On February 22, 2026 CStone Pharmaceuticals ("CStone," HKEX: 2616), an innovation-driven biopharmaceutical company focused on the research and development of therapies for oncology, autoimmune/inflammation, and other key disease areas, reported that the UK MHRA has granted a new indication for sugemalimab as a monotherapy for adult patients with unresectable stage III NSCLC with PD-L1 expression on ≥1% of tumour cells and no sensitising EGFR mutations, or ALK, ROS1 genomic aberrations and whose disease has not progressed following platinum-based chemoradiotherapy (CRT).

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Dr. Jason Yang, CEO, President of R&D, and Executive Director at CStone, stated, "Since its initial EU approval in July 2024, sugemalimab has become one of only two PD-(L)1 antibodies approved for stage III NSCLC in Europe, providing a comprehensive treatment option spanning both locally advanced, unresectable stage III and metastatic stage IV NSCLC. Its commercial footprint has now expanded to over 60 countries and regions globally, with market access applications approved or under regulatory review in more than ten countries. Furthermore, sugemalimab has been included in multiple national reimbursement systems—an affirmation of its recognized clinical value and pharmacoeconomic benefit."

Dr. Qingmei Shi, Chief Medical Officer of CStone, added, "The MHRA’s approval of sugemalimab for Stage III NSCLC represents another significant endorsement from a major international regulatory agency and will further unlock its global commercial potential. We are proud of CStone’s clinical development and regulatory affairs teams for their’ effective execution, invaluable experience in global registration, and ability to navigate mature regulatory frameworks in Europe and the UK. Sugemalimab in combination with chemotherapy treating stage IV NSCLC has received the highest-level recommendation [I, A] in the first-line setting for both squamous and non-squamous NSCLC in the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Non-Oncogene-Addicted Metastatic NSCLC Living Guideline. We look forward to the potential inclusion of this newly approved stage III NSCLC indication in this authoritative guideline in the near future. CStone will continue to advance regulatory filings for sugemalimab in additional indications, including gastric cancer (GC) and esophageal squamous cell carcinoma (ESCC)."

About Sugemalimab

The anti-PD-L1 monoclonal antibody sugemalimab was developed by CStone using OmniRat transgenic animal platform, which allows creation of fully human antibodies in one step. Sugemalimab is a fully human, full-length anti-PD-L1 immunoglobulin G4 (IgG4) monoclonal antibody, which may reduce the risk of immunogenicity and toxicity for patients, a unique advantage over similar drugs.

The EC and MHRA have approved sugemalimab for two indications:

In combination with platinum-based chemotherapy for the first-line treatment of patients with metastatic NSCLC with no sensitizing EGFR mutations, or ALK, ROS1 or RET genomic tumor aberrations; and
Monotherapy for adult patients with unresectable stage III NSCLC with PD-L1 expression on ≥1% of tumour cells and no sensitising EGFR mutations, or ALK, ROS1 genomic aberrations and whose disease has not progressed following platinum-based CRT.
The National Medical Products Administration (NMPA) of China has approved sugemalimab for five indications:

In combination with chemotherapy as first-line treatment of patients with metastatic squamous and non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations and metastatic squamous NSCLC;
For the treatment of patients with unresectable Stage III NSCLC whose disease has not progressed following concurrent or sequential platinum-based CRT;
For the treatment of patients with relapsed or refractory extranodal NK/T-cell lymphoma;
In combination with fluorouracil and platinum-based chemotherapy as first-line treatment of patients with unresectable locally advanced, recurrent or metastatic ESCC; and
In combination with fluoropyrimidine- and platinum-containing chemotherapy as first-line treatment for unresectable locally advanced or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma with a PD-L1 expression CPS ≥5.

(Press release, CStone Pharmaceauticals, FEB 22, 2026, View Source [SID1234662833])

On February 22, 2026 Clarity Pharmaceuticals (ASX: CU6) ("Clarity" or "Company"), a clinical-stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for patients with cancer, reported that yet another participant with mCRPC in the Cohort Expansion Phase (Phase II) of the SECuRE trial achieved undetectable PSA and negative PSMA PET. The undetectable PSA was measured following the first cycle and the negative PSMA PET was reported following the second cycle of 67Cu-SAR-bisPSMA (8 GBq each cycle).

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The participant is a 76-year-old man who was initially diagnosed with prostate cancer 15 years ago. He had radical prostatectomy to treat the primary disease and radiotherapy for local recurrence, having progressed to metastatic disease in 2020. Previous systemic anti-cancer treatments included an androgen receptor pathway inhibitor (ARPI) and androgen deprivation therapy (ADT). In 2025, the disease progressed further, and he was enrolled into the Cohort Expansion Phase of the SECuRE study with a baseline PSA of 3.25 ng/mL. Seven weeks after his first cycle of 67Cu-SAR-bisPSMA, this participant achieved undetectable PSA levels. He proceeded to receive one more cycle of 67Cu-SAR-bisPSMA, and no disease was observed on PSMA PET following the second dose (Figure 1). This participant exhibited mild (Grade 1) related AEs, including altered taste, dry eyes, eye pain, fatigue and salivary gland soreness (all resolved except fatigue). No haematological or renal AEs were observed to date.

This new case represents the fifth participant to achieve undetectable disease by radiographic assessment following 67Cu-SAR-bisPSMA treatment in Clarity’s SAR-bisPSMA theranostic program (3 participants who received up to four cycles of 8 GBq, and 2 participants who received up to three cycles of 12 GBq)2,3,4.

Update on previously reported participant with no detectable disease following 67Cu-SAR-bisPSMA treatment
Follow-up on the previously reported participant from the Cohort Expansion Phase (no detectable disease and absence of prior bone metastasis following three cycles of 8 GBq 67Cu-SAR-bisPSMA treatment)2, demonstrated that his PSA remains undetectable, with no disease identified on his latest PET conducted 1 month after the administration of the fourth cycle (Feb 2026; Figure 2). Following the first three cycles of 67Cu-SAR-bisPSMA, the participant exhibited mild (Grade 1) related AEs, most of which were gastrointestinal events, with no haematological or renal AEs2. Notably, no new safety signals have been observed during and since the administration of the fourth cycle to date.The interim data from this Phase II continues to confirm the favourable safety profile and promising efficacy seen in previous cohorts of SECuRE3 and supports the continuation of the trial with the aim to progress to a registrational Phase III study.

Clarity’s Executive Chairperson, Dr Alan Taylor, commented, "The momentum of data we are generating with our lead SAR-bisPSMA product in both theranostic and diagnostic trials is strong, with excellent results to date on all fronts. We are beyond excited to see yet another patient achieve undetectable disease following their 67Cu-SAR-bisPSMA treatments. What is particularly outstanding is that this new patient presented with undetectable PSA just 7 weeks after his first 8 GBq cycle, with a negative PSMA PET being reported after the second cycle. This result is particularly impressive given this participant has been battling prostate cancer for 15 years and is now free of any detectable disease based on PSA and PET assessments with only mild (Grade 1) AEs.

"While this outcome is extraordinary, we now know this is not just luck or coincidence. Despite the number of participants in the SECuRE trial being relatively small, this is now the fifth time we have seen a patient present with undetectable disease following their 67Cu-SAR-bisPSMA treatments2,3,4, and study recruitment is still ongoing. We are also excited to see that the previous participant in the Cohort Expansion Phase of the SECuRE trial to achieve undetectable disease observed by anatomical and molecular imaging2 continues to show undetectable disease during his last follow up in February 2026, following the fourth 67Cu-SAR-bisPSMA cycle. This is especially encouraging as this participant had bone metastasis at study entry and now continues to report excellent quality of life after his treatment with 67Cu-SAR-bisPSMA."

"Our methodical commitment to science and the highest standard of clinical development underpins our achievements to date. Combining the optimised bivalent "bis" structure with the benefits offered by the copper isotope pairing, enabled by the proprietary sarcophagine (SAR) chelating technology, is key to the benefits we are seeing from the SAR-bisPSMA products. The most recent data released from the Co-PSMA study clearly establishes that 64Cu-SAR-bisPSMA considerably outperforms its competitors in detecting prostate cancer recurrence and sheds light on the importance of the improved lesion detection, where the diagnostic benefits translate into enhanced patient management5. Our registrational diagnostic AMPLIFY6 and CLARIFY7 trials with 64Cu-SAR-bisPSMA are also nearing the end of recruitment, getting us closer to commercialisation. We now look forward to progressing the SECuRE trial recruitment and have already initiated the planning for a registrational Phase III trial, as we hope to see more people benefit from our unique theranostic product. Having three Fast Track Designations (FTDs) for SAR-bisPSMA gives us confidence to persevere harder than ever, and positive interactions with the US Food and Drug Administration (FDA) confirm that we are on the right track. Our team is motivated and driven to progress SAR-bisPSMA to the market through the entirety of the prostate cancer journey, from first detection to late-stage metastatic disease. As we continue to generate exceptional data, we believe SAR-bisPSMA is well positioned to fully exploit the current treatment and diagnostic challenges in radiopharmaceuticals and improve treatment outcomes for patients with cancer."

About the SECuRE trial
The SECuRE trial (NCT04868604)1 is a Phase I/IIa theranostic trial for identification and treatment of participants with PSMA-expressing mCRPC using 64Cu/67Cu-SAR-bisPSMA. 64Cu-SAR-bisPSMA is used to visualise PSMA-expressing lesions and select candidates for subsequent 67Cu-SAR-bisPSMA therapy. The trial is a multi-centre, single arm study, planning to enroll approximately 54 participants in the US. The overall aim of the trial is to determine the safety and efficacy of 67Cu-SAR-bisPSMA for the treatment of prostate cancer.

The SECuRE trial consists of the Dose Escalation (Phase I) and Cohort Expansion (Phase II) Phases. Based on the data from the Dose Escalation Phase, which demonstrated a favourable safety profile and efficacy of 67Cu-SAR-bisPSMA, the SECuRE trial progressed to the Cohort Expansion at an 8 GBq dose level as per the Safety Review Committee (SRC) recommendation (up to 6 cycles per patient in total)3.

Cohort 2 of the Dose Escalation phase of the trial, where participants were dosed with 8 GBq of 67Cu-SAR-bisPSMA, demonstrated a very low rate of related AEs while all three participants achieved PSA declines of 80% or more (PSA80)3. The Dose Escalation Phase also showed high PSA response rates of the mCRPC in the pre-chemotherapy setting with a favourable safety profile: 92% of pre-chemotherapy participants (12/13) demonstrated PSA drops greater than 35%, 61.5% (8/13) of participants achieved PSA reductions greater than 50%, and 46.2% (6/13) of participants achieved PSA reductions of 80% or more3. These results supported the progress of the trial to its Cohort Expansion Phase using 8 GBq multi-dose in participants who had not received chemotherapy in the mCRPC setting.

Recruitment is currently ongoing into the Cohort Expansion Phase which will include 24 participants. A subset of participants will be treated with the combination of 8 GBq of 67Cu-SAR-bisPSMA with enzalutamide (ARPI), in line with the positive results from the Enza-p trial8 and previous discussions with and advice from key global medical experts in the field of prostate cancer.

About SAR-bisPSMA
SAR-bisPSMA derives its name from the word "bis", which reflects a novel approach of connecting two PSMA-targeting agents to Clarity’s proprietary SAR technology that securely holds copper isotopes inside a cage-like structure, called a chelator. Unlike other commercially available chelators, the SAR technology prevents copper leakage into the body. SAR-bisPSMA is a Targeted Copper Theranostic that can be used with isotopes of copper-64 (Cu-64 or 64Cu) for imaging and copper-67 (Cu-67 or 67Cu) for therapy.

About Prostate Cancer
Prostate cancer is the second most common cancer diagnosed in men globally and the fifth leading cause of cancer death in men worldwide9. Prostate cancer is the second-leading cause of cancer death in American men. The American Cancer Institute estimates there will be about 333,830 new cases of prostate cancer in the US in 2026 and around 36,320 deaths from the disease.

(Press release, Clarity Pharmaceuticals, FEB 22, 2026, View Source [SID1234662832])

On February 20, 2026 Rakovina Therapeutics Inc. (TSX-V: RKV)(FSE: 7JO0) ("Rakovina" or the "Company"), a biopharmaceutical company advancing innovative cancer therapies through AI-powered drug discovery, reported that its previously announced financing has been upsized up to approximately $2 million.

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On January 27th, the Company announced that it has reached an agreement in principle with an existing investor to invest an additional $1.0 million in the Company by way of a non-brokered private placement (the "Debenture Private Placement") of an unsecured convertible debenture and two million common share purchase warrants. The Company anticipates that key terms of the convertible debenture would include:

a maturity date of January 28, 2029;
a conversion price of $0.20 per common share; and
an interest rate of 12% per annum payable semi-annually in cash.
Each warrant would be exercisable at $0.20 per common share until January 28, 2029, subject to customary adjustments. A subsequent news release will be issued in connection with the Debenture Private Placement once financing terms have been finalized.

Concurrently with the Debenture Private Placement, the Company proposes to offer up to 8,333,334 common shares at a price of $0.12 per share for additional gross proceeds of up to approximately $1.0 million by way of a non-brokered private placement (the "Common Share Private Placement" and, together with the Debenture Private Placement, the "Private Placements"). As consideration for services provided in connection with the Common Share Private Placement, the Company may pay a finder’s fee to certain eligible finders who introduce subscribers to the financing.

The terms of the Private Placements, as announced in the Company’s news release dated January 27, 2026, otherwise remain unchanged.

The Company intends to use the aggregate gross proceeds of the Private Placements to provide near-term working capital to support ongoing corporate activities and strategic initiatives while the Company continues to evaluate longer-term financing alternatives.

Closing of the Private Placements is subject to the Company obtaining all necessary corporate and regulatory approvals, including approval of the TSX Venture Exchange, and entry into definitive subscription agreements. Pursuant to applicable Canadian securities laws, all securities issued in connection with the Private Placements will be subject to a statutory hold period of four months plus a day from the date of issuance.

(Press release, Rakovina Therapeutics, FEB 20, 2026, View Source;utm_medium=rss&utm_campaign=rakovina-therapeutics-announces-upsized-financing-up-to-2-0-million [SID1234662860])

On February 20, 2026 ImmunityBio, Inc. (NASDAQ: IBRX), a commercial-stage immunotherapy company, reported a partnership with Biopharma and Cigalah, two of the largest and most respected healthcare commercial and distribution companies in the Middle East, to launch ANKTIVA (nogapendekin alfa inbakicept) in Saudi Arabia and, over time, across the broader MENA region.

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Under the agreement, Biopharma and Cigalah Healthcare will support the commercialization and distribution of ANKTIVA in two indications: In combination with Bacillus Calmette-Guérin (BCG) for patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) carcinoma in situ, with or without papillary disease; and in combination with a checkpoint inhibitor for patients with metastatic non-small cell lung cancer.

ImmunityBio has established a wholly owned subsidiary in Saudi Arabia, to support its distribution, commercialization, and growth across the Middle East and North Africa.

"We’re pleased to partner with two of the largest healthcare and distribution companies to launch to ANKTIVA to patients in Saudi Arabia and, across the broader Middle East and North Africa region," said Richard Adcock, President and CEO of ImmunityBio. "Their combined world-class commercial infrastructure and proven track record in bringing innovative therapies to patients with serious diseases will help accelerate access to ANKTIVA and support our commitment to serving physicians and health systems throughout the region, including Saudi Arabia, United Arab Emirates, Qatar and Egypt."

The MENA region has significant unmet needs for the treatment of serious cancers, which are on the rise in many countries. Lung cancer is among the most prevalent cancers in Saudi Arabia and is the third most common cancer among males over 45 years of age, according to the Saudi Ministry of Health1. Lebanon has the highest incidence of bladder cancer cases globally, while Syria and Egypt also rank among the countries with the greatest burden of the disease.2

"At Cigalah and Biopharma our goal is to ensure that physicians and their patients have ready access to the most advanced therapies available for the most difficult-to-treat diseases like cancer," said Tamer Eissa, General Manager, Biopharma. "That is exactly what ImmunityBio brings with ANKTIVA, and we are pleased to partner with them to help extend the lives of bladder and lung cancer patients in Saudi Arabia, and the rest of the Middle Eastern countries we serve."

"We have just returned from a highly productive trip to the Middle East and met with the leadership of Saudi FDA and the Emirates Drug Establishment (EDE) to advance the development of ANKTIVA for expanded patient and indication access to the Middle East," said Dr. Patrick Soon-Shiong, Founder, Executive Chairman, and Global Chief Scientific and Medical Officer of ImmunityBio. "I am highly encouraged by the collaborative engagement of the leadership of the regulatory authorities in the region and their desire to interact with ImmunityBio to expand access of the BioShield platform across multiple tumor types for their citizens. The initial approval by Saudi FDA for ANKTIVA in combination with checkpoint inhibitors, in patients with checkpoint failures in lung cancer has catalyzed the opportunity to build on Immunotherapy 2.0 across multiple tumor types with ANKTIVA as the backbone to NK cell therapy."

ANKTIVA received U.S. Food and Drug Administration approval in April 2024 for use in combination with BCG for the treatment of BCG-unresponsive NMIBC CIS, with or without papillary tumors. ANKTIVA was subsequently approved for the same indication by the UK Medicines and Healthcare products Regulatory Agency in July 2025 and the European Commission in February 2026, as well as the Saudi Food and Drug Authority (SFDA) in January 2026; in addition, the SFDA approved ANKTIVA in combination with a checkpoint inhibitor for the treatment of metastatic non-small cell lung cancer.

About ANKTIVA (nogapendekin alfa inbakicept)
The cytokine interleukin-15 (IL-15) plays a crucial role in the immune system by affecting the development, maintenance, and function of key immune cells—NK and CD8+ killer T cells—that are involved in killing cancer cells. By activating NK cells, ANKTIVA overcomes the tumor escape phase of clones resistant to T cells and restores memory T cell activity with resultant prolonged duration of complete response. ANKTIVA is a first-in-class IL-15 agonist IgG1 fusion complex, consisting of an IL-15 mutant (IL-15N72D) fused with an IL-15 receptor alpha, which binds with high affinity to IL-15 receptors on NK, CD4+, and CD8+ T cells. This fusion complex of ANKTIVA mimics the natural biological properties of the membrane-bound IL-15 receptor alpha, delivering IL-15 by dendritic cells and driving the activation and proliferation of NK cells with the generation of memory killer T cells that have retained immune memory against these tumor clones.

Saudi Arabia Indication and Usage
BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) carcinoma in situ:
ANKTIVA in combination with Bacillus Calmette-Guérin (BCG) is indicated for the treatment of adult patients with high-risk BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) of carcinoma in situ (CIS) with or without papillary disease.

Non-small cell lung cancer (NSCLC):
ANKTIVA is indicated in combination with immune checkpoint inhibitors for the treatment of adult patients with metastatic NSCLC with disease progression on or after standard of care (immune checkpoint inhibitors alone or in combination with chemotherapy). Patients with actionable genomic alteration should have disease progression on approved therapy for these alterations, before using ANKTIVA in combination with immune checkpoint inhibitors.

This indication is approved under accelerated approval based on the increase of ALC associated with overall survival in single arm study. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory clinical trials.

Limitation of use:
Insufficient evidence of benefit for the use of ANKTIVA in combination with immune checkpoint inhibitors in NSCLC with baseline ALC < 1.0 × 10³/μL. Experience is limited to patients with a baseline absolute lymphocyte count (ALC) ≥ 1.0 × 10³/μL who are maintained above this level after treatments.

IMPORTANT SAFETY INFORMATION

INDICATION AND USAGE:

ANKTIVA is an interleukin-15 (IL-15) receptor agonist indicated with Bacillus Calmette-Guérin (BCG) for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.

WARNINGS AND PRECAUTIONS: Risk of Metastatic Bladder Cancer with Delayed Cystectomy. Delaying cystectomy can lead to the development of muscle-invasive or metastatic bladder cancer, which can be lethal. If patients with CIS do not have a complete response to treatment after a second induction course of ANKTIVA with BCG, reconsider cystectomy.

DOSAGE AND ADMINISTRATION: For Intravesical Use Only. Do not administer by subcutaneous or intravenous routes.

Please see the complete Prescribing Information for ANKTIVA at Anktiva.com.

(Press release, ImmunityBio, FEB 20, 2026, View Source [SID1234662828])

On February 20, 2026 enGene Holdings Inc. (Nasdaq: ENGN or "enGene"), a clinical-stage, non-viral genetic medicines company, reported that management will participate in the following investor conferences:

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Oppenheimer 36th Annual Healthcare Life Sciences Conference
Date: Thursday, February 26, 2026
Format: Presentation
Time: 1:20 p.m. ET

Leerink Partners 2026 Global Healthcare Conference
Date: Monday, March 9, 2026
Format: Fireside chat
Time: 8:00 a.m. ET

Barclays 28th Annual Global Healthcare Conference
Date: Tuesday, March 10, 2026
Format: Fireside chat
Time: 9:00 a.m. ET

Citizens Life Sciences Conference
Date: Wednesday, March 11, 2026
Format: Fireside chat
Time: 1:40 p.m. ET

A live webcast of these events can be accessed on the "Events and Presentations" page under the "Investors" section of the enGene website at www.engene.com and will be archived there for 90 days.

(Press release, enGene, FEB 20, 2026, View Source [SID1234662827])