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Genentech has reported the 1yr. data from the P-III (MEERKAT & SANDCAT) trials assessing vamikibart (intravitreal; 0.25 or 1mg, Q4W) vs a sham procedure for ~16wks. in adults with UME, followed by PRN treatment through wk. 52
At 52wks., trial showed numerically greater vision gains in both trials (1EP), with sustained improvements in BCVA…
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The US FDA has approved Tecentriq (atezolizumab) and Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) with fluoropyrimidine & oxaliplatin for the adj. treatment of stage III deficient DNA mismatch repair (dMMR) colon cancer
Approval was based on the P-III (ATOMIC) trial in above-mentioned pts (n=712), which were randomized to either mFOLFOX6 plus Tecentriq for 12 cycles…
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Earendil Labs has entered into a research collaboration with Genentech to discover and develop multiple therapeutic bispecific antibody programs in oncology
Earendil Labs will lead antibody discovery & research through early clinical development for programs targeting certain pre-agreed target combinations, while Genentech will take over global clinical development & commercialization
As per the deal,…
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Genentech has reported topline P-II (CT-388-104) trial data assessing enicepatide (CT-388; QW, SC) vs PBO in 447 adults living with type 2 diabetes and overweight or obesity for 48wks.
Enicepatide met both 1EPs, with dose-dependent reductions in blood glucose & body weight at 48wks. At 24 mg, HbA1c fell 2.65% from 8.1% baseline, while…
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FDA has granted Priority Review to the sBLA of Enspryng for the treatment of myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD), with a PDUFA target action date set for Jan 10, 2027. Filing is also under EMA’s review, with a decision expected in Q3’27
sBLA was supported by the P-III (METEOROID) trial data, assessing Enspryng(60,…
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DUALITYBIO has entered into a collaboration & license agreement with Genentech to develop next-generation ADCs, leveraging DUALITYBIO’s DUPAC (DualityBio Unique Payload Antibody Conjugate) platform
DualityBio will discover & develop ADCs against Genentech-selected oncology targets using DUPAC payloads, leading discovery & early global development, while Genentech will secure exclusive global rights & take over development…
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Hanmi Pharm has entered into an exclusive licensing agreement with Genentech for the development, manufacturing, & commercialization of HM17321, for obesity & associated conditions such as T2D & CV diseases, globally, excl. South Korea
As per the deal, Hanmi will receive ~$190M upfront, with additional development, regulatory & commercial milestones representing the total deal…
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Astex has entered into an exclusive, worldwide research collaboration & license agreement with Genentech to identify small molecules with selective inhibitory activity for the treatment for breast cancer
Astex will license compounds from its breast cancer discovery program to Genentech and jointly optimize lead compounds through preclinical candidate selection, after which Genentech will lead…
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The US FDA has accepted sBLA for Genentech's Lunsumio VELO (mosunetuzumab-axgb; SC) + Polivy (polatuzumab vedotin-piiq) for treating adults with r/r LBCL, incl. diffuse large B-cell lymphoma (DLBCL), after ≥1L of systemic therapy (PDUFA: Feb 9, 2027)
sBLA was backed by the P-III (SUNMO) study assessing Lunsumio VELO + Polivy (IV) vs R-GemOx in the above…
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The US FDA has accepted sBLA & granted priority review to adj. Tecentriq (atezolizumab) & Tecentriq Hybreza (atezolizumab & hyaluronidase-tqjs) in combination with CT in stage III dMMR or MSI-H colon cancer (PDUFA: Oct 9, 2026)
sBLA was based on the P-III (ATOMIC) trial assessing Tecentriq to FOLFOX6 CT in 712 pts with stage…

