# Lilly Floods EASD With Obesity Data as Employers Push Back on GLP-1 Costs - Healthcare Podcast Weekly Digest - Week of October 2, 2026

> Healthcare Podcast Weekly Digest for the week of September 28 to October 2, 2026. Eli Lilly put out data on four weight-loss medicines at EASD while employers and insurers dropped GLP-1 coverage, uniQure's Huntington's gene therapy weakened at four years as a friendlier FDA took shape, and Medicare Advantage plan exits kept climbing.

## Healthcare Podcast Weekly Digest

### Week of October 2, 2026: Lilly Floods EASD With Obesity Data as Employers Push Back on GLP-1 Costs

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## Opening Summary

This was obesity-drug week. The big European diabetes meeting (EASD, in Milan) became a showcase for Eli Lilly, which put out data on four different weight-loss medicines in five days. On the podcasts, the conversation split in two:

- **Investors are asking how big Lilly can get.** Stock Club ran a full episode on whether Lilly could become the first $10 trillion company.
- **Employers and insurers are asking who pays.** Bloomberg's Everybody's Business and This Time Is Different both covered companies dropping coverage of GLP-1 weight-loss drugs.

Three other threads ran through the week:

- **A friendlier FDA.** Heidi Overton's confirmation hearing for FDA Commissioner reassured the biotech podcasts. Her first test is already in view: uniQure's Huntington's gene therapy, whose four-year data came in weaker than its three-year data.
- **Medicare Advantage keeps shrinking.** Medicare Advantage is the private-insurer version of Medicare. Becker's payer podcasts put fresh numbers on how many plans are leaving the market.
- **China, everywhere.** It came up on almost every biotech show: as a competitor, as a source of cheap drug candidates, and as the other side of an intellectual-property lawsuit.

The backdrop is a nervous market. Long-term interest rates are at multi-decade highs, and healthcare is acting as a place to hide. Healthcare stocks (tracked by the XLV fund) led the major sectors on at least one day this week, rising 1.8%, according to web market recaps. Lilly traded between roughly $1,145 and $1,187 a share.

## Key People This Week

| Speaker | Affiliation | Podcast | What they said |
|---|---|---|---|
| Emmet Savage | Profit (stock-picking service) | Stock Club, Oct 1 | Lilly is a 150-year-old company with a decades-long obesity franchise. A 10x gain from here needs only ~12.2% a year for 20 years. |
| Mike Mahoney | MyWallSt | Stock Club, Oct 1 | "Novo Nordisk let the door open and Eli Lilly busted through." |
| Hunt Lawrence | Telltales co-host | Telltales, Sep 30 | Lilly trades at about 50x free cash flow. The bull case is AI making every Lilly scientist far more productive. |
| Mike Nicoletti | Telltales co-host | Telltales, Sep 30 | If every drugmaker gets the same AI tools, "maybe they just compete away the profits and the consumer wins." |
| Steve Usdin | Washington Editor, BioCentury | BioCentury This Week, Sep 29 | Overton told senators President Trump's instruction was "to go fast." |
| Brian Skorney | Co-host | Biotech Hangout, Sep 25 | "The administration is really trying to calm the chaos of the FDA." |
| Matt Klein | Co-host | Biotech Hangout, Sep 25 | On Trump's "most favored nation" drug-price deals: "I suspect… it's coming for the mid-caps." |
| Adam Feuerstein | STAT | The Readout Loud, Oct 1 | uniQure's 44% slowing at four years "is still a very meaningful slowing of disease progression" for Huntington's. |
| Elaine Chen | STAT | The Readout Loud, Oct 1 | Novo now openly calls its drugs "weight loss drugs." That makes them easier for insurers to drop. |
| Helmy Eltoukhy | Co-CEO, Guardant Health | Squawk on the Street, Sep 25 | Guardant's blood-based cancer screening test is "the fastest-growing test in diagnostics history outside of COVID testing." |
| Ceci Connolly | CEO, Alliance of Community Health Plans | Becker's Healthcare / Payer Issues, Sep 30–Oct 1 | In 2026, 4.6 million Medicare Advantage members had to switch plans. "Billions, B as in boy" in extra risk-adjustment payments flow to one or two big public insurers. |
| Jakob Emerson | Payer industry analyst | Becker's Healthcare, Oct 1 | AI tools like UnitedHealthcare's "Avery" are "another competitive advantage that the big guys are going to have." |
| Karen Ignagni | CEO, EmblemHealth | Becker's Payer Issues, Sep 29 | "We have hospitals that are over 400% of Medicare." |
| Taylor Nicole Rogers | Bloomberg | Everybody's Business, Sep 25 | "There's never been an entire category of drugs that employers have carved out before." |
| Jason Moran | Managing Director, Cain Brothers (KeyBanc) | House Calls, Sep 30 | Pharma-services M&A is a "barbell" of mega-deals and small deals. "We're actually pretty bullish… over the next 6, 12, 18 months." |
| Brian Hilberdink | President, US Human Pharma, Boehringer Ingelheim | Citeline Podcasts, Sep 28 | "We're not interested in launching Me Too products." |
| Jeremy Levin | Executive Chairman, Ovid Therapeutics | Pharmaceutical Executive, Sep 30 | "The United States is treating biotech as a piñata, a political piñata." |
| David Niewolny | Global head of healthcare business development, NVIDIA | Faces of Digital Health, Sep 25 | Surgical robots now do about 20% of operations. The model is "augmented autonomy… always… a clinician in the loop." |

## Hot Topics

### 1. Eli Lilly's Obesity Pipeline at EASD

Lilly's main weight-loss and diabetes drug today is tirzepatide (sold as Zepbound and Mounjaro). This week it laid out what comes after. The four drugs below come from Lilly's announcements; the commentary comes from the podcasts.

**Retatrutide (a "triple" hormone shot, once weekly).** It mimics three gut hormones instead of tirzepatide's two.

- In TRIUMPH-2, a trial in people with type 2 diabetes and obesity, patients lost an average of **20.8% of body weight on the top 12 mg dose after 80 weeks**. Patients starting with a BMI of 35 or higher lost **23.4%**.
- **59.5%** of top-dose patients no longer counted as obese by the end.
- Up to 40% reached normal blood sugar (an A1C below 5.7%).
- Lilly plans to file for FDA approval in **Q1 2027**.
- Dave Knapp of *On The Pen GLP-1 News* (Oct 1) pointed to the companion TRIUMPH trial in people without diabetes. There, the lowest 4 mg dose produced **19%** weight loss, about what Zepbound's top dose delivers. The 12 mg dose produced **28.3%**. His takeaway is that many patients may never need the maximum dose. That matters because stomach side effects and heart-rate increases rise with dose.

**EloraTZP (tirzepatide plus a new amylin drug).** Amylin is another gut hormone that signals fullness.

- In a 367-person Phase 2b trial, patients lost up to **23.3%** (54 lbs) at 48 weeks. Tirzepatide alone produced **14.8%** in the same trial.
- The cost was tolerability. **10.8% to 27.0%** of patients on the combination quit because of side effects, versus 2.9% on tirzepatide alone.
- On *Squawk on the Street* (Sep 30), CNBC's Annika Kim-Constantino said Lilly cautioned against over-reading the side-effect numbers and will refine dosing before Phase 3, which starts by the end of 2026.
- UBS (Buy, $1,425 price target) wrote that the combination's results were "broadly in line with retatrutide." It argued Lilly is building a portfolio that no longer depends on tirzepatide.

**Foundayo (orforglipron, a once-daily pill).**

- A heart-safety trial, ACHIEVE-4, compared it with insulin in high-risk type 2 diabetes patients. Foundayo had a **23% lower** risk of cardiovascular death, heart attack or stroke. In pre-planned analyses, it had **53% lower** risk of cardiovascular death and **57% lower** risk of death from any cause.
- Knapp raised a commercial problem: the pill "has not taken off the way that the Wegovy pill has," even though the trial data favor it. In a head-to-head trial (ACHIEVE-3), Foundayo produced **9.2% weight loss vs 5.3%** for Novo's oral semaglutide 14 mg.
- Knapp's view of the two strategies: Lilly's small-molecule pill is "easier to manufacture, easier to scale up." Novo has been "quite strategic in how and when they released the higher doses."

**Zepbound vs. Novo's new high-dose Wegovy (7.2 mg).** Novo tripled Wegovy's dose to close the gap with Zepbound. Lilly's indirect comparison says the gap remains. How much depends on the statistical method:

- Counting everyone who started treatment, including people who stopped or switched (the "treatment-regimen" method): Zepbound 15 mg patients lost **4.5 percentage points more** weight.
- Counting only people who stayed on the drug as prescribed (the "efficacy" method): the gap shrinks to **1.8 points**, which is not statistically significant.
- Knapp's verdict: the 7.2 mg dose "gets pretty close" but doesn't fully close the gap. Lilly's headline number is real, but "alternative analyses show considerably smaller difference with uncertainty."

**The big-picture debate on Lilly the stock** (Stock Club, Oct 1):

- **The numbers they cited:** $1.1 trillion market value, about 40x earnings, Q2 revenue of **$23 billion (up 48%)**, and 2026 revenue guidance raised to **$85–87 billion**.
- **The price warning inside the beat:** realized prices fell **13%** in Q2 while volume rose **60%**.
- **The $10 trillion math:** Savage's scenario needs about $1.1 trillion of revenue by 2046 (a **13.6%** yearly growth rate), a ~33% profit margin and a 30x earnings multiple. At 20x, the same business is worth about $7.3 trillion.
- Mahoney admitted he regrets buying Novo instead of Lilly.

### 2. The Employer Revolt Against GLP-1 Costs

The podcasts made a clear case that the obesity boom has a payer problem.

- **The scale.** On *Everybody's Business* (Sep 25), Bloomberg's Taylor Nicole Rogers said about **1 in 10 Americans** are now on a GLP-1. Employers pay roughly **$500–$700 per employee per month** for them. Average employer health costs are around **$18,000–$19,000 per worker per year**, with premiums up **6.7%**.
- **Bank of America's bill.** On *This Time Is Different* (Sep 29), Ricky Mulvey noted CEO Brian Moynihan said the bank spends about **$250 million a year** on GLP-1s. That is more than 10% of its healthcare budget, up from zero a few years ago. Cigna and PepsiCo were named as having pulled back coverage.
- **The ROI problem.** The hosts cited research that the average real-world cost is **$23,000**, not the $60,000 a full five-year course would cost, because so many people stop early. Every $1 spent on GLP-1s also generates another **$0.22** of other outpatient spending. The payoff to employers arrives 10–15 years out, longer than most employees stay.
- **Mark Cuban's line,** quoted by Mulvey: "For the foreseeable future, the cost of healthcare benefits will get more people fired or not hired than artificial intelligence."
- **The human side.** Rogers read survey responses from workers choosing "between buying groceries for the family and staying on their medicine." Others described being able to "play with my kids for the first time in years."
- **The marketing twist.** On *The Readout Loud* (Oct 1), STAT's Elaine Chen noted Novo once asked reporters not to call GLP-1s weight-loss drugs. Now it runs ads like "Live Lighter" and "Summer Glow Up." Her warning: "If insurers stopped covering diabetes drugs, there would be uproar. But we don't have that same expectation when people stop covering obesity drugs."

### 3. uniQure's Huntington's Gene Therapy, Weaker Data and a Friendlier FDA

uniQure's one-time gene therapy, AMT-130, slowed Huntington's disease progression by **75% at three years**. At **four years** that fell to **44%** at the highest dose, in just **12 patients**. The result is no longer statistically significant.

- On *BioSpace* (Sep 30), Heather McKenzie said the drop disappointed investors. The company argued an updated outside comparison database had more missing data and underestimated how fast untreated patients decline.
- Feuerstein on *The Readout Loud* worried about durability: "We've seen this with other gene therapies where, over time, the efficacy… wanes." He still called 44% "very meaningful" for a disease where patients often die within a few years.
- **The policy story.** Under former FDA leaders Makary and Prasad, the FDA refused to review the therapy against a "natural history" comparison (outside patients rather than a placebo group). Under new leadership, the FDA has agreed to consider approval based on the three-year data. uniQure has filed. It expects an acceptance decision in Q4 2026, and BioSpace's Jeff Axt expects a final decision in "early or mid-2027."

### 4. Pancreatic Cancer Finally Gets a Breakthrough

Two podcasts covered Revolution Medicines' **daraxonrasib**, approved in August for previously treated metastatic pancreatic cancer.

- On *OncLive On Air* (Sep 30), oncologist Dr. Kim Reiss Binder said patients on the drug lived about **13 months vs ~6 months** on chemotherapy: "twice as long… something we've never seen before in a pancreatic cancer study." She called it "unquestionably one of maybe the biggest breakthrough… approval[s] that we've had in this disease… ever."
- **Why it matters beyond pancreatic cancer.** KRAS mutations drive **90%+** of pancreatic cancers and about **30%** of all solid tumors. For decades the protein was considered "undruggable." Binder's description: "smooth, like a golf ball with little divots in it, but no kind of deep pockets."
- *Crain's Daily Gist* (Sep 25) told the origin story. The science started at the University of Illinois in 2014, and the company moved to California in 2015 after a $45 million round led by Third Rock Ventures. Reporter John Asplund: "It's that coastal money that really drives basic science into translational medicine."
- A second pancreatic approval also landed. *OncLive* (Sep 28) covered Novocure's **Optune Pax**, a wearable device that uses electric fields against tumors, for locally advanced pancreatic cancer alongside chemotherapy. Dr. Davide Melisi called it "a gentle way of trying to control the cancer." He flagged the practical drawback: patients must wear it for long hours every day.

### 5. Amgen, Vertex and the Kidney/Immunology Readouts

From *Biotech Hangout* (Sep 25):

- **Amgen's dazodalibep** won a Phase 3 trial in Sjögren's disease, an autoimmune condition that attacks moisture-producing glands. A panelist called the data "clinically and statistically meaningful" with "very rapid onset of action." There was no excess of infections or blood clots, which hurt earlier drugs of this type.
- He sized the US market at about **$5 billion** for the systemic form of the disease and **$20 billion** for the symptom-driven form, assuming about $250,000 a year in pricing. A second readout is due by year-end.
- **Vertex's** kidney drug for APOL1-mediated kidney disease (about 250,000 US patients carry the high-risk gene variants) showed good protein-in-urine results in a broader patient group. A Phase 3 interim look is due within about six months.

### 6. Guardant Health and Blood-Based Cancer Testing

On *Squawk on the Street* (Sep 25), Guardant co-CEO Helmy Eltoukhy discussed a new FDA approval. Guardant's blood test now guides treatment for metastatic breast cancer patients on an AstraZeneca drug. In the supporting study, switching therapy early based on the blood test produced a **56% reduction in risk of death or progression**.

- Guardant's colorectal cancer blood test detects **83%** of cancers compared with colonoscopy. About **50 million** Americans skip colorectal screening.
- He framed three markets: **$10 billion** for late-stage cancer, **$20 billion** for monitoring cancer survivors and **$50 billion** for early detection.
- The stock is up about **70–75%** this year. Asked about strategic options, he called it a "great question" and said the company is growing on its own for now.

### 7. Managed Care, the Medicare Advantage Shake-Up and UnitedHealth

- **The numbers.** Ceci Connolly (ACHP) said the number of Medicare Advantage plans fell **10%** in 2026, and **4.6 million** members had to find a new plan. Jakob Emerson (Becker's, Oct 1) counted **12 insurers** exiting for 2027, eight of them owned by hospital systems. He expects about 3 million or more members to be displaced again.
- **What Connolly wants changed.** Medicare pays plans more for sicker members, a system called "risk adjustment." Connolly says it has gotten "so out of whack" that one or two big public insurers collect billions more than community plans. She wants CMS, Medicare's administrator, to move to an "inferred risk" model based on doctor visits, prescriptions and lab work, which would "take the coders out of the equation." Her member plans "are thrilled if they have a 1% to 2% margin."
- **Tougher audits from 2027.** On a separate Becker's episode (Sep 28), Milliman's Rick Gordon said CMS's 2027 rules remove **11** quality-rating measures and move toward auditing every eligible Medicare Advantage contract every year. They also exclude diagnoses from audio-only visits and from most unlinked chart reviews.
- **UnitedHealth's news.** UnitedHealthcare rolled out its 2027 Medicare Advantage plans on Oct 1. They will be available to **94%+** of Medicare-eligible people, and about 90% will have a $0-premium option. Emerson highlighted "Avery," UnitedHealthcare's AI assistant that "will call the doctor for you. It will book the appointment for you." The target is **20 million** members by the end of 2026.
- **UnitedHealth's legal overhang.** On Sep 30, a federal judge in Minnesota partly denied UnitedHealth's motion to dismiss a securities lawsuit brought by CalPERS, California's public pension fund. The surviving claim covers alleged misleading statements about the company's "portfolio refinement transactions." The suit also accuses former CEO Andrew Witty and current CEO Stephen Hemsley of insider trading. The judge wrote: "The Court agrees with CalPERS." The stock fell about 1.5% to around **$369**.

## Key Debates

### Is Eli Lilly Still Worth Buying at These Prices?

- **Bull:** Lilly is winning the obesity race outright, and its next drugs (retatrutide, EloraTZP, Foundayo) look better than its current best-seller. JPMorgan raised its target to **$1,500** ahead of the Oct 29 earnings report, citing Zepbound's uptake in Medicare and international growth. Telltales' Jason Wallace argued Lilly's data advantage is real: "You'd be hard-pressed to say that you have a better knowledge base to design molecules than Lilly."
- **Bear:** At roughly 40x earnings and 50x free cash flow, the stock already prices in huge success. Prices fell 13% in Q2. Employers are dropping coverage. Bloomberg's Max Chafkin asked on air: "Lilly is reporting unbelievable profits right now… Is it right for them to charge this much money?" Lilly also lost a jury verdict this week: it was ordered to pay Nektar **$90 million** for breaching a licensing agreement. Nektar had sought about $1 billion.

### Will AI Make Drugmakers Richer, or Just Make Drugs Cheaper?

- **Bull:** On Telltales, Hunt Lawrence asked: "If you equip everyone at Lilly with Claude or agents… how much more work would you get out of the scientific staff?" Jason Wallace said simulation "can remove years" from drug discovery. On Disruptors (Sep 29), Clarissa Desjardins of Congruence Therapeutics said AI cut her target-to-candidate timeline from 6–7 years to 3–4. It also cut the molecules her team makes from 2,000–5,000 to 200–500.
- **Bear:** Mike Nicoletti: if everyone has the same tools, "everybody's IQ… will approach the same level… maybe they just compete away the profits." On Keen On America (Sep 28), historian Barry Werth said AI in drug research is helpful "as a tool; not transformative." On Becker Private Equity & Business (Oct 1), ReAlta CEO Howard Berman added: "You cannot take shortcuts in this industry."

### Is the FDA Getting Better or Just Faster?

- **Better:** Steve Usdin (BioCentury) said Overton praised FDA staff and called the measles vaccine "safe, effective, and necessary." Her confirmation likely turns on whether Sen. Bill Cassidy "believes that she meant what she said." Brian Skorney (Biotech Hangout) said acting commissioner Diamantis is "doing a pretty good job cooling the temperature."
- **Worse, or too soon to tell:** Jeremy Levin (Pharmaceutical Executive) said last year's cuts mean "90% of the leadership left." He believes rebuilding will take "five to six years." On Biotech Hangout, Sam Fazeli asked about the FDA telling Compass Therapeutics it needs a new survival trial: "Is this a new toughness by the FDA or is it the right toughness?"

### Most-Favored-Nation Drug Pricing, Fair or Catastrophic?

"Most favored nation" (MFN) pricing ties what Americans pay for a drug to the lowest prices paid in other rich countries.

- **Fair:** Matt Klein (Biotech Hangout) has read Pfizer's MFN agreement, obtained through a public-records (FOIA) request. Under it, if Pfizer raises prices abroad, it shares the benefit with the US government. "If the government… is able to successfully push other countries to pay more for drugs, I think it's reasonable the taxpayers should get some of that benefit."
- **Catastrophic:** Levin called the MFN approach "catastrophic… to innovation." Sam Fazeli warned that cash-strapped Europe may respond by limiting how many patients get new drugs: "that's a really bad outcome."

### Who's Really Driving Healthcare Costs?

- EmblemHealth CEO Karen Ignagni blamed hospitals and pharma. She cited a Yale study finding that rising prices for each service, not administrative costs, drove **90%** of cost growth from 2011–2024. She also said drugmakers earn "profits in the 20 to 25% range." Her proposal is an "MLR for hospitals and pharmaceutical companies." An MLR, or medical loss ratio, is the rule that caps how much of each premium dollar insurers can keep.
- Former Medicare head Leslie Norwalk (13th & Park, Oct 1) defended margins: "If you don't have margin, you don't have services." She added that "people get upset when the margins get to be well into double digits."

## Emerging Themes

- **China as rival and supplier.** Desjardins said China now generates about **two-thirds** of new drug discoveries (her host's figure). Max Bronstein said on BioSpace (Oct 1) that China has passed the US in registered clinical trials. Telltales' Nicoletti argued this makes buying drug candidates *cheaper* for big pharma, because "there's a lot more competition for molecules." Merck's KRAS deal and Novo's Hengrui deal (see the Deals tracker) are examples.
- **Biotech's intellectual-property fight with China.** The Readout Loud covered Beam Therapeutics' lawsuit alleging a former scientist took trade secrets "on weekends late at night" before a Chinese-linked rival was formed. STAT's Allison DeAngelis said it reflects startup "fear… that scientists… will leave and go start companies in China."
- **Obesity care gets personal.** Several podcasts said the "most weight lost wins" era is ending:
  - Dr. Alicia Shelley (Back on Track, Sep 28), on Amgen's monthly shot MariTide: "the future of obesity treatment may not simply be just finding the medication that produces the greatest percentage of weight loss."
  - Boehringer's Brian Hilberdink said its drug survodutide aims at "quality of weight loss": visceral fat, liver health and keeping muscle.
  - On The Peter Attia Drive (Sep 28), Lloyd Klickstein said combining Lilly's muscle-preserving bimagrumab with semaglutide produced **22–23%** weight loss and **45.7%** fat loss.
- **AI arrives inside healthcare companies.** Highlights from the week:
  - Cain Brothers' Jason Moran noted Lilly and NVIDIA are building "the world's most powerful supercomputer that's actually owned and operated by a pharmaceutical company."
  - Moran also cited Anthropic's **$400 million** purchase of Coefficient Bio in April.
  - NVIDIA's David Niewolny said software-defined medical devices can update every **6–12 months**, compared with 5–10 year hardware cycles.
  - Nabla's Dr. Ed Lee (Becker's Digital Health, Sep 25) said clinical AI is moving from writing notes to understanding "what is actually happening" with a patient.
- **Reverse mergers are back.** BioCentury reported that reverse mergers paired with private funding rounds (PIPEs) nearly matched IPOs in 2026. In a reverse merger, a private company goes public by merging into an already-listed shell. Wedbush alone has done about 10 this year, versus just 7 for the whole industry in 2025. Biotech Hangout said the average biotech IPO raise is the highest on record, above even 2021.
- **Coverage losses feed medical debt.** Tradeoffs (Sep 30) said **5.8 million** people could drop Obamacare plans after enhanced subsidies lapsed, with new Medicaid rules in 2027 adding more. Stanford economist Neil Mahoney: "Medical debt more than any form of debt is a symptom of bad luck." Ignagni found it a "head scratcher" that a cancer diagnosis doesn't automatically exempt someone from Medicaid work requirements.

## Deals & M&A Tracker

| Deal | Terms | Source |
|---|---|---|
| **AstraZeneca → Summit Therapeutics** | **$2 billion** all-stock equity investment, not a buyout. It funds trials of ivonescimab, an immune-oncology drug that blocks both PD-1 and VEGF and that BioSpace called "perhaps the hottest asset in the hottest new class." Stifel says Summit's cash runway goes from under 1 year to **2–4 years**. Summit had $690M in cash in July. | BioSpace, Sep 30 |
| **Merck ← SciBrunch (KRAS "molecular glue")** | **$400M upfront**, over $2B total with milestones. BioCentury called it "one of the biggest ever for a preclinical asset." | BioCentury, Sep 29; web reports |
| **Novo Nordisk ← Hengrui (HRS-1596, weekly oral obesity drug)** | **$300M upfront**, up to **$2.6B** total. The drug hasn't entered human trials yet. Dave Knapp: "I'm not getting overly excited about this." | On The Pen, Oct 1 |
| **Eli Lilly ← InnoCare Pharma** | Discovery deal on up to five drug targets. Up to **$100M** upfront and near-term payments, about **$3.25B** in milestones, plus single-digit royalties. | News reports, Sep 24 |
| **Lilly's deal appetite** | CEO David Ricks told Bloomberg that Lilly will pursue *larger* deals in infectious disease, women's health and psychiatry. | News reports, Sep 28 |
| **Medtronic → Cornerstone Robotics** | **$700M** investment, with distribution rights to Cornerstone's surgical robot in some international markets. A challenge to Intuitive Surgical. | DeviceTalks, Sep 25 |
| **J&J divests Laminar** | J&J bought the heart-device maker for about **$400M** roughly three years ago, then suspended its pivotal trial in mid-2025. It has now spun Laminar out to a new venture-backed company. | DeviceTalks, Sep 25 |
| **Thermo Fisher → Clario** | **$8.9B**. Cain Brothers' example of mega-deals inflating pharma-services M&A totals even as deal counts fall. | House Calls, Sep 30 |
| **Lilly / Nektar verdict** | A jury found Lilly breached its licensing agreement with Nektar and awarded **$90M** plus interest. BTIG sees Nektar's sell-off as a "strong entry point" ($178 target). | News reports, Sep 27 |
| **Lilly / Foghorn** | The two companies ended their partnership on the cancer drug FHD-909. Foghorn is cutting about **40%** of its staff. | News reports, Oct 1 |

## Regulatory Watch

- **FDA Commissioner nominee Heidi Overton** had her Senate hearing on Sep 24. She needs 11 of the 12 Republican votes on the committee to advance. Committee chair Sen. Cassidy and Sen. Josh Hawley are the votes to watch (BioCentury; Biotech Hangout).
- **New Lilly approvals:**
  - **Onswik**, a once-weekly insulin for type 2 diabetes. It matched daily insulins in trials with more than 3,400 adults.
  - **Olumiant**, now approved for severe alopecia (hair loss) in patients 12 and older. 42% of patients on 4 mg regrew at least 80% of their scalp hair, versus 5% on placebo.
- **AbbVie's Juvmo (tavapadon)** was approved for Parkinson's. It is the first payoff from AbbVie's **$8.7B** Cerevel acquisition, and William Blair estimates its price at about **$59,000 a year** (BioSpace).
- **Pharma tariffs.** Usdin said the new tariff guidance "leaves a lot of questions unaddressed." It will raise costs "for small companies and mid-sized companies that are importing products." Web reports say phase two of the Section 232 drug tariffs took effect. They also say mid-sized drugmakers including Teva, UCB, CSL and BridgeBio signed Medicaid MFN agreements under a CMS program called "GENEROUS" in exchange for tariff exemptions. That fits Matt Klein's prediction that MFN is "coming for the mid-caps."
- **Medicare Advantage 2027 rules:** fewer quality-rating measures, audits of every contract, and stricter rules on which diagnoses count for payment (Milliman's Rick Gordon). CMS has also given plans new flexibility to cap enrollment (Ceci Connolly).
- **FAIR Act.** This bipartisan House bill, from Reps. Sessions and Peters, would let the FDA speed US clinical trials that trusted regulators in the UK, EU or Canada have already cleared, with a 30-day review. Patient advocate Teresa Barnes said a third of pulmonary fibrosis trials now run outside the US: "Speed is everything" (BioSpace, Oct 1).
- **Semaglutide vision risk.** Smart Investing (Sep 26) reported Danish courts awarded **27** patients up to $1.5M each for a rare optic-nerve condition that can cause sudden vision loss (about 2 in 10,000 users). 38 more cases are pending. The UK, Japan and Australia have added warnings; the FDA is reviewing but hasn't.
- **Semaglutide patent challenge.** Viatris filed a challenge to a Wegovy weight-loss patent that runs to 2038. Knapp: this is not "generic Wegovy coming sooner."

## Week Ahead

| Date | Event |
|---|---|
| **Through Oct 3** | European dermatology congress (EADV) in Vienna. Lilly's Ebglyss hand-and-foot eczema data: 53% clear or almost clear vs 27% on placebo. |
| **~Oct 10** | FDA decision dates on several new-drug applications, per web reports. The FDA calendar is lighter after a record September. |
| **Oct 13** | **UnitedHealth** and **Johnson & Johnson** Q3 earnings (before the open). They open healthcare earnings season. Watch UnitedHealth on medical costs and Medicare Advantage. |
| **Oct 15** | Medicare open enrollment begins. Plan exits and benefit cuts become real for seniors. |
| **Oct 20** | **Elevance** Q3 (before the open). **Intuitive Surgical** Q3 (after the close), with Medtronic's robot push in the background. |
| **Oct 21** | **Abbott** Q3 (before the open). |
| **Oct 29** | **Eli Lilly** Q3. JPMorgan expects another guidance raise. |
| **Nov 2–3** | Becker's Fall Payer Issues Roundtable, Chicago. |
| **Nov 4** | **Novo Nordisk** Q3. |
| **Nov 14** | FDA decision on **Summit's** ivonescimab in EGFR-mutated lung cancer. |
| **Q4 2026** | FDA acceptance decision on uniQure's Huntington's gene therapy. Phase 3 starts for Lilly's EloraTZP. Second Amgen dazodalibep (Sjögren's) readout. |
| **Coming weeks** | CMS's detailed data on how many Medicare Advantage members are being displaced. Possible Senate committee vote on Overton. |

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