The U.S. Food and Drug Administration (FDA) is expected to make approval decisions on several notable new therapies through early 2027. Each has the potential to change current treatment paradigms, displace existing therapies, or create entirely new categories of spend. For life sciences leaders, market access teams, and health economics professionals, understanding where these drugs fit in the current treatment landscape is essential. For health plan sponsors, pharmacy benefit managers, and formulary decision-makers, these potential approvals carry meaningful implications for benefit design, utilization management, and cost forecasting. Here are four pipeline drugs worth keeping an eye on.
1. CagriSema (cagrilintide and semaglutide)
Novo Nordisk | Obesity | NDA filed December 2025; FDA decision expected 2026
CagriSema is a once-weekly, fixed-dose combination injection pairing cagrilintide, an amylin analog, with semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist. It targets two distinct pathways involved in appetite regulation and energy balance. Novo Nordisk filed the New Drug Application (NDA) in December 20251 for adults with obesity or overweight with at least one weight-related comorbidity. CagriSema was once considered the single most anticipated drug launch of 2026 by projected revenue, but Barclays recently dropped its peak sales forecast from $12B to $2B based on the most recent clinical trial results released in February.2
$2 billion
CagriSema peak sales forecast
In the phase 3 REDEFINE program, CagriSema demonstrated a mean body weight reduction of approximately 22.7% in the first trial and 15.7% in a second trial over 68 weeks.3 Although these results exceeded Wegovy (semaglutide) 2.4 mg alone, the initial readout fell short of expectations for 25% or greater weight loss. The company remains confident in the program and in its broader obesity portfolio; separately, Novo Nordisk recently launched a higher-dose formulation of Wegovy (7.2 mg semaglutide, marketed as Wegovy HD), signaling continued investment in pushing the ceiling on semaglutide-based weight loss.4 If approved, CagriSema would enter a crowded class alongside Wegovy and Zepbound, as well as Eli Lilly's oral GLP-1 Foundayo, which was just approved, and is projected to generate $1.5 billion–$2.8 billion in sales this year alone.5,6 CagriSema’s dual-mechanism approach positions it as a potential premium-tier therapy. For market access teams, the key question will be whether the incremental weight loss over existing GLP-1 monotherapy justifies a higher price point, how it positions against recently approved orals and their recent price points, and how payers will differentiate it through step therapy, prior authorization, or formulary/benefit coverage.
2. Baxfendy (baxdrostat)
AstraZeneca | Hypertension | NDA accepted for Priority Review; PDUFA date expected Q2 2026
Baxfendy (baxdrostat) is a first-in-class oral aldosterone synthase (CYP11B2) inhibitor designed as an add-on therapy for adults with uncontrolled or treatment-resistant hypertension whose current medications do not provide adequate blood pressure lowering. AstraZeneca acquired Baxfendy through its $1.8 billion takeover of CinCor Pharma in early 2023, and the NDA was accepted with Priority Review by the FDA in December 2025.7
$5 billion
Baxfendy peak sales forecast
Phase 3 clinical trials demonstrated clinically meaningful systolic blood pressure reductions when Baxfendy was added to existing antihypertensive regimens. AstraZeneca sees a peak sales potential of $5 billion for Baxfendy used as an add-on agent to existing hypertension treatments, as monotherapy, and as a dual-action combination therapy with Farxiga.8 Resistant hypertension affects an estimated 12%–15% of all patients with hypertension in the United States.9 Although most antihypertensives are available as low-cost generics, Baxfendy would enter as a branded specialty product targeting patients for whom existing therapies have been ineffective. Baxfendy will not be alone in this space, as Mineralys Therapeutics submitted its rival aldosterone synthase inhibitor, lorundrostat, for FDA approval around the same time, and the competitive dynamics between the two will shape pricing and formulary strategy. Its place in therapy will depend on how it is positioned against mineralocorticoid receptor antagonists such as spironolactone, which is recommended in current guidelines but carries side effects, such as hyperkalemia, kidney function decline, and hormonal effects, that limit adherence.10,11 For health economics and outcomes research (HEOR) teams, the value proposition will hinge on whether improved blood pressure control translates to meaningful reductions in cardiovascular events and downstream healthcare costs.
3. Gedatolisib
Celcuity | HR+/HER2− Breast Cancer | PDUFA date: July 17, 2026
Gedatolisib is a potential first-in-class pan PI3K/mTOR inhibitor administered intravenously for the treatment of HR+/HER2−/PIK3CA wild-type (WT) ABC. Originally developed by Pfizer, it was licensed by Celcuity in 2021 and has since received both Fast Track and Breakthrough Therapy designations from the FDA. The NDA was submitted under the Real-Time Oncology Review (RTOR) program, and the agency has set a PDUFA goal date of July 17, 2026 after also receiving Priority Review.12
$2.5 billion
Gedatolisib peak sales forecast
In the pivotal phase 3 VIKTORIA 1 trial, the gedatolisib triplet regimen (with fulvestrant and palbociclib) demonstrated a median PFS of 9.3 months in patients with PIK3CA WT disease who had progressed on CDK4/6 inhibitors and aromatase inhibitors, compared with 2 months in those treated with fulvestrant alone.13 Unlike the current isoform-specific PI3K inhibitor alpelisib, gedatolisib inhibits all four class I PI3K isoforms and mTOR, which may broaden the treatable population and reduce the hyperglycemia that has limited the use of earlier agents in this class. Although hyperglycemia rates were relatively low at 2.3%, rates of neutropenia and stomatitis were more common at 62.3% and 19.2%, respectively, and are safety considerations that prescribers will need to weigh.14 Celcuity estimates peak annual sales of $2.5 billion, and the company has indicated that the wholesale acquisition cost is expected to be approximately $25,000, consistent with other PI3K pathway drugs.15 The company plans to commercialize gedatolisib itself in the United States and seek partners for international markets. Data in PIK3CA mutant disease, which could expand the treatable population, are expected in the first half of 2026. Its place in therapy will be shaped by how prescribers weigh the intravenous route of administration against the oral convenience of Relay Therapeutics' mutant-selective PI3K alpha inhibitor zovegalisib and other competing agents, and by payer willingness to cover combination regimens at premium price points compared to other therapies already on the market.
4. Ulixacaltamide
Praxis Precision Medicines | Essential Tremor | PDUFA date: January 29, 2027
Ulixacaltamide is a selective T-type calcium channel blocker being developed by Praxis Precision Medicines for the treatment of essential tremor. It has a novel mechanism of action that targets neuronal hyperexcitability through selective modulation of T-type calcium channels. The FDA granted Breakthrough Therapy designation in December 2025, and NDA submission occurred in February.16
$10 billion
Ulixacaltamide peak sales forecast
The development path for ulixacaltamide has been notable for its volatility. A phase 2 trial produced mixed results, and an interim futility analysis raised questions about the program's viability. However, both phase 3 trials met their primary endpoints in October 2025, validating the late-stage investment. Essential tremor affects an estimated 10 million people in the United States,17 yet only one FDA-approved treatment exists: propranolol, a generic beta blocker. This underserved population and limited competition contribute to Praxis’ estimated peak sales for ulixacaltamide of over $10 billion.18 Its place in therapy will be shaped by the strength of its clinical differentiation from propranolol and how market access teams position it, given the specialty price point. The unmet need and Breakthrough designation may support a compelling value story, but the lack of a direct clinical comparator and the low cost of the existing standard of care will require robust health economics evidence. Coverage and utilization management criteria, including how treatment failure on propranolol is defined, will be key variables in launch planning.
Action for stakeholders
The four drugs profiled here share a common thread: each enters a market where clinical differentiation alone will not determine commercial success. CagriSema faces a crowded field where the order of therapy and formulary positioning may be actively debated among manufacturers, payers, and prescribers. Baxfendy and gedatolisib must justify specialty pricing against entrenched lower-cost alternatives or complex combination regimens. Ulixacaltamide faces the challenge of establishing a new standard of care in a condition long managed by an inexpensive generic. For market access and HEOR teams, the window between now and approval is the moment to pressure-test value narratives, engage payers proactively, and develop the evidence packages and contracting terms that will define coverage outcomes. For health plan sponsors and PBMs, these approvals represent inflection points—not just in cost forecasting, but in how formulary and utilization management strategies will need to evolve to accommodate a more complex, more expensive, and increasingly competitive pipeline. Each of these therapies adds a new option for individuals whose current medical needs are not being met, and payers will need to find the right balance between providing access to these new options, ensuring appropriate use, and applying responsible cost control. With billions of dollars in projected revenue and healthcare spend at stake across these therapeutic areas, the commercial strategies deployed in 2026 will shape treatment paradigms and market dynamics well into the next decade.
1 Novo Nordisk. (2025, December 18). Novo Nordisk files for FDA approval of CagriSema, the first once-weekly combination of GLP-1 and amylin analogues for weight management. PR Newswire. Retrieved April 29, 2026, from https://www.prnewswire.com/news-releases/novo-nordisk-files-for-fda-approval-of-cagrisema-the-first-once-weekly-combination-of-glp1-and-amylin-analogues-for-weight-management-302645862.html.
2 Flick, M. (2026, February 24). Barclays slashes sales forecasts for Novo’s CagriSema by more than 80%. Reuters. Retrieved April 29, 2026, from https://www.reuters.com/business/finance/barclays-slashes-sales-forecasts-novos-cagrisema-by-more-than-80-2026-02-24/.
3 Novo Nordisk USA. (2025, June 22). CagriSema 2.4 mg / 2.4 mg demonstrated 22.7% mean weight reduction in adults with overweight or obesity in REDEFINE 1, published in NEJM [Press release]. Retrieved April 29, 2026, from https://www.novonordisk-us.com/media/news-archive/news-details.html?id=916354.
4 Novo Nordisk USA. (2026, April 7). Novo Nordisk’s Wegovy® HD available now nationwide [Press release]. Retrieved April 29, 2026, from https://www.novonordisk-us.com/media/news-archive/news-details.html?id=916529.
5 U.S. Food and Drug Administration. (2026, April 1). FDA approves first new molecular entity under national priority voucher program: Action marks the fastest approval of an NME since 2002. [News release]. Retrieved April 29, 2026, from https://www.fda.gov/news-events/press-announcements/fda-approves-first-new-molecular-entity-under-national-priority-voucher-program.
6 FirstWord Pharma. (2026, April 3). Wall Street sees multi-billion dollar debut for Lilly’s obesity pill despite Novo lead. Retrieved April 29, 2026, from https://firstwordpharma.com/story/7161536.
7 AstraZeneca. (2025, December 2). Baxdrostat New Drug Application accepted under FDA Priority Review in the US for patients with hard-to-control hypertension. Retrieved April 29, 2026, from https://www.astrazeneca.com/media-centre/press-releases/2025/baxdrostat-new-drug-application-accepted-under-fda-priority-review-in-the-us-for-patients-with-hard-to-control-hypertension.html.
8 AstraZeneca. (2026, February 10). FY and Q4 2025 results: Conference call and webcast for investors and analysts. Retrieved April 29, 2026, from https://www.astrazeneca.com/content/dam/az/PDF/2025/Q4-FY/Full-year-Q4-2025-results-presentation.pdf.
9 Carey, R.M., Calhoun, D.A., Bakris, G.L., Brook, R.D., Daugherty, S.L., Dennison-Himmelfarb, C.R., & Egan, B.M., et al. (2018, September 13). Resistant hypertension: Detection, evaluation, and management: A scientific statement from the American Heart Association. Hypertension, 72(5). e53–e90. Retrieved April 29, 2026, from https://www.ahajournals.org/doi/10.1161/HYP.0000000000000084.
10 Witham, M.D., Gillespie, N.D., & Struthers, A.D. (2004, July 27). Tolerability of spironolactone in patients with chronic heart failure – a cautionary message. British Journal of Clinical Pharmacology, 58(5), 554–557. Retrieved April 29, 2026, from https://bpspubs.onlinelibrary.wiley.com/doi/10.1111/j.1365-2125.2004.02187.x.
11 U.S. Food and Drug Administration. (n.d.). Aldactone® (spironolactone) tablets for oral use. Retrieved April 29, 2026, from https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/012151s080lbl.pdf.
12 Celucity. (2026, January 20). Celucity announces FDA acceptance of New Drug Application for Gedatolisib in HR+/HER2−/PIK3CA wild-type advanced breast cancer {Press release]. Retrieved April 29, 2026, from https://ir.celcuity.com/news-releases/news-release-details/celcuity-announces-fda-acceptance-new-drug-application.
13 Celucity. (2026, March 9). Celucity announces publication of results from PIK3CA wild-type cohort phase 3 VIKTORIA-1 study of Gedatolisib regimens in HR+/HER2− advanced breast cancer in Journal of Clinical Oncology [Press release]. Retrieved April 29, 2026, from https://ir.celcuity.com/news-releases/news-release-details/celcuity-announces-publication-results-pik3ca-wild-type-cohort.
14 Celucity. (2026, March 25). Celucity Inc. reports release of fourth quarter and full year 2025 financial results and provides corporate update [Press release]. Retrieved April 29, 2026, from https://ir.celcuity.com/news-releases/news-release-details/celcuity-inc-reports-release-fourth-quarter-and-full-year-2025.
15 Investing.com. (2026, March 25). Earnings call transcript: Celucity beats Q4 2025 EPS forecast, stock rises. Retrieved April 29, 2026, from https://uk.investing.com/news/transcripts/earnings-call-transcript-celcuity-beats-q4-2025-eps-forecast-stock-rises-93CH-4577620.
16 Praxis. (2026, February 19). Praxis Precision Medicines provides corporate update and reports fourth quarter and full-year 2025 financial results [Press release]. Retrieved April 29, 2026, from https://ir.praxismedicines.com/news-releases/news-release-details/praxis-precision-medicines-provides-corporate-update-and-18.
17 Internation Essential Tremor Foundation. (n.d.). Awareness, education, support and research for people affected by essential tremor. Retrieved April 29, 2026, from https://essentialtremor.org/.
18 Praxis. (2026, February 19). Praxis February 2026 Corporate Presentation. Retrieved April 29, 2026, from https://ir.praxismedicines.com/static-files/58c2b269-98d6-4a9f-9b5a-876900c3d945.