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Further endorsement of amsulostat’s potential with positive opinion for Orphan Drug Designation in the EU for myelofibrosis

On November 17, 2025 Syntara Limited (ASX: SNT), a clinical-stage drug development company, reported that it has received a positive opinion on the submission of Orphan Drug Designation (ODD) from the European Medicines Agency (EMA) for its advanced clinical asset amsulostat (SNT-5505) for the treatment of myelofibrosis (MF).

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An ODD grant will provide numerous incentives for Syntara in the European Union (EU) as it develops amsulostat, including ten years market exclusivity upon approval, clinical trial protocol assistance, access to the centralised authorisation procedure in Europe, and certain fee reductions.

Amsulostat already has ODD in the US from the Food & Drug Administration (FDA) for the treatment of MF.

Myelofibrosis is a disorder in which normal bone marrow tissue is gradually replaced with a fibrous scar-like material. Over time, this leads to progressive bone marrow failure. It can occur at any age but is usually diagnosed later in life, between the ages of 60 and 70 years, with its cause remaining largely unknown.

Syntara recently announced positive top-line Phase 2a data for amsulostat in MF, with patients sub optimally controlled on ruxolitinib with 73% achieving at least a 50% reduction in total symptom score, and nearly half showing meaningful spleen volume reduction after a year of treatment. This sustained improvement in clinical measures of efficacy is backed up by excellent tolerability and no treatment-related adverse events.

Syntara has received feedback from the FDA on a recommended pathway for further development, and is progressing a design for the next trial of amsulostat.

Syntara CEO Gary Phillips commented: "Receipt of this positive opinion for Orphan Drug Desgination in the EU comes after detailed review of the amsulostat pre-clinical and clinical dossier by the EMA, providing further validation of the potential that the drug has to benefit myelofibrosis patients. We continue to engage with our advisors and regulatory authorities to design a clinical trial that leverages the product’s strong differentiating features as a well-tolerated and effective therapy. Our goal is to ensure the study design is compelling for investors and strategic partners by clearly demonstrating how amsulostat can positively impact the current standard of care."

(Press release, Syntara, NOV 17, 2025, https://mcusercontent.com/add2e2fa70ec3d0eeaf2a93cc/files/42cc5d05-d389-5ba0-606c-034c87587de6/03023812.pdf [SID1234660003])

US FDA Approves Jecho Bio’s Independently Developed Long-Acting IL-15 (JL19001) Injection for Clinical Trials for Non-Muscle-Invasive Bladder Cancer

On November 14, 2025 Jecho (Tianjin) Biopharmaceutical Co., Ltd. ("Jecho Bio"), a global, clinical stage biopharmaceutical company advancing medicines focusing in oncology, reported a major regulatory milestone. Jecho’s independently developed innovative drug, JL19001, an IL-15/human serum albumin fusion protein, has been approved by the U.S. Food and Drug Administration (FDA) to begin clinical trials for non–muscle-invasive bladder cancer.

This achievement further advances the international clinical development for JL19001, as it was approved to begin clinical trials by China’s National Medical Products Administration (NMPA) in September 2025.

Notably, this approval is the tenth IND clearance and second U.S. FDA IND clearance Jecho Bio has obtained, validating Jecho Bio’s strong capabilities in innovative drug development.

About JL19001 Injection

JL19001 is a recombinant fusion protein composed of human serum albumin (HSA) and IL-15Rα/IL-15. It activates NK cells and CD8+ T cells, enhancing both innate and adaptive immune responses. When used in combination with Bacillus Calmette–Guérin (BCG) therapy for patients with non–muscle-invasive bladder cancer (NMIBC), it may help patients avoid radical cystectomy and improve both survival rates and quality of life.

(Press release, Jecho Laboratories, NOV 14, 2025, View Source [SID1234660001])

Inhibrx Reports Third Quarter 2025 Financial Results

On November 14, 2025 Inhibrx Biosciences, Inc. (Nasdaq: INBX) ("Inhibrx" or the "Company") reported financial results for the third quarter of 2025. Following the completion of the sale of INBRX-101 (the "101 Transaction") by Inhibrx, Inc. (the "Former Parent") to Sanofi S.A. and the Former Parent’s concurrent spin-off of the Inhibrx business in May 2024, the biopharmaceutical company now has two programs in ongoing clinical trials.

Recent Corporate Highlights

On October 23, 2025, Inhibrx announced positive topline results from its registrational trial of ozekibart (INBRX-109) in chondrosarcoma and provided an update on its colorectal cancer and Ewing sarcoma expansion cohorts.

Ozekibart met its primary endpoint in chondrosarcoma, demonstrating a statistically significant and clinically meaningful improvement in median progression-free survival compared to placebo.
Key secondary endpoints reinforce the primary benefit, demonstrating meaningful improvements in disease control and patient quality of life.
Inhibrx plans to submit to the U.S. Food and Drug Administration a biologics license application in the second quarter of 2026.
Interim data from expansion cohorts in patients with colorectal cancer and Ewing sarcoma demonstrate high response and disease control rates in difficult-to-treat, heavily pretreated patients.
Financial Results

Cash and Cash Equivalents . As of September 30, 2025, Inhibrx had cash and cash equivalents of $153.1 million, as compared to $186.6 million as of June 30, 2025.
R&D Expense . Research and development expenses were $28.5 million for the third quarter of 2025, as compared to $38.9 million for the third quarter of 2024. The decrease was primarily related to a decrease in process development and manufacturing activities performed by our CDMO partners during the prior year in connection with the Company’s clinical trial for ozekibart (INBRX-109). In addition, personnel-related expenses decreased as a result of a decrease in headcount in the current period.
G&A Expense . General and administrative expenses were $5.3 million during the third quarter of 2025, compared to $7.9 million during the third quarter of 2024. The decrease was primarily related to decreased legal expenses following the conclusion of legal proceedings as well as decreased personnel-related expenses as a result of a decrease in headcount in the current period.
Other Expense. Other expense was $1.4 million during the third quarter of 2025, as compared to other income of $2.9 million during the third quarter of 2024. Other expense in the current period consisted of $3.2 million of interest expense on the Company’s $100.0 million outstanding debt balance, offset in part by other income. Other income during each period consisted of interest income earned on the Company’s sweep and money market account balances. During the third quarter of 2024, the Company did not incur any interest expense following the extinguishment of all outstanding debt in connection with the 101 Transaction.
Net Loss. Net loss was $35.3 million during the third quarter of 2025, or $2.28 per share, basic and diluted, as compared to a net loss of $43.9 million during the third quarter of 2024, or $2.84 per share, basic and diluted.

(Press release, Inhibrx, NOV 14, 2025, View Source [SID1234659998])

Nuvalent Announces Timing of Topline Pivotal Data for TKI Pre-treated Patients with Advanced ALK-positive NSCLC from ALKOVE-1 Clinical Trial of Neladalkib

On November 14, 2025 Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, reported that the company will host a webcast and conference call on Monday, November 17, 2025 at 8:00 a.m. ET, to discuss topline pivotal data for neladalkib, an investigational ALK-selective inhibitor, in TKI pre-treated patients with advanced ALK-positive non-small cell lung cancer from the global ALKOVE-1 Phase 1/2 clinical trial.

Webcast and Conference Call Information

To access the call, please dial +1 (800) 836-8184 (domestic) or +1 (646) 357-8785 (international) at least 10 minutes prior to the start time and ask to be joined to the Nuvalent call.

Accompanying slides and a live video webcast will be available in the Investors section of the Nuvalent website at https://investors.nuvalent.com/events. A replay and accompanying slides will be archived on the Nuvalent website for 30 days.

About Neladalkib and the ALKOVE-1 Phase 1/2 Clinical Trial

Neladalkib is an investigational brain-penetrant ALK-selective inhibitor created with the aim to overcome limitations observed with currently available ALK inhibitors. Neladalkib is designed to remain active in tumors that have developed resistance to first-, second-, and third-generation ALK inhibitors, including tumors with single or compound treatment-emergent ALK mutations such as G1202R. In addition, neladalkib is designed for central nervous system (CNS) penetrance to improve treatment options for patients with brain metastases, and to avoid inhibition of the structurally related tropomyosin receptor kinase (TRK) family. Together, these characteristics have the potential to avoid TRK-related CNS adverse events seen with dual TRK/ALK inhibitors and to drive deep, durable responses for patients across all lines of therapy. Neladalkib has received U.S. Food and Drug Administration (FDA) breakthrough therapy designation for the treatment of patients with locally advanced or metastatic ALK-positive non-small cell lung cancer (NSCLC) who have been previously treated with 2 or more ALK tyrosine kinase inhibitors and orphan drug designation for ALK-positive NSCLC.

The ALKOVE-1 trial (NCT05384626) is a first-in-human Phase 1/2 clinical trial for patients with advanced ALK-positive NSCLC and other solid tumors. The completed Phase 1 portion enrolled ALK-positive NSCLC patients who previously received at least one ALK TKI, or patients with other ALK-positive solid tumors who had been previously treated or for whom no satisfactory standard of care exists. The Phase 1 portion of the trial was designed to evaluate the overall safety and tolerability of neladalkib, with additional objectives including determination of the recommended Phase 2 dose (RP2D), characterization of the pharmacokinetic profile, and evaluation of preliminary anti-tumor activity. The global, single arm, open label Phase 2 portion is designed with registrational intent for TKI pre-treated patients with advanced ALK-positive NSCLC. Global enrollment in ALKOVE-1 remains ongoing for adult and adolescent patients with ALK-positive solid tumors outside of NSCLC, and adolescent patients with ALK-positive NSCLC.

(Press release, Nuvalent, NOV 14, 2025, View Source [SID1234659997])

PRISM BioLab Achieved Initial Milestone and Receives the Milestone Payment in Drug Discovery Collaboration with Ono Pharmaceutical Co., Ltd.

On November 14, 2025 PRISM BioLab, Co. Ltd. ("PRISM") announces that today, PRISM and Ono Pharmaceutical Co., Ltd. (Headquarters: Osaka; President and COO: Toichi Takino; hereinafter "Ono") reported to have achieved the initial milestone in the drug discovery collaboration and PRISM has confirmed receipt of the milestone payment.

PRISM and Ono have entered into a "Joint Research and Licensing Agreement" on April 25, 2024, (hereinafter "the Agreement") for drug discovery in the oncology field. Under this Agreement, PRISM received an upfront payment and joint research fees, launched a joint research project (hereinafter "the Project") to discover clinical candidate compounds against targets proposed by Ono, utilizing PRISM’s proprietary peptide-mimetic technology "PepMetics". PepMetics is a technology based on small molecules targeting protein-protein interactions (PPIs).

The Project has progressed as planned under the collaboration of both companies, and has achieved the milestone defined in the Agreement for the drug discovery research stage. PRISM will receive the milestone payment and joint research fees from Ono. The milestone payment will be recorded as business revenue in the first quarter of PRISM’s fiscal year ending September 2026 (October 1, 2025 – September 30, 2026). The joint research funding will be allocated proportionally throughout the period of the next phase of the joint research. While the specific amounts of the milestone payment and joint research funding are not disclosed under the terms of the Agreement, the total amount corresponds to approximately 80% of our net sales for the previous fiscal year (FY ended September 2025), as stated in our "Financial Results for the Fiscal Year Ended September 2025 (JGAAP) " released today.

The Project will accelerate the search for clinical candidate compounds through collaborative research with Ono, and leveraging PRISM’s expertise in structural biology and computational chemistry. The Agreement stipulates multiple milestones, and PRISM will receive milestone payments according to the progress of drug discovery research and subsequent stages, including clinical development conducted by Ono. Furthermore, if clinical candidate compounds lead to the commercialization of new drug, PRISM will receive royalties based on product sales.

"We are delighted to have achieved the first milestone in drug discovery research targeting previously challenging targets identified by Ono.", said Dai Takehara, President & CEO of PRISM. "This first step toward creating innovative new drugs is the achievement of the collaborative efforts of researchers from both companies, and we are grateful for this opportunity. We will continue dedicating our full effort to this project to achieve research outcomes in the next stage."

PRISM will maintain its strong relationship with Ono, further advance the joint research project, and strive for the creation of groundbreaking new drugs in the oncology field. This achievement demonstrates the potential of PRISM’s PepMetics technology and is expected to contribute to the company’s long-term growth and enhancement of corporate value.

(Press release, PRISM Pharma, NOV 14, 2025, View Source [SID1234659996])