Gilead Sciences to Acquire Arcellx for $7.8B

Shots: Gilead Sciences has entered into a definitive agreement to acquire Arcellx, incl. anito-cel from their 2022 collaboration & Arcellx’s D-Domain CAR technology platform, for the implied equity value of $7.8B As per the deal, Gilead, which owns ~11.5% of Arcellx, will launch a tender offer for $115/share, plus a non-transferable CVR of $5/CVR tied…

ByRidhi RastogiFebruary 23, 2026

NEWS

Dr. Reddy’s Reports the US FDA’s BLA Acceptance for DRL_AB (Biosimilar, Orencia)

Shots: The US FDA has accepted 351 (k) BLA for DRL_AB (IV), a proposed interchangeable biosimilar to Orencia (abatacept) Upon approval, DRL_AB will be indicated for adults with mod. to sev. active rheumatoid arthritis, adults with active psoriatic arthritis, & pts (≥6yrs.) with mod. to sev. active polyarticular juvenile idiopathic arthritis BLA was supported by extensive…

ByRidhi RastogiFebruary 23, 2026

NEWS

Henlius Reports the FDA IND Clearance to Initiate P-I Trial of HLX15-SC (Biosimilar, Darzalex Faspro)

Shots: The US FDA has granted IND clearance to initiate P-I trial of HLX15-SC, a biosimilar version of Darzalex Faspro (daratumumab), for the 1L treatment of multiple myeloma In Jun 2024, the P-I study of HLX15 (IV; Biosimilar, Darzalex) met its 1EP, demonstrating similar PK & comparable safety & immunogenicity to US, EU, & China-sourced…

ByRidhi RastogiFebruary 16, 2026

NEWS

Adlai Nortye Doses First Patient in the P-I Trial of AN9025 to Treat Solid Tumors Harboring RAS Mutations

Shots: Adlai Nortye has dosed the first patient in the US with AN9025 in its ongoing P-I trial for the treatment of advanced or metastatic solid tumors harboring RAS mutations Trial is being conducted by Adlai Nortye with ASK Pharm as a multi-regional study under a license agreement granting Adlai Nortye ex-China rights to AN9025,…

ByRidhi RastogiFebruary 12, 2026

NEWS

Evogene and Shanghai Lishan Biopharmaceuticals Partner for BMC128

Shots: Biomica (Evogene’s subsidiary) & Shanghai Lishan Biopharmaceuticals have entered into an exclusive worldwide licensing agreement for BMC128, currently in P-I trial As per the deal, Lishan Biotech will receive exclusive rights to develop, manufacture, & commercialize BMC128, with Biomica receiving development milestone payments & royalties on future commercial sales Lishan Biotech is planning to…

ByRidhi RastogiFebruary 5, 2026

NEWS

Daiichi Sankyo Reports First Patient Dosing in P-I/II Trial of DS3790 for R/R B-Cell Non-Hodgkin Lymphoma

Shots: Daiichi Sankyo has dosed the first patient with DS3790 in the P-I/II trial for pts with r/r B-cell non-Hodgkin lymphoma The trial will assess DS3790 in ~420 pts with r/r B-cell NHL, evaluating safety endpoints as well as efficacy endpoints incl. overall response, DCR, DoR, time to response, PFS, & OS DS3790 is a…

ByRidhi RastogiFebruary 5, 2026

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…

ByRidhi RastogiFebruary 4, 2026

NEWS

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

NEWS

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

Gilead Sciences to Acquire Arcellx for $7.8B

Dr. Reddy’s Reports the US FDA’s BLA Acceptance for DRL_AB (Biosimilar, Orencia)

Henlius Reports the FDA IND Clearance to Initiate P-I Trial of HLX15-SC (Biosimilar, Darzalex Faspro)

Adlai Nortye Doses First Patient in the P-I Trial of AN9025 to Treat Solid Tumors Harboring RAS Mutations

Evogene and Shanghai Lishan Biopharmaceuticals Partner for BMC128

Daiichi Sankyo Reports First Patient Dosing in P-I/II Trial of DS3790 for R/R B-Cell Non-Hodgkin Lymphoma

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

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