founder. "We believe that observing first clinical responses in multiple patients at just 1/10th of the dose at which first clinical responses were observed with RMC-6236 is thesis-reinforcing in terms of ERAS-0015's potential differentiation."
Erasca plans to present initial Phase 1 monotherapy data for ERAS-0015 in the first half of 2026, with monotherapy expansion and combination dose escalation cohorts set to begin in the second half. The company is also advancing ERAS-4001, a potential first-in-class pan-KRAS inhibitor, with initial Phase 1 data expected in the second half of 2026.
Karyopharm Therapeutics Inc. (NASDAQ:KPTI) posted full-year 2025 total revenue of $146 million, with U.S. XPOVIO net product revenue reaching $114.9 million on steady demand across the multiple myeloma market. Fourth-quarter revenue rose 11.8% year-over-year to $34.1 million, while loss from operations improved 43% in the period, reflecting disciplined expense management as research and development costs fell 17% versus Q4 2024.
"As we enter 2026, Karyopharm is approaching a defining period marked by important upcoming clinical milestones and a continued focus on disciplined execution, positioning the Company at a potential inflection point," said Richard Paulson, President and Chief Executive Officer of Karyopharm Therapeutics. "If SENTRY is successful, we have the potential to meaningfully improve outcomes for patients and introduce the first-ever combination therapy in myelofibrosis, a setting with significant unmet need."
Karyopharm guided 2026 total revenue to $130 million to $150 million and expects top-line data from the Phase 3 SENTRY trial in myelofibrosis in March 2026, followed by a mid-2026 readout from its Phase 3 XPORT-EC-042 trial in TP53 wild-type endometrial cancer. Cash, cash equivalents, and investments totaled $64.1 million as of December 31, 2025.
Acrivon Therapeutics, Inc. (NASDAQ:ACRV) announced that its lead candidate ACR-368 achieved a 39% overall response rate in an updated interim analysis of the registrational-intent Phase 2b trial in endometrial cancer, rising to 44% in patients with two or fewer prior lines of therapy. Among patients with the serous subtype, confirmed response rates reached 67% in OncoSignature-positive patients and 52% in all-comers, reinforcing the biomarker-driven approach. Acrivon has received both FDA Fast Track designation for ACR-368 and Breakthrough Device designation for its OncoSignature companion assay.
"We are also very encouraged by the initial clinical data for ACR-2316, including the favorable tolerability profile and observed tumor shrinkage across multiple AP3-prioritized tumor types," said Peter Blume-Jensen, M.D., Ph.D., chief executive officer and co-founder of Acrivon Therapeutics. "We believe these achievements represent transformative progress toward delivering meaningful new precision medicine treatment options for cancer patients with high unmet need."
Acrivon is now enrolling Arm 3, targeting up to 90 serous endometrial cancer patients treated with ACR-368 plus ultra-low dose gemcitabine, with enrollment completion expected in Q4 2026. The company has also submitted a Phase 3 confirmatory protocol to the FDA for ACR-368 combined with anti-PD-1 therapy in frontline endometrial cancer and reported approximately $119 million in cash as of December 31, 2025.
CONTACT:
USA NEWS GROUP
[email protected]
(604) 265-2873
DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. USA News Group is a wholly-owned subsidiary of Market IQ Media Group, Inc. ("MIQ"). MIQ has been paid a fee for Oncolytics Biotech Inc. advertising and digital media from the company directly. There may be 3rd parties who may have shares of Oncolytics Biotech Inc., and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ own shares of Oncolytics Biotech Inc. which were purchased in the open market, and reserve the right to buy and sell, and will buy and sell shares of Oncolytics Biotech Inc. at any time without any further notice commencing immediately and ongoing. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material, including this article, which is disseminated by MIQ has been approved by Oncolytics Biotech Inc.; this is a paid advertisement, we currently own shares of Oncolytics Biotech Inc. and will buy and sell shares of the company in the open market, or through private placements, and/or other investment vehicles.
While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between the any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment.
SOURCES:
- https://www.oncologynurseadvisor.com/news/fda-accelerated-approval-oncology-drugs-improved-patient-survival/
- https://www.targetedonc.com/view/fda-oncology-update-january-2026-new-horizons-in-precision-medicine
