Alligator Bioscience announces preliminary outcome in rights issue

On September 21, 2026 Alligator Bioscience AB ("Alligator Bioscience" or the "Company"), reported the preliminary outcome of the rights issue of units that was announced on 23 July 2026 (the "Rights Issue"). The preliminary outcome indicates that the Rights Issue has been subscribed to approximately 17.1 percent with and without exercise of unit rights, of which approximately 16.7 percent were subscribed for by exercise of unit rights and approximately 0.5 percent were subscribed for without exercise of unit rights. The preliminary outcome thus indicates that guarantee commitments will be utilized with approximately 29.7 percent of the Rights Issue. Based on the preliminary outcome, Alligator Bioscience will initially receive SEK 58.8 million from the Rights Issue before issue costs and repayment of bridge loans.

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The subscription period in the Rights Issue ended on 18 September 2026. The Rights Issue comprised a maximum of 3,140,534,240 units whereof each unit consists of two (2) ordinary shares, one (1) warrant series TO 15 and one (1) warrant series TO 16. The preliminary outcome indicates that subscriptions with and without exercise of unit rights amount to a total of 538,108,763 units, corresponding to approximately 17.1 percent of the Rights Issue. The Rights Issue is thus subscribed below the guaranteed level and guarantee commitments will need to be utilized with approximately 29.7 percent of the Rights Issue, corresponding to a total of 931,891,237 units.

The final outcome of the Rights Issue is expected to be announced on 22 September 2026.

Advisers
APREA Partners AB acts as financial adviser in connection with the Rights Issue. Setterwalls Advokatbyrå AB is legal adviser to Alligator Bioscience. Vator Securities AB acts as the issuing agent in connection with the Rights Issue.

(Press release, Alligator Bioscience, SEP 21, 2026, View Source [SID1234670967])

Telix and ITM Join Forces to Create a Radiopharmaceutical Powerhouse

On September 21, 2026 Telix reported it has signed a strategic agreement to lead a merger with ITM Isotope Technologies Munich SE ("ITM"), a global leader in radioisotope production and radiopharmaceutical development.

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The merger will further strengthen Telix’s leadership as a vertically integrated radiopharmaceutical company with the capabilities required to develop, manufacture and deliver innovative treatments to patients globally. The combined organization will be uniquely positioned as a radiopharmaceutical industry leader, differentiated by a world-class scaled isotope manufacturing business with a validated global distribution network, a market-leading commercial precision medicine platform and the industry’s most extensive therapeutic radiopharmaceutical pipeline.

Founded in 2004, ITM is a private company with a leading commercial scale radioisotope manufacturing and global distribution network spanning over 65 countries. ITM is a key supplier of 177Lu and – with a compound annual growth rate (CAGR) of 40% from 2021 to 2025 – delivered annual revenue of US$273 million in 20252. This commercial momentum is underpinned by increasing global demand for TRT and radioisotopes for commercially approved products and assets under clinical development. The global nuclear medicine market is forecast to reach US$41 billion by 20343.

ITM’s late-stage novel pipeline is complementary to Telix and includes ITM-11 (177Lu-edotreotide), a differentiated somatostatin receptor (SSTR)-targeted treatment for GEP-NETs. ITM-11 has completed a successful Phase 3 trial (COMPETE, NCT03049189)4 and fully enrolled a second indication expansion Phase 3 study (COMPOSE, NCT04919226) with an interim analysis expected in H1 2027. If approved, ITM-11 has the potential to accelerate Telix’s entry into the commercial therapeutic market and expand its presence in neuroendocrine tumors, a commercially validated and clinically significant market for TRT.

The combined organization is expected to generate unaudited pro forma 2026 revenue and income exceeding US$1.3 billion5, based on management estimates. ITM’s radioisotope manufacturing business is profitable and generates cash flow. Continued growth from manufacturing, cost savings and further synergies and pipeline optimization are expected to support a positive EBITDA6 contribution in 20277 and onward. If approved by health regulators, the launch of ITM-11 is expected to drive further upside, with the potential to generate additional high-margin therapeutic revenue in the near term.

Telix Managing Director and Group CEO, Dr. Christian Behrenbruch, said, "This merger positions Telix at the forefront of the consolidation that is occurring as the industry matures. ITM is the leader in radioisotope production, with deep scientific expertise and a track record of value-adding innovation. We have enjoyed a close working relationship with ITM for many years and there is strong management alignment for the rationale behind this transaction. By combining our complementary strengths, we will create a company with commercial scale, world-leading supply and the most exciting theranostic drug portfolio in the sector. Importantly, this combination further expands our late-stage therapeutic pipeline with two completed Phase 3 trials and deepens radioisotope security, while bringing together the mission critical capabilities needed to deliver radiopharmaceutical treatments to patients around the world."

ITM Chief Executive Officer, Dr. Andrew Cavey, added, "Joining two radiopharmaceutical pioneers creates a company with unmatched breadth and depth across the value chain, supported by deep expertise and talent. Our management teams have a track record of working together and a nuanced understanding of our respective commercial strengths and customer relationships. Together, we believe Telix and ITM will be uniquely positioned to capitalize on rapidly growing global demand for radiopharmaceuticals to the benefit of both Shareholders and patients."

Deal Terms

Under the terms of the agreement and subject to Shareholder approval, Telix will acquire 100% of the shares in ITM for US$1.65 billion upfront on a cash-free/debt-free basis expected as follows:

US$1.25 billion will be paid to the sellers in the form of 105.8 million Telix shares (priced at the 30-day trailing VWAP as of signing of US$11.841) and released to the sellers as Nasdaq-listed ADRs at the end of their respective escrow periods;
US$302 million of net debt will be assumed by Telix at closing; and
US$96 million of management equity rollover and transaction expenses payable by the sellers8; and in each case subject to closing adjustments.
Additional contingent consideration of up to US$700 million will become payable upon the achievement of specified regulatory approvals and sales milestones for ITM-11 as set out below:

Up to US$250 million upon U.S. Food and Drug Administration (FDA) approval of ITM-11 across three different indications:
US$100 million upon FDA approval for expected first indication in G1-G2 GEP-NETs no later than December 31, 2027;
US$100 million upon FDA approval for G2-G3 GEP-NETs indication no later than December 31, 2030; and
US$50 million upon FDA approval for Lung NETs indication no later than December 31, 2031; and
Up to US$450 million based on ITM-11 net global sales in FY 2030 in excess of US$150 million.
All milestone consideration will be payable in cash or Shares9 at Telix’s election10. Consideration paid to ITM Shareholders at closing is subject to financial adjustments at closing, indemnity holdbacks, and escrow (lockup) restrictions on the Shares issued at closing of up to 15 months which may be waived in limited part to allow the sellers to pay their tax and transaction expense liabilities.

Upon completion of the transaction, Telix Shareholders will own approximately 76.3% and ITM Shareholders will own approximately 23.7% of Telix shares on issue. The transaction has been approved by Telix’s Board of Directors and, as of signing, Shareholders holding over 90%11 of ITM’s Shares. The transaction is expected to close by the end of FY 2026 subject to Telix Shareholder approval as required under the ASX Listing Rules, regulatory approvals, and other customary closing conditions.

Refer to the Investor Presentation lodged today with the ASX for further information on the transaction.

A Notice of Meeting will be sent to Telix Shareholders for an extraordinary general meeting expected to be held in November 2026.

(Press release, Telix Pharmaceuticals, SEP 21, 2026, View Source [SID1234670964])

Antengene Announces First Patient Dosed in Pivotal Phase III CLINCH-3 Study of ATG-022

On September 20, 2026 Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative, commercial-stage global biotech company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for autoimmune diseases, solid tumors and hematological malignancies, reported that the first patient has been dosed in China in the pivotal Phase III CLINCH-3 study of ATG-022. ATG-022 is a CLDN18.2 antibody-drug conjugate (ADC) being evaluated for the treatment of CLDN18.2+ advanced gastric or gastroesophageal junction adenocarcinoma.

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ATG-022 was previously granted Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA). This designation has facilitated efficient regulatory communications and supported the rapid advancement of the CLINCH-3 study. Initiated in China with the first patient dosed and planned for expansion into a multi-regional clinical trial (MRCT), the CLINCH-3 study is intended to generate robust clinical evidence to support a future marketing approval application for ATG-022 as monotherapy for CLDN18.2+ advanced gastric or gastroesophageal junction adenocarcinoma.

The CLINCH-3 study is led by Prof. Lin Shen from Peking University Cancer Hospital as the principal investigator. This is a randomized, controlled, open-label, multicenter Phase III clinical study designed to evaluate the efficacy and safety of ATG-022 versus treatment of investigator’s choice in patients with CLDN18.2+ advanced gastric or gastroesophageal junction adenocarcinoma. The initiation of this pivotal study is supported by encouraging results from the Phase I/II CLINCH studies, which showed that ATG-022, as monotherapy, demonstrated a differentiated robust efficacy and well tolerated safety profile in patients with advanced gastric or gastroesophageal junction adenocarcinoma. As of June 26, 2026, among patients with moderate to high CLDN18.2 expression (IHC 2+ ≥ 20%), in the 1.8 mg/kg dose cohort, the recommended phase 2 dose (RP2D), the ORR was 46.7% (14/30) with confirmed ORR of 40% (12/30), the DCR was 86.7% (26/30), and the mOS had not yet been reached after a median follow‑up of 14.03 months. Among patients with low/ultra-low CLDN18.2 expression treated at the efficacious dose range of 1.8-2.4 mg/kg, the ORR was 28.6% (6/21) and the DCR was 52.4% (11/21). In addition, multiple patients achieved complete responses (CR). In terms of safety, compared with the data cutoff of December 25, 2025, the incidence of Grade ≥3 treatment‑related adverse events (TRAEs) in the 1.8 mg/kg dose cohort increased slightly from 19.4% to 21.0%, with only 9.7% of patients experiencing dose reduction due to TRAEs. Despite more than six additional months of treatment exposure and follow‑up, the incidence of Grade ≥3 TRAEs remained broadly stable in the 1.8 mg/kg dose cohort. Together with its robust antitumor activity, encouraging survival outcomes and favorable tolerability, these data position ATG-022 as a potential best-in-disease therapy for gastric cancer or gastroesophageal junction adenocarcinoma.

"The dosing of the first patient in CLINCH-3 marks an important step in the clinical evaluation of ATG-022." said Professor Lin Shen of Peking University Cancer Hospital, principal investigator of the CLINCH-3 study. "Patients with advanced gastric or gastroesophageal junction adenocarcinoma continue to face substantial unmet medical needs, particularly after disease progression on existing therapies. The antitumor efficacies and manageable safety profile observed in the Phase I/II study demonstrate therapeutic potential, supporting advancement of ATG-022 into the pivotal Phase III clinical study. CLINCH-3 will provide important evidence regarding whether ATG-022 can improve clinical outcomes for patients with CLDN18.2+ disease. We look forward to conducting this study with scientific rigor and working closely with participating investigators and study centers."

Antengene will continue to advance the three complementary clinical development pathways planned for ATG‑022: CLINCH-3 provides a near-term registration pathway for ATG-022 monotherapy at the optimized RP2D 1.8 mg/kg dose in 3L+ gastric/GEJ cancer with CLDN18.2 IHC 2+ ≥ 20%, establishing ATG-022 in gastric cancer. CLINCH-2 is evaluating ATG-022 in 1L in combination with standard-of-care chemotherapy and anti-PD-1 therapy, targeting the broadest CLDN18.2-positive population starting from IHC 1+ ≥ 1%, with the goal of supporting 1L registration and unlocking the full potential of ATG-022 in gastric cancer. Meanwhile, the CLINCH basket trial is expanding ATG-022 beyond gastric cancer, with encouraging efficacy already observed in multiple non-gastric CLDN18.2-positive solid tumors. Through this strategy, the company aims to maximize the clinical potential of ATG-022 and bring innovative, impactful therapies to patients in China and around the world.

(Press release, Antengene, SEP 20, 2026, View Source [SID1234670965])

BlossomHill Therapeutics Reports Second Quarter 2026 Financial Results

On September 18, 2026 BlossomHill Therapeutics, Inc. (Nasdaq: BLSM), a clinical-stage biopharmaceutical company applying an intentional, chemistry-based approach to design and develop innovative small molecule medicines for the treatment of cancer, reported financial results for the second quarter 2026 and highlighted recent progress.

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"We’ve achieved meaningful progress across our pipeline, as well as our significant corporate milestones, since the beginning of the second quarter," said Jean Cui, Ph.D., Founder, President and Chief Executive Officer of BlossomHill Therapeutics. "In April, we presented our first preclinical data from our pseudo-irreversible pan-KRAS inhibitor BH-501284, built on a novel chemical scaffold, at AACR (Free AACR Whitepaper) where we highlighted the sustained target engagement leading to tumor regression at low dose levels. At ASCO (Free ASCO Whitepaper) in early June we presented the preliminary safety, PK and antitumor activities of BH-30643 in Phase 1 dose escalation of the SOLARA trial, along with the initial efficacy data in C797S-positive NSCLC. More recently we announced that BH-30643 received Fast Track designation, an important regulatory milestone that reflects the FDA’s recognition of the potential for this molecule. We also presented encouraging safety data and early signs of anti-leukemic activity observed with BH-30236, our novel macrocyclic CLK inhibitor, both as a monotherapy and in combination with venetoclax, at EHA (Free EHA Whitepaper) in the middle of June. We are now looking forward to our end-of-phase 1 meeting with the FDA later this year. With a strong balance sheet following our successful initial public offering in August, we believe we are well positioned to deliver important clinical and regulatory milestones over the coming quarters as we continue advancing our intentionally designed medicines that address significant unmet medical needs in cancer treatment."

Recent Business Highlights and Corporate Updates:

Strengthened the balance sheet with approximately $168.3 million in gross proceeds from the initial public offering (IPO) in August 2026
Announced the U.S. Food and Drug Administration (FDA) granted Fast Track designation to BH-30643, a macrocyclic OMNI-EGFR inhibitor, for the treatment of adult patients with advanced or metastatic epidermal growth factor receptor (EGFR) C797S-positive non-small cell lung cancer (NSCLC) after prior treatment with a third-generation EGFR tyrosine kinase inhibitor (TKI)
Presented preliminary results of BH-30643 from dose escalation and backfill cohorts in the ongoing Phase 1/2 SOLARA trial in advanced or metastatic EGFR-mutant NSCLC at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2026 annual meeting, and additional follow up data at IASLC 2026 World Conference on Lung Cancer, which highlighted a 45% objective response rate and 88% disease control rate observed in patients with C797S resistance to prior TKIs, with or without concurrent T790M mutation
Presented the first preclinical data from the pseudo-irreversible pan-KRAS inhibitor BH-501284, built on a novel chemical scaffold, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2026 annual meeting
Presented initial clinical data from the ongoing first-in-human Phase 1/1b trial of BH-30236, an orally bioavailable, macrocyclic CDC-like kinase (CLK) inhibitor, in relapsed or refractory acute myeloid leukemia (R/R AML) and higher-risk myelodysplastic syndromes (HR-MDS) at the European Hematology Association (EHA) (Free EHA Whitepaper) 2026 Congress
Expanded the Company’s Board of Directors with the appointments of Sheila Gujrathi, M.D., and John Schmid

Anticipated Upcoming Milestones:
BH-30643

Q4 2026: End of Phase 1 meeting regarding a recommended Phase 2 dose selection and a potential accelerated approval pathway in C797S resistance
Q1 2027: First patient dosed in anticipated pivotal Phase 2 trial
1H 2027: Updated Phase 1 data, including C797S durability
2H 2027: Updated Phase 1 data on TKI-naive durability and initial chemo combo cohort data
BH-501284

Q1 2027: Investigational New Drug submission

BH-30236

1H 2027: Updated Phase 1 data on safety and anti-leukemic effect

Second Quarter 2026 Financial Results

Research and development (R&D) expenses for the second quarter of 2026 were $21.4 million, compared with $12.5 million for the same period in 2025. The increase was primarily due to greater clinical development expenses driven by the SOLARA trial, expenses to support IND-enabling studies for BH-501284, and greater costs related to personnel, facilities and other overhead.

General and administrative (G&A) expenses for the second quarter of 2026 were $3.3 million, compared with $1.6 million for the same period in 2025. The increase was primarily due to greater legal expenses, personnel-related expenses and overhead.

Net loss for the second quarter of 2026 was $23.8 million, or $(8.75) per basic and diluted share, compared with a net loss of $13.2 million, or $(5.51) per basic and diluted share for the same period in 2025. The increase in net loss was primarily attributable to increased operating expenses.

Cash and cash equivalents totaled $95.4 million as of June 30, 2026. BlossomHill subsequently completed its IPO in August 2026 in which it sold 10,516,240 shares of its common stock, including partial exercise of the over-allotment option, for gross proceeds of $168.3 million. BlossomHill believes that its cash and cash equivalents as of June 30, 2026, together with the proceeds from its IPO, will be sufficient to fund its operations into the second quarter of 2028.

About BH-30643
BH-30643 is an investigational, novel, orally bioavailable, non-covalent, macrocyclic, brain active, mutant-selective, OMNI-EGFR inhibitor for the treatment of EGFR-mutant NSCLC. BH-30643 was designed to overcome the limitations of currently approved EGFR inhibitors, which were discovered over a decade ago without the current, modern understanding of the structure and protein dynamics of mutant EGFRs. In preclinical studies, BH-30643 demonstrated potent inhibitory activity across diverse EGFR mutation categories – classical mutations, on-target resistance mutations such as C797S with or without T790M, atypical mutations and exon 20 insertions – while maintaining marked selectivity over wild-type EGFR. BH-30643 has received Fast Track designation and is being evaluated in SOLARA, a global Phase 1/2, first-in-human clinical trial spanning more than 40 sites in 10 countries. Ongoing dose expansion cohorts are enrolling in both TKI-pretreated and TKI-naive settings, including a C797S resistance cohort. For additional information on SOLARA, including a list of study sites and how to enroll, please visit clinicaltrials.gov (NCT06706076).

About BH-30236
BH-30236 is an investigational orally bioavailable, macrocyclic inhibitor of the CDC-like kinase (CLK) family. BH-30236 was intentionally designed to potently inhibit CLK, leading to modulation of aberrant alternative splicing in cancerous tissue, targeting the same aberrant splicing machinery that drives relapsed or refractory (R/R) acute myeloid leukemia (AML) and higher-risk myelodysplastic syndromes (HR-MDS) disease biology and that cancer cells exploit to develop resistance to venetoclax, FLT3 inhibitors and cytarabine. BH-30236 is being evaluated in a Phase 1/1b multicenter, open-label, first-in-human dose escalation and expansion trial in adults with R/R AML and HR-MDS. The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to BH-30236 for the treatment of AML. For additional information on this trial, including a list of study sites and how to enroll, please visit clinicaltrials.gov (NCT06501196).

About BH-501284
BH-501284 is an investigational, orally bioavailable pan-KRAS inhibitor, which utilizes a novel Switch-II chemical scaffold to achieve prolonged, potent and selective inhibition of KRAS mutations. We believe this molecule, which uses a non-covalent scaffold, is unique in its potential to achieve tight and durable binding, a feature described as "pseudo-irreversible" binding. In preclinical studies, BH-501284 has achieved pseudo-irreversible binding characteristics with high binding affinity, while maintaining high selectivity for KRAS.

(Press release, BlossomHill Therapeutics, SEP 18, 2026, View Source [SID1234670960])

CHMP recommends approval of Johnson & Johnson’s TECVAYLI®▼ (teclistamab) in relapsed/refractory multiple myeloma after at least one prior therapy

On September 18, 2026 Johnson & Johnson, a worldwide leader in multiple myeloma, reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of an indication extension of TECVAYLI (teclistamab) for the treatment of adult patients with RRMM who have received at least one prior therapy.

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Addressing evolving treatment needs in relapsed or refractory multiple myeloma
Many patients with multiple myeloma relapse after first-line therapy, and treatment options are increasingly limited once the disease becomes refractory to established treatment classes such as anti-CD38 monoclonal antibodies and lenalidomide.3,4 Despite recent advances, there remains a critical need for additional effective immunotherapy options, particularly in earlier lines of therapy.3,4

Expert and company perspectives support teclistamab use earlier in the treatment pathway
"Relapsed or refractory multiple myeloma remains a complex disease, with diverse and evolving patient needs," said Ester in ’t Groen, EMEA Therapeutic Area Head, Haematology, Johnson & Johnson. "This positive CHMP opinion reflects the importance of teclistamab in multiple myeloma and further reinforces its potential as a foundational immunotherapy after first-line treatment. By providing steroid-sparing combination and monotherapy regimens, teclistamab has the potential to expand the choices for patients living with the disease and redefine what’s possible in multiple myeloma."

"Today’s recommendation reflects our longstanding commitment to transforming outcomes for patients with multiple myeloma by advancing innovative therapies, such as teclistamab, into earlier lines of treatment, where they have the greatest potential to change the trajectory of the disease," said Yusri Elsayed, M.D., M.H.Sc., Ph.D., Global Therapeutic Area Head, Oncology, Johnson & Johnson. "By investing across the treatment continuum, from established foundations of care to novel immunotherapies, we remain focused on delivering differentiated treatment options that address patients’ diverse needs at every stage of their disease, all with the goal of improving long-term outcomes and, where possible, moving people closer to durable remission and, ultimately, cure."

Teclistamab monotherapy demonstrated significant improvements in progression-free and overall survival compared to standard of care
The CHMP recommendation is supported by data from the Phase 3 MajesTEC-9 study (NCT05572515), evaluating the efficacy and safety of teclistamab, a bispecific T-cell engager, as a monotherapy versus pomalidomide, bortezomib and dexamethasone (PVd) or carfilzomib and dexamethasone (Kd) in patients with RRMM who have received one to three prior lines of therapy, including an anti-CD38 monoclonal antibody and lenalidomide.5

Significant improvements were observed in both progression-free survival (PFS) and overall survival (OS).1 Treatment with teclistamab demonstrated a 71% reduction in the risk of disease progression or death (hazard ratio [HR], 0.29; 95% confidence interval [CI], 0.23-0.38; p<0.001) and a 40% reduction in the risk of death (HR, 0.60; 95% CI, 0.43-0.83; p = 0.002) compared to standard of care.1 Additionally, all key secondary endpoints showed significant improvement with teclistamab versus standard of care, including nearly two-thirds of patients achieving a complete response or better (≥CR, 65.9% vs. 16.8%; p<0.001).1

Safety profile consistent with that established in prior studies
The safety profile for teclistamab in the study was consistent with its known safety profile.6 The median duration of treatment on teclistamab was almost two times longer than standard of care (13.1 months vs. 7.0 months), with similar rates of adverse events (AEs) observed between teclistamab and standard of care (99.7% vs. 97.9%).1 Grade 3/4 AEs occurred in 84.9% of teclistamab recipients versus 76.3% of PVd or Kd recipients, while Grade 5 AEs occurred in 6.5% versus 3.5%, respectively.1 Infections were more frequent with teclistamab than with standard of care (Grade 3/4, 41.6% vs. 29.0%), and rates of Grade 3 or higher infections decreased over time.1

This regulatory milestone builds on the recent European Commission approval of teclistamab in combination with daratumumab for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior therapy, based on the results of the MajesTEC-3 study published in The New England Journal of Medicine.7 Together, these two Phase 3 studies help establish the potential of teclistamab-based regimens as an important treatment option across a broad second-line population.7

About the MajesTEC-9 study
MajesTEC-9 (NCT05572515) is an ongoing, randomised Phase 3 study comparing teclistamab monotherapy with pomalidomide, bortezomib and dexamethasone (PVd) or carfilzomib and dexamethasone (Kd) in patients with relapsed/refractory multiple myeloma (RRMM) who have received 1–3 prior lines including lenalidomide and an anti-CD38 monoclonal antibody.5 The primary endpoint is progression-free survival (PFS); secondary endpoints include complete response or better (≥CR), duration of response (DoR), overall survival (OS), safety and patient-reported outcomes.1

About Teclistamab
Teclistamab received European Commission (EC) approval in August 2022 for the treatment of patients with RRMM who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody, and have demonstrated disease progression on the last therapy.8 In August 2023, the EC approved a Type II variation application for teclistamab, providing the option for a reduced dosing frequency of 1.5 mg/kg every two weeks in patients who have achieved a complete response (CR) or better for a minimum of six months.9 In August 2026, the EC also approved a Type II variation application for teclistamab in combination with daratumumab as early as second line for RRMM.7

Teclistamab is an off-the-shelf (or ready-to-use) bispecific antibody.6,10 Teclistamab, a subcutaneous injection, redirects T-cells through two cellular targets (BCMA and CD3) to activate the body’s immune system to fight cancer.6 Teclistamab is currently being evaluated in several combination studies.11,12,13,14

To date, more than 30,700 patients have been treated worldwide with teclistamab.15

For a full list of adverse events and information on dosage and administration, contraindications and other precautions when using teclistamab, please refer to the Summary of Product Characteristics at: View Source

In line with EMA regulations for new medicines and those given conditional approval, teclistamab is subject to additional monitoring.6

About Multiple Myeloma
Multiple myeloma is a complex blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow.16,17 In multiple myeloma, these malignant plasma cells continue to proliferate, accumulating in the body and crowding out normal blood cells, as well as often causing bone destruction and other serious complications.18,19 In the European Union, it is estimated that more than 35,000 people were diagnosed with multiple myeloma in 2024, and more than 21,900 patients died.20 Patients living with multiple myeloma experience relapses which become more frequent with each line of therapy, while remissions become progressively shorter.21,22,23 Whilst some patients with multiple myeloma initially have no symptoms, others can have common signs and symptoms of the disease, which can include bone fracture or pain, low red blood cell counts, fatigue, high calcium levels, infections, or kidney damage.

(Press release, Johnson & Johnson, SEP 18, 2026, View Source [SID1234670959])