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Summit Therapeutics Inc (NASDAQ: SMMT) delivers innovative therapies for high-need medical conditions through focused research in genetic disorders and infectious diseases. This dedicated news hub provides investors and industry observers with essential updates on clinical progress, regulatory milestones, and strategic collaborations.
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Summit Therapeutics (NASDAQ: SMMT) reports positive interim overall survival analysis results for ivonescimab from the HARMONi-2 Phase III trial in China. The study, conducted by Akeso, compared ivonescimab monotherapy to pembrolizumab in patients with PD-L1 positive advanced non-small cell lung cancer (NSCLC).
Key findings include:
- Overall survival hazard ratio of 0.777 favoring ivonescimab at 39% data maturity, suggesting a potential 22% reduction in death risk versus pembrolizumab
- Previously reported primary endpoint showed statistically significant improvement in progression-free survival with hazard ratio of 0.51 (p<0.0001)
- Chinese NMPA has approved ivonescimab for this second indication
Summit is currently conducting HARMONi-7, a global Phase III trial evaluating ivonescimab against pembrolizumab in similar patient population, with registrational intent for the US and other regions.
Summit Therapeutics (NASDAQ: SMMT) has announced it will release its first quarter 2025 financial results and provide an operational update after market close on Thursday, May 1, 2025. The company will host a live webcast earnings conference call at 4:30 PM ET on the same day. Investors and interested parties can access the webcast through the company's website at www.smmttx.com. A recorded version of the conference call will be made available on the website for those unable to attend the live session.
Summit Therapeutics (NASDAQ: SMMT) announced positive results from Akeso's Phase III HARMONi-6 clinical trial, where ivonescimab plus chemotherapy demonstrated statistically significant superiority in progression-free survival (PFS) compared to tislelizumab plus chemotherapy in first-line treatment of squamous non-small cell lung cancer (NSCLC).
The trial, conducted in China, showed meaningful PFS benefits across both PD-L1 positive and negative tumors, with no new safety concerns identified. This marks the first known Phase III trial showing significant improvement over PD-(L)1 inhibitor therapy combined with chemotherapy in NSCLC.
Following the success of HARMONi-2, this is the second instance where ivonescimab-based regimens have shown superior results versus standard-of-care PD-(L)1 inhibitor treatments. Summit is currently enrolling patients in HARMONi-3, a global Phase III trial comparing ivonescimab plus chemotherapy against pembrolizumab plus chemotherapy in first-line metastatic NSCLC.
Summit Therapeutics (NASDAQ: SMMT) has announced the granting of inducement stock options to ten new employees. The awards, approved by the Company's Compensation Committee, allow the purchase of up to 176,915 shares of common stock at an exercise price of $19.29 per share, matching the closing price on March 31, 2025.
The options, granted in accordance with Nasdaq Listing Rule 5635(c)(4), feature a ten-year term and will vest in equal annual installments over four years. These awards were drawn from an equity incentive pool established on January 22, 2025, specifically designated for new employee inducements.
Summit Therapeutics (NASDAQ: SMMT) has announced the granting of inducement stock options to seven new employees. The options allow for the purchase of up to 147,500 shares of common stock at an exercise price of $20.13 per share, which was the closing price on March 17, 2025.
The options, approved by Summit's Compensation Committee, have a ten-year term and will vest in equal annual installments over a four-year period. These awards were granted as inducement material under Nasdaq Listing Rule 5635(c)(4) and were drawn from an equity incentive pool established on January 22, 2025.
Summit Therapeutics (NASDAQ: SMMT) has appointed Robert LaCaze as Chief Commercial Officer, reporting to Manmeet S. Soni, Chief Operating Officer and Chief Financial Officer. LaCaze brings over 35 years of biopharmaceutical executive leadership experience, particularly in oncology.
LaCaze previously served as Executive Vice President and Head of Oncology Strategic Business Unit at Bayer Healthcare, and Senior Vice President at Bristol-Myers Squibb leading their immuno-oncology franchise. Most recently, he was CEO and President of Mnemo Therapeutics.
His expertise spans biologics, cell therapies, radiopharmaceuticals, and diagnostics, with a track record of launching multi-billion-dollar products. LaCaze will be instrumental in Summit's commercial strategy for ivonescimab, their novel cancer product candidate.
Summit Therapeutics (NASDAQ: SMMT) has announced the granting of inducement stock options to 12 new employees. The awards, approved by the Company's Compensation Committee, collectively allow for the purchase of up to 122,650 shares of common stock.
The options were granted on March 11, 2025, with a ten-year term and an exercise price of $18.50 per share, matching the closing price of Summit's common stock on Nasdaq that day. These options were drawn from an equity incentive pool reserved on May 3, 2024, and January 22, 2025, specifically for new employee inducements under Nasdaq Listing Rule 5635(c)(4). The options will vest in equal annual installments over a four-year period.
Akeso announced that its partner Summit Therapeutics (NASDAQ: SMMT) has entered a clinical trial collaboration with Pfizer (NYSE: PFE) to evaluate ivonescimab, a novel PD-1/VEGF bispecific antibody, in combination with several of Pfizer's antibody drug conjugates (ADCs) across multiple solid tumor settings.
The collaboration aims to accelerate development of potentially landscape-changing combinations to improve standards of care for cancer patients with serious unmet needs. Each study will evaluate ivonescimab plus one of Pfizer's vedotin ADCs in distinct solid tumor settings to determine safety profiles and potential anti-tumor activity.
Under the agreement, Summit will provide ivonescimab while Pfizer will conduct the studies, with oversight from both companies. Both parties retain rights to their respective products. The studies are planned to begin in mid-2025, with further details to be announced later.
Summit Therapeutics (NASDAQ: SMMT) has reported its financial results for Q4 and full-year 2024. The company completed enrollment for its global Phase III HARMONi trial in NSCLC, with top-line data expected mid-2025. Summit announced a new clinical trial collaboration with Pfizer to evaluate ivonescimab in combination with vedotin ADCs, with trials starting mid-2025.
Financial highlights include cash and equivalents of $412.3 million as of December 31, 2024, up from $186.2 million in 2023. The company reported a GAAP net loss of $221.3 million ($0.31 per share) for 2024, compared to $614.9 million ($0.99 per share) in 2023. R&D expenses increased to $150.8 million from $59.4 million in 2023, while G&A expenses rose to $60.5 million from $30.3 million.
The company has expanded its HARMONi-3 trial to include both squamous and non-squamous histologies and received FDA Fast Track designation for ivonescimab in combination with chemotherapy for NSCLC patients.
Summit Therapeutics (NASDAQ: SMMT) has announced a clinical trial collaboration with Pfizer (NYSE: PFE) to evaluate ivonescimab, a novel PD-1/VEGF bispecific antibody, in combination with Pfizer's antibody drug conjugates (ADCs) across multiple solid tumor settings.
The collaboration aims to assess ivonescimab with several of Pfizer's vedotin-based ADCs in distinct solid tumor settings to determine safety profiles and potential anti-tumor activity. Summit will provide ivonescimab while Pfizer will conduct the studies, with both companies overseeing the trials. Both parties maintain their respective product rights.
The clinical trials are scheduled to begin in mid-2024, with further details to be announced later. The partnership focuses on developing novel mechanisms beyond current available treatments, particularly targeting non-small cell lung cancer and other solid tumors.
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