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TRIUMPH-2 assessed retatrutide (4, 9, or 12mg, QW) vs PBO in 1152 pts with T2D & obesity/overweight, with trial using a stepwise dose-escalation approach at Q4W. Lilly plans to file BLA in Q1’27
At 80wks., avg. body weight reductions were 12.7% (4mg), 19.1% (9mg), & 20.8% (12mg) vs 4%, plus A1C reduced by 1.4%,…
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Tolerance Bio has entered into an exclusive license agreement with Tanabe Pharma for MT-2990, an anti-IL-33 monoclonal antibody, across all indications
Tanabe Pharma has granted Tolerance Bio worldwide development & manufacturing rights, and ex-Japan exclusive commercialization rights for MT-2990 (TLB-33), while Tanabe will retain commercialization rights in Japan
As per the deal, Tanabe will…
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The US FDA has approved Emcitate (tiratricol) for the treatment of peripheral thyrotoxicosis in adults & pediatric pts with monocarboxylate transporter 8 (MCT8) deficiency (Allan–Herndon–Dudley syndrome)
Approval was supported by an extensive clinical development program assessing Emcitate in pts with MCT8 deficiency, incl. ReTRIACt, Triac Trial I, Triac Trial II, Erasmus Medical Center (EMC)…
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AstraZeneca will invest $2B in Summit through convertible preferred shares, representing a conversion price of $18.36/share, while the companies will collaborate on the development of ivonescimab & sonesitatug vedotin (sone-ve).
The clinical collaboration will evaluate ivonescimab with sone-ve in GI cancers, with studies expected to begin soon. Companies will share study costs, while each…
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The US FDA has approved Degevma, a biosimilar version of Xgeva (denosumab), following FDA approval of Ponlimsi (biosimilar, Prolia) in Mar 2026, with launch of both biosimilars anticipated in coming mos.
Approval was backed by extensive data, incl. analytical & clinical data showing similar efficacy, safety & immunogenicity profile as the reference product
Degevma…
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Hengrui Pharma has entered into a license agreement with Novo for HRS-1596, a P-I-ready GLP-1 receptor & gastric inhibitory polypeptide receptor dual agonist, with potential for QW oral dosing
As per the deal, Novo will obtain exclusive rights to develop, manufacture & commercialize HRS-1596 globally, excl. Mainland China, the Hong Kong SAR, the Macao…
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The NMPA has approved Jaypirca (100 & 50mg) as a monotx. for the treatment of adults with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), expanding its use across all lines of therapy & regardless of prior covalent BTK inhibitor treatment
Approval was backed by the P-III trials: BRUIN CLL-313 assessed Jaypirca in 282 pts with treatment-naïve…
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Kodiak has reported the P-III (DAYBREAK) trial data assessing Zenkuda (tarcocimab tedromer) and tabirafusp-ted (KSI-501) in parallel vs aflibercept in pts with wet age-related macular degeneration (wAMD)
Zenkuda met its 1EP, showing meaningful vision gains & rapid, sustained retinal drying, with 54% of pts achieving 6mos. durability at Yr. 1. tabirafusp-ted also met its vision…
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FDA approval was based on the P-III (TEMPO) program, which evaluated Juvmo in early PD pts not taking oral levodopa (TEMPO-1 & 2) & as an adjunct to oral levodopa vs PBO + levodopa in PD pts with motor fluctuations (TEMPO-3)
At Wk. 26 in TEMPO-1, Juvmo showed MDS-UPDRS Part II scores of −1.6…
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Merck & SciBrunch have entered into an exclusive global license agreement for SPR2015, with Merck receiving exclusive rights to develop, manufacture & commercialize SPR2015 worldwide
As per the deal, SciBrunch will receive ~$400M upfront & payment associated with development, commercialization & other milestones across multiple indications, representing the total deal value of ~$2.13B
SPR2015…

