On April 23, 2026 Independent biopharmaceutical company Specialised Therapeutics (ST) reported that Minjuvi (tafasitamab), in combination with rituximab and lenalidomide, has been registered by the Therapeutic Goods Administration (TGA) for the treatment of Australian adults with relapsed or refractory follicular lymphoma (R/R FL) (Grade 1-3a).1

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The TGA registration establishes Minjuvi as the first and only chemotherapy-free CD19 and CD20 dual-targeted immunotherapy combination regimen to be approved in Australia for this group of patients.2

"While most patients with follicular lymphoma respond well to initial treatment and patients’ prognosis has improved, around one in five will see their lymphoma return within two years, which is often linked to poorer long-term outcomes," said Professor Judith Trotman, Senior Staff Specialist and Lymphoma Group Lead in the Haematology Department at Concord Repatriation General Hospital in Sydney. "For these patients, current therapies do not always deliver durable responses, highlighting the urgent need for evidence-based options that can meaningfully extend and improve their lives."

Follicular Lymphoma (FL) is the second most common form of non-Hodgkin Lymphoma (NHL), accounting for 20-30% of all NHL cases.4 An estimated 1,500 Australians are newly diagnosed with FL each year.5

"The TGA registration of Minjuvi marks an important new advance for patients with relapsed or refractory follicular lymphoma, bringing Australian clinical practice in line with accepted global standards of care," said Professor Trotman.

The TGA registration of Minjuvi in combination with rituximab and lenalidomide in R/R FL was based on the results from the global Phase 3 inMIND clinical study. This trial evaluated the efficacy and safety of the regimen in 652 patients, including 548 participants with R/R FL. Notably, 54 Australians participated across 12 local trial sites across the country.6

In the clinical trial, patients receiving the Minjuvi combination regimen achieved a statistically significant and clinically meaningful improvement in median progression-free survival (PFS) of 22.4 months (compared to 13.9 months in patients receiving placebo added to lenalidomide and rituximab) — representing a 57% reduction in the risk of disease progression, relapse or death.6

Minjuvi was generally well-tolerated, with a manageable safety profile.6 The most common adverse reactions in the Phase 3 study (≥20%) in patients receiving Minjuvi, excluding laboratory abnormalities, were respiratory tract infections (including COVID-19 infection and pneumonia), diarrhoea, rash, fatigue, constipation, musculoskeletal pain and cough.6

In 2021, ST entered into an exclusive distribution agreement with Incyte (NASDAQ:INCY) to commercialise Minjuvi in Australia, New Zealand and Singapore.

"Follicular lymphoma is an incurable blood cancer and treatment options after relapse remain limited, with each recurrence more challenging to find effective treatments," said Carlo Montagner, ST Chief Executive Officer. "We are extremely proud to bring the first and only chemotherapy-free treatment option to eligible Australians with relapsed or refractory follicular lymphoma, addressing a critical need for new therapies that may lower the risk of disease progression, relapse or death."

"The Minjuvi approval represents the ninth time ST has successfully navigated the Project Orbis process since 2021," said Mr Montagner. "With TGA registration secured, we are committed to working with the Pharmaceutical Benefits Advisory Committee and Department of Health, Disability and Ageing to enable equitable access to Minjuvi for Australians with relapsed or refractory follicular lymphoma as soon as possible."

For further details on Minjuvi, contact your healthcare professional and please refer to the approved Australian Consumer Medicine Information or Product Information available from the TGA website.

PBS Information: Minjuvi is not listed on the Pharmaceutical Benefits Scheme (PBS).

Important safety Information on Minjuvi7

Minjuvi should be administered to patients with an active infection only if the infection is treated appropriately and well controlled. Patients with a history of recurring or chronic infections may be at increased risk of infection and should be monitored appropriately. Patients should be advised to contact their healthcare professionals if fever or other evidence of potential infection, such as chills, cough or pain on urination, develops. Treatment with Minjuvi in combination with lenalidomide and/or rituximab should not be initiated in female patients unless pregnancy has been excluded.

In the inMIND study, the most common adverse reactions were infections (68%), including viral infections (41%) and bacterial infections (27%); neutropenia (57%), rash (36.4%), asthenia (34.9%), pyrexia (19%), thrombocytopenia (17%), anaemia (17%), infusion related reaction (15.9%), pruritus (15.6%), and headache (10.4%). The most common serious adverse reactions were infections (26%), including viral infections (13%) and bacterial infections (6%), febrile neutropenia (2.8%), and pyrexia (1.8%).

Treatment with tafasitamab can cause serious or severe myelosuppression including neutropenia, thrombocytopenia, and anaemia. Complete blood counts should be monitored throughout treatment and prior to administration of each treatment cycle.

(Press release, Specialised Therapeutics Australia, APR 23, 2026, View Source [SID1234664733])

On April 22, 2026 Outlook Therapeutics, Inc. (Nasdaq: OTLK) ("Outlook Therapeutics" or the "Company"), a biopharmaceutical company focused on enhancing the standard of care for bevacizumab for the treatment of retina diseases, reported that it has entered into a definitive agreement for the purchase and sale of an aggregate of 16,129,033 shares of its common stock (or pre-funded warrants in lieu thereof) at an offering price of $0.31 per share of common stock (or per pre-funded warrants in lieu thereof) in a registered direct offering priced at-the-market under Nasdaq rules. Additionally, in a concurrent private placement, the Company will issue unregistered warrants to purchase up to an aggregate of 16,129,033 shares of common stock at an exercise price of $0.31 per share. The unregistered warrants will become exercisable on the later of (i) the date of stockholder approval of the issuance of the shares underlying the warrants and (ii) the effective date of an amendment to the Company’s certificate of incorporation to increase the authorized shares of the Company and will expire five years following the later of (x) the date the unregistered warrants are first exercisable and (y) the effective date of the registration statement registering the resale of the shares of common stock issuable upon exercise of the unregistered warrants. The closing of the offering is expected to occur on or about April 23, 2026, subject to the satisfaction of customary closing conditions.

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

The aggregate gross proceeds to the Company from the offering are expected to be approximately $5.0 million, before deducting the placement agent’s fees and other offering expenses payable by the Company. The potential additional gross proceeds to the Company from the unregistered warrants, if fully exercised on a cash basis, would be approximately $5.0 million. No assurance can be given that any of the unregistered warrants will be exercised for cash. The Company intends to use the net proceeds from this offering primarily for working capital and general corporate purposes.

The shares of common stock (or the pre-funded warrants in lieu thereof and the pre-funded warrant shares issuable thereunder) (but excluding the unregistered warrants and the shares of common stock issuable thereunder) are being offered and sold by the Company in a registered direct offering 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. The offering of the shares of common stock (or the pre-funded warrants in lieu thereof and the shares of common stock issuable thereunder) in the registered direct offering is being made only by means of a base prospectus and prospectus supplement that forms a part of the effective registration statement. A final prospectus supplement relating to the registered direct offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Electronic copies of the final prospectus supplement and the accompanying base prospectus, when available, may also be obtained from 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].

The unregistered warrants described above are being offered and sold by the Company in a transaction not involving a public offering under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Securities Act"), and/or Regulation D promulgated thereunder and, along with the shares of common stock issuable thereunder, have not been registered under the Securities Act or applicable state securities laws. Accordingly, the unregistered warrants and the shares of common stock issuable thereunder may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.

The Company also has agreed to amend certain outstanding warrants to purchase up to an aggregate of 2,142,854 shares of the Company’s common stock that were previously issued to an investor on January 16, 2025, with an exercise price of $2.26 per share, effective upon the closing of the offering, such that the amended warrants will have a reduced exercise price of $0.31 per share, will be exercisable beginning on the effective date of stockholder approval of the issuance of the shares upon exercise of the amended warrants and will expire five years from the effective date of such stockholder approval.

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, APR 22, 2026, View Source [SID1234664685])

On April 22, 2026 Prestige Biopharma IDC, the innovative drug research institute of Prestige Biopharma, reported that it has filed a patent for ‘IDC224,’ a next-generation subcutaneous (SC) delivery platform designed to simultaneously enhance the administration convenience and therapeutic efficacy of antibody therapeutics.

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While most current antibody therapeutics are administered via intravenous (IV) infusion—typically requiring more than an hour and dedicated medical assistance—subcutaneous (SC) administration offers a rapid, highly convenient alternative for patients. Given the high patient convenience and the mitigation of risks associated with repeated vascular access, the global pharmaceutical and biotechnology industry is witnessing a strategic shift from IV to SC delivery methods.

However, antibody therapeutics face significant technical barriers regarding the stable delivery of high-concentration formulations, necessitating advanced engineering for successful SC conversion. Prestige Biopharma IDC has addressed these challenges with the development of its proprietary IDC224 technology.

The IDC224 platform is characterized by a unique liquid-to-gel transition mechanism; the drug is administered in a liquid state and subsequently transforms into a gel upon exposure to body temperature. This process facilitates the sustained release of the drug, effectively extending its therapeutic duration and reducing dosing frequency. Furthermore, the platform enables the uniform loading of high-concentration antibodies, thereby maximizing delivery efficiency. It also secures a strong competitive edge in safety by utilizing biocompatible and biodegradable materials.

The project lead overseeing the development of IDC224 stated, "This platform was engineered to optimize the mode of administration, drug delivery efficiency, and patient convenience in tandem. In pre-clinical studies applying this platform to gastric, ovarian, and breast cancer models, we confirmed improved therapeutic efficacy compared to conventional methods." The representative added, "This patent is a follow-up to our existing composition patent and holds significant value as a ‘use patent,’ which newly defines the anticancer efficacy achieved through this specific composition."

Notably, this technology is designed to facilitate the potential SC conversion of Tuznue, Prestige Biopharma’s trastuzumab biosimilar, which is currently approved in Europe in its existing formulation. This technology therefore holds substantial strategic value in further strengthening product competitiveness and enabling future differentiated administration options for patients and healthcare providers.

A spokesperson for Prestige Biopharma IDC remarked, "The IDC224 platform is designed not only to enhance the durability of an antibody’s therapeutic effect but also to improve ease of administration. We plan to expand the application of this technology to a diverse portfolio of antibody therapeutics in the future."

About Tuznue

Tuznue is a biosimilar of Herceptin (trastuzumab), developed to offer a more cost-effective therapeutic alternative for patients. It maintains comparable efficacy and safety profiles to the original branded medication. Tuznue is indicated for the treatment of patients with HER2-positive metastatic breast cancer (MBC), HER2-positive early breast cancer (EBC), and HER2-positive metastatic gastric cancer (MGC).

(Press release, Prestige BioPharma, APR 22, 2026, View Source [SID1234664701])

On April 22, 2026 Oxford Vacmedix (OVM), the UK biotech company developing novel immunotherapies to treat cancer, reported the successful completion of the Phase 1 trial of OVM-200. The primary endpoint for safety has been met as well as the secondary endpoints for immune response and dose selection. In addition, there are early observations of clinical efficacy in NSCLC and in prostate cancer.

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This Phase 1 clinical trial of OVM-200 is a multicentre, open‑label, first‑in‑human evaluation of OVM‑200, an immunotherapy developed using Oxford Vacmedix’s Recombinant Overlapping Peptide (ROP) therapeutic platform. 36 Patients with advanced NSCLC (non‑small cell lung cancer), ovarian cancer, or prostate cancer and with no HLA restrictions, were treated in the trial. The results show:

Excellent Safety Profile (primary endpoint): OVM‑200 is very well tolerated with no serious adverse drug reactions or no dose‑limiting toxicities. The only adverse effects were Grade 1 injection‑site reactions.
Very strong Immunogenicity (secondary endpoint): the immune response for both antibodies and for T cells were very strong even in an advanced Stage IV patient population. The immune responses data conclusively demonstrates the dual mode of action of the ROP technology.
Therapeutic Dose established (secondary endpoint) based on the immune response, the 2mg dose was chosen for Phase 1b with expanded immunisations of up to 11 doses of 2mg being used.
Early observations of clinical efficacy with stable disease in NSCLC and PSA response in prostate cancer.
Professor Shisong Jiang, founder and Chief Scientific Officer of Oxford Vacmedix, said:

We are delighted to be able to confirm these results for this Phase 1 trial of OVM-200 and with this first step toward providing accessible immunotherapy for all patient types. This progress has only been possible through the participation of the patients in the trial and the dedication of the staff in the clinics.

William Finch, Chief Executive Officer of Oxford Vacmedix, said:

This completion of the clinical trial of OVM-200 marks an important milestone for the company and shows the potential of the ROP technology. We are very pleased to have reached this significant inflection point and are already in discussion with Series B investors to fund Phase 2 trials for OVM-200.

(Press release, Oxford Vacmedix, APR 22, 2026, View Source;utm_medium=rss&utm_campaign=successful-ovm-200-phase-1-trial [SID1234664686])

On April 22, 2026 Abbisko Therapeutics (HKEX: 02256) reported that the company presented six latest preclinical and translational research findings in poster sessions at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, held from April 17 to 22, 2026, in San Diego, USA.

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The presentations span multiple key innovation areas, including the pan-KRAS inhibitor ABSK211, the 4th generation EGFR inhibitor ABK-EGFR-1, the CDK4 selective inhibitor ABK-CDK4, the MTA-cooperative PRMT5 inhibitor ABSK131, as well as a ctDNA-based study investigating resistance mechanisms to the FGFR2/3 inhibitor ABSK061.

pan-KRAS Inhibitor ABSK211

ABSK211 is a potent, highly selective, and orally bioavailable small-molecule pan-KRAS inhibitor developed by Abbisko Therapeutics. It demonstrates broad inhibitory activity against multiple KRAS mutations, addressing significant unmet medical needs in KRAS-driven cancers. At AACR (Free AACR Whitepaper) 2026, Abbisko presented preclinical data for both monotherapy and combination strategies of ABSK211.

Monotherapy: Broad and Potent Inhibition Across KRAS Mutations

KRAS mutations are highly prevalent across multiple cancers, including pancreatic (~90%), colorectal (~35%), and lung cancer (~25%). While several pan-KRAS inhibitors have entered clinical development, there remains a critical need for enhanced potency.

In preclinical studies, ABSK211 demonstrated:

Robust in vitro activity: ABSK211 significantly reduced cell viability across multiple KRAS alterations (including G12, G13, Q61, and WT amplification) at sub-nanomolar to nanomolar concentrations. Meanwhile ABSK211 displayed marginal inhibition in KRAS wild-type cell line with normal copy.
Strong in vivo efficacy: Oral administration induced deep tumor regression in multiple KRAS G12V xenograft models, with robust target engagement.
Broad mutation coverage: Consistent and significant antitumor activity was observed in models harboring KRAS G12D/C/S and G13D mutations.
These findings support the clinical advancement of ABSK211, which is currently undergoing IND-enabling studies.

Poster Information

Title: Preclinical characterization of ABSK211: A highly potent, orally bioavailable and selective pan-KRAS inhibitor with broad and robust activity in KRAS-driven tumors
Time: April 22, 2026, 9:00 AM – 12:00 PM (PT)
Location: Poster Section 13, Board #10
Abstract #: 7090
Combination Therapy: Multi-Mechanistic Synergy Enhances Antitumor Activity

Combination therapy is widely considered a key strategy to improve treatment outcomes in KRAS-mutant cancers. ABSK211 demonstrated synergistic antitumor activity with multiple therapeutic agents:

In vitro synergy: Significant anti-proliferative synergy with PRMT5 inhibitors across KRAS mutations; strong synergy observed with EGFR monoclonal antibodies and chemotherapy in KRAS G12D/G12V models.
Enhanced in vivo efficacy: Combination regimens with PRMT5 inhibitors, cetuximab, immunotherapies, and chemotherapy showed superior tumor growth inhibition and improved durability compared to monotherapy.
These results demonstrate that ABSK211 can significantly enhance antitumor efficacy through multi-mechanistic synergy, supporting its further development in combination strategies.

Poster Information

Title: ABSK211, a highly potent and orally available pan-KRAS inhibitor, demonstrates robust antitumor efficacy in combination with multiple agents
Time: April 22, 2026, 9:00 AM – 12:00 PM (PT)
Location: Poster Section 13, Board #3
Abstract #: 7083
4th Generation EGFR Inhibitor ABK-EGFR-1

ABK-EGFR-1 is a novel 4th generation EGFR inhibitor developed by Abbisko Therapeutics, specifically designed to target the EGFR C797S resistance mutation. It combines high selectivity with central nervous system (CNS) penetration to address key clinical challenges following resistance to 3rd generation EGFR TKIs.

Targeting C797S-Mediated Resistance

The EGFR C797S mutation is a clinically validated mechanism of resistance to third-generation EGFR TKIs, with an estimated 51,000–146,000 cases annually worldwide. Currently, no approved therapies specifically target this mutation, representing a significant unmet clinical need. Preclinical studies showed that ABK-EGFR-1:

Exhibits high selectivity over wild-type EGFR and other kinases.
Demonstrates significant in vivo antitumor activity in multiple EGFR C797S-driven xenograft models, effectively inhibiting tumor growth.
Possesses excellent blood-brain barrier penetration and favorable drug-like properties.
These findings support further development of ABK-EGFR-1 as a next-generation targeted therapy for EGFR-resistant cancers, particularly for patients with brain metastases.

Poster Information

Title: Discovery and characterization of ABK-EGFR-1, a 4th generation EGFR C797S Inhibitor with excellent selectivity and brain penetration
Time: April 21, 2026, 2:00 PM – 5:00 PM (PT)
Location: Poster Section 53, Board #7
Abstract #: LB350
CDK4 Selective Inhibitor ABK-CDK4

ABK-CDK4 is a highly selective, brain-penetrant small-molecule CDK4 inhibitor developed by Abbisko Therapeutics. It is designed to selectively target CDK4, reduce CDK6-related toxicity, and expand treatment potential for patients with brain metastases.

Differentiation Through Selectivity and CNS Penetration

1st generation CDK4/6 inhibitors (e.g., palbociclib, ribociclib, and abemaciclib) have demonstrated clinical benefit in breast cancer, but CDK6 inhibition is associated with dose-limiting hematologic toxicities. In addition, 20–40% of breast cancer patients develop brain metastases, while current therapies have limited CNS exposure.

Preclinical studies showed that ABK-CDK4:

High selectivity: Over 50-fold selectivity for CDK4 versus CDK6, potentially reducing CDK6-related toxicity.
CNS penetration: Favorable CNS exposure (Kpuu > 0.5) and drug-like properties.
Antitumor activity: Effective inhibition of Rb phosphorylation and tumor growth in HR+/HER2− breast cancer models
These results suggest that ABK-CDK4 may overcome key limitations of current CDK4/6 inhibitors and provide a differentiated therapeutic option.

Poster Information

Title: Discovery of ABK-CDK4, a selective and brain-penetrant CDK4 inhibitor
Time: April 20, 2026, 9:00 AM – 12:00 PM (PT)
Location: Poster Section 20, Board #13
Abstract #: 1905
MTA-cooperative PRMT5 inhibitor ABSK131

ABSK131 is a potent and selective small-molecule MTA-cooperative PRMT5 inhibitor developed by Abbisko Therapeutics, targeting MTAP-deleted tumors, and is currently in clinical development.

Broad Synergy Across Multiple Therapeutic Modalities

MTAP homozygous deletion occurs in approximately 10–15% of solid tumors and frequently co-exists with oncogenic drivers such as KRAS and EGFR. In addition, MTAP abnormities are associated with poor prognosis following standard-of-care therapies across multiple cancer types. Therefore, there remains a significant unmet need for novel and effective combination therapies centered on MTA-cooperative PRMT5 inhibitor for MTAP-deleted tumors, with the potential to enable precision patient stratification and deliver synergistic therapeutic benefits.

Preclinical studies demonstrated that ABSK131 exhibits strong synergistic activity with multiple therapies:

KRAS inhibitors: Enhanced tumor growth inhibition in KRAS-mutant, MTAP-deleted models when combined with AMG 510 or ABSK141.
EGFR inhibitors: Improved anti-proliferative and in vivo antitumor activity in EGFR-mutant, MTAP-deleted NSCLC models when combined with osimertinib.
MAT2A inhibitors: Consistent synergistic effects across multiple tumor models when combined with IDE397.
Chemotherapy: Synergistic activity observed both in vitro and in vivo when combined with carboplatin in NSCLC models.
These findings support ABSK131 as a potential backbone therapy for combination strategies in MTAP-deleted tumors.

Poster Information

Title: Synergistic antitumor activity of the MTA-cooperative PRMT5 inhibitor ABSK131 in combination with multiple therapeutic agents in diverse cancer models
Time: April 21, 2026, 9:00 AM – 12:00 PM (PT)
Location: Poster Section 14, Board #23
Abstract #: 4504
FGFR2/3 Inhibitor ABSK061

ABSK061 is a highly potent and selective small-molecule FGFR2/3 inhibitor developed by Abbisko Therapeutics. It has demonstrated encouraging efficacy and safety in Phase I studies and is currently being evaluated in a Phase II trial for gastric cancer.

ctDNA Analysis Reveals Resistance Mechanisms

Acquired resistance remains a major challenge limiting the long-term benefit of targeted therapies. Using ctDNA-based next-generation sequencing (NGS), Abbisko conducted longitudinal genomic analyses comparing baseline and progression samples to elucidate resistance mechanisms to ABSK061:

On-target resistance: Polyclonal acquired FGFR2 mutations in the FGFR2 kinase domain were commonly observed in gastric cancer and cholangiocarcinoma.

Off-target resistance: FGFR2-Atered NSCLC was prone to develop acquired alterations in genes involved in RTK/RAS pathways.

These findings provide important molecular insights into resistance mechanisms and inform the design of future combination and sequential treatment strategies.

Poster Information

Title: Circulating tumor DNA (ctDNA)-based profiling of acquired resistance to the fibroblast growth factor receptor (FGFR)2/3 inhibitor lavengratinib(ABSK061) in patient(pt)s with advanced solid tumors
Time: April 21, 2026, 9:00 AM – 12:00 PM (PT)
Location: Poster Section 45, Board #14
Abstract #: 5319

At AACR (Free AACR Whitepaper) 2026, Abbisko Therapeutics showcased the latest preclinical and translational research advances across multiple pipeline programs, demonstrating its strong capabilities in drug discovery and development. As these programs continue to advance into clinical stages, the company is further strengthening its globally competitive R&D platform.

Looking ahead, Abbisko Therapeutics will continue to focus on addressing unmet medical needs and accelerating the translation of innovative discoveries into clinical applications, with the goal of delivering more first-in-class and best-in-class therapies to patients worldwide.

(Press release, Abbisko Therapeutics, APR 22, 2026, View Source;abbisko-therapeutics-showcases-six-research-advances-highlighting-pan-kras-4th-generation-egfr-and-synthetic-lethality-approaches-302751184.html [SID1234664702])