Laguna Biotherapeutics Reports the US FDA IND Clearance for LGNA-100 to Treat High-Risk Pediatric Leukemias

Shots: The US FDA has granted IND clearance to LGNA-100, Laguna Biotherapeutics’ lead clinical candidate from the QUAIL platform, to initiate the P-I trial The P-I single ascending dose study will assess safety, tolerability, & mechanism of LGNA-100 via IV infusion in pediatric & young adults with high-risk acute leukemias & MDS post αβ-depleted HSCT…

ByRidhi Rastogi4 days ago

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Kestrel Therapeutics Inks AbbVie Deal Worth up to $1.45B with Option to Acquire

Shots: Kestrel has entered into a strategic agreement with AbbVie, structured as a warrant deal, granting AbbVie an exclusive option to acquire Kestrel upon achievement of key development milestones As per the deal, AbbVie will fund development of KST-6051, with an exclusive option to acquire Kestrel based on development & regulatory milestone completion, representing the…

ByRidhi Rastogi5 days ago

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Regeneron Reports the US FDA Accelerated Approval of Otarmeni (lunsotogene parvec-cwha) in Genetic Hearing Loss

Shots: Otarmeni was approved under CNPV for pediatric & adult pts with sev. to profound and profound sensorineural hearing loss due to biallelic OTOF gene variants, with preserved outer hair cell function & no prior cochlear implant. It will be provided free of charge in the US by Regeneron Approval was based on the P-I/II…

ByRidhi RastogiApril 24, 2026

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EpiBiologics Reports First Patient Dosed in P-I Study of EPI-326 for EGFR-Driven Solid Tumors

Shots: EpiBiologics has dosed the first patient in a global P-I study evaluating EPI-326, a tissue-selective bispecific antibody targeting EGFR, in advanced solid tumors The first-in-human study will assess safety, tolerability, PK, and preliminary anti-tumor activity in pts with NSCLC and HNSCC, with potential expansion into colorectal cancer Preclinical data showed robust anti-tumor activity across…

ByPrince GiriApril 20, 2026

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Nuvalent Reports the US FDA’s NDA Submission for Neladalkib to Treat ALK-Positive NSCLC

Shots: The US FDA has received the NDA of neladalkib for the treatment of TKI pre-treated pts with advanced ALK-positive NSCLC NDA was supported by global P-I/II (ALKOVE-1) trial of neladalkib in TKI-pretreated advanced ALK-positive NSCLC, showing favorable activity incl. intracranial responses, targeting key progression drivers, & a generally well-tolerated safety profile; data to be…

ByRidhi RastogiApril 8, 2026

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Merck to Acquire Terns Pharmaceuticals for ~$6.7B

Shots: Merck has entered into a definitive agreement to acquire Terns, incl. its asset TERN-701 asset, expanding its oncology pipeline As per the deal, Merck will acquire Terns for $53/share in cash, representing a total equity value of ~$6.7B (~$5.7B net of acquired cash); closing is expected in Q2’26 TERN-701 is being evaluated in the…

ByRidhi RastogiMarch 25, 2026

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ARTHEx Biotech’s ATX-01 Secures the US FDA Fast Track Designation for Myotonic Dystrophy Type 1

Shots: The US FDA has granted FTDto ATX-01 for the treatment of Myotonic Dystrophy Type 1 (DM1) ATX-01 showed increased free MBNL, improved splicing abnormalities, & restored function in animal models, & is being evaluated in the P-I/IIa (ArthemiR) study ATX-01 is an RNA-based therapeutic designed to inhibit miR-23b, which results in increased MBNL protein…

ByRidhi RastogiMarch 11, 2026

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TaiGen Completes Enrolment and Doses First Patient with Insilico Medicine’s ISM4808 in P-I Trial

Shots: Insilico Medicine & TaiGen have reported complete enrolment of the trial & dosing of the first patient with ISM4808 in the P-I trial to treat CKD-related anemia The P-I study consists of both single-ascending-dose & multiple-ascending-dose cohorts, designed to evaluate ISM4808 in healthy adults against PBO In Dec 2025, TaiGen gained exclusive rights to…

ByRidhi RastogiMarch 6, 2026

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IDEAYA Biosciences Reports the First Patient Enrolment in P-I Trial of IDE034

Shots: IDEAYA Biosciences has enrolled the first patient in its P-I dose escalation/expansion trial of IDE034, a B7H3/PTK7 bispecific TOP1 ADC, for solid tumors The company is planning to assess the safety, tolerability, & PK of IDE034 as monotx. in a P-I trial & explore combinations with DDR-targeting agents, incl. its proprietary PARG inhibitor, IDE161…

ByRidhi RastogiFebruary 25, 2026

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Frontier Biotechnologies and GSK Forge ~$1B Global Licensing Deal for siRNA Therapeutics

Shots: Frontier has entered into an exclusive licensing agreement with GSK for two Small Interfering RNA (siRNA) assets in immunology, incl. one IND-stage candidate & one preclinical program As per the deal, GSK will gain exclusive global rights to develop, manufacture, & commercialize two of Frontier’s siRNA candidates, while Frontier will receive $40M upfront, up…

ByRidhi RastogiFebruary 24, 2026

Laguna Biotherapeutics Reports the US FDA IND Clearance for LGNA-100 to Treat High-Risk Pediatric Leukemias

Kestrel Therapeutics Inks AbbVie Deal Worth up to $1.45B with Option to Acquire

Regeneron Reports the US FDA Accelerated Approval of Otarmeni (lunsotogene parvec-cwha) in Genetic Hearing Loss

EpiBiologics Reports First Patient Dosed in P-I Study of EPI-326 for EGFR-Driven Solid Tumors

Nuvalent Reports the US FDA’s NDA Submission for Neladalkib to Treat ALK-Positive NSCLC

Merck to Acquire Terns Pharmaceuticals for ~$6.7B

ARTHEx Biotech’s ATX-01 Secures the US FDA Fast Track Designation for Myotonic Dystrophy Type 1

TaiGen Completes Enrolment and Doses First Patient with Insilico Medicine’s ISM4808 in P-I Trial

IDEAYA Biosciences Reports the First Patient Enrolment in P-I Trial of IDE034

Frontier Biotechnologies and GSK Forge ~$1B Global Licensing Deal for siRNA Therapeutics

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