Iovance fell 35.4% on October 29, 2026 after lifileucel’s 24.6% lung cancer response rate matched last year’s interim and it pivoted to biomarker selection.
Last updated: October 30, 2026
Iovance Biotherapeutics lost 35.4% of its value on October 29, 2026 after reporting a 24.6% objective response rate for lifileucel in second line nonsquamous lung cancer, in line with last year’s interim, and pivoting its registrational plan to a biomarker selected cohort called POSITILITY.
Scope: this briefing covers Thursday, October 29, 2026, including Iovance’s precision TIL pivot, third quarter results from Eli Lilly, Merck and Gilead, FDA’s individualized genome editing draft guidance, two IPO pricings, and the session’s market moves.
Why did Iovance fall 35% after calling its lung cancer data positive?
Because the headline number did not move and the plan narrowed. Lifileucel’s 24.6% objective response rate in 69 patients matched the 25.6% interim Iovance reported in 39 patients in November 2025, and the new registrational strategy targets a biomarker selected subset of the disease.
Iovance Biotherapeutics reported updated results from the registrational Phase 2 IOV-LUN-202 study of lifileucel, its autologous tumor infiltrating lymphocyte (TIL) cell therapy, in patients with nonsquamous metastatic non small cell lung cancer whose disease progressed on or after platinum chemotherapy and a checkpoint inhibitor. As of the October 14, 2026 data cutoff, 17 of 69 patients responded, a 24.6% objective response rate that the company itself describes as consistent with the 25.6% rate previously reported in 39 patients. The 17 responses include 15 confirmed responses and two unconfirmed partial responses awaiting confirmation. The release reports no duration of response figure and no new numeric safety data, saying both remained consistent with previous reports under a reduced dose lymphodepletion regimen.
The new information sits in the retrospective biomarker analysis, summarized below. Patients were enrolled without prospective selection, four patients with unassessed KRAS status are excluded from the subgroup arithmetic, and the subgroups are small and overlapping, so these are hypothesis generating cuts rather than controlled comparisons.
| Population (retrospective) | n | Objective response rate |
|---|---|---|
| All treated nonsquamous mNSCLC | 69 | 24.6% (17 of 69) |
| KRAS wild type | 30 | 43.3% (13 of 30) |
| KRAS mutant | 35 | 11.4% (4 of 35) |
| KRAS wild type plus HER2 wild type | 25 | 52.0% (13 of 25) |
| Plus current or former smoker | 22 | 59.1% (13 of 22), two complete responses |
Read the table from the bottom up and the market’s reaction becomes legible: 13 of the 17 responses came from 22 of the 69 patients, which means the therapy is doing most of its work in less than a third of the population it was being developed for, and the KRAS mutant half of the study responded at 11.4%. Iovance closed at 9.56, down 35.4% from Wednesday’s 14.81 in the first session after the data (our arithmetic from exchange settled closes). Wednesday night’s announcement of the webcast had called the results positive without disclosing figures, which is why this briefing held the outcome as unknown until today.
What is the POSITILITY cohort and Iovance’s precision TIL strategy?
POSITILITY is a new prospective, biomarker enriched cohort inside the ongoing IOV-LUN-202 trial, designed with registrational intent and enrolling from November 2026. Selection uses KRAS wild type status, refined by HER2 wild type status and current or former smoking history.
Iovance says the criteria draw on standard tumor genomic testing and routinely collected smoking history rather than a novel assay, and it cites preclinical work linking oncogenic KRAS signaling to impaired antigen presentation as the biological rationale. The company estimates the enriched population at roughly 45% of US nonsquamous metastatic non small cell lung cancer cases. Enrollment begins in November 2026 at the first of more than 70 existing trial sites, and Iovance intends the cohort to support a potential registrational pathway, subject to FDA feedback. A frontline trial in the enriched population, OPTILISM, is planned for 2027, supported by a seven patient frontline cohort in which six of seven KRAS wild type patients with smoking history responded to lifileucel plus pembrolizumab, with HER2 status not assessed. The supplemental biologics license application for the broader nonsquamous population is still planned for 2027, from a final dataset of roughly 80 patients, with FDA discussions ongoing. Interim chief executive Frederick Vogt said the findings are reshaping how the company develops TIL therapy for lung cancer.
How much revenue did Eli Lilly report in Q3 2026?
Eli Lilly reported $24.4 billion of third quarter revenue, up 39% from $17.6 billion a year earlier, driven by 53% volume growth against a 15% decline in realized prices. The company raised its 2026 revenue guidance to $91 to 92 billion.
| Lilly Q3 2026 | Sales | Change |
|---|---|---|
| Total revenue | $24,397M | +39% |
| Mounjaro | $10,723M | +65% (outside US +93%) |
| Zepbound | $5,352M | +49% |
| Jaypirca | $228M | +59% |
| Ebglyss | $202M | +59% |
| Kisunla | $193M | +175% |
| Foundayo (orforglipron) | $184M | first revenue |
| Omvoh | $114M | +76% |
GAAP earnings per share rose 16% to $7.22 and non GAAP EPS rose 7% to $7.48; both include $4.57 per share of acquired IPR&D charges, roughly $4.2 billion in the quarter, primarily from the AtaiBeckley and Curevo acquisitions. US revenue rose 34% to $15.1 billion and revenue outside the US rose 47% to $9.3 billion. Full year guidance moved to $91 to 92 billion of revenue from $85 to 87 billion, a $5.5 billion raise at the midpoint per the release, with the performance margin outlook raised to 52.0 to 52.5% from 49.0 to 50.5%. On earnings, Lilly raised underlying non GAAP EPS guidance by $4.07 at the midpoint, more than offset by the $4.57 of acquired IPR&D charges, for an updated range of $35.00 to $36.00. The release also lists a run of period approvals: Mounjaro for cardiovascular risk reduction in type 2 diabetes, the once weekly basal insulin Onswik on September 24, Inluriyo with Verzenio on September 18, Jaypirca in previously untreated CLL on October 2, and Olumiant for pediatric severe alopecia areata on September 25. Phase 3 trials of eloralintide plus tirzepatide start in Q4 2026. The release gives no filing timing for retatrutide or new Foundayo approval dates. In trade coverage of the earnings call, BioSpace reported that Foundayo had passed 45,000 patients by the end of the quarter and that the company credited the Medicare GLP-1 Bridge program, which it said covers 500,000 patients on Lilly obesity medicines, 80% of them new to incretins; those figures are company statements via BioSpace, not in the release.
How did Merck’s third quarter defend the Keytruda franchise?
Merck grew sales 5% to $18.1 billion and raised both guidance midpoints, while Keytruda showed the franchise transition in one line: the intravenous product fell 5% to $7.77 billion, but Keytruda plus the subcutaneous Keytruda Qlex grew 6% to $8.6 billion.
Keytruda Qlex contributed $830 million against $5 million a year ago, which means the subcutaneous conversion is now large enough to more than cover the decline of the infusion franchise it is replacing. Elsewhere in the quarter, Winrevair sales nearly doubled to $694 million, Gardasil rose 14% to $2.0 billion, Enflonsia reached $187 million in its first RSV season at scale, and Ohtuvayre added $184 million from the Verona acquisition, while Bridion fell 67% on generic competition. GAAP EPS fell 12% to $2.04 and non GAAP EPS fell 3% to $2.49, including a $0.12 per share charge for a global license to SciBrunch’s preclinical oral KRAS G12D inhibitor MK-2690. Full year guidance narrowed and rose: sales of $66.8 to 67.3 billion and non GAAP EPS of $2.77 to $2.82, from $2.66 to $2.76 previously.
The pipeline section carried real news. The sacituzumab tirumotecan (sac-TMT) BLA in previously treated endometrial cancer was accepted with a PDUFA date of June 15, 2027, and Merck says it is in discussions with FDA and hopeful for an earlier approval, consistent with the early action pattern this briefing has tracked all year. FDA approved Welireg plus Lenvima in previously treated advanced renal cell carcinoma. The ifinatamab deruxtecan BLA in small cell lung cancer was voluntarily withdrawn. The intismeran autogene program with Moderna reported a 42% reduction in the risk of recurrence or death in adjuvant melanoma at ESMO. Enflonsia’s expansion sBLA carries a March 22, 2027 PDUFA date and the Idvynso sNDAs an April 22, 2027 date.
What did Gilead report, and why is Friday its first reaction session?
Gilead raised its 2026 product sales guidance to $31.0 to 31.3 billion from $30.1 to 30.4 billion after HIV sales grew 18% to $6.2 billion in the third quarter. The release crossed at 4:02 pm Eastern, after the close, so Friday is the first session that can price it.
Total product sales rose 13% to $8.3 billion, and 16% to $8.2 billion excluding Veklury. Biktarvy grew 10% to $4.1 billion and Descovy 49% to $1.0 billion. Trodelvy rose 42% to $506 million, liver disease sales 13% to $927 million, while cell therapy fell 18% to $355 million and Veklury 69% to $86 million. GAAP EPS was $1.94 and non GAAP EPS $2.55. The loss guidance tells the capital allocation story: Gilead expects a full year non GAAP loss per share of $1.20 to $0.85 because the year carries roughly $9.88 per share of acquired IPR&D from $12.4 billion of charges tied to the Arcellx, Tubulis, Ouro Medicines and PepStar transactions, the last of which, an oral IL-23R inhibitor program with the Phase 1 asset HCXT-2001, was announced alongside the results. FDA approved Bixlenvo, a bictegravir and lenacapavir single tablet regimen for virologically suppressed adults. The oral alpha 4 beta 7 inhibitor emvistegrast met its Phase 2 primary endpoint in ulcerative colitis, with Phase 3 planned for 2027. Cash stood at $6.4 billion at quarter end.
What does FDA’s individualized genome editing draft guidance change?
It lets sponsors of individualized genome editing products add new product variants to an existing BLA without each variant counting as a new product, provided the variants sit inside a predefined individualized feature space. FDA announced the draft on Tuesday, October 27, per BioPharma Dive.
The draft guidance, titled Individualized Human Genome Editing Products: Considerations for BLA Submission and Postapproval Management, is dated October 2026 and issued by the Center for Biologics Evaluation and Research. Its central construct is the individualized feature space, the predefined set of product variations, such as guide RNA sequences, that a single license can cover for products sharing the same editing method and outcome. The document states that adding a new product variant within a predefined feature space should not be considered to result in a new product, and it describes both adding variants within an established feature space and expanding that space after licensure. It cross references the agency’s February 2026 plausible mechanism framework draft, which governs the evidence side of individualized therapies; October’s document governs the license and lifecycle side. The docket number and comment deadline sit in the Federal Register notice, which we could not retrieve tonight. BioPharma Dive, which first reported the announcement on Wednesday, quoted TD Cowen calling the approach plug and play and flagging Prime Medicine as a beneficiary, with Prime shares up 15% and Beam up 8% on Wednesday per the article. This briefing cut the story on Wednesday night because no primary document had been verified; the guidance text has now been fetched and the item prints as a dated catch up.
What did BioMarin license for Fabry disease?
BioMarin licensed HM15421/GC1134A, a long acting recombinant alpha galactosidase A enzyme replacement therapy in Phase 1/2, from GC Biopharma and Hanmi Pharm for $70 million upfront plus up to $405 million in milestones and tiered royalties, with worldwide rights outside Korea.
The asset is designed for extended half life and stability to support subcutaneous dosing, which BioMarin says could make it the first subcutaneous enzyme replacement therapy for Fabry disease. Chief executive Alexander Hardy framed the deal as building on this year’s Amicus acquisition and reaching Fabry patients beyond those with mutations amenable to Galafold. The combined potential consideration of up to $475 million before royalties is our arithmetic from the release’s components.
Which IPOs priced and who else reported after Thursday’s close?
Two biotech IPOs priced Thursday evening and both debut Friday, October 30: Aspen Neuroscience at $15.00 for roughly $140.6 million gross, and Bambusa Therapeutics, upsized, at $16.00 for about $168.9 million gross. A heavy earnings wave also crossed after the close.
| IPO | Price | Shares | Gross proceeds | Focus |
|---|---|---|---|---|
| Aspen Neuroscience (ASPE) | $15.00 | 9,375,000 | ~$140.6M | Autologous iPSC derived cell therapy for Parkinson’s disease (sasineprocel) |
| Bambusa Therapeutics (BBTX) | $16.00 | 10,555,555 | $168.9M | Long acting bispecific antibodies for immunology, lead in atopic dermatitis |
Both offerings are expected to close November 2, and both carry 30 day overallotment options. These are the latest names from the IPO queue this briefing has tracked since October, and their first sessions land on a tape that just cut a data stage cell therapy company by a third.
Penumbra, in its first quarter as a pending Boston Scientific acquisition, reported revenue of $410.1 million, up 15.6%, with US sales up 17.9% and global thrombectomy up 18.1%, and it suspended the usual rituals: per the release, it will not provide full year 2026 guidance or host a call given the pending acquisition. GAAP diluted EPS was $1.07, including $7.1 million of acquisition related costs. Stryker, Illumina, Dexcom, Exelixis, Biohaven, BridgeBio, Supernus, Stoke, CareDx, PTC Therapeutics, Immuneering and ResMed also reported after the close, and Merit Medical reported results, raised its full year outlook and announced the acquisition of Solo Pace in TAVR pacing, per its release headlines; their first reaction sessions are Friday. During the day, Novavax said it earned a $125 million milestone as Sanofi launched a Phase 3 trial of a combination influenza and COVID vaccine in Europe, and Seer said it remains an independent public company following its special committee review.
Which biotech and pharma stocks moved on October 29, 2026?
Iovance’s 35.4% decline was the session’s defining move; Lilly rose 6.6% on its guidance raise and Merck 3.8% on its beat, against a nearly flat XBI. All closes are exchange settled, and percentage moves are our arithmetic.
| Ticker | Close (Oct 29) | Move | Context |
|---|---|---|---|
| IOVA | 9.56 | −35.4% | First reaction to IOV-LUN-202 update and precision pivot |
| LLY | 1,373.70 | +6.6% | Q3 revenue +39%, 2026 guidance to $91 to 92B |
| MRK | 146.33 | +3.8% | Q3 beat, both guidance midpoints raised |
| AMGN | 460.73 | +2.0% | Fifth straight gain into its November 3 report |
| SMMT | 16.20 | +2.7% | Still below its pre readout level into the November 14 decision |
| XBI / SPY | 157.79 / 769.36 | +0.2% / −0.4% | Sector flat, market slightly lower |
Elsewhere on the watch list: Zai Lab’s offering closing release is now absent a fourth night, with our searches surfacing only the October 22 pricing items and a November 2024 closing release that does not apply; ZLAB closed at 22.36, down 3.0%. Liquidia’s six session winning streak ended at 44.99, down 1.6%, still with no disclosure behind the run. Gilead, Penumbra and the rest of the evening reporters see first reactions Friday.
Frequently asked questions
What response rate did lifileucel show in lung cancer?
In the Phase 2 IOV-LUN-202 study, lifileucel showed a 24.6% objective response rate in 69 patients with nonsquamous metastatic non small cell lung cancer after platinum chemotherapy and checkpoint inhibitor therapy, as of an October 14, 2026 cutoff.
What is the KRAS wild type response rate in IOV-LUN-202?
In a retrospective analysis, KRAS wild type patients responded at 43.3% (13 of 30), versus 11.4% (4 of 35) for KRAS mutant patients. Adding HER2 wild type status and smoking history raised the rate to 59.1% in 22 patients.
What is the POSITILITY trial?
POSITILITY is a prospective, biomarker enriched cohort within IOV-LUN-202 that begins enrolling in November 2026. It selects patients by KRAS wild type status, HER2 wild type status and smoking history, and Iovance intends it to support registration, subject to FDA feedback.
When will Iovance file for approval of lifileucel in lung cancer?
Iovance plans a supplemental biologics license application in the broader nonsquamous population in 2027, from a final dataset of roughly 80 patients, with FDA discussions ongoing.
How much revenue did Eli Lilly report in the third quarter of 2026?
Eli Lilly reported $24.4 billion in Q3 2026 revenue, up 39% year over year, on 53% volume growth against a 15% decline in realized prices.
What is Eli Lilly’s 2026 revenue guidance?
Lilly raised its full year 2026 revenue guidance to $91 to 92 billion from $85 to 87 billion, a $5.5 billion raise at the midpoint, with non GAAP EPS guidance of $35.00 to $36.00 after acquired IPR&D charges.
How much did Mounjaro and Zepbound sell in Q3 2026?
Mounjaro sales were $10.7 billion, up 65%, with sales outside the US up 93%. Zepbound sales were $5.4 billion, up 49%.
What were Keytruda sales in Q3 2026?
Keytruda sales were $7.77 billion, down 5%. Including the subcutaneous Keytruda Qlex, which contributed $830 million, the franchise grew 6% to $8.6 billion.
What is Merck’s full year 2026 guidance?
Merck expects 2026 sales of $66.8 to 67.3 billion and non GAAP EPS of $2.77 to $2.82, both midpoints raised, with the EPS range including a $0.12 per share license charge.
What is the PDUFA date for Merck’s sac-TMT in endometrial cancer?
The BLA was accepted with a PDUFA date of June 15, 2027, and Merck says it is hopeful for an earlier approval.
What is Gilead’s 2026 product sales guidance?
Gilead raised 2026 product sales guidance to $31.0 to 31.3 billion from $30.1 to 30.4 billion, while guiding to a full year non GAAP loss per share of $1.20 to $0.85 because of $12.4 billion in acquired IPR&D charges.
What does the FDA individualized genome editing guidance say?
The October 2026 CBER draft says adding a new product variant within a predefined individualized feature space should not be considered a new product, allowing one BLA to cover a family of individualized genome editing products that share an editing method.
At what prices did Aspen Neuroscience and Bambusa price their IPOs?
Aspen Neuroscience priced 9,375,000 shares at $15.00 for roughly $140.6 million gross. Bambusa Therapeutics priced an upsized 10,555,555 shares at $16.00 for about $168.9 million gross. Both debut on Nasdaq on October 30, 2026.
Why did Penumbra not give 2026 guidance?
Penumbra said that given its pending acquisition by Boston Scientific it would not provide full year 2026 guidance or host an earnings call. Q3 revenue rose 15.6% to $410.1 million.
What did BioMarin pay for the Fabry enzyme therapy license?
BioMarin agreed to pay GC Biopharma and Hanmi Pharm $70 million upfront plus up to $405 million in milestones and tiered royalties for worldwide rights outside Korea to HM15421/GC1134A, a Phase 1/2 long acting enzyme replacement therapy for Fabry disease.
Sources
Primary sources (October 29, 2026 unless noted): Iovance Biotherapeutics press release (GlobeNewswire); Eli Lilly third quarter 2026 earnings release (investor.lilly.com); Merck third quarter 2026 earnings release (SEC Form 8-K, Exhibit 99.1); Gilead Sciences third quarter 2026 earnings release (gilead.com); Penumbra third quarter 2026 earnings release (SEC Form 8-K, Exhibit 99.1); Aspen Neuroscience IPO pricing release; Bambusa Therapeutics IPO pricing release; BioMarin, GC Biopharma and Hanmi Pharm license announcement; Novavax milestone release; Amgen webcast notice (October 28); AbbVie earnings call notice (October 1); FDA draft guidance, Individualized Human Genome Editing Products (October 2026, CBER).
Trade coverage, attributed: BioPharma Dive (October 28, FDA guidance announcement and market reaction); BioSpace (October 29, Lilly earnings call coverage, Medicare GLP-1 Bridge figures). Market closes are exchange settled; percentage moves are our arithmetic.
