Revolution Medicines’ August approval for its pancreatic cancer drug didn’t just validate its breakthrough RAS-targeting technology — it offered more justification for the biotech’s high-flying market valuation.
In the months leading up to the approval, Revolution’s market valuation soared above $40 billion amid positive phase 3 data for Rasonque, which it heralded as a “landmark change” in care. Although Revolution didn’t have any other FDA-approved drugs before Rasonque, that valuation had placed it in the ranks of large, long-established drug developers like Takeda Pharmaceuticals and Sandoz Group.
Whether Revolution still deserves its high valuation remains a matter of analyst debate, and in the long run will come down to how well it executes on its launch plans and scores additional FDA nods for Rasonque in other indications.
In the meantime, other highly valued up-and-comers are providing the next tests for whether the market is getting their worth right.
Each carries a multibillion-dollar valuation tied to a different question. For Summit Therapeutics, it’s about whether an experimental cancer drug can win FDA approval. Abivax’s valuation is tied to whether promising clinical results can support a new treatment for inflammatory disease, while for Viking Therapeutics, it comes down to whether an obesity contender can compete against established industry heavyweights.
~$13 billion market cap
Summit Therapeutics: Will its buzzy cancer drug win its first FDA nod?
Summit Therapeutics’ market cap is hovering around $13 billion, according to Yahoo Finance, amid ongoing buzz around its investigational PD-1/VEGF bispecific treatment. Dubbed ivonescimab, the treatment has a long clinical track record in China, where it was originally developed by Akeso, and has already won market approval.
Now, Summit is looking to recreate that success in the U.S., EU and several other regions with a broad phase 3 program studying the drug as a monotherapy or in combination with different chemotherapy drugs in various cancer settings.
Summit’s first approval target is in a type of non-small cell lung cancer. Earlier this year, the FDA accepted Summit’s application for ivonescimab in patients with EGFR-mutated locally advanced or metastatic non-squamous NSCLC and set an action date for Nov. 14.
While Summit awaits a regulatory decision, upcoming trial readouts could further validate its technology and address a key lingering question. Will the drug’s effectiveness outside of China be enough to win an FDA nod?
Summit submitted the drug for FDA approval based on phase 3 data from its global Harmoni trial, which demonstrated a median progression-free survival of 6.8 months in combination with chemotherapy, compared to 4.4 months in the placebo-plus-chemotherapy arm. Although the primary analysis of that trial showed a “positive overall survival trend,” it also “did not reach statistical significance” in that regard, Summit reported.
But updated analysis in June on overall survival, which could be necessary for FDA approval, showed that ivonescimab “continued to demonstrate a positive OS trend and a consistent efficacy and safety profile in Asian and western patients compared with chemotherapy alone,” according to Summit.
Summit has cast a wide net for ivonescimab with several phase 3 studies in different lung cancer indications along with a phase 3 in colorectal cancer. It announced a collaboration with Revolution last year to evaluate ivonescimab in combo with three RAS-inhibitors and is studying the drug globally in biliary tract cancer as well.
~$7 billion market cap
Abivax: Will positive phase 3 results for a novel inflammatory disease drug turn into a U.S. filing?
France-based Abivax isn’t just highly valued on the market, it’s also long been viewed as a potential Big Pharma takeover target.
The company’s lead candidate obefazimod leverages a novel mechanism of action — microRNA-124 — to treat inflammatory diseases and has “mega-blockbuster potential in the U.S. alone,” according to Abivax. While Abivax is in the clinic for multiple indications, it's furthest along in moderate to severe active ulcerative colitis, where it’s knocking on the door of an FDA nod.
Abivax indicated earlier this year it had a “positive pre-NDA interaction” with the FDA and plans to file for approval in the indication by the end of 2026.
Still, the biotech and its stock prices have been on an up-and-down ride this year. Phase 3 data released in June showed that obefazimod not only far outperformed a placebo in ulcerative colitis, it produced remission rates higher than many treatments already on the market.
But reported cancer cases among some study participants sent shares for Abivax tumbling, before further data showing the malignancies were in line with normal rates for that demographic helped stock prices recover.
Abivax’s bid to win FDA approval will be a test case for how well its data holds up to scrutiny. The company also expects to report mid-stage results for the treatment in Crohn’s disease by mid-2027.
~$3 billion market cap
Viking Therapeutics: Will the obesity upstart find a competitive edge against Big Pharma rivals?
The conversation around weight loss treatments still mostly revolves around market leaders Eli Lilly and Novo Nordisk. But Viking Therapeutics is one of several companies plugging away in the clinic with potential next-generation contenders.
The appeal of Viking’s clinical-stage pipeline is threefold. The San Diego-based company’s lead asset VK2735 is a dual GLP-1/GIP agonist, an approach that’s been shown in the clinic to have a slight weight loss advantage over drugs targeting the GLP-1 pathway alone.
Viking is also testing VK2735 as both an injectable and oral therapy, which would broaden its market reach.
And the treatment has shown durability at lower dosing levels, an emerging strategy for drug developers looking for an edge in the weight loss market. In September, Viking revealed topline results from a maintenance study for VK2735 showing that at 21 weeks, participants in one every-other-week dosing group maintained 97% of the mean weight loss achieved during weekly dosing.
It doesn’t all come down to Viking’s mid- to late-stage program for VK2735. The company has also launched a phase 1 study of its dual amylin and calcitonin receptor agonist for obesity this year. Viking also completed a phase 2b study for a candidate in metabolic dysfunction-associated steatohepatitis.
But because of the size and scope of its clinical program, analysts anticipate it could still be a few years before Viking gets a product to market. The company remains in fundraising mode, most recently raising over $500 million through a common stock and convertible senior notes offering in September.
