On April 27, 2026 Terns Pharmaceuticals, Inc. ("Terns" or the "Company") (Nasdaq: TERN), a clinical-stage oncology company, reported that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to TERN-701, a novel, oral allosteric BCR::ABL1 inhibitor, for the treatment of adult patients with Ph+ CML in the chronic phase without the T315I mutation previously treated with two or more TKIs.

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"There remains an urgent need for CML treatments that offer improved efficacy, safety, and tolerability over current therapies," said Scott Harris, chief development and operations officer at Terns. "This designation from the FDA supports the significant potential of TERN-701 to be a best-in-disease therapy for CML patients and offer substantial improvement based on the faster, deeper responses compared to prior TKIs and encouraging safety and tolerability profile observed to date."

"This Breakthrough Therapy Designation, along with the recent agreement for Merck to acquire Terns, has the potential to accelerate efforts to advance TERN-701 to a pivotal trial and to patients," said Amy Burroughs, chief executive officer of Terns. "This is an exciting time for everyone involved in the TERN-701 program. We are grateful to the investigators, patients and community advocates whose dedication and support have made these advancements possible."

Breakthrough Therapy Designation (BTD) is intended to expedite the development and review of potential new medicines designed to treat serious conditions or address significant unmet medical needs. Based on FDA guidelines, the medicine needs to have shown encouraging preliminary clinical evidence that demonstrates potential for substantial improvement over available medicines.

TERN-701 BTD is based on data from the ongoing Phase 1/2 CARDINAL clinical trial of TERN-701 in patients with CML previously treated with at least one prior TKI and who experienced treatment failure, suboptimal response or treatment intolerance. TERN-701 has shown promising activity, with encouraging rates of major molecular response and deep molecular response observed at week 24. Importantly, this includes responses in patients with high baseline disease burden who previously received multiple lines of therapy, including many who were treated with an allosteric TKI. The majority of treatment-emergent adverse events were reported as low grade with a low incidence of severe adverse events and discontinuations.

(Press release, Terns Pharmaceuticals, APR 27, 2026, View Source [SID1234664795])

On April 27, 2026 Syntara Limited (ASX: SNT), a clinical-stage drug development company, reported that it has received positive feedback from the U.S. Food and Drug Administration (FDA) following a constructive in person Type C meeting regarding the planned Phase 2b clinical trial of its lead candidate, amsulostat, for the treatment of patients with myelofibrosis (MF) who have had an inadequate response to standard of care.

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Following a review of amsulostat’s development to date, the FDA supported the proposed Phase 2b study design and provided guidance on the detail of the study and overall development pathway for amsulostat. This feedback represents a major milestone for the company, enabling progression into late-stage clinical development and creating opportunity for further engagement with potential commercial partners.

The Phase 2b study will be a double blind, placebo-controlled study of amsulostat added to standard of care (JAK inhibition) for patients who have had an inadequate response. The primary endpoint will be achievement of 50% reduction in total symptom score (TSS50) after 9 months of treatment. Subject to final protocol review, the number of patients to be studied is expected to be approximately 100.

Syntara Chief Executive Officer Gary Phillips said: "We are delighted to have received a positive FDA review of the trial protocol for the planned Phase 2b study. Amsulostat has a differentiated and competitive safety and efficacy profile, with strong potential as a breakthrough therapy for MF patients with an inadequate response to standard of care. We are also advancing amsulostat’s development into myelodysplastic syndrome (MDS), where two clinical studies are currently ongoing.

With additional clinical milestones expected over the next 12 months, including top-line data from the Phase 2 study of SNT-4728 for isolated REM sleep behaviour disorder (iRBD), a prodromal feature of Parkinson’s disease, and results from a placebo-controlled study of SNT-9465, a topical pan-LOX inhibitor for hypertrophic scarring; 2026 is shaping up to be a landmark year for Syntara."

(Press release, Syntara, APR 27, 2026, https://mcusercontent.com/add2e2fa70ec3d0eeaf2a93cc/files/2cc7439a-7a49-d9c3-e873-9f0527792fed/Positive_FDA_feedback_for_Amsulostat_P2b_trial.pdf [SID1234664812])

On April 27, 2026 CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a clinical-stage oncology company advancing leronlimab, a first-in-class humanized monoclonal antibody targeting the CCR5 receptor with therapeutic potential across multiple indications, including metastatic triple-negative breast cancer ("mTNBC") and colorectal cancer ("mCRC"), reported the successful enrollment and initial dosing of the first participant in its Expanded Access Program (EAP) for patients with triple-negative breast cancer (TNBC).

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The EAP is designed to provide eligible patients access to leronlimab outside of a clinical study setting. The program is intended for patients who have exhausted available treatment options and are not eligible for ongoing or planned clinical studies, in accordance with U.S. Food and Drug Administration (FDA) guidelines.

"Dosing the first patient in our EAP marks an important step in making leronlimab available to individuals with urgent unmet medical needs, while also advancing our understanding of CCR5 biology in the treatment of aggressive cancers," said Jacob Lalezari, M.D., CEO of CytoDyn. "Data generated through this program may further inform how CCR5 inhibition influences the tumor microenvironment, including its potential role in modulating PD-L1 expression and supporting combination approaches with immune checkpoint inhibitors."

"For patients with advanced triple-negative breast cancer who have exhausted standard treatment options, expanded access programs can provide additional avenues for care," said Namita Chittoria, M.D., Assistant Professor at the Huntsman Cancer Institute and the University of Utah, and a member of CytoDyn’s Scientific Advisory Board. "Leronlimab is an investigational therapy being evaluated in this difficult-to-treat setting, and access outside of a clinical study may offer a meaningful option for select patients – both as an additional treatment opportunity and as a way to preserve valuable time with family. Beyond individual use, these programs also inform our understanding of emerging therapies."

In addition to providing compassionate access, the EAP is expected to generate real-world insights into the biological activity of leronlimab in heavily pretreated patients. Recent data, presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026, highlight the potential role of CCR5 inhibition in modulating the tumor microenvironment in metastatic triple-negative breast cancer, with observed associations in PD-L1 expression and broader immune signaling pathways. Together, these findings provide a scientific foundation for the EAP and support continued exploration of leronlimab as a strategy to enhance responses to immune checkpoint inhibitor (ICI) therapies.

To support execution of the program, the Company has engaged With Every Patient (WEP Clinical) as the clinical research organization to support program execution, including patient identification, site coordination, and regulatory compliance. The EAP is now open for physician referrals, and CytoDyn expects to expand participation as additional sites are activated. The program will operate under applicable U.S. Food and Drug Administration (FDA) guidelines, and additional information for physicians and eligible patients, including referral details, is available on the Company’s website at www.cytodyn.com.

(Press release, CytoDyn, APR 27, 2026, View Source [SID1234664827])

On April 27, 2026 Oncolytics Biotech Inc. (Nasdaq: ONCY) ("Oncolytics" or the "Company"), a clinical-stage immunotherapy company developing pelareorep, an investigational, systemically delivered immunotherapy that has been shown to activate innate immune-sensing pathways, reported that a Type C meeting with the U.S. Food and Drug Administration ("FDA") has resulted in alignment on the design of a pivotal clinical study to support approval of pelareorep in patients with unresectable metastatic squamous cell carcinoma of the anal canal ("SCAC").

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"We want to thank the FDA for its very clear guidance and helping us create an efficient pathway for pelareorep in a disease that is desperate for new treatments," said Jared Kelly, Chief Executive Officer of Oncolytics. "While a single-arm study was possible in this setting, following a productive discussion with the FDA and in consideration of recent regulatory decisions regarding similar studies, we have aligned on a randomized controlled trial designed to potentially support both accelerated approval and full approval within the same study. This approach directly addresses relevant and rigorous evidentiary standards while allowing for approval based on multiple endpoint assessments."

SCAC is a rare gastrointestinal malignancy affecting more than 10,000 patients annually in the United States. Patients whose disease progresses following first-line chemotherapy/checkpoint inhibitor treatment have no FDA-approved therapeutic options and limited National Comprehensive Cancer Network recommended treatments. In a recent study combining pelareorep with a checkpoint inhibitor in second-line and later SCAC, the combination achieved a median duration of response of 15.5 months versus 9.5 months and 12-month survival of 82% versus 45.7%, each measured against the current standard of care.1

"The post-first-line SCAC setting remains an area of significant unmet need," said Dr. Van Morris, Associate Professor in the Department of Gastrointestinal Medical Oncology at The University of Texas MD Anderson Cancer Center in Houston, TX. "Pelareorep provides a strong rationale for evaluation in this population, and the study design represents a thoughtful and appropriate approach to advancing new options for these patients."

The Company plans to incorporate FDA feedback into the final protocol, which is expected to be a single, randomized controlled trial for which accelerated approval and full approval could be applied at different points in time.

(Press release, Oncolytics Biotech, APR 27, 2026, View Source [SID1234664796])

On April 27, 2026 Xcovery Holdings, Inc., (Xcovery) an evidence-based, innovation-driven pharmaceutical company, reported an agreement with EVERSANA, a leading provider of commercialization services to the global life sciences industry, to support and expand the U.S. commercial launch of ENSACOVE (ensartinib), the company’s novel therapy for adult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC).

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Ensacove (ensartinib) is a next generation ALK inhibitor jointly developed by Xcovery and Betta Pharmaceuticals, Co. Ltd. (Betta). It is indicated for the treatment of adult patients with ALK-positive locally advanced or metastatic NSCLC as detected by an FDA-approved test who have not previously received an ALK inhibitor and is now available in the United States as a treatment for these patients (www.ensacove.com).

Under the agreement, EVERSANA will provide comprehensive end‑to‑end commercialization services for Xcovery, including but not limited to agency of record, market access, commercial and medical teams to support the company’s strategy to make Ensacove available to more patients across the U.S.

"The approval of Ensartinib was a major milestone in our mission to advance precision oncology," said Giovanni Selvaggi, M.D., Chief Medical Officer of Xcovery Holdings, Inc. "As we expand the U.S. launch of ENSACOVE, we are focused on ensuring that patients and providers have the support they need. EVERSANA brings highly experienced, scalable commercialization capabilities, and we’re pleased to partner with them to broaden patient access."

"EVERSANA was built to help companies just like Xcovery implement more impactful commercial strategies which will allow more patients to benefit from therapies like Ensartinib," said Gregory Skalicky, President, EVERSANA.

About ENSACOVE

ENSACOVE (ensartinib) is a kinase inhibitor indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK) positive locally advanced or metastatic non-small cell lung cancer (NSCLC) who have not previously received an ALK inhibitor.

ENSACOVE is contraindicated in patients who have experienced a severe hypersensitivity reaction to ENSACOVE, FD&C Yellow No. 5 (tartrazine), or to any of its components.
ENSACOVE can cause the following serious adverse reactions. Withhold, reduce the dose, or permanently discontinue ENSACOVE based on severity.

Interstitial Lung Disease (ILD)/Pneumonitis occurred in 5% of patients, including 1.3% Grade 3 and 0.4% Grade 4. Monitor patients for new or worsening symptoms indicative of ILD/pneumonitis and immediately withhold ENSACOVE if suspected. Permanently discontinue in patients with ILD/pneumonitis.

Hepatotoxicity, including drug-induced liver injury can occur. 59% of patients had increased alanine aminotransferase (ALT), including 5% Grade 3. Increased aspartate aminotransferase (AST) occurred in 58% of patients, including 1.8% Grade 3. Increased bilirubin occurred in 12% of patients, including 2.3% Grade 3 and 0.2% Grade 4. There was one case of drug-induced liver injury. Monitor liver function tests at baseline and every 2 weeks during the first cycle of treatment, and then monthly or as clinically indicated.

Dermatologic Adverse Reactions can occur, including drug reaction with eosinophilia and systemic symptoms (DRESS), rash, pruritus, and photosensitivity. Dermatologic adverse reactions occurred in 80% of patients, including Grade 3 in 14% of patients. Rash occurred in 72% of patients, including Grade 3 in 12% of patients. Pruritus occurred in 32% of patients, including 2.4% Grade 3. There was one Grade 3 case (0.2%) of DRESS. Advise patients to limit direct sun exposure during treatment and for at least 1 week after discontinuation. Monitor for dermatologic adverse reactions during treatment.
Bradycardia occurred in 6% of patients. All bradycardia events were Grade 1 or 2. Monitor heart rate regularly during treatment.

Hyperglycemia. Increased blood glucose occurred in 44% of patients, including Grade 3 in 2.5% (based on laboratory data). Monitor serum glucose periodically during treatment.
Visual Disturbances occurred in 8% of patients (0.2% Grade 3) and included blurred vision, diplopia, photopsia, vitreous floaters, visual impairment, visual field defect, and reduced visual acuity. Advise patients to report visual symptoms during treatment and obtain ophthalmologic evaluation in patients with visual disturbances.

Increased Creatine Phosphokinase (CPK) occurred in 43% of patients who had CPK laboratory data available, with Grade 3 in 1.5% and 0.5% Grade 4. Advise patients to report any unexplained muscle pain, tenderness, or weakness. Monitor CPK periodically during treatment.

Hyperuricemia occurred in 6% of patients, with 0.4% Grade 3 and 0.7% Grade 4. Monitor uric acid periodically during treatment and initiate urate-lowering medications as clinically indicated.
ENSACOVE can cause fetal harm. Advise patients of the potential risk to a fetus and to use effective contraception during treatment and for 1 week after the last dose.

ENSACOVE contains FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons.

The most common adverse reactions (incidence ≥20%) were rash, musculoskeletal pain, constipation, pruritus, cough, nausea, edema, vomiting, fatigue, and pyrexia.

Drug Interactions: Avoid concomitant use of P-gp inhibitors and moderate or strong CYP3A inhibitors or inducers.

Lactation: Advise women not to breastfeed during treatment and for 1 week after the last dose.
Use in Specific Populations: Avoid use of ENSACOVE in patients with severe hepatic impairment (total bilirubin >3 times ULN and any AST).

(Press release, Xcovery, APR 27, 2026, View Source [SID1234664813])