Neurocrine reported third-quarter results after the close on today. Total revenue rose 41% to $1.12 billion, and net product sales passed $1 billion in a quarter for the first time. All three marketed products grew. The company raised its INGREZZA guidance for the second time this year and cut its SG&A guidance, so it now expects to sell more while spending less to do it.

What matters in the print

1. The INGREZZA guide looks conservative. INGREZZA sold $2,174 million in the first nine months ($657M, $716M and $801M). The new $2.900-2.925 billion range implies Q4 of only $726-751 million. That is 10-14% above Q4 2025’s $657.5 million, but below Q3 even after removing the roughly $20 million order-timing benefit that management says will reverse. With mid-teens prescription growth expected in Q4 and the usual fourth-quarter gross-to-net pressure, we expect INGREZZA to land at or above the top of the range. We read the guide as a cushion, not a warning.

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In my Oct 20 brief, i mentioned that the Oct 25 is highly anticipated, and “A clear win against an approved immunotherapy outside lung cancer would help with Western doubts about China only data, though it won’t settle them.”

Earlier today, October 25, Akeso presented the full results of HARMONi-GI1 (LBA8) in ESMO’s Presidential Symposium in Madrid, and Summit, which holds ivonescimab rights in the U.S., Europe, Japan and other markets, put out a companion release.

In August Akeso had said the trial met its survival goal but gave no numbers. Now we have them.

HARMONi-GI1 randomized 682 patients in China with untreated advanced biliary tract cancer (BTC: cancers of the bile ducts and gallbladder) to ivonescimab or durvalumab (Imfinzi), each with gemcitabine and cisplatin (GemCis), followed by blinded maintenance. Imfinzi plus GemCis is today’s global standard of care, so this was a head to head test against an approved immunotherapy, not against chemo alone.

The Read

This is a clean win against a real comparator. A hazard ratio of 0.75 against Imfinzi is notable when Imfinzi itself only beat chemo with a hazard ratio of 0.80 in TOPAZ-1. The control arm’s median of 12.1 months is in line with what Imfinzi plus GemCis did in TOPAZ-1 (12.8 months), so the result does not come from a weak control. Progression-free survival (HR 0.61) and response rate (+21 points) point the same way. Fewer ivonescimab patients went on to later treatment (31.8% vs 45.9%), which if anything works against the experimental arm. This is the first time a PD-1/VEGF bispecific has beaten an approved checkpoint inhibitor on overall survival outside lung cancer.

The benefit is concentrated in one tumor type. Intrahepatic cholangiocarcinoma, cancer of the bile ducts inside the liver and 58% of patients, drove the result with a hazard ratio of 0.63. In extrahepatic bile duct cancer (HR 0.94) and gallbladder cancer (HR 0.95), the point estimates still favored ivonescimab but the confidence intervals cross 1.0 comfortably. These subgroups are small, so this may be noise, but Western regulators and doctors will ask about it. Gallbladder cancer is a larger share of BTC in some regions than in this trial.

The safety bill is the VEGF bill. Grade 3/4 side effects were higher (82.0% vs 72.3%), mostly low white-cell counts. VEGF type effects were clearly higher: proteinuria (protein in the urine) 32.2% vs 11.8%, hypertension 15.0% vs 2.4% and bleeding 9.7% vs 6.5%. Bleeding deserves attention in BTC, where many patients have biliary stents. On the other side, serious adverse events (43.4% vs 43.7%), severe immune-related events (4.1% each), discontinuations (3.5% vs 5.6%) and fatal events (3.2% vs 3.8%) were similar or better, and patients stayed on ivonescimab longer (7.8 vs 5.7 months).

What it means for SMMT

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Yesterday, October 21, Invivyd presented preclinical data on VMS063, its measles antibody, at IDWeek 2026 in Washington, D.C.

VMS063 targets the measles fusion (F) protein. It binds a highly conserved site and locks the protein in its pre-fusion shape, so the virus cannot fuse with and enter cells.

That is the same playbook behind the approved RSV antibodies for infants. In lab tests it neutralized both older and current measles strains, including B3 and D8, the two genotypes driving today’s outbreaks, in both authentic virus and pseudovirus assays.

The antibody is half-life extended, built for a high barrier to resistance, and Invivyd plans intramuscular or subcutaneous versions so one product could treat measles and protect people before or after exposure.

Manufacturing scale-up has started, with clinical development targeted for 2027.

Why measles, and why now

If you have been following, the backdrop is real.

The CDC counted 4,410 confirmed U.S. measles cases as of October 15, already about 93% above the 2,289 cases in all of 2025 and the most in decades.

Ten percent of patients have been hospitalized and 42 new outbreaks have been reported this year. Invivyd estimates that more than nine million U.S. school age children are not protected.

There is no approved antiviral for measles. Today doctors rely on the MMR vaccine within 72 hours of exposure, immune globulin within six days for people who cannot be vaccinated, and vitamin A plus supportive care once someone is sick. A potent, long-acting antibody given as a shot could improve on pooled immune globulin for post-exposure protection and would be the first targeted treatment.

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Today’s data supports the label and the eventual commercial story. The near-term catalysts are still the NDA resubmission and the Sopharma arbitration.

What happened

Earlier today, at CHEST 2026, Achieve presented 52 week efficacy results from ORCA-OL, an open label study of cytisinicline 3 mg three times daily with behavioral support.

The population was hard by design. All 475 dosed participants had already tried to quit in an earlier ORCA trial and were still smoking or vaping, and 71% had received cytisinicline in that trial.

The smokers averaged 56 years old with 37 years of smoking and a median of five prior quit attempts, and more than a third had also failed varenicline, bupropion or both. Many had hypertension, depression, cancer or COPD, and 86% were taking other medications.

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Canada is a useful addition but small. The stock is waiting on the Q3 launch numbers and the filing for the larger non-obstructive HCM market.

What happened

On Monday, October 19, Health Canada approved MYQORZO (aficamten) for adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM), NYHA class II–III. oHCM is an inherited condition where thickened heart muscle blocks blood leaving the heart. Health Canada issued its formal approval on the strength of the Phase 3 SEQUOIA-HCM trial:

• Exercise capacity: peak oxygen uptake, a standard exercise test measure, improved by 1.74 mL/kg/min versus placebo at 24 weeks (p=0.000002).

• Safety: serious adverse events were 5.6% on drug versus 9.3% on placebo.

• Heart pumping function: LVEF, the share of blood the heart pumps out with each beat, fell below 50% in 3.5% of patients on drug versus 0.7% on placebo.

As in the U.S., the Canadian label carries a boxed warning for heart failure and requires echocardiograms before and during treatment. This is the fifth approval in under a year, after the U.S., China, the EU and the UK.

Cytokinetics also set its Q3 report for November 4.

The stock rose 1.1% on Monday while the XBI gained 2.5%. In other words, the market treated Canada as housekeeping.

The read

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The Alzheimer’s trial is a footnote. The Vykat XR safety debate is what moves the stock right now.

What happened

Today, October 20, Neurocrine started a Phase 2 trial of NBI-1117567 (”NBI-’567”) in mild to moderate Alzheimer’s disease. NBI-’567 is a once daily oral drug that switches on the brain’s M1 and M4 muscarinic receptors, mainly M1. It is being tested as an add-on to an acetylcholinesterase inhibitor (the donepezil class of standard Alzheimer’s drugs), to see if it improves thinking and memory.

The trial:

• Patients: about 135 adults aged 50 to 85, all on a stable acetylcholinesterase inhibitor.

• Design: randomized, double blind, high or low dose versus placebo, 12 weeks of treatment.

• Main endpoint: change in a standard battery of memory and thinking tests at week 12. Secondary endpoints are ADAS-Cog13 and CDR Sum of Boxes, two common Alzheimer’s rating scales.

• Timing: estimated completion is June 2028.

• Partner: NBI-’567 came from Neurocrine’s 2021 deal with Nxera. Nxera received a $10 million milestone when the FDA cleared the trial to proceed in August.

The stock rose 3.7% . The XBI rose 3.6%, so the move was the sector, not the news.

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What happened this week

Yesterday, October 19, Summit made two announcements.

1. A new Phase II trial in kidney cancer. Summit opened sites for SMT112-216, which is a randomized, open label Phase II study run with Akeso. It will enroll about 100 patients in the U.S. and China with untreated advanced clear cell renal cell carcinoma, the most common form of kidney cancer. Patients go into one of four arms:

• ivonescimab plus cadonilimab, Akeso’s PD-1/CTLA-4 bispecific

• ivonescimab plus ipilimumab

• ivonescimab alone

• nivolumab plus ipilimumab, the standard of care comparator

This runs alongside Summit’s existing collaboration with Arcus, which pairs ivonescimab with casdatifan (a HIF-2α inhibitor) in a similar kidney cancer setting.

I think including the standard of care comparator is a very good idea. This aims to challenge the current standard practice and the market will be eagerly waiting for these results…

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Honestly, the selling doesn’t look like a reaction to company news.

On last week’s Biotech Hangout, sell side analysts called it the largest hedge fund pullback from biotech in more than five years. They cited a Goldman prime brokerage chart showing funds cutting biotech risk in six of the past eight weeks.

I think there are two things that are important to note:

• October 31. Many funds close their fiscal year then, which is the most likely point for the forced selling to ease.

• The Fed. It meets October 27–28, the week after this one. It raised rates to 3.75–4.00% in September. Markets now price only about a 17–25% chance of another hike this month, with December the more likely date.

The big event is ESMO, Madrid, October 23–27

This will be the main event of the week, but most of it lands on the weekend. Expect the stock moves on Monday the 26th, not this week. ESMO has 12 late-breaking abstracts in its top tier Presidential Symposium sessions this year. Most of the companies have already said their trials hit the main goal. What ESMO adds is how big the benefit was.

What I will be watching:

• INTerpath-001 (Moderna / Merck), Saturday the 24th, 10:30 AM ET. This is the Phase 3 trial of the personalized mRNA cancer vaccine intismeran plus Keytruda, versus Keytruda alone, in 1,137 patients with melanoma removed by surgery. The companies said in August that it extended the time before the cancer came back and the time before it spread. The question now is the size of the gap between the arms.

  • In the Phase 2b, the combination cut the risk of recurrence or death by 49% at five years. Something close to that would be a strong result.

  • Moderna hosts an investor call at 1:00 PM ET the same day.

  • Moderna rose 12% on the day the slot was announced, so i would say a lot of this is already in the price.

• HARMONi-GI1, Sunday the 25th. This is Akeso’s Phase 3 overall survival trial of ivonescimab against Imfinzi plus chemo in first line biliary tract cancer, a head to head test against the current standard.

  • The trial enrolled 682 patients, all in China. That limits how much Western regulators will rely on it.

  • It still matters to Summit (SMMT) holders as more evidence that the PD-1/VEGF approach works beyond lung cancer.

  • Summit’s U.S. PDUFA date for ivonescimab in EGFR-mutant lung cancer is November 14.

• TroFuse-005 (Merck), Monday the 26th. This trial tested sac-TMT, Merck’s TROP2 antibody-drug conjugate (ADC), against chemo in 776 patients with endometrial cancer that progressed after both platinum chemo and immunotherapy. Merck already said it improved both overall survival and progression free survival.

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  The Kidney Week, Denver, October 22-25

  The opening plenary on Thursday morning will feature three IgA nephropathy trials…

• Vera Therapeutics (VERA), ORIGIN 3, Thursday 9:05 AM MT. Vera presents the final efficacy analysis of ORIGIN 3 for Trutakna (atacicept), which already has accelerated approval. The interim analysis showed a 46% drop in proteinuria (protein in the urine, a marker of kidney damage) versus placebo at week 36.

  • What matters now is whether the effect held up, and whether kidney function (eGFR) data hint at the long-term benefit needed for full approval.

  • Vera presents its PIONEER basket trial data on Saturday.

Travere (TVTX) brings nine data sets for Filspari, including final results from SPARTAN, its first-line IgA nephropathy study.

FDA calendar

The week is light as far as FDA decisions goes…

A few notable tickers that are on FDA calendar are Regeneron and Viatris.

Any other impromptu events will be communicated in my briefs.

Apart from FDA calendar, we are now into earning season. I will be reporting all earning calls on our watchlist. So this week and the next might be a lot of emails and most of them about earning and updates from meetings.

Enjoy the week and happy investing…

Disclaimer: The views expressed in this article are solely my own and are based on my personal research and analysis. This content is for informational purposes only and should not be considered financial, investment, or legal advice. Always conduct your own research before making investment decisions.

Last week, before the market open on Thursday 15th, Recursion announced four things:

• A $200M follow on offering. It sold 61.54M shares at $3.25, about a 13% discount to the prior close, for roughly $187M net. Buyers included Janus Henderson, Invus, ARK and Driehaus.

• More REC-4881 data in FAP (familial adenomatous polyposis, an inherited condition that causes many precancerous gut polyps). The TUPELO study used 4 mg once daily, with a September 10 data cutoff:

  • After 12 weeks, the median drop in total polyp burden was 47%, and 87% of patients had some reduction.

  • In the upper GI tract, the median drop was 55%. Two patients had reductions of 98% or more, and 6 of 12 improved by at least one Spigelman stage (which is a standard grading of upper-GI disease severity).

  • Twelve weeks after stopping the drug, 85% were still below baseline overall and 92% in the upper GI.

  • No side effects above Grade 3 were reported, but 4 of 26 patients stopped because of side effects.

• The first efficacy data for REC-1245, its RBM39 degrader in cancer:

  • Three partial responses (two confirmed) in heavily pretreated endometrial and liver cancer, all at doses of 45 mg or higher.

  • Disease control in 11 of 12 patients at those doses.

  • The 65 mg dose went above the maximum tolerated dose, so 45 mg goes forward into expansion cohorts.

• A Sanofi milestone. Sanofi took an option on its first development candidate, an oral drug for inflammatory disease, which triggered a $10M payment. Total Sanofi payments now stand at $144M.

Recursion also said it will look for partners for REC-617 (CDK7) and REC-3565 (MALT1). Its runway, including the new money, now reaches into 2029.

How the stock traded

Thursday was actually strong: the stock closed at $4.16, up 11.2%, even though the deal was already public. Friday took all of that back. RXRX fell 19.6% to $3.46 on about 41M shares traded, only about 7% above the deal price.

About 36% of the float is sold short, which probably explains much of Thursday’s jump. Friday was the market pricing in the new shares.

If you remember my August piece on “Three biotech stocks I’m avoiding”, Recursion was on of the three.

Here is the article below if you wish to refresh your memory. And by the way, the other stock was RARE, which has fallen over 45% since then

Here is why i am maintaining the AVOID verdict for now, and what would change my mind on RXRX.

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On Thursday, October 14, Viking started SUNRISE, the Phase 3 program for its oral (once daily tablet) version of VK2735. It has two trials of 560 adults each:

• SUNRISE-1: people with obesity or overweight and at least one weight related condition.

• SUNRISE-2: people who also have type 2 diabetes.

• Design: patients take 27.5 mg, 35 mg or 55 mg once a day, or placebo, for 68 weeks. The main endpoint is percent weight loss versus placebo.

Also, a week earlier, on October 6, Viking began an oral maintenance study for patients who first lost weight on the weekly injection. The company later corrected that release. The study tests daily pills, monthly or every other week injections, and placebo, not “weekly oral” doses. Part 2 results are due in 2027.

This all follows a busy September:

• Maintenance data: results for the injectable showed patients kept up to 90% of their weight loss when switched to monthly shots, and up to 97% on every other week shots.

• Financing: Viking then raised more than $500 million in an upsized deal that closed September 28. It sold stock at $35 and $225 million of 2% convertible notes that convert at about $50.75. The underwriters bought their full extra allotment, so net proceeds were roughly $550 million.

Why the stock is down anyway. Shares are in the mid $20s, well below the $35 offering price, and fell about 8% on the day after SUNRISE was announced. There are three reasons.

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Invivyd makes antibodies that protect against COVID.

It has one product on the market, PEMGARDA, sold under an emergency use authorization that ends on June 29, 2027.

Everything else rides on VYD2311, which is a more potent successor that can be given as a single shot in the arm.

On September 29 the Invivyd reported a clean Phase 3 tolerability win against an mRNA vaccine and said it would file for Accelerated Approval based on safety and antibody levels, holding back the efficacy data until after approval.

The stock fell about 12% that day and now trades at $0.66.

My view is this is a cheap and binary setup. At the price of ~$0.66, the cash covers more than the market value. And the enterprise value is only about $94 million for a late-stage asset with a plausible fast regulatory path. Although, there is some ongoing concerns as i will highlight them below. Definitely a speculative buy, price target will change as catalysts come in. I would start with smaller position and accumulate depending on catalysts and de-risking events …

Limited OFFER to subscribe for FOUNDING member at 34% off the usual price. Send me a message and i will get you set up…

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This is a part (ii) piece for NBIX: The scientific deep dive for pipeline products.

Part (i) is HERE:

Now onto the second part on scientific deep dive.

As mentioned earlier, there is varying takes in the street about NBIX…

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Here is a quick summary for folks who are in a rush:

Executive Summary

The Hook. Neurocrine sells INGREZZA (valbenazine), a once daily VMAT2 inhibitor that dampens the excess dopamine signalling behind tardive dyskinesia (TD) and Huntington’s chorea. It is a $2.85B a year drug.

Since 2024 the company has added two orphan launches:

• CRENESSITY (crinecerfont), the first CRF1 receptor antagonist for classic congenital adrenal hyperplasia (CAH). It reached a $734M annualized run rate in only its sixth full quarter.

• VYKAT XR (diazoxide choline), the only approved treatment for hyperphagia in Prader-Willi syndrome. Neurocrine bought it with Soleno Therapeutics for $2.9B in May-2026.

Q2-26 revenue was $959M (+39%). Non-GAAP EPS was $2.85, and 2026 INGREZZA guidance was raised to $2.825–2.875B.

The funny thing is that the stock fell 10% on that beat and raise and sits 24% below its July high. At $141.37 it trades on 11.8x consensus 2027 EPS ($11.97). With this multiple, the market thinks is about to shrink.

So the reason actually has to do with what is to come in 2029. 1st of January 2029 to be exact. On this date, INGREZZA becomes eligible for Medicare price negotiation when the small biotech exception lapses.

CMS selects drugs in February-2027 and publishes the negotiated price around November-2027. Roughly 60% of INGREZZA’s volume is Medicare. Its direct competitor AUSTEDO (Teva) has already been negotiated to $4,093 per 30 days from 2027, 38% below list. In other words, the market is pricing INGREZZA’s Medicare reset from a precedent.

The Bull Case

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The bigger picture hasn’t changed. XBI topped out near $170 in August and has been drifting since, pressured by a string of disappointing trial readouts, a 10 year yield sitting around 5%, nervousness about the midterms and fewer takeovers of public biotechs, and o course, interest rates and the geopolitics.

Per the interviews i have seen, some folks at wall street believe that investors have become more cautious as they worry about the pull before the year end.

Not much is expected from this coming week. It is more about macro data and positioning than big events. But you never know, biotech moves fast and a lot more can happen (especially on the m&a side).

What is on the Calendar so far:

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I hope y’all are having a relaxing weekend. Just got some time to catch up on some positions i have written about, and finish the write ups i had not finished.

I initially started writing about this update on October 8, so you will notice that the share price is quoted as $1.05. And the numbers are run on $1.05, but the Friday price is $1.07.

I initiated on Talphera in July at about $1.46 with a $3.50 target. The stock closed today at $1.05, down roughly 28%.

I looked hard for a reason and did not find any company specific one. There has been no trial setback, no safety signal and no financing. Since the Q2 report on August 12, the company has put out only a conference notice.

What did change is the timeline. The topline we expected in 2026 now looks like early 2027, and the approval we expected in 2027 now looks like late 2027.

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Radiopharma is a hot market right now despite recent setbacks. There is still a lot of enthusiasm in this modalities and the m&a deals are a proof.

Sofie is a contract manufacturer (CDMO). They run about 15 production sites across the U.S. They are the ones who made the GE Healthcare’s Flycardo PET heart imaging agent.

This deal also hands GE U.S. rights to FAPI-74, a pan-cancer PET radiotracer which is in development.

The transaction is expected to close in the first half of 2027.

GE is positioning itself to lead this field and i think this is a strategic acquisition. PET radiotracers are short lived (the F-18 label has a ~110 minute half life).

So owning local manufacturing and distribution capacity is a structural advantage as theranostics and PET diagnostics scale.

This is the same logic that drove Novartis, Lilly, BMS and others to buy their way into the space.

My current view is that the core bet, OCU400’s Phase 3 in retinitis pigmentosa reading out in Q1 2027, is intact.

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I am writing this little piece to give some clear update, now that the dust has settled. The main goal is to look whether there is still some opportunity in the stock, which is now trading at $9.82. But first thing first, let’s look at what actually happened to MPLT.

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The asthma study had missed its primary endpoint, and we said the COPD readout would decide what came next. It came this morning, it was clean, and the stock is up about 58%.

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Summit therapeutics has announced that AstraZeneca will invest $2B in SMMT through convertible preferred stock.

This is roughly $18.36 per share.

Summit stock jumped about 17%.

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