Shares of Tectonic Therapeutic Inc. (NASDAQ:TECX) closed Jan. 30 at $54.84, up $29.12, or 113%, on what Leerink analyst David Risinger called in his report “the most impressive hemodynamic results we have seen” in heart failure with preserved ejection fraction. Watertown, Mass.-based Tectonic unveiled positive interim data from the phase Ib acute hemodynamic trial with lead candidate TX-45, a long-acting, Fc-relaxin fusion protein. Read More
In a devastating blow to the company and large B-cell lymphoma patients relapsed or refractory to CD19 CAR T-cell therapy, Cargo Therapeutics Inc. terminated the phase II study of its lead CD22 cell therapy, firicabtagene autoleucel (firi-cel), and is cutting its workforce by 50% and evaluating strategic options, following disappointing data on durability of response and serious safety events, some of which were fatal. Read More
Alterity Therapeutics Ltd. reported positive top-line phase II results for lead candidate ATH-434 for treating multiple system atrophy, a rare neurological disorder similar to Parkinson's disease. Read More
The five-year voluntary pricing deal between pharma companies and the U.K. Department of Health is under severe pressure after the rebate the industry is due to pay leapt from 15.3% in 2024 to 22.9% for 2025. That has put “a very real strain” on companies, which have not factored this into their 2025 budgets because they were planning around an agreed forecast that the 2025 rebate rate would remain at around 15%, according to the Association of the British Pharmaceutical Industries (ABPI). Read More
One of the uncertainties in the changing of the guard in both the U.S. administration and Congress is the future of 340B reforms. Now the Inflation Reduction Act makes reforms more critical than ever, as it requires manufacturers of drugs selected for price negotiations to certify that they’re giving 340B entities the lowest price, be it the 340B discount or the maximum fair price set by the CMS as part of the negotiation process. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Cullinan, Durect, Eli Lilly, Oqory, Regulus, Taiho, Tris, Vincerx, Zentalis. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Ayala, Dewpoint, I-Mab, Leveragen, Moonlight Bio, Mitsubishi Tanabe, OS Therapies, Solita, TNF, Zentalis. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Emmaus, Iaso, Novo Nordisk, Scholar Rock, Vicore, Vyluma, Zhaoke. Read More
