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Precision BioSciences Receives $7.5M in Proceeds from TG Therapeutics for Azer-cel Clinical Milestone in Multiple Sclerosis

On March 2, 2026 Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage gene editing company utilizing its novel proprietary ARCUS platform to develop in vivo gene editing therapies for high unmet need diseases, reported the achievement of a clinical milestone under its license agreement with TG Therapeutics, Inc. (Nasdaq: TGTX). The milestone payment for azercabtagene zapreleucel (azer-cel) was triggered by progress of a Phase 1 clinical trial of azer-cel in progressive forms of multiple sclerosis (MS). As a result of this milestone event, Precision will receive $7.5 million in proceeds, inclusive of $5.25 million cash and $2.25 million for the purchase of 201,504 shares of Precision common stock by TG Therapeutics at $11.17 per share, pursuant to the terms of the companies’ license agreement. Existing cash and cash equivalents, inclusive of the azer-cel milestone proceeds, continued fiscal and operating discipline, and availability of the ATM facility, are expected to provide sufficient cash runway through 2028.

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"We are pleased with TG Therapeutics’ continued advancement of azer-cel in progressive multiple sclerosis and with the achievement of this clinical milestone," said Michael Amoroso, President and Chief Executive Officer of Precision BioSciences. "Their clinical progress reflects the potential of azer-cel in autoimmune diseases such as multiple sclerosis and underscores the value of our strategic partnering approach. Importantly, it also highlights the additive value of our partnered programs as we enter a catalyst-rich 2026, with multiple potential data and development milestones complementing progress across our wholly-owned in vivo gene editing pipeline."

In January 2024, Precision BioSciences announced a licensing deal, granting TG Therapeutics exclusive worldwide rights to develop and commercialize azer-cel in autoimmune diseases and other non-oncology indications. Under the agreement, Precision received upfront and potential near-term economics and remains eligible for additional development, regulatory, and commercial milestone payments, as well as royalties on net sales. Precision is eligible to receive up to $288 million in additional milestone payments as well as high-single-digit to low-double-digit royalties on net sales.

(Press release, Precision Biosciences, MAR 2, 2026, View Source [SID1234663182])

Orca Bio to Present Clinical Data on Its Pipeline of High-Precision Cell Therapies at the 52nd Annual Meeting of the EBMT

On March 2, 2026 Orca Bio, a late-stage biotechnology company committed to transforming the lives of patients through high-precision cell therapy, reported that clinical data will be presented in seven oral and poster sessions at the 52nd Annual Meeting of the EBMT from March 22-25 in Madrid.

The encore presentations will include data on the company’s pipeline of investigational allogeneic T-cell immunotherapies for the treatment of multiple hematologic malignancies, including Orca-T and Orca-Q.

"Our participation at this year’s meeting of the EBMT provides an important opportunity to engage directly with the global transplant community as we continue our shared efforts to advance the field of allogeneic stem cell transplant," said Nate Fernhoff, Ph.D., co-founder and chief executive officer of Orca Bio. "As we progress toward the potential FDA approval of Orca-T, the strength and consistency of our data reinforce our commitment to delivering a new therapy for patients with blood cancer. We look forward to being in Madrid to connect with clinicians and partners from around the world and to participate in scientific exchange focused on improving patient outcomes."

The EBMT abstracts are now available at www.ebmt.org/annual-meeting-2026. Details of the Orca Bio presentations follow:

Oral Session: OS14 | Graft Manipulation and Conditioning

Title: Orca-T Demonstrates Favorable Quality of Life and Healthcare Resource Use Compared to Standard AlloHSCT plus Tac/MTX for GVHD Prevention in a Randomized Phase 3 Clinical Trial (Precision-T)

Date and Time: Wednesday, March 25 at 08:30 AM – 08:39 AM CET

Location: N107

Oral Session: OS14 | Graft Manipulation and Conditioning

Title: Clinical Outcomes in Orca-T and Registry-Based Post-Transplant Cyclophosphamide Patients: An Observational Comparison

Date and Time: Wednesday, March 25 at 08:39 AM – 08:48 AM CET

Location: N107

Oral Session: OS12 | Acute GVHD – Clinical

Title: Cost-Effectiveness of Orca-T vs Allo-HCT with Conventional GVHD Prophylaxis for the Treatment of Advanced Hematologic Malignancies in the United States

Date and Time: Tuesday, March 24 at 2:39 PM – 2:48 PM CET

Location: N101-102

Poster Session: A

Title: Interim Clinical Outcomes in Orca-T with Reduced Intensity Conditioning: An Observational Comparison to Registry-Based Post-Transplant Cyclophosphamide Patients

Presentation ID: A038

Date and Time: Monday, March 23 at 6:00 PM – 7:00 PM CET

Location: Pavilion 9

Poster Session: A

Title: Scalable Manufacturing and Nationwide Distribution of Orca-T: A Precision-Engineered Allogeneic Immune Cell Therapy

Presentation ID: A145

Date and Time: Monday, March 23 at 6:00 PM – 7:00 PM CET

Location: Pavilion 9

Poster Session: A

Title: Preliminary Safety and Efficacy of Myeloablative Orca-Q in Patients with Haploidentical Donors

Presentation ID: A043

Date and Time: Monday, March 23 at 6:00 PM – 7:00 PM CET

Location: Pavilion 9

Poster Session: A

Title: Clinical Outcomes in Myelodysplastic Syndrome Patients Treated with Orca-T or Post-Transplant Cyclophosphamide Patients: A Registry-Based Comparison

Presentation ID: A085

Date and Time: Monday, March 23 at 6:00 PM – 7:00 PM CET

Location: Pavilion 9

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 regulatory T-cells, hematopoietic stem 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). The Biologics License Application (BLA) for Orca-T is currently under Priority Review with the FDA with a Prescription Drug User Fee Act (PDUFA) target action date of April 6, 2026.

About Orca-Q
Orca-Q is Orca Bio’s second-generation investigational allogeneic T-cell immunotherapy being evaluated in clinical trials for the treatment of multiple hematologic malignancies, including in patients with haploidentical and mismatched donors. Orca-Q is a proprietary composition of stem cells combined with specific T-cell subsets derived from healthy donors and engineered by Orca Bio’s high-precision platform.

(Press release, Orca Bio, MAR 2, 2026, View Source;utm_medium=rss&utm_campaign=orca-bio-to-present-clinical-data-on-its-pipeline-of-high-precision-cell-therapies-at-the-52nd-annual-meeting-of-the-ebmt [SID1234663181])

Oncolytics Biotech® Launches Randomized Colorectal Cancer Study

On March 2, 2026 Oncolytics Biotech Inc. (Nasdaq: ONCY) ("Oncolytics" or the "Company"), a clinical-stage immunotherapy company developing pelareorep, reported the initiation of a metastatic colorectal cancer ("mCRC") Phase 2 study that will be referred to as REO 033.

In this trial, second-line ("2L") RAS-mutated (which includes KRAS), microsatellite-stable ("MSS") mCRC patients will be randomized to a control arm of bevacizumab (Avastin) and fluorouracil, leucovorin, irinotecan ("FOLFIRI") or an experimental arm of pelareorep, bevacizumab, and FOLFIRI. The study is powered for statistical significance, with each study arm expected to enroll 30 patients. All participants will have failed their initial treatment with platinum-based chemotherapy. The primary endpoint of the study is objective response rate ("ORR"), with progression-free survival ("PFS"), overall survival ("OS"), safety, and biomarker analysis as other endpoints. The trial will be sponsored by Oncolytics with Sanjay Goel, M.D., M.S., FASCO, Professor of Medicine at Rutgers Cancer Institute of New Jersey, as the Lead Investigator. The Company is expecting to initiate the first study site later this month and provide preliminary data by year-end.

"I am honored to lead this study as I have a long track record working with pelareorep and have witnessed its ability to improve patient outcomes in a meaningful way," said Dr. Goel. "The colorectal cancer data we recorded in the REO 022 study continues to be compelling to this day, as evidenced by the Fast Track Designation, and I hope we can generate additional exciting data in this new trial to support registration."

The previous REO 022 clinical study of pelareorep, bevacizumab, and FOLFIRI in this population demonstrated a median OS of 27 months and a median PFS of 16.6 months, both of which substantially exceed the median 11.2- and 5.7-month OS and PFS, respectively, observed for standard-of-care therapy. Similarly, ORR in the same study was 33% for pelareorep-containing therapy compared to approximately 10% for standard-of-care treatment.1-2 Last month, the Company announced that pelareorep in combination with bevacizumab and FOLFIRI was granted Fast Track Designation by the U.S. Food & Drug Administration in 2L KRAS-mutant, MSS mCRC.

"The potential to improve clinical outcomes compared to the standard-of-care in the second-line setting would have the potential to benefit patients around the world who are affected by colorectal cancer," 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, and member of the Oncolytics Biotech Gastrointestinal Scientific Advisory Board. "An immunotherapy with the potential to improve outcomes would improve treatment options in colorectal cancer and would be highly welcomed, especially as we are seeing more and more younger patients being diagnosed with colorectal cancer."

(Press release, Oncolytics Biotech, MAR 2, 2026, View Source [SID1234663180])

Lantheus Receives FDA Tentative Approval for Lutetium Lu 177 Dotatate (PNT2003), Radioequivalent to LUTATHERA®

On March 2, 2026 Lantheus Holdings, Inc. ("Lantheus" or the "Company") (NASDAQ: LNTH), the leading radiopharmaceutical-focused company committed to enabling clinicians to Find, Fight and Follow disease to deliver better patient outcomes, reported that it has received U.S. Food and Drug Administration (FDA) tentative approval for the Abbreviated New Drug Application (ANDA) for Lutetium Lu 177 Dotatate (PNT2003), a radioequivalent1 version of LUTATHERA (lutetium Lu 177 dotatate). LUTATHERA is indicated for the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors.

"As the first radioequivalent to LUTATHERA to receive FDA tentative approval, PNT2003 marks an important step forward in Lantheus’ work to advance treatment options for patients with GEP-NETs. This milestone comes at a time when advances in imaging and evolving clinical guidelines are enabling the identification of more patients who stand to benefit from targeted radiopharmaceutical therapies. As the leading radiopharmaceutical-focused company, we remain committed to meeting this growing demand and look forward to making PNT2003 available to patients pending final FDA approval," said Mary Anne Heino, Chief Executive Officer of Lantheus.

The FDA tentative approval indicates that the FDA has completed its review of the ANDA and that it meets the requirements for approval under the Federal Food, Drug and Cosmetics Act. Full approval of the ANDA is subject to the expiration of the 30-month stay in June 2026, triggered in connection with a Hatch-Waxman patent litigation.

Lantheus licensed exclusive worldwide rights (excluding certain territories) to PNT2003 from POINT Biopharma Global, Inc. in December 2022. To read the press release announcing that licensing transaction, please click here. POINT was acquired by Eli Lilly and Company in December 2023.

About GEP-NETs
Neuroendocrine tumors (NETs) are rare, often slow-growing cancers that can develop throughout the body. A subset known as gastroenteropancreatic NETs (GEP-NETs) affects the digestive system and pancreas and may be functional or non-functional depending on hormone activity.2 Over the last few decades, the incidence of GEP-NETs has increased significantly, with the prevalence in the U.S. estimated to be approximately 200,000 patients.3 Because GEP-NETs often grow slowly and cause non-specific symptoms, up to 50% are initially misdiagnosed, with patients waiting an average of 4.3 years from symptom onset to diagnosis.

(Press release, Lantheus, MAR 2, 2026, View Source [SID1234663179])

Kairos Pharma Announces Signing of Binding Strategic Asset Acquisition of Exclusive Worldwide Rights to CL-273 From OrbiMed and Torrey Pines Investment-Backed Celyn Therapeutics

On March 2, 2026 Kairos Pharma, Ltd. (NYSE American: KAPA), a clinical-stage biopharmaceutical company focused on innovative cancer therapeutics, reported that it has entered into binding terms to acquire CL-273 from Celyn Therapeutics, Inc., a company backed by OrbiMed and Torrey Pines Investment.

John Yu, M.D., Kairos Pharma Chief Executive Officer, commented: "The signing of binding terms to acquire CL-273 represents a pivotal step in building Kairos Pharma’s next generation of targeted therapies for EGFR-mutant lung cancer. This transaction is expected to be value-accretive. CL-273’s AI-designed, wild-type-sparing pan-EGFR profile positions it as a potentially best-in-class asset in a large, fast-growing $16.2 billion lung cancer market with significant unmet needs due to the development of resistance. Given its prestigious backing, we believe partnering with Celyn Therapeutics offers additional high-quality science to our existing pipeline. We believe in the rigor of the data package supporting CL-273. We further believe that together with an OrbiMed-backed innovator, Kairos Pharma is strongly positioned to deliver a highly differentiated, potentially best-in-class, EGFR inhibitor to patients worldwide."

CL-273 is an investigational, reversible, wild-type-sparing pan-EGFR small-molecule inhibitor discovered using a proprietary AI-driven drug discovery platform backed by OrbiMed and other leading healthcare investors. This unique drug targets the resistant mutations that develop when using EGFR tyrosine kinase inhibitors, thereby reversing resistance. Specifically engineered for EGFR-mutant type of lung cancer (NSCLC), the EGFR-mutated lung cancer treatment market is estimated at $16.2 billion in 2026 (Future Market Insights). EGFR mutations are present in approximately 10–15% of NSCLC cases in Western populations and up to 50% in Asian populations (CoherentMI), creating a substantial addressable patient population worldwide.

Celyn Therapeutics brings deep domain expertise in small-molecule oncology drug development. Kairos Phama believes that OrbiMed’s support of Celyn underscores the quality of CL-273’s discovery and this transaction is expected to align the Company with OrbiMed’s longstanding track record in building category-defining oncology companies. By acquiring CL-273, Kairos aims to accelerate the development of a next-generation, AI-designed EGFR inhibitor for patients with EGFR-mutant NSCLC worldwide.

D. Boral Capital, LLC acted as the sole financial advisor.

(Press release, Kairos Pharma, MAR 2, 2026, View Source [SID1234663178])