Orca Biosystems, Inc.

Orca will use the money to scale up for commercialization. Orca Bio has disclosed $250 million in funding, flooding its balance sheet with cash to buoy preparations for the commercialization of a blood cancer cell therapy.California-based Orca filed for FDA approval of its allogeneic T-cell immunotherapy Orca-T last year. Using purified donor regulatory T cells, Orca-T is designed to prevent graft-versus-host disease (GvHD) with less immunosuppression than is required for conventional allogeneic hematopoietic stem cell transplantation (alloHSCT). The FDA is set to decide by April 6 whether to approve the drug candidate as a treatment for hematological malignancies, including acute myeloid leukemia, acute lymphoblastic leukemia and myelodysplastic syndromes.Orca has been gearing up for commercialization in anticipation of approval. Friday, the biotech said it has raised $250 million across two rounds, including a series F financing that closed last month, and that it secured up to $100 million in credit from Silicon Valley Bank. An Orca spokesperson said the capital raised was comparable between the two rounds. The previously undisclosed series E round completed in 2024, the spokesperson said.Orca disclosed its $192 million series D round in a Securities and Exchange Commission filing in 2020, but no entries appear for the two subsequent rounds. Orca will use the money to scale up for commercialization, including by adding manufacturing capacity on the East Coast to complement its existing operations in California. The biotech put Steve Gavel in charge of commercial activities in June. However, Gavel, who worked on the Carvykti launch at Legend Biotech, lasted just a few months at Orca before joining Cabaletta Bio in October. Mike Hirschmann, who joined Orca as senior vice president of U.S. commercial, stepped up to the chief commercial officer role when Gavel departed. Like Gavel, Hirschmann worked at Legend before joining Orca. If Orca-T wins approval, the commercial team will need to persuade physicians to use the product over existing methods for preventing GvHD. A phase 3 trial linked Orca-T to significantly better survival free from moderate-to-severe chronic GvHD in patients with hematological malignancies than conventional alloHSCT with tacrolimus and methotrexate. The combination of tacrolimus and methotrexate is one way physicians try to prevent GvHD in these patients.Other trials found that antithymocyte globulin (ATG) and cyclophosphamide (PTCy) are better at preventing GvHD than tacrolimus and methotrexate. A retrospective analysis of patients in a phase 1b trial of Orca-T yielded evidence that the therapy may have advantages over PTCy. Yet the researchers who wrote up Orca’s phase 3 data said a randomized trial versus PTCy or ATG may be needed to reach a definitive conclusion. 

Orca Bio has pulled together $250 million in new financing for the commercial launch of its treatment for complications from allogeneic stem cell transplants. The money comes in part from two of Orca’s most recent financing rounds — a Series E and a Series F — which together totaled $250 million, a company spokesperson told Endpoints News in an email. That’s on top of up to $100 million in additional liquidity that Orca secured last year in a tweak to its credit facility with Silicon Valley Bank, according to a Friday release . The funds will help Orca prepare for the launch of Orca-T, an allogeneic T cell therapy that’s under FDA review for patients with certain types of blood cancer who are getting a stem cell transplant from a donor. The agency is expected to make a decision by April 6. Orca said it plans to add manufacturing capacity on the East Coast to back up its current operations in Sacramento, CA. In a Phase 3 trial that enrolled patients with various blood cancers who were getting a stem cell transplant, 78% of those who received Orca-T on top of a standard immunosuppressive agent called tacrolimus were free of moderate-to-severe chronic graft-versus-host disease, compared with 38% of those who received tacrolimus and methotrexate. Error: Survey not found. Graft-versus-host disease can cause the body to attack the cells from a stem cell transplant, causing complications. Editor’s note: This story has been corrected to reflect the amount of money Orca raised in its recent rounds.

Novartis picks its next US radioligand siteNovartis will build a new radioligand therapy (RLT) manufacturing facility in Winter Park, Florida, expanding its US footprint as part of a broader $23-billion investment in the country announced last April.The site, expected to come online by 2029, will become the company's fourth US-based RLT plant, joining existing facilities in Indiana, New Jersey as well as California, which was completed just last November. A fifth RLT manufacturing site is also planned.The Florida location is designed to improve delivery of the highly time-sensitive cancer treatments to patients across the southeastern portion of the country, supporting Novartis' efforts to maintain a "steady rate of >99% of doses administered on the planned day."Novartis' RLT portfolio consists of Pluvicto (lutetium Lu 177 vipivotide tetraxetan) for PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) and Lutathera (lutetium Lu 177 dotatate) for certain neuroendocrine tumours.Orca Bio nets $250M ahead of FDA cell therapy verdictOrca Bio said it secured $250 million in new financing as it gears up for a potential commercial launch of its lead cell therapy, Orca-T, dependent on an FDA decision in a few months.The funding includes a series F round closed in December led by Lightspeed Venture Partners and follows additional recent financings, along with an amendment to the company's Silicon Valley Bank credit facility that provides up to $100 million in extra liquidity.The California-based biotech plans to use the capital to prepare for commercial readiness, including adding East Coast manufacturing capacity to complement its existing Sacramento operations, as it prepares for the April 6 PDUFA date for Orca-T, an investigational allogeneic T-cell therapy for blood cancers.Meanwhile, Orca Bio is pushing ahead with other programmes in its pipeline. It launched a new Phase II trial, called SERENE-T, evaluating Orca-T in patients with acute myeloid leukaemia and myelodysplastic syndromes receiving reduced-intensity or nonmyeloablative conditioning, and has also begun enrolling additional cohorts in an expanded Phase Ib study of its second-generation allogeneic T-cell immunotherapy, Orca-Q.MEDIPOST aims for US market with stem cell therapySouth Korean biotech MEDIPOST closed a $140-million financing round to support a Phase III study in the US for its mesenchymal stem cell (MSC) therapy to treat symptomatic cartilage defects in patients with knee osteoarthritis. The funding was led by Skylake Equity Partners and Crescendo Equity Partners, with participation from Korea's leading growth equity fund.MEDIPOST's Cartistem — which comprises allogeneic umbilical cord blood-derived MSCs — has been approved in the company's domestic market since 2012. In the US, the firm has finished Phase I/IIa testing and plans to start a late-stage study early this year.The new funds will be used to expand scientific and operational capabilities, build infrastructure and scale manufacturing processes.a16z's Bio + Health refreshes with $700MThe venture capital firm a16z said Friday it has raised $700 million to invest in biotech and healthtech companies.The raise comes about a year after the VC's Bio + Health unit teamed up with Eli Lilly to launch the Biotech Ecosystem Venture Fund with $500 million to tackle healthcare's "complex challenges." In 2025, a16z backed biotech firms including Cartography Biosciences and Gate Bioscience, and began 2026 by investing in AI-powered drug development startup Boltz Lab. The financing — which, across all of a16z's funds, reached $15 billion — is intended to help the US retain its top spot as the global technology leader in a landscape that is "intensely competitive with China," a concern flagged by US security leaders in December. For related analysis, see Vital Signs: Charting China's course westward into 2026.Matthew Dennis and Elizabeth Eaton contributed to this report.