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Astellas and Pfizer Gain FDA Priority Review for Padcev + Keytruda in Muscle-Invasive Bladder Cancer (MIBC), Regardless of Cisplatin Eligibility
Shots: The US FDA has accepted sBLA & granted priority review to perioperative Padcev + Keytruda/Keytruda Qlex for the treatment of pts with MIBC, regardless of cisplatin eligibility (PDUFA: Aug 17, 2026) sBLA was supported by the P-III (EV-304/KEYNOTE-B15) trial assessing neoadj. Padcev + Keytruda, followed by surgery & then adj. Keytruda + Padcev vs…
TJ Biopharma Licenses Felzartamab to Biogen for Greater China in ~$850M Deal
Shots: TJ Bio has granted Biogen exclusive rights to felzartamab in Greater China, giving Biogen full global ownership as the drug advances through P-III trials across multiple immune-mediated diseases As per the deal, TJ Bio will receive $100M upfront, with ~$750M in commercial & sales milestones, plus mid-single to low-double-digit % of royalties on Greater…
Eli Lilly to Acquire Kelonia Therapeutics for ~$7B
Shots: Eli Lilly has entered into a definitive agreement to acquire Kelonia Therapeutics, expanding Lilly’s genetic medicine capabilities As per the deal, Lilly will acquire Kelonia for ~$7B in cash, incl. $3.25B upfront, & additional clinical, regulatory & commercial milestone payments; closing expected in H2’26 Acquisition will add Kelonia’s in vivo gene placement system (iGPS0) & its lead asset, KLN-1010, a one-time IV…
Pheast Therapeutics Reports Early P-Ia Data for PHST001 at AACR 2026
Shots: Pheast Therapeutics presented initial P-Ia data for PHST001 at AACR Annual Meeting 2026, demonstrating target engagement, innate immune activation, and early clinical activity PHST001 (anti-CD24 macrophage checkpoint inhibitor) was generally well tolerated, across dose-escalation cohorts and early signals of clinical activity were observed incl. tumor shrinkage and disease stabilization Preclinical data showed enhanced tumor…
Astrazeneca
AstraZeneca Reports Positive P-III (MIRANDA) Data for Tozorakimab in COPD
Shots: AstraZeneca announced that tozorakimab met the 1EP in the P-III (MIRANDA) study, significantly reducing annualised rate of moderate-to-severe COPD exacerbations across pts. with COPD that still experiencing exacerbations while on inhaled SoC In study pts. (n=1,454) received tozorakimab 300mg or PBO on top of SoC once every two weeks, including former and current smokers,…
Innate Pharma to Present P-II (MATISSE) Interim Data of IPH5201 in NSCLC at AACR 2026
Shots: Innate Pharma to present interim P-II (MATISSE) data (n=40) for IPH5201 at AACR Annual Meeting 2026, highlighting early efficacy in resectable NSCLC IPH5201 (anti-CD39) combined with durvalumab and chemotherapy showed promising pathological complete response (pCR) rates of 35.7% (PD-L1 ≥1%) and 50% (PD-L1 ≥50%) The study continues enrollment in PD-L1–positive pts., supporting further evaluation…
Pulnovo Raises $100M Led by Medtronic to Advance PADN System for Pulmonary Hypertension
Shots: Pulnovo Medical secured an oversubscribed $100M financing round led by Medtronic, with existing participation from EQT, Qiming Venture Partners, Gaorong Ventures, OrbiMed, and Lilly Asia Ventures The Pulnovo Medical and Medtronic also entered a strategic commercial agreement to explore future global commercialization opportunities leveraging the commercial synergy between Pulnovo and Medtronic, along with Medtronic’s distinctive and…
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…