Summit Therapeutics Inc Stock Price, News & Analysis

Summit Therapeutics (NASDAQ:SMMT) announced updated data from its Phase III HARMONi trial for ivonescimab plus chemotherapy in EGFR-mutated NSCLC patients. In the longer-term follow-up analysis of Western patients, the treatment showed an improved overall survival (OS) trend with a nominal p-value of 0.0332 versus chemotherapy alone.

Key findings include median OS of 16.8 months for ivonescimab plus chemotherapy vs. 14.0 months for placebo plus chemotherapy. North American patients showed particularly promising results with OS hazard ratio of 0.70. The treatment demonstrated statistically significant progression-free survival (PFS) improvement with hazard ratio of 0.52 (p<0.00001) and higher overall response rates of 45% vs. 34% for placebo.

The safety profile remained manageable with 7.3% discontinuation rate due to treatment-related adverse events.

Summit Therapeutics (NASDAQ: SMMT) has announced a conference call on September 8, 2025, at 8:00 AM ET to discuss data from their Phase III clinical trial, HARMONi. The presentation will be featured in the Presidential Symposium at the 2025 World Conference on Lung Cancer (WCLC) in Barcelona.

The HARMONi trial is evaluating ivonescimab plus platinum-doublet chemotherapy versus placebo in patients with EGFR-mutated non-small cell lung cancer (NSCLC) who have progressed after treatment with 3rd generation EGFR TKI. The presentation will be accessible through Summit's website, with an archived version available afterward.

Summit Therapeutics (NASDAQ: SMMT) announced that data from their Phase III HARMONi trial of ivonescimab will be presented at the WCLC 2025 Presidential Symposium on September 7, 2025. The trial evaluated ivonescimab plus chemotherapy versus placebo in EGFR-mutated non-small cell lung cancer (NSCLC) patients.

The study demonstrated statistically significant improvement in progression-free survival with a hazard ratio of 0.52 (p<0.00001). While overall survival showed a positive trend with a hazard ratio of 0.79, it did not reach statistical significance (p=0.057). The presentation will be delivered by Dr. Jonathan Goldman from UCLA, marking ivonescimab's second consecutive year at the WCLC Presidential Symposium.

Summit Therapeutics (NASDAQ:SMMT) reported significant progress in Q2 2025, highlighted by positive results from multiple Phase III trials of ivonescimab. The HARMONi trial demonstrated statistically significant improvement in progression-free survival with a hazard ratio of 0.52 (p<0.00001) in EGFR-mutated NSCLC patients.

The company's financial position showed $297.9 million in cash and investments as of June 30, 2025, down from $412.3 million in December 2024. A significant non-cash expense of $466.6 million was recorded due to stock option modifications. The company established a new $360 million ATM offering facility with J.P. Morgan.

Key operational highlights include positive interim survival analysis in the HARMONi-2 study, NMPA approval in China for first-line PD-L1 positive advanced NSCLC, and a new clinical collaboration with Revolution Medicines for RAS(ON) inhibitor combinations.

Summit Therapeutics (NASDAQ: SMMT) has granted inducement stock options to seven new employees, totaling 71,275 shares of common stock. The options were awarded on June 2, 2025, with a ten-year term and an exercise price of $17.72 per share, matching the company's closing stock price on the grant date. These options will vest in equal annual installments over four years and were granted from a pre-approved equity incentive pool established on January 22, 2025. The awards were made in accordance with Nasdaq Listing Rule 5635(c)(4) and received approval from Summit's Compensation Committee.

Summit Therapeutics (NASDAQ: SMMT) has announced its participation in the 46th Annual Goldman Sachs Global Healthcare Conference in Miami, Florida. The company's management team will deliver a fireside chat presentation on June 9, 2025, at 1:20 PM ET. During the presentation, they will provide a corporate overview and updates on their progress, with particular focus on ivonescimab, their innovative investigational bispecific antibody. The presentation will be accessible live through Summit's website www.smmttx.com, with an archived version available afterward.

Summit Therapeutics announced positive topline results from HARMONi, a global Phase III trial evaluating ivonescimab plus chemotherapy in EGFR-mutated non-small cell lung cancer (NSCLC) patients. The study met its primary endpoint, showing a 48% reduction in disease progression or death risk compared to chemotherapy alone (HR=0.52, p<0.00001). The trial also showed a positive trend in overall survival with a hazard ratio of 0.79, though not reaching statistical significance (p=0.057). The safety profile was manageable, with 56.9% of patients in the treatment arm experiencing Grade 3+ adverse events versus 50.0% in the control arm. The study included patients from both Asian (62%) and Western (38%) countries, demonstrating consistent benefits across regions. Summit is considering the timing of a BLA filing, noting FDA's requirement for statistically significant overall survival benefit for marketing authorization.

Summit Therapeutics (NASDAQ: SMMT) has announced inducement grants of stock options to nine new employees. The options collectively allow for the purchase of up to 94,050 shares of common stock at an exercise price of $22.75 per share, which was the closing price on May 14, 2025. The options have a ten-year term and will vest in equal annual installments over a four-year period. These grants were approved by Summit's Compensation Committee and were awarded in accordance with Nasdaq Listing Rule 5635(c)(4), which allows for inducement grants to new employees.

Summit Therapeutics (SMMT) reported significant progress in Q1 2025 for its lead drug ivonescimab. The company announced that HARMONi-6 Phase III trial met its primary endpoint, showing superior progression-free survival when combining ivonescimab with chemotherapy versus tislelizumab (PD-1 inhibitor) plus chemotherapy in first-line squamous NSCLC treatment. Additionally, ivonescimab received approval in China for first-line NSCLC treatment in PD-L1 positive tumors, with interim overall survival HR of 0.777. The company continues enrollment in global Phase III trials HARMONi-3 and HARMONi-7. Financially, Summit reported cash and investments of $361.3M as of March 31, 2025, with a GAAP net loss of $62.9M ($0.09 per share) for Q1 2025. The company strengthened its leadership by appointing Robert LaCaze as Chief Commercial Officer.