Summit Therapeutics Inc.
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Range $15 – $38
Price Chart
About the company
Summit Therapeutics Inc. is a biopharmaceutical firm dedicated to discovering, developing, and commercializing therapeutic solutions, primarily targeting infectious diseases across the United States and Latin America. The company's clinical development pipeline is heavily concentrated on therapies for Clostridioides difficile infection (CDI).
- CEO
- Robert W. Duggan
- IPO
- 2015
- Employees
- 265
- HQ
- Miami, FL, US
AI snapshot
Six angles, distilled from the data.
The stock is still in a corrective regime after a large run, trading below its 200-day average of 16.41 while holding above the 50-day at 14.78. The setup remains constructive versus the 52-week low of 12.07, but it is still far from the 52-week high of 29.23, so shareholders should watch for a sustained reclaim of long-term trend.
Street sentiment is constructive, with a Buy consensus and 15 Buys against 8 Holds and no Sells. The average target sits at 28.58, well above the last close, while recent actions have mostly been reiterations and upgrades, including Jefferies moving to Buy and Bernstein lifting its view to Market Perform.
The earnings profile is still uneven, with only 1 beat in the last 7 quarters and the next report due 2026-10-19. Consensus EPS trends from -1.16 in 2027 to -0.66 in 2028 and 0.08 in 2029, so shareholders should watch whether losses narrow faster than expected and whether guidance supports that path.
Recent insider activity is a clear net-buying signal. The strongest purchases came from the two Co-CEOs, with 3.81 million shares each bought on 2026-06-12, and additional open-market buying from the COO/CFO on 2026-06-04; recent awards are separate compensation noise, not the main signal.
Profitability remains deeply negative, with ROE at -192.51% and ROA at -101.61%. Revenue growth is still weak at -100% YoY, but the balance sheet is a major offset: cash and equivalents of 529.5 million versus total debt of 15.5 million leaves net cash of 514.0 million.
SMMT trades as a high-variance biotech name where pipeline execution matters more than current earnings power. The valuation still screens rich versus the broader healthcare sector on a negative P/E of -13.94, so the market is paying for clinical and commercial optionality rather than present fundamentals.
Similar companies
Peers in the same neighborhood.
- Market Cap
- $12.45B
- P/E
- -13.94
- Fwd P/E
- 193.82
- PEG
- 0.30
- P/S
- 0.00
- P/B
- 19.28
- EV/EBITDA
- -14.08
- Div Yield
- 0.00%
- Gross Margin
- 0.00%
- Op Margin
- 0.00%
- Net Margin
- 0.00%
- ROE
- -204.33%
- ROIC
- -134.14%
Latest fiscal year · YoY change
- Revenue
- $0+0.0%
- Gross Profit
- $0+0.0%
- Op Income
- $-1,094,374,000
- Net Income
- $-1,079,586,000-510.7%
- EPS
- $-1.44-476.0%
- OCF Growth
- -111.1%
- FCF Growth
- -111.3%
- 52W High
- $29.23
- 52W Low
- $12.07
- 50D MA
- $14.82
- 200D MA
- $16.38
- Beta
- -1.24
- RSI (14)
- 47
- Avg Volume
- 5.10M
Earnings call summaries
Pick a quarter — each call distilled into takeaways, results, and a bull vs bear read.
Summit said updated HARMONi survival data strengthened its case for ivonescimab ahead of the November 14 FDA decision, while the company continued to expand its global pipeline and prepare for launch.· July 23, 2026
- Updated HARMONi OS analysis showed a hazard ratio of 0.76 in both the total population and the Western subgroup, with management saying longer follow-up brought Western results in line with Asia.
- The FDA review of the BLA is ongoing, with a PDUFA date of November 14; management said it does not expect the date to move, but that is up to the agency.
- HARMONi-3 completed enrollment in both squamous and non-squamous cohorts; management expects the squamous PFS readout in the second half of 2026 and another OS look in the first half of 2027.
- Cash ended Q2 2026 at approximately $690.7 million, helped by $231 million raised through the ATM, while operating cash use was about $140 million in the quarter.
- Summit highlighted new and expanding collaborations with Revolution Medicines, GSK, and Arcus, and said ivonescimab has over 65 investigator-sponsored trials in various stages.
Summit ended Q2 2026 with approximately $690.7 million in cash, up from $598.7 million at the end of Q1 2026. The quarter’s increase in cash was driven mainly by $231 million raised from the ATM facility, offset by about $140 million of operating cash use. Total GAAP operating expenses were $220.5 million in Q2 2026 versus $195.2 million in Q1 2026; non-GAAP operating expenses were $151.8 million versus $122.4 million. Management did not give revenue or EPS figures on the call. For guidance, Summit said the HARMONi BLA remains under FDA review with a target PDUFA date of November 14, expects HARMONi-3 squamous PFS data in the second half of 2026, and expects the next independent OS look in the first half of 2027. It also said the GSK collaboration should enroll its first patient later this quarter and the Arcus combo should generate initial data by mid next year.
Bob Duggan framed ivonescimab as Summit’s core platform asset and emphasized that the drug now has four Phase III readouts, all positive, plus two approvals in China and a pending U.S. BLA. His tone was highly optimistic and strategic, stressing broad interest from big pharma, a growing clinical footprint, and the potential to use ivonescimab across multiple solid tumors and combinations. He repeatedly described the opportunity as platform-like and said the company is preparing for commercialization ahead of a possible FDA decision later this year.
Manmeet Soni focused on liquidity, expense growth, and launch readiness. He said cash finished the quarter at approximately $690.7 million, with the increase from Q1 primarily reflecting $231 million raised via ATM and roughly $140 million used in operations; he also noted the company filed a new ATM prospectus supplement for up to $380 million and has no debt. GAAP operating expenses rose to $220.5 million from $195.2 million, and non-GAAP operating expenses increased to $151.8 million from $122.4 million, mostly because of higher R&D tied to HARMONi-GI3, HARMONi-3, and HARMONi-7. He also said commercial leadership is in place, market access and marketing teams are built, and MSLs have been ramped up for a potential launch.
Analysts pressed management on whether the updated HARMONi OS data should translate to frontline settings like HARMONi-3, and management said the key variable is follow-up time, not region alone. They also asked whether the delayed HARMONi-3 readout implies weaker performance; management said the study was fully global from the start, enrollment timing differed by region, and the earlier interim had limited follow-up and a higher significance bar. Several questions focused on OS timing, alpha spend, and whether the new HARMONi analysis could affect the November 14 PDUFA date; management said the PDUFA timing is up to the FDA, the interim OS looks are formal analyses, and the alpha spend for the early supportive look is minimal. There was also a competitive question about amivantamab and TROP-2 ADCs, and management argued ivonescimab’s differentiator is its mechanism plus a manageable safety profile and the possibility that different patients respond to different drugs.
The company’s bullish case is that ivonescimab keeps showing consistent survival trends as follow-up matures, including a 0.76 OS hazard ratio in the updated HARMONi cut and management’s view that Western and Asian results are converging. Summit also has multiple shots on goal, with HARMONi-3, HARMONi-7, HARMONi-GI3, and new collaborations that could broaden the asset’s use beyond lung cancer. Management sounded confident about a potential U.S. launch later this year and said physician/KOL enthusiasm remains strong.
The main risk is that the U.S. BLA is still under FDA review, the agency has said statistically significant OS is needed in this setting, and management would not rule out regulatory timing changes or an ODAC. The company is also spending heavily, with Q2 operating expenses rising and cash burn of about $140 million from operations in the quarter, so execution will matter if launch timing slips. On the clinical side, HARMONi-3 timing has moved out to later 2026 and 2027, and management acknowledged that event rates have slowed, leaving investors waiting for more mature survival data.
AI summary of the company's earnings call · Paraphrased · Not investment advice
- Free Float
- 13.8%
- Shares Outstanding
- 797.75M
- Float Shares
- 110.35M
of shares held by institutions
240 13F filers
Buy/sell ratio 0.00. Sells can include pre-scheduled 10b5-1 plan sales, not just discretionary selling.
Top institutional holders
Largest 13F positions, with quarter-over-quarter change.
| Holder | Shares | Δ Quarter |
|---|---|---|
| Baker Bros. Advisors LP | 32.79M | ▼ 3.60M |
| Vanguard Group Inc | 11.18M | ▼ 202.51K |
| Fmr LLC | 10.04M | ▼ 809.25K |
| State Street Corp | 9.54M | ▲ 2.51M |
| Blackrock, Inc. | 9.53M | ▼ 124.72K |
| Vanguard Capital Management LLC | 5.73M | ▲ 22.68K |
| Ubs Group AG | 5.23M | ▲ 1.55M |
| Vanguard Portfolio Management LLC | 5.04M | ▼ 191.06K |
| Goldman Sachs Group Inc | 4.51M | ▲ 4.20M |
| Price T Rowe Associates Inc | 3.89M | ▼ 4.38M |
| Point72 Asset Management, L.P. | 3.70M | ▲ 2.91M |
| Geode Capital Management, LLC | 3.43M | ▲ 111.41K |
Held by 304 ETFs
Biggest fund positions in SMMT by dollar value.
Recent insider transactions
Who's buying, who's selling, and how much.
| Date | Insider | Type | Shares |
|---|---|---|---|
| Jun 12, 26 | Zanganeh Mahkam | buy | 3,810,000 |
| Jun 12, 26 | DUGGAN ROBERT W | buy | 3,810,000 |
| Jun 4, 26 | DUGGAN ROBERT W | buy | 100,000 |
| Jun 4, 26 | Zanganeh Mahkam | buy | 100,000 |
| Jun 4, 26 | Soni Manmeet Singh | buy | 25,000 |
| Jun 4, 26 | Soni Manmeet Singh | buy | 25,000 |
| Jan 8, 26 | Anand Bhaskar | other | 30,000 |
| Jan 2, 26 | Zanganeh Mahkam | other | 11,232 |
| Jan 2, 26 | DUGGAN ROBERT W | other | 11,232 |
| Jan 2, 26 | Booth Robert F. | other | 35,000 |
A “Sell” may be a pre-scheduled 10b5-1 plan sale rather than a discretionary decision — read insider selling with that in mind.
Our SMMT coverage
Recent articles, reports, and earnings notes.
Summit Therapeutics (SMMT): Ivonescimab Approval Optionality
Summit Therapeutics is a high-risk, high-upside oncology story centered on ivonescimab and a November 2026 FDA decision. The stock offers meaningful regulatory upside, but the business still has no product revenue and remains dependent on one drug.

Summit Therapeutics Inc. (SMMT) climbs 14% on ivonescimab data
Summit Therapeutics Inc. (SMMT) climbs after fresh Phase III ivonescimab results strengthened the drug's oncology case. The move follows an overall survival benefit in biliary tract cancer and comes ahead of key FDA and conference milestones that could further shape the stock's outlook.

Summit Therapeutics (SMMT): Ivonescimab Drives High-Reward Buy
Summit Therapeutics is a high-risk, high-upside oncology story built around ivonescimab, with positive Phase III data and an FDA review underway. The stock looks attractive for investors willing to accept binary regulatory risk in exchange for platform-scale potential.
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HARMONi-GI1, a Phase III Trial Featuring Ivonescimab Plus Chemotherapy Compared to Durvalumab Plus Chemotherapy in First-Line Treatment of Patients with Advanced Biliary Tract Cancer from China, to Be Showcased in Presidential Symposium at ESMO 2026
businesswire.com · Sep 22
Updated HARMONi Data Presented at WCLC 2026 Demonstrate Consistent Overall Survival Results with Ivonescimab Plus Chemotherapy in Western and Asian Patients
businesswire.com · Sep 15
Ivonescimab Monotherapy Demonstrates a Statistically Significant & Clinically Meaningful Benefit Compared to Pembrolizumab Monotherapy in PD-L1-Positive Advanced NSCLC in Akeso's HARMONi-2 Study Condu
gurufocus.com · Sep 13
Ivonescimab Monotherapy Demonstrates a Statistically Significant & Clinically Meaningful Benefit Compared to Pembrolizumab Monotherapy in PD-L1-Positive Advanced NSCLC in Akeso's HARMONi-2 Study Conducted in China
businesswire.com · Sep 13
Bank of New York Mellon Corp Takes $6.28 Million Position in Summit Therapeutics PLC $SMMT
defenseworld.net · Sep 5
SMMT Stock Soars on NSCLC Drug Survival Data Beating Keytruda in China
zacks.com · Sep 4
Better Cancer Therapy Than Keytruda? Summit Therapeutics Partner's Ivonescimab Outperforms in Lung Cancer Study
benzinga.com · Sep 3
November 14 Is The Make-Or-Break Moment For Summit Therapeutics' Cancer Bet
seekingalpha.com · Sep 3
Headlines from third-party outlets — TickerSpark isn't affiliated with these sources.
AI analysis · Last refreshed September 26, 2026 · Live quote · Not investment advice