Here's your full roundup of what's been moving in clinical trials, FDA decisions, M&A, and policy.
FDA Drug Approvals
Keytruda / Keytruda Qlex (pembrolizumab) — Ovarian Cancer: The biggest oncology approval of the period. The FDA approved Keytruda and Keytruda Qlex in combination with paclitaxel, with or without bevacizumab, for adults with PD-L1+ platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma who have received one or two prior treatment regimens. Based on the Phase 3 KEYNOTE-B96 trial, the regimen reduced the risk of disease progression or death by 28% and the risk of death by 24% vs. placebo. This is the first PD-1 inhibitor ever approved for this population — a population that historically had almost nothing after platinum failure. A big moment for the field. FDA Link | Merck Press Release
Adquey (difamilast 1% ointment): Approved February 12, 2026 for mild-to-moderate atopic dermatitis in adults and pediatric patients aged 2 and older. A novel non-steroidal topical PDE4 inhibitor from Acrotech Biopharma and Otsuka — the third PDE4 inhibitor in this class, joining crisaborole and roflumilast. No application-site stinging issue that plagued earlier entrants, and a strong Phase III IGA success rate. FDA Approval Letter | Acrotech Press Release
Filkri (filgrastim-laha): Approved February 17, 2026 as a biosimilar to Neupogen for neutropenia across multiple oncology and radiation settings. Accord BioPharma's sixth biosimilar approval — part of a stated push to build one of the deepest biosimilar portfolios in the industry. More competition, more access, lower costs. The biosimilar engine keeps running. Accord BioPharma Press Release
Bysanti (milsaperidone): Approved February 20, 2026 for acute bipolar I disorder and schizophrenia in adults. Vanda Pharmaceuticals' new chemical entity that rapidly interconverts to iloperidone — a pharmacokinetic bridging strategy that allowed the FDA review to leverage 100,000+ patient-years of iloperidone real-world data. Commercial availability expected Q3 2026, with a Phase 3 MDD adjunctive study reading out by year-end. Vanda Press Release
Loargys (pegzilarginase-nbln): FDA granted accelerated approval February 23, 2026 to Immedica Pharma's enzyme replacement therapy for hyperargininemia in patients aged 2 and older with Arginase 1 Deficiency — an ultra-rare metabolic disorder affecting only an estimated 250 patients in the U.S. First and only therapy proven to lower plasma arginine. Expected to be commercially available in April 2026. FDA Approval Letter | Immedica Press Release
Desmoda (desmopressin acetate oral solution): Approved February 25, 2026 for central diabetes insipidus across all ages. A new formulation of a well-established molecule — important for patients who can't use intranasal or injectable routes. Source
Summary Table: Recent FDA Actions (Feb 12 – Mar 13, 2026)
| Brand Name | Active Ingredient | Company | Indication | Approval Date |
|---|---|---|---|---|
| Keytruda / Keytruda Qlex | Pembrolizumab | Merck | Platinum-Resistant Ovarian Cancer (PD-L1+) | 10-Feb-2026 |
| Adquey | Difamilast 1% | Acrotech / Otsuka | Atopic Dermatitis | 12-Feb-2026 |
| Filkri | Filgrastim-laha | Accord BioPharma | Neutropenia (Biosimilar to Neupogen) | 17-Feb-2026 |
| Bysanti | Milsaperidone | Vanda | Schizophrenia / Bipolar I | 20-Feb-2026 |
| Loargys | Pegzilarginase-nbln | Immedica | Arginase 1 Deficiency | 23-Feb-2026 |
| Desmoda | Desmopressin acetate | — | Central Diabetes Insipidus | 25-Feb-2026 |
M&A Deals
Servier acquires Day One Biopharmaceuticals: $2.5 billion (Announced March 6, 2026). An all-cash deal expected to close Q2 2026, adding Day One's pediatric low-grade glioma program to Servier's rare oncology portfolio. Servier is foundation-governed rather than shareholder-driven, which makes this a notably long-term bet rather than a near-term commercial play. Source
GSK licenses linerixibat to Alfasigma: up to $690 million (Announced March 9, 2026). GSK out-licenses its cholestatic pruritus drug for primary biliary cholangitis to Italian pharma Alfasigma — $300M upfront and $100M on approval, with a PDUFA date of March 24. It's always interesting when a company licenses away an asset days before a decision. Watch this one for context after the 24th. Source
Clinical Trial Setbacks
Claseprubart (CIDP) — Dianthus Therapeutics: Interim responder analysis results from the Phase 3 CAPTIVATE trial in chronic inflammatory demyelinating polyneuropathy came in on March 9, 2026. The data were mixed enough to keep investors on edge, though the company still has a full Phase 3 readout ahead and substantial cash runway into 2028. Source
North American Enrollment — A Brewing Regulatory Problem: Worth flagging as a trend: FDA's ODAC recently voted 8–1 against the applicability of the STARGLO trial's results to the US population, in large part because less than 5% of patients enrolled were from the United States. Regulators are increasingly scrutinizing multinational datasets that lack meaningful US representation. This isn't one failure — it's a pattern that could create late-stage approval risk for sponsors who rely heavily on ex-US enrollment. A conversation the industry needs to have now, not at submission. Source
Macro: The NIH Funding Disruption Is Real and Getting Bigger
This deserves its own section because it's affecting our world directly. A new analysis published in JAMA Internal Medicine found that NIH grant terminations have disrupted 383 clinical trials — about 1 in 30 of all active NIH-funded studies — affecting over 74,000 enrolled patients and representing $1.81 billion in lost funding. Infectious disease trials were hit hardest (14.4% terminated), followed by prevention-focused and behavioral intervention studies. The Northeast and globally-sited trials bore disproportionate impact. Source — AJMC
As one researcher put it: "Clinical trials aren't light switches. You can't just flip them off without consequences." The human cost is immediate; the scientific cost — missed evidence, disrupted longitudinal data, broken patient trust — compounds over years. Sponsors running trials with NIH co-funding or academic partnerships need to be actively pressure-testing their continuity plans right now.
Trials to Watch in the Coming Weeks
A few high-stakes readouts are imminent:
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Orforglipron (Eli Lilly): March PDUFA date for this once-daily oral GLP-1. If approved, the pricing decision will set the tone for the entire oral obesity drug market. Oral GLP-1s are expected to capture roughly 20% of an $80B+ category by 2030 — how Lilly prices this one matters for everyone downstream. Source
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Linerixibat (Alfasigma, formerly GSK): PDUFA March 24. First-in-class IBAT inhibitor for cholestatic pruritus in primary biliary cholangitis. The GSK-to-Alfasigma licensing deal announced March 9 added some intrigue to what was already a closely watched decision.
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Pelacarsen (Novartis/Ionis): Phase 3 Lp(a)HORIZON data expected H1 2026. At least one analyst has called this the "biggest biotech event of the entire year" — if successful, it could establish Lp(a) as a mainstream cardiovascular treatment target and open up an entirely new drug class. Source
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Remternetug (Eli Lilly, Alzheimer's): Top-line Phase 3 TRAILRUNNER-ALZ 1 data expected H1 2026. Lilly's next anti-amyloid antibody after donanemab — the Alzheimer's pipeline pressure is real and building.
The Big Picture
Three themes dominate this period.
The NIH funding situation is a structural risk, not a one-off. Sponsors, CROs, and sites that relied on federal co-funding need to redesign for resilience — politically-driven trial terminations mid-stream are now a real operational scenario, not a theoretical one.
Ovarian cancer finally has an immunotherapy option. The Keytruda approval in platinum-resistant disease closes a long-standing gap. The fact that this is the first positive IO trial in the space after years of failures is worth appreciating — it took the right trial design, the right population selection, and a companion diagnostic to make it work.
M&A remains aggressive and well-funded. The Servier and GSK deals this period are consistent with what the broader industry is projecting: 20+ acquisitions over $1B in 2026, driven by the patent cliff bearing down on most of the top 12 pharma companies. Rare oncology and CNS assets continue to command the highest premiums. Source
Quick Links
Clinical Trials Dashboard: https://lebolger.github.io/Intellitrials/2026dashboard.html
M&A Tracker: lebolger.github.io/Intellitrials/docs/mnatracker.html
FDA Approvals: https://lebolger.github.io/Intellitrials/fda-approvals.html
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