Shots:
J&J has entered into a definitive agreement to acquire Halda Therapeutics, strengthening its oncology pipeline
As per the deal, J&J will acquire Halda for $3.05B in cash, with the deal treated as a business combination & expected to close in the coming months
Acquisition will add Halda’s Regulated Induced Proximity TArgeting Chimera (RIPTAC) platform…
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Neurogene has reported interim data from the pediatric cohort (4-10yrs.) of the ongoing P-I/II trial assessing NGN-401 for the treatment of females with Rett syndrome
As of Oct 30, 2025, all pediatric pts (n=8) had functional gains across Rett syndrome domains, achieving 35 developmental milestones in fine motor, communication & ambulation. These gains were…
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Doc.com launches its AI & blockchain-powered telemedicine platform in the US to improve patient access, data security, & care coordination
Pts can securely connect with licensed in-state healthcare providers via mobile using the platform, with up to 15min. of complimentary teleconsultation offered during launch, available in eligible jurisdictions & subject to applicable regulations, followed…
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Lyell has acquired global rights to LYL273 (excl. mainland China, Hong Kong, Macau & Taiwan) for the treatment of metastatic colorectal cancer & other GCC-expressing cancers from ICT
As per the deal, ICT will receive $40M upfront, 1.9M Lyell shares, ~$30M in clinical, ~$115M in late-stage regulatory, & ~$675M in sales milestones, plus ~1.85M additional…
Shots:
Daiichi Sankyo has dosed the first patient with DS3610 in P-I trial for the treatment of advanced, metastatic or unresectable solid tumors
The P-I trial will evaluate DS-3610 in advanced or metastatic solid tumors to determine the recommended dose, assessing PK & immunogenicity endpoints plus safety endpoints incl. DLTs & AEs. Exploratory endpoints like…
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The EMA has granted PRIME designation to NRTX-1001 for adults with drug-resistant focal epilepsy, based on preclinical & emerging clinical data
NRTX-1001 is also being evaluated in 2 ongoing P-I/II trials for drug-resistant unilateral & bilateral mesial temporal lobe epilepsy (MTLE), with P-III (EPIC) trial planned to begin in H2’25 for drug-resistant MTLE
The…
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GSK has entered into a worldwide exclusive license agreement with Empirico to develop & commercialize EMP-012
As per the deal,Empirico will lead P-I development of EMP-012, following which GSK will take over global development, regulatory filings, & commercialization, with Empirico receiving $85M upfront, ~$660M in development, regulatory & commercial milestones, & tiered royalties on…
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The US FDA has approved Omvoh (200mg/2mL, SC, QM) as a maintenance treatment of adults with mod. to sev. active ulcerative colitis; PFS & prefilled pen to be available in early 2026
Approval was based on P-I trial assessing Omvoh (200mg/2mL, SC) single injection vs 2 100mg/1mL injections in participants, which showed bioequivalence between the…
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The US FDA has granted BTD to sonrotoclax for adults with r/r MCL & accepted BeOne’s request for participation in Project Orbis for concurrent global review of the therapy
Decision was based on P-I/II (BGB-11417-201) assessing sonrotoclax in r/r MCL pts previously treated with BTKi & anti-CD20 therapy; Part 1 enrolled 22 pts on…
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The US FDA has granted FTD to ADCE-D01 for the treatment of soft tissue sarcoma (STS)
ADCE-D01 is being evaluated in P-I/II (ADCElerate1/EUCT) dose escalation & expansion study as a monotx. for metastatic &/or unresectable STS, with enrolment ongoing in the US & EU
ADCE-D01 is an ADC targeting uPARAP & conjugated to the…

