FDA approvals: Rasonque, Lisraya and Bixlenvo lead the Aug. 21–28 ledger
A date-bounded review of three novel drugs, Gilead's Bixlenvo combination, major label expansions and the verified portion of the FDA device ledger for Aug. 21–28, 2026.
At a glance
This issue covers FDA actions dated August 21 through August 28, 2026, within the scheduled boundary of August 21, 2026 at 17:00 through August 28, 2026 at 17:00, UTC-05:00. FDA approval tables use calendar dates, so August 21 and August 28 entries are included as date-bounded records rather than as events timed to the two publication cutoffs. The FDA novel-drug table lists three novel approvals in the period: Mimrylo, Lisraya and Rasonque. The Drugs@FDA two-week report adds Bixlenvo, a new combination, and multiple supplemental actions. 12
| Action | Product | What changed | Why it matters |
|---|---|---|---|
| Novel drug approval | Mimrylo (rusfertide) | Treatment of erythrocytosis in adults with polycythemia vera | A new hepcidin-mimetic approach for hematocrit control; FDA's table does not list a sponsor or launch terms. 1 |
| Novel drug approval | Lisraya (brepocitinib) | Treatment of dermatomyositis in adults | First approved oral targeted option in this disease, with a JAK-class boxed warning and a reported $35,000 wholesale acquisition cost. 34 |
| Novel drug approval | Rasonque (daraxonrasib) | Treatment of metastatic pancreatic adenocarcinoma in specified adults | Phase 3 median overall survival was 13.2 months versus 6.7 months with standard chemotherapy; UBS raised its price target after approval and pricing. 56 |
| Original new combination | Bixlenvo (bictegravir/lenacapavir) | Once-daily fixed-dose tablet for virologically suppressed adults with HIV-1 who meet resistance and regimen-stability conditions | It targets a defined group that may be unable to use existing single-tablet regimens; the two-day start still uses oral Sunlenca. 78 |
| Major supplemental actions | Ziihera/Tevimbra, Mounjaro, Imaavy, Sunlenca | New first-line oncology combinations, a cardiovascular-risk indication and maintenance dose, a warm autoimmune hemolytic anemia indication, and a Bixlenvo-linked loading-label change | These actions alter treatment selection or use; several other report entries have only a category-level description in the captured FDA record. 2 |
| Verified device records | BoneMRI, Cimilre Dual Max, Medtronic Percept RC supplement | Two Aug. 21 510(k) substantial-equivalence decisions and one Aug. 21 PMA 30-Day Notice | The records establish regulatory actions, while the public device surfaces do not expose a complete Aug. 22–28 item-level ledger. 91011 |
New drugs and new combinations
Mimrylo: a new option for polycythemia vera
The FDA listed Mimrylo, whose active ingredient is rusfertide, as approved on August 28 for erythrocytosis in adults with polycythemia vera (PV). PV is a blood disorder in which excess red-cell production raises blood viscosity; the treatment goal described by Takeda and Protagonist is sustained hematocrit below 45% to reduce thrombotic risk and symptoms. 112
The FDA's novel-drug table does not identify Mimrylo's sponsor. Takeda and Protagonist said in their earlier NDA announcement that Protagonist discovered rusfertide and led its development through Phase 3, while Takeda handled the U.S. regulatory strategy under a worldwide collaboration. That announcement predates the approval and supplies development-partner context rather than an approval-day sponsor field. 12
The companies' VERIFY program enrolled 293 adults with uncontrolled hematocrit despite standard care and reported better hematocrit control, fewer phlebotomies and improved patient-reported fatigue and symptom burden with rusfertide plus standard care. The same release reported injection-site reactions in 47.4% of rusfertide-treated patients, anemia in 25.6% and fatigue in 19.6%, mostly grade 1 or 2. 12
Commercial read. The approval establishes a new mechanism and a weekly self-injection opportunity in PV. The available sources give no prevalence estimate, addressable-patient count, price or approval-specific market reaction. Investors should wait for the launch terms and early uptake; clinicians should compare durable hematocrit control and injection burden with current therapy; patients and advocates should watch coverage criteria and out-of-pocket access.
Lisraya: the first oral targeted treatment for adult dermatomyositis
The FDA approved Lisraya, or brepocitinib, on August 27 for adults with dermatomyositis. The FDA describes the disease as a rare autoimmune condition affecting muscle and skin. Priovant Therapeutics is the sponsor named in the FDA announcement. 3
The approval rests on a Phase 3, randomized, placebo-controlled study of 241 adults. Participants received brepocitinib 30 mg once daily, 15 mg once daily or placebo for 52 weeks. The 30-mg dose produced a higher Total Improvement Score than placebo and made corticosteroid reduction more likely by week 48. Total Improvement Score is a composite measure of overall disease improvement across clinical assessments. 3
The safety trade-off is prominent. Lisraya carries the JAK-class boxed warning for serious infections, mortality, malignancy, major adverse cardiovascular events and thrombosis. The FDA lists upper-respiratory infection, headache, fatigue, urinary-tract infection and nausea among the common adverse reactions. 3
Roivant reported a $35,000 wholesale acquisition cost for a 30-count bottle of 30-mg tablets, immediate U.S. launch on August 28, specialty-pharmacy distribution and a support program through which eligible patients may pay as little as $0 per month. The same filing summarized literature and claims analyses estimating 23,000 to 70,000 U.S. adults with dermatomyositis and said Roivant expects U.S. exclusivity at least through 2039. Those population, price and exclusivity figures are company-reported estimates and expectations. 4
Commercial read. Lisraya gives clinicians a once-daily oral option with a steroid-sparing result, while its boxed warning makes patient selection and monitoring central to adoption. The first launch test is reimbursement for a rare-disease therapy priced at $35,000 WAC; the available filing reports no approval-specific stock-price reaction or analyst-rating change. 4
Rasonque: a first broad RAS-targeted therapy in metastatic pancreatic cancer
The FDA approved Rasonque, or daraxonrasib, on August 26 for adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or who are not candidates for multiagent systemic therapy. Revolution Medicines is the sponsor. 513
In the FDA-cited randomized, open-label Phase 3 trial of 500 adults with previously treated metastatic pancreatic adenocarcinoma, median overall survival was 13.2 months with Rasonque versus 6.7 months with standard chemotherapy. Common adverse reactions included rash, diarrhea, stomatitis, nausea, fatigue, vomiting, abdominal pain, edema, decreased appetite and hemorrhage. 5
BioPharma Dive reported a $39,800 list price for a 30-day supply, based on comments from Revolution executives. The publication also reported more than 2,000 compassionate-use recipients by early August and an RBC Capital Markets estimate of about $11.5 billion in peak annual sales. The price, patient count and sales forecast are attributed company or analyst figures. 14
The competitive question is whether Rasonque can turn broad RAS targeting into durable use beyond the approved later-line setting. BioPharma Dive reported that earlier mutation-specific KRAS drugs had reached the market without becoming large sellers, while Revolution is testing daraxonrasib in earlier pancreatic-cancer settings and in a Phase 3 non-small-cell lung cancer study. Those programs remain future opportunities rather than part of the current label. 14
Commercial read. Rasonque has the clearest approval-specific investor signal in this issue. Investing.com reported that UBS kept a Buy rating and raised Revolution's price target from $220 to $265 after approval and pricing; the same article reported other analyst targets ranging from $179 to $280 among named firms. These are reported analyst actions, not an independent valuation. 6
Bixlenvo: a single tablet for a defined HIV treatment problem
The FDA approved Bixlenvo, a fixed-dose tablet containing bictegravir 75 mg and lenacapavir 50 mg, on August 27 as a complete regimen for adults with HIV-1 whose virus is suppressed below 50 copies of HIV RNA per milliliter on a stable regimen, with no known or suspected resistance to either component. Gilead Sciences is the company listed on the FDA application record. 715
Bixlenvo changes the maintenance regimen while preserving a two-day initiation step: patients take Bixlenvo with oral Sunlenca tablets on days 1 and 2, then take Bixlenvo once daily from day 3. Gilead's ARTISTRY-1 and ARTISTRY-2 results showed comparable maintenance of virologic suppression at week 48 after switching from complex regimens or Biktarvy, according to the company's approval announcement. The FDA approval letter requires postmarketing pediatric studies and a resistance study, so long-term use in children and resistance surveillance remain open obligations. 815
Reuters reported that about 5% of people living with HIV in the United States take complex regimens involving more than one tablet a day, citing Gilead. The company also reported a $4,595 wholesale acquisition cost for a 30-day supply through coverage of the launch. The estimate and price are attributed to Gilead or its spokesperson. 16
Commercial read. Bixlenvo's addressable opportunity is narrower than the overall U.S. HIV-treatment market because patients need virologic suppression and component-level susceptibility. The product's commercial test is whether the smaller tablet and one-pill maintenance regimen justify switching from effective alternatives, while clinicians must preserve the two-day Sunlenca loading step and screen drug interactions. The available sources report no approval-specific analyst action for Gilead.
Label and efficacy actions
Ziihera and Tevimbra: two first-line HER2-positive combinations
On August 25, the FDA approved zanidatamab-hrii (Ziihera, Jazz Pharmaceuticals) with tislelizumab-jsgr (Tevimbra, BeOne Medicines USA) and fluoropyrimidine- and platinum-containing chemotherapy as first-line treatment for adults with unresectable locally advanced or metastatic gastric, gastroesophageal junction or esophageal adenocarcinoma that is HER2-positive by an FDA-approved test. The FDA also approved Ziihera with chemotherapy alone for the IHC 3+ subgroup. Two companion diagnostic devices from Ventana Medical Systems/Roche identify the relevant HER2-positive patients. 17
In HERIZON-GEA-01, the Ziihera-plus-Tevimbra arm had median overall survival of 26.4 months versus 19.2 months with trastuzumab plus chemotherapy, and median progression-free survival of 12.4 months versus 8.1 months. The Ziihera-plus-chemotherapy arm improved progression-free survival; its interim overall-survival result was not statistically significant at the analysis cited by FDA. Ziihera carries a boxed warning for diarrhea and embryo-fetal toxicity, while Tevimbra carries immune-mediated and infusion-related warnings. 17
Commercial read. The label creates two biomarker-defined first-line routes and ties uptake to HER2 testing and chemotherapy capacity. Investing.com reported that Jazz shares rose 2.3% after the approval and cited an estimate that about 20% of gastroesophageal adenocarcinoma patients are HER2-positive; the article's separate current-quote display showed a different move, so the 2.3% figure should be read as reported approval-day reaction rather than a live quote. 18
Mounjaro: cardiovascular-risk reduction and a maintenance dose
FDA approved two Mounjaro supplements for Eli Lilly on August 27. SUPPL-44 added an indication to reduce the risk of major adverse cardiovascular events, meaning cardiovascular death, nonfatal myocardial infarction or nonfatal stroke, in adults with type 2 diabetes at high risk for those events. SUPPL-45 added the 2.5-mg dose as an option for ongoing glycemic control. The approval letter also updated warnings and precautions about diabetic-retinopathy complications based on the SURPASS-CVOT trial. 19
Commercial read. The cardiovascular indication gives prescribers a labeled outcome beyond glucose control, while the 2.5-mg maintenance option changes how some patients may remain on therapy. The FDA letter provides no incremental patient count, price or approval-specific market reaction, so the commercial effect remains a question for Lilly's prescribing and reimbursement data. 19
Imaavy: a second immune-mediated blood disorder indication
The FDA approved an August 24 efficacy supplement for Imaavy (nipocalimab-aahu), sponsored by Janssen Biotech, and the revised label adds warm autoimmune hemolytic anemia (wAIHA) for adults and children 12 years and older who are currently or previously treated with corticosteroids. Imaavy already carried an indication for generalized myasthenia gravis in antibody-positive adults and patients 12 years and older. 2021
The revised label uses different infusion schedules for the two diseases: generalized myasthenia gravis receives a loading dose followed by maintenance every two weeks, while wAIHA receives a loading dose followed by dosing every four weeks. Both uses require intravenous infusion, dilution and infection and hypersensitivity monitoring. 21
Commercial read. The supplement expands the use of an existing Fc-receptor blocker into a second rare immune-mediated disease and may improve treatment-center utilization. The FDA materials provide no price, prevalence or approval-specific investor reaction; clinicians need to distinguish the wAIHA schedule from the gMG schedule when evaluating the label.
Sunlenca: the label change that makes Bixlenvo's start work
FDA approved Sunlenca SUPPL-24 on August 27 for labeling updates covering oral Sunlenca tablets as the loading component of the initiation regimen with bictegravir/lenacapavir fixed-dose tablets in virologically suppressed adults. The change is a clinical-use companion to Bixlenvo's new approval rather than a separate new antiviral indication. 22
Commercial read. Gilead now has to launch two products as one treatment start: Bixlenvo for maintenance and Sunlenca tablets for days 1 and 2. Clinicians and pharmacists should treat the loading step as part of the approved regimen, while investors should track whether the added initiation complexity affects switching.
Other captured NDA and BLA actions
The FDA's two-week report warns that late approvals may be added to Drugs@FDA after the report period and directs readers to the monthly All Approvals report for comprehensive reporting. The rows below preserve the actions captured in this run without assigning a clinical change that the available record does not describe. 2
| Date | Product and application | FDA action captured | Reader interpretation |
|---|---|---|---|
| Aug. 27 | Ozempic, NDA 209637 | SUPPL-44, labeling | The captured report gives the category and date; the exact label change is pending direct review. 2 |
| Aug. 27 | Ultratag, NDA 019981 | SUPPL-11, manufacturing/CMC | A chemistry, manufacturing and controls action; the captured record gives no new indication. 2 |
| Aug. 26 | Gattex Kit, NDA 203441 | SUPPL-28, REMS | A risk-management action; the captured record gives no new indication. 2 |
| Aug. 26 | Vobrig, NDA 213225 | ORIG-1, Type 5 new formulation or new manufacturer | An original application record with a formulation or manufacturing change; the captured report gives no indication detail. 2 |
| Aug. 26 | Zepbound, NDA 217806 | SUPPL-41, efficacy; also repeated under autoinjector and Kwikpen records | The captured report does not state the efficacy change. 2 |
| Aug. 25 | Tivicay, NDA 204790; Tivicay PD, NDA 213983 | SUPPL-34 and SUPPL-7, efficacy | The captured report does not state the efficacy changes. 2 |
| Aug. 25 | Benlysta, BLAs 125370 and 761043 | SUPPL-90 and SUPPL-39, labeling | The captured records establish labeling actions; the exact change was unavailable in the detail captured for this issue. 23 |
Medical devices
Verified Aug. 21 records
The FDA record for BoneMRI, 510(k) K260584, lists Mriguidance B.V. as applicant and an August 21 decision of substantially equivalent. The record classifies it under product code QIH as automated radiological image processing software. The public record captured here gives no intended-use statement, predicate-device detail, clinical data or commercial information. 9
The FDA record for Cimilre Dual Max, 510(k) K260643, lists Cimilre Co., Ltd. as applicant and an August 21 decision of substantially equivalent. The record classifies it under product code HGX as a powered breast pump in obstetrics and gynecology. The public record gives no clinical or commercial data and does not specify the predicate device in the captured text. 10
The FDA also lists Medtronic's P960009 S543 action on August 21 for the Percept RC deep-brain-stimulation implantable neurostimulator family. The action is a 30-Day Notice covering a manufacturer, sterilizer, packager or supplier process change. It is a PMA supplement, not a new original PMA approval; the record identifies the device's generic use as an implanted electrical stimulator for parkinsonian tremor. 11
Commercial read. The two 510(k) decisions establish regulatory entry points for a radiology software product and a powered breast pump, but the public records provide too little intended-use, clinical or market detail to estimate adoption or revenue. The Medtronic record changes a process in an existing PMA family; it should not be counted as a new implantable-neurostimulator approval.
The device ledger remains incomplete for Aug. 22–28
The FDA 510(k) landing page captured in this run was last updated August 24 and displayed no current-week decision results. The FDA PMA landing page was last updated August 17 and displayed no August 21–28 decision records. The directly verified detail pages above establish three August 21 actions, while the public landing and downloadable surfaces did not expose a complete item-level ledger for August 22–28. This issue therefore reports a captured official ledger, not a claim that no other device decisions occurred. 2425
Commercial read across the week
Four patterns matter for different readers:
- Rasonque has the strongest near-term valuation signal. The FDA trial provides a survival comparison in a difficult later-line cancer, while the reported $39,800 monthly list price and UBS price-target increase create a clear launch and valuation test. The price and forecast remain attributed figures. 56
- Lisraya pairs a rare-disease launch with a high monitoring burden. Roivant's reported population and price support a focused specialty-pharmacy launch, while the JAK boxed warning makes safety screening and follow-up part of the product's adoption case. 34
- Bixlenvo's market is defined by regimen complexity, resistance history and the two-day Sunlenca start. The approval simplifies maintenance for an eligible group, but the group is smaller than the overall treated HIV population. 1516
- HER2 testing becomes a commercial gate for Ziihera-based first-line care. The survival signal applies to biomarker-defined gastroesophageal cancers, and the FDA approved companion diagnostics alongside the treatment combinations. 17
What matters next
- Rasonque launch evidence: Follow net price, early treated-patient counts, time to treatment and real-world safety. Those measures will test whether the reported price and analyst sales forecasts translate into use. 14
- Lisraya access and safety: Watch payer coverage, specialty-pharmacy onboarding and the extent to which the boxed-warning risks affect treatment selection in adults with dermatomyositis. 34
- Bixlenvo implementation: Check whether clinics and pharmacies reliably deliver the Sunlenca initiation tablets, and track the postmarketing resistance and pediatric studies required in the approval letter. 15
- Ziihera testing and treatment capacity: Monitor HER2 test turnaround, companion-diagnostic use and the real-world delivery of the three-drug-plus-chemotherapy regimen. 17
- Device database refresh: Recheck CDRH's 510(k) and PMA records for Aug. 22–28 additions before treating this week's device count as final. 2425
References
- 1
- 2Drugs@FDA: FDA Approved Drug Products
accessdata.fda.gov
- 3
- 4Roivant Sciences Ltd. Reports Material Event
stocktitan.net
- 5
- 6UBS raises Revolution stock price target to $265 on drug pricing
ca.investing.com
- 7NDA 221104 Drugs@FDA record
accessdata.fda.gov
- 8U.S. FDA approves Gilead's Bixlenvo
gilead.com
- 9BoneMRI 510(k) K260584
accessdata.fda.gov
- 10Cimilre Dual Max 510(k) K260643
accessdata.fda.gov
- 11Medtronic Percept RC PMA supplement P960009S543
accessdata.fda.gov
- 12
- 13Rasonque FDA application record
accessdata.fda.gov
- 14Revolution's daraxonrasib wins FDA approval
biopharmadive.com
- 15Bixlenvo NDA approval letter
accessdata.fda.gov
- 16
- 17
- 18Jazz rises after Ziihera approval
investing.com
- 19Mounjaro supplement approval letter
accessdata.fda.gov
- 20Imaavy Drugs@FDA record
accessdata.fda.gov
- 21Imaavy prescribing information revised August 2026
accessdata.fda.gov
- 22Sunlenca supplement approval letter
accessdata.fda.gov
- 23Benlysta 2026 label
accessdata.fda.gov
- 24FDA 510(k) Premarket Notification
accessdata.fda.gov
- 25FDA Premarket Approval database
accessdata.fda.gov
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