Last updated: October 12, 2026
Merck’s remigromig met its noninferiority endpoint in the pivotal BRUNELLO trial, gaining 9.1 letters at one year against ranibizumab’s 11.8, with higher retinopathy rates. The FDA separately cleared three approvals on Friday: Tecentriq, Weltruza, and Hovilpri.
This article covers the full BRUNELLO dataset presented Saturday at AAO 2026, Friday’s three FDA approvals, the closed Vaxcyte and Spyre offerings, two IPO debuts, Monday morning’s two scheduled readouts, and Freenome’s ACG validation data, with sources for the weekend of October 9 to 11, 2026.
What did Merck’s BRUNELLO trial show at one year?
Both remigromig doses met the noninferiority primary endpoint against ranibizumab in diabetic macular edema at Week 52, but trailed the comparator numerically on vision gains and carried markedly higher rates of proliferative diabetic retinopathy events and adverse event discontinuations.
Merck presented the one year results of BRUNELLO (NCT06571045) on Saturday, October 10 at the American Academy of Ophthalmology meeting in New Orleans. The trial randomized 984 adults with diabetic macular edema 1:1:1 to remigromig 0.5 mg, remigromig 0.8 mg, or ranibizumab 0.5 mg, all given intravitreally every four weeks during year one. Remigromig is a trispecific agonist of the Wnt signaling pathway, a new mechanism in a field anti VEGF agents have owned for more than a decade.
| Arm | Mean BCVA change at Week 52 (95% CI) | Multiplicity adjusted p value |
|---|---|---|
| Remigromig 0.5 mg | +9.1 letters (8.1 to 10.1) | 0.0129 |
| Remigromig 0.8 mg | +8.7 letters (7.7 to 9.8) | 0.0222 |
| Ranibizumab 0.5 mg | +11.8 letters (10.7 to 12.8) | comparator |
Merck said the differences fell within the prespecified noninferiority margin and were not clinically meaningful. No secondary endpoint, including BCVA and central subfield thickness superiority, favored remigromig over ranibizumab.
What did the safety data show, and why does it matter?
The September topline announcement disclosed that safety event rates ran higher in the remigromig arms but withheld the numbers. The full table released Saturday shows proliferative diabetic retinopathy related adverse events at roughly seven times the comparator rate, a computation that is our arithmetic from the reported rates.
| Safety measure | Remigromig 0.5 mg | Remigromig 0.8 mg | Ranibizumab 0.5 mg |
|---|---|---|---|
| PDR related adverse events | 6.7% | 6.1% | 0.9% |
| Discontinuations due to adverse events | 4.9% | 4.5% | 0.9% |
Merck said PDR cases were generally manageable with standard care and that additional analyses are underway. The company said the results will be discussed with regulatory authorities, without a filing timeline. The commercial case for remigromig rests on durability: year two of BRUNELLO shifts to a personalized treatment interval algorithm, and the second pivotal study BAROLO (NCT06957080) continues in DME alongside SUPER TUSCAN (NCT07205887), a Phase 2 study in neovascular AMD and retinal vein occlusion. Merck shares closed Friday at 145.60 before the Saturday release, making Monday the first reaction session.
The same meeting carried Roche and Genentech’s one year Phase 3 data for vamikibart in uveitic macular edema from the MEERKAT and SANDCAT trials. The Saturday release was qualitative: a numerically higher proportion of treated patients achieved vision gains versus sham, about two thirds of eligible patients needed no retreatment after week 16, and the FDA decision on the filed application is expected by July 2027, per the company.
What did the FDA approve on Friday, October 9?
Three approvals landed the same day: Roche’s Tecentriq for adjuvant treatment of stage III dMMR colon cancer, Teva’s Weltruza as the first once monthly subcutaneous olanzapine for schizophrenia, and Asahi Kasei’s Hovilpri (pritelivir) for refractory mucocutaneous HSV lesions in immunocompromised adults.
| Product | Company | Indication | Key evidence |
|---|---|---|---|
| Tecentriq (atezolizumab), incl. Tecentriq Hybreza | Roche / Genentech | Adjuvant stage III dMMR colon cancer, with a fluoropyrimidine and oxaliplatin | ATOMIC, n=712: 50% reduction in risk of recurrence or death; 36 month disease free survival 86% vs 76% |
| Weltruza (olanzapine extended release injectable suspension) | Teva | Schizophrenia in adults; first once monthly subcutaneous olanzapine LAI | SOLARIS, n=675: PANSS improvement across three doses vs placebo; no loading dose, no oral supplementation, no post injection monitoring |
| Hovilpri (pritelivir) | Asahi Kasei | Mucocutaneous HSV lesions refractory (with or without resistance) to standard antiviral treatment in immunocompromised adults | PRIOH-1, n=101: complete lesion healing by Day 28 in 63% vs 34% for investigator’s choice (adjusted difference 28.4 points, p=0.0047) |
Why is the Tecentriq colon cancer approval significant?
It moves checkpoint inhibition into the adjuvant setting for mismatch repair deficient colon cancer, a curative intent population where the ATOMIC trial cut the risk of recurrence or death in half when atezolizumab was added to chemotherapy after surgery.
The approval, announced early Friday, covers both the intravenous form and the subcutaneous Tecentriq Hybreza. For diagnostics and pathology operators, an adjuvant dMMR indication raises the stakes on universal mismatch repair testing of resected colon cancers: the test result now changes curative intent therapy, not only metastatic management or Lynch syndrome screening.
What does Weltruza change in long acting antipsychotics?
Olanzapine has been the efficacy benchmark among oral antipsychotics, but its existing long acting injectable carries a post injection delirium and sedation syndrome risk that requires supervised observation after every dose. Teva’s label, per the company, requires no post injection monitoring, no loading dose, and no oral supplementation.
Weltruza, developed as TEV-‘749, dosed subcutaneously once monthly at 318 mg, 425 mg, or 531 mg (corresponding to 10, 15, or 20 mg daily oral olanzapine), improved PANSS scores across doses in the Phase 3 SOLARIS study of 675 adults. Teva did not release effect sizes. Discontinuations due to common adverse events were 5% versus 4% for placebo, and Teva expects US availability in the coming weeks, per its release. The EMA accepted the European application in May 2026.
What is Hovilpri and who is it for?
Pritelivir is an oral helicase primase inhibitor, a mechanism that does not depend on the viral thymidine kinase activation that resistance mutations disable, which is why it works against acyclovir resistant herpes simplex infections in immunocompromised patients.
In PRIOH-1, 63% of patients achieved complete lesion healing by Day 28 versus 34% on investigator’s choice therapy, which included intravenous foscarnet. Response rates through Day 42 were 82% versus 42%, adverse reactions 22% versus 54%, and discontinuations for adverse drug reactions 2% versus 20%, per the release. Asahi Kasei, which acquired developer AiCuris in April per Reuters, estimates about 15,000 addressable US patients and peak sales above $400 million in the mid to late 2030s, and expects availability before the end of 2026. The approval crossed Friday evening at 6:41 pm, a reminder that the agency clears significant drugs into weekends.
What closed in biotech capital markets this week?
Vaxcyte’s concurrent offerings closed October 9 with both overallotment options exercised in full, netting about $1.1 billion, and Spyre’s $350 million offering closed October 7 per its counsel. Both stocks rallied Friday, and two IPOs debuted at or below their offer prices.
| Deal | Terms | Status |
|---|---|---|
| Vaxcyte equity offering | 7,412,500 shares at $64.00 plus 400,000 pre funded warrants at $63.999; greenshoe of 1,171,875 shares exercised in full Oct 7; net ~$544.3M | Closed Oct 9 (8-K) |
| Vaxcyte convertible notes | $575M total (incl. $75M option exercised in full) of 1.50% notes due Oct 15, 2032; conversion price ~$89.60 | Closed Oct 9 (8-K); net ~$558.7M |
| Spyre Therapeutics follow on | 4,117,648 shares at $85.00, $350M gross, priced Oct 5 | Closed Oct 7 per counsel Ropes & Gray; company closing release not located as of Oct 11 |
| TRexBio IPO (TRXB) | 8,333,334 shares at $14.00, ~$116.7M gross | Debuted Oct 9; settled close $14.00, exactly at offer; closing expected Oct 13 |
| Retension Pharmaceuticals IPO (RTSN) | Upsized to 3.75M shares at $12.00, $45.0M gross, per the release as carried by RTTNews; funds a Phase 2b of RTN-001 in uncontrolled hypertension | Debuted Oct 9; settled close $10.53, 12.2% below offer (our arithmetic); closing expected on or about Oct 13 |
Combining the two net proceeds figures in Vaxcyte’s 8-K gives approximately $1.103 billion, our arithmetic. Both greenshoes were exercised within roughly a day of pricing, and the stock closed Friday at 71.38, up 9.8% from Thursday (our arithmetic), recovering a piece of the post announcement drawdown once the cash was banked. Spyre closed Friday at 85.69, up 7.2% and back 0.8% above its $85.00 offer price (our arithmetic), completing the round trip from 6.0% below offer earlier in the week.
What readouts land Monday morning?
Two companies scheduled Monday, October 12 topline announcements on Sunday evening: Mirum’s Phase 3 EXPAND study of Livmarli in ultra rare cholestatic liver diseases, and First Tracks Biotherapeutics’ Phase 1b Cohort 1 of ANB033 in celiac disease. Neither outcome was public when this article was prepared.
Mirum announced Sunday at 5:00 pm that it will host an investor call Monday at 8:30 am ET to share topline results from EXPAND, which studies Livmarli (maralixibat) for cholestatic pruritus in ultra rare cholestatic liver diseases in patients six months and older. Mirum closed Friday at 86.01, up 5.7% from Thursday (our arithmetic); the move preceded the Sunday announcement and no company disclosure explains it.
First Tracks Biotherapeutics, the immunology company spun off from AnaptysBio in April 2026, said Sunday it will report topline data Monday morning with an 8:30 am ET webcast for Cohort 1 of its Phase 1b gluten challenge study of ANB033, a CD122 antagonist, in celiac disease. The timing is notable: argenx’s FB102, also an anti CD122 antibody, delivered the mechanism’s first celiac win on October 8. Monday brings the field’s second celiac CD122 readout within a week, from a company that launched with about $180 million in cash and a runway into Q2 2028, per its releases.
How much better is Freenome’s next generation CRC test?
The updated SimpleScreen CRC blood test improved sensitivity for advanced precancerous lesions to 18.2% from 13.7% and for high grade dysplasia to 41.9% from 30.5%, while holding colorectal cancer sensitivity around 80% and specificity at 90%. The data get a late breaking oral presentation at ACG 2026 on October 14.
| Measure (US Census weighted) | Next generation test | Original (PREEMPT CRC) |
|---|---|---|
| Colorectal cancer sensitivity | 80.4% (95% CI 70.2 to 87.7; n=89) | 81.1% (n=72) |
| Advanced precancerous lesion sensitivity | 18.2% (95% CI 16.3 to 20.4; n=1,570) | 13.7% (n=2,567) |
| High grade dysplasia sensitivity | 41.9% (95% CI 34.0 to 50.3; n=157) | 30.5% (n=110) |
| Specificity (no colonoscopy findings) | 90% | 90% range per prior reporting |
The figures come from Freenome’s July 9, 2026 topline release on the clinical validation study, which used blinded, previously unevaluated samples from PREEMPT CRC plus previously tested samples; Sunday’s announcement selects the dataset for a late breaking oral presentation at the American College of Gastroenterology meeting on October 14. The first generation test was approved in July 2026 and launched commercially in late September through Abbott, which holds exclusive US commercialization. A $70 million Abbott milestone is tied to FDA approval of the next generation version and technology transfer, per the July release. Freenome plans a supplemental PMA. The strategic context: blood based screening wins on adherence, but advanced adenoma sensitivity remains the gap against stool based tests and colonoscopy, and each point of improvement narrows the strongest argument against the category.
What else happened over the weekend?
BridgeBio presented new evidence from two franchises, and several watched items stayed quiet, with verification scopes noted.
BridgeBio’s Sunday ASBMR presentation added evidence from the Phase 3 CALIBRATE study of encaleret in autosomal dominant hypocalcemia type 1: per the company’s release as carried by StockTitan, all encaleret participants reported improvement in at least one symptom versus 46% on conventional therapy, 91% versus 0% reached at least the lower normal limit for parathyroid hormone at 24 weeks, the FDA has accepted the application with Priority Review and a May 8, 2027 target action date, and the first participant was dosed in RECLAIM-HP, a roughly 160 patient Phase 3 in chronic hypoparathyroidism. The CALIBRATE topline itself dates to October 2025; Sunday’s data are congress analyses, not a new readout.
Separately at HFSA, an independent matched electronic health record study of 2,684 ATTR-CM patients associated BridgeBio’s acoramidis with an 18% lower risk than tafamidis on a composite of death, all cause hospitalization, new atrial fibrillation, or diuretic intensification (p<0.01), with 27% lower cardiovascular and heart failure hospitalization risk (p<0.001); death and new atrial fibrillation alone were not significantly different, and the company flagged residual confounding and short follow up, per its release as carried by StockTitan. This is a different study from the September claims based analysis published in Cardiology and Therapy; the two should not be conflated.
Items that stayed quiet, each checked Sunday night, October 11: Medtronic has not announced MiniMed exchange offer results or proration (scope: the Medtronic newsroom index, latest item October 7, and the StockTitan news index through Sunday); CMS has not published a GENEROUS model final participation count (scope: the cms.gov newsroom, items visible through October 9); no Atebrioz pricing document has surfaced (scope: web searches, launch coverage only); and no new filing was found in PhRMA’s suit against the GLOBE model (scope: web searches, all coverage dated October 7 to 8). Spyre’s own closing press release also remains unposted, though the closing itself is confirmed per counsel.
Which stocks moved on Friday?
Friday’s session rewarded completed financings and marked two IPO debuts. All closes are exchange settled; percentage moves are our arithmetic against Thursday’s closes.
| Ticker | Friday Oct 9 close | Move | Context |
|---|---|---|---|
| PCVX | 71.38 | +9.8% | Both offerings closed Oct 9 with greenshoes exercised in full; ~$1.1B net banked |
| SYRE | 85.69 | +7.2% | Back 0.8% above the $85.00 offer; closing confirmed Oct 7 per counsel |
| MIRM | 86.01 | +5.7% | Move preceded Sunday’s EXPAND call announcement; no disclosure explains it |
| TRXB | 14.00 | flat vs offer | Debut session closed exactly at the $14.00 IPO price |
| RTSN | 10.53 | −12.2% vs offer | Debut session after the upsized $45.0M IPO priced at $12.00 |
Frequently asked questions
Did remigromig fail BRUNELLO?
No. Both doses met the prespecified noninferiority primary endpoint against ranibizumab with multiplicity adjusted p values of 0.0129 and 0.0222. The trial succeeded statistically; the commercial question is whether a numerically smaller vision gain with higher PDR event rates can compete before durability data arrive.
What is remigromig’s mechanism?
It is a trispecific agonist of the Wnt signaling pathway given by intravitreal injection, a different mechanism from the anti VEGF agents (ranibizumab, aflibercept, faricimab) that define current DME care.
When could remigromig reach the market?
Merck gave no filing timeline, saying results will be discussed with regulatory authorities. The BAROLO Phase 2b/3 study in DME is ongoing, and year two BRUNELLO data on personalized treatment intervals will address the durability argument.
What is the difference between Weltruza and Zyprexa Relprevv?
Both deliver long acting olanzapine, but Weltruza is subcutaneous, once monthly, and per Teva requires no post injection monitoring, while the older intramuscular product carries a post injection delirium and sedation syndrome risk requiring supervised observation after each dose.
How big is the pritelivir market?
Asahi Kasei estimates about 15,000 US patients with refractory mucocutaneous HSV, mostly immunocompromised, and projects peak annual sales above $400 million in the mid to late 2030s, per statements carried by Reuters.
What did the ATOMIC trial show for Tecentriq?
In 712 patients with stage III dMMR colon cancer, adding atezolizumab to adjuvant chemotherapy cut the risk of recurrence or death by 50%, with 36 month disease free survival of 86% versus 76%, per the Roche release.
How much money did Vaxcyte actually raise?
The 8-K reports net proceeds of approximately $544.3 million from the equity offering and approximately $558.7 million from the convertible notes, about $1.103 billion combined (our arithmetic), with both overallotment options exercised in full on October 7.
Did the TRexBio and Retension IPOs succeed?
Both priced and traded, which itself marks an open window. Neither commanded a premium: TRexBio settled its debut exactly at the $14.00 offer and Retension closed 12.2% below its $12.00 offer (our arithmetic).
What is EXPAND studying?
Mirum’s Phase 3 EXPAND evaluates Livmarli (maralixibat) for cholestatic pruritus in ultra rare cholestatic liver diseases in patients six months and older, beyond its approved Alagille syndrome and PFIC indications. Topline lands Monday, October 12.
Why does the First Tracks readout matter beyond one small trial?
ANB033 is a CD122 antagonist, the same target class argenx validated in celiac disease with FB102 on October 8. A second positive celiac readout within a week would begin to establish a class effect; a miss would mark FB102’s win as molecule specific for now.
Is the Freenome data new?
The figures were first disclosed in the July 9, 2026 topline release. What is new is the venue: a late breaking oral presentation at ACG 2026 on October 14, giving gastroenterologists the validation detail behind the sensitivity improvements.
What is the significance of 18.2% advanced precancerous lesion sensitivity?
It is the category’s known weakness. Blood tests detect most cancers but few precancers, which limits their prevention value versus colonoscopy or stool DNA testing. The jump from 13.7% is meaningful progress that still leaves the gap wide.
When do MiniMed exchange results arrive?
The exchange offer expired at midnight at the end of Friday, October 9. As of Sunday night, October 11, Medtronic had not announced results or proration; an announcement is expected this week, after which MiniMed trades independently.
When does Q3 earnings season start for the sector?
Johnson & Johnson is scheduled for Tuesday, October 13 per published earnings calendars, opening a reporting season in which managements’ commentary on holding binary risk will be read against this month’s financing wave.
Sources
Primary sources: Merck press release, October 10, 2026 (BRUNELLO one year results, carried in full by wire aggregators including StockTitan); Roche and Genentech press releases, October 9 and 10, 2026 (Tecentriq approval; vamikibart one year data); Teva press release, October 9, 2026 (Weltruza approval, via trade carries); Asahi Kasei press release, October 9, 2026 (Hovilpri approval, via StockTitan carry); Vaxcyte Form 8-K filed October 9, 2026 (sec.gov, fetched directly); Freenome press releases, July 9 and October 11, 2026 (investors.freenome.com; StockTitan carry); Mirum Pharmaceuticals press release, October 11, 2026; First Tracks Biotherapeutics press release, October 11, 2026; BridgeBio press releases, October 11, 2026 (via StockTitan carries; full releases not independently fetched); Retension Pharmaceuticals pricing release, October 9, 2026 (via RTTNews carry; Form 424B4 on file at sec.gov).
Corroborating coverage: Reuters (pritelivir approval, October 9); Ropes & Gray deal announcement (Spyre closing, October 7); RTTNews; Renaissance Capital (Retension terms context); HCPLive, AJMC, Psychiatric Times (Weltruza); Ophthalmology Times (AAO coverage). Market closes: exchange settled closes via Robinhood, October 9, 2026; percentage moves are our arithmetic. Verified absences: Medtronic newsroom and StockTitan index (MiniMed results); cms.gov newsroom (GENEROUS); web searches October 11 (Atebrioz pricing; PhRMA v GLOBE docket), scopes as stated in the body.
Related coverage
Read our Friday report on argenx’s UNITY futility stop and the FB102 celiac win that set up Monday’s CD122 readout, our coverage of PhRMA’s suit against the GLOBE model, our report on Vaxcyte’s $1 billion raise that closed this week, and our analysis of the VAX-31 Phase 3 win that started it.
