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Biofrontera Announces FDA Approval of Ameluz® Red Light PDT for the Treatment of Superficial Basal Cell Carcinoma

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])

Perspective Therapeutics Announces Clinical Collaboration and Supply Agreement with Merck to Evaluate [212Pb]PSV359 in Combination with Keytruda® (Pembrolizumab) in FAP-α Positive Solid Tumors

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.

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])

Data Safety Monitoring Board (DSMB) Recommends Continuing BriaCell’s Phase 3 Metastatic Breast Cancer Study

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).

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])

Leads Biolabs’ Opamtistomig (LBL-024) Oral Presentation Demonstrates Robust Response and PFS Benefits in First‑Line NSCLC

On September 14, 2026 Nanjing Leads Biolabs Co., Ltd. ("Leads Biolabs" or the "Company," Stock Code: 9887.HK) reported that updated Phase II data for opamtistomig (LBL-024), its proprietary PD-L1/4-1BB bispecific antibody, plus chemotherapy as first-line treatment for non-small cell lung cancer (NSCLC), were presented in an oral presentation at the 2026 World Conference on Lung Cancer (WCLC).

The updated data demonstrated robust and durable antitumor activity across both squamous and non-squamous NSCLC, including high response rates in squamous NSCLC regardless of PD-L1 expression and deep, durable responses in PD-L1-positive non-squamous NSCLC. The findings further support the potential of opamtistomig’s differentiated dual-target mechanism to broaden the clinical benefit of immunotherapy in first-line NSCLC.

Highlights

Robust efficacy across NSCLC: As of July 1, 2026, 63 treatment-naïve patients had been enrolled, including 31 non-squamous and 32 squamous NSCLC patients. More than 90% had stage IV disease, and a considerable proportion had multiple metastases, including brain and liver metastases. PD-L1 TPS ≥1% was observed in only 35.5% of non-squamous and 43.8% of squamous patients, well below the 60%–70% in the general NSCLC population. Median follow-up was 7.1 months. Among 62 efficacy-evaluable patients, ORR was 71.0%, DCR was 95.2%, and the 6-month PFS rate was 70.6%.
Strong and consistent efficacy in squamous NSCLC: ORR was 87.1%, DCR was 96.8%, and the 6-month PFS rate was 86.7%. Comparable benefit was observed regardless of PD-L1 expression, with ORRs of 84.6% in PD-L1-positive and 88.2% in PD-L1-negative patients, and 6-month PFS rates of 84.6% and 87.4%, respectively.
Deep and durable responses in non-squamous NSCLC: Among PD-L1-positive patients, ORR was 81.8%, DCR was 100.0%, and the 6-month PFS rate was 90.0%. Notably, substantial responses were also observed in patients with low PD-L1 expression (TPS 1%–49%).
Favorable safety: Opamtistomig plus chemotherapy demonstrated a manageable safety profile generally consistent with PD-(L)1 antibody-based chemotherapy combinations, with no new safety signals observed.
These findings support the potential of opamtistomig’s differentiated PD-L1/4-1BB dual-target mechanism to provide broad and durable clinical benefit across PD-L1 expression levels, including patient populations that remain underserved by conventional immunotherapy.

As the first PD-L1/4-1BB bispecific antibody to enter NDA review globally, opamtistomig is being developed as a potential next-generation IO 2.0 backbone therapy. It is currently being evaluated in 14 solid tumor indications, with clinical evidence emerging across seven tumor types, including NSCLC, ESCC, EP-NEC, BTC, and platinum-resistant ovarian cancer. Approximately 800 patients with solid tumors have been treated to date, with a favorable overall safety profile.

Executive Commentary
Dr. Charles Cai, Chief Medical Officer of Leads Biolabs, said: "The updated WCLC data are highly encouraging. With longer follow-up, tumor shrinkage continued to deepen and ORR continued to increase, providing further evidence of the durability of opamtistomig’s antitumor activity. Particularly noteworthy is the consistent efficacy observed regardless of PD-L1 expression in squamous NSCLC, together with deep and durable responses in PD-L1-positive non-squamous NSCLC, including patients with low PD-L1 expression.

Despite more than 90% of patients having stage IV disease and many presenting with difficult-to-treat metastatic disease, opamtistomig plus chemotherapy continued to demonstrate encouraging efficacy and PFS outcomes. These findings further support its potential clinical value in first-line NSCLC. We are advancing Phase III development and look forward to bringing this next-generation immunotherapy to more patients."

About NSCLC
According to data from the International Agency for Research on Cancer (IARC) in 2022, there are approximately 2.48 million new cases of lung cancer and approximately 1.82 million lung cancer-related deaths worldwide each year. According to data published by the National Cancer Center of China, there were approximately 1.18 million new lung cancer cases and approximately 743,000 lung cancer-related deaths in China in 2024. NSCLC accounts for approximately 85% of all lung cancer cases. Due to the aggressive nature of NSCLC and the lack of effective early screening methods, approximately 70% of patients with NSCLC in China are diagnosed at an advanced stage.

Patients with NSCLC harboring actionable genetic alterations (AGAs) such as epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK) and ROS proto-oncogene 1 (ROS1) may benefit from corresponding targeted therapies, while patients without AGAsstill rely primarily on immunotherapy in combination with chemotherapy. Further prolonging survival and achieving more durable and deeper responses remain key unmet needs in clinical practice. In squamous NSCLC, AGAs are rare, and patients generally cannot benefit from targeted therapies. Commonly used drugs such as pemetrexed and bevacizumab are also unsuitable for squamous NSCLC due to efficacy or safety concerns, resulting in limited treatment options. Although PD-1/PD-L1 inhibitors in combination with chemotherapy have expanded treatment options for patients with squamous NSCLC, prognosis remains poorer than in non-squamous NSCLC due to differences in biology, clinical features and treatment responses, with a median PFS of only 5 to 8 months and a median overall survival (OS) of 17 to 27 months, highlighting a significant unmet medical need for more effective treatment options.

About Opamtistomig
Opamtistomig (LBL-024) is emerging as a next-generation pan-cancer backbone therapy with potential overall survival (OS) benefit that simultaneously targets PD-L1 and the co-stimulatory receptor 4-1BB. Currently, opamtistomig is being evaluated in 14 indications, including one pivotal single-arm registrational study, one confirmatory Phase III study, and nine proof-of-concept studies, covering major indications such as NSCLC and multiple cold tumors. To date, opamtistomig has demonstrated robust antitumor activity across seven tumor types—extrapulmonary neuroendocrine carcinoma (EP-NEC), non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), biliary tract cancer (BTC), hepatocellular carcinoma (HCC), esophageal squamous cell carcinoma (ESCC), and ovarian cancer (OC)—highlighting its clinical value and broad therapeutic promise.

Developed using Leads Biolabs’ proprietary X-Body bispecific platform, opamtistomig is designed to simultaneously block PD-1/PD-L1 immune suppression and conditionally activate 4-1BB, an agonist pathway, resulting in a potent and synergistic anti-tumor immune response. It has a safety profile comparable to PD-1/PD-L1 inhibitors and demonstrates broader-spectrum anti-cancer potential. Mechanistically, 4-1BB agonism can reactivate exhausted T cells and promote robust T-cell proliferation, offering significant promise for PD-1/PD-L1–resistant or immunologically "cold" tumors and potentially offering durable survival benefits.

Recognizing its clinical potential, opamtistomig received Breakthrough Therapy Designation (BTD) from China’s National Medical Products Administration (NMPA) in October 2024, and Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) in November 2024. Additionally, in January 2026, opamtistomig was granted Fast Track Designation (FTD) by the FDA and ODD by the European Commission, further underscoring its potential to address unmet medical needs in this patient population. In July 2026, its New Drug Application (NDA) was granted priority review designation by the NMPA, followed by NDA acceptance in August 2026, positioning opamtistomig as a potential world’s first approved 4-1BB-targeting antibody, the first approved agonist antibody, and the first approved treatment for EP-NEC.

(Press release, Nanjing Leads Biolabs, SEP 14, 2026, View Source [SID1234670850])

Cullinan Therapeutics to Host Virtual Analyst and Investor Event Today to Feature Zipalertinib Plus Chemotherapy Phase 3 REZILIENT3 Data Presented at the IASLC 2026 World Conference on Lung Cancer

On September 14, 2026 Cullinan Therapeutics, Inc. (Nasdaq: CGEM), a clinical-stage biopharmaceutical company accelerating potential first- or best-in-class, disease-modifying T cell engagers in autoimmune diseases and cancer, reported that it will host a virtual event for analysts and institutional investors today at 8:00 a.m. ET to discuss the results from the planned interim analysis of the Phase 3 REZILIENT3 trial of zipalertinib plus chemotherapy presented in Presidential Symposium 2 at the International Association for the Study of Lung Cancer’s (IASLC) 2026 World Conference on Lung Cancer (WCLC).

Virtual Event Details

Cullinan Therapeutics will host a virtual event for analysts and institutional investors today at 8:00 a.m. ET. Participants from Cullinan Therapeutics include Nadim Ahmed, Chief Executive Officer, and Jeffrey Jones, MD, MBA, Chief Medical Officer.

A live webcast will be available via the events page of Cullinan Therapeutics’ investor relations website at View Source A replay will be archived on the website following the event.

(Press release, Cullinan Oncology, SEP 14, 2026, View Source [SID1234670849])