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NEWS

Relay Therapeutics’ Zovegalisib Receives the US FDA Breakthrough Therapy Designation for PIK3CA-Mutant Advanced Breast Cancer

Shots: The US FDA has granted BTD to zovegalisib + fulvestrant for the treatment of adults with PIK3CA mutant, HR+/HER2- locally advanced or metastatic breast cancer following recurrence or progression on or after treatment with a CDK4/6 inhibitor Designation was supported by P-I/II (ReDiscover) trial data of zovegalisib + fulvestrant ± CDK inhibitors, showing activity…
February 4, 2026

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NEWS

Quanterix Seeks US FDA Approval for Multi-Analyte Algorithmic Blood Test to Diagnose Alzheimer’s Disease

Shots: The US FDA has received 510(k) premarket notification for the multi-analyte algorithmic blood test to diagnose Alzheimer’s disease Submission was backed by data across three independent cohorts & 1,800+ pts, published in the Alzheimer’s & Dementia: Diagnosis, Assessment & Disease Monitoring The blood test uses Quanterix’s Simoa tech to integrate five AD biomarkers (p-Tau217,…
February 4, 2026

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NEWS

Zonsen PepLib Biotech and Eli Lilly Partner to Advance Peptide-Based Therapies

Shots: Zonsen PepLib Biotech has entered into a worldwide R&D and license agreement with Eli Lilly to jointly advance peptide-based drug candidates using PepLib’s robust & diverse peptide libraries & discovery platforms As per the deal, PepLib will screen & identify optimal peptide molecules using its in-house platform, while Lilly will oversee IND-enabling activities, clinical…
February 4, 2026

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NEWS

Exelixis Reports the US FDA’s NDA Acceptance of Zanzalintinib + Tecentriq for Metastatic Colorectal Cancer (mCRC)

Shots: The US FDA has accepted NDA of zanzalintinib + Tecentriq (atezolizumab) for the treatment of adults with mCRC who have been previously treated with fluoropyrimidine, oxaliplatin & irinotecan-based CT, &, if RAS wild-type, an anti-EGFR therapy (PDUFA: Dec 03, 2026) NDA was based on P-III (STELLAR-303) trial assessing zanzalintinib in combination with atezolizumab (n=451)…
February 3, 2026

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Astrazeneca and Daiichi-Sankyo New
NEWS

Daiichi Sankyo and AstraZeneca Report the US FDA Priority Review for Datroway to Treat Metastatic Triple Negative Breast Cancer

Shots: FDA has accepted sBLA & granted priority review to Datroway (datopotamab deruxtecan) for the 1L treatment of adults with unresectable or metastatic TNBC, who are ineligible for PD-1/PD-L1 inhibitor therapy (PDUFA: Q2’26) sBLA was backed by the global P-III (TROPION-Breast02) trial assessing Datroway vs CT in 644 above-mentioned pts, which showed 5mos. improvement in…
February 3, 2026

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Novo-Nordisk
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Novo Nordisk Reports P-III (REIMAGINE 2) Trial Data on CagriSema for Type 2 Diabetes

Shots: The P-III trial evaluated CagriSema (SC; QW), a fixed-dose combination of cagrilintide & semaglutide, at two dose levels (2.4mg/2.4mg & 1mg/1mg) vs semaglutide (2.4 & 1mg), cagrilintide (2.4mg) alone, & PBO in 2,728 pts with T2D inadequately controlled with metformin ± an SGLT2 inhibitor At 68wks., CagriSema (2.4/2.4mg) outperformed semaglutide (2.4mg), reducing HbA1c by…
February 3, 2026

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NEWS

Genentech to Advance RNAi Therapeutics with SanegeneBio in a ~$1.7B Deal

Shots: SanegeneBio has entered into a global licensing agreement with Genentech (Roche) to advance one of its RNAi programs, using SanegeneBio's RNAi platform As per the deal, Genentech will receive exclusive worldwide rights to develop & commercialize the program, with SanegeneBio handling early development activities, after which Genentech will lead subsequent development & commercialization efforts …
February 3, 2026

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Incyte
NEWS

The CHMP Recommends Incyte’s Zynyz to Treat Squamous Cell Carcinoma of the Anal Canal (SCAC)

Shots: The CHMP has recommended Zynyz (retifanlimab) + Pt-based CT as 1L treatment of adults with metastatic or with inoperable locally recurrent SCAC Opinion was based on P-III (POD1UM-303/InterAACT2) trial assessing Zynyz + carboplatin & paclitaxelvs PBO & CT in treatment-naïve SCAC pts P-III trial showed a 37% PFS improvement (mPFS: 9.3 vs 7.4mos.); data…
February 3, 2026

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