The potential for TL1A-targeting duvakitug to impact unmet needs of patients with ulcerative colitis (UC) and Crohn’s disease (CD), and to provide anti-fibrotic effects for a host of other diseases, boosted shares of Teva Pharmaceutical Industries Ltd. and Sanofi SA by 25% and 7%, respectively, in early trading Dec. 17, as the partners released what analysts call “best-in-class” results from the phase IIb Relieve UCCD trial and prepare for a phase III trial in 2025. In UC, placebo-adjusted clinical remission rates were 15.7% with the low dose of duvakitug and 27.4% with the high dose at week 14, while in CD, the rates were 13% with the low dose and 34.8% with the high dose. “It is rare to bring a new medicine to this stage successfully, but even more rare in two indications on the same day,” said Eric Hughes, Teva’s executive vice president of global R&D and chief medical officer. The results follow Teva and Sanofi’s $1.5 billion licensing deal for the drug in October 2023.

Tenaya sinks on early data with gene therapy in HCM

Shares of Tenaya Therapeutics Inc. (NASDAQ:TNYA) were trading at $1.30, down $1.58, or 54%, after the company reported early data from the first cohort of patients in the Mypeak-1 phase Ib/II trial with TN-201 gene therapy for the potential treatment of MYBPC3-associated hypertrophic cardiomyopathy (HCM), which is caused by insufficient levels of myosin-binding protein C (MyBP-C). Preliminary data from three patients in the first dose cohort of 3E13 vg/kg showed that TN-201 was generally well-tolerated, with readily detectable vector DNA in the heart, evidence of transgene RNA expression, and increasing TN-201 mRNA and MyBP-C protein levels over time. Circulating biomarkers of cardiac muscle strain and injury stayed mostly stable, and other markers of HCM showed stability or directional improvement in the first two patients dosed, though longer-term data are needed to characterize TN-201’s activity. Tenaya will continue to follow the first three patients with more data due next year from the first cohort and the higher-dose second cohort, Tenaya said.

Danish regulators question possible Ozempic link to rare eye condition

The Danish Medicines Agency is to ask the EMA’s pharmacovigilance committee to investigate a potential increased risk of an acute eye condition in diabetic patients being treated with the glucagon-like peptide-1 receptor agonist Ozempic (semaglutide). That follows on from two independent studies of data from the national patient registries of Denmark and Norway, which suggested the risk of nonarteritic anterior ischemic optic neuropathy, in which the optic nerve is damaged by a sudden loss of blood supply, has doubled since Ozempic was put on the market in 2018.

Freed from a clinical hold, Biomea menin inhibitor has strong phase II data in T2D

Released from a clinical hold by the U.S. FDA in late September, Biomea Fusion Inc.’s menin inhibitor, icovamenib, has charged ahead to produce positive top-line data from a phase II study in type 2 diabetes. The randomized, double-blind, 3-to-1 placebo-controlled study produced statistically significant and clinically meaningful reductions in HbA1c at week 26, a crucial measure of determining glycemic control. Data from the study, which has three dosing arms, showed that those completing the dosing protocol had a mean HbA1c reduction of 0.36 (p=0.022). Still, the company’s stock (NASDAQ:BMEA) had sunk at midday, with shares trading 17% lower at $4.85 each.

Candid, Epimab ink $1B T-cell engager deal in autoimmune disease

Candid Therapeutics Inc. and Epimab Biotherapeutics Inc. have entered a $1 billion research collaboration to discover and develop novel T-cell engager candidates for autoimmune indications. Under terms, Epimab is entitled to an undisclosed up-front payment, development and sales milestones totaling more than $1 billion, as well as royalties on net sales, assuming multiple drug candidates are advanced through commercialization. In exchange, Candid gains exclusive worldwide rights to develop and commercialize programs discovered under the collaboration.

SK Biopharma, Proen team up to develop new radiopharmaceuticals

SK Biopharmaceuticals Co. Ltd. and Proen Therapeutics Co. Ltd. joined hands in a research collaboration to advance up to two preclinical small protein-based radiopharmaceuticals by 2027 – the year SK Biopharmaceuticals aims to “become a leading radiopharma player” worldwide. Under the partnership announced Dec. 17, SK Biopharmaceuticals will work with and use Proen’s Artbody platform to develop up to two radiopharma candidates over the next three years.

Kyorin in-licenses Bayer’s phase II sleep apnea drug for €85M+

Kyorin Pharmaceutical Co. Ltd. has acquired Bayer AG’s phase II obstructive sleep apnea candidate, BAY-2925976, in a deal worth €85M (US$89.3 million) plus sales-based royalties and commercial milestones. Under terms of the deal, Tokyo-based Kyorin will pay Bayer an up-front payment of €15 million plus development-based milestone payments up to €70 million, as well as sales-based royalties and commercialization milestone payments. In exchange, Kyorin gains exclusive worldwide rights to manufacture, develop and commercialize BAY-2925976, an alpha 2C adrenoceptor antagonist, and its backup compound.

Also in the news

Abbvie, Abliva, Accord, Alkemist, Alphina, Arcutis, Ascendis, Assertio, Atea, Basilea, Betaglue, Biohaven, Candid, Celltrion, Checkpoint, Corcept, CSL, Dermata, Edgewise, Eli Lilly, Epimab, Foghorn, Galderma, Genprex, GSK, Ideaya, Immix, Innovent, Innoviva, Inventiva, Larimar, Lib, Maia, Medigene, Menarini, Merck, Neurocrine, Newamsterdam, Nimble, Nona, Organon, Outlook, Palatin, Palisade, Pepgen. Pharming, Promise, Puretech, Reviva, Scisparc, Theolytics, Trevi, Upstream, Viridian.