On September 14, 2026 Bionano Genomics, Inc. (Nasdaq: BNGO) reported three new independently authored, peer-reviewed publications demonstrating the clinical utility of OGM in high-risk hematologic malignancies — myelodysplastic syndromes (MDS), acute myeloid leukemia (AML), and therapy-related myeloid neoplasms (t-MN). The studies, published in Modern Pathology, the International Journal of Cancer, and npj Precision Oncology, reinforce a growing body of evidence that OGM can detect prognostically important structural genomic alterations that elude standard karyotyping, FISH, and targeted sequencing panels.

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MD Anderson Cancer Center: Chromoanagenesis by OGM defines an ultra-high-risk MDS subset.

Researchers at The University of Texas MD Anderson Cancer Center, led by Guilin Tang, PhD, used OGM to study 332 samples from subjects with MDS, identifying chromoanagenesis (CAG), a catastrophic single-event genomic restructuring process, in 15.9% of cases overall and 17.6% of newly diagnosed subjects. The study, published in Modern Pathology (Wei et al., 2026), found that:

CAG-positive by OGM subjects had a median overall survival of just 9.9 months, significantly shorter than non-CAG subjects where median survival was not reached.
CAG by OGM showed the potential to confer prognostic information beyond existing risk-stratification systems, potentially enabling the identification of patients for early allogeneic transplantation or TP53-targeted clinical trials.

University of Oulu: Cryptic structural variants uncovered in "normal karyotype" AML.

A separate study from the University of Oulu and collaborators, led by Tuomo Mantere, PhD, used OGM to analyze 48 samples of cytogenetically normal AML (CN-AML) — a subgroup that appears unremarkable on standard karyotyping but is clinically heterogeneous. Published in the International Journal of Cancer (Turtinen et al., 2026), the study found that:

OGM detected clinically relevant structural variants or copy-neutral loss-of-heterozygosity in 46% of cases classified as "normal" by conventional karyotyping.
Recurrent alterations included KMT2A partial tandem duplications (10% of cases), RUNX1 disruptions, NF1 deletions, and a novel putative FOXP1:EYA2 fusion not previously reported in the literature.
Subjects with OGM-detected abnormalities had significantly worse overall survival than those without (p = 0.005).

Josep Carreras Leukaemia Research Institute: OGM refines risk in therapy-related neoplasms and younger MDS.

A multicenter Spanish study led by Mar Mallo, PhD, and Francesc Solé, PhD, at the Josep Carreras Leukaemia Research Institute in collaboration with a Spanish hospital network applied OGM to two clinically distinct: 48 subjects with therapy-related myeloid neoplasms (t-MN) and 65 subjects with younger-onset MDS (yMDS, age ≤60). Published in npj Precision Oncology (Mestre et al., 2026), the study found that:

OGM was interpretable in 100% of samples, including all 8 cases where conventional banding analysis (CBA) failed due to lack of dividing cells, and identified 134 additional genomic alterations.
OGM refined cytogenetic classification in 52.0% of karyotypically abnormal cases and detected clinically relevant structural alterations in 9.8% of cases with a normal karyotype, including reclassification of subjects into the therapeutically relevant MDS with isolated 5q- category.
OGM-defined genomic complexity was independently associated with overall survival; chromoanagenesis emerged as the strongest independent predictor of inferior survival in multivariable analysis (HR 9.26), exceeding even TP53 mutation status.
Integrating OGM findings into IPSS-R and IPSS-M scoring shifted 16.7% of t-MN and up to 12.8% of yMDS subjects into higher-risk prognostic categories, which could have implications for treatment planning, including identification of biallelic TP53 inactivation.

Key highlights across all three studies:

Three independent academic centers, spanning the U.S., Finland, and Spain, each show the potential for OGM to identify clinically actionable genomic complexity that conventional cytogenetic workups miss.
All three studies link OGM findings directly to overall and/or disease-specific survival.
Findings support a potential role for OGM in refining prognostication beyond IPSS-R/IPSS-M and ELN2022 classification systems, including in patients who otherwise appear lower-risk by standard testing, and in cases where conventional karyotyping fails outright due to lack of dividing cells.
Across all three cohorts, chromoanagenesis and TP53 disruption consistently emerge as markers of a biologically distinct, ultra-high-risk disease subset best captured by genome-wide structural variant detection.

"These three independent studies, spanning MDS, AML, and therapy-related myeloid neoplasms, all point to the same conclusion: a meaningful fraction of high-risk genomic complexity in myeloid malignancies is simply invisible to conventional karyotyping," said Al Luderer, PhD, chairman and interim chief executive officer of Bionano. "As OGM adoption continues to expand, we expect to see more of this kind of evidence connecting structural variant detection directly to potential patient outcomes and treatment decisions."

(Press release, Bionano Genomics, SEP 14, 2026, View Source [SID1234670855])

On September 14, 2026 Asimov, the company building an AI-native synthetic biology platform to advance therapeutic development, reported a cell line development partnership with Sidewinder Therapeutics, a biopharmaceutical company pioneering the development of next-generation bispecific ADCs (antibody-drug conjugates) for the treatment of cancer. As part of a broader collaboration across multiple products, Asimov successfully delivered a cell line for Sidewinder’s bispecific antibody candidate for solid tumors.

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"We are excited to be partnering with Sidewinder Therapeutics to advance their novel bispecific, which represents a powerful approach to targeting and treating solid tumors," said Alec Nielsen, co-founder and CEO at Asimov. "Complex molecules such as Sidewinder’s 4-chain bispecific can be challenging to express, and achieving such high titers for this molecule is a testament to the strength of both our team and our CHO Edge System."

Asimov has worked closely with the Sidewinder team on a custom cell line development program for this 4-chain bispecific antibody. In order to achieve the required expression levels and quality attributes, Sidewinder relied on Asimov’s CHO Edge system, which combines a GS knock-out CHO host, hyperactive transposase, genetic parts library, and Kernel, Asimov’s AI-driven genetic design software.

"With a pipeline of first-in-class bispecific ADCs, we needed to find a cell line development partner with the technical capabilities required to deliver high expression levels while simultaneously achieving consistent product quality," said Eric Murphy, Ph.D., co-founder and CEO at Sidewinder. "The team at Asimov has exceeded expectations, and we’re excited to be progressing toward the clinic with such a high performing cell line."

(Press release, Sidewinder Therapeutics, SEP 14, 2026, View Source [SID1234670854])

On September 14, 2026 Biofrontera Inc. (NASDAQ: BFRI) ("Biofrontera" or the "Company"), a biopharmaceutical company specializing in the development and commercialization of photodynamic therapy (PDT) in dermatology, reported that the U.S. Food and Drug Administration (FDA) has approved the Company’s supplemental New Drug Application (sNDA) for Ameluz (aminolevulinic acid hydrochloride) topical gel, 10%, in combination with photodynamic therapy using the BF-RhodoLED lamp series, for the treatment of superficial Basal Cell Carcinoma (sBCC) in adults1.

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With this approval, Ameluz becomes the first and only PDT drug approved by the FDA for the treatment of a skin cancer, and the only topical PDT in the United States indicated to treat both a pre-cancerous skin condition, actinic keratosis (AK), and a skin cancer. The sBCC indication expands the addressable market for Ameluz and strengthens its position in medical dermatology. This label expansion also furthers Biofrontera’s strategy of broadening the clinical utility of its Red-Light PDT platform. Hermann Luebbert, Chief Executive Officer and Chairman of Biofrontera, stated: "FDA approval of Ameluz for superficial basal cell carcinoma is a defining milestone for Biofrontera. Ameluz is now the first and only photodynamic therapy approved in the United States to treat a skin cancer, which sets our platform apart in medical dermatology and gives dermatologists an effective, non-surgical option for a very common tumor. This approval reflects years of disciplined investment in the clinical development of Ameluz, and the latest stage in the ongoing expansion of our PDT platform." He added "We are planning an official launch of the sBCC indication late in the fourth quarter of 2026 through the first quarter of 2027 with our existing commercial organization and installed lamp base. We believe the approval represents a further driver of long-term growth for our existing customers. It also gives new Dermatology practices a reason to purchase a RhodoLED lamp and begin to use Ameluz PDT, expanding our overall installed base." This new indication utilizes the same topical product (Ameluz) and the same red-light device as the Company’s AK indication, so our existing customers will be able to rapidly adopt this new treatment option.

Basal cell carcinoma (BCC) is the most common skin cancer in the United States, with approximately 3.6 million cases diagnosed annually, according to the Skin Cancer Foundation. Published estimates suggest that the superficial subtype accounts for approximately 15%-20% of BCC cases, or an estimated 540,000 to 720,000 sBCC cases annually in the U.S.2. Superficial BCC lesions can be up to several cm in diameter and are frequently located on the trunk and extremities and often present as multiple lesions, for which non-surgical, tissue-sparing treatment options are limited.

The approval is supported by a multicenter, randomized, double-blind, vehicle-controlled Phase 3 trial in 187 adults with histologically confirmed sBCC. The primary endpoint was a composite of both clinical and histological complete response of a main target lesion 12 weeks after the start of the last PDT cycle. This rigorous target was achieved in 66% of subjects treated with Ameluz PDT (95/145) compared with 5% of subjects treated with placebo-PDT (2/42). Histological clearance of the main target lesion was seen in 76% of Ameluz PDT treated patients versus 19% with Placebo-PDT, and 83% of Ameluz-treated subjects achieved complete clinical clearance of all target lesions compared with 21% for Placebo-PDT. The most common adverse reactions were application-site reactions consistent with the known safety profile of Ameluz PDT.

Dr. M. Shane Chapman, MBA, board certified dermatologist, Professor and Founding Chair, Department of Dermatology, Dartmouth Hitchcock Medical Center and the Dartmouth Geisel School of Medicine, and a key contributor to the Phase 3 study added "For many patients with superficial basal cell carcinoma — those with multiple lesions, lesions in cosmetically sensitive locations, or for whom surgery would not be preferred — treatment options have been limited. This FDA approval for Ameluz and the RhodoLED gives us a rigorously studied, non-surgical option that we can deliver in our office. As someone who has worked with PDT for many years, I see this as a meaningful expansion in the use of this treatment."

(Press release, Biofrontera, SEP 14, 2026, View Source [SID1234670853])

On September 14, 2026 Perspective Therapeutics, Inc. ("Perspective," the "Company," "we," "us," and "our") (NYSE AMERICAN: CATX), a radiopharmaceutical development company pioneering advanced treatments for cancers throughout the body, reported a clinical trial collaboration agreement with Merck (NYSE: MRK), known as MSD outside of the United States and Canada.

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The agreement supports the evaluation of Perspective’s targeted alpha-particle therapy [212Pb]PSV359 in combination with Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy. This combination will be evaluated under an amendment to the Company’s ongoing Phase 1/2a study of [212Pb]PSV359 in patients with certain types of non-small cell lung cancer and colorectal cancer that express fibroblast activation protein alpha (FAP-α) (clinicaltrials.gov identifier NCT06710756). The study has completed enrollment in the first three monotherapy dose cohorts.

Perspective is sponsoring the study, and Merck is providing pembrolizumab at no cost.

"FAP-α is associated with the majority of solid tumors and with a tumor microenvironment historically characterized by poor drug penetration and immune suppression or exclusion," said Markus Puhlmann, Perspective’s Chief Medical Officer. "By combining targeted radiopharmaceutical treatment with a well-established immune checkpoint inhibitor, we aim to evaluate whether this approach can reshape the tumor environment and potentially improve treatment outcomes for patients with advanced FAP-α-positive solid tumors."

About FAP-α

FAP-α is a protein abundantly expressed on the surface of cancer-associated fibroblasts (CAFs) in the stroma, a part of the tumor microenvironment (TME) in the majority of epithelial cancers. In addition to expression on CAFs, FAP-α is expressed on certain cancer cells themselves, including sarcomas and mesotheliomas.1,2,3,4 Higher FAP-α expression has been found to be associated with poor prognosis in a number of solid tumors such as non-small cell lung cancer, colorectal cancer, pancreatic cancer, stomach cancer, mesothelioma, head and neck cancer, esophageal cancer, and ovarian cancer.5,6,7,8,9,10 Expression of FAP-α in healthy tissues is usually low.3,4

About PSV359

PSV359 was designed to target and deliver 212Pb to tumor sites expressing FAP-α, associated with multiple highly prevalent solid tumors, with patients in need of additional treatment options. The targeting moiety may also be radiolabeled with 203Pb or 68Ga (known as PSV377) to detect FAP-α expression in individual patients. Preclinical imaging and therapy as well as human imaging results suggest Perspective’s proprietary targeting ligand has improved levels of target engagement and uptake in tumors, as well as reduced retention in healthy tissues, which may result in a desirable therapeutic index.

Perspective is conducting a multi-center, open-label, dose-finding and dose-expansion study (clinicaltrials.gov identifier NCT06710756) of [212Pb]PSV359 in patients with advanced solid tumors that express FAP-α as determined by imaging with [203Pb]PSV359. The primary objective of the dose finding phase of the study is to assess the safety and tolerability of various doses of [212Pb]PSV359 in order to determine the recommended Phase 2 dose to be used in the expansion phase of the study, where anti-tumor activities may be an additional primary outcome measure.

(Press release, Perspective Therapeutics, SEP 14, 2026, View Source [SID1234670852])

On September 14, 2026 BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXL) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company developing novel immunotherapies to transform cancer care, reported that the independent Data Safety Monitoring Board (DSMB) has issued its seventh consecutive positive recommendation following review of clinical data from BriaCell’s pivotal Phase 3 Bria-ABC study of Bria-IMT plus immune checkpoint inhibitor (CPI) in patients with metastatic breast cancer (NCT06072612).

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Following its review, the DSMB raised no safety or other clinical concerns and recommended that the study continue without modifications. DSMB meetings occur quarterly in accordance with the study protocol. BriaCell’s ongoing pivotal Phase 3 study is being conducted under Fast Track designation granted by the US Food and Drug Administration (FDA), reflecting the significant unmet medical need in metastatic breast cancer.

"We are very encouraged by the DSMB’s seventh consecutive positive recommendation to continue BriaCell’s pivotal Phase 3 Bria-ABC study," said Dr. William V. Williams, President and Chief Executive Officer of BriaCell. "This milestone represents continued progress in developing BriaCell’s novel immunotherapies for patients with urgent unmet medical needs."

(Press release, BriaCell Therapeutics, SEP 14, 2026, View Source [SID1234670851])