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The US FDA Grants IND Clearance to Harbour BioMed’s HBM7004 to Initiate P-I Trial in Advanced Solid Tumors
Shots: The US FDA has granted IND clearance to initiate the P-I trial assessing the safety, tolerability, PK, & anti-tumor activity of Harbour Biomed's HBM7004 in advanced solid tumors  Preclinical studies showed that HBM7004 induced B7H4-dependent intratumoral T-cell activation, strong anti-tumor activity, in vivo stability, & reduced systemic toxicity, while combination with a B7H4x4-1BB BsAb…
May 8, 2026
Beacon Therapeutics Reports P-II (DAWN) Trial Data on Laru-zova in X-Linked Retinitis Pigmentosa (XLRP)
Shots: Beacon has reported the 12mos. data from P-II (DAWN) trial assessing laruparetigene zovaparvovec (laru-zova) in pts with XLRP who have previously been treated with an AAV vector-based gene therapy delivering the full-length RPGR protein Data showed sustained improvements in low luminance visual acuity (LLVA) & microperimetry mean sensitivity through Mos. 12, with 50% of…
May 8, 2026
Incyte
Incyte Reports 24-week P-III (TRuE-AD4) Trial Data on Opzelura (Ruxolitinib) Cream in Moderate Atopic Dermatitis (AD)
Shots: The P-III (TRuE-AD4) study assessed Incyte's Opzelura cream (BID) vs vehicle in 241 adults with mod. AD who had an inadequate response, intolerance, or contraindication to topical corticosteroids (TCSs) & calcineurin inhibitors (TCIs); data presented at EADV’26 As previously reported, the study met its co-1EPs, with 83.5% pts achieving EASI75 & 74.4% reaching IGA-TS, while 74.3% pts…
May 8, 2026
Waiv Partners with Daiichi Sankyo to Advance AI-Driven Biomarker Discovery for ADC Program
Shots: Waiv has collaborated with Daiichi Sankyo to lead digital pathology biomarker discovery for an ADC program, leveraging its end-to-end computational pathology platform Waiv will use its platform to analyze early-phase trial data, incl. tumor microenvironment profiling across H&E & IHC slides, biomarker discovery, & outcome prediction, aimed at identifying biomarkers of treatment response The…
May 7, 2026
Roche to Acquire PathAI for ~$1.05B
Shots: Roche has entered into a definitive merger agreement to acquire PathAI, building on their 2021 partnership, which scaled up in 2024 to incl. the development of AI-enabled companion diagnostic algorithms As per the deal, Roche will acquire PathAI for $750M upfront & ~$300M in additional milestone payments; closing is expected in H2’26 The acquisition…
May 7, 2026
Angelini Pharma to Acquire Catalyst Pharmaceuticals for ~$4.1B
Shots: Angelini Pharma has entered into a definitive agreement to acquire all outstanding shares of Catalyst, marking Angelini’s entry into the US market As per the deal, Angelini will acquire Catalyst for $31.5 per share in cash, for a total equity value of ~$4.1B; closing is expected in Q3’26  The acquisition will strengthen Angelini’s Brain Health…
May 7, 2026
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