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Pierre Fabre Pharmaceuticals Announces Type A Meeting Agreed with U.S. Food and Drug Administration (FDA) for Tabelecleucel Biologic License Application (BLA)

On March 12, 2026 Pierre Fabre Pharmaceuticals, Inc., reported that the U.S. Food and Drug Administration (FDA) has agreed to Type A meeting for the biologic license application for tabelecleucel, an allogeneic T-cell therapy with a proposed indication for relapsed/refractory (R/R) Epstein-Barr Virus Positive Post-Transplant Lymphoproliferative Disease (EBV+ PTLD).

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"We look forward to a collaborative and productive discussion with the FDA on a timely path forward to achieving accelerated approval of tabelecleucel in R/R EBV+ PTLD, an acute disease with no FDA-approved treatment options," said Adriana Herrera, Chief Executive Officer of Pierre Fabre Pharmaceuticals Inc., the Pierre Fabre Laboratories pharmaceutical subsidiary in the United States. "It is essential to agree upon a timely approach to resubmission as the lifespan of patients with R/R EBV+ PTLD in the U.S. is often measured in weeks to months following failure of standard treatment."

The meeting will address the Complete Response Letter received by PFP from the agency on January 9, 2026. The company anticipates providing a regulatory update on the outcome of the meeting in the second quarter.

(Press release, Pierre Fabre, MAR 12, 2026, View Source [SID1234663517])

Whitehawk Therapeutics Reports Fourth Quarter and Full-Year 2025 Financial Results and Recent Highlights

On March 12, 2026 Whitehawk Therapeutics, Inc. (Nasdaq: WHWK), a clinical-stage oncology therapeutics company applying advanced technologies to established tumor biology to efficiently deliver improved antibody drug conjugate (ADC) cancer treatments, reported financial results for the fourth quarter and full-year ended December 31, 2025, and provided recent corporate highlights.

"Last year marked our evolution into Whitehawk Therapeutics, a boldly pragmatic company developing the next generation of ADC cancer treatments. We progressed three programs through IND-enabling work in tandem, while building the capabilities required to execute efficiently in the clinic as we enter 2026," said Dave Lennon, PhD, President and CEO of Whitehawk Therapeutics. "Whitehawk combines established but underexploited tumor targets with a differentiated ADC platform. With two active Phase 1 studies for HWK-007 and HWK-016, and a third IND submission for HWK-206 planned mid-year, we are energized by the opportunity to translate our strategy into clinical data with the potential to have a meaningful impact for patients."

Q4 2025 and Recent Operational Highlights:

Advanced development of PTK7-targeted HWK-007 and MUC16-targeted HWK-016 into Phase 1. In January, Whitehawk announced regulatory progress for these programs, which are both now actively recruiting Phase 1 trials.
The HWK-007 Phase 1 trial will initially evaluate activity in lung and ovarian cancers, two PTK7-expressing tumor types with established precedent data, as well as endometrial cancer, one of the highest PTK7-expressing tumor types.
The HWK-016 Phase 1 trial will initially evaluate activity in two high MUC16-expressing gynecologic cancers, ovarian and endometrial.

Strengthened management with new CMO. In December 2025, Whitehawk appointed Margaret Dugan, MD, as Chief Medical Officer (CMO). Dr. Dugan brings more than 30 years of global oncology drug development experience, with extensive expertise in early-stage clinical development and regulatory strategy.

Presented real-world analysis confirming PTK7 as a broadly expressed, clinically relevant target across solid tumors. Whitehawk presented data at the AACR (Free AACR Whitepaper)-NCI-EORTC meeting that established PTK7 as the third most highly expressed tumor marker among clinically validated and emerging ADC targets, present in ~70% of tumors. We believe these findings support the potential of PTK7 as a pan-tumor target.
Fourth Quarter and Full Year 2025 Financial Results:

Cash, cash equivalents and short-term investments as of December 31, 2025, were $145.7 million as compared to $47.2 million as of December 31, 2024. Cash is anticipated to fund operations into 2028 based on current plans.

Net loss for the three months ended December 31, 2025, was $23.3 million as compared to $18.3 million for the three months ended December 31, 2024. Net loss for the full-year ended December 31, 2025, was $20.6 million, as compared to $63.7 million for the same period in 2024. The full-year net loss includes an $87.3 million gain on the divestiture of AADI Subsidiary.
Anticipated Milestones:

Preclinical data – expect to present preclinical data across the portfolio at an upcoming medical congress in Spring 2026.

HWK-206 – plan to submit an Investigational New Drug application to the U.S. Food and Drug Administration in mid-2026 for HWK-206 in small-cell lung cancer and neuroendocrine tumors; Phase 1 recruitment planned to start in Q3 2026.

HWK-007 and HWK-016 – ongoing recruitment into Phase 1 trials, with initial results expected in 1H 2027.

(Press release, Whitehawk Therapeutics, MAR 12, 2026, View Source [SID1234663516])

Earendil Labs and WuXi Biologics Enter Strategic Collaboration to Accelerate Development and Manufacturing of Bispecific/Multispecific Antibodies and ADCs

On March 12, 2026 Earendil Labs, a global leader in AI-driven research and development of next-generation biologics therapeutics, and WuXi Biologics (2269.HK), a global leading Contract Research, Development and Manufacturing Organization (CRDMO), reported the signing of a strategic collaboration agreement on the development and manufacturing of multiple novel bispecific and multispecific antibodies and ADC candidates in Earendil Labs’ pipeline targeting autoimmune disease, cancer, and other diseases.

Under the agreement, WuXi Biologics will provide end-to-end biologics development and manufacturing services, including cell line development, process and bioassay development, drug product formulation development, and GMP manufacturing. The collaboration is designed to accelerate regulatory timelines, enhance CMC execution reliability, and support scalable global clinical development across Earendil Labs’ programs.

WuXi Biologics has built a strong track record in developing complex biologics, particularly its technology strengths in bispecific and multispecific antibodies and ADCs. By 2025, a total of 945 projects were advancing on the company’s integrated CRDMO platform, with bispecific and multispecific antibodies representing one of the fastest‑expanding categories. Leveraging next‑generation technology platforms such as the WuXia TrueSite targeted‑integration CHO cell line platform and the WuXiHigh high‑throughput formulation platform—together with expanded capabilities for high‑dose and subcutaneous delivery, including the Hyaluronidase Co‑Formulation platform and large‑volume device solutions—the company provides development pathways designed to increase efficiency, strengthen product consistency, and enable seamless scale‑up from early research through commercial manufacturing.

Jian Peng, PhD, CEO of Earendil Labs, said: "Partnering with WuXi Biologics enables us to advance our pipeline with greater speed, precision, and CMC excellence. By integrating Earendil Labs’ AI-driven protein‑engineering capabilities with WuXi Biologics’ deep expertise in complex biologics as well as its proven end‑to‑end development and manufacturing capabilities, we can more efficiently advance our pipeline toward clinical milestones to deliver meaningful clinical benefit and transform patient treatment."

Zhenping Zhu, MD, PhD, President & co-CEO of Earendil Labs, added: "Earendil Labs has built a robust and highly competitive pipeline within the past three years. This partnership with WuXi Biologics strengthens our ability to translate AI-driven innovation into high-quality clinical and commercial assets. WuXi Biologics’ proven expertise in complex biologics and global development makes them a strong strategic partner as we build a differentiated, multi-asset therapeutic pipeline for the treatment of various human diseases."

Chris Chen, PhD, CEO of WuXi Biologics, commented, "We are delighted to enter this strategic collaboration with Earendil Labs, a company distinguished by its strong scientific leadership and innovative approach to advancing next‑generation immunotherapies. By leveraging our proven expertise across complex biologics—including bispecific and multispecific antibodies as well as ADCs—and our industry‑leading technology platforms across drug research, development and manufacturing, we aim to accelerate the advancement of Earendil Labs’ innovative pipeline. Through this collaboration, we are poised to accelerate development, ensure robust and scalable manufacturing, and ultimately bring transformative therapies to patients worldwide."

(Press release, Earendil Labs, MAR 12, 2026, View Source [SID1234663515])

Aminex Therapeutics Receives Second FDA Orphan Drug Designation for AMXT 1501 for Malignant Glioma Including DIPG – a Highly Aggressive Childhood Brain Cancer

On March 12, 2026 Aminex Therapeutics, Inc., a clinical-stage biotechnology company focused on developing a novel metabolic-targeted therapy to treat adult and pediatric cancers, reported that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to AMXT 1501 in combination with difluoromethylornithine (DFMO) for the treatment of malignant glioma, including diffuse intrinsic pontine glioma (DIPG). This is the company’s second Orphan Drug Designation, following the ODD granted in October 2025 for neuroblastoma.

"This second Orphan Drug Designation is a powerful validation of AMXT 1501’s potential to make a meaningful difference for patients facing some of the most devastating cancers," said Mark Burns, PhD, Chief Scientific Officer and President of Aminex Therapeutics. "DIPG is heartbreaking — children diagnosed with this brain tumor have virtually no effective treatment options and very little time. We are committed to changing that."

DIPG is an aggressive brainstem tumor that primarily strikes children aged 5 to 10, with a median survival of less than 12 months from diagnosis. There is currently no cure.

For Families of Children with DIPG and Other High-Risk Cancers: A Trial Is Now Enrolling

The Beat Childhood Cancer Research Consortium at Penn State College of Medicine, in partnership with Aminex, is actively enrolling patients in a national Phase 1/2 clinical trial of AMXT 1501 plus DFMO in pediatric patients with DIPG, neuroblastoma, sarcomas and other high-risk childhood cancers. The trial is planned to open at 50 clinics nationwide and enroll patients. For more information, visit ClinicalTrials.gov (NCT06465199) to learn more.

AMXT 1501 is also being evaluated in adults with solid tumors including breast cancer and metastatic melanoma in an active Phase 1b/2 multicenter trial (NCT07287917.)

The FDA’s Orphan Drug Designation provides Aminex with development incentives including tax credits, fee waivers, and seven years of market exclusivity upon potential approval.

(Press release, Aminex Therapeutics, MAR 12, 2026, View Source;a-highly-aggressive-childhood-brain-cancer-302711779.html [SID1234663514])

Plus Therapeutics Reports 2025 Results, Business Progress and 2026 Anticipated Milestones for REYOBIQ™ Clinical Program and CNSide® Commercial Rollout

On March 12, 2026 Plus Therapeutics, Inc. (Nasdaq: PSTV) ("Plus" or the "Company"), a healthcare company developing and commercializing precision diagnostics and radiopharmaceuticals for central nervous system (CNS) cancers, reported financial results for the fourth quarter and year ended December 31, 2025 and provides an overview of recent and upcoming business highlights.

"Our team remains highly focused on achieving our 2026 targets," said Marc H. Hedrick, M.D., Plus Therapeutics President and Chief Executive Officer. "Specifically, our top priority goals are CNSide commercial scale-up and REYOBIQ pivotal trial readiness; we also are looking aggressively for ways to over achieve where possible."

Q4 2025 AND RECENT HIGHLIGHTS

Corporate

Completed an upsized public offering generating $15 million in gross proceeds, extending the Company’s projected cash runway and supporting CNSide commercialization and advancement of two ongoing Phase 2 clinical programs
REYOBIQ Development

Secured American Medical Association Category III CPT reimbursement code for convection-enhanced delivery with REYOBIQ, unlocking market access and growth potential of REYOBIQ therapy in recurrent glioblastoma and pediatric brain cancer
Incorporating constructive Type B meeting feedback from the FDA to help accelerate clinical development timelines and facilitate submission of application for the approval of REYOBIQ for patients with leptomeningeal metastases (LM)
Highlighted three REYOBIQ clinical data presentations at the World Federation of Neuro-Oncology Societies/Society for Neuro-Oncology (WFNOS/SNO), building upon body of real world clinical experience with REYOBIQ in both primary and metastatic CNS cancers that continue to show promising safety profile and signs of efficacy
CNSide CSF Assay Platform

Expanded CNSide laboratory licensing to 49 of 50 U.S. states, having recently added Pennsylvania and California; enables access to CNSide Tumor Cell Enumeration (TCE) test to approximately 95% of the U.S. population
Continued to expand the CNSide Diagnostics team to support national test adoption
Announced second of planned national coverage agreements with Humana effective October 29, 2025. Combined with UnitedHealthcare national coverage agreement, CNSide CSF laboratory test policy coverage now reaches approximately 67 million people throughout the U.S.
Full Year 2025 FINANCIAL RESULTS

The Company’s cash and investments balance was $13.1 million on December 31, 2025 compared to $3.6 million on December 31, 2024
Recognized $5.2 million in grant revenue in the year ending December 31, 2025 and $5.8 million for the year ending December 31, 2024, which in both periods represents CPRIT’s share of the costs incurred for the advancement of our REYOBIQ development for the treatment of patients with LM
Total operating loss for the year ending December 31, 2025 was $15.3 million versus $14.7 million for the year ending December 31, 2024, with the increase primarily attributed to expansion of the CNSide operations team
Net loss for the year ending December 31, 2025 was $22.4 million, or $(0.29) per basic share versus $13.0 million, or $(1.95) per basic share, for the year ending December 31, 2024. The change in the net loss for the year ended December 31 was primarily due to change in fair value of derivative instruments from the Q1 2025 financings
Anticipated MILESTONES and OUTLOOK for 2026

REYOBIQ clinical program:

Define optimal dose/interval for REYOBIQ in the ReSPECT-LM Phase 2 trial; anticipate reporting data in Q3 2026
Completing enrollment in the ReSPECT-GBM Phase 2 trial for glioblastoma and conduct an End of Phase meeting with FDA with the goal of aligning on pivotal trial design. Data expected in Q4 2026
Complete commercial manufacturing scale up for REYOBIQ
Begin enrollment in the ReSPECT-PBC pediatric brain cancer Phase 1 trial
The Company expects research and development expenditures to increase in 2026 compared to 2025, due to increased costs for the ReSPECT-LM clinical trial, manufacturing scale up for REYOBIQ commercial and approval trial drug availability, and initial patient enrollments in the ReSPECT-PBC clinical trial, together with expansion of CNSide research and development teams.

CNSide commercial roll out:

Expand U.S. commercial payer coverage to >150 million covered lives
Secure Medicare coverage pathway
Achieve > 1,250 annualized test orders
Launch additional CSF tumor characterization assays to expand the CNSide platform
The Company expects general and administrative expenditures to increase in 2026 as compared to 2025 due to expanded CNSide commercial operations team (including sales, customer service and laboratory operations), such that the goal is for CNSide Diagnostics to breakeven by 2027.

About Leptomeningeal metastases (LM)
Leptomeningeal metastases (LM) are a rare but severe complication of advanced cancer, affecting the fluid-lined structures of the central nervous system. LM occurs in approximately 5% of patients with metastatic cancer, with breast cancer, lung cancer, and melanoma being the most common sources. Median survival is typically 2-6 months, and effective treatment options are limited, highlighting the urgent need for novel therapies.

About REYOBIQ (rhenium Re186 obisbemeda)
REYOBIQ (rhenium Re186 obisbemeda) is a novel injectable radiotherapy specifically formulated to deliver direct targeted high dose radiation in CNS tumors in a safe, effective, and convenient manner to optimize patient outcomes. REYOBIQ has the potential to reduce off target risks and improve outcomes for CNS cancer patients, versus currently approved therapies, with a more targeted and potent radiation dose. Rhenium-186 is an ideal radioisotope for CNS therapeutic applications due to its short half-life, beta energy for destroying cancerous tissue, and gamma energy for real-time imaging. REYOBIQ is being evaluated for the treatment of recurrent glioblastoma, leptomeningeal metastases, and pediatric brain cancer in the ReSPECT-GBM, ReSPECT-LM, and ReSPECT-PBC clinical trials. ReSPECT-GBM is supported by an award from the National Cancer Institute (NCI), part of the U.S. National Institutes of Health (NIH), and ReSPECT-LM is funded by a three-year $17.6M grant by the Cancer Prevention & Research Institute of Texas (CPRIT). The Company’s ReSPECT-PBC clinical trial for pediatric brain cancer is supported by a $3 million grant from the U.S. Department of Defense’s Peer Reviewed Cancer Research Program.

(Press release, Plus Therapeutics, MAR 12, 2026, View Source [SID1234663512])