On May 19, 2026 Propanc Biopharma, Inc. (Nasdaq: PPCB) ("Propanc" or the "Company"), a biopharmaceutical company focused on developing novel treatments for chronic diseases, including recurrent and metastatic cancer, reported that a Contract and Development Manufacturing Organization (CDMO) has been engaged for the GMP manufacture of the Company’s lead asset, PRP, for the upcoming Phase 1b, First-In-Human (FIH) study in 30 – 40 advanced cancer patients suffering from solid tumors. Based in Europe, the CDMO provides end-to-end services for preclinical and clinical projects, with extensive experience in decoding biologics production (plasmid DNA and recombinant proteins) providing services of cell line generation, banking and characterization, analytical development, process development and batches production of both drug substances and drug products (decoding biologics production refers to the specialized process of understanding, optimizing, and controlling the manufacturing of complex medicines derived from living cells, such as proteins, vaccines, and monoclonal antibodies).

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"After a thorough process, management are pleased to undertake this pivotal step for GMP production of PRP for the upcoming Phase 1 FIH clinical study which we plan to file the clinical trial application for later this year. Further, I am confident we have selected the right partner to execute our plan to enter early-stage clinical development, at the earliest opportunity," said Mr. James Nathanielsz, Propanc’s Chief Executive Officer. "PRP is a world first clinical study of proenzyme therapy by once weekly intravenous (IV) administration for the treatment of advanced cancer patients suffering from solid tumors. Management believes PRP is a first in class therapy which has the potential to enhance survival prospects for late-stage patients like recent clinical advancements observed with other candidates in the sector, such as KRAS inhibitors. Results from this upcoming trial can potentially be transformative for the Company, and its shareholders."

Unlike most treatment approaches which kills cancer cells directly, PRP induces differentiation so that cells return towards a normal state and die off naturally. Compassionate use data from a study published in Scientific Reports, an online Nature journal, demonstrates a significant life extension of 19 from 46 terminal patients suffering from a range of solid tumors via a fixed combination of trypsinogen and chymotrypsinogen in a suppository formulation, administered once daily, without severe, or even serious side effects observed from treatment. The planned Phase 1b study for PRP administered once weekly intravenously will be at significantly higher doses based on non-clinical safety and tolerability studies, which translates to a safe starting dose in humans. PRP achieved Orphan Drug Designation status from the US Food and Drug Administration (USFDA) for the treatment of pancreatic cancer in 2017.

(Press release, Propanc, MAY 19, 2026, View Source [SID1234665865])

On May 19, 2026 Cullinan Therapeutics, Inc. (Nasdaq: CGEM), a clinical-stage biopharmaceutical company accelerating potential first- or best-in-class, high-impact therapies in autoimmune diseases and cancer, reported that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to CLN-049, a novel, investigational FLT3xCD3 T cell engager, for the treatment of relapsed/refractory (R/R) acute myeloid leukemia (AML).

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"FDA Orphan Drug Designation for CLN-049 emphasizes both the urgent need for new therapies for people living with relapsed or refractory acute myeloid leukemia – including patients with TP53-mutated AML who currently face a particularly poor prognosis – and the potential of this FLT3-directed T cell engager to expand treatment options across the broadest population of AML patients," said Jeffrey Jones, MD, MBA, Chief Medical Officer, Cullinan Therapeutics. "Coupled with promising results from our ongoing Phase 1 program, this designation by the FDA reinforces a shared goal to rapidly advance novel therapies for patients living with AML."

About Orphan Drug Designation

The U.S. FDA’s Orphan Drug Designation provides orphan status to drugs and biologics intended to prevent, diagnose, or treat rare diseases or conditions that affect fewer than 200,000 people in the United States. Orphan Drug Designation qualifies sponsors for certain development incentives, including tax credits for qualified clinical trials, exemption from certain FDA user fees, and the potential for seven years of market exclusivity in the United States following marketing approval.

About CLN-049

CLN-049 is a novel, investigational FLT3xCD3 T cell engager. CLN-049 is designed to target FLT3-expressing leukemia cells, offering a new immunotherapeutic approach for treating acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). CLN-049 binds to both mutated and non-mutated FLT3, enabling targeted action regardless of FLT3 mutational status, making the investigational treatment widely applicable to a broad population.

CLN-049 is being studied in a Phase 1, open-label, multicenter, first-in-human, multiple ascending dose study evaluating safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of intravenously (IV) administered CLN-049 in patients with relapsed/refractory AML or MDS (NCT05143996) and in a parallel Phase 1, open-label, dose escalation and dose expansion study for the treatment of patients with AML with measurable residual disease (MRD) (EUCT 2023-506572-27-00).

CLN-049 has received Fast Track designation from the U.S. Food and Drug Administration for the treatment of relapsed/refractory AML.

About Acute Myeloid Leukemia

Acute myeloid leukemia (AML) is a cancer of the blood and bone marrow, and the most common form of acute leukemia in adults.1,2 It is characterized by the rapid growth of abnormal white blood cells that crowd out healthy cells, leading to infections, fatigue, and bleeding.3 Each year in the U.S., approximately 22,000 people are diagnosed with AML, and about half as many lives are lost to the disease.4 Globally, AML affects an estimated 144,000 people annually, with approximately 130,000 deaths.5

Despite recent advances, outcomes for patients with AML remain poor, particularly for those with relapsed or refractory disease, where five-year survival is 10% or less.4,6 Patients with high-risk genetic features, such as complex karyotype or TP53 mutations, face especially limited options.7,8 Intensive treatments like chemotherapy and stem cell transplantation may be inaccessible for many older patients due to severe side effects.8 Currently, there are no approved immunotherapies for AML, underscoring the urgent need for novel therapeutic approaches that can improve outcomes for patients and their families facing this life-threatening disease.

(Press release, Cullinan Oncology, MAY 19, 2026, View Source [SID1234665882])

On May 19, 2026 Amplia Therapeutics Limited (ASX:ATX; OTCQB:INNMF), ("Amplia" or the "Company"), reported that it is initiating a Phase 2b study of narmafotinib in pancreatic cancer exploring a new dosing regimen. Designed in alignment with FDA feedback, the study will form the basis – and first stage – of a registrational study in this indication given the high existing unmet need for innovative treatments. Narmafotinib is a best-in-class FAK inhibitor that has received orphan drug designation and fast track designation from the U.S. FDA as a potential treatment in pancreatic cancer.

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To-date narmafotinib has shown no significant tolerability burden over chemotherapy alone, and we have observed a range of compelling efficacy signals across responses and survival. This has been achieved with only an intermittent dosing schedule, giving us confidence that moving into daily dosing may further enhance the therapeutic potential of narmafotinib", said Dr Chris Burns, CEO and Managing Director of Amplia. "We have been able to accelerate this phase of the narmafotinib program with redeployed resources, including drug product, following the wind-down of recruitment in the AMPLICITY trial. We believe our registrational study submission to the FDA will be stronger for the inclusion of this portion of the Phase 2b study and we look forward to further engagement with regulators."

The study will investigate, for the first time, a daily dosing schedule for narmafotinib, at two dosing levels, with the chemotherapies gemcitabine and Abraxane in newly diagnosed advanced pancreatic cancer patients. In this first stage, each dosing cohort will have 6 patients (12 patients in total), which will be combined with gemcitabine and Abraxane given on their conventional schedule. In addition to safety and tolerability, pharmacokinetics (PK) and efficacy will be assessed. Exploratory endpoints will include effects on disease biomarkers as well as effects on fibrosis, a key indicator of FAK activity. The study will enrol patients across 3-4 sites in Australia. The Company anticipates patient enrolment will begin by the fourth quarter of this year with the safety, tolerability and PK assessment for the 12 patients completed in the second quarter of 2027.

(Press release, Amplia Therapeutics, MAY 19, 2026, View Source [SID1234665832])

On May 19, 2026 Veracyte, Inc. (Nasdaq: VCYT) reported that the company will be participating in the following investor conferences.

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William Blair 46th Annual Growth Stock Conference – Chicago, IL
Presentation on Tuesday, June 2nd at 2:00 p.m. Central Time
2026 Jefferies Global Healthcare Conference – New York, NY
Fireside chat on Thursday, June 4th at 8:10 a.m. Eastern Time

Live audio webcasts of the company’s presentations will be available by visiting Veracyte’s website at View Source Replays of the webcasts will be available for 90 days after each live presentation broadcast.

(Press release, Veracyte, MAY 19, 2026, View Source [SID1234665866])

On May 19, 2026 Amplia Therapeutics Limited (ASX:ATX; OTCQB:INNMF), ("Amplia" or the "Company"), reported that it is initiating a Phase 2b study of narmafotinib in pancreatic cancer exploring a new dosing regimen. Designed in alignment with FDA feedback, the study will form the basis – and first stage – of a registrational study in this indication given the high existing unmet need for innovative treatments. Narmafotinib is a best-in-class FAK inhibitor that has received orphan drug designation and fast track designation from the U.S. FDA as a potential treatment in pancreatic cancer.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"To-date narmafotinib has shown no significant tolerability burden over chemotherapy alone, and we have observed a range of compelling efficacy signals across responses and survival. This has been achieved with only an intermittent dosing schedule, giving us confidence that moving into daily dosing may further enhance the therapeutic potential of narmafotinib", said Dr Chris Burns, CEO and Managing Director of Amplia. "We have been able to accelerate this phase of the narmafotinib program with redeployed resources, including drug product, following the wind-down of recruitment in the AMPLICITY trial. We believe our registrational study submission to the FDA will be stronger for the inclusion of this portion of the Phase 2b study and we look forward to further engagement with regulators."

The study will investigate, for the first time, a daily dosing schedule for narmafotinib, at two dosing levels, with the chemotherapies gemcitabine and Abraxane in newly diagnosed advanced pancreatic cancer patients. In this first stage, each dosing cohort will have 6 patients (12 patients in total), which will be combined with gemcitabine and Abraxane given on their conventional schedule. In addition to safety and tolerability, pharmacokinetics (PK) and efficacy will be assessed. Exploratory endpoints will include effects on disease biomarkers as well as effects on fibrosis, a key indicator of FAK activity. The study will enroll patients across 3-4 sites in Australia. The Company anticipates patient enrolment will begin by the fourth quarter of this year with the safety, tolerability and PK assessment for the 12 patients completed in the second quarter of 2027.

(Press release, Amplia Therapeutics, MAY 19, 2026, View Source [SID1234665883])