Shots:
Nanjing Leads Biolabs has enrolled the first patient in P-Ib/II trial assessing opatisumab as monotx. & in combination with toripalimab, for the treatment of 1L advanced melanoma in China
Additionally, Opatisumab is being evaluated as monotx. in a registrational study for EP-NEC that completed enrolment in Aug 2025, & is also under investigation in multiple P-II trials…
Shots:
Japan’s MHLW has granted ODD to mosliciguat for the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD)
Mosliciguat (dry powder inhaler) is being evaluated in an ongoing global P-II (PHocus) trial against PBO among ~120 PH-ILD adults, with trial design to be presented at ERS Congress 2025
Mosliciguat is an sGC activator that…
Shots:
Fosun Pharma has granted Expedition global rights to develop, manufacture, & commercialize XH-S004, excl. Mainland China, Hong Kong SAR, & Macau SAR, where Fosun will retain its rights
As per the deal, Fosun will receive $120M incl. upfront & development milestone payments, with ~$525M in sales milestones
XH-S004 (DPP-1 inhibitor, PO) is being investigated…
Shots:
PharmaShots speaks with Thomas Chalberg, Founder and CEO of Genascence Corporation, and Annahita Keravala, Founder and CSO of Genascence Corporation
Thomas and Annahita speak eloquently about Genascence's current lead program, GNSC-001, for osteoarthritis of the knee, and shed light on the unmet medical needs in the disease
The duo highlighted the safety and tolerability…
Shots:
Flare Therapeutics has dosed its first patient with FX-909 in P-Ib trial for the treatment of locally-advanced or metastatic urothelial cancer
The P-Ib trial will assess FX-909 (30 & 50mg; QD) in 40 pts, incl. a biomarker-defined population, building on clinical PoC achieved in P-Ia, with P-Ia data to be presented in 2025. Efficacy…
Shots:
The US FDA has granted accelerated approval to Lynozyfic for the treatment of r/r MM pts, who have received ≥4L therapy, incl. a proteasome inhibitor, an immunomodulatory agent & an anti CD38 mAb based on P-I/II (LINKER-MM1) trial in >300 pts; a SC P-I trial portion & IV P-II dose expansion portion is ongoing
In…
Shots:
Eli Lilly has entered into a definitive agreement to acquire Verve Therapeutics to advance cardiovascular therapies
As per the deal, Lilly will acquire Verve for $10.50/share in an all-cash transaction totaling ~$1B, along with one non-tradeable CVR of $3/share tied to first pts dosing with VERVE-102 for ASCVD in P-III trial by year 10 post-closing;…
Shots:
P-Ib/II (TUPELO) trial (enrolment ongoing) assessed REC-4881 (4 or 8mg, QD) in FAP, with P-II evaluating efficacy via upper & lower endoscopy at Wk. 0, 13 (on-treatment), & 25 (off-treatment) in pts (≥55yrs.) with APC mutations
As of Mar 17, 2025, 4mg (n=6) showed a median 43% polyp burden decrease; 5/6 had reductions of…
Shots:
Novartis to acquire Regulus Therapeutics incl. its lead asset, farabursen via its wholly owned subsidiary, which will merge with Regulus upon closing, resulting in Regulus becoming an indirect wholly owned subsidiary of Novartis
As per the deal, Regulus will get ~$0.8B upfront, with shareholders receiving $7/share in cash, & ~$0.9B upon achievement of a…
Shots:
The EC has granted conditional approval to Lynozyfic for the treatment of adults with r/r multiple myeloma based on P-I/II (LINKER-MM1) trial data assessing Lynozyfic in >300 pts; P-II dose expansion portion is ongoing. BLA under the US FDA’s Review (PDUFA: Jul 10, 2025)
In the trial, 117 pts on 200mg had a 71% ORR, with…

