On April 1, 2026 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, reported that its management team will be participating in the 25th Annual Needham Virtual Conference on Wednesday, April 15, 2026.

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(Press release, Personalis, APR 1, 2026, View Source [SID1234664141])

On April 1, 2026 Orca Bio, a late-stage biotechnology company committed to transforming the lives of patients through high-precision cell therapy, reported that the U.S. Food and Drug Administration (FDA) has extended the review timeline of its Biologics License Application (BLA) for Orca-T for the treatment of patients with hematologic malignancies. The new Prescription Drug User Fee Act (PDUFA) target action date is July 6, 2026.

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The extension follows Orca Bio’s recent submission of updated chemistry, manufacturing and controls (CMC) information in response to requests from the FDA as part of the standard review process. The FDA classified the submission as a Major Amendment (MA) to the BLA, which extends the review by three months. Importantly, the FDA has not requested any additional clinical data. Orca Bio believes that the updated information submitted in the amendment does not affect the benefit-risk conclusions of the BLA.

"We appreciate the frequent engagement with the FDA throughout the review process," said Nate Fernhoff, co-founder and chief executive officer at Orca Bio. "Our continued focus is on preparing for the potential approval and commercial launch of Orca-T. We remain committed to working with the Agency, physicians and the broader blood cancer community to deliver this important therapy to patients with hematologic malignancies as quickly as possible."

The BLA for Orca-T was granted Priority Review by the FDA and Orca-T previously received Regenerative Medicine Advanced Therapy (RMAT) and Orphan Drug Designation.

About Orca-T
Orca-T is an investigational allogeneic T-cell immunotherapy under evaluation for the treatment of multiple hematologic malignancies including acute leukemias and myelodysplastic syndromes. Orca-T is composed of highly purified hematopoietic stem cells, regulatory T-cells and conventional T-cells derived from either related or unrelated matched donors. Orca-T has received Regenerative Medicine Advanced Therapy (RMAT) and Orphan Drug Designation for the prevention of graft versus host disease or death in patients eligible for hematopoietic stem cell transplant from the U.S. Food and Drug Administration (FDA).

(Press release, Orca Bio, APR 1, 2026, View Source;utm_medium=rss&utm_campaign=orca-bio-announces-fda-review-extension-of-bla-for-orca-t-for-the-treatment-of-hematologic-malignancies [SID1234664126])

On April 1, 2026 NeOnc Technologies Holdings, Inc. (Nasdaq: NTHI) ("NeOnc" or the "Company"), a multi-Phase 2 clinical-stage biopharmaceutical company developing novel therapies for central nervous system (CNS) cancers, reported financial results for the quarter and year ended December 31, 2025, and provided an update on recent operational achievements and upcoming milestones.

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Amir Heshmatpour, Chief Executive Officer, Executive Chairman, and President, commented:

"Q4 2025 and early 2026 marked important inflection points for NeOnc. We completed NEO212’s Phase 1 dose escalation and established a recommended Phase 2 dose of 610 mg, with early signs of possible anti-tumor activity in heavily pretreated patients.

In parallel, the NEO100 Phase 2a study in recurrent IDH1-mutant high-grade glioma is fully enrolled. Updated Phase 1/2a data suggested a 24% radiographic remission rate, 44% six-month progression-free survival, and no significant toxicity.

We also strengthened the balance sheet through a PIPE financing anchored by Cinctive Capital’s $10 million commitment, expanded the leadership team, and advanced our Middle East strategy through NuroMENA.

Looking ahead, we plan to hold a Type B End-of-Phase 1 FDA meeting for NEO212. We also expect a preliminary NEO100 Phase 2a data readout in approximately five months. We believe these near-term catalysts position NeOnc to deliver value-creating milestones for shareholders in the months ahead."

Fourth Quarter and Recent Highlights

Clinical Milestones & Data

NEO212 — Phase 1 Complete, RP2D Set at 610 mg:
Early signs of possible clinical efficacy, including potential durable disease control in heavily pretreated recurrent GBM and brain metastasis patients, observed even within the safety-focused phase
The company intends to request a Type B End-of-Phase 1 FDA meeting to align on a potential pivotal, registrational Phase 2 study
Exploring an Accelerated Approval pathway
First oral bio-conjugated temozolomide asset is mechanistically differentiated by its potential ability to overcome MGMT-mediated TMZ resistance.
NEO100 — Phase 2a Fully Enrolled: Completed enrollment in the NEO100 Phase 2a trial for IDH-1 mutant recurrent high-grade glioma, with an interim data readout expected in ~5 months (approximately August 2026).
Updated NEO100 Clinical Results Show Possible Durable Efficacy in Recurrent IDH1-Mutant Gliomas:
Expanded 25-patient cohort from Phase 1/2a and compassionate-use experience, intranasal NEO100
Suggested a 24% radiographic remission rate (6/25)—3× the ~8% historically seen with salvage therapies
44% six-month progression-free survival (vs. 21–31% historical benchmarks)
36% of patients (9/25) alive ≥18 months post-treatment initiation
No significant toxicity even under prolonged chronic dosing
Reinforces NEO100’s potential as a first-in-class, CNS-penetrant metabolic therapy for recurrent WHO Grade III/IV IDH1-mutant astrocytoma.
NEO100 & Ultrasound: Announced AI-driven findings demonstrating that ultrasound may enhance the potency of NEO100 against primary and metastatic brain tumors, pointing toward a potential combination approach.

Middle East Expansion (NuroMENA)

Executive Chairmanship: His Highness Sheikh Nahyan bin Zayed Al Nahyan assumed the role of Executive Chairman of NuroMENA, NeOnc’s UAE-based subsidiary, to advance a UAE-US partnership in brain cancer treatment.
Operational Agreements: NuroMENA executed a Master Services Agreement with M42’s IROS and expanded its Board of Directors.

Strengthening Leadership & Securing Growth Capital

PIPE Financing: Raised a PIPE investment anchored by a $10 million commitment from Cinctive Capital Management, strengthening the balance sheet to advance clinical priorities.
Chief Executive Officer: Named Amir Heshmatpour as CEO to lead the company’s next phase of clinical and corporate development.
Chief Accounting Officer: Appointed David Choi as CAO to oversee the Company’s accounting, financial reporting, internal controls, and corporate governance functions.
Scientific Advisory Board Expansion: Added two leading neuro-oncologists — Dr. David M. Ashley, Director of Duke’s Preston Robert Tisch Brain Tumor Center, and Dr. Alexandra M. Miller, Chief of Neuro-Oncology at NYU Langone’s Perlmutter Cancer Center — deepening the company’s scientific bench.

Investor & Media Engagement

Broadcast Exposure: Featured across multiple New to The Street segments on Bloomberg Television (U.S., MENA, and Latin America) and Fox Business, increasing visibility among retail and institutional audiences.
Investor Events & KOL Calls: Hosted multiple investor and key opinion leader conference calls presenting clinical data updates and participated in the New to The Street Accredited Investor Event at Hudson Yards, New York.

Financial Results for Q4 2025

G&A expenses: $4,818k vs. $1,680k in Q4 2024, reflecting expanded marketing, rent, travel, and Middle East partnership-related costs.
R&D expenses: $3,638k vs. $3,045k in Q4 2024, driven by active management of NEO100 trial sites, recruitment for NEO212, initiation of NEO100-3, and overall patient recruitment activity.
Net loss: $62.1 million or $3.20 per diluted share, compared to $11.9 million or $0.69 per diluted share in Q4 2024, primarily due to increased general and administrative expenses, as well as stock-based compensation expenses.

(Press release, Neonc, APR 1, 2026, View Source [SID1234664142])

On April 1, 2026 Pasithea Therapeutics Corp. (NASDAQ: KTTA) ("Pasithea" or the "Company"), a clinical-stage biotechnology company developing PAS-004, a next-generation macrocyclic MEK inhibitor, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to PAS-004 for the treatment of NF1-associated PN causing significant morbidity.

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"We appreciate the FDA’s decision that PAS-004 meets the criteria for Fast Track designation for this indication," said Dr. Tiago Reis Marques, Chief Executive Officer of Pasithea. "The ability to have early and frequent interactions with the FDA supports our goal to expeditiously develop PAS-004 for patients with NF1-associated PN causing significant morbidity."

Fast Track designation includes the following opportunities to facilitate Fast Track product development:

Frequent communications with the FDA review team throughout the product development process

Rolling Review, which allows portions of a marketing application to be reviewed and assessed by the FDA before the company submits the complete application

In addition, a Fast Track designation product may potentially be eligible for accelerated approval and/or priority review if relevant criteria are met. For more information, see the FDA’s website at
View Source

The Company is currently conducting a Phase 1/1b multicenter, open-label, dose escalation trial of PAS-004 in adult participants with symptomatic, inoperable, incompletely resected, or recurrent NF1-PN (NCT06961565).

About NF1- PN

Plexiform neurofibromas (PN) are tumors originating from the nerve sheath that grow through and around nerves and may involve multiple nerve branches. Thirty to fifty percent (30-50%) of patients with NF1 will harbor PNs, which can undergo malignant transformation. PN-related morbidities are primarily caused by the direct impact of the tumor on surrounding structures and can be life-threatening when they compress vital organs or when they become malignant.

(Press release, Pasithea Therapeutics, APR 1, 2026, View Source [SID1234664127])

On April 1, 2026 Senti Biosciences, Inc. (Nasdaq: SNTI) ("Senti Bio"), a clinical-stage biotechnology company developing next-generation cell and gene therapies using its proprietary Gene Circuit platform, reported the publication of new peer-reviewed research in Cell Systems demonstrating its systematic framework for engineering NOT-gated chimeric antigen receptor (CAR) circuits in both T cells and natural killer (NK) cells. The study demonstrates how Logic-Gated receptor designs can significantly improve the efficacy, precision, and safety of cell therapies by enabling immune cells to selectively eliminate tumor cells while sparing healthy tissue. This foundational paper complements Senti’s recent announcements on positive clinical data with its Logic-Gated SENTI-202 product in the treatment of relapsed/refractory Acute Myeloid Leukemia presented at the 2025 American Society for Hematology Annual Meeting.

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The paper, titled "NOT-gated Chimeric Antigen Receptor Circuits in T and NK Cells," presents a comprehensive evaluation of dual-receptor CAR circuits that integrate an activating CAR (for cancer killing) with an inhibitory CAR (for healthy cell protection). By quantitatively analyzing more than 60 CAR circuit designs, the study defines core design principles that govern activation strength, inhibition dynamics, antigen dose response and functional durability across immune cell types.

"This study highlights the power of synthetic biology to introduce decision-making into living medicines," said Tim Lu, M.D., Ph.D., Chief Executive Officer and Co-Founder of Senti Biosciences. "By systematically dissecting the interaction between activating and inhibitory CARs, we provide a roadmap for building immune cells that are both effective and precise."

The study identifies inhibitory CARs based on the LIR1 receptor as particularly potent regulators of immune cell activity, outperforming several canonical immune checkpoint receptors. In T cells, optimized NOT-gated CAR circuits not only improved discrimination between tumor and healthy cells but also reduced markers of cellular exhaustion and preserved cytotoxic killing of cancer cells following repeated antigen exposure. These findings suggest that inhibitory CAR signaling can provide benefits beyond target specificity, potentially improving the durability of therapeutic responses.

"These results show that inhibitory CARs have very interesting and underappreciated properties that can improve the performance of immune cell therapies," said Wilson Wong, Ph.D., Professor of Biomedical Engineering at Boston University, and Scientific Co-Founder of Senti.

Importantly, the authors demonstrate that many NOT-gated CAR designs exhibited high performance in both T cells and NK cells. In an in vivo mixed-cell xenograft model, NOT-gated CAR T cells and CAR NK cells selectively eliminated tumor cells while sparing off-tumor cells expressing protective antigens. These results highlight the portability of logic-gated CAR circuits across ex vivo and in vivo CAR modalities, and their potential to treat cancers where clean tumor-specific targets are unavailable.

The findings further support the applicability of Senti Biosciences’ Gene Circuit platform to cell and gene therapy, which is designed to program cells with logic-based control over therapeutic activities. NOT-gated CAR circuits represent a foundational approach for enhancing safety and expanding the therapeutic window of engineered immune cells in cancer and other diseases. A patent application has been filed covering aspects of the technology described in the study.

The full article is now available online in Cell Systems.

(Press release, Senti Biosciences, APR 1, 2026, View Source [SID1234664143])