This year’s class of seven standout drug launches features the oral weight-loss showdown, a potentially safer CAR-T drug, and the ‘holy grail’ of cancer research.
Oral convenience is moving from a niche advantage to a market expansion strategy as pills vie to reshape competitive landscapes.
First-time launchers are playing a higher-stakes game, as they seek to balance capital with execution pressure.
Payers are the real competitive battlefield, so market access and pricing strategy will be crucial.
Speed and operational excellence are becoming competitive advantages; positioning will drive success beyond clinical data.
The patent cliff is creating opportunities, but also raising the bar for commercial models.
It’s become a mini writing ritual for me over the last few years. Once the dust settles from the J.P. Morgan Healthcare Conference, I usually compile a short list of standout drug launches for the year ahead.
For this latest installment, I sought input from biotech investment managers, poured over summaries of JPM presentations, and scoured media and analyst reports. I also asked a couple of Beghou partners to opine on various aspects of commercialization, including Robert Rouse on the market-access landscape and Jenny Herritz on some of the unique challenges facing first-time launchers. I’m grateful for their expert commentary.
This year’s list spotlights seven late-stage assets set for commercial launch in 2026, spanning obesity and oncology to cardiovascular and immunology/inflammation (I&I). The main criteria for the drugs are both good efficacy and a strong potential market. It’s by no means comprehensive.
Oral drugs, some of them first-in-class, make a strong showing. And with four of these companies in the developmental stage – Cogent, Nuvalent, Revolution Medicines, and Arcellx – that also gives this list a first-time launch slant.
But this year’s cohort isn’t just notable for the science. It signals a deeper shift in how launches will be won. Convenience is challenging biologics. First-time launchers are commercializing in a capital-conscious environment. And payers, not prescribers, may prove the ultimate gatekeepers of growth.
For commercial leaders, 2026 will be about strategic pricing, disciplined infrastructure build, and smart market expansion in a payer-constrained world.
Revenue targets and any future approval dates are best estimates as of press time and are subject to change.
Bezuclastinib, or “bezu,” is Cogent Bioscience’s lead drug and is set for launch in two different disease states.
Bezu targets a mutation in a group of enzymes called tyrosine kinase. These enzymes act as “on-off” switches for various cell functions, including production of mast cells, a type of white blood cell.
The mutation that bezu targets, called KIT D816V, locks those enzymes in the “on” position. This causes mast cells to build up in the bone marrow, an immune system disorder known as systemic mastocytosis (SM) which is associated with gastrointestinal, skin, and respiratory symptoms. Similar mutations have been implicated in advanced gastrointestinal stromal tumors (GIST). Clinical data from Cogent’s PEAK and APEX studies, respectively, has suggested solid efficacy in both diseases.
By this April, the drugmaker says it will complete submission of its new drug application (NDA) for use of bezu, in combination with older drug sunitinib, in second-line GIST. NDAs for nonadvanced systemic mastocytosis (NonAdvSM), as well as the advanced form of SM, are set to follow in the first half of the year.
The company anticipates a U.S. commercial launch for at least the NonAdvSM indication by late 2026. Leerink Partners estimated peak sales of around $5.7 billion for bezu, of which $2.8 billion will come from GIST and the rest from SM in its various forms, according to a report in BioSpace.
As bezu would be Cogent’s first commercial offering, the company is counting on the dual launch to help it move beyond the clinical stage without the need to raise additional capital. As of the start of the year, its cash balance was about $900 million, enough to fund operations until 2028.
“First-time launchers always have this pressure to gate some of their spend,” said Herritz, “because if the data doesn't go the way they want it to, they have to be a little bit more conservative.”
Cogent plans to bring bezu to the U.S. market itself. The senior commercial leadership team is in place, and the U.S. commercial footprint amounts to about 100 employees, Cogent reported at JPM. Management also noted that an expanded access program (EAP) is currently active to build physician familiarity ahead of approval.
Pending a decision by the Food and Drug Administration, which is expected in April thanks to a priority review voucher, Lilly’s oral GLP-1 orforglipron will go toe-to-toe against Novo Nordisk’s recently launched Wegovy pill.
Novo’s pill is an oral version of the drugmaker’s semaglutide, the active ingredient in injectable GLP-1s Wegovy and Ozempic. The manufacturers say their new pills will open up treatment to patients for whom injections aren’t a viable option, either due to an aversion to shots, their high cost, or any other reason.
But there are important differences between them. The two pills’ clinical trials were conducted separately, and under different parameters, making efficacy comparisons imperfect. Yet Novo’s pill was associated with more weight loss – a 16.6% average reduction, versus 12.4% for its chief rival.
On the other hand, due to their respective formulations, the package insert for Lilly’s pill will read something along the lines of “take anytime,” while Wegovy’s PI will advise patients to “take on an empty stomach and wait 30 minutes before eating or drinking.”
That convenience factor, along with orforglipron’s cardiometabolic benefits, will tilt the scales in Lilly’s favor, analysts predict. A 2025 Goldman Sachs analysis, cited by CNBC, estimated orforglipron will grab a 60% share, or roughly $13.6 billion, of the daily oral segment of the weight-loss drug market by 2030. Novo’s oral semaglutide will take a 21% share, or about $4 billion, per the investment bank.
Future entrants will claim the remaining 19% share. Drugmakers expected to report data this year on their experimental obesity pills include Viking Therapeutics, Structure Therapeutics, and AstraZeneca, along with Roche and Pfizer. Orforglipron is also being investigated as a treatment for diabetes, obstructive sleep apnea, and hypertension.
Doses of the Wegovy pill can be had at cash prices of $149 to $499 per month for people getting them through the direct-to-consumer websites NovoCare and TrumpRx. Lilly pledged a similar starting price.
“If they have points of differentiation, then they can generally price at a bit of a premium,” advised Rouse, referring to orforglipron’s ability to be taken without regard to water and food consumption.
But he predicts the forthcoming pill’s price will be “in the same ballpark” as Wegovy’s, from a WAC (wholesale acquisition cost) and cash basis.
Lilly launched its direct-buying site LillyDirect in 2024, after which Novo and others followed suit. The sites bypass pharmacy benefit managers (PBMs), traditional insurers and pharmacy distributors, enabling drugmakers to offer their products for less.
Given the popularity and cost of weight-loss drugs as well as the large number of Americans who already pay for them out of pocket, direct sales of these drugs likely has had a big impact in terms of disrupting the PBM model.
Between the manufacturer buying sites on the branded side, and Mark Cuban's Cost Plus Drugs online pharmacy on the generics side, “The PBM model is definitely under assault,” added Rouse.
Another pipeline pill that’s making waves is icotrokinra. The IL-23 inhibitor, co-developed with Protagonist Therapeutics, is under review by the FDA for use in moderate-to-severe plaque psoriasis and is slated to launch this year, J&J CEO Joaquin Duato confirmed during the company’s JPM presentation.
If approved, icotrokinra, which J&J will sell under the brand name Icotyde, would be the first oral to target the IL-23 receptor. That would add it to a plaque psoriasis treatment armamentarium that also includes J&J’s IL-23 biologic Tremfya.
But Duato expects Icotyde to grow the market, as existing therapies have only penetrated 30% to 40% of this sector. Like in obesity, oral drugs can unlock access to those who are needle-hesitant and other new swaths of patients.
Beyond psoriasis and psoriatic arthritis, Icotyde is being investigated in moderate-to-severe active ulcerative colitis and in IBD.
Analysts at GlobalData predict sales of $3.2 billion by 2031. Tremfya, currently a $5-billion drug, is slated to grow annual revenue to $9.2 billion by 2031.
Duato said the company will “put our best effort” behind both the new oral and biologic Tremfya, leaving the choice for one or the other ultimately up to the discretion of doctor and patient. Rouse doesn’t expect Icotyde to cannibalize sales from its older injectable.
“Simplifying it – getting it into pill form, as opposed to something that's injected or infused – almost always opens up the marketplace,” he said.
As both are IL-23 drugs, the mechanism of action is already well understood. But clinicians may have questions about how the pill’s efficacy, tolerability, and safety compare to the biologic. Payers will want to see how their outcomes stack up.
That being the case, J&J could face payer resistance simply for growing the treatment market, which leads to a more substantial budget impact.
“If someone’s grown the market by 20, 30, 40, 50% over the near term, now payer costs have gone up in the aggregate,” explained Rouse. “That's something payers will watch out for.”
I first came across cell therapy company Arcellx shortly before JPM 2024, when anito-cel (anitocabtagene autoleucel), its lead asset, was in Phase 2 testing for the blood cancer multiple myeloma (MM). The last two years have progressed well. Gilead, its co-commercialization and co-development partner, announced a deal this week to buy the rest of the biotech for $7.8 billion, and 2026 could be the year its first product hits the market.
The investigational CAR T-cell therapy was filed with the FDA for use in fourth-line MM, and along with the acquisition, Gilead said the agency had accepted the marketing application and set a review date of Dec. 23.
An approval for anito-cel in relapsed or refractory MM would put it into competition with J&J/Legend Biotech’s Carvykti and Bristol Myers Squibb/2Seventy Bio’s Abecma, both of which are marketed for second-line use. Clinical data suggest the new cell therapy has similar efficacy to Carvykti but may have an edge in safety.
The main safety concern involves delayed neurotoxicity. Carvykti carries a boxed warning for potentially life-threatening adverse events, including Parkinsonism and Guillain-Barré syndrome. Study results shared by Arcellx thus far haven’t linked anito-cel to this side effect.
Arcellx and its investors have been playing up those differences since at least 2023. But anito-cel’s potentially cleaner safety profile might be slightly exaggerated, considering Carvykti’s strong sales ($1.9 billion in 2025).
If approved, the new cell therapy is expected to become Gilead’s best-selling CAR-T product and a multibillion-dollar product. Factoring into that forecast is anito-cel’s plan to move into earlier lines of therapy, including a regulatory filing for anito-cel in 2L+ multiple myeloma as soon as next year.
If approved, anito-cel will need to distinguish itself against some formidable incumbents. In addition to safety, manufacturing speed may be another attribute.
Like many other CAR-T cell therapies, anito-cel is autologous – i.e., manufactured from the patient’s own cells. That’s a complex, time-consuming process that can extend patients’ wait time to more than three weeks in some cases.
Arcellx’s commercial partner, Gilead, holds the top spot for the fastest commercial turnaround at 14 days for its Yescarta cell therapy. It’s also upped its CAR-T manufacturing capacity over the last few years. Payers will demand economic justification, but in a space where patients face rapidly progressing disease, speed could become a key differentiator.
The cardiovascular (CV) epidemic continues to be the leading cause of deaths in America, with heart attacks and stroke contributing to most of these fatalities. To reduce their CV risk, millions take lipid-lowering drugs like statins. But there’s a group of people whose LDL cholesterol levels remain stubbornly high, and Merck’s enlicitide could be an attractive option for them.
Enlicitide targets the PCSK9 protein to help reduce LDL-C levels in those who remain at high risk of heart attacks despite taking statins. The peptide drug, which is being co-developed with UCB, could also become this category’s first oral entrant.
Existing injectable PCSK9 inhibitors, which include the monoclonal antibodies Praluent (alirocumab) from Sanofi/Regeneron along with Amgen’s Repatha (evolocumab), are effective at giving patients who need it that extra boost. Yet the shots remain widely underused.
Designed to provide efficacy similar to the monoclonal antibodies, Merck’s asset cut cholesterol by as much as 60% versus placebo in just six months, in a trial involving adults with a condition called heterozygous familial hypercholesterolemia (HeFH).
Does it lower the risk of heart attacks? CV outcomes data will take time to accrue. For now, the stage is set for a more convenient – and appropriately priced – cholesterol-lowering agent.
Enlicitide is expected to achieve “multibillion-dollar” peak annual sales, according to a Merck forecast shared at a recent investor event.
Merck has already pledged to offer its new peptide pill at an “affordable price” through its direct-to-patient program. The company can lean into cost and convenience in its patient messaging, but will it be enough to secure reimbursement?
“Insurers may resist reimbursing purely for convenience,” advised Rouse. “So, Merck does need to be strategic in how they price. They probably want to price below the anti-PCSK9 monoclonal antibodies. That will give them some running room.”
The company must avoid missteps that hindered earlier PCSK9 inhibitors. The two injectables eventually were shown to do a better job of cutting the rate of heart attacks and strokes for some people than statins like Pfizer’s Lipitor and Merck’s Zocor. But payers initially balked at their initial price tags of $14,000 per year for a lifetime of treatment. Both drugmakers later slashed prices by 60%, but plans were slow to change their exclusions.
The new pill, if approved, will have other competition. Novartis’ injectable Leqvio (inclisiran), launched a few years ago, has been rapidly gaining share thanks to its more convenient twice-yearly dosing schedule, along with a lower price than that of either Praluent or Repatha. LIB Therapeutics’ Lerochol, a long-acting PCSK9 which was approved late last year, is expected to debut this spring.
Merck brought the first statin – Mevacor – to market back in ‘87. Decades later, it’s poised to play the role of CV innovator once again.
Neladalkib may not be Nuvalent’s first targeted cancer drug to reach market, but it may be the most highly anticipated. Following talks with the FDA late last year, the company plans to submit an NDA for the kinase inhibitor in previously treated patients with ALK-positive non-small cell lung cancer (NSCLC) in the first half of 2026.
Kinase inhibitors targeting ALK-mutated NSCLC are a multibillion-dollar market, and investors foresee a role for neladalkib. Royalty Pharma, for one, secured royalty interests in the drug and another Nuvalent kinase inhibitor, zytosanthinib, which the company already filed for ROS1-positive NSCLC in previously treated patients.
With an FDA decision date due in September, zytosanthinib could become the biotech’s first commercial launch. But neladalkib seems to be the buzzier asset.
The drug showed sustained efficacy and a broadly manageable safety profile, according to pivotal data reported by Nuvalent in November based on a trial in subjects previously treated with tyrosine kinase inhibitors. A Phase 3 study is underway, with potential approval later this year.
Annual sales of neladalkib could reach about $3.5 billion by 2035, as per a consensus of analyst estimates cited by MSN.
Nuvalent is actively building U.S. commercial infrastructure to support the potential U.S. launches of both drugs for this year. It’s well-capitalized to do so, with a cash runway – reportedly around $1.2 billion – expected to fund operations into 2029.
With multiple cancer drugs, including blockbuster therapies Keytruda (Merck) and Opdivo (BMS), set to lose patent exclusivity though 2028, “it's a great time for companies to be commercializing an oncology drug for the first time,” noted Herritz, especially precision indications.
The patent cliff on older brands encourages these biotechs not just to advance their pipelines, but to build enterprise value, too. In financial terms, that means growing equity and reducing debt. Herritz said this makes them more attractive to suitors who are on the hunt to replace revenue by bolting on later-stage, de-risked (but pricey) assets for acquisition deals.
The drugs Revolution is developing are designed to thwart RAS, a molecular driver of various common cancers which, since its ‘90s-era discovery, has been thought to be “undruggable.” What some have called the “holy grail of cancer research” may finally be within reach.
RevMed’s pancreatic-cancer treatment candidate, daraxonrasib, represents the company's most significant near-term asset. Top-line data from the fully enrolled, Phase 3 RASolute 302 study in second-line metastatic pancreatic cancer are expected in the first half of the year.
The company already shared what appeared to be encouraging long-term follow-up data for the agent in that setting. For instance, overall survival (OS) was 13.1 months in patients with the most common type of RAS mutation (called G12X), or 15.6 months in subjects with any RAS mutation, versus 7.4 months in those treated with the standard of care.
RevMed is testing daraxonrasib alone and in combination with chemo in the first-line pancreatic cancer setting, and it’s also exploring the compound for use in lung and colon cancers. RAS genes' involvement in three of the top four cancer killers explains why they’ve spurred such intense interest in drug development. Should RevMed’s lead drug work safely, a three-decade quest may finally come to fruition.
Daraxonrasib, if approved, could become the main treatment in pancreatic cancer, leading to $10 billion in 2035 worldwide sales, according to a Mizuho Securities estimate cited by The Wall Street Journal.
Sitting on an asset portfolio with strong potential, most pre-commercial biotechs want to progress R&D in hopes of reaching patients and hitting sales targets. But they can’t always afford to make the requisite investments to build company value.
RevMed bucks that trend, boasting a financial position which appears to be stronger than most first-time launchers. Its cash holdings stood at $1.9 billion as of the end of Q3 2025, with access to an additional $1.75 billion in committed capital through an agreement with Royalty Pharma.
This war chest not only enables it to execute late-stage programs, but also to be highly selective of deals. The Wall Street Journal recently reported that Merck had been in talks to buy the cancer-drug biotech in a deal valued at $30 billion. Talks cooled because the two couldn’t agree on price, according to the report.
For first-time launchers, “There's pressure to advance the drug but not to build, and then there's the flip side of the pressure – improve your walk-away position,” explained Herritz.
“Many commentators recommend continuing to build so that you keep your optionality open to commercialize yourself,” she added. “You keep on increasing your enterprise value in case you don't find a suitor that meets your needs.”