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Rocket Pharmaceuticals Receives the US FDA’s RMAT Designation of RP-A601 to Treat PKP2-Arrhythmogenic Cardiomyopathy

Shots:The US FDA has granted Regenerative Medicine Advanced Therapy (RMAT) designation to RP-A601 for the treatment of PKP2-arrhythmogenic cardiomyopathyDesignation was supported by ongoing P-I trial, where all 3 adults treated with a single dose of RP-A601 (8x10¹³ GC/kg) showed enhanced PKP2 protein expression, incl. 110% & 398% increase in 2 pts with low…
22 hours ago

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Debiopharm Enters a ~$267M Licensing Deal with Repare Therapeutics for Lunresertib

Shots:Debiopharm has entered into an exclusive global licensing agreement with Repare Therapeutics for lunresertib (PKMYT1 inhibitor) to treat difficult-to-treat solid tumorsAs per the deal, Repare will receive $10M upfront, ~$257M in clinical, regulatory, commercial & sales milestones, incl. $5M in near-term payments & net sales-based single-digit royaltiesDebiopharm will assume sponsorship of P-I (MYTHIC)…
3 days ago

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Otsuka Pharmaceutical Acquires CAN10 Immunology Program from Cantargia for ~$613M

Shots:Otsuka Pharmaceutical has entered into an agreement with Cantargia for the acquisition of all assets related to its P-I IL-1RAP antagonist program, CAN10Otsuka Pharmaceutical will handle global development, regulatory approvals, manufacturing, & commercialization of CAN10. Otsuka has also acquired 3G5 as a backup antibody & holds exclusive negotiation right for next-gen IL-1RAP antibodies…
4 days ago

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BioAtla Presents Preliminary P-I Trial Data of BA3182 in Patients with Treatment Refractory Metastatic Adenocarcinoma at ESMO 2025

Shots:BioAtla has shared ongoing P-I dose-escalation trial data on BA3182 for treatment-refractory metastatic adenocarcinoma at ESMO 2025As of June 20, 2025, 39 pts received BA3182 (QW) in the range of 0.0026 to 0.6mg with either 0, 1, or 2 priming doses, 4–7 days before treatment; 17 received IV doses (0.0026–0.032mg) & 22 received SC doses…
July 7, 2025

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PulseSight Therapeutics Reports First Patient Dosing with PST-611 in P-I (PST-611-CT1) Trial for Dry AMD/Geographic Atrophy 

Shots:PulseSight Therapeutics has dosed first pts in the P-I (PST-611-CT1) trial to assess safety & tolerability of PST-611 in humansThe P-I single ascending dose study will evaluate safety & determine maximum tolerated dose of PST-611 for P-IIa trial in 6–12 pts with dry age-related macular degeneration/geographic atrophy pts, with preliminary results expected in…
July 7, 2025

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Brii Biosciences Enters a Licensing Deal with Joincare Pharmaceutical for BRII-693 to Treat Bacterial Infections

Brii Biosciences has entered into a license & technology transfer agreement with Joincare to develop & commercialize BRII-693 in the Greater China regionAs per the deal, Joincare will handle development, regulatory activities & commercialization of BRII-693 in Greater China in exchange for an upfront payment as well as development & commercial milestones, with net…
July 4, 2025

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Neurocrine Biosciences Initiates P-I Study of NBIP-01435 to Treat CAH

Neurocrine initiated a P-I first-in-human study of NBIP-01435 to assess safety, PK/PD, tolerability, and immunogenicity in healthy adults via SC injection for the potential treatment of congenital adrenal hyperplasia (CAH)NBIP-01435 (CRF1 antagonist) aims to improve androgen control and reduce glucocorticoid dosing. In Dec’24, the FDA approved Neurocrine's crinecerfont, an oral CRF1 antagonist, to treat…
July 1, 2025

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Libertas Bio Licenses Gusacitinib to Sanofi

Shots:Formation Bio reported that its subsidiary, Libertas Bio, has licensed gusacitinib, an oral dual JAK/SYK inhibitor, to Sanofi, which will investigate it in a new, previously unstudied indication through a P-I trialThe deal could total up to €545M ($627.64M), including upfront and milestone payments, along with low to mid-teen royalties on future sales…
June 25, 2025

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