ASCO week closed with one result that changed the conversation about lung cancer. Ivonescimab cut the risk of death by 34% in squamous NSCLC. The data landed in a Plenary Session. It was published simultaneously in The Lancet. It was the first time in the 61-year history of ASCO that a China-originated drug has been featured in the Plenary. Separately, a hypertension drug developer filed its FDA application and presented Phase 3 data at the European cardiology meeting. A micro-cap RNA therapy company initiated its first Phase 2 trial in colorectal cancer.
A 34% reduction in death risk just made ivonescimab the most watched cancer drug of the year
May 31. The HARMONi-6 Phase 3 trial data for ivonescimab dropped at the ASCO Plenary in Chicago. Ivonescimab plus chemotherapy reduced the risk of death by 34% versus tislelizumab plus chemotherapy in first-line squamous non-small cell lung cancer. Median overall survival was 27.9 months in the ivonescimab arm versus 23.7 months in the control arm. The 24-month survival rate was 64.7% versus 48.6%. The hazard ratio was 0.66.
Ivonescimab is a bispecific antibody (a drug engineered to bind two different targets simultaneously) targeting both PD-1 and VEGF. Think Keytruda and Avastin combined into a single molecule. Summit Therapeutics (Nasdaq: SMMT) holds the rights outside of China from its partner Akeso. The US FDA accepted a biologics license application (BLA) for ivonescimab in January 2026 with a PDUFA date of November 14, 2026. Summit shares have risen roughly 600% in the two years since ivonescimab first beat Keytruda in a Chinese trial.
The open question is whether results from trials conducted entirely in China translate to the broader global patient population. HARMONi-6 was a single-region study run in China and sponsored by Akeso. The FDA will be scrutinizing that dataset carefully. A positive PDUFA decision in November would make ivonescimab the first China-originated cancer drug approved in the US. If the FDA wants additional Western data, the timeline gets more complicated. Summit conference call is June 1 at 7 a.m. ET. Filings on SEC EDGAR.
Lorundrostat has an FDA decision in December and $646 million to get there
Mineralys Therapeutics (Nasdaq: MLYS) presented new data from the Phase 3 LAUNCH-HTN trial of lorundrostat at the European Society of Hypertension 2026 meeting this week. The data covers patients with hypertension and chronic kidney disease. Lorundrostat is an aldosterone synthase inhibitor (a drug that blocks the enzyme that produces aldosterone, a hormone that drives high blood pressure when overactive). The FDA accepted Mineralys’s new drug application in May with a PDUFA target date of December 22, 2026.
The commercial opportunity is substantial. Roughly 30% of American adults have hypertension. Of those, an estimated 20 to 30% are resistant or uncontrolled despite standard treatment. Lorundrostat is targeting that specific population. Cash stands at $646 million as of March 31, funded into 2028. Six of eight covering analysts rate the stock a Strong Buy. Goldman Sachs lowered its price target to $42 from $49 in May but maintained its conviction on the December approval. Stock at roughly $24. Filings on SEC EDGAR.
A micro-cap RNA therapy company just started its first Phase 2 trial in colorectal cancer
TransCode Therapeutics (Nasdaq: RNAZ) initiated its Phase 2a clinical trial with TTX-MC138 in patients with ctDNA-positive (circulating tumor DNA — fragments of cancer DNA detectable in a blood test, indicating active disease) colorectal cancer this week. TTX-MC138 is an RNA-based therapy targeting microRNA-10b, a molecule that drives cancer cell survival and spread. The trial uses ctDNA positivity as the patient selection criterion, which focuses the study on patients with confirmed active disease.
TransCode is a Canadian-founded company built on University of Waterloo technology. Micro-cap. Very small cash position. RNA delivery in solid tumors is technically difficult. The Phase 2a initiation is the first real clinical test of whether the platform works in humans at this stage. No efficacy data yet. The enrollment timeline and interim signal will determine whether this becomes a larger story. Filings on SEC EDGAR.
Three catalysts worth tracking before the end of the year.
Summit conference call June 1 at 7 a.m. ET. Watch for any commentary on FDA interactions ahead of the November 14 PDUFA and any update on the HARMONi US trial designed to generate Western patient data.
Mineralys December 22 PDUFA: the next catalyst is a pre-approval meeting with the FDA if one is scheduled. Any guidance update or label negotiation news between now and December moves the stock.
TransCode Phase 2a enrollment: the company has not disclosed a target enrollment size or interim analysis timeline. First update on patient recruitment will be the next signal.
Sources
- CNBC: Summit Akeso ivonescimab improves survival in HARMONi-6 trial, May 31, 2026
- Business Wire: Summit Therapeutics HARMONi-6 OS results press release, May 31, 2026
- PRNewswire: Akeso HARMONi-6 data ASCO Plenary, May 31, 2026
- StockTitan: Mineralys Therapeutics LAUNCH-HTN ESH 2026 data presentation, May 29, 2026
- StockAnalysis: Mineralys Therapeutics MLYS overview, FDA NDA PDUFA December 22, 2026
- StockTitan: TransCode Therapeutics Phase 2a initiation TTX-MC138 colorectal cancer, May 2026
Editorial Disclosure
This roundup is based entirely on publicly available information including press releases, regulatory filings, and clinical trial disclosures. Securities discussed include Summit Therapeutics Inc. (Nasdaq: SMMT), Mineralys Therapeutics Inc. (Nasdaq: MLYS), and TransCode Therapeutics Inc. (Nasdaq: RNAZ). aktiego.com has not received any compensation from any company mentioned, their management, investor relations representatives, or any third party. No staff member or principal of aktiego.com holds a position in any security mentioned at the time of publication. Summit Therapeutics is included on the basis of the clinical significance of the HARMONi-6 data presented at ASCO on May 31, 2026, the final day of the coverage window; its market capitalization is above the typical size threshold for this roundup and is noted accordingly. All HARMONi-6 clinical trial data was generated from a single-region study conducted exclusively in China and sponsored by Akeso; the FDA’s assessment of this data for a US approval decision remains ongoing with a PDUFA date of November 14, 2026. Ivonescimab is investigational and not yet FDA approved. Lorundrostat is investigational and not yet FDA approved; PDUFA date is December 22, 2026. TTX-MC138 is investigational and in Phase 2a; no efficacy data has been established. TransCode Therapeutics has a limited cash position; investors should review the most recent 10-Q on SEC EDGAR for liquidity details. These are speculative investments carrying significant risk including potential total loss of capital. Coverage on aktiego.com is provided for informational and educational purposes only. aktiego.com is not a registered investment advisor. Nothing in this article constitutes financial, investment, or professional advice. Readers are encouraged to conduct their own due diligence and consult a qualified financial advisor before making any investment decisions. For more information please see our full DISCLAIMER.
