5 new drug launches that defied industry expectations

 

A clearly superior clinical profile, reasonable pricing and easy access has helped a handful of recently approved therapies achieve impressive launches.

“Some drug launches arrive quietly; others redraw the map,” according to Shikha Bhardwaj, associate consultant at DelveInsight.

Over the last year or so, biopharma has witnessed several products that have done just that. These medicines performed strongly right out of the gate, delivering sales and uptake numbers that easily beat analyst and investor expectations.

To maximize their chances of a blowout launch, companies should strive to develop drugs that not only stand above the rest in terms of safety and efficacy but also address a critical gap in the current landscape, Gregory Renza, managing director & senior biotechnology equity research analyst at Truist Securities, told BioSpace.

“The profile is now doing the selling, and the commercial build is designed around demand that already exists rather than demand that has to be created,” he said.

A good example of this is Revolution Medicines’ Rasonque, approved in August for pancreatic cancer, Renza said. “Pancreatic cancer has gone a very long time without meaningful innovation, and the Phase 3 result is unprecedented there,” he added, pointing to data released in April that demonstrated overall survival more than double placebo.

“Differentiation is the marketing,” Renza said. “The launches working today are those with categorically new profiles, not incrementally better ones.”

Other big launches this year, like Novo’s oral Wegovy and Insmed’s Brinsupri, follow this playbook of having a clearly superior clinical profile, bolstered by a strong evidence base, reasonable pricing and ready accessibility.

“The next generation of successful launches will need more than scientific novelty,” DelveInsight’s Bhardwaj said in an email interview. “They will require a defensible clinical advantage, a price payers can justify, evidence that holds up over time, and a launch strategy that turns approval into sustained access and adoption.”

Below, BioSpace examines five drug launches defying expectations.

Novo springs out of the gate with oral Wegovy

When Novo launched the oral version of its obesity drug Wegovy on Jan. 5, analysts weren’t expecting much. After all, the Danish drugmaker had fumbled a years-long lead in the GLP-1 game to Eli Lilly, which many now regard as the weight loss leader. And, at the time, Lilly’s competitor pill was just months behind.

But Novo took everyone by surprise. After just a week on the market, oral Wegovy reached almost 3,100 patients, a strong opening salvo that sent the pharma’s shares up 6.5%. During the pharma’s first quarter call in May, CEO Maziar Mike Doustdar claimed that, at least outside of vaccines, oral Wegovy has the “strongest launch in U.S. pharma.” At the time, Novo touted $355 million in sales for the pill’s first commercial quarter.

“Novo built the launch around access rather than promotion,” Bhardwaj told BioSpace. More than 70,000 pharmacies across the U.S. and at least nine telehealth providers carry the pill, she explained. With a starting price of $149 per month for self-paying patients, oral Wegovy is “a consumer product as much as a prescription drug.”

But the oral obesity story is far from closed. Q2 sales for oral Wegovy hit $496 million, 2% behind consensus expectations. Meanwhile, Lilly’s Foundayo—which costs between $139 and $349 per month—seems to be rebounding from a slow launch after its April approval and is gaining ground. In an Oct. 2 note tracking scripts for these obesity medicines, BMO Capital Markets noted that prescriptions for oral Wegovy declined 1% from the previous week, while Foundayo grew 20.5%. Lilly still lags Novo in overall uptake volume.

RevMed offers option for pancreatic cancer at last with Rasonque

After securing a speedy approval in August—just five weeks after filing, courtesy of the FDA’s Commissioner’s National Priority Voucher program—Revolution Medicines’ pancreatic cancer drug Rasonque is now on track to achieving “one of the top oncology launches of all time,” Leerink Partners forecasted in an Oct. 5 note.

While RevMed has yet to reveal official sales figures for Rasonque, Bhardwaj agrees with Leerink and expects initial uptake to be strong. There was “substantial pre-launch clinical exposure” for the drug, she explained. “Through an expanded-access program, more than 2,000 patients had already received the drug, giving a broad group of oncologists experience with its use before commercial launch.”

RevMed has set Rasonque’s list price at $39,800 for a 30-day supply—a “substantial cost,” she told BioSpace, though through commercial insurance, some patients could pay as little as $0 out of pocket. While such steep discounts could boost uptake, they are also likely to raise payer questions “of whether the drug’s clinical benefit justifies its price.”

On this front, RevMed appears to be in good standing. In April, the Phase 3 RASolute 302 study—which supported Rasonque’s approval—showed that the drug doubled overall survival versus chemotherapy in patients with metastatic pancreatic cancer who had undergone prior treatment. Overall survival was one of the trial’s primary endpoints, alongside progression-free survival, which Rasonque also met.

“An unprecedented efficacy profile can carry a price through both the regulatory and payer gates simultaneously,” Truist’s Renza noted.

Some uncertainties remain, however. In October, the FDA released data pointing to a lower objective response rate with Rasonque in patients carrying certain KRAS mutations, including the G12D variant. Analysts remain largely unperturbed; Truist Securities at the time noted that the finding represents “a small crack in the data” for Rasonque.

Gilead to go big or go home with HIV preventative Yeztugo

Gilead has set a high bar for its twice-year HIV pre-exposure prophylactic (PrEP) therapy Yeztugo: Hit blockbuster status—or rake in $1 billion in sales—in its first full calendar year on the market.

Approved in June 2025, Yeztugo is a long-acting preventative treatment designed to be administered once every six months. The problem with such a long interval between doses is adherence: Patients may not return for their second or subsequent injections.

That doesn’t seem to be a problem yet for Yeztugo. During the pharma’s second quarter earnings call, Chief Commercial and Corporate Affairs Officer Johanna Mercier said there is a “high level of persistency” with Yeztugo: more than seven in 10 patients who were initially treated returned for their second dose. This rate is “well above other PrEP options,” Mercier claimed on the call.

Yeztugo continues to move toward its blockbuster goal for this year. In the first six months of 2026, the long-term injection made $397 million. BMO in an Oct. 9 note forecasted $282.3 million in Q3 earnings for the drug, based on script data.

In an Aug. 4 note, however, analysts at Mizuho Securities pointed out that, for the first time ever, Gilead’s PrEP portfolio crossed the $1 billion quarterly earnings mark. Yeztugo hit Q2 sales of $232 million, while Descovy, a daily preventative pill, brought in $801 million.

J&J, Protagonist race past the incumbents with oral Icotyde

Approved in March for plaque psoriasis, Johnson & Johnson and Protagonist Therapeutics’ IL-23 blocker Icotyde, designed to be taken orally daily, “breaks from the injectable model that has dominated moderate-to-severe psoriasis for two decades,” Aparna Thakur, assistant project manager at DelveInsight, told BioSpace in an email.

Top psoriasis treatments, such as AbbVie’s Humira, Novartis’ Cosentyx and J&J’s own product Stelara, require injections. There is an oral powerhouse in Bristol Myers Squibb’s Sotyktu—which Thakur calls “the leading existing oral psoriasis drug”—but this drug bowed to Icotyde in the Phase 3 ICONIC-ADVANCE 1 and 2 studies, according to a March 2025 readout.

“Early uptake has been fast,” Thakur said of Icotyde. In the third quarter, J&J reported that the pill has reached more than 20,000 patients, the pharma reported last week, though specific sales figures have not been revealed.

Icotyde’s launch is “tracking better than most/all launches in psoriatic diseases,” Tom Cavanaugh, executive VP and worldwide chairman of Innovative Medicine, said during the pharma’s earnings call.

But for Thakur, “the most important signal is who is using it.”

“About 60% of early patients had never received systemic therapy, suggesting Icotyde is expanding the market rather than simply taking patients from competing drugs,” she said.

This market expansion is particularly important for J&J as it weathers biosimilar erosion for Stelara, which in the third quarter dropped some 54% worldwide to $716 million. Stelara hit peak sales of $10.9 billion in 2023. The first Stelara biosimilar, Amgen’s Wezlana, launched in the U.S. in January 2025.

Insmed’s Brinsupri delivers ‘blowout result’ despite high price tag

Capping off this list is Insmed’s Brinsupri, which in August 2025 became the first-ever FDA-approved therapy for bronchiectasis, a chronic lung disease characterized by thickened and scarred airways.

Brinsupri costs $88,000 per year. The drug “carries a rare-disease-style price, yet bronchiectasis affects hundreds of thousands of diagnosed patients in the U.S.,” Thakur noted. Medicines for such large populations typically launch at lower prices, she explained, which helps secure broad payer coverage.

Despite premium pricing, Brinsupri has been performing well. During its first commercial quarter—Q4 2025—Brinsupri brought in $144.6 million. The drug has continued to grow, hitting $309.2 million in the second quarter, a 49% quarter-on-quarter increase.

Mizuho Securities in an Aug. 13 note said that Insmed delivered “a blowout Brinsupri result.”

The biotech expects Brinsupri to keep growing and has projected full-year sales of $1.25 billion to $1.4 billion.

For Insmed, keeping patients on Brinsupri will be crucial to meeting the blockbuster goal, Thakur said. “Brinsupri’s benefit is fewer exacerbations over time, which patients cannot feel day to day, so those with side effects or no immediate change may stop even if the drug is working,” she said. “At $88,000 a year, each early dropout removes most of a patient’s expected revenue, so persistence matters as much as new starts.”

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