Antibody-drug conjugate (ADC)-focused Callio Therapeutics debuted on March 3 with the closing of a $187 million series A financing round based on cancer drug technology and assets in-licensed from Hummingbird Bioscience Pte Ltd.
The U.S. FDA approved 12 drugs in January, falling below the 2024 monthly average of 19. Only three new molecular entities received approval, trailing the yearly average of just over four per month.
The prospect of U.S. tariffs on pharmaceuticals became more than just speculation this week, with President Donald Trump saying those tariffs likely would begin at 25% and climb over the year. His comments came in response to a question at a Feb. 18 news conference that followed the signing of two unrelated executive orders. Asked about the planned rate for tariffs on semiconductors and pharmaceuticals, Trump responded that it would be 25% and higher and it would “go very substantially higher over [the] course of a year.”
Cosette Pharmaceuticals Inc. announced plans to acquire Adelaide, Australia-based Mayne Pharma Pty Ltd. for AU$672 million (US$430 million) to grow its women’s health and dermatology franchise in the U.S. Under terms, Cosette, of Bridgewater, N.J., will acquire 100% of Mayne’s shares at AU$7.40 per share in cash. The price represents a 37% premium to Mayne’s closing share price on Feb. 20. The deal is expected to close in the second quarter of 2025.
Radiance Biopharma Inc. bought its way into the ROR1 antibody-drug conjugate (ADC) space through a potential $1 billion-plus licensing deal, including a $15 million up-front payment, with CSPC Megalith Biopharmaceutical Co. Ltd. for rights to RB-164 (SYS-6005) in the U.S. and select countries.
Kyorin Pharmaceutical Co. Ltd. struck two licensing deals recently, including one with Hyfe Inc. Feb. 25 to develop the world’s potential first prescription digital therapeutic for chronic cough in Japan.
Biomissile Pharmaceuticals Co. Ltd. is developing multispecific antibodies that overcome resistance associated with antibody-drug conjugates via its next-generation natural killer (NK) cell engagers. “ADCs are very efficacious, but they do have a drawback with side effects and resistance, because ultimately ADCs are similar to chemotherapy because you bring toxins to the tumor site,” Biomissile co-founder and CEO Chao Tu told BioWorld.
Dealmaking in the Asia Pacific (APAC) region took off this week, with the latest showcasing Genome & Co.’s licensing deal with Ellipses Pharma Ltd. for GENA-104, a phase I-ready immuno-oncology asset, under undisclosed terms Feb. 11.
Kura Oncology Inc. and Kyowa Kirin Co. Ltd.’s selective oral menin inhibitor, ziftomenib, met the primary endpoints in the phase II registrational Komet-001 trial in patients with relapsed/refractory NPM1-mutant acute myeloid leukemia (AML), and Kura expects to submit its NDA to the U.S. FDA in the second quarter of 2025.
The Biosecure Act may have died with the 118th U.S. Congress, but efforts to stop U.S. government funding of R&D in China are alive and well. Rep. Claudia Tenney, R-N.Y., introduced the Stop Funding our Adversaries Act in the House Feb. 7 to prohibit direct and indirect federal funding of research in China or entities owned by China.
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