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…

ByRidhi RastogiFebruary 4, 2026

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nChroma Bio Reports First Patient Dosing in P-I/II Trial of CRMA-1001 for HBV Infection

Shots: nChroma Bio has dosed the first patient with CRMA-1001, an epigenetic silencer, in a P-I/II trial for the treatment of hepatitis B virus (HBV) infection The open-label study is evaluating the safety, tolerability, PK/PD, & efficacy of CRMA-1001 in adults with CHB across single & multiple-ascending dose cohorts, with enrollment ongoing Additionally, the company…

ByRidhi RastogiJanuary 29, 2026

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Elevar Therapeutics Seeks the US FDA Approval for Lirafugratinib to Treat Cholangiocarcinoma

Shots: The US FDA has received an NDA of lirafugratinib for the 2L treatment of cholangiocarcinoma (CCA) patients with FGFR2 fusion or rearrangement NDA was backed by the P-I/II (ReFocus) trial, which showed 46.5% ORR, 12mos. PFS rate of 49.2% (mPFS: 11.3mos.), 12mos. OS of 74.6% (mOS: 22.8mos.), DCR of 96.5%, & mDoR of 11.8mos.,…

ByRidhi RastogiJanuary 29, 2026

NEWS

Mabwell Doses First US Patient in P-I/II Trial of 7MW4911 for Gastrointestinal (GI) Cancers

Shots: Mabwell has dosed the first patient with 7MW4911 in a P- I/II study in the US for the treatment of advanced colorectal cancer & other advanced GI tumors Preclinical studies showed that 7MW4911 delivered potent antitumor activity across CDX/PDX GI tumor models & outperformed MMAE/DXd-based ADCs in multidrug-resistant settings. It also reversed tumor progression after…

ByRidhi RastogiJanuary 23, 2026

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iRegene Therapeutics’ NouvNeu001 Receives the US FDA RMAT Designation in Parkinson’s Disease

Shots: The US FDA has granted RMAT designation to NouvNeu001 for the treatment of Parkinson's disease The P-I data showed marked improvements in MDS-UPDRS Part III motor scores, as low-dose pts achieved 30.6 (OFF; 52.82% improvement) & 12.9 (ON; 54.67% improvement) points at 12mos. & high-dose pts 23.3 (OFF) & 9.67 (ON) at 9mos., with…

ByRidhi RastogiJanuary 20, 2026

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Phanes Therapeutics Reports P-II (TWINPEAK) Trial Data on Spevatamig + CT in Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC)

Shots: The P-I/II (TWINPEAK) trial data assessed spevatamig alone & in combinations to treat advanced gastric, GEJ, pancreatic ductal or biliary tract adenocarcinomas in the US As of Dec 12, 2025, 107 pts received spevatamig alone or in combination; 42 with 1L mPDAC were treated with spevatamig + GnP, with spevatamig (2mg/kg, QW) data presented…

ByRidhi RastogiJanuary 12, 2026

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Merck Initiates P-III (KANDLELIT-007) trial of Calderasib + Keytruda Qlex for KRAS G12C-Mutant Nonsquamous NSCLC

Shots: Merck has initiated P-III (KANDLELIT-007) trial of calderasib (MK-1084) + Keytruda Qlex for the 1L treatment of pts with KRAS G12C-mutant, advanced or metastatic nonsquamous NSCLC Trial will assess calderasib (PO, QD) + Keytruda Qlex (SC; Q6W) vs Keytruda Qlex + pemetrexed (IV) + CT in ~ 675 newly diagnosed pts with KRAS G12C-mutant nonsq. NSCLC, evaluating PFS as 1EP…

ByRidhi RastogiJanuary 8, 2026

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Adlai Nortye Licenses AN9025 to ASK Pharm in a ~$230M Deal

Shots: Adlai Nortye has granted ASK Pharm exclusive rights to develop, manufacture, & commercialize AN9025 in mainland China, Hong Kong & Macao, with Adlai retaining rights in other regions As per the deal, Adlai will receive ~$230M, incl. >$20M in upfront & near-term milestone, plus tiered royalties ranging from a high single-digit to mid-teens %…

ByRidhi RastogiDecember 29, 2025

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CARsgen Reports the NMPA’s Dual IND Application Submission for CT0596 to Initiate P-Ib/II Trials in R/R MM and pPCL

Shots: Chinese NMPA received two IND applications for CT0596 to initiate P-Ib/II trials in r/r multiple myeloma (MM) & primary plasma cell leukemia (pPCL), respectively IIT in China showed favorable efficacy as of Aug 31, 2025, with 6/8 evaluable R/R MM pts achieving PR or better (3 CR/sCR, 1 VGPR, 2 PR) at an mFU…

ByRidhi RastogiDecember 29, 2025

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Gilead Sciences to Acquire Repare Therapeutics’ Polθ ATPase Inhibitor RP-3467 for ~$30M

Shots: Repare Therapeutics has entered into a definitive asset purchase agreement with Gilead Sciences for the acquisition of Repare's RP-3467, a polymerase theta (Polθ) ATPase inhibitor, strengthening Gilead’s precision oncology pipeline Under the Agreement, Repare will receive up to $30M in total consideration, including $25M upfront (subject to customary adjustments) and an additional $5M upon…

ByPrince GiriDecember 25, 2025

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

nChroma Bio Reports First Patient Dosing in P-I/II Trial of CRMA-1001 for HBV Infection

Elevar Therapeutics Seeks the US FDA Approval for Lirafugratinib to Treat Cholangiocarcinoma

Mabwell Doses First US Patient in P-I/II Trial of 7MW4911 for Gastrointestinal (GI) Cancers

iRegene Therapeutics’ NouvNeu001 Receives the US FDA RMAT Designation in Parkinson’s Disease

Phanes Therapeutics Reports P-II (TWINPEAK) Trial Data on Spevatamig + CT in Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC)

Merck Initiates P-III (KANDLELIT-007) trial of Calderasib + Keytruda Qlex for KRAS G12C-Mutant Nonsquamous NSCLC

Adlai Nortye Licenses AN9025 to ASK Pharm in a ~$230M Deal

CARsgen Reports the NMPA’s Dual IND Application Submission for CT0596 to Initiate P-Ib/II Trials in R/R MM and pPCL

Gilead Sciences to Acquire Repare Therapeutics’ Polθ ATPase Inhibitor RP-3467 for ~$30M

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