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.
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.
It’s one step backward in order to take two steps forward at Zentalis Pharmaceuticals Inc. In a restructuring to help fund the second part of its potentially registration-enabling Denali study, Zentalis has laid off 40% of its workforce. The clinical trial of azenosertib, Zentalis’ lead candidate and a WEE1 kinase inhibitor, is for treating advanced solid tumors and hematologic malignancies. The therapy is designed to make cancer cells self-destruct.
In an indication that has proved difficult for biopharma to conquer, Regulus Therapeutics Inc. disclosed further positive data from its ongoing phase Ib study testing RGLS-8429 in autosomal dominant polycystic kidney disease and laid out its plans to move straight into a phase III trial later this year, with the potential for an accelerated U.S. approval.
With positive results from a phase III study, ITM Isotope Technologies Munich SE said it has reached a landmark. The clinical trial of ITM-11, a synthetic, targeted radiotherapeutic agent for treating inoperable, progressive grade 1 or grade 2 gastroenteropancreatic neuroendocrine tumors, met its primary endpoint of prolonging progression-free survival when compared to the mTOR inhibitor everolimus, a targeted molecular therapy and a standard of care.
Some favorable and some not-so-great results from separate midstage trials testing the anti-dickkopf homolog 1 antibody sirexatamab in combo regimens for two types of gastrointestinal tumors vexed Leap Therapeutics Inc. (NASDAQ:LPTX), shares of which ended Jan. 28 at 66 cents, down $1.60, or 71%.
A new bioprinting platform to create tissues that can change shape as a result of forces generated by the cells, similar to what happens naturally during organ development, was developed by researchers from the University of Galway, Ireland.
Positive data for Veru Inc.’s enobosarm lend more weight to the potential progress of the company’s body-mass preservation program in patients taking Wegovy (semaglutide). The side effect of lean mass loss has dogged those taking GLP-1s. The study results didn’t support the company’s stock on the day of the data release as it had the previous four weeks.
What a difference 60 weeks can make. That’s the lesson Akero Therapeutics Inc. shared with the rollout of what executives called “unprecedented” data from the phase IIb Symmetry trial testing efruxifermin (EFX), its FGF21 receptor agonist, in patients with compensated cirrhosis due to metabolic dysfunction-associated steatohepatitis (MASH). While earlier findings had shown only a trend in improvement at 36 weeks, full 96-week results showed more than doubling of earlier effect size, hitting the primary endpoint and sending shares of Akero (NASDAQ:AKRO) up 97% to close Jan. 27 at $51.71.
In December 2024 BioWorld recorded 212 clinical trial updates, an increase from 180 in November and closely aligning with 219 in October. The month saw 16 successful phase III outcomes, along with two mixed results and two trial failures. Eli Lilly and Co. reported that its FDA-approved weight-loss drug Zepbound (tirzepatide) outperformed Novo Nordisk A/S’s Wegovy (semaglutide) in the phase IIIb Surmount-5 trial.
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