On April 23, 2026 Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX), a U.S. specialty pharmaceutical company, reported it has entered into an agreement with an affiliate of Apotex ("Apotex"), the largest Canadian based pharmaceutical company to integrate their branded U.S. businesses. Under the terms of the agreement, Apotex will acquire Cumberland’s line of branded pharmaceuticals for cash consideration of $100 million, and create a platform to deliver specialty medicines that improve the quality of patient care. The transaction is subject to authorization and approval by Cumberland’s shareholders.

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Cumberland will retain its pipeline product candidates which it intends to focus on developing following the closing of the transaction. It will also retain its majority ownership position in Cumberland Emerging Technologies Inc.

"Our business has two distinct profiles – with established commercial operations typical of a specialty pharmaceutical company and an exciting development pipeline often associated with a biotechnology firm" said A.J. Kazimi, CEO of Cumberland. "This transaction unlocks value for our shareholders and enables us to focus on the large market opportunities associated with our pipeline product candidates. We believe that the integration of these products with Apotex will create more critical mass to support patient care and provide enhanced career opportunities for our commercial team".

"This transaction will strengthen our ability to support patients in some of the most critical moments of their care journey," said Jeff Watson, President & CEO of Apotex. "As a Force for Health, we are committed to improving access to high-quality medicines and ensuring that patients, families, and clinicians have the treatments they rely on. Integrating Cumberland’s commercial business into the Apotex family will enhance our ability to deliver a meaningful health impact to patients across the United States."

In addition to its portfolio of FDA approved brands involved in the transaction with Apotex, Cumberland is developing ifetroban, a potent thromboxane antagonist through a series of programs designed to address unmet medical needs with significant market potential.

The Company has announced breakthrough results in a Phase II clinical study of ifetroban in patients with cardiomyopathy associated with Duchenne muscular dystrophy ("DMD"). This rare, fatal genetic neuromuscular disease results in deterioration of the skeletal, heart and lung muscles. Interactions with the FDA are underway regarding the study results and remaining requirements for approval. The program has received Orphan Drug, Rare Pediatric Disease and more recently Fast Track designations from the FDA.

Cumberland also has a Phase II clinical program evaluating its ifetroban product candidate in patients with Systemic Sclerosis ("SSc") or scleroderma, a debilitating autoimmune disorder characterized by diffuse fibrosis of the skin and internal organs. Enrollment in that study is completed and the next milestone will be announcement of the top-line study results.

The Company’s third development program involves the treatment with ifetroban in patients with Idiopathic Pulmonary Fibrosis ("IPF"), the most common form of progressive fibrosing interstitial lung disease. Enrollment in the Phase II study is well underway at medical centers across the U.S., with interim safety and interim efficacy results pending.

(Press release, Cumberland Pharmaceuticals, APR 23, 2026, View Source [SID1234669063])

On April 23, 2026 Epitopea, a transatlantic biotech developing off-the-shelf, durable, RNA-based cancer immunotherapies, reported that it has received approval from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and the Regional Ethics Committee (REC) for its clinical trial application (CTA) for its first-in-human clinical trial (OVACT) of its lead program, CryptiVax-1001, targeting advanced high-grade serous ovarian cancer.

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Epitopea also announces the appointment of Professor Susana Banerjee (MBBS MA PhD FRCP), a Consultant Medical Oncologist and Research Lead for the Gynaecology Unit at The Royal Marsden NHS Foundation Trust and Professor in Women’s Cancers at the Institute of Cancer Research, as Chief Investigator of the OVACT trial.

Dr. Klaus Edvardsen, MD, Chief Medical Officer of Epitopea, commented, "We are excited by the achievement of this significant regulatory milestone, which is a credit to our dedicated clinical and wider Epitopea team. We also welcome Professor Banerjee to her role as Chief Investigator of our first clinical trial. Her world-class expertise in ovarian cancer and leadership in global clinical development will bring invaluable insights as we transition to a clinical-stage company."

OVACT is a Phase 1/1b dose escalation and expansion trial designed to evaluate the safety, tolerability, immunogenicity, and early clinical activity of CryptiVax-1001 in HRP+/BRCA-wildtype high-grade serous ovarian cancer patients.

High-Grade Serous Ovarian Cancer(HGSOC) remains one of the most difficult-to-treat solid tumors, with most patients (~80%) presenting with advanced or metastatic disease. While most women respond to first-line platinum chemotherapy, nearly all ultimately relapse and progress to platinum-resistant disease. Existing maintenance options leave a major therapeutic gap among HRP+/BRCA-wildtype patients, who represent roughly half of the ovarian cancer population.

Professor Banerjee added: "There is a substantial unmet need in homologous recombination proficient (HRP) ovarian cancer, where available maintenance therapies deliver limited durable benefit. Epitopea’s CryptiVax-1001 vaccine, which targets a novel repertoire of tumor-specific antigens, has the potential to meaningfully extend remission for patients with few effective treatment options."

Epitopea’s pipeline is enabled by CryptoMapTM, a proprietary discovery engine that identifies tumor-presented antigens arising from the dark genome, a previously inaccessible source of novel, tumor-specific targets. These antigens, known as CryptigensTM, demonstrate high inter-patient sharing, enabling development of true off-the-shelf mRNA immunotherapies.

(Press release, Epitopea, APR 23, 2026, View Source [SID1234664720])

On April 23, 2026 Tempus AI, Inc. (NASDAQ: TEM), a technology company leading the adoption of AI to advance precision medicine, and the Keck School of Medicine of USC and Keck Medicine of USC, reported a multi-faceted collaboration aimed at transforming patient care and accelerating research through the power of data and AI. This collaboration is designed to transform care delivery across more than 1.5 million annual patient visits to the USC Norris Comprehensive Cancer Center, the Keck Hospital of USC, USC Verdugo Hills and all USC-affiliated hospitals and clinics across Southern California.

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The collaboration is built on four foundational pillars, co-created to drive clinical impact, research scale, and long-term innovation. These include clinical testing, which enables personalized medicine by integrating Tempus’ advanced molecular diagnostics and comprehensive genomic profiling into Keck Medicine’s clinical workflows; clinical trial matching, which automates the identification of eligible patients for targeted therapies and clinical trials through Tempus’ TIME Trial Program; clinical care gap pathways, which use AI-driven insights to identify and close gaps in patient care; and research collaboration and co-development, which accelerates the translation of academic insights into validated diagnostics and therapies while jointly developing AI tools that connect research discoveries to clinical care.

"By working closely with Tempus, and in collaboration with clinical, research, and operational leaders across USC, we are aligning research, clinical care, and innovation priorities that put the patient first," said Vasiliki Anest, PhD, Chief Innovation Officer at the Keck School of Medicine of USC. "Our patient-focused commitment is to ensure discoveries and clinical innovations move thoughtfully and responsibly into practice, expanding access to personalized care and clinical trials, supporting physicians, and improving patient outcomes."

"We are tremendously excited to embark on this collaboration with USC, an institution that shares our commitment to advancing healthcare through data and technology," said Ezra Cohen, MD, Chief Medical Officer of Oncology at Tempus. "By bringing together Tempus’ AI-powered platform with USC’s world-class research and clinical expertise, we have the opportunity to create a powerful, integrated ecosystem that meaningfully transforms care delivery."

(Press release, Tempus, APR 23, 2026, View Source [SID1234664737])

On April 23, 2026 Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating Fast Track designated GLSI-100, an immunotherapy to prevent breast cancer recurrences, reported that an abstract has been accepted for publication at the upcoming 2026 ASCO (Free ASCO Whitepaper) Annual Meeting along with a corresponding poster presentation.

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The 2026 ASCO (Free ASCO Whitepaper) Annual Meeting will be held from May 28 to June 2, 2026. The full text of the abstract and poster will be available on June 1, 2026, the day of the presentation.

CEO Snehal Patel commented, " We look forward to meeting many of our principal investigators at the conference. Our abstract will be the second abstract co-authored by the Company and the full Steering Committee of FLAMINGO-01 presenting preliminary injection site reaction immune response data from the non-HLA-A*02 open-label arm."

In addition to ASCO (Free ASCO Whitepaper), the Company plans to attend ESMO (Free ESMO Whitepaper) Breast, BIO partnering, and investor conferences in the coming months.

About the 2026 ASCO (Free ASCO Whitepaper) Annual Meeting

ASCO is the world’s leading professional organization for physicians and oncology professionals caring for people with cancer. ASCO (Free ASCO Whitepaper) offers premier scientific events for oncology professionals, patient advocates, industry representatives, and major media outlets worldwide. The ASCO (Free ASCO Whitepaper) Annual Meeting program features poster presentations, poster discussion sessions, clinical science symposia, and dynamic education sessions about recent advancements in cancer research, treatment, and patient care. For more information, please visit the conference website at: View Source

About FLAMINGO-01 Open Label Phase III Data

More than 1,300 patients have been screened with a current screen rate of approximately 800 patients per year. The 250 patient non-HLA-A*02 arm is now fully enrolled, where all patients received GLSI-100, which is 5 times more treated patients and recurrence rate data than the approximately 50 patients treated in the Phase IIb trial. The Primary Immunization Series (PIS), which includes the first 6 GLSI-100 injections over the first 6 months and is required to reach peak protection, is followed by 5 booster injections given every 6 months to prolong the immune response, thereby providing longer-term protection.

In the non-HLA-A*02 arm, a preliminary analysis of recurrence rates after the PIS is completed shows an approximately 70-80% reduction in recurrence rate.
This observation is trending similarly to the Phase IIb trial results and hazard ratio where HLA-A*02 patients were treated and where breast cancer recurrences were reduced up to 80% compared to a 20-50% reduction in recurrence rate by other approved products.
The immune response at baseline prior to any GLSI-100 treatment, the increasing immune response during the PIS, and the safety profile of non-HLA-A*02 patients is trending similarly to the HLA-A*02 arms of FLAMINGO-01 and to the Phase IIb study.
The AACR (Free AACR Whitepaper) Meeting 2026 delayed-type-hypersensitivity (DTH) poster can be downloaded here.
The frequency of DTH reactions increased by approximately 4x (290%) in the total open-label non-HLA-A*02 population, increasing from 5.2% of the patients experiencing a DTH reaction at baseline, prior to any GLSI-100 administration, to 20.4% of the patients experiencing a DTH reaction in month 4 or month 6 (McNemar, p < 0.001).
As reported in Table 1 of the poster, each HLA-A type exhibited more frequent immune reactivity after treatment with GLSI-100 than at baseline with frequency increasing from 100% to 700%.
Baseline DTH reaction prior to any treatment suggests that GP2 may be a natural antigen and that GP2 specific T cells may exist in some patients prior to any treatment with GLSI-100. Baseline immune response to GP2 prior to any vaccination with GP2 was also observed in the Phase IIb trial and is being observed in the blinded randomized arms of FLAMINGO-01, where HLA-A*02 only patients are being vaccinated.
Analysis of the open label data from FLAMINGO-01 has been conducted in a manner that maintains the study blind. The open label recurrence rate, immune response, and safety data is based on the patients enrolled to date in FLAMINGO-01 and the data provided by the clinical sites so far, which is not completed or fully reviewed, and is thus preliminary. While comparing any preliminary FLAMINGO-01 data to the Phase IIb clinical trial data may be possible, these preliminary results are not a prediction of future results, and the results at the end of the study may differ.

About GLSI-100 Phase IIb Study

In the prospective, randomized, single-blinded, placebo-controlled, multi-center (16 sites led by MD Anderson Cancer Center) Phase IIb clinical trial of HLA-A*02 breast cancer patients, 46 HER2/neu 3+ over-expressor patients were treated with GLSI-100, and 50 placebo patients were treated with GM-CSF alone. After 5 years of follow-up, there was an 80% or greater reduction in cancer recurrences in the HER2/neu 3+ patients who were treated with GLSI-100, followed, and remained disease free over the first 6 months, which we believe is the time required to reach peak immunity and thus maximum efficacy and protection. The Phase IIb results can be summarized as follows:

80% or greater reduction in metastatic breast cancer recurrence rate over 5 years of follow-up with a peak immune response at 6 months and well-tolerated safety profile.
The PIS elicited a potent immune response as measured by local skin tests and immunological assays.
About FLAMINGO-01 and GLSI-100

FLAMINGO-01 (NCT05232916) is a Phase III clinical trial designed to evaluate the safety and efficacy of Fast Track designated GLSI-100 (GP2 + GM-CSF) in HER2 positive breast cancer patients who had residual disease or high-risk pathologic complete response at surgery and who have completed both neoadjuvant and postoperative adjuvant trastuzumab based treatment. The trial is led by Baylor College of Medicine and currently includes US and European clinical sites from university-based hospitals and academic and cooperative networks with plans to open up to 150 sites globally. In the double-blinded arms of the Phase III trial, approximately 500 HLA-A*02 patients are planned to be randomized to GLSI-100 or placebo, and up to 250 patients of other HLA types are planned to be treated with GLSI-100 in a third arm. The trial has been designed to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, where 28 events will be required. An interim analysis for superiority and futility will be conducted when at least half of those events, 14, have occurred. This sample size provides 80% power if the annual rate of events in placebo-treated subjects is 2.4% or greater.

For more information on FLAMINGO-01, please visit the Company’s website here and clinicaltrials.gov here. Contact information and an interactive map of the majority of participating clinical sites can be viewed under the "Contacts and Locations" section. Please note that the interactive map is not viewable on mobile screens. Related questions and participation interest can be emailed to: [email protected]

About Breast Cancer and HER2/neu Positivity

One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 300,000 new breast cancer patients and 4 million breast cancer survivors. HER2 (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.

(Press release, Greenwich LifeSciences, APR 23, 2026, View Source [SID1234664721])

On April 23, 2026 CatalYm reported that the first patient has been dosed in the Phase 2/3 VINCIT trial (Visugromab IN Cachexia International Trial, NCT07112196). The global study is evaluating the company’s lead anti-GDF-15 antibody visugromab in patients with cancer-associated cachexia.

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The randomized, double-blind, placebo-controlled Phase 2/3 trial will enroll about 518 patients with cachexia associated with a range of advanced cancers, including non-small cell lung cancer (NSCLC), colorectal cancer (CRC), and other solid tumors.

Cachexia is a severe metabolic condition marked by involuntary weight loss, muscle wasting, and impaired treatment tolerance. In some types of cancer, it can affect up to 70% of patients and is responsible for 20-40% of cancer-related deaths1. Elevated GDF-15 levels are known to play a central role in the development of cachexia. Despite a high unmet medical need, there are currently no approved pharmacological treatments available.

"Cachexia remains one of the most debilitating and under-addressed complications in oncology," said Sujata Rao, MD, Chief Medical Officer at CatalYm. "Following the promising weight gain data observed in our earlier trial and growing evidence of GDF-15’s role in metabolic wasting, this trial is a critical step in establishing visugromab as a novel therapeutic option for patients with advanced cancers."

"The data guiding this trial show that GDF-15 is more than a bystander in cancer progression. It plays a central role in both immune resistance and metabolic decline," said Scott Clarke, Chief Executive Officer at CatalYm. "By targeting GDF-15, visugromab has the potential to open a new therapeutic path for patients whose treatment outcomes are severely impacted by cachexia."

The VINCIT trial is an adaptive Phase 2/3 study to evaluate the efficacy and safety of visugromab in reversing cachexia. In Part 1, participants are randomized to receive one of three visugromab dose levels or placebo every four weeks for 12 weeks. Based on interim analyses, a recommended dose will be selected for Part 2, which will randomize patients 2:1 to visugromab or placebo for up to 52 weeks. The trial will include clinical sites across the globe. Primary endpoints include changes in body weight and appetite over 12 weeks. Secondary endpoints assess muscle mass and function, physical activity, tumor response, overall survival, patient-reported quality of life, and safety. The study also includes exploratory pharmacodynamic and biomarker assessments.

Visugromab is a humanized, monoclonal antibody that targets Growth Differentiation Factor-15 (GDF-15), a tumor-derived cytokine known to drive immune suppression and cachexia. In the exploratory Phase 1/2a GDFATHER trial (NCT04725474), visugromab in combination with PD-1 inhibitor nivolumab demonstrated deep and durable anti-tumor activity as well as a favorable safety profile in patients with relapsed or refractory NSCLC, hepatocellular carcinoma (HCC) and urothelial cancer (UC). The trial also provided early clinical evidence for visugromab’s potential to alleviate cancer cachexia, including meaningful weight gain in the subset of patients with moderate or severe weight loss at trial entry. These findings support visugromab’s dual potential to maintain or restore immune function and counteract cancer cachexia.

About cancer cachexia and GDF-15

Cancer cachexia is a complex and debilitating syndrome that affects up to 70% of patients with advanced cancer1. The condition is closely linked to elevated GDF-15 levels, which drive severe and progressive weight loss, muscle wasting, reduced appetite, and metabolic disturbances through activation of the GFRAL receptor in the brainstem. Unlike starvation, cachexia cannot be fully reversed with nutritional support alone, as it is driven by a combination of systemic inflammation, tumor-derived factors, and metabolic dysregulation. This condition significantly diminishes the quality of life for cancer patients and severely impacts their ability to tolerate and respond to treatment, often leading to poorer outcomes and increased mortality.

About Visugromab

Visugromab is a monoclonal antibody that neutralizes Growth Differentiation Factor-15 (GDF-15), a locally acting immunosuppressant produced by tumors which fosters immunotherapy resistance and drives cachexia in people with cancer. Neutralizing GDF-15 with visugromab reverses key cancer resistance mechanisms to reinstate an efficient anti-tumor response by re-enabling immune cell activation, proliferation and induction of interferon-γ. In addition, visugromab also mitigates cancer cachexia, a severe condition affecting a significant number of advanced cancer patients by inhibiting the activation of the GFRAL pathway in the brainstem, a key driver of weight loss and appetite suppression in cancer patients.

(Press release, Catalym, APR 23, 2026, View Source [SID1234664738])