On August 17, 2026 Faeth Therapeutics (Nasdaq: FTH), a clinical-stage oncology company developing multi-node therapies for cancer patients, including its lead program PIKTOR, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the combination of sapanisertib and serabelisib (PIKTOR) with paclitaxel for the treatment of patients with advanced or recurrent endometrial cancer whose tumors harbor a PI3K/AKT/mTOR pathway alteration and who have previously been treated with platinum-based chemotherapy and an immune checkpoint inhibitor (ICI).

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"Fast Track designation for PIKTOR reflects the significant unmet need in advanced endometrial cancer for patients whose disease has progressed despite platinum-based chemotherapy and an immune checkpoint inhibitor," said Anand Parikh, Chief Executive Officer of Faeth Therapeutics. "We believe PIKTOR’s multi-node approach to the PI3K/AKT/mTOR pathway is well suited to this population as our preclinical data suggests that PIKTOR can resensitize patients to chemotherapy."

About PIKTOR

PIKTOR is an investigational, proprietary, all-oral combination of serabelisib, a selective PI3K-alpha inhibitor, and sapanisertib, an mTORC1/mTORC2 inhibitor, designed to inhibit multiple nodes of the PI3K/AKT/mTOR pathway. According to published literature, this pathway is dysregulated in up to 50% of all solid tumors, making it one of the most prevalent therapeutic targets in oncology. PIKTOR is being evaluated in a Phase 2 trial in second-line advanced endometrial cancer (Study FTH-PIK-201), with topline data anticipated by year-end 2026. PIKTOR is also being evaluated in a Phase 1b/2 trial in HR+/HER2- advanced breast cancer (Study FTH-PIK-101), in which the first patient was dosed in April and interim data is anticipated in 2027.

(Press release, Faeth Therapeutics, AUG 17, 2026, View Source [SID1234670184])

On August 17, 2026 UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, reported the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its investigational drug UGN-103 (mitomycin) for intravesical solution. UGN-103 is a next-generation mitomycin formulation being developed for the treatment of adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). It is built on the clinical and commercial foundation of ZUSDURI (mitomycin) for intravesical solution.

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"The NDA submission for UGN-103 marks another important milestone in advancing our vision to redefine the treatment of urothelial cancers," said Liz Barrett, President and CEO of UroGen. "UGN-103 represents the next evolution in our portfolio and is designed to provide a more streamlined manufacturing process, simplified reconstitution and extended shelf-life of the reconstituted product while leveraging our RTGel technology."

The NDA for UGN-103 is supported by the clinical data from the ongoing Phase 3 UTOPIA trial, a single-arm, multicenter study evaluating the efficacy and safety of UGN-103 in adult patients with recurrent LG-IR-NMIBC. UGN-103 demonstrated a 77.8% three-month complete response (CR) rate (95% CI: 68.3%, 85.5%) and a 94.5% six-month duration of response (DOR) by Kaplan-Meier estimate (95% CI: 86.1%, 97.9%). Both the three-month CR rate and the DOR observed at six months with UGN-103 in the UTOPIA trial are consistent with those observed in the pivotal ENVISION trial of ZUSDURI. Because these findings are derived from separate clinical studies, no formal cross-trial comparison was performed.

About UGN-103
In January 2024, UroGen entered into a licensing and supply agreement with medac to develop UGN-103 for recurrent LG-IR-NMIBC. UGN-103 is designed to reinforce and build on the clinical and commercial foundation of ZUSDURI, the first and only FDA-approved treatment for adults with recurrent LG-IR-NMIBC. The program maintains UroGen’s innovative and proven RTGel technology, enabling sustained mitomycin exposure in the bladder, while incorporating next-generation enhancements, including a more streamlined manufacturing process and simplified reconstitution to support improved ease of use in clinical practice. UroGen holds U.S. patents covering the combination of its proprietary RTGel technology with medac’s licensed lyophilized mitomycin formulation, as well as the use of UGN-103 in LG-IR-NMIBC, with intellectual property coverage expected to extend into July 2044.

About ZUSDURI
ZUSDURI (mitomycin) for intravesical solution is an innovative drug formulation of mitomycin, approved for the treatment of adults with recurrent LG-IR-NMIBC. Utilizing UroGen’s proprietary RTGel technology (a sustained release, hydrogel-based formulation), ZUSDURI is delivered directly into the bladder by a trained healthcare professional using a urinary catheter in an outpatient setting, thereby enabling the treatment of tumors by non-surgical means.

About Non-Muscle Invasive Bladder Cancer (NMIBC)
LG-IR-NMIBC affects around 82,000 people in the United States every year and of those, an estimated 59,000 are people experiencing recurrence. Bladder cancer primarily affects older populations with increased risk of comorbidities, with the median age of diagnosis being 73 years. Guideline recommendations for the management of NMIBC include transurethral resection of bladder tumor (TURBT) as the standard of care. Up to 70 percent of NMIBC patients experience at least one recurrence, and LG-IR-NMIBC patients are even more likely to recur and face repeated TURBT procedures. Learn more about NMIBC at www.BladderCancerAnswers.com.

About UTOPIA
The UTOPIA trial is a single-arm, multicenter study evaluating the efficacy and safety of UGN-103 in 99 patients across global sites. Enrolled patients received 75 mg of UGN-103 via intravesical instillation in an outpatient setting once weekly for six weeks. The primary endpoint is CR rate at three months, with responders entering a follow-up phase of up to 12 months to assess DOR. For more information on the UTOPIA study, please visit View Source

(Press release, UroGen Pharma, AUG 17, 2026, View Source [SID1234670183])

On August 17, 2026 Philogen S.p.A. (BIT:PHIL) reported the publication in the Journal of Clinical Oncology (JCO) of updated efficacy and safety results from the randomized Phase III PIVOTAL study (PH-L19IL2TNF-02/15; NCT02938299), evaluating Nidlegy (Daromun; L19IL2/L19TNF) as a neoadjuvant treatment for patients with locally advanced, fully resectable melanoma.

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The article, entitled "Neoadjuvant Intralesional Daromun (L19IL2/L19TNF) in Resectable Locally Advanced Melanoma: An Update on the Efficacy and Safety Results of the PIVOTAL Phase III Trial", was published online in the Journal of Clinical Oncology on 11 August 2026 (Vol. 44, Issue 23; doi: 10.1200/JCO-26-00852).

The JCO publication represents an updated analysis of the PIVOTAL Phase III results previously published in Annals of Oncology in 2025 (Kähler et al., Annals of Oncology, 2025, 36, 1166). While the previous publication reported the primary recurrence-free survival analysis at a median follow-up of less than two years, the updated JCO analysis reports efficacy and safety results at a median follow-up of approximately three years from randomization and includes additional post-hoc analyses of event-free survival (EFS).

At the longer follow-up, the updated analysis confirmed a clinically and statistically significant improvement in recurrence-free survival (RFS) for patients receiving neoadjuvant Nidlegy followed by surgery compared with patients undergoing upfront surgery. The hazard ratio for recurrence or death was 0.55 (95% CI, 0.38- 0.78; P<0.001), corresponding to a 45% reduction in the hazard of recurrence or death. Median RFS was 23.8 months in the Nidlegy plus surgery arm compared with 6.5 months in the surgery-only arm. The 3-year RFS rates were 35.7% and 16.6%, respectively.

The updated analysis also confirmed a significant benefit in distant metastasis-free survival (DMFS), with a hazard ratio of 0.53 (95% CI, 0.33-0.83; P=0.005). Median DMFS was 38.7 months in the Nidlegy plus surgery arm compared with 14.0 months in the surgery-only arm, while the 3-year DMFS rates were 51.2% and 28.7%, respectively.

In addition, a post-hoc EFS analysis in the overall study population was consistent with the primary RFS results, with a hazard ratio of 0.71 (95% CI, 0.51-0.98; P=0.034). The publication also reports analyses in patients with recurrent melanoma, who represented 87% of the study population, showing a consistent clinical benefit from neoadjuvant Nidlegy, including in patients who had previously received systemic therapies.

The updated safety profile of Nidlegy remained manageable, with no new safety signals of concern. No treatment-related adverse events above Grade 3 and no treatment-related deaths were reported.

Prof. Dr. Dario Neri, Chief Executive Officer and Chief Scientific Officer of Philogen, commented: "The publication of these updated PIVOTAL results in the Journal of Clinical Oncology provides important longerterm confirmation of the clinical benefit initially reported in Annals of Oncology. With median follow-up now of approximately three years, Nidlegy continues to demonstrate meaningful improvements in recurrencefree and distant metastasis-free survival compared with upfront surgery, with a manageable safety profile and no new safety signals. We are particularly encouraged by the consistency of the results in patients with recurrent melanoma, including patients previously treated with systemic therapies. These findings further support the potential role of Nidlegy as a neoadjuvant treatment for patients with locally advanced, fully resectable melanoma."

Nidlegy is partnered with Sun Pharma for the treatment of Skin Cancers in Europe, New Zealand and Australia.

About Nidlegy (Daromun)

Nidlegy is a biopharmaceutical product, proprietary to Philogen, designed for the treatment of skin cancer. It consists of two active ingredients, L19IL2 and L19TNF. The two ingredients are manufactured independently and mixed prior to intralesional administration. The L19 antibody is specific to the Extra Domain B of Fibronectin, a protein expressed in tumors (and other diseases) but absent in most healthy tissues. Interleukin 2 (IL2) and Tumor Necrosis Factor (TNF) are pro-inflammatory cytokines with a potent anti-tumor activity. Nidlegy is currently being investigated in two Phase III clinical trials for the treatment of locally advanced melanoma, and in Phase II clinical trials for the treatment of High-Risk Basal Cell Carcinoma and other non-melanoma skin cancers.

About the PIVOTAL Phase III study

PIVOTAL is a phase III, international, multi-center, randomized, comparator-controlled, parallel-group study
evaluating the efficacy and safety of intratumoral injections of Nidlegy as a neoadjuvant treatment, followed
by standard-of-care treatment (surgery), as opposed to standard-of-care treatment (i.e., surgery alone), in melanoma patients with locally advanced, fully resectable cutaneous, sub-cutaneous (including satellite/in transit metastases), or nodal metastases accessible to intratumoral injection. For both arms, adjuvant treatment with approved drugs was allowed. Nidlegy was injected intralesionally up to four times, once a week, before surgery. The trial enrolled 256 patients in Europe across 22 clinical centers in Germany, Italy, France and Poland.

About locally advanced fully resectable melanoma

Melanoma is a skin tumor which begins when melanocytes start growing without control. Melanocytes are found in the basal layer of the epidermis at the boundary with the next layer (the dermis). Locally advanced melanoma is a metastatic cancer in which neoplastic lesions have spread to drainage areas of regional lymph nodes and can appear as micrometastases, satellite/in transit metastases, and/or lymph node metastases. To date, patients with resectable disease receive surgery, possibly followed by approved adjuvant systemic therapies. There is no approved drug for the treatment of locally advanced fully resectable melanoma in the neoadjuvant setting.

(Press release, Philogen, AUG 17, 2026, View Source [SID1234670178])

On August 17, 2026 Labcorp Holdings Inc. (NYSE: LH), a global leader of innovative and comprehensive laboratory services, reported it will host an Investor Day on Thursday, September 10, 2026, from 9 a.m. to noon ET.

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Chairman and CEO Adam Schechter, Executive Vice President and CFO Julia Wang and other members of the executive leadership team will discuss the company’s go-forward strategy, capital deployment priorities and long-term financial outlook. Presentations will be followed by a Q&A session.

A live webcast of the event will be available through the Labcorp Investor Relations website beginning at 9 a.m. ET. A replay of the webcast and supporting materials will be available after the conclusion of the event.

(Press release, LabCorp, AUG 17, 2026, View Source [SID1234670177])

On August 17, 2026 Galmed Pharmaceuticals Ltd. (NASDAQ: GLMD) ("Galmed" or the "Company"), a clinical-stage biopharmaceutical company focused on liver, cardiometabolic and oncology diseases, reported significant results from a pre-clinical study of a combination of Aramchol and Xtandi (enzalutamide) for prostatic cancer.

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Prostate cancer is the second most common cancer in men worldwide and remains a significant cause of cancer-related morbidity and mortality. Androgen signaling plays a central role in the development and progression of prostate cancer. For this reason, anti-androgen therapy and related androgen axis-targeting approaches represent important modalities in the treatment of prostate cancer. Despite the availability of anti-androgen therapies, there remains a need for improved treatment regimens that may be used alone or in combination with existing anti-androgen therapies, including in patients having resistant, recurrent, advanced, metastatic, or otherwise difficult-to-treat prostate cancer.

Recent publications indicate that prostate cancer tumors can adapt to SoC treatments such as enzalutamide by altering their lipid metabolism. Both enzalutamide-sensitive and resistant cells depend on this lipid desaturation pathway. Combining enzalutamide (an androgen receptor blocker) with an SCD1 inhibitor blocks this lipid synthesis and desaturation, potentially leading to decreased cell viability, and delayed development of drug resistance.

The data we present today, demonstrate that a combination of Aramchol (an SCD1 inhibitor) with enzalutamide resulted in 3–4-fold increase in cell death (compared with enzalutamide as a single agent) and that the interaction gets stronger, the longer the drugs are on board. The VCaP prostate cancer cell line features high expression of wild-type androgen receptors, the clinically relevant AR-V7 splice variant, and the TMPRSS2-ERG gene fusion, sourced from a vertebral metastasis of a 59 year old Caucasian mCSPC patient.

Previously Galmed demonstrated that Aramchol synergistically interacts with docetaxel (Taxotere) a potent, semisynthetic chemotherapy medication, to cause greater than additive killing in a whole range of tumor types where docetaxel is approved, including prostate cancer cells. The results from those studies support the further evaluation of Aramchol in combination with approved prostate cancer therapies, including combining Aramchol with enzalutamide (with or without GnRH analogue) and as the anti-androgen interaction starts to wear off, switch to a combination of Aramchol with docetaxel.

Allen Baharaff, Galmed’s Co-founder and CEO, commented: "The data we present today is a result of our research work in prevention of drug resistance to blockbuster agents in oncology (as previously reported in our earlier press releases). Global sales for Xtandi (marketed by Astellas Pharma and Pfizer) reached approximately $8 billion and $6 billion globally in 2024 and 2025 (accounting for roughly 4% of Pfizer’s total revenue). The main composition of matter patents for enzalutamide (sold as Xtandi) expire in 2026 in Europe and 2027 in the United States (Patent US9126941 & Patent US8183274). A combination of Aramchol and enzalutamide could potentially become a lifecycle management for Xtandi in light of the U.S. price cut scheduled to begin in 2027 as well as a key differentiating factor for any generic competitor trying to capture a portion of this multibillion-dollar market. Galmed is planning to initiate discussions with potential partners based on a patent application for the combination that has been recently submitted".

(Press release, Galmed Pharmaceuticals, AUG 17, 2026, View Source [SID1234670176])