On March 23, 2026 Prestige Biopharma reported positive topline results from its Phase 3 SAMSON-II study evaluating HD204, a proposed biosimilar to Avastin (bevacizumab) in adult patients with advanced non-squamous non-small cell lung cancer (NSCLC).

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SAMSON-II is a randomized, double blind, parallel group, multicenter Phase 3 study conducted in 625 patients across 91 centers in 15 countries. Patients were randomized in a 1:1 ratio to receive HD204 or Avastin in combination with standard chemotherapy.

The study met its primary endpoint of overall response rate (ORR) at Week 18, demonstrating clinical equivalence between HD204 and Avastin within the prespecified equivalence margin. ORR at Week 18 was 48.7% in the HD204 arm compared with 46.5% in the Avastin arm. The risk ratio was 1.047 (95% confidence interval [CI]: 0.86–1.27), and the risk difference was 0.022 (95% CI: −0.07–0.11), with both estimates falling within the predefined equivalence range.

Secondary efficacy endpoints were supportive of the primary analysis. Comparable overall response rates were observed at Week 12, and time-to-event outcomes demonstrated similar progression-free survival (PFS) and overall survival (OS) between treatment groups, with no statistically significant differences identified.

HD204 demonstrated a safety and tolerability profile consistent with the established safety experience of bevacizumab. Treatment-related adverse events were reported in 33.9% of patients receiving HD204 and 34.4% of patients receiving Avastin, while treatment-related serious adverse events occurred in 5.2% and 8.3% of patients, respectively. No new or unexpected safety signals were identified.

The clinical outcomes observed in SAMSON-II were consistent with the high degree of analytical and clinical pharmacokinetic (PK) similarity demonstrated between HD204 and Avastin. SAMSON-II results strengthen the collective global experience showing that sensitive analytical characterization and comparative clinical PK studies can reliably predict equivalent clinical performance in biosimilar development. Prestige Biopharma is advancing regulatory pathways for HD204 based on the strong analytical and clinical PK programs, while sharing the SAMSON-II findings to further contribute to the global scientific experience in biosimilar evaluation.

"These results illustrate the increasing precision with which biosimilarity can be established through advanced analytical and clinical PK studies," said Dr. Lisa Park, Chief Executive Officer of Prestige Biopharma. "Our experience with HD204 supports the view that well-designed development programs can reliably anticipate clinical performance, enabling more focused and efficient biosimilar development. By reducing unnecessary clinical burden, such advances can accelerate patient access to high-quality biologic medicines and support more sustainable healthcare systems worldwide."

(Press release, Prestige BioPharma, MAR 23, 2026, View Source [SID1234663844])

On March 23, 2026 Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted protein degradation medicines, reported that two oral presentations and three poster presentations highlighting the breadth of its research pipeline and scientific leadership will be presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2026 Annual Meeting, to be held April 17-22, 2026, in San Diego, California.

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The presentations will provide additional mechanistic validation of CBL-B, Aurora kinase A (AURKA) and mutant BRAF as therapeutic targets across multiple cancer indications and will highlight the potential of Nurix’s orally bioavailable degraders to effectively suppress the oncogenic activity of these proteins in preclinical models.

Additionally, Gwenn Hansen, Ph.D., chief scientific officer of Nurix Therapeutics, has been selected to speak in an AACR (Free AACR Whitepaper) Advances session on induced proximity pharmacology, including targeted protein degradation. AACR (Free AACR Whitepaper) Advances sessions bring together leading scientific perspectives to provide a comprehensive view of recent developments, the current state of research, and emerging challenges in the field.

Oral Presentation Details:

Title: Designing Effective Degrader Therapeutics: What Early Clinical Experience Has Taught Us
Speaker: Gwenn Hansen, Ph.D., chief scientific officer, Nurix Therapeutics
Session type: Advances in Diagnostics and Therapeutics
Session title: Induced Proximity Pharmacology: Degraders and Beyond
Session date and time: Wednesday, April 22, 2026, 10:15 a.m. – 11:45 a.m. PT

Title: Discovery and characterization of CBL-B intramolecular glue inhibitors that increase T cell activation and suppress tumor growth
Presenter: Fred Cohen, Ph.D.
Session type: Minisymposium
Session category: Chemistry
Session title: Targeted Therapies
Session date and time: Tuesday, April 21, 2026, 4:30 p.m. PT
Abstract presentation #: 6733

Poster Presentation Details:

Title: NRX-4972, a selective, oral, Aurora kinase A degrader, demonstrates increased efficacy in an SCLC tumor model, and greater in vitro synergy than an AURKA inhibitor
Presenting author: Ryan Rountree, Ph.D.
Session category: Targeted Protein Degradation and Induced Proximity
Session title: Targeted Protein Degradation and Induced Proximity
Session date and time: Tuesday, April 21, 2026, 9:00 a.m. – 12:00 p.m. PT
Poster #: 5166

Title: NRX-0305, an orally bioavailable, CNS penetrant pan-mutant BRAF degrader demonstrates robust efficacy in intracranial models of melanoma brain metastasis and primary glioma
Presenting author: Sasha Borodovsky, Ph.D.
Session category: Experimental and Molecular Therapeutics
Session title: Proximity-Induced Drug Discovery 1
Session date and time: Tuesday, April 21, 2026, 9:00 a.m. – 12:00 p.m. PT
Poster #: 4617

Title: NRX-0305 is an orally bioavailable, pan-mutant BRAF degrader that exhibits single-agent and combination efficacy with MEKi or anti-EGFR across Class 1/2/3 BRAF-mutant cancers
Presenting author: Ya-Wen Lu, Ph.D.
Session category: Experimental and Molecular Therapeutics
Session title: Proximity-Induced Drug Discovery 2
Session date and time: Tuesday, April 21, 2026, 2:00 p.m. – 5:00 p.m. PT
Poster #: 5801

About NX-1607
NX-1607 is an investigational first-in-class oral inhibitor of the E3 ligase Casitas B-lineage lymphoma proto-oncogene B (CBL-B) being developed for immuno-oncology indications, including a range of solid tumor types. CBL-B is a cytoplasmic E3 ubiquitin ligase that negatively regulates T cell activation, making it an attractive target for immuno-oncology and offering a novel therapeutic approach to treat solid tumors. Inhibition of CBL-B in preclinical studies reverses T cell exhaustion, alleviates tumor induced immunosuppression, and may also exert direct antitumor effects. Nurix is evaluating NX-1607 in an ongoing Phase 1 trial in adults in a range of oncology indications. This study includes a thorough investigation of both dose and schedule in the Phase 1a portion. Additional information on the NX-1607 clinical trial can be accessed at www.clinicaltrials.gov (NCT05107674).

About NRX-0305
NRX-0305 is a potent, selective, and orally bioavailable CNS-penetrant pan-mutant BRAF degrader that Nurix is exploring for use in oncology. Nurix has reported preclinical data demonstrating potent anti-tumor activity in multiple cell line-derived and patient-derived xenograft disease models representing Class I, Class II, and Class III B-RAF mutations. Anti-tumor activity was also observed in the setting of CNS disease and treatment-resistance, suggesting the potential for utility across a broad range of solid tumor types.

About NRX-4972
NRX-4972 is a CNS-penetrant, orally bioavailable and highly selective degrader of Aurora A kinase (AURKA). AURKA is an oncogene frequently overexpressed in adult solid tumors, hematologic malignancies, and pediatric cancers. Several AURKA inhibitors are effective in preclinical tumor models, but this activity has failed to translate into clinical efficacy. To address the limitations of inhibitors, Nurix has designed bifunctional targeted protein degraders of AURKA that enable removal of both enzymatic and scaffolding functions.

(Press release, Nurix Therapeutics, MAR 23, 2026, View Source [SID1234663825])

On March 23, 2026 OverT Bio, a biotechnology company developing next-generation therapies for solid tumors, reported the formation of its Clinical Advisory Board, comprised of internationally recognized leaders in oncology and cellular immunotherapy. The members of OverT’s Clinical Advisory Board are Dr. Kristen Hege, Dr. David Miklos, Dr. Dmitriy Zamarin, and Dr. Robert Wenham.

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The Clinical Advisory Board will provide strategic guidance on OverT’s clinical development plans, including trial design, indication prioritization, and translational strategy, as the company advances its lead asset, OVT-101 towards the clinic. OVT-101 is an off-the-shelf gamma delta CAR-T therapy targeting Claudin-6 and programmed for potency and durability using novel reprogramming strategies discovered with OverT’s massively-parallel overexpression platform. Using DNA barcoding, OverT’s unique platform has analyzed thousands of genes in primary human immune cells and identified which ones make better therapies when challenged by multiple forms of tumor immunosuppression.

"We are honored to welcome this exceptional group of clinicians and scientists to our Clinical Advisory Board," said Dr. Mat Legut, co-founder and CEO of OverT Bio. "Each member brings deep expertise in immune therapies and solid tumor oncology, which will be critical for our success in the clinic."

Kristen Hege, MD is a clinician-scientist and seasoned executive who led the first-in-class BCMA CAR-T program (Abecma) in multiple myeloma from inception through FDA approval at Bristol-Myers Squibb. She was most recently Senior Vice President of Early Clinical Development in Oncology/Hematology and Cell Therapy at BMS. In addition to her corporate leadership, Dr. Hege was the Clinical Professor of Medicine at UCSF, where she cared for patients with blood cancers for nearly three decades. She continues to shape the future of innovative cancer therapies by serving on the board of directors for multiple biotechnology companies.

David Miklos, MD, PhD is the Chief of Stanford’s Bone Marrow Transplant and Cell Therapy Program that provides over 700 cancer cell therapies annually. As a leading clinical expert, he has served as a principal investigator on pivotal trials for several CAR-T cell therapies in lymphoma and multiple myeloma. His translational research focuses on human correlative assays to optimize CAR-T therapy including ctDNA MRD, tumor antigen quantification, CAR-T immune phenotyping (CAR-FACS), and their single cell RNA and DNA characterization.

Dmitriy Zamarin, MD, PhD is the Section Head of Gynecologic Medical Oncology, and co-director of Center of Excellence for Gynecologic Cancers at Icahn School of Medicine at Mount Sinai. He has served as a principal investigator and a translational chair on multiple institutional and cooperative group clinical trials and serves as the translational research co-chair on the NRG Oncology Cervical Cancer committee. His clinical and laboratory research is focused on cancer cell-intrinsic mechanisms of immune recognition and resistance and development of novel therapeutics. Prior to his leadership role at Mount Sinai, he was a physician-scientist at Memorial Sloan Kettering Cancer Center, where he led numerous early-phase clinical trials testing immune-based treatment combinations.

Robert Wenham, MD is the Chair of the Department of Gynecologic Oncology and Senior Member in the Molecular Medicine Program at H. Lee Moffitt Cancer Center and Research Institute. He has directed numerous clinical trials evaluating targeted therapies, immunotherapies, and novel chemotherapeutics for ovarian, cervical, and uterine cancers. Recognized for his commitment to surgical excellence and innovative patient care, he has played a critical role in bringing life-extending therapies from the laboratory directly to the clinic. He has received the Molly Cade Ovarian Cancer Research Award from the Gynecologic Cancer Foundation. Dr. Wenham also serves in vital leadership capacities within national oncology cooperatives, including the Gynecologic Oncology Group (GOG), where he helps shape the national research agenda for women’s cancers.

"Building a Clinical Advisory Board of this caliber is an important step as we translate our platform into the clinic," said Dr. Francesco Galimi, Chief Medical Officer of OverT Bio. "Their collective experience across cellular therapies and solid tumors will be invaluable in shaping a thoughtful and efficient clinical development strategy for our programs."

The formation of the Clinical Advisory Board marks an important milestone as OverT Bio continues to build its clinical strategy and advance its lead program toward first-in-human studies.

(Press release, OverT Bio, MAR 23, 2026, View Source [SID1234663845])

On March 23, 2026 Amplia Therapeutics Limited (ASX:ATX; OTCQB:INNMF), ("Amplia" or the "Company"), reported mature data from the ongoing ACCENT clinical trial in advanced pancreatic cancer in which the Company’s lead drug narmafotinib is combined with chemotherapy showing a median overall survival of 11.1 months, and five complete responses recorded to date.

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Expert central reading of the clinical data by a contracted independent laboratory has reclassified some of the response data, identifying an additional four (4) confirmed complete responses (CRs). This brings the total CR’s for all patients in the ACCENT trial receiving a 400 mg dose of narmafotinib to five (5), resulting in a CR rate of 7.8% (5/64) which is unprecedented in this indication. Notably, this does not include the pathological complete response (pCR) recorded in the ACCENT trial, announced in June 2025. A confirmed CR means that CT scans have confirmed the disappearance of measurable tumours and metastases for two months or more, without the appearance of new lesions.

An additional confirmed partial response (PR) has also been identified, resulting in an updated Objective Response Rate (ORR) of 35.9% (23/64) for all patients in both stages of the 1b/2a ACCENT trial on a 400 mg dose of narmafotinib. As of 15 March 2026, four (4) patients remain on study, with one patient approaching 24 months on trial.

Up until the independent analysis, all clinical response data reported to the market has been based on analysis by the clinical investigator at each trial site. The Company has always planned for an independent data analysis to occur toward the conclusion of the trial, and with the anticipated completion in Q3 2026 this analysis was recently initiated. The expert and independent ‘central read’ laboratory has used the standardized and internationally recognized RECIST 1.1 criteria for measuring how a patient’s cancer responds to treatment.

(Press release, Amplia Therapeutics, MAR 23, 2026, View Source [SID1234663804])

On March 23, 2026 Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on enhancing the standard of care for bevacizumab for the treatment of retina diseases, reported that it has commenced a best-efforts public offering of its common stock (or pre-funded warrants in lieu thereof) and accompanying warrants exercisable for shares of its common stock. The offering is subject to market and other conditions and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

Outlook Therapeutics intends to use the net proceeds from the offering primarily for working capital and general corporate purposes.

The securities described above are being offered by Outlook Therapeutics pursuant to a "shelf" registration statement on Form S-3 (File No. 333-278340) that was originally filed with the Securities and Exchange Commission (the "SEC") on March 28, 2024, and became effective on April 5, 2024. This proposed public offering is being made only by means of a prospectus supplement and an accompanying prospectus that form a part of the effective registration statement. A preliminary prospectus supplement and an accompanying prospectus related to the proposed public offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to this proposed public offering may also be obtained, when available, by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (212) 856-5711 or e-mail at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

(Press release, Outlook Therapeutics, MAR 23, 2026, View Source [SID1234663826])