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 20, 2026 Exact Sciences Corporation (NASDAQ: EXAS) ("Exact Sciences"), a leading provider of cancer screening and diagnostic tests, reported that its stockholders voted to approve the proposed acquisition of Exact Sciences by Abbott (NYSE: ABT) at the special meeting of stockholders held earlier today.

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At the special meeting, preliminary results showed that more than 99% of the votes cast, representing approximately 67% of the total outstanding shares of Exact Sciences common stock as of the January 9, 2026 record date for the special meeting, were voted in favor of the transaction. Final voting results from the special meeting will be reported by Exact Sciences in a Current Report on Form 8‑K filed with the U.S. Securities and Exchange Commission (the "SEC").

Subject to the satisfaction or waiver of the remaining conditions to closing, the transaction is expected to close before the end of the second calendar quarter of 2026. Under the terms of the definitive agreement with Abbott, upon completion of the transaction, Exact Sciences’ stockholders will be entitled to receive $105.00 in cash, without interest and subject to any applicable withholding taxes, for each share of Exact Sciences common stock they owned as of immediately before the completion of the transaction.

(Press release, Exact Sciences, FEB 20, 2026, View Source [SID1234662817])

On February 20, 2026 Fennec Pharmaceuticals Inc. (NASDAQ:FENC; TSX: FRX), a specialty pharmaceutical company, reported new real world data supporting potential use of PEDMARK (sodium thiosulfate injection) in adults with head and neck cancers were presented as a digital poster at the 2026 Multidisciplinary Head and Neck Cancers Symposium (MHNCS) in Palm Desert, CA from February 19 – 21, 2026.

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Findings from a multi-institutional retrospective review of 15 adults with head and neck cancers (HNC) showed that PEDMARK could be safely given ≥six hours after cisplatin dosing and was easy to incorporate into the real-world care plan for adults with HNC. This strict post-cisplatin timing is a validated approach intended to preserve cisplatin antitumor activity and no disruption to curative-intent cisplatin-based treatment delivery was observed as part of the study review.

"Head and neck cancer is one of the most common cancers globally,i underscoring why these results are encouraging for clinicians. Importantly, the data support the potential of the drug to address cisplatin-induced hearing loss – a major and often overlooked survivorship challenge – without compromising cisplatin’s proven antitumor activity," said Maria A. Velez, M.D., M.S., coauthor of the study and clinical instructor in the Division of Hematology/Oncology at UCLA Health.

"Cisplatin-induced hearing loss remains one of the most underrecognized yet deeply consequential toxicities associated with cancer treatment," said Leslie Worona, FNP-BC, OCN, coauthor of the study and oncology nurse practitioner at Mount Sinai Hospital. "The findings that most patients – even those with high rates of pre-existing hearing impairment – who received PEDMARK experienced no measurable hearing loss during or after treatment supports further exploration of PEDMARK use in additional patient populations and tumor types such as HNC."

PEDMARK was shown to be well tolerated, with only isolated, self-limited infusion events and no grade 3 or 4 toxicities.

"These new findings are critical to demonstrating the feasibility, scalability and long-term value of PEDMARK beyond those studied in our pivotal clinical program," said Pierre S. Sayad, PhD, M.S., chief medical officer of Fennec Pharmaceuticals. "Additionally, these data may help to strengthen the case for broader clinical adoption in a sizable patient population at high risk for permanent hearing loss."

The study’s primary endpoint evaluated feasibility, defined by timing adherence (≥6 hours) and operational metrics, including administration setting (home vs. clinic infusion) and chair time for infusion-center dosing. Secondary endpoints included infusion-related events, need for antiemetic escalation, and completion of on-treatment and post-treatment audiology assessments.

PEDMARK is currently approved for pediatric patients one month of age and older with localized, non-metastatic solid tumors, and is also recognized by the National Comprehensive Cancer Network with a 2A recommendation for use in adolescent and young adult patients.

About Cisplatin-Induced Ototoxicity

Cisplatin and other platinum-based chemotherapies are widely used to treat solid tumors and have been vital in improving survival rates. Unfortunately, these life-saving treatments often result in permanent, irreversible hearing loss, also known as ototoxicity.ii

Hearing loss from cisplatin treatment is not rare. Studies show that between 60-90% of patients treated with cisplatin may develop hearing loss, depending upon the dose and duration of chemotherapyiii. Many of those treated with cisplatin will require lifelong hearing aids or cochlear implants, which can be helpful for some, but do not reverse the hearing loss and can be costly over time.iv Treatment-induced hearing loss can reduce quality of survivorship as it impacts many aspects of life, such as speech and language skills, academic performance, social-emotional development, career potential and the ability to live independently.v,vi While audiologic monitoring is recommended to help manage ototoxicity, it is currently underutilized in certain cancer patient populations.

PEDMARK (sodium thiosulfate injection)

PEDMARK is the first and only U.S. Food and Drug Administration (FDA) approved therapy indicated to reduce the risk of ototoxicity associated with cisplatin treatment in pediatric patients 1 month of age and older with localized, non-metastatic, solid tumors. It is a unique formulation of sodium thiosulfate in single-dose, ready-to-use vials for intravenous use in pediatric patients. PEDMARK is also the first and only therapeutic agent with proven efficacy and safety data with an established dosing regimen, across two open-label, randomized Phase 3 clinical studies, the Children’s Oncology Group (COG) Protocol ACCL0431 and SIOPEL 6.

Additionally, PEDMARK is recommended for the adolescent and young adult (AYA) population by the National Comprehensive Cancer Network, or NCCN, with a 2A endorsement.

Approximately 500,000 patients in the U.S. are diagnosed annually with cancers that could be treated with a platinum-based chemotherapy.vii,viii The incidence of ototoxicity depends upon the dose and duration of chemotherapy, and many of those treated will require lifelong hearing aids. Until the FDA approval of PEDMARK, there were no preventative agents for this hearing loss. Patients with hearing loss resulting from cancer treatment have a statistically significant worse quality of life compared with peers who have no hearing loss.ixx

PEDMARK has been studied by co-operative groups in two Phase 3 clinical studies of survival and reduction of ototoxicity, COG ACCL0431 and SIOPEL 6. Both studies have been completed. The COG ACCL0431 protocol enrolled childhood cancers typically treated with intensive cisplatin therapy for localized and disseminated disease, including newly diagnosed hepatoblastoma, germ cell tumor, osteosarcoma, neuroblastoma, medulloblastoma, and other solid tumors. SIOPEL 6 enrolled only hepatoblastoma patients with localized tumors.

Indications and Usage

PEDMARK (sodium thiosulfate injection) is indicated to reduce the risk of ototoxicity associated with cisplatin in pediatric patients 1 month of age and older with localized, non-metastatic solid tumors.

Limitations of Use

The safety and efficacy of PEDMARK have not been established when administered following cisplatin infusions longer than 6 hours. PEDMARK may not reduce the risk of ototoxicity when administered following longer cisplatin infusions, because irreversible ototoxicity may have already occurred.

Important Safety Information

PEDMARK is contraindicated in patients with history of a severe hypersensitivity to sodium thiosulfate or any of its components.

Hypersensitivity reactions occurred in 8% to 13% of patients in clinical trials. Monitor patients for hypersensitivity reactions. Immediately discontinue PEDMARK and institute appropriate care if a hypersensitivity reaction occurs. Administer antihistamines or glucocorticoids (if appropriate) before each subsequent administration of PEDMARK. PEDMARK may contain sodium sulfite; patients with sulfite sensitivity may have hypersensitivity reactions, including anaphylactic symptoms and life-threatening or severe asthma episodes. Sulfite sensitivity is seen more frequently in people with asthma.

PEDMARK is not indicated for use in pediatric patients less than 1 month of age due to the increased risk of hypernatremia or in pediatric patients with metastatic cancers.

Hypernatremia occurred in 12% to 26% of patients in clinical trials, including a single Grade 3 case. Hypokalemia occurred in 15% to 27% of patients in clinical trials, with Grade 3 or 4 occurring in 9% to 27% of patients. Monitor serum sodium and potassium levels at baseline and as clinically indicated. Withhold PEDMARK in patients with baseline serum sodium greater than 145 mmol/L.

Monitor for signs and symptoms of hypernatremia and hypokalemia more closely if the glomerular filtration rate (GFR) falls below 60 mL/min/1.73m2.

Administer antiemetics prior to each PEDMARK administration. Provide additional antiemetics and supportive care as appropriate.

The most common adverse reactions (≥25% with difference between arms of >5% compared to cisplatin alone) in SIOPEL 6 were vomiting, nausea, decreased hemoglobin, and hypernatremia. The most common adverse reaction (≥25% with difference between arms of >5% compared to cisplatin alone) in COG ACCL0431 was hypokalemia.

Please see full Prescribing Information for PEDMARK at: www.PEDMARK.com.

(Press release, Fennec Pharmaceuticals, FEB 20, 2026, View Source [SID1234662818])

On February 20, 2026 PDS Biotechnology Corporation (Nasdaq: PDSB) ("PDS Biotech" or the "Company"), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers, reported the adoption of a protocol amendment to its Phase 3 VERSATILE-003 clinical trial. The amendment includes PFS as an interim primary endpoint to support a potential accelerated approval pathway for PDS0101 in HPV16-positive recurrent and/or metastatic head and neck cancer. Median overall survival (mOS) remains the trial’s primary endpoint for full approval, consistent with the Company’s prior regulatory dialogue and post-meeting communication following its Type C meeting with the U.S. Food and Drug Administration ("FDA"). Following the FDA’s standard 30-day wait period since filing of the amended protocol to the Investigational New Drug (IND) Application, without objection, the Company is proceeding with the amended protocol.

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"Including PFS as an interim primary endpoint provides a potential pathway to shorten the duration of VERSATILE-003 and accelerate the timeline to regulatory submission, as well as making the trial more cost efficient," said Frank Bedu-Addo, PhD, President and Chief Executive Officer of PDS Biotech. "Survival and safety will continue to anchor full approval, and we remain confident in the path we’ve outlined and in our commitment to advancing a promising targeted immunotherapy for the rapidly growing population of patients with HPV16-positive recurrent and/or metastatic head and neck cancer."

(Press release, PDS Biotechnology, FEB 20, 2026, View Source [SID1234662820])

On February 20, 2026 Oncotelic Therapeutics Inc. (OTCQB: OTLC) reported its placement in an editorial published by BioMedWire (BMW), one of 75+ brands within the Dynamic Brand Portfolio@IBN (InvestorBrandNetwork), a specialized communications platform with a focus on financial news and content distribution for private and public companies and the investment community.

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To view the full publication, "Drug-Delivery Breakthroughs, Cross-Indication Research Accelerate New Momentum in CNS and Oncology Development," please visit: View Source

Biotechnology mergers and acquisitions ("M&As") are increasingly shaped by a clear strategic evolution. Pharmaceutical companies are prioritizing clinical-stage and late-stage programs supported by human data rather than early discovery platforms with uncertain timelines. Following a period where capital heavily favored preclinical innovation, investors and acquirers are now focusing on assets that demonstrate safety signals, efficacy data and clearer pathways toward commercialization.

Within this shifting landscape, companies holding diversified clinical-stage portfolios across oncology and central nervous system ("CNS") indications are drawing renewed attention. One such example is Oncotelic Therapeutics Inc., which recently announced expanded international intellectual property coverage for OT-101, its proprietary TGF-β antisense therapeutic platform. The development strengthens protection across neurology, oncology and CNS drug-delivery technologies aimed at crossing the blood-brain barrier.

(Press release, Oncotelic, FEB 20, 2026, View Source [SID1234662822])