Newsletter · 2026-10-04 · Ashutosh Agarwal

Lilly Widens Its Obesity Lead at EASD as AstraZeneca Buys Into Summit - Weekly Pharma/Biotech Podcast Recap - Week of October 4, 2026

Weekly Pharma/Biotech Podcast Recap for the week of October 4, 2026. Eli Lilly's retatrutide and amylin-combination data dominated EASD while Novo Nordisk paid $300 million for a Chinese weekly pill, AstraZeneca put $2 billion into Summit Therapeutics, uniQure's Huntington's gene therapy faded at four years and the stock fell 37%, and FDA nominee Heidi Overton's hearing drew mixed reviews with a vote now expected after the midterms.

Weekly Pharma/Biotech Podcast Recap

Week of October 4, 2026: Lilly Widens Its Obesity Lead at EASD as AstraZeneca Buys Into Summit

The week in one paragraph: Eli Lilly owned the week again. At EASD, Europe's big diabetes meeting in Milan, Lilly showed that its next-generation shot retatrutide drove 21% weight loss in people with diabetes, and the full medical-journal paper showed close to 30% weight loss at two years in heavier patients. Novo Nordisk's answer was a $300 million bet on a Chinese pill that has not yet been tested in people. Outside obesity, the biggest story was AstraZeneca putting $2 billion into Summit Therapeutics, the US partner on what one host called "potentially the biggest binary event I've ever seen in the history of biotechnology." Gene therapy took a hit when uniQure's Huntington's data faded and the stock fell 37%. In Washington, FDA nominee Heidi Overton's hearing got mixed reviews, and two podcasts now expect her vote to slip until after the November midterms. The biotech stock index (the XBI, an index of small and mid-sized US biotech stocks) is still up 27% this year, but specialist investors are hurting under the surface.

Dominant Themes

Theme 1: Lilly's obesity lead gets wider at EASD

At least six podcasts covered Lilly's new obesity data this week. The message was the same everywhere: Lilly now has several next-generation drugs, and each one is moving the bar higher.

• Retatrutide in diabetes. Retatrutide is a "triple agonist," meaning one weekly shot that acts on three gut-hormone targets at once (GLP-1, GIP and glucagon). On Biotech Hangout, analyst Brian Skorney highlighted the TRIUMPH-2 result: 21% weight loss in people with type 2 diabetes at 80 weeks. He said this matters because diabetics usually lose much less weight than other patients on these drugs, "so crossing a 20% boundary here is very meaningful." He added that the side effects "continue to look pretty tolerable" (Biotech Hangout).
• The full retatrutide paper. The New England Journal of Medicine published the full TRIUMPH-1 trial. On On The Pen, host Dave Knapp read out the numbers. At 80 weeks, average weight loss was 19% at the 4 mg dose, 25.9% at 9 mg and 28.3% at 12 mg, measured on the "efficacy estimate" basis (people who stayed on the drug). People in an extension study who started with a BMI of at least 35 reached about 30% average weight loss at 104 weeks. Knapp called these "the largest average number of weight loss that we've ever seen from an obesity medicine" (On The Pen).
• A new problem: too much weight loss. Knapp's main point was that the lowest dose already matches today's best drugs. So the old habit of pushing everyone to the highest dose may not make sense. At the top dose, "a meaningful group actually reached a BMI under 25." In other words, some patients ended up too thin to even qualify for the drug (On The Pen).
• What a cardiologist saw. On Medscape's This Week in Cardiology, Dr. John Mandrola said the 9–12 mg doses produced 24–25% weight loss versus 4% on placebo in the 2,400-patient trial: "A 250-pound person becomes a 200-pound person in about a year. It's remarkable." Systolic blood pressure dropped about 10 points, and the share of patients with prediabetes fell from 39% to 6%. His one worry was heart rate, which rose 7 and 9 beats per minute at the highest doses. He thinks that "should give us pause" for patients with a weak heart pump, a condition called heart failure with reduced ejection fraction (This Week in Cardiology).
• The amylin combo. Lilly also tested tirzepatide (the drug in Mounjaro and Zepbound) together with its experimental amylin drug. Amylin is another gut hormone that makes people feel full. CNBC's Annika Kim Constantino reported the combo hit about 23% weight loss at 48 weeks, versus nearly 15% on high-dose tirzepatide alone, in patients with obesity and diabetes. Phase 3 trials start at the end of this year (Squawk on the Street, 9/30). The catch: Skorney noted 27% of patients dropped out, versus 3% on tirzepatide alone, with "high nausea rate and vomiting." Bloomberg Intelligence's Sam Fazeli still called it a first: "I don't think we'd ever seen 23%... weight loss at that time point" (Biotech Hangout).
• Fazeli's summary of the meeting: "Lilly is firing on all cylinders here... pretty much every other data point was a bit of a meh" (Biotech Hangout).

Theme 2: The Lilly–Novo comparison games, and why the headline number depends on the math

Lilly brought two "indirect comparisons" to EASD. These compare results from separate trials instead of testing the drugs side by side. On The Pen walked through why the headline numbers need care.

• Zepbound vs. high-dose Wegovy. Novo has tripled the Wegovy dose to 7.2 mg. Lilly's analysis said tirzepatide 15 mg produced 4.5 percentage points more weight loss than semaglutide 7.2 mg. That figure uses the "treatment regimen" method, which counts everyone, including people who stopped the drug. Using the "efficacy" method (only people who stayed on the drug), the gap shrank to 1.8 points at 15 mg and 0.7 points at 10 mg, and neither result was statistically significant. Knapp's take: "That number is real, but it's real within the treatment regimen analysis," and tripling the Wegovy dose "may not completely close the gap... but it gets pretty close" (On The Pen).
• The pills. Lilly's pill Foundayo (orforglipron) was compared with Novo's 25 mg oral semaglutide in diabetics. Foundayo showed 1.5 points more weight loss and 0.3 points more A1c reduction at 52 weeks (A1c is the standard blood-sugar measure), with other methods giving ranges of 1.5–2.4 points and 0.3–0.6 points. Against the lower 14 mg Novo pill, Lilly does have a true head-to-head trial: 9.2% vs. 5.3% weight loss, and 2.2 vs. 1.4 points of A1c reduction (On The Pen).
• Novo's real-world pill data. Novo released data from the telehealth company Ro. Patients who switched from injections (Zepbound or Wegovy) to the Wegovy pill kept losing weight after three months. CNBC's read: "patients may not have to actually stay on injections forever" (Squawk on the Street, 9/30).

Theme 3: Novo's deal for a weekly pill and its fight to protect semaglutide

• Hengrui deal. Novo paid $300 million upfront, in a deal worth up to $2.6 billion, for HRS-1596 from China's Jiangsu Hengrui. It is a dual GLP-1/GIP drug designed as a once-a-week pill. Knapp's concern: "it hasn't even entered phase one." He thinks Novo may really be buying access to the know-how for making a protein-based drug work as a weekly pill, though Novo licensed only the one molecule, not Hengrui's whole platform (On The Pen).
• Why that matters for Novo. The daily Wegovy pill "uses 10 times the amount of semaglutide per day" compared with the weekly shot, because so little of a protein drug survives the stomach (Knapp put the absorbed share at "I believe 0.1%"). Lilly's Foundayo is a small-molecule drug, meaning a simpler chemical that is easier and cheaper to make at scale. Knapp also said Novo "kind of lost the game" by focusing on amylin instead of GIP for so long (On The Pen).
• Sam Fazeli's read: Novo "used to have one" GLP-1/GIP drug, but "it kind of disappeared off the pipeline." This deal fills the gap against what tirzepatide does for Lilly (Biotech Hangout).
• Patent fight. Viatris, through its Mylan unit, filed a "Paragraph IV" challenge. That is the legal step where a generic maker tells the FDA it believes a patent is invalid or does not apply to its version. The target is US patent 12,551,536, issued in February 2026, which covers semaglutide for weight management and runs to October 2038. Knapp's framing: this case is not about cheap Wegovy arriving soon. It decides "whether generic competition starts in 2030s or whether Novo patents can keep competitors out for a lot longer" (On The Pen).
• Novo's new marketing. On The Readout Loud, STAT's Elaine Chen described a big change in how Novo sells. Novo once told her it didn't like the phrase "weight loss drugs." Now it runs ads with slogans like "Live Lighter" and "Summer Glow Up," because "insurance coverage has stalled" and it is leaning on direct-to-consumer cash sales. Her warning: "It ultimately seems like these drugs are headed towards the over-the-counter direction," and these "are such powerful drugs" that she isn't sure that is safe (The Readout Loud).

Theme 4: The next wave of obesity drugs: muscle, less frequent dosing and "quality" weight loss

• Boehringer's angle. Boehringer Ingelheim's US pharma president Brian Hilberdink, a former Novo employee, described entering a market with "two companies right now, one of them with a market cap that floats around a trillion dollars." Rather than race for the biggest number on the scale, Boehringer will pitch its GLP-1/glucagon drug survodutide on "the quality of weight loss": liver fat, visceral fat (the harmful fat around the organs) and keeping lean muscle (Citeline Podcasts).
• But the data was modest. Mandrola noted survodutide's SYNCHRONIZE-2 trial (750 patients) produced 8% and 9% weight loss versus 4% on placebo, "only about a 5% difference," with a smaller heart-rate rise of about 3 beats per minute (This Week in Cardiology).
• Muscle drugs face a regulatory wall. Regeneron showed MRI data suggesting its anti-myostatin antibody trevogrumab, given with semaglutide, kept "more or less all of the muscle." But Skorney asked how such a drug gets approved if "the FDA probably isn't going to accept MRIs." Fazeli added that Roche dropped its own myostatin program. Coverage analyst Greg Sivanovich flagged Corbus Pharmaceuticals' CB1 drug, which had "differentiated safety tolerability" but "got no credit for it" from investors (Biotech Hangout).
• The muscle-drug backstory. On The Peter Attia Drive, Dr. Lloyd Klickstein described the bimagrumab-plus-semaglutide study (BELIEVE, 507 patients; bimagrumab later went to Lilly). The high-dose combination produced 22–23% weight loss at 72 weeks, but 45.7% loss of starting body fat, which he called "the first medical therapy that gives fat loss equivalent to or superior than bariatric surgery." He also explained why the trial used body weight as its main goal even though he preferred waist size: "what do investors and potential acquirers think? Everybody cares about what the approval endpoint's going to be" (The Peter Attia Drive).
• Amgen's monthly shot. A clinician podcast reviewed Amgen's MariTide, which turns on GLP-1 but blocks GIP and is being tested every 4 or 8 weeks. In Phase 2 (592 adults), people without diabetes lost about 12–16% at 52 weeks versus about 2.5% on placebo and "had not clearly reached a weight loss plateau" (Back on Track).
• The effect on food companies. The CPG Guys cited a Cornell study: households with a GLP-1 user cut grocery spending 6% within six months, and savory snack purchases fell 11%. They put the number of US adults on these drugs at about 15 million (The CPG Guys).

Theme 5: AstraZeneca's $2 billion Summit stake and a busy week for deals

• The Summit deal. AstraZeneca bought about 10% of Summit Therapeutics for $2 billion in stock, at a premium. Summit is developing ivonescimab, licensed from China's Akeso. It is a "PD-1/VEGF bispecific," a single antibody that both releases the immune system's brakes on cancer and cuts off the tumor's blood supply. BioSpace's Annalee Armstrong said Summit had about $690 million in cash as of July, "enough for about a year of runway." Stifel analysts now see the money lasting two to four years (BioSpace, 9/30).
• Why it's unusual. In a normal deal, the bigger company licenses the drug. Here Summit keeps ivonescimab, gains access to AstraZeneca cancer drugs to combine with it, and has AstraZeneca paying for some of the trials. Fazeli searched Bloomberg's deals database and "couldn't find one" similar deal where the partner supplying the combination drug also pays for the trials. Later in the week, Daiichi Sankyo joined with its TROP2 antibody-drug conjugate, a "guided missile" type of cancer drug, starting with triple-negative breast cancer (Biotech Hangout).
• The puzzle. Eric Schmidt noted Summit tried to raise about $500 million from public investors "just a few months ago" at a lower price "and they kind of came up short," yet AstraZeneca paid a premium. Summit told him AstraZeneca has seen no hidden data: "The public markets have seen everything." The stock rose almost 10% on the week (Biotech Hangout).
• Regeneron–Sanofi renew vows. The two companies extended their 20-year partnership with four new antibodies aimed at the same pathway as Dupixent, their mega-blockbuster eczema and asthma drug. Terms: $1 billion upfront to Regeneron, up to $7 billion in milestones, profits split 50-50. Fazeli passed on a buy-side friend's joke that the deal was "like an old married couple driving their car, taking the foot off the gas and coming to a stop in the middle of the road in silence." More useful: Sanofi's CFO said he expects to push generic Dupixent out "a few years beyond" its 2031 main patent date, and Bloomberg Intelligence's patent team thinks protection can stretch to late 2037 (Biotech Hangout).
• M&A keeps running. BioSpace counted 73 biotech acquisitions so far this year, three quarters of the way through, against 72 in all of last year. Armstrong said "M&A has picked up considerably" (BioSpace, 9/30). ReAlta Life Sciences CEO Howard Berman agreed: "you have seen recently this year the M&A increasing dramatically, and I don't think that's going to slow down... with the amount of cash that pharma has, they need to use it and spend it," especially for rare diseases (Becker Business).

Theme 6: China is now the source of the industry's new drugs

• Three China deals in one week, per Fazeli: Novo–Hengrui ($300M upfront, $2.6B total); Merck paying $400M upfront, up to $2.13B, for a preclinical oral KRAS G12D drug from a Chinese company (a pancreatic-cancer target, which puts Merck up against Revolution Medicines); and Novartis paying $575M upfront, up to $7.2B, to China's Abogen for an mRNA-based T-cell engager, a drug that recruits immune cells to attack disease. He also said that at the World Conference on Lung Cancer, "when I look at the five notes that we wrote from the conference, guess what? They were all China-associated assets" (Biotech Hangout).
• The numbers behind it. On Sinica, consultant Dr. Ruby Wang said China's share of out-licensing deals worth more than $50 million went from 5% to 50% in the first half of 2026. She called oncology China's strongest area and immunology its slowest. The host added a counterpoint: China still had only about 4.8% of the global biotech market in 2024, versus about 35% for the US (Sinica Podcast).
• The trust problem. The Readout Loud covered Beam Therapeutics' lawsuit against China-based Yoltec. Beam alleges a former employee accessed trade secrets on nights and weekends, then joined Yoltec. Yoltec later licensed technology to US venture firms, creating a new US company that competes directly with Beam. Reporter Allison DeAngelis said the case "speaks to this fear that's emanating through the industry right now" (The Readout Loud).
• Washington's response. On BioSpace's Denatured, former Biden health-innovation official Max Bronstein said "China actually eclipsed the United States in terms of the number of registered clinical trials," calling it "a major wake up call." He is pushing the bipartisan FAIR Act, which would speed US access to trials and drugs already approved abroad. Patient advocate Teresa Barnes said about a third of pulmonary fibrosis trials are being run outside the US (BioSpace, 10/1).

Theme 7: Heidi Overton's FDA hearing, MAHA tensions and tariff confusion

• The hearing, read by BioCentury. Washington editor Steve Usdin called it "mixed." The good news for industry: Overton said President Trump told her to "go fast," citing China and national security. She endorsed Operation Trial Blazer (a plan to speed early-stage drug development) and the "plausible mechanism" pathway, an approval route for custom therapies, and said it should go "beyond N of 1" (treatments built for a single patient). Unlike former commissioner Marty Makary, "she didn't denigrate FDA staff" and called the measles vaccine "safe, effective, and necessary" (BioCentury This Week).
• The problem votes. Committee chair Sen. Bill Cassidy said RFK Jr. made him promises about vaccines and then broke them, so how can he trust Overton? Sen. Josh Hawley is "likely not going to vote for her unless he believes that she's going to overturn" the relaxed rules on the abortion pill mifepristone. On timing, Usdin said: "I wouldn't be surprised if it was delayed until after the midterms." His biggest worry is that no one asked how she would fix an agency hurt by "poorly conceived and chaotically implemented organizational changes" and low morale (BioCentury This Week).
• A second view. On Medicine: The Truth, Dr. Robert Pearl said Cassidy wrote that her support for Trump's executive order scaling back childhood vaccinations "alone is almost disqualifying." Pearl also expects the vote after the midterms and noted that new members of Congress are not seated until January 3, 2027 (Fixing Healthcare Podcast).
• The MAHA Summit. On Paging America, a podcast run by health-care activists, the hosts said doctors lobbied HELP Committee senators against Overton and that "today was a bad day for Dr. Heidi Overton." They said the MAHA Summit was sponsored by UnitedHealth Group and looked "sparsely populated." They also cited an open letter from MAHA leaders, signed by 859 lead signatories, threatening to pull support from Trump and RFK Jr. unless the mRNA vaccine platform is removed. Politico's Carmen Paun said there is speculation Kennedy "might just resign" if Democrats win a chamber of Congress (Paging America).
• What companies see day to day. Regulatory lawyers on the Medical Alley podcast said the drug, biologics and device centers are all run by acting heads, so "I don't really know what policy is going to come forth." Meanwhile front-line reviewers are "digging in... looking at the stats," which surprises clients who "thought we were deregulating." They pointed to about 100 warning letters about drug promotion sent in a single week last September, and to RFK Jr.'s views: "very pro-peptide," pro-wearables, anti-TV drug ads (The Medical Alley Podcast).
• Tariffs. Usdin said the long-promised guidance on pharma tariffs finally came out and "leaves a lot of questions unaddressed." Companies that think they qualify for an exemption were given an email address and a list of questions, with decisions made "case-by-case" by the Commerce Department. He expects higher costs for small and mid-sized importers, especially for products made in China, Australia and Canada (BioCentury This Week).

Theme 8: Biotech stocks: a good year on paper, a painful quarter for specialists

• The scoreboard. Greg Sivanovich of Biotech Hangout: the XBI is up 27% this year, versus 7% for the broad health-care fund XLV, 13% for the S&P 500 and 17% for the Nasdaq. But it peaked at $169 in late August and is down about 9% since (Biotech Hangout).
• Pain under the surface. Eric Schmidt said the XBI was "essentially flat in Q3." That flat number hides a split. The stocks propping up the index are ones "very few of our specialist fund clients own," including heavily shorted names like Moderna, Iovance and Summit, while "the companies that everyone owns are just getting hammered." He cited Morgan Stanley prime-brokerage data showing "massive dispersion," and said it all "started... with the Moderna vaccine news back in August." His summary: "a pretty good year... But, man, really tough last six months for many clients" (Biotech Hangout).
• IPOs and the new kind of reverse merger. Sivanovich counts about 23 biotech IPOs this year, on pace for 30-plus, with T-Rex Bio, Iambic and City Therapeutics in the queue. Oura's pulled IPO is not seen as a warning for biotech; a banker told Schmidt "he's not seeing a lot of read through into our space" (Biotech Hangout). BioCentury's Paul Bonanos said reverse mergers (where a private company goes public by merging into an existing listed company) are now "almost as many as IPOs in 2026." These are "not your father's reverse mergers." They come with a nine-figure private investment (a PIPE) at the same time, which gives the company "pricing certainty" and lets specialist investors choose who gets in. New companies built on Asian drug assets are using the route too (BioCentury This Week).
• A warning on funding with data. Immix Biopharma reported what Sivanovich called "stellar" results: an 89% complete response rate in 45 patients with AL amyloidosis, a rare disease where abnormal proteins build up in the heart and kidneys. But Immix announced a $125 million stock sale the same morning, which capped the stock, and it closed down almost 10% (Biotech Hangout).

Theme 9: Gene and cell therapy reality check

• uniQure. uniQure's Huntington's gene therapy AMT-130 showed 44% slowing of disease progression at four years, in 12 high-dose patients, down from 75% at three years. Executives blamed an updated comparison database with more missing data, but BioSpace's Heather McKenzie said "it basically came across as trying to defend a thesis" (BioSpace, 9/30). The stock fell 37% that day and about 5% more since. The approval filing is in, with priority review requested (Biotech Hangout).
• The bigger question. Asked whether gene therapy is living up to "one and done," Skorney said: "it's been slower than I expected... I thought we were going to have more of a renaissance earlier." He pointed to Sarepta, which is making its micro-dystrophin protein but "has not demonstrated efficacy" in pivotal trials. Fazeli said venture investors remain "quite gung-ho," but "from a pharma side... I suspect they'll go cold for a while" (Biotech Hangout).
• CAR-T for autoimmune disease. CAR-T means re-engineering a patient's own immune cells into a drug. A few weeks ago Novartis reported three deaths in its autoimmune CAR-T trials and paused studies; BMS paused too. This week Kyverna, the leader in the field, reported clean one-year data in 26 patients with stiff person syndrome, with no high-grade cytokine release syndrome (a dangerous immune overreaction). BioSpace's view: it "may not be the full scale of the market" people once hoped for, but it could be very important for some patients (BioSpace, 9/30).
• Radiopharmaceuticals. On Business of Biotech, AdvanCell CEO Philina Lee discussed the company's oversubscribed $350 million Series D (July). AdvanCell makes "alpha" radiation drugs, which cause double-strand DNA breaks that are "virtually irreparable." It uses lead-212, drawn from thorium-228, which Lee says is far more plentiful than the actinium that "hundreds of companies" are fighting over. All Phase 1 and 2 doses so far, "hundreds of doses," were made in-house in Brisbane, and the company is now building a US manufacturing network (Business Of Biotech).

Theme 10: A good week of FDA approvals

• AbbVie won approval for tavapadon in Parkinson's. It is the first selective D1/D5 dopamine drug, works in early and late disease and with or without levodopa, and is priced at about $59,000 a year per William Blair. It is the first drug to reach market from AbbVie's $8.7 billion Cerevel buyout, whose main asset failed in schizophrenia (BioSpace, 9/30).
• Lilly won approval for its once-weekly insulin, opening "another front in the Novo rivalry" (BioSpace, 9/30).
• Mirum won approval for zilurgisertib, licensed from Incyte, in FOP, an ultra-rare disease (about 900 patients worldwide) where muscle slowly turns to bone. It is the third approved drug for the disease. Gross price: about $1.7 million, versus $1.5–2 million for Regeneron's injected rival (Biotech Hangout).

Active Debates

1. How big is Lilly's lead, really?

• Lead keeps growing: Fazeli said "Lilly is firing on all cylinders," with a GLP-1/GIP/glucagon drug and a GLP-1/GIP/amylin combo, and the rest of EASD was "a bit of a meh." Skorney said the market "sees them as the leader and it seems like they're going to remain that way for some time to come" (Biotech Hangout).
• Gap is smaller than headlines say: Knapp showed that the 4.5-point Zepbound edge over high-dose Wegovy drops to 1.8 points, not statistically significant, under a different method (On The Pen). Boehringer's Hilberdink argued the race to "drop the greatest number of pounds" is the wrong contest (Citeline Podcasts).

2. Is AstraZeneca's Summit stake a vote of confidence or a cheap option?

• Bull: Schmidt hopes it is "a young couple on a raging honeymoon," and if this drug class becomes "the next backbone" of cancer treatment, "there's a lot of upside in summit shares" (Biotech Hangout).
• Skeptic: Fazeli said he had heard "so many variety of theses" from investors. In one reading, AstraZeneca wanted "skin in the PD-1 VEGF game" without spending more than $2 billion, and had to fund Summit to keep it alive: "how much of a tick in the box is that?" He also rejected the rumor that AstraZeneca moved because it knows its own AVANZAR trial failed: "if they knew that, they would have to announce it" (Biotech Hangout).

3. Is Moderna overvalued after its run?

• Fazeli asked how Moderna can be worth about $70 billion when Sanofi, "with such a deep business," sits around $90 billion. There has been "at least one solid downgrade" to sell. Possible addition to the Nasdaq-100 did not move the stock. The next test is the kidney cancer (RCC) readout with Merck. Fazeli read Merck R&D head Dean Li's comments, calling the RCC and bladder trials "bookends" on expected results, as negative, while "others were just saying that this is Merck that's always conservative" (Biotech Hangout).

4. Did DM1 muscle drugs fail because of the drug or the test?

• After Novartis's drug from its Avidity acquisition failed in myotonic dystrophy type 1 (DM1), Dyne's stock fell. Schmidt framed the debate: "did Novartis... fail because of the drug or did they fail because of the endpoint?" The main measure, vHOT, is a timed hand-opening test that he called "subjective" and noisy. But "the more I look at the [Avidity] data... the more holes I see in it," and Dyne "seems like they've got a better data package. So I wouldn't be surprised if this did work... the stock's going to rip." Skorney: "I don't think the street's giving a very high probability of success" (Biotech Hangout).

5. Will Overton make the FDA steadier, or more political?

• Steadier: BioCentury's Usdin said her messages on speed, staff and vaccine safety will be "very welcome... especially to staff at FDA" (BioCentury This Week).
• More political: Paging America's hosts called her "an anti-abortion zealot" and "an anti-vax zealot" and criticized her for not saying the president could be wrong (Paging America). Pearl pointed to Cassidy's "almost disqualifying" comment (Fixing Healthcare Podcast).

6. Is China a threat or a supplier?

• Supplier: Big pharma keeps buying. Wang says China's drugs are "first-in-class, best-in-class assets that are beating current Western standards" (Sinica Podcast).
• Threat: The Beam–Yoltec lawsuit and China passing the US in trial registrations are fueling calls for faster US rules (The Readout Loud; BioSpace, 10/1). On Novo's Hengrui deal, Fazeli's tongue-in-cheek line: "Listen, I don't have a particular penchant to keep talking about China. I'm just observing here" (Biotech Hangout).

Stock-by-Stock Bull/Bear

Notable Quotes

"This is, as we've called out before, potentially the biggest binary event I've ever seen in the history of biotechnology."

Eric Schmidt on Summit's HARMONi-3 trial, Biotech Hangout (link)

"If they come out and say OS is immature, I think people would take that as they're not seeing a directional positive in there."

Sam Fazeli on how to read the HARMONi-3 press release (OS means overall survival), Biotech Hangout (link)

"The companies that everyone owns are just getting hammered."

Eric Schmidt on specialist biotech funds in Q3, Biotech Hangout (link)

"It's remarkable."

Dr. John Mandrola on a 250-pound person becoming 200 pounds in about a year on retatrutide, This Week in Cardiology (link)

"If four milligrams of retatrutide gives someone enough benefit, that person may never need 12 milligrams."

Dave Knapp, On The Pen (link)

"This is the first medical therapy that gives fat loss equivalent to or superior than bariatric surgery."

Dr. Lloyd Klickstein on bimagrumab plus semaglutide, The Peter Attia Drive (link)

"It ultimately seems like these drugs are headed towards the over-the-counter direction."

STAT's Elaine Chen on Novo's new marketing, The Readout Loud (link)

"I think it's been slower than I expected... I thought we were going to have more of a renaissance earlier. And it's been harder, but science is a hard thing."

Brian Skorney on gene therapy, Biotech Hangout (link)

"I wouldn't be surprised if it was delayed until after the midterms."

Steve Usdin on the Overton vote, BioCentury This Week (link)

"I thought we were deregulating. And now we're in the weeds with these, you know, same kind of issues we've been having over the years."

Regulatory lawyers describing their clients' surprise, The Medical Alley Podcast (link)

"With the amount of cash that pharma has, they need to use it and spend it."

ReAlta CEO Howard Berman on M&A, Becker Business (link)

"They're not your father's reverse mergers."

BioCentury's Paul Bonanos (link)

Catalysts to Watch

• Summit / ivonescimab FDA decision, on or before Nov 14, 2026, in EGFR-mutant lung cancer (BioSpace, 9/30).
• HARMONi-3 results: progression-free survival "late this year," overall survival "early next year." Hosts now think it could slip to late Q4 or early 2027 (Biotech Hangout).
• ESMO: Amgen's DeLLphi-305 small-cell lung cancer trial "has hit." Fazeli expects "a doubling of OS," which could "reset the bar" for first-line treatment (Biotech Hangout).
• AstraZeneca's AVANZAR trial, reading out "soon" (Biotech Hangout).
• Moderna/Merck kidney cancer (RCC) readout, the next big test for Moderna (Biotech Hangout).
• uniQure filing acceptance in Q4, with a possible decision in early or mid 2027 (BioSpace, 9/30).
• Lilly amylin + tirzepatide Phase 3 start, end of 2026 (Squawk on the Street).
• Dyne DM1 registrational data, next year (Biotech Hangout).
• Immix final update, March 2027 (Biotech Hangout).
• Overton committee vote. Senators are waiting on her written answers, and the vote could slip past the Nov 3 midterms (BioCentury This Week).
• Pharma tariff exemptions. Watch whether Commerce decisions arrive and whether there is an appeals process (BioCentury This Week).
• More biotech IPOs: T-Rex Bio, Iambic, City Therapeutics (Biotech Hangout).
• More Summit combination deals: Fazeli expects "a few more in the next few months" (Biotech Hangout).