Following a May phase II readout and a recent presentation of Tourmaline Bio Inc.’s long-acting anti-IL-6 IgG2 monoclonal antibody, pacibekitug, for atherosclerotic cardiovascular disease (ASCVD), Novartis AG offered $1.4 billion, or $48 per share, to buy the barely 4-year-old company. Previously shelved by Pfizer Inc., which had been developing it for autoimmune disorders, pacibekitug fell into the hands of New York-based Tourmaline through a May 2022 license agreement. In addition to the Tranquility phase II trial in ASCVD, the company’s lead product is also in the phase IIb Spirited trial for thyroid eye disease, a readout for which is expected in early 2026. Read More
The U.S. FDA issued a complete response letter (CRL) for the NDA to privately held Saol Therapeutics Inc.’s rare disease treatment, sodium dichloroacetate (SL-1009), for pyruvate dehydrogenase complex deficiency. The inhibitor of pyruvate dehydrogenase kinases is the only drug in development for treating the rare genetic disorder, according to Cortellis. There are no FDA-approved treatments for the disease. Read More
Countries in the Asia Pacific (APAC) region have an opportunity, or a time-limited “gap,” to become leaders on the global biotechnology stage, panelists at the Bio Asia 2025 conference said in Singapore Sept. 9. Read More
Positive phase I results in small-cell lung cancer (SCLC) from Ideaya Biosciences Inc. and partner Hengrui Pharmaceuticals Co. Ltd. with IDE-849, a potentially first-in-class antibody-drug conjugate targeting delta-like ligand 3 (DLL3) and topoisomerase 1, sharpened interest in the DLL3 mechanism, which gave Zai Lab Ltd. a phase Ia/Ib win this year in extensive-stage (ES) SCLC. Read More
Although 2024 showed signs of recovery, 2025 is once again reflecting an IPO slowdown, with global biopharma IPO proceeds in the first seven months of the year falling to their lowest level since 2016. Read More
Speaking at a Sept. 9 media briefing on the newly released Make America Healthy Again Strategy, U.S. Health and Human Services Secretary Robert Kennedy confirmed what could be the worst fears of many vaccine experts. Read More
Regulatory snapshots, including global drug submissions and approvals, and other regulatory decisions and designations: Innocare, Lexicon, Mabwell, Neuronos, Takeda. Read More
