Newsletter · · Ashutosh Agarwal
Lilly Keeps Pulling Away as Novo's Reset Lands Badly and Viking Draws Takeover Talk - Healthcare Podcast Weekly Digest - Week of September 25, 2026
Healthcare Podcast Weekly Digest for the week of September 21–25, 2026. Novo's Capital Markets Day set a $23 billion by 2035 target and the stock still fell about 8%, Eli Lilly broke ground on a $6.5 billion Foundayo plant while winning about 7 of 10 new Medicare GLP-1 starts, and Viking jumped 35% as maintenance data turned it into the obesity sector's favorite takeover target.
Healthcare Podcast Weekly Digest
Week of September 25, 2026: Lilly Keeps Pulling Away as Novo's Reset Lands Badly and Viking Draws Takeover Talk
Lilly keeps pulling away, Novo's big reset lands badly, and Viking turns into the obesity sector's favorite takeover target.
1. Opening Summary
On Monday, Sept 21, Novo held its Capital Markets Day in London. That's the once-a-year event where a company sets out its long-term plan for investors. Novo laid out a path to $23 billion in pipeline revenue by 2035 and promised five "multi-blockbuster" drugs by 2030.
Investors sold anyway. The stock fell about 8% to its lowest level since April.
That same day Eli Lilly broke ground on a $6.5 billion factory in Houston for its weight-loss pill Foundayo. Its CEO, David Ricks, went on CNBC to say Lilly is winning about 7 of every 10 new Medicare patients starting a GLP-1 drug. (GLP-1s are the class of drugs behind Ozempic, Wegovy, Mounjaro and Zepbound.)
The next day, small-cap Viking Therapeutics jumped 35%, its best day since February 2024. New data showed patients kept most of their weight off even when they took its injection less often.
Those three stories set the tone for the week's healthcare podcasts:
- Obesity drugs were the main event. The questions: who wins, who gets bought, and whether pills or shots take over.
- Washington stayed noisy. Topics included Medicare paying for obesity drugs, Medicare cuts to lab-test payments, a fraud crackdown on the ACA marketplace, a court fight over whether Lilly's next obesity drug counts as a "biologic," and pharma tariff rules that BioCentury called "a total mystery" with only days to go.
- Biotech is hot, maybe too hot. One podcast host warned that biotech's big lead over the Nasdaq has, in past cycles, shown up late in bull markets.
Healthcare stocks (the XLV fund) rose about 0.6% on the week, per web market recaps. That came in a week when the Fed raised rates for the first time since 2023.
2. Key People This Week
| Speaker | Affiliation | Podcast | What they said |
|---|---|---|---|
| Michael Yee | Senior pharma & biotech analyst and global head of biotech equity research, UBS | CNBC's Fast Money (Sept 21) | "We've been very consistent on this. We think it's a value trap." (On Novo) |
| David Ricks | CEO, Eli Lilly | Halftime Report (Sept 21) | "I think there's about 700,000 new seniors who've started on GLP-1 medicine just since July 1... We're capturing about 7 out of 10 of those new patients." |
| Mike Doustdar | CEO, Novo | Brew Markets (Sept 21), as relayed by host Dylan Lewis | Competition won't be "Coke versus Pepsi. It's going to be Coke and Pepsi and Fanta and Dr. Pepper and Red Bull." |
| Tim Seymour | Fast Money panelist, holds Novo | CNBC's Fast Money (Sept 21) | "It's even more of a value trap today than it was yesterday... Lilly at 32 times forward, Novo at 11 and a half times forward." |
| Joe Terranova | Halftime Report panelist, owns Lilly | Halftime Report (Sept 21) | Lilly is "a trillion dollar basically biotech close to a 30 times valuation" and has done about "$20 billion" of deals so far in 2026 |
| Jim Lebenthal | Halftime Report panelist | Halftime Report (Sept 21) | Lilly's valuation "has come down quite a bit, and it's becoming quite attractive." He still prefers AbbVie, AstraZeneca and Vertex |
| Brad Zimmerman | Cabot Wealth Network | Cabot Street Check (Sept 18) | "If biotech starts diverging lower, that's your warning that we're on borrowed time." |
| Nick Galakatos | Global Head of Life Sciences, Blackstone | The BioCentury Show (Sept 18) | "It's not uncommon now to see a phase three program cost in excess of a billion dollars." |
| Dr. Finny Kuruvilla | Co-CIO, Eventide Investments | Faith & Finance (Sept 22) | Called a RAS-targeting pancreatic cancer drug "the most exciting story of 2026" |
| Dave Knapp | Host, On The Pen GLP-1 News | On The Pen (Sept 22) | Said the retatrutide court fight "has implications beyond retatrutide" for every next-generation peptide drug |
| Paul Bonanos | News editor, BioCentury | BioCentury This Week (Sept 22) | Said the IPO market is busy, but "I wouldn't call it a mania" |
| Chris Kempczinski | CEO, McDonald's | Squawk on the Street (Sept 23) | GLP-1s have no meaningful impact yet at ~10% of U.S. adults, but will matter more at 20–30% |
3. Hot Topics
Novo's Reset: The Plan Was Fine, and the Stock Still Fell
Several podcasts dug into Monday's event. They agreed on one thing: Novo told investors what they expected to hear, and that wasn't enough.
What Novo announced (BioSpace, "Novo's turnaround plan, weight loss wins, Ultragenyx's Sanfilippo approval, IPO blitz," Sept 23; Brew Markets, "Novo's Next Act & What Happened to Nike?," Sept 21):
- $23 billion in pipeline sales by 2035. At least five drugs with "multi-blockbuster potential" by 2030, including CagriSema (a mix of cagrilintide and semaglutide) and cagrilintide on its own. BioSpace noted Novo had about $20 billion in revenue last year, "so not too much of a stretch."
- Ten times more production capacity for the Wegovy pill by 2030. About 1.5 million patients are on it today. Doustdar called it probably the most successful pharma launch ever. He also told investors on manufacturing: "you don't have to worry about this anymore."
- 4,000 more jobs gone. That brings the total to about 13,000 since last year, or nearly 17% of the workforce. Novo told BioSpace these came mostly from attrition and not backfilling roles, not layoffs.
- A new name. "Novo Nordisk" is now just "Novo," and the 100-year-old bull logo now faces right.
Why investors didn't buy it:
- Market share is still slipping. Michael Yee (UBS) on CNBC's Fast Money ("Meta Surges As Muse Optimism Grows... And Novo's Growth Plans Disappoint," Sept 21):
"You have an incumbent GLP-1 obesity player that's facing significant headwinds and declining market share. And obviously that is because Lilly offers a significantly better drug, is taking market share, and is beating numbers."
- Profit margins raised doubts. Yee said "part of the reason the stock was down was because the margin guidance," and called Novo "a show me story." He thinks a turnaround is possible "over a few years, but it's going to take time... people want to bet on the growth story, not the value story."
- The patent clock. On Brew Markets, the hosts pointed out that semaglutide's U.S. patent runs out in 2032, and about half of Novo's revenue is tied to it. The stock is down about 70% since mid-2024, and full-year revenue is expected to be flat to down 6%.
- Too much riding on one drug. A Fast Money panelist noted that "75% of their revenues comes from one molecule."
Novo's M&A hint made things worse the next day. Doustdar told CNBC Europe that Novo is interested in acquisitions "when the gap can be filled with that M&A." Novo's U.S. shares didn't recover from Monday's drop (CNBC's Fast Money, "Meta's Muse Ripple Effects... And A Coiled Spring In Google," Sept 22).
Lilly: The Winner, Now Trying to Spread Its Bets
- Medicare is growing the market. Medicare started covering obesity drugs on July 1. Ricks said about 700,000 new seniors have started a GLP-1 since then, and Lilly is winning about 70% of them. He called it "very market expansionary, which is what we had hoped." He even praised the government's rollout: "I really haven't heard that many problems with the logistics" (Halftime Report, "Stocks Rise as Oil and Yields Ease: Your Next Move," Sept 21).
- How the pill fits in. Foundayo, Lilly's daily pill, now takes about one in three new prescriptions in the GLP-1 pill category, "growing week on week." Ricks said doctors still use the Zepbound injection for patients "with the most body weight and the most complications." He sees the pill as the fit for people who "just need to lose 25, 30 pounds."
- Diabetes is the next big step. Lilly expects a U.S. decision on Foundayo for type 2 diabetes later this year. Ricks's surprising point: "today still the oral GLP-1 medicines are the same size as the obesity market." He said the drug showed A1C (a standard blood-sugar measure) falling "more than two points," and "a cardiovascular benefit seems to be emerging that's even beyond our expectations."
- The valuation debate on Halftime. Joe Terranova (who owns it) says Lilly can keep climbing, because it is using GLP-1 cash to diversify through about $20 billion of deals this year. Jim Lebenthal (who doesn't own it) says the price is getting attractive, but asks "can they diversify beyond GLP-1s, beyond obesity?"
- Wall Street price targets edged up. Goldman Sachs raised its target to $1,371 (from $1,367) and Guggenheim to $1,284 (from $1,273). Guggenheim cited Zepbound returning to CVS's list of covered drugs (its "formulary") on Oct 1. The average analyst target is about $1,359. Lilly traded around $1,167 on Sept 21.
- New approvals. The FDA approved Inluriyo plus Verzenio for ESR1-mutated breast cancer (Sept 18) and Onswik (efsitora alfa), a once-weekly insulin for type 2 diabetes (Sept 24). On the Diabetes Dialogue podcast ("Weekly Insulin Efsitora Alfa Gets FDA Approval for Type 2 Diabetes," Sept 24), clinicians Diana Isaacs and Natalie Bellini said the trials showed blood-sugar control as good as daily glargine insulin, with 43% lower rates of low blood sugar (hypoglycemia).
- Beyond weight loss. BioSpace reported Phase 1 data on Lilly's next-generation drug brenipatide in alcohol use disorder and depression. Stomach side effects were similar to placebo. Two Phase 3 trials are due to report in early 2028.
Viking: The Obesity Drug Everyone Wants to Own
- The data. Viking's injection VK2735 produced 17.7% weight loss at 21 weeks, and the results held up when patients were dosed every two weeks or monthly. CNBC's Fast Money said weight loss hadn't leveled off, and that patients kept about 97% of it on the less-frequent schedule (roughly 90% on monthly dosing). Stomach side effects looked like placebo during the 12-week maintenance period (BioSpace, Sept 23).
- What analysts said. Truist said the results landed in its "best case scenario." William Blair called it a "maintenance trifecta."
- Why it matters. Most of today's obesity drug business depends on patients taking a shot every week, forever. A Fast Money panelist said a drug you can take less often is "potentially troubling for the ones that have a model that's sort of based on the premise of maintaining."
- Takeover talk. One Fast Money panelist estimated a Viking deal would be a "seven and a half, $8 billion deal." Others noted that at a roughly $3.5 billion market value it "could be a game changer for a company that needs to add on." Web reports say Viking then raised $500 million: $275 million in stock at $35 a share and $225 million in convertible notes (debt that can turn into stock later).
- The skeptic. Yee is less sure: "Viking, I think, remains a question mark for a lot of people, given that it's still just a peptide, still going to do peptide manufacturing." Peptides are protein-like molecules that are harder to make in bulk than traditional small-molecule pills. He finds Structure Therapeutics (GPCR) and its amylin drug more interesting as a buyout target. (Amylin is a gut hormone that helps control appetite.)
Pancreatic Cancer: A Big Step Forward
Dr. Finny Kuruvilla of Eventide Investments called Revolution Medicines' RAS-targeting drug "the most exciting story of 2026" (Faith & Finance, "Investing in Medical Innovation with Dr. Finny Kuruvilla," Sept 22).
RAS is a protein that tells cells to keep dividing. For decades it was considered "undruggable." Kuruvilla explained that the new drug uses a "molecular glue" that brings in another protein to switch RAS off. The result, in his words: "normally metastatic pancreatic cancer has a median survival of 6.7 months. And with this particular therapy... survival is now 13.2 months."
Gene Therapy Win for Ultragenyx
The FDA approved Ultragenyx's gene therapy for Sanfilippo syndrome type A, a fatal genetic brain disease in children often called "childhood Alzheimer's." Shares rose about 10–12% (Science News Daily, Sept 18).
On BioSpace, CEO Emil Kakkis described a patient treated at age five who is "still running around." Most children with the disease are bedridden by their teens and don't live past 15. It was Ultragenyx's second gene therapy approval in about a month. It came right after its drug apazunersen failed a Phase 3 trial in Angelman syndrome.
The GLP-1 Economy Beyond Pharma
- Food companies. On Squawk on the Street (Sept 23), McDonald's CEO Chris Kempczinski said GLP-1s have no meaningful effect yet at about 10% of U.S. adults, but will matter more at 20–30%. Users "still crave McDonald's food but buy smaller portions," so the menu is changing.
- A portfolio view. Luke Guerrero of KPP Financial (InvestTalk, "The Weight-Loss Drug Boom Hits Its Middle Age," Sept 23) cited estimates of 30 million users by 2030 eating 5–10% fewer calories. He suggests owning the drugmakers only if you believe higher volumes will make up for falling prices, and holding less in food stocks.
- Doctor payments. Washington Post data journalist Lydia Sitholm (The Gist Healthcare Podcast, Sept 21) reported that Lilly and Novo paid about $270 million to roughly 250,000 prescribers over seven years. That is the largest paid-prescriber network across the 400-plus drugs studied.
Hospitals and Managed Care
- Hospital margins are shrinking. Health:Further ("208 - Hospital Margins Crater, Half of Hospitals Still Hide Prices, and OpenAI's $1.2T Question," Sept 18) reported hospital operating margins fell to 1.4% in July, down from 2.2% in May–June. The hosts also said more than half of hospitals still don't fully follow price-transparency rules, because "the fines aren't that scary right now."
- HCA picked OpenAI. On the same podcast: HCA tested Microsoft Copilot, Google Gemini and OpenAI before choosing OpenAI as its AI partner. The hosts said OpenAI "benefited from going third," since HCA had learned what it wanted and the models had gotten better. They added that CEOs Sam Hazen and Sam Altman "vibed the best."
- Insurers' costs are creeping up. Wells Fargo says the pace of "IDR" filings sped up sharply in June and July. IDR is the arbitration process doctors use to fight insurers over surprise-billing payments. The firm says this adds 10–20 basis points (0.10–0.20 percentage points) to its medical-cost estimates for managed care companies.
- UnitedHealth named Jodee Kozlak to a new Chief Administrative Officer role, starting Sept 28, to lead its "enterprise modernization" push.
- Medicare Advantage coding. On A Health Podyssey ("Medicare Advantage Risk Adjustment: Why CMS's Payment Cuts Didn't Raise Premiums," Sept 22), a UC Berkeley researcher and her Health Affairs co-authors discussed the 2024 change to how CMS scores patients' health. The goal was to cut aggressive "upcoding," meaning recording patients as sicker to earn higher payments. CMS projected risk scores would fall about 2 percentage points and save about $7 billion in 2024. Their research found the cuts did not lead to higher premiums for members.
Lab-Test Cuts Hit Quest and LabCorp
The Morning Market Briefing ("Sports ETFs Are Coming + Medicare Cuts Hit Quest and LabCorp," Sept 22) covered a proposed Medicare cut under PAMA, the law that sets what Medicare pays for lab tests. It could cut payments by up to 15% a year. Quest and LabCorp fell 5–6%.
The hosts' view: the worst case is about 1% of Quest's revenue, and "I think this is negotiation." They're more interested in how fast Quest's self-pay testing business is growing.
4. Key Debates
Novo: Bargain or Value Trap?
A "value trap" is a stock that looks cheap but stays cheap, or gets cheaper, because the business keeps getting worse.
Bull case
- Novo trades at about 11.5 times next year's expected earnings, versus about 32 times for Lilly.
- The Wegovy pill is a real hit, with 1.5 million patients.
- Management may be setting targets low on purpose so it can beat them. Yee allowed "you could argue perhaps they're being conservative."
- Tim Seymour is still holding: "Even if margins are going down, we're in good shape. So I don't mind holding the stock."
Bear case
- Yee: "It's a value trap." Lilly's drugs are "significantly better," and injections will still be "65% or 75% of the overall market."
- Heavy dependence on one molecule, with the patent running out in 2032.
- M&A talk suggests the pipeline can't close the gap by itself.
Lilly at ~30 Times Earnings: Still Worth Buying?
Bull case
- Terranova: GLP-1 cash is paying for about $20 billion of deals, which "is going to set us for long-term future success."
- Yee expects Lilly to hold about 65% of the obesity market over the next five to seven years. He compares Lilly's pipeline of newer drugs to "iPhone 18, 19, 20."
- Big data is coming soon: retatrutide ("Triple G," which targets three gut hormones) and amylin combinations.
Bear case
- Lebenthal: can Lilly grow "beyond GLP-1s, beyond obesity"? Brew Markets noted about two-thirds of Lilly's sales come from tirzepatide drugs.
- Guerrero: cheaper copycat drugs mean "margin compression" for both leaders.
- Viking's data raises the chance of patients using the drugs less often over time.
Is Biotech's Big Run a Warning Sign?
The warning. Brad Zimmerman (Cabot Street Check, "AI May Kill Us All. But Biotech Is the Bigger Threat to Stocks," Sept 18) points out that the Nasdaq Biotech Index is up 48.7% over the past year, versus 18.7% for the Nasdaq. Biotech peaked a few weeks before the Nasdaq in 2000, and about nine months before it in 2021 (February vs. November). His rule: "If the NASDAQ biotech index or XBI... starts deteriorating, trim positions, get off margin."
The pushback. His co-host Chris Preston sees this as "maybe the seventh inning of this bull market." Zimmerman himself says biotech "is still in the technical uptrend." The warning only counts if biotech starts falling while the Nasdaq keeps rising.
A different angle. André Perold, CIO of HighVista Strategies, which manages $14 billion (Capital Allocators, "André Perold – Investing Through Exponential Change," Sept 21), sees small biotech as a lasting source of mispriced stocks. These single-drug companies either get bought or fail, and big funds can't easily trade in and out of them.
Autoimmune CAR-T: A Problem With One Product or the Whole Approach?
CAR-T is a therapy that re-engineers a patient's own immune cells. It has been moving from cancer into autoimmune diseases. On BioCentury This Week ("Ep. 388 - Biotech IPOs, CAR T safety & pharma tariffs," Sept 22), Lauren Martz reported three patient deaths in Novartis trials from an inflammatory reaction called IEC-HS. That has set off "this moment of panic across sort of the whole industry."
Competitors point to Novartis's fast two-day manufacturing process. Cells made that way can release more of an inflammatory signal called interferon gamma. Martz's warning: fast manufacturing "was meant to be the safer alternative. T-cell engagers are meant to be safer too." T-cell engagers are antibody drugs that do a similar job without cell manufacturing.
5. Emerging Themes
- Less frequent dosing is the next battleground in obesity. Viking's maintenance data brings to life the old Novo idea a Fast Money panelist recalled: "almost like a vaccine, like a weight loss vaccine. You take it once a year."
- Deciding what legally counts as a "biologic." Lilly is suing the FDA to have retatrutide classified as a biologic, a category for large protein-based drugs. That would block compounding pharmacies from making copies and give Lilly longer exclusivity. On the eve of the Sept 24 oral arguments, the Justice Department pointed the court to a recent Seventh Circuit case (Franco v. Chobani) that gave weight to FDA scientific judgment. Dave Knapp noted Novo's amylin/GLP-1 drug is 68 amino acids long, "well within the FDA's framework for a biologic." He expects the ruling to affect "the entire peptide and obesity landscape" (On The Pen, "Retatrutide in Court, Compound GLP-1 Under Fire," Sept 22).
- China as a drug source. A STAT reporter on the ground in Shanghai (The Readout Loud, "The FDA's Overton era, and dispatches from Shanghai," Sept 24) called it "basically a gold rush." One Chinese biotech CEO told him "U.S. companies cannot compete. We are too fast. We are too efficient." U.S. investors are setting up new non-Chinese companies to hold licensed Chinese drugs, which makes them easier to sell to U.S. pharma. Lilly's InnoCare deal this week fits the pattern.
- Buying the drug, not the company. Nick Galakatos said Blackstone Life Sciences' $6.3 billion fund (the largest private fund dedicated to life sciences, 40% bigger than the last one) invests "in products" and gets paid in royalties, meaning a share of each product's sales. With Phase 3 trials now costing over $1 billion, he says scale is the edge: "not do five times as many deals, but do deals that were sometimes five times larger" (The BioCentury Show, "Ep. 119 - Blackstone's Galakatos on funding biotech's hardest mile," Sept 18).
- AI for finding drugs. Anthropic CEO Dario Amodei said Claude found a previously unknown enzyme system in a wet-lab workflow. He argued AI could help cure most diseases in 5–10 years if used across the whole drug pipeline (AI Chat, "Claude Makes Bio Discovery in Wet Lab, OpenAI Solves 100 Math Problems," Sept 23). Demis Hassabis said Isomorphic Labs aims to cut discovery from years to months (If/Then, Sept 23). Novo has also partnered with Anthropic on AI drug development (The Rundown, Sept 21).
- AI for hospital paperwork. Oracle Health's Seema Verma said EHRs (electronic health record systems) built in the 1990s make AI a "bolt-on." She says Oracle is building new EHRs designed for AI from the start: automatic note-taking, billing codes and prior authorizations (The Podcast by KevinMD, "Making AI work for physicians," Sept 22).
- Beyond GLP-1s in obesity. Moonwalk Biosciences CEO Alex Aravanis is going after fat tissue directly with siRNA, a type of drug that silences specific genes, as a treatment that doesn't work by cutting appetite. The company raised a $70 million oversubscribed Series B (Business Of Biotech, Sept 21).
6. Deals & M&A Tracker
| Deal | Terms | Why it matters |
|---|---|---|
| Eli Lilly – InnoCare Pharma | Up to $100M upfront and near-term payments, about $3.25B in milestones, plus single-digit royalties, across up to 5 targets | Another big pharma bet on Chinese drug discovery |
| Novo – Orbis Medicines | Multi-drug deal worth up to $1.4B | Pills for heart and metabolic diseases |
| Novo – Calliope | Three early-stage obesity molecules (one possible first-in-class peptide, two small molecules), terms not disclosed | Novo adding pill-friendly small molecules |
| Eli Lilly – Ty Beckley (closed July) | $2.8B upfront, up to $3.8B with earnouts | Phase 3 psychedelic 5-MeO-DMT for treatment-resistant depression (Citeline Podcasts, Sept 18) |
| Telix – ITM Isotope Technologies | $1.65B upfront ($1.25B in stock), up to $700M in milestones, about $2.35B total (web reports) | Supply of radioactive isotopes for cancer drugs, plus Phase 3 ITM-11 |
| Waystar (WAY) | Exploring a sale, per Reuters | RBC sees Oracle as the "obvious first name" buyer, with UnitedHealth's Optum next. It kept Outperform and a $44 target, and shares rose 8% premarket to $27 |
| Viking Therapeutics | Potential target. Panelist estimate about $7.5–8B. Raised $500M after the data (web reports) | Seen as a "low risk, high reward" add-on for obesity drug makers |
| Elektra (IPO) | Upsized to $350M, priced at midpoint, fell 12% on day one | Broke a streak of nine straight IPOs that rose on their first day |
| ADARx Pharma (IPO) | Set terms for about $350M | siRNA drugmaker with three clinical-stage drugs |
| North (reverse merger) | $180M in new funding via merger plus private placement | Reverse mergers, where a private company goes public by merging into a listed one, are "in fashion again" (Bonanos) |
| Lesata – Mireya | $225M in fresh capital | High triglycerides and acromegaly drugs |
| Moonwalk Biosciences | $70M Series B | Fat-tissue siRNA obesity platform |
| Blackstone – Alnylam (earlier deal, discussed by Galakatos) | $2B package: royalties on Leqvio plus debt and equity | Example of funding a company to profitability without selling new shares |
Bonanos summed up the market for going public: busy, "but I wouldn't call it a mania." About as many biotechs have joined Nasdaq through mergers as through traditional IPOs this year.
7. Regulatory Watch
- Retatrutide court fight. Oral arguments in Lilly's appeal against the FDA were held Sept 24, after the DOJ's late letter citing the Chobani case. The outcome will decide whether compounding pharmacies can copy the drug (On The Pen, Sept 22).
- Pressure on compounders. The FDA sent warning letters to one of the largest U.S. compounding pharmacies. Knapp's summary of the FDA's message: "you can't just add B12 to tirzepatide and mass produce it."
- FDA leadership. Heidi Overton, the White House pick for FDA Commissioner, got a hearing before the Senate HELP Committee "a little sooner than we expected" (BioCentury This Week, Sept 22).
- Pharma tariffs. BioCentury, Sept 22: "there's a handful of days to go and pharma tariff rules are a total mystery. What's not a mystery is which biotechs will be most affected."
- Medicaid drug pricing. Web reports say all 50 states, D.C. and Puerto Rico applied to join the GENEROUS Medicaid model, which ties state Medicaid drug prices to "most-favored-nation" pricing, the lowest price paid in other wealthy countries. About 26 drugmakers are said to take part.
- ACA fraud crackdown. CMS canceled about 315,000 unauthorized enrollments covering more than 760,000 people in the federal ACA marketplace and expects about $2.2 billion in subsidies to come back.
- Lab-test payment cuts (PAMA). Medicare proposed cuts of up to 15% a year. The proposal is now open for public comment.
- A faster path for medical devices. On Connected With Latham ("Drug Pricing and Market Access: The RAPID Pathway," Sept 21), lawyers Chris Schott, Nate Beaton and Danny Machado explained RAPID. It lines up FDA approval with Medicare coverage for breakthrough devices, shrinking a typical five-year gap to 60–90 days. They noted CMS is at the same time proposing to repeal other coverage routes for new technology.
- Medicare Advantage star ratings. Star ratings are Medicare's quality scores for insurance plans, and they drive bonus payments. On The Astonishing Healthcare Podcast (Sept 18), Judi Health's Jay Tran and Angela Kalantarova said the drug-review program known as MTM becomes a scored measure in 2027. Eligibility will expand a lot, with the industry expecting 3–4 times as many eligible members.
- Recent approvals discussed on podcasts:
- Lilly's Onswik weekly insulin and Inluriyo plus Verzenio
- Ultragenyx's Sanfilippo gene therapy
- Bayer's finerenone for kidney disease in type 1 diabetes, the first drug for that use in 30 years. It cut a key urine marker of kidney damage (urine albumin-to-creatinine ratio) by 25%.
- Animal testing. Web reports say the FDA issued a rule on Sept 21 explicitly allowing non-animal methods (organ-on-a-chip, human cell models, computer modeling) for drug safety testing.
8. Week Ahead
- EASD diabetes meeting (next week). Ricks: "There's more data actually next week at the EASD... on Foundayo, on retatrutide, our next generation GLP-1, and on a new combination of tirzepatide plus another experimental amylin medicine called eloralintide. So big week next week for diabetes and obesity data."
- Zepbound back on CVS's formulary (Oct 1). Guggenheim built this into its higher Lilly target.
- Pharma tariff rules take effect. Watch which biotechs BioCentury flagged as most exposed once the details come out.
- Retatrutide ruling. A decision could come any time after the Sept 24 arguments.
- Lilly's "Triple G" and amylin data. Yee said investors will hear about them "in a month or two."
- Foundayo for type 2 diabetes. Lilly expects the FDA decision "later this year."
- FDA decisions (dates from web reports): Roivant/Priovant's brepocitinib for dermatomyositis and Scholar Rock's apitegromab for spinal muscular atrophy, both around Sept 30.
- Novo's M&A next move. After Doustdar's comments, Structure Therapeutics (GPCR), Viking and Summit Therapeutics were all named on Fast Money as possible targets.
- Nektar v. Lilly verdict. B. Riley said the jury appeared to be settling on a breach finding, with the damages figure "a significant contested piece." Wedbush cut its Nektar target to $50 from $80.
- ESMO (Oct 23–27). The big European cancer conference, and the next major showcase for oncology data.