On November 17, 2025 Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, reported the completion of the submission of its New Drug Application ("NDA") to the U.S. Food and Drug Administration ("FDA") for gedatolisib in hormone receptor positive ("HR+"), human epidermal growth factor receptor 2 negative ("HER2-"), advanced breast cancer ("ABC"). The NDA was submitted under the FDA’s Real-Time Oncology Review ("RTOR") program, which is intended to facilitate shorter regulatory review periods. Gedatolisib previously received both Breakthrough Therapy and Fast Track designations based on promising preliminary clinical data. The submission is based on clinical data from the PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 clinical trial.

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"This NDA submission is an important milestone, and it brings gedatolisib one step closer to becoming available for patients with HR+/HER2- advanced breast cancer," said Brian Sullivan, CEO and co-founder of Celcuity. "We look forward to working with the FDA during the NDA review process. We believe the unprecedented efficacy results and overall safety profile of the gedatolisib regimens are potentially practice changing for patients with HR+/HER2- advanced breast cancer."

The NDA submission is based on the positive clinical results for the PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 trial. The efficacy results established several new milestones in the history of drug development for HR+/HER2- ABC. The gedatolisib-triplet (gedatolisib, fulvestrant and palbociclib) reduced the risk of disease progression or death by 76% compared to fulvestrant based on a hazard ratio of 0.24. The median progression-free survival ("PFS") was 9.3 months with the gedatolisib-triplet versus 2.0 months with fulvestrant, an incremental improvement of 7.3 months. The gedatolisib-doublet (gedatolisib and fulvestrant) reduced the risk of disease progression or death by 67% compared to fulvestrant based on a hazard ratio of 0.33. The median PFS was 7.4 months with the gedatolisib-doublet versus 2.0 months with fulvestrant, an incremental improvement of 5.4 months.

Gedatolisib

Gedatolisib is an investigational, multi-target PI3K/AKT/mTOR ("PAM") inhibitor that potently targets all four Class I PI3K isoforms, mTORC1, and mTORC2 to induce comprehensive blockade of the PAM pathway.1,2,3 As a multi-target PAM inhibitor, gedatolisib’s mechanism of action is highly differentiated from currently approved single-target inhibitors of the PAM pathway.2 Inhibition of only a single PAM component results in cross-activation of the uninhibited components, which limits the suppression of PAM pathway activity. Gedatolisib’s comprehensive PAM pathway inhibition enables full suppression of the PAM pathway by minimizing the adaptive cross-activation that occurs with single-target inhibitors. Unlike single-target inhibitors of the PAM pathway, gedatolisib has demonstrated comparable potency and cytotoxicity in PIK3CA-mutant and wild-type breast tumor cells in nonclinical studies and early clinical data.

About RTOR

The FDA established the RTOR program to facilitate a more efficient review process for drugs to ensure that safe and effective treatments are available to patients as early as possible, while improving review quality and engaging in early iterative communication with the applicant. To be considered for RTOR, submissions should demonstrate the following: 1) clinical evidence from adequate and well-controlled investigation that indicates the drug may demonstrate substantial improvement on a clinically relevant endpoint over available therapies; 2) easily interpreted clinical trial endpoints; and 3) no aspect of the submission is likely to require a longer review time. Additional information about RTOR can be found at: View Source

(Press release, Celcuity, NOV 17, 2025, View Source [SID1234660015])

On November 17, 2025 Propanc Biopharma, Inc. (Nasdaq: PPCB) ("Propanc" or the "Company"), a biopharmaceutical company developing novel treatments for recurrent and metastatic cancer, reported an update on corporate progress and reported financial results for the first quarter ended September 30, 2025 (Year end June 30).

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Corporate and R&D Highlights

Advancing PRP Toward Phase 1b First-in-Human Trial (2026)

Propanc continues to advance its lead candidate, PRP, toward a world-first Phase 1b clinical study in 30–40 patients with advanced solid tumors at the Peter Mac Cancer Center in Melbourne. GMP manufacturing scale-up, analytical method validation, and preparation of the Investigator’s Brochure and Clinical Trial Application are underway. Purification processes have been successfully scaled, delivering >95% purity to pharmaceutical standards. Two related patents are in drafting.

Progressing Rec-PRP Synthetic Program

Rec-PRP, a fully synthetic recombinant version of PRP designed for improved stability and global scalability, is undergoing biological validation against the bovine-derived formulation. Supporting research has identified methods enabling large-scale production, with patent drafting in progress. Rec-PRP will enter formal preclinical development following potency evaluation.

POP1 Joint Research Program Extension

Propanc is negotiating a 12-month extension with the Universities of Jaén and Granada to expand the POP1 research program. Recent findings show PRP significantly reduces tumorigenicity in Gemcitabine-resistant pancreatic cancer and modulates malignant cells toward a less aggressive phenotype. Additional patents are being prepared based on these results.

Corporate and Financial Updates

Nasdaq Listing & Public Offering

The Company closed an underwritten public offering of 1,000,000 shares at $4.00 per share, raising gross proceeds of $4 million. Propanc’s common stock began trading on the Nasdaq Capital Market on August 15.

$100 Million Private Placement Facility

Propanc entered into a private placement agreement for up to $100 million to accelerate clinical development. The Company received an initial $1 million investment upon issuance of 100 shares of Series C Convertible Preferred Stock.

Q1 Financial Summary (Quarter Ended September 30, 2025)

Total current assets: $17 million
Total current liabilities reduced by $2 million
Net cash from financing activities: $2.53 million
Quarter-end cash: $600,000
$1 million initial tranche from the Series C facility subsequently received
The Company expects the financing facility to support planned R&D activities, including advancement of PRP and Rec-PRP.

Management Commentary

"Our first quarter delivered meaningful progress across clinical, financial, and strategic initiatives," said James Nathanielsz, CEO of Propanc. "We are focused on initiating the Phase 1b PRP clinical trial, advancing Rec-PRP into preclinical development, and expanding our IP portfolio. With our recent Nasdaq uplisting and long-term financing facility, we are well-positioned to accelerate commercialization of our proenzyme technology."

(Press release, Propanc, NOV 17, 2025, View Source [SID1234660031])

On November 17, 2025 One-carbon Therapeutics AB, a clinical-stage biotechnology company pioneering a novel cancer therapy, reported that the first subject has been successfully dosed in its ODIN Phase 1/2 clinical trial (NCT07151040) evaluating TH9619, a first-in-class MTHFD1/2 inhibitor.

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This milestone was achieved at START Madrid/Fundación Jiménez Díaz University Hospital, under the supervision of Dr. Victor Moreno, Director of Clinical Research and Principal Investigator. Dr. Moreno commented: "I am pleased that our subjects now have access to next-generation investigational therapies such as TH9619. This study opens new possibilities for cancer treatments where options remain limited, and we look forward to continuing collaborating with One-carbon Therapeutics."

"Dosing the first subject in our ODIN study represents a significant step in turning our cutting-edge science into first-in-class therapies," said Ana Slipicevic, Chief Executive Officer of One-carbon Therapeutics. "TH9619 embodies our unique strategy of targeting one-carbon metabolism proteins, by killing cancer cells while sparing normal cells and bringing new hope to subjects with high unmet medical need. We are deeply grateful to the investigators, clinical teams, our collaborators, and most importantly, the subjects who make this progress possible."

About TH9619

TH9619 is a first-in-class, potent, small-molecule, and a dual inhibitor of MTHFD1/2, highly overexpressed and cancer-specific enzymes within the one-carbon metabolic pathway – TH9619 kills cancer cells via a dual mechanism of action (1) inhibition of MTHFD1 traps folate leading to thymidine depletion (2) inhibition of nuclear MTHFD2 disrupts DNA damage response and repair pathways. With its unique characteristics, TH9619 kills tumor cells, while sparing healthy tissue.

About ODIN Phase 1/2 Clinical Study

This is a first in human, multicenter, open label, dose escalation and expansion study, aiming at evaluating safety, pharmacokinetics, pharmacodynamics and preliminary anti-tumor activity of TH9619 as monotherapy in subjects with advanced refractory solid tumors, including colorectal cancer, non-small cell lung cancer, head & neck squamous cell carcinoma, gastric cancer or gastroesophageal junction cancer. The trial is currently being conducted across leading academic and clinical research centers in the United Kingdom, France, and Spain, with expansion planned across additional European sites in the coming months.

Clinicaltrials.gov NCT07151040; EudraCT No. 2024-519639-40-00

(Press release, One-carbon Therapeutics, NOV 17, 2025, View Source [SID1234661124])

On November 17, 2025 Circio Holding ASA (OSE: CRNA), a biotechnology company developing novel circular RNA expression technology for gene and cell therapy, reported an invitation to a live webcast at 10:00am CET on Monday 24 November 2025.

In the webcast, CTO Dr. Thomas B Hansen will present Circio´s latest in vitro and in vivo results on the circVec circular RNA expression platform. Recent findings include design and testing of novel circVec constructs and extended in vivo screening and validation of circVec for AAV gene therapy.

CEO Dr. Erik D Wiklund will provide a general corporate and strategy update.

Presenters:
CEO Dr. Erik Digman Wiklund
CTO Dr. Thomas Birkballe Hansen

Time: 10:00 CET on 24 November 2025

Click here to access Teams webcast
Meeting ID: 366 918 860 415 63
Passcode: Kn2Pq9pM

Questions can be submitted in advance by email to Erik D Wiklund: [email protected] or directly in the live webcast

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(Press release, Circio, NOV 17, 2025, View Source [SID1234660016])

On November 17, 2025 Phio Pharmaceuticals Corp. (NASDAQ: PHIO) is a clinical-stage siRNA biopharmaceutical company developing therapeutics using its proprietary INTASYL gene silencing technology to eliminate cancer reported that a podium presentation highlighting INTASYL siRNA Drug Technology will be held at the Advanced Therapies USA 2025 Congress in Philadelphia, PA at the Pennsylvania Convention Center from November 18-19, 2025.

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Podium Presentation Details are as follows:

Title: INTASYL Synthesized siRNA Drug Technology
Down-regulating Gene Expression
Presenting Author: Melissa Maxwell, M.S.
Date: November 18, 2025
Location: Innovation Showcase (Track 2, Seminar Theatre)
Time: 1:15 PM EDT

"The INTASYL siRNA technology represents a promising approach to enhance cancer treatment." said Robert Bitterman, CEO and Chairman of the Board, Phio Pharmaceuticals. "Further the INTASYL compound PH-762 may fulfill a medical need for a non-surgical treatment option for patients with cutaneous carcinomas."

(Press release, Phio Pharmaceuticals, NOV 17, 2025, View Source [SID1234660032])