Last updated: September 1, 2026
The White House announced most favored nation pricing agreements with nine more drugmakers on August 31, 2026: Alcon, Astellas, BeOne, BridgeBio, CSL, Kyowa Kirin, Sun Pharma, Teva and UCB. None of the publicly named Midsized Biotech Alliance members signed, Teva describes its deal as an intent to agree, and Eli Lilly separately agreed to buy Merida Biosciences for up to $2.875 billion.
This page covers the second round of most favored nation (MFN) drug pricing agreements announced August 31, 2026, what the nine companies actually committed to in their own words, Eli Lilly’s acquisition of Merida Biosciences, the BioMarin and Ascendis Yuviwel settlement, the ESC Congress data from Arrowhead and AstraZeneca, Jazz’s second overall survival readout for Ziihera, the FDA approval of Besremi in essential thrombocythemia, and Monday’s log of delivered catalysts and sponsor closes.
Which nine companies signed MFN drug pricing deals on August 31, 2026?
The White House fact sheet names Alcon, Astellas Pharma, BeOne Medicines, BridgeBio, CSL, Kyowa Kirin, Sun Pharma, Teva Pharmaceuticals and UCB, bringing the total to 26 manufacturers that the administration says cover 89% of the branded drug market, with a collective $19.6 billion US manufacturing investment pledge.
Those are the government’s figures and framing. The company side reads differently company by company, which is why the table below pairs each name with what its own release says. Only BridgeBio is headquartered in the United States. The rest are Swiss, Japanese, Indian, Israeli, Australian and Belgian companies with US operations, which is a different population from the one Bloomberg described on August 26 when it reported that midsize biotech deals were coming as soon as Monday.
| Company | Headquarters | What the company’s own release says (August 31, 2026) | What the White House fact sheet adds |
|---|---|---|---|
| BridgeBio Pharma | Palo Alto, California | Attruby (acoramidis) enters Medicaid through the GENEROUS Model; Attruby continues in Medicare Part D; the company “does not expect to be subject to future pricing mandates”; terms confidential | Listed as a signatory; no company specific terms |
| BeOne Medicines | Basel, Switzerland (China founded) | GENEROUS participation; future FDA approved products priced in line with other developed markets; Section 232 tariff exemption tied to an onshoring agreement; additional $300 million at Hopewell, New Jersey; more than $1 billion total US manufacturing; about 120 jobs | Listed as a signatory |
| Teva Pharmaceuticals | Tel Aviv, Israel | “Intent to reach agreement” and “active discussions”; GENEROUS Medicaid alignment for select medicines “when finalized”; prospective MFN commitment on future launches; an API reserve; conditions confidential | Counted among the nine; 45 metric tons of metronidazole and 4.8 tons of amlodipine to the strategic API reserve |
| CSL | Melbourne, Australia | Per Fierce Healthcare, CSL tied its agreement to the $1.5 billion Kankakee, Illinois immunoglobulin expansion announced in March 2026; CSL’s Diego Sacristan called it “a sustainable and stable access framework” | Listed as a signatory |
| UCB | Brussels, Belgium | No terms fetched | 163 tons of levetiracetam to the strategic API reserve |
| Sun Pharma | Mumbai, India | No terms fetched | 71.4 tons of clindamycin and 6.75 tons of doxycycline to the reserve |
| Astellas Pharma | Tokyo, Japan | No terms fetched | 25 kilograms of tacrolimus to the reserve |
| Kyowa Kirin | Tokyo, Japan | No terms fetched | Listed as a signatory |
| Alcon | Geneva, Switzerland | No terms fetched | Listed as a signatory (eye care: glaucoma, macular degeneration named among covered categories) |
Sources for the table: the White House fact sheet of August 31, 2026, and the BridgeBio, BeOne and Teva releases of the same date. The comparator country list (Canada, Denmark, France, Germany, Italy, Japan, Switzerland and the United Kingdom) is per Fierce Pharma; the fact sheet does not print it. Patients For Affordable Drugs noted the same day that the prices, duration, enforcement mechanism and concessions have not been made public, and that state participation is optional.
Did any Midsized Biotech Alliance members sign the MFN deals?
No. Fierce Pharma reported that none of the alliance’s original members appear in the round, and the two names most in frame from the August 26 Bloomberg report, Alnylam and BioMarin, are absent from the White House list. No statement from either company on the round surfaced in our search on the evening of August 31.
That matters because the alliance formed in February 2026 specifically to argue that midsize companies cannot absorb MFN pricing the way large pharma can. The incentive structure has not changed: an April Bloomberg report, carried by Fierce, described a planned 100% tariff on imported drugs with exemptions for companies holding MFN agreements, and the GENEROUS Medicaid opt in deadline is September 30. What the August 31 round shows is who accepted those terms first, and it was companies with foreign parents, existing US plants and mature products, plus one US biotech with a single approved product in a disease where the reference country prices are already set.
How does the second MFN round compare with the first?
Round one ran from Pfizer on September 30, 2025 to Regeneron in April 2026 and covered 17 large companies. Round two took four months to assemble, covers nine smaller companies, and adds strategic API reserve contributions as a new deal component that did not feature in the round one announcements.
| Feature | Round one (Sept 2025 to April 2026) | Round two (August 31, 2026) |
|---|---|---|
| Companies | 17 (Pfizer first; Regeneron last) | 9 |
| Typical signatory | Global large cap pharma | Foreign midcap pharma and specialty companies plus one US biotech |
| Medicaid MFN pricing | Yes | Yes (GENEROUS Model) |
| Prospective MFN on new launches | Yes | Yes (BeOne and Teva language) |
| Tariff relief | Yes (three year suspensions reported) | Yes (Section 232 exemption; BeOne explicit) |
| US manufacturing pledges | Yes, company by company | $19.6 billion collective; only BeOne ($300 million) and CSL ($1.5 billion, previously announced) itemized in company or trade sources |
| Strategic API reserve contributions | Not a feature | New: UCB, Sun, Teva, Astellas |
| Medicare impact | Limited | Not released (STAT); BridgeBio says it does not expect future pricing mandates |
What did Eli Lilly agree to pay for Merida Biosciences?
Lilly will pay up to $2.875 billion in cash, split between an upfront payment and contingent milestones that the company did not break out, for Merida Biosciences of Cambridge, Massachusetts, whose lead program MER511 is in Phase 1 for Graves’ disease and thyroid eye disease. The deal is expected to close in the fourth quarter of 2026.
MER511 is a biologic designed to selectively degrade the pathogenic thyroid stimulating autoantibodies that drive Graves’ disease, leaving the rest of the antibody repertoire alone. Lilly’s release says initial Phase 1 data showed “robust reductions in pathogenic thyroid stimulating antibodies with a favorable initial safety profile.” The Phase 1 started in December, per Fierce Biotech. MER769, a preclinical program aimed at IgE mediated disease (food allergy, asthma, chronic spontaneous urticaria), and earlier kidney programs in membranous nephropathy come with it. Merida left stealth in 2025 with $121 million from Third Rock Ventures, per Fierce.
| Term | Detail (Lilly release, August 31, 2026) |
|---|---|
| Total consideration | Up to $2.875 billion, cash |
| Upfront versus milestones | Both present; split not disclosed |
| Lead asset | MER511, Phase 1, Graves’ disease and thyroid eye disease; selective autoantibody degrader |
| Other programs | MER769 (preclinical, IgE mediated allergy); membranous nephropathy and other immune kidney diseases |
| Close | Q4 2026, subject to regulatory approvals |
| Merida | Cambridge, Massachusetts; CEO Adam Townsend; founder and CSO Dario Gutierrez; Third Rock backed |
On the binary ledger this is column six entry eleven, and like Lilly’s Amplitude deal it lands in the “undisclosed split” bucket, which means it cannot be placed on the cash share curve. The curve so far runs from about 4% cash at the platform stage (Genentech and DualityBio) to about 50% at the registrational stage (Biohaven and SK). A Phase 1 asset with a full buyout structure sits somewhere between the 8% Genentech paid Hanmi for a Phase 1 obesity program and the registrational tier, but without the split it is a range, not a point.
What are the terms of the BioMarin and Ascendis Yuviwel settlement?
Under a binding term sheet announced August 30 and 31, 2026, Ascendis Pharma will pay BioMarin a 20% royalty on Yuviwel (navepegritide) net sales in the United States, retroactive to first commercial sale, and 18% in the European Union, Brazil and South Korea, through May 20, 2030, in exchange for a license to BioMarin’s patents for all current and potential indications, including achondroplasia and hypochondroplasia.
The settlement dismisses the US International Trade Commission Section 337 investigation, the Northern District of California case and litigation in Brazil, Denmark, Germany and South Korea. No upfront payment was disclosed. Ascendis reiterated its guidance of more than €500 million in 2026 operating cash flow and €5 billion in 2030 revenue. Per Fierce Pharma, Yuviwel was approved in February 2026, generated €8 million in the second quarter after an April launch, and 90% of BioMarin’s US patients were still on Voxzogo in July; Jefferies estimated $280 million in US and $440 million in ex US royalties through 2030.
| Term | Detail (BioMarin and Ascendis releases) |
|---|---|
| US royalty | 20% of Yuviwel net sales, retroactive to first commercial sale |
| EU, Brazil, South Korea royalty | 18% of net sales |
| Term | Through May 20, 2030 |
| Scope | All current and potential indications, including hypochondroplasia; combination use |
| Cases dismissed | ITC Section 337; N.D. California; Brazil; Denmark; Germany; South Korea |
| Structure | Binding term sheet; definitive agreement to follow, timing not given |
| Closes Aug 31 | BMRN $65.23 (+0.9%); ASND $263.04 (+6.1%) |
What did Arrowhead’s plozasiran show at ESC 2026 that the July topline did not?
The full SHASTA-3 and SHASTA-4 presentation on August 30 added the acute pancreatitis rate ratio (0.22, 95% CI 0.07 to 0.67, p=0.008), the absolute risk reduction (4.1%, number needed to treat 24), the safety table and the glycemic control signal (14.3% versus 8.7%). The headline triglyceride reductions of 79% and 81% and the 78% and 100% pancreatitis reductions were all disclosed in the July 22 topline.
| Measure | July 22 topline | ESC 2026 full data (August 30) |
|---|---|---|
| Patients randomized | Not itemized | 757 across both trials |
| Dose | 25 mg SC every three months | Same; four doses over 12 months |
| Median TG reduction, month 12 | 79% (SHASTA-3), 81% (SHASTA-4) | Same, p<0.0001; placebo about 27% |
| TG below 500 mg/dL | Not disclosed | 91% and 93% versus 51% and 50% |
| TG below 150 mg/dL | Not disclosed | 52% and 55% versus 7.9% and 2.0% |
| Acute pancreatitis, pooled | 78% reduction | RR 0.22 (0.07 to 0.67), p=0.008; ARR 4.1%; NNT 24; first event HR 0.26 |
| High risk subgroup (TG ≥500 with prior AP) | Not disclosed | 91% reduction; ARR 34%; NNT 3 |
| Highest risk (TG >880 with prior AP) | 100% reduction | Same |
| TEAEs / serious TEAEs | “No new safety signals” | 73% both arms; 8.3% versus 10% |
| Worsening glycemic control | Not disclosed | 14.3% versus 8.7% |
| Hypersensitivity, liver | None; no meaningful LFT change | No anaphylaxis; no Hy’s law; hepatic fat p=0.70 |
| Deaths | Not disclosed | Three on plozasiran, attributed to preexisting conditions |
| Filing | sNDA planned | sNDA before end 2026 with the priority review voucher bought August 4 |
| ARWR close | $88.59 (Aug 27) | $84.91 (Aug 28) to $82.39 (Aug 31, −3.0%) |
Analyst readings diverged on the glycemic signal. Stifel called the profile “arguably best in class,” Cantor’s Prakhar Agrawal said plozasiran looked safer than Ionis’s Tryngolza across several metrics, and BMO favored Tryngolza on the diabetes comorbidity question, per BioSpace and BioPharma Dive. Tryngolza’s roughly 7% hypersensitivity and 7% liver enzyme rates are BioSpace’s figures.
What did Jazz report from the second interim analysis of HERIZON-GEA-01?
Jazz said on August 31 that Ziihera (zanidatamab-hrii) plus chemotherapy, without tislelizumab, produced a statistically significant and clinically meaningful overall survival improvement over trastuzumab plus chemotherapy at the second interim analysis, with the hazard ratio improved from the first interim. The company disclosed no hazard ratio, median or p value and has submitted the data to a medical meeting in the fourth quarter of 2026.
| Comparison (versus trastuzumab plus chemo) | First interim (NEJM, May 27, 2026) | Second interim (August 31, 2026) |
|---|---|---|
| Ziihera + tislelizumab + chemo, OS | 26.4 versus 19.2 months; HR 0.72; significant | Not restated |
| Ziihera + tislelizumab + chemo, PFS | 12.4 versus 8.1 months; HR 0.63 | Not restated |
| Ziihera + chemo, OS | Median “more than two years”; not significant; second interim guided mid 2026 | Statistically significant; HR “improved”; no numbers |
| Ziihera + chemo, PFS | 12.4 versus 8.1 months; HR 0.65 | Not restated |
| FDA label (August 25, 2026) | Triplet for IHC 3+ and IHC 2+/ISH+; doublet for IHC 3+ | |
| JAZZ close | $244.54 (Aug 28) | $250.68 (Aug 31, +2.5%) |
This is the fourth positive readout in two weeks disclosed without an effect size, after INTerpath-001, HARMONi-GI1 and CROSSING. It is also the only one of Monday’s delivered events whose sponsor closed higher.
What did the FDA approve Besremi for on August 31, 2026?
The FDA approved PharmaEssentia’s Besremi (ropeginterferon alfa-2b-njft) for adults with essential thrombocythemia regardless of genotype or disease status, including newly diagnosed patients who have never received cytoreductive therapy. The company calls it the first new FDA approved treatment for ET in nearly three decades; the target action date had been August 30, a Sunday.
The approval release says Besremi “achieved superior durable response rates compared with anagrelide and reduced thromboembolic events over 12 months” in the Phase 3 SURPASS-ET trial but prints no numbers. At acceptance in January, CancerNetwork reported the trial enrolled 91 patients on ropeginterferon and 83 on anagrelide with modified ELN response rates of 42.9% versus 6.0% (p=0.0001); Fierce Pharma cited 43% versus 6% at months nine to twelve and an ET population of roughly 148,000 in the United States. Besremi has been approved in polycythemia vera since 2021 and is PharmaEssentia’s only commercial product; the company is listed in Taiwan, so it has no US close to log.
| Item | Detail |
|---|---|
| Indication | Adults with essential thrombocythemia, any genotype or disease status, including cytoreduction naive |
| Trial | SURPASS-ET, Phase 3, open label, randomized, anagrelide controlled (NCT04285086) |
| Primary endpoints | Durable modified ELN response; durable hematologic control |
| Response (attributed) | 42.9% versus 6.0%, p=0.0001 (CancerNetwork, January 2026); 43% versus 6% (Fierce Pharma) |
| Target action date | August 30, 2026 (CancerNetwork); approval announced August 31 |
| Boxed and serious risks (release) | Neuropsychiatric, autoimmune, ischemic and infectious disorders |
| Prior indication | Polycythemia vera (2021); BESREMi Pen approved June 2026 |
Which catalysts were delivered on August 31, 2026, and how did the sponsors close?
Seven US traded sponsors delivered a promised or dated event on Monday and one closed higher. The log below continues the tally promised in Monday’s edition, with exchange closes from August 28 to August 31.
| Delivered event | Who set the date | Headline | What the primary document says | Sponsor close, Aug 28 to Aug 31 |
|---|---|---|---|---|
| MFN midsize round | Bloomberg (“as soon as Monday”) | Nine midsize drugmakers sign | Nine names, none from the alliance; one US biotech; Teva calls it an intent to agree | BBIO $76.60 to $76.59 (flat); TEVA $36.44 to $36.05 (−1.1%); ONC $366.73 to $359.58 (−1.9%); UCB $35.18 to $34.84 (−1.0%) |
| Arrowhead SHASTA-3 and SHASTA-4 at ESC | ESC program (Hot Line, Aug 30) | 78% fewer pancreatitis events; best in class | Every headline number was in the July 22 topline; new items were CI, NNT, deaths and glycemic signal | ARWR $84.91 to $82.39 (−3.0%) |
| AstraZeneca Luminara Phase 2 at ESC | ESC program (final day) | Oral relaxin agonist “shows promise” | Per Fierce: ESVI −5.4 mL/m2 in the LVEF ≤35% cohort; SVRI −15% to −21%; 375 patients | AZN $162.70 to $162.13 (−0.4%) |
| Jazz HERIZON-GEA-01 second interim | Jazz (“mid 2026”) | Second survival win | Significant OS for the doublet; no HR, median or p; Q4 meeting | JAZZ $244.54 to $250.68 (+2.5%) |
| Besremi ET approval | FDA (target Aug 30) | First new ET drug in nearly 30 years | Approved one calendar day after a Sunday target; no efficacy numbers in the release | Taiwan listed; no US close |
Not on a date but delivered the same day: Lilly and Merida (LLY $1,174.61 to $1,156.73, −1.5%, no cause assigned) and BioMarin and Ascendis (BMRN +0.9%, ASND +6.1%). Boston Scientific’s newsroom update was still stamped August 30 at 8:25 pm ET as of Monday evening; BSX closed $48.30 (+3.1%), no cause assigned. Amylyx closed $33.75, a second session below its $35.50 offer price, with no closing announcement on its news index as of the evening of August 31.
What else happened on August 31, 2026?
Lonza named Samanta Cimitan, most recently CEO of Celonic, as its first Chief Commercial Officer effective January 1, 2027, per Fierce Pharma, which also cited first half 2026 sales of CHF 3.4 billion, up 16%. Electra Therapeutics filed for a Nasdaq listing under ETRA to fund a Phase 2/3 trial of ipsoprubart, an anti SIRP antibody with Breakthrough and PRIME designations in secondary hemophagocytic lymphohistiocytosis, after a $183 million Series C in October 2025 that included Sanofi, per Fierce Biotech. Kardium received up to $31.25 million from the Canadian government’s Strategic Response Fund toward a $125 million Vancouver expansion that would take Globe pulsed field ablation output from 500 to 30,000 units a year, per MedTech Dive. Novavax’s XFG formulation of Nuvaxovid picked up approvals in the United States, the European Union and Japan, distributed through Sanofi and Takeda, per BioPharm International.
Frequently asked questions
Which companies are in the second round of MFN drug pricing deals?
Alcon, Astellas Pharma, BeOne Medicines, BridgeBio, CSL, Kyowa Kirin, Sun Pharma, Teva Pharmaceuticals and UCB, per the White House fact sheet of August 31, 2026.
Did Alnylam or BioMarin sign an MFN deal?
No. Neither appears on the White House list, and Fierce Pharma reported that none of the Midsized Biotech Alliance’s original members signed. No statement from either company on the round surfaced as of the evening of August 31.
Is Teva’s MFN deal signed?
Not by Teva’s account. Its August 31 release describes “a shared commitment” and “active discussions,” with terms to apply “when finalized.” The White House counts Teva among the nine.
What does the GENEROUS Model do?
It is the CMS Medicaid pathway through which participating manufacturers offer state Medicaid programs prices aligned with those in high income comparator countries; states choose whether to participate, and the opt in deadline is September 30, 2026.
How much are the nine companies investing in US manufacturing?
The White House puts the collective pledge at $19.6 billion. Only two pieces are itemized in company or trade sources: BeOne’s additional $300 million at Hopewell, New Jersey, and CSL’s previously announced $1.5 billion Kankakee, Illinois expansion.
What is the strategic API reserve?
The fact sheet lists active pharmaceutical ingredient contributions to a strategic reserve: 163 tons of levetiracetam from UCB, 71.4 tons of clindamycin and 6.75 tons of doxycycline from Sun, 45 metric tons of metronidazole and 4.8 tons of amlodipine from Teva, and 25 kilograms of tacrolimus from Astellas.
How much is Lilly paying for Merida Biosciences?
Up to $2.875 billion in cash, combining an upfront payment and milestones that Lilly did not break out. Closing is expected in the fourth quarter of 2026.
What is MER511?
Merida’s lead program, a biologic that selectively degrades the pathogenic thyroid stimulating autoantibodies behind Graves’ disease and thyroid eye disease. It entered Phase 1 in December, per Fierce Biotech, and Lilly says early data showed robust antibody reductions with a favorable initial safety profile.
What royalty will Ascendis pay BioMarin on Yuviwel?
20% of net sales in the United States, retroactive to first commercial sale, and 18% in the European Union, Brazil and South Korea, through May 20, 2030, under a binding term sheet that ends the patent litigation in all jurisdictions.
What was new in Arrowhead’s ESC presentation of SHASTA-3 and SHASTA-4?
The rate ratio and confidence interval for acute pancreatitis (0.22, 0.07 to 0.67), the absolute risk reduction and number needed to treat (4.1%, 24), the high risk subgroup NNT of 3, the full adverse event table, the 14.3% versus 8.7% worsening glycemic control rate and three deaths on drug attributed to preexisting conditions. The 79% and 81% triglyceride reductions and the 78% and 100% pancreatitis reductions were disclosed on July 22.
Did Jazz disclose the hazard ratio for Ziihera plus chemotherapy?
No. The August 31 release says the overall survival benefit is statistically significant and clinically meaningful and that the hazard ratio improved versus the first interim, but gives no hazard ratio, median or p value. The data go to a medical meeting in the fourth quarter of 2026.
What is Besremi approved for now?
Polycythemia vera since 2021 and, as of August 31, 2026, adults with essential thrombocythemia regardless of genotype or disease status, including newly diagnosed patients who have not received cytoreductive therapy.
How many of Monday’s delivered catalysts saw the sponsor close higher?
One of seven US traded sponsors: Jazz (+2.5%). BridgeBio, Teva, BeOne, UCB, Arrowhead and AstraZeneca all closed flat or lower. Combined with Friday’s zero for five, the running count for the week’s tally stands at one of twelve.
Has Boston Scientific restored shipping?
Not as of the evening of August 31. The company’s newsroom update, still dated August 30 at 8:25 pm ET, targets partial restoration of shipping for some products during the week of August 31 and reports no unauthorized activity since August 25.
Sources
Primary sources. White House, “Fact Sheet: President Donald J. Trump Announces Deal with Nine Additional Pharmaceutical Manufacturers to Lower Drug Prices for Americans,” August 31, 2026. BridgeBio Pharma release, August 31, 2026 (GlobeNewswire). BeOne Medicines release, August 31, 2026. Teva Pharmaceuticals release, “Teva and Trump Administration Announce Intent to Reach Agreement,” August 31, 2026 (GlobeNewswire). Eli Lilly and Company release, “Lilly to acquire Merida Biosciences,” August 31, 2026. BioMarin Pharmaceutical release on the Ascendis settlement, August 30, 2026 (PR Newswire); Ascendis Pharma release, August 31, 2026 (GlobeNewswire). Arrowhead Pharmaceuticals releases of July 22 and August 30, 2026. Jazz Pharmaceuticals releases of May 27 and August 31, 2026. PharmaEssentia release on the Besremi ET approval, August 31, 2026 (Business Wire). Boston Scientific newsroom, “Update on recent cybersecurity incident,” as of August 30, 2026. Exchange closes via Robinhood market data.
Trade and general press (attributed where used). Fierce Pharma (MFN round, Lonza, Besremi, BioMarin and Ascendis, Ziihera), Fierce Healthcare (CSL), Fierce Biotech (Merida, Electra, AstraZeneca Luminara), STAT (MFN), BioSpace (Arrowhead analyst views), BioPharma Dive (ESC roundup), CancerNetwork (Besremi sBLA acceptance), MedTech Dive (Kardium), BioPharm International (Nuvaxovid), Patients For Affordable Drugs statement, all August 31, 2026 unless noted.
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