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The United Kingdom approves Zepzelca® (lurbinectedin) by PharmaMar in combination with atezolizumab for first-line maintenance treatment of small cell lung cancer

On September 24, 2026 PharmaMar (MSE: PHM) reported that the Medicines and Healthcare products Regulatory Agency (MHRA) has granted approval in the United Kingdom for Zepzelca (lurbinectedin) in combination with atezolizumab (Tecentriq) as a first-line maintenance treatment for adults with extensive-stage small cell lung cancer (ES-SCLC), whose disease has not progressed following first-line induction therapy with atezolizumab, carboplatin, and etoposide.

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This approval is based on the results of the Phase III IMforte trial.[1]

According to the National Lung Cancer Audit (NLCA), 37,750 people were diagnosed with lung cancer in England only in 2023. Since small cell lung cancer (SCLC) accounts for approximately 15% of all lung cancer cases, this would correspond to roughly to 5,700 SCLC cases annually[2].

With this authorization, the United Kingdom joins the list of the territories where this combination has been approved, bringing the total number to 21, including the European Union (EU) and the United States.

(Press release, PharmaMar, SEP 24, 2026, View Source [SID1234671047])

HCW Biologics Inc. Announces Pricing of $1.5 Million Private Placement

On September 24, 2026 HCW Biologics Inc. (the "Company" or "HCW Biologics"), (NASDAQ: HCWB), a clinical-stage biopharmaceutical company developing transformative fusion immunotherapeutics to treat autoimmune diseases, cancer and senescence-associated dysplasia, reported the pricing of its $1.5 million private placement (the "Offering") with an existing stockholder of the Company, (the "Investor"). Pursuant to a securities purchase agreement entered into on September 23, 2026 with the Investor (the "Purchase Agreement"), the Company agreed to issue and sell an aggregate of 903,614 units (the "Units"), with each Unit consisting of (i) one pre-funded warrant (a "Pre-Funded Warrant") to purchase one share of the Company’s common stock, par value $0.0001 per share, ("Common Stock") and (ii) the right to receive one common stock purchase warrant (a "Common Warrant") to purchase one share of Common Stock, and subject to, stockholder approval of the issuance thereof.

In connection with the Offering, the Company will issue 903,614 Pre-Funded Warrants. Subject to stockholder approval, which the Company is obligated to seek pursuant to the terms of the Purchase Agreement, the Investor will also be entitled to receive Common Warrants to purchase up to an aggregate of 903,614 shares of Common Stock.

Maxim Group LLC is acting as the sole placement agent for the Offering.

The combined purchase price for each Unit consisting of a Pre-Funded Warrant and the right to receive one Common Warrant upon, and subject to, stockholder approval of the issuance thereof, was $1.6599 per Unit. The Pre-Funded Warrants have an exercise price of $0.0001 per share of Common Stock, are exercisable immediately and will not expire until exercised in full. The Common Warrants will have an exercise price of $1.66 per share and will expire on the five and one half (5.5) year anniversary of their issuance. Under Nasdaq Listing Rule 5635(d), the Company is required to obtain stockholder approval before issuing the Common Warrants because the potential issuance of shares upon exercise of the Common Warrants could exceed the thresholds set forth in such rule. Following receipt of stockholder approval, the Company will issue the Common Warrants to the Investor in accordance with the Purchase Agreement.

The Company intends to use the net proceeds from this Offering to continue clinical trials for HCW9302, advance its IND-enabling studies for its T-Cell Engager, HCW11-018b, and its second-generation immune checkpoint inhibitor, HCW11-040, and for general corporate purposes.

On September 23, 2026, the Company also entered into a registration rights agreement with the Investors, pursuant to which the Company agreed to submit to the U.S. Securities and Exchange Commission (the "SEC") a registration statement on Form S-1 within 15 trading days of the closing of the Offering covering the resale of the shares of Common Stock issuable upon exercise of the Pre-Funded Warrants and the shares of Common Stock issuable upon exercise of the Common Warrants. The Company also agreed to use commercially reasonable efforts to cause the registration statement to be declared effective by the SEC within 60 days following the closing of the Offering.

The number of shares of Common Stock the Company that may be held by the Investor, including those shares issued at closing and upon the exercise of Pre-Funded Warrants from time to time in the Offering, may not exceed 9.99% of the number of shares of the Company’s Common Stock outstanding immediately after giving effect to such issuances.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

(Press release, HCW Biologics, SEP 24, 2026, View Source [SID1234671046])

Grant of Restricted Stock Units and Warrants to Employees in Genmab

On September 24, 2026 Genmab A/S (Nasdaq: GMAB) reported that the Board of Directors decided to grant 13,794 restricted stock units and 13,331 warrants to employees of the Company and the Company’s subsidiaries.

Each restricted stock unit is awarded cost-free and provides the owner with a conditional right to receive one share in Genmab A/S of nominally DKK 1. The fair value of each restricted stock unit is equal to the closing market price on the date of grant of one Genmab A/S share, DKK 2,268.

The restricted stock units will vest on the first banking day of the month following a period of three years from the date of grant. Furthermore, the restricted stock units are subject to vesting conditions set out in the restricted stock unit program adopted by the Board of Directors. Information concerning Genmab’s restricted stock unit program can be found on www.genmab.com under Investors > Governance > Compensation > Restricted Stock Units.

The exercise price for each warrant is DKK 2,268. Each warrant is awarded cost-free and entitles the owner to subscribe one share of nominally DKK 1 subject to payment of the exercise price. By application of the Black-Scholes formula, the fair value of each warrant can be calculated as DKK 781.96.

The warrants vest three years after the grant date, and all warrants expire at the seventh anniversary of the grant date. The new warrants have been granted on the terms and conditions set out in the warrant program adopted by the Board of Directors on February 23, 2021. Information concerning Genmab’s warrant schemes can be found on www.genmab.com under Investors > Governance > Compensation > Warrants.

(Press release, Genmab, SEP 24, 2026, View Source [SID1234671045])

Cullinan Therapeutics Highlights Fourth Quarter 2026 Milestones Across Immunology and Oncology T Cell Engager Portfolio

On September 24, 2026 Cullinan Therapeutics, Inc. (Nasdaq: CGEM; "Cullinan"), a clinical-stage biopharmaceutical company accelerating potential first- or best-in-class, disease-modifying T cell engagers in autoimmune diseases and cancer, reported fourth quarter 2026 milestones across its immunology and oncology pipeline.

"We look forward to providing several updates across our T cell engager programs in the fourth quarter of 2026. Starting with autoimmune diseases, for CLN-978 we look forward to sharing the most comprehensive clinical data set to date for a CD19 T cell engager across all indications, with multi-dose regimen data reported concurrently for SLE, RA, and now Sjögren’s disease also. For velinotamig, we will provide multi-dose regimen data from the ongoing Phase 1 dose escalation study as we advance the program in plasma cell driven diseases. Together, our CD19- and BCMA-targeted programs reflect a differentiated approach to treating autoimmune diseases, aiming to address distinct disease drivers across a broad range of conditions. For CLN-049, we plan to provide an update with longer follow up from the dose escalation portion of our ongoing Phase 1 study in a broad, all-comer population of relapsed/refractory AML patients. We look forward to rapidly progressing this program and initiating our potentially registrational Phase 2 study, following our recent successful meeting with the FDA," said Nadim Ahmed, President and CEO of Cullinan Therapeutics.

The Company plans to share the following immunology and oncology pipeline updates in Q4 2026:

•
CLN-978 (CD19xCD3 T cell engager): treatment-refractory moderate to severe systemic lupus erythematosus (SLE), difficult-to-treat rheumatoid arthritis (RA), and treatment-refractory moderate to severe Sjögren’s disease (SjD)
o
Multi-dose and single target dose regimen data in SLE, RA, and SjD in December
•
Velinotamig (BCMAxCD3 T cell engager): treatment-refractory autoimmune diseases driven by long-lived plasma cells
o
Multi-dose regimen data from the ongoing Genrix Bio Phase 1 dose escalation study in SLE to be shared in poster session at ACR Convergence 2026 on November 8, 2026, 10:30 a.m. to 12:30 p.m. ET

•
CLN-049 (FLT3xCD3 T cell engager): relapsed/refractory acute myeloid leukemia (AML)
o
Updated data from the dose escalation portion of the Phase 1 study in December

(Press release, Cullinan Oncology, SEP 24, 2026, View Source [SID1234671044])

HUTCHMED Highlights Clinical Data to be Presented at the ESMO Congress 2026

On September 24, 2026 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:HCM; HKEX:13) reported that new and updated data from several studies of compounds discovered by HUTCHMED will be presented at the European Society for Medical Oncology ("ESMO") Congress 2026, taking place on October 23-27, 2026, in Madrid, Spain.

Notably, results from two positive Phase III studies evaluating the savolitinib and osimertinib combination have been selected for oral presentations. Results from the global SAFFRON study will be featured in the Presidential Symposium session, while results from the SANOVO study in China will be presented in a Proffered Paper session, both highlighting important new clinical data. Having two Phase III studies featured as late-breaking abstracts underscores the potential of this all-oral, chemo-free combination to deliver meaningful advancements for patients with non-small cell lung cancer ("NSCLC").

The SAFFRON Global Phase III Study has been selected for a Presidential Symposium oral presentation. The study evaluated the combination in patients with epidermal growth factor receptor (EGFR)-mutated NSCLC with MET overexpression or amplification following disease progression on osimertinib. The trial reported positive high-level results on August 17, 2026, demonstrating a statistically significant and clinically meaningful improvement in progression-free survival ("PFS") and overall survival ("OS") compared to doublet platinum-based chemotherapy.

The SANOVO China Phase III Study has been selected for a Proffered Paper oral presentation. The study evaluated the combination in previously untreated patients with locally advanced or metastatic NSCLC harboring activating EGFR mutations and MET overexpression. The trial reported positive high-level results on August 31, 2026, demonstrating a statistically significant and clinically meaningful improvement in PFS and a clinically meaningful benefit in OS versus osimertinib monotherapy.

Details of the presentations are as follows:

Abstract title Presenter/Lead author Presentation details
SPONSORED STUDIES
Osimertinib (osi) + savolitinib (savo) vs platinum–pemetrexed (plat–pem) in EGFRm MET-overexpressed (OE) and/or -amplified (AMP) advanced NSCLC post-osi: SAFFRON Phase (Ph) 3 primary results
Shun Lu
(Shanghai, China) LBA6
Presidential Symposium II
Alicante Auditorium – Hall 6
Sunday, October 25, 2026
16:30 – 18:15 CEST
Savolitinib or Placebo Combined with Osimertinib in Treatment-Naïve Advanced NSCLC with EGFR Mutation and MET Overexpression: Results from the Phase 3 SANOVO Study Yi-Long Wu
(Guangzhou, China) LBA69
Proffered paper 2: NSCLC, metastatic
Alicante Auditorium – Hall 6
Monday, October 26, 2026
08:30 – 10:00 CEST
Updated results from a fruquintinib Expanded Access Program for patients with previously treated metastatic colorectal cancer Stefan Kasper
(Essen, Germany) 848P
Poster Session: Colon cancer
Association between dose adjustment and treatment outcomes in patients with advanced renal cell carcinoma receiving fruquintinib plus sintilimab: A post-hoc analysis of the FRUSICA‑2 trial Yuanyuan Qu (Shanghai, China) 3655eP
E-poster Session: Renal cancer
Efficacy of fruquintinib plus sintilimab in special populations with advanced renal cell carcinoma: A subgroup analysis of FRUSICA‑2 study Kaiwei Yang
(Beijing, China) 3667eP
E-poster Session: Renal cancer
Final phase 2 analysis of surufatinib plus camrelizumab, nab‑paclitaxel and gemcitabine in first‑line metastatic pancreatic cancer
Shukui Qin
(Nanjing, China) 3156P
Poster Session: Pancreatic cancer

INVESTIGATOR-INITIATED STUDIES
Fruquintinib plus capecitabine maintenance after first-line anti‑EGFR antibody plus chemotherapy in RAS/BRAF wild-type metastatic colorectal cancer: A phase Ib/II study Lin Yang/ Letian Zhang
(Beijing, China) 877eP
E-poster Session: Colon cancer
Real-world effectiveness and safety of fruquintinib in patients with metastatic colorectal cancer in Spain: The FrESP study Ana Fernandez Montes (Ourense, Spain) 880eP
E-poster Session: Colon cancer
CONCEPT (COmbinatioN of CEtuximab Plus fruquintinib Treatment ± immunotherapy): A multicenter, randomized, open-label phase II trial in first-line pMMR RAS/BRAF wild-type unresectable metastatic colorectal cancer Kefeng Ding (Hangzhou, China) 890eP
E-poster Session: Colon cancer
A real-world study of low-dose fruquintinib combined with trifluridine/tipiracil hydrochloride (TAS-102) in the third‑line and beyond treatment of metastatic colorectal cancer Yuehong Cui/ Li Liang
(Shanghai, China) 903eP
E-poster Session: Colon cancer
Real-world outcomes with fruquintinib in heavily pretreated metastatic colorectal cancer: Impact of patient and disease characteristics Maria Maddalena Laterza (Pozzuoli, Italy) 964eP
E-poster Session: Colon cancer
A phase II, open-label, randomized study of doublet chemotherapy (FOLFOX or FOLFIRI) plus fruquintinib compared with doublet chemotherapy (FOLFOX or FOLFIRI) plus bevacizumab in second line setting for a metastatic colorectal cancer: ULYSSE- FFCD2406 – PRODIGE115 (trials in progress) Jean Marc Phelip (Saint‑Étienne, France) 991eTiP
E-poster Session: Colon cancer
Phase II study of fruquintinib plus utidelone in platinum‑resistant recurrent ovarian cancer (FRUTD Trial) Zheng Feng
(Shanghai, China) 1283P
Poster Session: Gynaecological cancers
Fruquintinib plus eribulin in patients with metastatic HR+, HER2‑breast cancer after progression on endocrine therapy plus CDK4/6 inhibitor: Updated results from a phase II study Yuan Yuan
(Nanjing, China) 1896eP
E-poster Session: HR+ breast cancer
Fruquintinib plus sintilimab and XELOX as first‑line treatment for advanced gastric or gastroesophageal junction adenocarcinoma: A single‑arm, open‑label, multicenter phase II study Hua Wang
(Nanchang, China) 2980eP
E-poster Session: Oesophagogastric cancer
Fruquintinib plus cadonilimab and S-1 in previously treated unresectable locally advanced or metastatic esophageal squamous cell carcinoma: preliminary efficacy and safety results from a phase Ib/II study Huiyan Luo (Guangzhou, China) 2981eP
E-poster Session: Oesophagogastric cancer
Nanoliposomal irinotecan (nal‑IRI) combined with fruquintinib as second-line treatment for advanced gastric cancer: A single‑arm, open‑label, dose-escalation and expansion phase I/II trial Jieer Ying/ Qi Xu
(Hangzhou, China) 2986eP
E-poster Session: Oesophagogastric cancer
FRUQUITAS trial: ENGIC intergroup randomized phase III of trifluridine/tipiracil +/- fruquintinib in pre-treated metastatic gastro‑oesophageal adenocarcinoma David Tougeron (Poitiers, France) 3079eTiP
E-poster Session: Oesophagogastric cancer
CHOICE III: short-course preoperative radiotherapy followed by fruquintinib plus anti–PD‑1 antibody (serplulimab) for neoadjuvant treatment of pMMR/MSS mid‑to‑low locally advanced rectal cancer: A single‑arm, single‑center, prospective phase II study Wei Zhang
(Shanghai, China) 3582eTiP
E-poster Session: Rectal and anal cancer
First-line fruquintinib plus serplulimab for metastatic non‑clear cell renal cell carcinoma: Updated results from the phase II FRONTIER study Jiwei Huang
(Shanghai, China) 3614P
Poster Session: Renal cancer
Latest efficacy and safety analysis of surufatinib combined with EP regimen and serplulimab as first-line treatment for extrapulmonary neuroendocrine carcinoma Tao Zhang/ Zhenyu Lin
(Wuhan, China) 2394RO
Rapid Oral Session: NETs and endocrine tumours
Pamplona Auditorium – Hall 5
Friday, October 23, 2026
16:15 – 17:45 CEST
Surufatinib combined with toripalimab and nab‑paclitaxel/ gemcitabine chemotherapy as first‑line treatment for advanced pancreatobiliary-type ampullary carcinoma: A prospective phase II Clinical Trial Juan Du
(Nanjing, China) 507eP
E-poster Session: Biliary tract cancer, incl. cholangiocarcinoma
Efficacy and safety of surufatinib in combination with CAPTEM in advanced G2/G3 Neuroendocrine Tumors: Results from a single‑arm, phase II Trial Wei Wang
(Guangzhou, China) 2403P
Poster Session: Neuroendocrine tumours
Surufatinib plus S‑1/temozolomide as first-line therapy in MGMT‑low advanced pancreatic neuroendocrine tumours (SUSTEM‑p): An open‑label, single‑centre phase Ib/II trial Yihebali Chi
(Beijing, China) 2411P
Poster Session: Neuroendocrine tumours
Updated results of a prospective, open‑label study of surufatinib plus CAPTEM as conversion therapy for unresectable pancreatic neuroendocrine tumors Ziyao Wang
(Chengdu, China) 2412P
Poster Session: Neuroendocrine tumours
Matching‑adjusted indirect comparison of surufatinib versus high‑dose OCT‑LAR in patients with advanced GEP‑NETs who progressed on prior SSA Therapy Jianming Xu
(Beijing, China) 2415P
Poster Session: Neuroendocrine tumours
Surufatinib combined with octreotide LAR for the treatment of G1/G2 GEP‑NETs: A single‑arm, prospective, open‑label phase II study Xiaofeng Sun
(Nanjing, China) 2439eP
E-poster Session: Neuroendocrine tumours
Six weeks of induction gemcitabine plus nab paclitaxel (AG) followed by sequential surufatinib plus AG or AG alone as first line therapy for locally advanced or metastatic pancreatic ductal adenocarcinoma (mPDAC): A single center, two cohort, phase II study Jin Xu/ Jialin Li
(Shanghai, China) 3168P
Poster Session: Pancreatic cancer
A phase Ib/II study of radiotherapy combined with surufatinib and sintilimab for localized high‑risk limb and trunk soft tissue sarcomas: A prospective single‑center trial Yan Wang
(Shanghai, China) 3739P
Poster Session: Sarcoma
Surufatinib plus serplulimab, etoposide, and carboplatin as first‑line treatment for extensive-stage small cell lung cancer (ES‑SCLC): Updated results from a single‑arm, phase Ia/Ib trial Haipeng Xu/ Longfeng Zhang
(Fuzhou, China) 3831P
Poster Session: Small cell lung cancer

About Fruquintinib
Fruquintinib is a selective oral inhibitor of all three vascular endothelial growth factor receptors ("VEGFR") -1, ‑2 and -3. Fruquintinib is co-developed and co-commercialized in China by HUTCHMED and Eli Lilly and Company under the brand name ELUNATE. Takeda holds the exclusive worldwide license to further develop, commercialize, and manufacture fruquintinib outside mainland China, Hong Kong and Macau, marketing it under the brand name FRUZAQLA.

About Savolitinib
Savolitinib is an oral, potent and highly selective MET tyrosine kinase inhibitor that has demonstrated clinical activity in advanced solid tumors. It blocks atypical activation of the MET receptor tyrosine kinase pathway that occurs because of mutations (such as exon 14 skipping alterations or other point mutations), gene amplification or protein overexpression. Savolitinib is being jointly developed by AstraZeneca and HUTCHMED, and commercialized by AstraZeneca under the brand name ORPATHYS.

About Surufatinib
Surufatinib is a novel, oral angio-immuno kinase inhibitor that selectively inhibits the tyrosine kinase activity associated with VEGFRs and fibroblast growth factor receptor (FGFR), which both inhibit angiogenesis, and colony stimulating factor-1 receptor (CSF-1R), which regulates tumor-associated macrophages, promoting the body’s immune response against tumor cells. Surufatinib is marketed in China by HUTCHMED under the brand name SULANDA. HUTCHMED currently retains all rights to surufatinib worldwide.

(Press release, Hutchison China MediTech, SEP 24, 2026, View Source [SID1234671035])