Nanjing Leads Biolabs Reports First Patient Enrolment in P-Ib/II Trial of Opatisumab for Advanced Melanoma

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 ChinaAdditionally, 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…

ByRidhi RastogiSeptember 12, 2025

NEWS

Pulmovant and Roivant’s Mosliciguat Receives MHLW’s Orphan Drug Designation for Pulmonary Hypertension Associated with Interstitial Lung Disease

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 2025Mosliciguat is an sGC activator that…

ByRidhi RastogiSeptember 5, 2025

NEWS

Expedition Therapeutics Enters a ~$645M Licensing Deal with Fosun Pharma for XH-S004

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 rightsAs per the deal, Fosun will receive $120M incl. upfront & development milestone payments, with ~$525M in sales milestonesXH-S004 (DPP-1 inhibitor, PO) is being investigated…

ByRidhi RastogiAugust 12, 2025

SPOTLIGHT

CXO Talks: Thomas Chalberg & Annahita Keravala from Genascence in a Candid Conversation with PharmaShots

Shots:PharmaShots speaks with Thomas Chalberg, Founder and CEO of Genascence Corporation, and Annahita Keravala, Founder and CSO of Genascence CorporationThomas 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 diseaseThe duo highlighted the safety and tolerability…

ByAditya SinghAugust 11, 2025

NEWS

Flare Therapeutics Reports First Patient Dosing in P-Ib Trial of FX-909 for Urothelial Cancer

Shots:Flare Therapeutics has dosed its first patient with FX-909 in P-Ib trial for the treatment of locally-advanced or metastatic urothelial cancerThe 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…

ByRidhi RastogiAugust 7, 2025

NEWS

Regeneron’s Lynozyfic (Linvoseltamab-gcpt) Receives the US FDA’s Accelerated Approval for R/R Multiple Myeloma

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 ongoingIn…

ByRidhi RastogiJuly 3, 2025

NEWS

Eli Lilly to Acquire Verve Therapeutics for ~$1.3B

Shots:Eli Lilly has entered into a definitive agreement to acquire Verve Therapeutics to advance cardiovascular therapiesAs 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;…

ByRidhi RastogiJune 17, 2025

NEWS

Recursion Presents Preliminary P-Ib/II (TUPELO) Trial Data of REC-4881 for Familial Adenomatous Polyposis (FAP) at DDW 2025

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 mutationsAs of Mar 17, 2025, 4mg (n=6) showed a median 43% polyp burden decrease; 5/6 had reductions of…

ByRidhi RastogiMay 5, 2025

NEWS

Novartis to Acquire Regulus Therapeutics for ~$1.7B

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 NovartisAs per the deal, Regulus will get ~$0.8B upfront, with shareholders receiving $7/share in cash, & ~$0.9B upon achievement of a…

ByRidhi RastogiMay 1, 2025

NEWS

Regeneron’s Lynozyfic (Linvoseltamab) Receives the EC’s Conditional Approval for R/R Multiple Myeloma

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…

ByRidhi RastogiApril 29, 2025

Nanjing Leads Biolabs Reports First Patient Enrolment in P-Ib/II Trial of Opatisumab for Advanced Melanoma

Pulmovant and Roivant’s Mosliciguat Receives MHLW’s Orphan Drug Designation for Pulmonary Hypertension Associated with Interstitial Lung Disease

Expedition Therapeutics Enters a ~$645M Licensing Deal with Fosun Pharma for XH-S004

CXO Talks: Thomas Chalberg & Annahita Keravala from Genascence in a Candid Conversation with PharmaShots

Flare Therapeutics Reports First Patient Dosing in P-Ib Trial of FX-909 for Urothelial Cancer

Regeneron’s Lynozyfic (Linvoseltamab-gcpt) Receives the US FDA’s Accelerated Approval for R/R Multiple Myeloma

Eli Lilly to Acquire Verve Therapeutics for ~$1.3B

Recursion Presents Preliminary P-Ib/II (TUPELO) Trial Data of REC-4881 for Familial Adenomatous Polyposis (FAP) at DDW 2025

Novartis to Acquire Regulus Therapeutics for ~$1.7B

Regeneron’s Lynozyfic (Linvoseltamab) Receives the EC’s Conditional Approval for R/R Multiple Myeloma

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