On July 15, 2026 Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, "Telix") and St Vincent’s Hospital reported that the first patients have been dosed with TLX597-Tx (177Lu-DOTA-HYNIC-panPSMA) in the OPTIMAL-e trial, led by Professor Louise Emmett for patients with metastatic hormone-sensitive prostate cancer (mHSPC) at St Vincent’s Hospital in Sydney, Australia.

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OPTIMAL-e is a single-arm, open-label trial, evaluating adaptive-dosed TLX597-Tx in combination with androgen deprivation therapy (ADT) and an androgen receptor pathway inhibitor (ARPI) in men with mHSPC. The study will evaluate the impact of TLX597-Tx on PSA4 response rate in an earlier treatment setting, assessing its potential to improve both the depth and durability of PSA response, while further evaluating the safety of dose intensification.

TLX597-Tx is a highly-targeted next generation small molecule RLT5 designed to improve efficacy and quality of life in earlier-stage metastatic prostate cancer. It has demonstrated a favorable biodistribution and dosimetry profile in prior studies including OPTIMAL-PSMA6, suggesting low exposure to salivary glands and the kidneys, the healthy organs of concern with PSMA RLT, and high uptake in PSMA-expressing tumors.

Louise Emmett, MD, Director of Theranostics and Nuclear Medicine, St. Vincent’s Hospital, and Lead Investigator of the OPTIMAL-e study, said, "I am excited to lead the OPTIMAL-e trial, which is evaluating an adaptive treatment approach designed to tailor therapy to each patient’s response. By using PSMA-PET7 imaging and PSA measurements to monitor disease burden, treatment can be continued when the PSMA target persists, and paused when there is a significant reduction in tumor burden. This individualized strategy aims to maintain disease control while minimizing unnecessary treatment exposure, with the potential to keep patients in a low-volume disease state for longer and support quality of life. The findings from OPTIMAL-e may help shape future treatment strategies and advance precision medicine for men living with prostate cancer."

David N. Cade, MD, Group Chief Medical Officer, Telix, said, "The initiation of OPTIMAL-e marks an important evolution of PSMA-targeted radioligand therapy for earlier metastatic prostate cancer, where maintaining quality of life is paramount. While the currently approved radioligand therapy has demonstrated a modest improvement in overall survival in advanced-stage disease, we believe earlier intervention may offer the potential to further improve outcomes and prolong quality of life for patients."

TLX597-Tx has not received marketing authorization in any jurisdiction.

About OPTIMAL-e

OPTIMAL-e is a Phase 2, non-randomized pilot study evaluating adaptive-dosed TLX597-Tx (177Lu-DOTA-HYNIC-panPSMA) in combination with ADT and an ARPI in patients with metastatic hormone-sensitive prostate cancer (mHSPC). Adaptive dosing of 177-Lu-PSMA is the concept of only treating if the PSMA target is persistent, while pausing treatment if there is a marked reduction in the tumor target, with re-treatment at first confirmed PSA rise (once the target has returned). The study is investigating whether intensified, response-adapted PSMA-targeted radioligand therapy can deepen responses, improve disease control and enable treatment pauses for selected patients based on PSMA-PET imaging and PSA outcomes.

TLX597-Tx is being developed alongside TLX591-Tx (lutetium-177 (177Lu) rosopatamab tetraxetan), Telix’s lead antibody-based prostate cancer therapy candidate, currently the subject of the Phase 3 ProstACT Global8 trial in mCRPC9, which is actively dosing patients in jurisdictions with regulatory approval. TLX591-Tx and TLX597-Tx exhibit complementary modes-of-action, suggesting the potential for distinct applications in mCRPC and mHSPC settings as part of Telix’s portfolio approach to treating prostate cancer.

(Press release, Telix Pharmaceuticals, JUL 15, 2026, View Source [SID1234669249])

On July 15, 2026 Boehringer Ingelheim reported continued sales growth in the first half of 2026, driven by strong growth in the U.S. due to increased demand for JARDIANCE (empagliflozin) and successful new launches. Group net sales increased by 16.2%* to EUR 15.8 billion, with Human Pharma contributing EUR 13.1 billion and Animal Health EUR 2.6 billion.

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Shashank Deshpande, Chairman of the Board of Managing Directors and Head of Human Pharma, Boehringer Ingelheim said: "The strong uptake of our new products JASCAYD and HERNEXEOS show the value of the scientific innovation behind these medicines for patients, bringing real progress in areas with significant unmet medical need. In an era of accelerated medical discovery, where the boundaries of what is possible are continuously expanding, innovation-friendly environments such as the United States play a critical role in ensuring new therapies reach patients more rapidly."

Frank Hübler, Member of the Board of Managing Directors responsible for Finance, added: "Our business results show that, in Human Pharma and Animal Health, we successfully navigated a challenging macroeconomic environment and political uncertainties. We remain focused on delivering innovative medicines to patients and animals worldwide. Looking ahead, we need to direct our long-term investments to where they are closest to our growth markets and where they can create the best possible impact for patients. This also includes engaging with governments around the globe to create an environment that appropriately recognizes the value of innovative medicines and ensures patient access."

Human Pharma: Growth supported by key launches

Human Pharma sales grew 20.1%* to EUR 13.1 billion, supported by the new product launches. Established products such as JARDIANCE for the treatment of chronic kidney disease, type 2 diabetes and heart failure remained major growth drivers, contributing EUR 5.7 billion in net sales in the first half of the year. The positive development of JARDIANCE was supported by a large and growing patient base, as well as changes in the U.S. pricing and reimbursement environment, which drove significant volume growth. This trend is in line with Boehringer’s commitment to ensuring continued patient access and affordability. Without the JARDIANCE volume effect, the growth of the Human Pharma Business Unit in the first six months would have been in line with the overall pharma market.

The company also saw a successful uptake of its most recent product launches, JASCAYD (nerandomilast) and HERNEXEOS (zongertinib), particularly in the U.S., as both medicines were able to gain significant traction thanks to the innovation-friendly climate in the U.S. but also in China and Japan. Streamlined processes as well as stronger incentives for innovation in these geographies paved the way for swiftly making these breakthrough medicines available to patients.

JASCAYD, for the treatment of idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF), saw a strong uptake reflecting the urgent need for new treatment options in a disease area that has seen limited therapeutic progress for many years. Following approvals in the United States, China and Japan, as well as Thailand, the United Arab Emirates, the UK and Brazil, JASCAYD is awaiting EU approval from the European Medicines Agency (EMA).

HERNEXEOS, an oral treatment for HER2-mutant advanced non-small cell lung cancer, marked the company’s successful re-entry into oncology after ten years with launches in the U.S., China and Japan. The company expects that HERNEXEOS will be available for European patients only from 2028 after Phase III data becomes available.

Boehringer continued to advance its late-stage pipeline programs during the first half of 2026, realizing significant progress in oncology and cardio-renal-metabolic diseases. Positive Phase III data for survodutide demonstrated the medicine’s potential to address metabolic and liver health in addition to overweight and obesity. Progress with a next-generation triple agonist underlines Boehringer’s ambition to build a broad obesity and metabolic health portfolio.

At the same time, Boehringer Ingelheim initiated three Phase III oncology trials, reinforcing its goal to expand precision cancer care. The company also advanced key assets such as obrixtamig, an experimental cancer immunotherapy, and apecotrep, an investigational drug targeting kidney disease. Research momentum also continued to be strong, with five new compounds entering clinical trials. The Boehringer Human Pharma R&D pipeline spans around 80 projects.

Animal Health: Focus on new launches and emerging disease outbreaks response

The Animal Health business reported net sales of EUR 2.6 billion in the first six months of 2026, a 0.4%* increase compared to the previous year. The performance reflected a modestly growing animal health market, with increased consumer price sensitivity and fewer veterinary visits in several countries.

The company continues to execute its 2026 launch plan, including LENZELTA, a new vaccine that advances mastitis prevention in dairy cows and has launched in several EU countries, and Eko Vet+ | CANINEBEAT AI, an AI-based solution that helps detect heart murmurs in dogs and has already launched in the U.S., the UK and Germany. Boehringer Ingelheim also continues to support responses to emerging animal disease outbreaks, including New World screwworm in the U.S., after receiving Emergency Use Authorizations (EUAs) earlier this year from the U.S. Food and Drug Administration.

The company continues to progress its R&D pipeline in Animal Health, with strong candidates across infectious and non-infectious diseases as well as parasiticides, building a solid innovation foundation for the future in pets, equine, and livestock animals.

(Press release, Boehringer Ingelheim, JUL 15, 2026, View Source [SID1234669248])

On July 15, 2026 BPGbio, a clinical-stage biopharmaceutical company advancing mitochondrial-targeted therapeutics for patients, reported encouraging preliminary clinical findings from its ongoing Phase 2 study evaluating BPM31510, an investigational mitochondrial therapy, in combination with standard-of-care radiation therapy (RT) and temozolomide (TMZ) in newly diagnosed glioblastoma multiforme (GBM) patients. The data were presented at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

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The multi-center Phase 2 study (NCT04752813) is evaluating BPM31510, a lipid nano dispersion of oxidized CoQ10 administered with vitamin K1, as a neo-adjuvant and concurrent therapy alongside RT and TMZ in newly diagnosed GBM patients who have not received prior treatment.

Among patients evaluable per protocol (N=39), preliminary findings demonstrated a strong median overall survival (OS) of 19.3 months led by nearly 2X median OS compared to historical controls for the hardest-to-treat subgroup. Specifically:

Unmethylated subgroup: In 24 patients with MGMT unmethylated tumors, a group associated with poor prognosis and efficacy to standard of care—BPGbio observed a preliminary median OS of 29.3 months, nearly doubling the historical control baseline of 12.7-15.5 months.
Methylated subgroup: The median OS for the MGMT methylated patient cohort has not yet been reached due to high ongoing survival rates.
Findings remain preliminary, subject to final readout audit and are still being collected and analyzed.
The study also demonstrated that BPM31510 was generally well tolerated in combination with standard chemoradiation, with no new drug-related serious adverse events (SAEs) observed in treatment-naïve patients in the frontline setting.

"As the data continue to mature, we are increasingly encouraged by the preliminary findings emerging from both cohorts, particularly the overall survival trends observed in the cohort with MGMT unmethylated glioblastoma," said Niven R. Narain, Ph.D., President and CEO of BPGbio. "These findings further reinforce our belief that targeting mitochondrial dysfunction and altered tumor metabolism may represent an important new therapeutic approach for aggressive solid tumors such as GBM. We look forward to advancing the program toward topline and final data readout."

BPM31510 is designed to target the tumor microenvironment and alter the mitochondrial metabolic machinery to modulate oxidative phosphorylation reactivation and ROS production, thereby restoring the apoptotic function in tumors. In cancer, altered mitochondrial metabolism supports tumor growth, therapeutic resistance and adaptation to oxidative stress. BPM31510 was designed to address these metabolic vulnerabilities while supporting efficient metabolism in non-tumorigenic tissues.

The Phase 2 study has completed enrollment, with 51 patients enrolled across leading U.S. cancer centers. BPGbio anticipates topline data from the study in late fall 2026.

The ASCO (Free ASCO Whitepaper) presentation, titled "Trial in Progress: Update on a Phase 2 Study of BPM31510 (a lipid nanodispersion of oxidized CoQ10) with Vitamin K in Combination with Standard of Care RT and TMZ in Glioblastoma (GBM) Patients Without Prior Therapy" (Abstract TPS2101), was presented by study principal investigator Seema Nagpal, M.D., Professor of Neurology and Neurological Sciences at Stanford University School of Medicine. The poster can be found here.

BPGbio anticipates presenting more advanced data from the Phase 2 trial at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Meeting in Madrid, Spain this Fall.

(Press release, BPGbio, JUL 15, 2026, View Source [SID1234669247])

On July 15, 2026 Senti Biosciences Holdings, Inc. (NASDAQ: SNTI) ("SBH" or the "Company") reported a strategic transaction designed to sharpen its focus on next-generation controllable genetic medicines powered by its Regulator Dial technology platform (the "Retained Assets") and unlock value for its Gene-Circuit-enabled pipeline, including SENTI-202, currently being advanced by its wholly owned subsidiary, Senti Biosciences, Inc.

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Under the terms of this transaction, a newly formed privately held biotechnology company ("NewCo") controlled by affiliates of Celadon, the Company’s largest investor, will acquire the Company’s assets relating to its Gene-Circuit-enabled pipeline, including the rights to SENTI-202 in exchange for a contingent value right (a "CVR"), which will be distributed to equity holders providing up to $60 million in milestone payments over a seven-year period tied to the future success of SENTI-202.

After the closing of the transaction, SBH plans to seek additional financing to allow its team to focus on advancing early-stage programs built around its proprietary Regulator Dial platform, including a controllable gene therapy for Rett Syndrome and controllable, armored tumor-infiltrating lymphocytes ("TILs") for solid tumors designed to improve efficacy and safety. SBH believes this technology addresses one of the most important challenges in modern biotechnology—the ability to dynamically control powerful genetic medicines after they have been administered to patients. Both retained SBH programs build upon the Company’s foundation at the intersection of synthetic biology and artificial intelligence to accelerate and optimize Regulator-Dial-powered therapies.

As previously announced here, SENTI-202 was granted Regenerative Medicine Advanced Therapies (RMAT) designation by FDA and exhibited durable Measurable Residual Disease (MRD)-negative responses from a 22 patient Phase 1 trial, which compares favorably with current FDA approved therapies for relapsed/refractory acute myeloid leukemia (AML). In addition, the Company has identified a specific attribute in its NK donors ("Donor X characteristic") that correlates with efficacy of SENTI-202, with 50% (7/14) of the patients achieving a composite CR (cCR) when they received any SENTI-202 doses manufactured from Donor X-characteristic-derived NK cells in Cycle 1. The Donor X characteristic is found in ~50% of adult donors, is independent of HLA or KIR matching, and will be used in all future SENTI-202 manufacturing, thus supporting SENTI-202’s allogeneic off-the-shelf usage.

NewCo intends to continue development of SENTI-202, an FDA Regenerative Medicine Advanced Therapy (RMAT)-designated clinical stage asset for AML and other blood cancers, as well as other Logic Gate-enabled therapies for solid tumors and Gene-Circuit-powered programs, such as in vivo CAR.

The CVR milestone structure consists of:

$10 million upon filing and acceptance of a Biologics License Application (BLA) for SENTI-202;
$20 million upon FDA approval of a BLA for SENTI-202; and
$30 million upon achievement of $200 million in cumulative net sales of SENTI-202.

The CVR structure is intended to give SBH’s stockholders value in connection with future development, regulatory, and commercial achievements while enabling the NewCo to focus resources on advancing SENTI-202 and the Gene Circuits franchise.

"This transaction will allow the two companies to focus their resources and accelerate the delivery of powerful new genetic medicines to patients across multiple categories and diseases while allowing the SBH stockholders to potentially benefit from the success of both entities," said Timothy Lu, M.D., Ph.D, the Company’s CEO.

The transaction has been approved by SBH’s board of directors and remains subject to customary closing conditions, including approval by SBH’s stockholders and other conditions set forth in the definitive agreement.

Additional information regarding the proposed transaction, including a copy of the definitive transaction agreement and the form of agreement governing the CVRs, will be provided in a Current Report on Form 8-K filed by SBH with the U.S. Securities and Exchange Commission and available at sec.gov.

(Press release, Senti Biosciences, JUL 15, 2026, View Source [SID1234669246])

On July 15, 2026 Ernexa Therapeutics (Nasdaq: ERNA), an industry innovator developing novel cell therapies for the treatment of advanced cancer and autoimmune disease, reported compelling new preclinical data independently validating the anti-tumor activity of its lead cell therapy candidate, ERNA-101, in combination with PD-1 checkpoint inhibition.

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The independently conducted study successfully reproduced earlier findings generated at The University of Texas Anderson Cancer Center, demonstrating complete tumor clearance and durable long-term survival in a substantially larger study. The results further strengthen confidence in ERNA-101’s mechanism of action and provide important third-party validation as the Company advances toward its planned Investigational New Drug (IND) submission in the third quarter of 2026 and anticipated first-in-human Phase 1 clinical trial in the fourth quarter.

In the study, ERNA-101 combined with anti-PD-1 therapy achieved complete tumor clearance and long-term survival in 10 of 15 treated animals (67%). Remarkably, no complete tumor clearance or durable survival was observed in any of the remaining 45 animals treated with ERNA-101 alone, anti-PD-1 alone, or left untreated, demonstrating the unique anti-tumor activity of the combination therapy.

"This independent study represents an important milestone as we transition from a preclinical company to a clinical-stage oncology company," said Sanjeev Luther, President and Chief Executive Officer of Ernexa Therapeutics. "Independent reproduction of these findings in a larger, statistically robust study substantially increases our confidence in ERNA-101 and meaningfully strengthens the scientific foundation supporting our upcoming IND submission. Perhaps most importantly, complete tumor eradication and long-term survival were observed only with the ERNA-101 combination therapy, reinforcing our belief that ERNA-101 has the potential to unlock the full therapeutic benefit of checkpoint inhibitors in ovarian cancer and potentially many other immunologically ‘cold’ solid tumors. With IND submission planned this quarter and our first clinical study expected later this year, we believe Ernexa is entering one of the most important value-creating periods in the Company’s history."

Earlier studies performed by The University of Texas Anderson Cancer Center demonstrated that ERNA-101 selectively homes to ovarian tumors and delivers its engineered IL-7/IL-15 fusion cytokine directly into the tumor microenvironment. This localized immune activation increased infiltration of cancer-fighting T cells into tumors that typically evade immune detection, providing the biological rationale for combining ERNA-101 with PD-1 checkpoint inhibitors.

The newly completed independent study reproduced those findings and further demonstrated that this strategy generates durable anti-tumor responses that were not achieved with either therapy alone.

"One of the greatest challenges in immuno-oncology is that many solid tumors remain effectively invisible to the immune system," said Robert H. Pierce, M.D., Chief Scientific Officer of Ernexa Therapeutics. "These independently generated results provide compelling validation that ERNA-101 may successfully remodel the tumor microenvironment, recruit and activate T cells, and dramatically enhance the activity of PD-1 checkpoint inhibitors. Independent confirmation of these findings is particularly meaningful because reproducibility is one of the strongest indicators supporting successful clinical translation. We believe ERNA-101 has the potential to become an important combination immunotherapy platform for ovarian cancer and potentially numerous other immunologically ‘cold’ solid tumors where today’s checkpoint inhibitors have produced limited clinical benefit."

The study was conducted by an independent contract research organization using expanded treatment groups in an immunocompetent ID8luc-ova syngeneic ovarian cancer model. Tumor burden was monitored longitudinally through bioluminescence imaging to evaluate treatment response and confirm complete tumor clearance.

The study included four treatment arms:

ERNA-101 plus anti-PD-1
ERNA-101 monotherapy
Anti-PD-1 monotherapy
Untreated control

Complete tumor clearance and durable long-term survival were observed exclusively in the combination therapy group, further validating the synergistic mechanism between ERNA-101 and PD-1 blockade.

With completion of this independent validation study, Ernexa remains on track to submit its IND application during the third quarter of 2026 and initiate its first-in-human Phase 1 clinical trial during the fourth quarter of 2026.

(Press release, Ernexa Therapeutics, JUL 15, 2026, View Source [SID1234669245])