On November 5, 2026 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported financial results for the third quarter ended September 30, 2026. Unless otherwise stated, all comparisons are for the third quarter of 2026 compared to the third quarter of 2025.

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Product revenue, net consists entirely of revenue from sales of NERLYNX, Puma’s first commercial product. Product revenue, net in the third quarter of 2026 was $54.1 million, compared to product revenue, net of $51.9 million in the third quarter of 2025. Product revenue, net in the first nine months of 2026 was $149.6 million, compared to $144.2 million in the first nine months of 2025.

Based on accounting principles generally accepted in the United States (GAAP), Puma reported net income of $6.0 million, or $0.12 per basic share and $0.11 per diluted share, for the third quarter of 2026, compared to net income of $8.8 million, or $0.18 per basic share and $0.17 per diluted share, for the third quarter of 2025.

Net income for the first nine months of 2026 was $10.4 million, or $0.20 per basic and diluted share, compared to net income of $17.7 million, or $0.35 per basic and diluted share, for the first nine months of 2025.

Non-GAAP adjusted net income was $8.0 million, or $0.15 per basic and diluted share, for the third quarter of 2026, compared to non-GAAP adjusted net income of $10.5 million, or $0.21 per basic and diluted share, for the third quarter of 2025. Non-GAAP adjusted net income for the first nine months of 2026 was $16.3 million, or $0.32 per basic share and $0.31 per diluted share, compared to non-GAAP adjusted net income of $23.0 million, or $0.46 per basic and diluted share, for the first nine months of 2025. Non-GAAP adjusted net income excludes stock-based compensation expense. For a reconciliation of GAAP net income to non-GAAP adjusted net income and GAAP net income per share to non-GAAP adjusted net income per share, please see the financial tables at the end of this news release.

Net cash provided by operating activities for the third quarter of 2026 was $14.6 million, compared to $9.7 million in the third quarter of 2025. Net cash provided by operating activities for the first nine months of 2026 was $31.6 million, compared to net cash provided by operating activities of $27.4 million in the first nine months of 2025. At September 30, 2026, Puma had cash, cash equivalents and marketable securities of $108.5 million, compared to cash, cash equivalents and marketable securities of $97.5 million at December 31, 2025.

"Third quarter U.S. NERLYNX sales were positively impacted by increased year-over-year demand and were negatively impacted by higher than expected gross to net due to an increase in Medicaid and 340B sales, as well as a delay in sales to Puma’s ex-U.S. commercial partners that shifted from the third quarter to the fourth quarter," said Alan H. Auerbach, Chairman, Chief Executive Officer and President of Puma. "We continue to anticipate increased year-over-year demand for NERLYNX, while we continue to advance alisertib across our ALISCA clinical development programs. During the quarter, we initiated ALISCA-Lung2, a Phase II trial evaluating alisertib in combination with paclitaxel in patients with advanced small cell lung cancer, further expanding our clinical development program in this area, while we are continuing to enroll the ALISCA-Breast1 and ALISCA-Lung1 trials."

Mr. Auerbach added, "We anticipate the following key milestones over the next 12 months: (i) presentation of updated data from ALISCA-Breast1, a Phase II trial of alisertib in combination with endocrine treatment in patients with chemotherapy-naïve HER2-negative, hormone receptor-positive metastatic breast cancer (San Antonio Breast Cancer Symposium, December 2026); (ii) initiation of discussions with global regulatory agencies regarding the Phase III trial design for alisertib in combination with endocrine treatment in patients with chemotherapy-naïve HER2-negative, hormone receptor-positive metastatic breast cancer (H1 2027); (iii) continued

enrollment in ALISCA-Breast1, a Phase II trial of alisertib in combination with endocrine treatment in patients with chemotherapy-naïve HER2-negative, hormone receptor-positive metastatic breast cancer to obtain more data in biomarker focused populations (H2 2026); (iv) continued enrollment of ALISCA-Lung1, a Phase II clinical trial of alisertib monotherapy for the treatment of patients with extensive stage small cell lung cancer and ALISCA-Lung2, a Phase II trial evaluating alisertib in combination with paclitaxel in patients with advanced small cell lung cancer (Q4 2026); and (v) presentation of updated data from ALISCA-Lung1, a Phase II clinical trial of alisertib monotherapy for the treatment of patients with extensive stage small cell lung cancer (2027)."

Revenue

Total revenue consists of product revenue, net from sales of NERLYNX, Puma’s first commercial product, and royalty revenue. For the third quarter ended September 30, 2026, total revenue was $55.1 million, of which $54.1 million was net product revenue and $1.0 million was royalty revenue. This compares to total revenue for the third quarter of 2025 of $54.5 million, of which $51.9 million was net product revenue and $2.6 million was royalty revenue. For the first nine months of 2026, total revenue was $156.4 million, of which $149.6 million was net product revenue and $6.8 million was royalty revenue. This compares to total revenue for the first nine months of 2025 of $152.9 million, of which $144.2 million was net product revenue and $8.7 million was royalty revenue. The third quarter and first nine months of 2026 included a $2.1 million reduction to royalty revenue as a change in accounting estimate, reflecting the receipt of new third-party market data confirming that the market share of generic versions of NERLYNX in China reached a specified threshold during the period.

Operating Costs and Expenses

Total operating costs and expenses were $49.8 million for the third quarter of 2026 , compared to $44.9 million for the third quarter of 2025. Operating costs and expenses in the first nine months of 2026 were $147.4 million, compared to $132.7 million in the first nine months of 2025. The year-to-date increases were primarily attributable to increases in R&D expenses and cost of sales.

Cost of Sales

Cost of sales was $15.2 million for the third quarter of 2026, compared to $12.2 million for the third quarter of 2025. Cost of sales was $38.1 million for the first nine months of 2026, compared to $35.0 million for the first nine months of 2025. The increases in cost of sales for the third quarter and first nine months of 2026 were due primarily to higher product sales to an international partner.

Selling, General and Administrative Expenses

Selling, general and administrative (SG&A) expenses were $16.3 million for the third quarter of 2026, compared to $16.8 million for the third quarter of 2025. SG&A expenses for the first nine months of 2026 were $52.3 million, compared to $52.5 million for the first nine months of 2025, and were virtually unchanged year over year.

Research and Development Expenses

Research and development (R&D) expenses were $18.3 million for the third quarter of 2026, compared to $15.9 million for the third quarter of 2025. R&D expenses for the first nine months of 2026 were $57.0 million, compared to $45.2 million for the first nine months of 2025. The $11.8 million year-over-year increase for the first nine months resulted primarily from an $8.9 million increase in clinical trial expense, reflecting increased alisertib study activity, and an increase of approximately $2.9 million in internal R&D expense, primarily due to increased employee compensation including the hiring of a new executive.

Total Other Income (Expenses)

Total other income was $0.9 million for the third quarter of 2026, compared to total other expenses of $0.4 million for the third quarter of 2025. Total other income was $2.0 million for the first nine months of 2026, compared to total other expenses of $1.5 million for the first nine months of 2025. The $3.5 million year-over-year increase in other income for the first nine months of 2026 resulted primarily from a decrease in interest expense, reflecting a lower debt balance, as Puma paid down its debt principal in May 2026, partially offset by the termination of subleases as of March 31, 2026 and unfavorable exchange rates on Euro-denominated transactions.

Fourth Quarter and Full Year 2026 Financial Outlook

Fourth Quarter 2026

New Full Year 2026

Prior Full Year 2026

Net Product Revenue

$56–$58 million

$206–$208 million

$205–$209 million

Royalty Revenue

$11–$12 million

$18–$19 million

$19–$22 million

Total Revenue

$67–$70 million

$224–$227 million

$224–$231 million

Net Income*

$10–$12 million

$20–$22 million

$17–$20 million

Gross to Net Adjustment

28%–29%

27.5%–28%

26.5%–27.5%

Conference Call

Puma Biotechnology will host a conference call to report its third quarter 2026 financial results and provide an update on the Company’s business and outlook at 1:30 p.m. PT/4:30 p.m. ET on Thursday, November 5, 2026. The call may be accessed by dialing (877) 709-8150 (domestic) or (201) 689-8354 (international). Please dial in at least 10 minutes in advance and inform the operator that you would like to join the "Puma Biotechnology Conference Call." A live webcast of the conference call and presentation slides may be accessed on the Investors section of the Puma Biotechnology website at View Source A replay of the call will be available shortly after completion of the call and will be archived on Puma’s website for 90 days.

(Press release, Puma Biotechnology, NOV 5, 2026, View Source [SID1234674340])

On November 5, 2026 Genmab reported Financial Results for the Nine Months of 2026.

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Highlights

•Epcoritamab approved in Europe (as TEPKINLY) and Japan (as EPKINLY) in combination with R² for the treatment of adult patients with relapsed or refractory FL
•Initiation of two new Phase 3 trials for petosemtamab in first- and second-line CRC
•Genmab revenue increased 22% compared to the first nine months of 2025, to $3,238 million

"The third quarter of 2026 reinforced the breadth of our late-stage portfolio. TEPKINLY plus R2 became the first bispecific-based therapy approved in Europe for second-line FL, extending epcoritamab’s reach as a core therapy across B-cell malignancies. We also broadened our petosemtamab program with new Phase 3 studies in CRC, underscoring our confidence in this asset beyond head and neck cancer. As anticipated, we are now in our data-rich fourth quarter, where we have delivered pivotal readouts across our three late-stage assets, epcoritamab, Rina-S (rinatabart sesutecan) and petosemtamab, supporting multiple regulatory submissions and potential launches in 2027," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

Financial Performance First Nine Months of 2026
•Revenue was $3,238 million for the first nine months of 2026 compared to $2,662 million for the first nine months of 2025. The increase of $576 million, or 22%, was primarily driven by higher DARZALEX and Kesimpta royalties and higher EPKINLY net product sales.
•Royalty revenue was $2,699 million in the first nine months of 2026 compared to $2,219 million in the first nine months of 2025, an increase of $480 million, or 22%. The increase in royalties was driven by higher net sales of DARZALEX and Kesimpta.
•Net sales of DARZALEX by J&J were $12,410 million in the first nine months of 2026 compared to $10,448 million in the first nine months of 2025, an increase of $1,962 million or 19%.
•Global net sales of EPKINLY/TEPKINLY were $491 million in the first nine months of 2026 compared to $333 million in the first nine months of 2025, an increase of $158 million or 47%.
•Cost of product sales were $234 million for the first nine months of 2026 compared to $157 million for the first nine months of 2025. The increase of $77 million, or 49%, was primarily driven by the profit-sharing amounts payable to AbbVie related to EPKINLY sales.
•Acquisition and integration related charges related to the integration of Merus were $87 million in the first nine months of 2026.
•Amortization of acquired intangible assets was $35 million for the first nine months of 2026 compared to $9 million for the first nine months of 2025. The increase of $26 million, was primarily driven by the amortization of the Merus technology platform.
•Operating expenses were $2,018 million in the first nine months of 2026 compared to $1,498 million in the first nine months of 2025, an increase of $520 million or 35%.
•Adjusted operating expenses, which exclude Acquisition and integration related charges and Amortization of acquired intangible assets, were $1,896 million for the first nine months of 2026 compared to $1,489 million for the first nine months of 2025. The increase of $407 million, or 27%, was primarily driven by investment in our product pipeline, including the advancement of Rina-S and petosemtamab, and our global commercialization capabilities in preparation for their anticipated launches.
•Operating profit was $986 million in the first nine months of 2026 compared to $1,007 million in the first nine months of 2025. Adjusted operating profit, which excludes Acquisition and integration related charges and Amortization of acquired intangible assets, was $1,108 million in the first nine months of 2026 compared to $1,016 million in the first nine months of 2025.

Non-IFRS Financial Measures
Our Adjusted operating expenses and adjusted operating profit excludes acquisition and integration related charges and amortization of acquired intangible assets. These charges were recognized in current as well as prior periods and will likely reoccur in future periods. These items are excluded from operating expenses and operating profit because the Company believes they neither relate to the ordinary course of the Company’s business nor reflect the Company’s underlying business performance.

Non-IFRS information is intended to portray the results of our baseline performance, supplement or enhance management’s, analysts’ and investors’ overall understanding of our underlying financial performance and facilitate comparisons among current, past and future periods. This information is not intended to be considered in isolation or as a substitute for the related financial measures prepared in accordance with IFRS and may not be the same as or comparable to similarly titled measures presented by other companies due to possible differences in method and in the items being adjusted. We encourage investors to review our financial statements and publicly-filed reports in their entirety and not to rely on any single financial measure.

The reconciliations of financial performance from IFRS to Non-IFRS for the first nine months of 2026 and 2025 were as follows:
2026 Actual Exclude 2026 Adjusted 2025 Actual Exclude 2025 Adjusted
(USD million) IFRS A&I* Amort** Non-IFRS IFRS A&I* Amort** Non-IFRS
Operating Expenses / Adj. Operating Expenses*** $ (2,018) 87 35 $ (1,896) $ (1,498) — 9 $ (1,489)
Operating Profit / Adj. Operating Profit $ 986 87 35 $ 1,108 $ 1,007 — 9 $ 1,016

* Acquisition and integration related charges
** Amortization of intangible assets acquired through acquisitions
***Includes all expenses presented within Total costs and operating expenses, less cost of product sales.
Key Company Events Post-Quarter End
•October: Positive topline results from the Phase 3 EPCORE DLBCL-2 trial evaluating fixed treatment duration epcoritamab in combination with standard of care rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone (R-CHOP), compared to R-CHOP alone, in newly diagnosed patients with diffuse large B-cell lymphoma (DLBCL) with an International Prognostic Index (IPI) score of 2 to 5. Data will be submitted for presentation at a future medical meeting. Genmab and AbbVie Inc. (AbbVie) will engage global regulatory authorities to determine next steps.
•October: Positive topline results from the global Phase 3 RAINFOL-02 trial of Rina-S in patients with platinum-resistant ovarian cancer (PROC) regardless of Folate Receptor Alpha (FRα) expression level or prior treatment with mirvetuximab. The trial met its primary endpoint of progression-free survival (PFS), with Rina-S demonstrating a statistically significant and clinically meaningful improvement compared with investigator’s choice chemotherapy in the intent-to-treat (ITT) and in the primary analysis set (PAS) populations. Based on these results, Genmab plans to engage with regulatory authorities worldwide regarding potential next steps. The data will also be submitted for presentation at a future medical meeting.
•October: Positive topline results from the global Phase 3 LiGeR-HN1 trial (NCT06525220) evaluating petosemtamab in combination with pembrolizumab versus pembrolizumab in patients with first-line (1L) PD-L1 positive recurrent/metastatic head and neck squamous cell carcinoma (HNSCC). The trial met both of its primary endpoints of overall survival (OS) and objective response rate (ORR), regardless of HPV status. Based on these positive topline results, Genmab plans to engage global regulatory authorities and will submit the full results from LiGeR-HN1 for presentation at a future medical meeting.

Outlook
Genmab is maintaining its 2026 financial guidance published August 6, 2026.
Conference Call
Genmab will hold a conference call to discuss the results for the first nine months of 2026 today, Thursday, November 5, at 6:00 pm CET, 5:00 pm GMT or 12:00 pm EST. To join the call please use the below registration link. Registered participants will receive an email with a link to access dial-in information as well as a uniquepersonal PIN: View Source A live and archived webcast of the call and relevant slides will be available at www.genmab.com/investor-relations.
Contact
Marisol Peron, Senior Vice President, Global Communications & Corporate Affairs
T: +1 609 524 0065; E: [email protected]

Andrew Carlsen, Vice President, Head of Investor Relations
T: +45 3377 9558; E: [email protected]

(Press release, Genmab, NOV 5, 2026, View Source [SID1234674339])

On November 5, 2026 Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688), an innovation-driven, global biopharma, reported financial results for the third quarter of 2026, along with recent product highlights and corporate updates

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"We are approaching a defining period for Zai Lab, as we advance toward bringing our first internally developed innovative medicines to patients globally," said Dr. Samantha Du, Founder, Chairperson and Chief Executive Officer of Zai Lab. "The strong first-line combination data for zocilurtatug pelitecan (zoci) presented at ESMO (Free ESMO Whitepaper) strengthen our confidence in its potential to become an ADC backbone of choice in small cell lung cancer. 2027 is set to be a pivotal year, with a potential first U.S. BLA submission for zoci and continued advancement of our first-line registrational development strategy in small cell lung cancer. Beyond zoci, ZL-1503 adds a second global program, targeting atopic dermatitis, one of the largest opportunities in immunology. Together with our commercially profitable China business, which we expect to return to growth in 2027, these advancements position Zai Lab to create substantial value for patients and shareholders."

"In first-line small cell lung cancer, zoci 1.6mg/kg plus atezolizumab demonstrated an 81.8% confirmed response rate and an encouraging 81.9% six-month progression-free survival rate, with a favorable tolerability profile," said Rafael G. Amado, M.D., President, Head of Global Research and Development at Zai Lab. "This profile supports taking a standard chemotherapy-free regimen into a global Phase 3 study and gives us a strong foundation to build on with T-cell engager combinations. Our registrational programs in SCLC and neuroendocrine carcinomas are advancing toward readouts that could support our first U.S. BLA submission in 2027. In atopic dermatitis, ZL-1503 is designed to block two drivers of disease at once: IL-13 for inflammation and IL-31Rα for itch, with a half-life that could support less frequent dosing. We will present first-in-human data at ACAAI in November and initial patient data in the first half of 2027, and we expect two additional oncology and immunology programs to enter the clinic in 2027."

Third Quarter 2026 Financial Results
•Total revenue was $108.2 million in the third quarter of 2026, compared to $116.1 million for the same period in 2025. Product revenue, net was $107.6 million in the third quarter of 2026, compared to $115.4 million for the same period in 2025. Net product revenue increased 2% versus the second quarter of 2026, primarily driven by NUZYRA, supported by increased market coverage and penetration, and KarXT, which was launched in June 2026, partially offset by a decrease in OPTUNE due to evolving competition in the glioblastoma market.
•Research and Development (R&D) expenses were $49.8 million in the third quarter of 2026, compared to $47.9 million for the same period in 2025.
•Selling, General and Administrative (SG&A) expenses were $70.1 million in both the third quarter of 2026 and the same period in 2025. R&D and SG&A both remained relatively flat year over year, reflecting continued efforts to streamline the organization, optimize resource allocation, and enhance operating efficiency as the company advances its next phase of growth.
•Loss from operations was $63.0 million in the third quarter of 2026, $47.6 million when adjusted to exclude certain non-cash expenses including depreciation, amortization, and share-based compensation. A reconciliation of loss from operations (GAAP) to adjusted loss from operations (non-GAAP) is included at the end of this release.

•Net loss was $46.1 million in the third quarter of 2026, or a loss per ordinary share attributable to shareholders of $0.04 (or loss per American Depositary Share (ADS) of $0.41), compared to a net loss of $36.0 million for the same period in 2025, or a loss per ordinary share of $0.03 (or loss per ADS of $0.33). The increase in net loss was primarily due to a $13.6 million in inventory write-downs in 2026.
•Cash and cash equivalents, current restricted cash, and short-term investments totaled $659.7 million as of September 30, 2026, compared to $717.5 million as of June 30, 2026.
Corporate Updates
•On October 22, 2026, the Company entered into a securities purchase agreement with certain accredited investors, relating to the sale of 11,340,000 ADSs, each representing ten ordinary shares of the Company with a par value of $0.000006 per share, at an offering price of $22.04 per ADS in a private placement transaction. The private placement closed on October 27, 2026, and the Company received gross proceeds of approximately $250.0 million, resulting in net proceeds to the Company of approximately $241.2 million after deducting placement agent fees and other expenses. The Company intends to use the net proceeds to fund the development of pipeline assets and for working capital and other general corporate purposes.
Recent Pipeline Highlights
Below are key product candidate updates since our last earnings release:
Oncology Pipeline
•Zocilurtatug Pelitecan (zoci, DLL3-Targeting ADC) (formerly ZL-1310):
•First-Line Extensive-Stage Small Cell Lung Cancer (1L ES-SCLC): In October 2026, Zai Lab presented promising data at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2026 from the ongoing Phase 1 study evaluating zoci in combination with atezolizumab as a first-line treatment for ES-SCLC. At the selected zoci dose of 1.6 mg/kg, the zoci plus atezolizumab doublet achieved a confirmed objective response rate (ORR) of 81.8% and an estimated 6-month progression-free survival (PFS) rate of 81.9% among 33 efficacy evaluable patients in 1L ES-SCLC. Among the first 15 patients with at least six months of follow-up, who had a median follow-up of 10.0 months, median PFS had not been reached. The doublet regimen was generally well tolerated, with 9.1% of patients experiencing Grade 3 or higher adverse events attributed to zoci and only one reported case of Grade 1 interstitial lung disease (ILD) or pneumonitis in this cohort. Based on the encouraging efficacy and favorable safety profile, Zai Lab is advancing the zoci 1.6 mg/kg plus PD-L1 inhibitors doublet into a global Phase 3 study in 1L ES-SCLC.
•Combinations with T-Cell Engagers (TCEs): Zai Lab continues to evaluate zoci in combination with TCEs including tarlatamab and obrixtamig, in collaboration with partners Amgen and Boehringer Ingelheim, respectively. These combinations are designed to pair zoci’s rapid tumor-debulking activity and favorable tolerability profile with T-cell-mediated killing, with the goal of deepening and extending responses in SCLC.
•Second-Line+ Extrapulmonary Neuroendocrine Carcinomas (2L+ epNECs): Zai Lab completed enrollment in the Phase 2 expansion portion of the ongoing global Phase 1b/2 study evaluating zoci in patients with 2L+ epNEC. Based on feedback from the U.S. Food and Drug Administration (FDA), Zai Lab will pursue a potential accelerated approval pathway based on this single-arm expansion study with topline data expected in the first half of 2027.
Immunology, Neuroscience, and Infectious Disease Pipeline
•ZL-1503 (IL-13/IL-31Rα):
•In October 2026, Zai Lab announced that initial first-in-human data from the single ascending dose (SAD) portion of the global Phase 1/1b study in healthy volunteers is expected to be shared for the first time at the American College of Allergy, Asthma & Immunology (ACAAI) 2026 Annual Scientific Meeting, taking place November 12–16, 2026, in Phoenix, AZ. Findings will include pharmacokinetic (PK) data following single-dose administration, as well as pharmacodynamic (PD) data on atopic dermatitis (AD)-related biomarkers across a range of ZL-1503 doses. The presentation will also include initial safety and immunogenicity data.
•In October 2026, Zai Lab completed enrollment for the global Phase 1 intravenous-to-subcutaneous (IV-to-SC) bioavailability bridging study.
•VYVGART (FcRn):
•Generalized myasthenia gravis (gMG) and chronic inflammatory demyelinating polyneuropathy (CIDP): In October 2026, the Center for Drug Evaluation (CDE) accepted the Chemistry, Manufacturing, and Controls (CMC) variation application for the addition of pre-filled syringe presentation of efgartigimod subcutaneous (SC) for the treatment of gMG and CIDP.
•Myositis: In August 2026, Zai Lab and partner argenx announced positive topline results from the Phase 3 ALKIVIA study evaluating VYVGART Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) in adults with autoimmune myositis. The study met its primary endpoint of mean Total Improvement Score (TIS) at week 52 in the combined study population of immune-mediated necrotizing myopathy (IMNM) and dermatomyositis (DM) patients (p=0.0011). Patient improvements were observed early and sustained throughout the study, with a consistent treatment effect across IMNM and DM. Zai Lab participated in the ALKIVIA study in Greater China.
•Sjögren’s Disease: In October 2026, argenx announced that it will discontinue the Phase 3 UNITY study of efgartigimod SC in adults with moderate-to-severe Sjögren’s disease. The decision is based on a recommendation from an Independent Data Monitoring Committee to stop the study for futility following an interim analysis, having concluded that the UNITY study is unable to meet its primary endpoint. Safety was consistent with efgartigimod’s established profile, and no new safety signals were identified.
•Elegrobart (Anti-IGF-1R, subcutaneous): Zai Lab completed enrollment in the Phase 3 registrational study for the treatment of thyroid eye disease in China.

Anticipated Major Milestones in the Fourth Quarter of 2026 and Full Year 2027
Global Pipeline
Zocilurtatug Pelitecan (zoci, DLL3-Targeting ADC; formerly ZL-1310)
•Second-Line Plus ES-SCLC: Complete enrollment in the global pivotal Phase 3 DLLEVATE study followed by a potential interim analysis in the second half of 2027. The randomized, open-label study is evaluating the safety and efficacy of zoci compared to investigator’s choice single agent chemotherapy (ICT) in patients with relapsed SCLC who have progressed on or after platinum-based first-line therapy as second-line therapy or one line of chemotherapy followed by tarlatamab.
•First-Line ES-SCLC: Initiate the global randomized Phase 3 study evaluating zoci 1.6 mg/kg in combination with PD-L1 inhibitors by year-end 2026.
•Second-Line epNECs: Provide topline data from the Phase 2 expansion portion of the ongoing global Phase 1b/2 study evaluating zoci in patients with second-line epNEC, with the potential to support a U.S BLA submission for accelerated approval in 2027.
ZL-1503 (IL-13/IL-31Rα)
•Complete enrollment in the multiple ascending dose (MAD) portion of the Phase 1/1b study in patients with AD with initial clinical data from the MAD portion expected in the first half of 2027.
ZL-6201 (LRRC15 ADC)
•Provide topline results from the dose-escalation portion of the global Phase 1a/b study evaluating ZL-6201 in patients with sarcoma and selected tumors in the first half of 2027.
ZL-1311 (MUC17/CD3)
•Submit an IND application in the U.S. in 2026 and initiate a global Phase 1 study in the first half of 2027.
ZL-1222 (PD-1/IL-12)
•Submit an IND application in the U.S. and initiate a global Phase 1 study in 2027.
Regional Pipeline
Efgartigimod (FcRn)
•Myositis: Potential China supplemental Biologics License Application (sBLA) submission in 2027, supported by the positive Phase 3 ALKIVIA data.
•Seronegative generalized myasthenia gravis: Potential China sBLA submission in 2027.
•Ocular myasthenia gravis: Potential China sBLA submission in 2027.
•Graves’ Disease: Initiate enrollment in the global Phase 3 VitaliThy study in Greater China in 2027.
Elegrobart (Anti-IGF-1R, subcutaneous)
•Provide topline results from the China Phase 3 registrational study in 2027.

Conference Call and Webcast Information
Zai Lab will host a live conference call and webcast today, November 5, 2026, at 8:00 a.m. ET (9:00 p.m. HKT). Listeners may access the live webcast by visiting the Company’s website at View Source Participants must register in advance of the conference call.
Details are as follows:
–Registration link for webcast (preferred): View Source
–Registration link for dial-in: View Source
All participants must use the link provided above to complete the online registration process in advance of the conference call. Dial-in details will be in the confirmation email which the participant will receive upon registering.
A replay will be available shortly after the call and can be accessed by visiting the Company’s website.

(Press release, Zai Laboratory, NOV 5, 2026, View Source [SID1234674330])

On November 5, 2026 Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer and Bispebjerg and Frederiksberg Hospital, University of Copenhagen, Denmark, reported that the first patient with proficient mismatch repair (pMMR) rectal cancer has successfully been dosed in the Phase 1 OV-PRIME-R 2 trial. The investigator-sponsored trial is evaluating BT-001, an armed oncolytic virus administered via intratumoral injection which will be followed by intravenous pembrolizumab3 . This population, which represents approximately 95% of rectal cancer cases, has to date shown poor response to immunotherapy alone.

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Henry G. Smith, PhD, Associate Professor and consultant surgeon at Abdominal Center K, Bispebjerg and Frederiksberg Hospital University of Copenhagen and Principal Investigator, commented: "We are excited to launch this investigator-sponsored trial, which explores an innovative approach to treating rectal cancer in patients with proficient mismatch repair status. By combining BT-001, an armed oncolytic virus, with anti-PD-1 therapy, in patients with localized disease, we aim to enhance the immune response and potentially improve outcomes for patients by reducing the risks of relapse or even reducing the number who need surgery at all. This study represents an important step toward more effective and less toxic treatment strategies for this underserved population."

"We are proud to support this investigator-sponsored trial in collaboration with the University of Copenhagen, evaluating BT-001 in patients with rectal cancer at high risk of relapse and severe toxicities from standard of care," added Emmanuelle Dochy, MD, Chief Medical Officer of Transgene. "BT-001 has already demonstrated excellent tolerability and the ability to transform "cold" tumors into biologically active ones. This study aims to further validate its potential to improve outcomes and quality of life for cancer patients."

While neoadjuvant (chemo)-radiotherapy can reduce recurrence and enable organ preservation in some patients with rectal cancer, fewer than 30% achieve a complete response and some patients still develop distant recurrences. Current adjuvant options are also limited, highlighting the need for effective, well-tolerated treatments that can prevent relapse without compromising quality of life.

The aim of this study is to investigate the safety, tolerability, and efficacy of neoadjuvant treatment with BT-001 combined with an anti-PD-1 antibody prior to standard surgery in patients with primary, localized rectal cancer.

Transgene and BioInvent are co-developing BT-001, developed using Transgene’s Invir.IO platform armed to express GM-CSF and BioInvent’s full-length anti-CTLA-4 monoclonal antibody, to trigger a strong anti-tumor immunity while minimizing systemic exposure.

With the ability to induce both local and systemic anti-tumor immune responses (see press release), BT-001 is a prime candidate to remodel the pMMR rectal cancer tumor microenvironment and enhance immune checkpoint inhibition without adding significant treatment-related toxicity, as evidenced by early clinical trials of BT-001 in patients with treatment-resistant metastatic cancers.

(Press release, Transgene, NOV 5, 2026, View Source [SID1234674329])

On November 5, 2026 Step Pharma ("the Company"), the global leader in CTPS1 inhibition for targeted cancer treatment, reported that an oral presentation disclosing the first preliminary data from its ongoing, open-label phase 2 VECTRA trial of dencatistat for high risk essential thrombocythaemia (ET) will be delivered at the 68th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, taking place in New Orleans, Louisiana from 12–15 December 2026.

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ET is a rare blood cancer characterised by the overproduction of platelets and increased risk of thrombosis that can lead to serious complications such as stroke or heart attack. The VECTRA trial is evaluating the safety, tolerability and efficacy of dencatistat, the Company’s first-in-class, highly selective, oral CTPS1 inhibitor, in up to 50 participants with high-risk ET across sites in the US, EU and UK. The trial’s primary endpoints are efficacy, safety, and tolerability. Secondary endpoints include durability of haematologic response and rates of thrombosis, haemorrhage, and disease transformation.

As of 21 July 2026, 10 out of 12 (83%) evaluable participants achieved platelet normalisation, and all achieved a platelet count of <600 ×10⁹/L, with a median maximal platelet reduction of 76% (22–86%) and no thromboembolic events occurring. A favourable tolerability profile was observed with nine participants (64%) having treatment related adverse events, predominantly anaemia and nausea. Further data will be presented at the meeting.

Oral Presentation Details:

Presentation title: A phase 2 study of dencatistat, an oral CTP synthase 1 inhibitor, for the treatment of high risk essential thrombocythemia; preliminary data from the VECTRA study.

Session: 634: Myeloproliferative Syndromes: Clinical and Epidemiological: Molecular Insights and New Approaches in MPNs

Date and time: Monday 14 December 2026, 4:00 PM to 4:15 PM CT

Presenter: Michael Loschi MD PhD

Location: Hall B, Ernest N. Morial Convention Center (MCCNO), New Orleans, Louisiana

Further details of the VECTRA trial can be found on ClinicalTrials.gov under the identifier NCT06786234.

(Press release, Step Pharma, NOV 5, 2026, View Source [SID1234674328])