Skip to content Skip to footer
Subscribe Now
NEWS

Deciphera Pharmaceuticals Reports the CHMP’s Positive Opinion of Romvimza for Symptomatic Tenosynovial Giant Cell Tumor (TGCT)

Shots: The CHMP has recommended Romvimza (vimseltinib) to treat symptomatic TGCT with physical function deterioration in adults for which surgery may lead to functional impairment or severe morbidity; EC’s decision is expected in Q3'25 Opinion was based on P-I/II trial as well as P-III (MOTION) trial, which evaluated Romvimza vs PBO in surgery-ineligible pts without…
July 29, 2025

Read more

NEWS

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 cardiomyopathy Designation 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…
July 18, 2025

Read more

NEWS

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 tumors As 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 royalties Debiopharm will assume sponsorship of P-I (MYTHIC)…
July 16, 2025

Read more

NEWS

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, CAN10 Otsuka 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…
July 15, 2025

Read more

NEWS

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 2025 As 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

Read more

NEWS

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 humans The 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

Read more

NEWS

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 region As 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

Read more

NEWS

HanchorBio Out-Licenses HCB101 to Shanghai Henlius Biotech For ~$202M

Shots: HanchorBio entered into an out-licensing agreement with Shanghai Henlius Biotech and granted exclusive rights to develop and commercialize HCB101 in Greater China, Southeast Asia, and MENA Under the terms and agreement, HanchorBio will receive $10M upfront and up to $192M in development and regulatory milestones, plus tiered royalties Henlius will also oversee development, production,…
July 1, 2025

Read more

NEWS

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

Read more

Load more