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 trial The deal could total up to €545M ($627.64M), including upfront and milestone payments, along with low to mid-teen royalties on future sales…

ByDipanshu Dixit3 days ago

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Merck and Daiichi Sankyo Report First Patient Dosing with Ifinatamab DXd in P-III (IDeate-Prostate01) Trial for mCRPC

Shots: Merck & Daiichi Sankyo have dosed first pts with ifinatamab deruxtecan (I-DXd) in its P-III (IDeate-Prostate01) trial for metastatic castration-resistant prostate cancer (mCRPC), which was initiated based on positive P-I/II (IDeate-PanTumor01) trial data The P-III (IDeate-Prostate01) trial will evaluate I-DXd (12mg/kg) vs docetaxel (75mg/m²) plus corticosteroid in ~1440 mCRPC pts, who progressed during or after…

ByRidhi RastogiJune 19, 2025

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NextCure Signs a ~$745M Licensing Agreement with Simcere Zaiming for SIM0505

Shots: Simcere has granted NextCure exclusive global rights to develop, manufacture, & commercialize SIM0505 to treat solid tumors, excl. Greater China, where Simcere will retain its rights As per the deal, Simcere will receive ~$745M in upfront, development, regulatory & sales milestones, along with net sales-based royalties up to double-digits outside of Greater China. NextCure…

ByRidhi RastogiJune 17, 2025

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Philochem and RayzeBio Enter Into a Development and Commercialization Deal of ~$1.35B

Shots: Philochem and RayzeBio (BMS) entered into a development and commercialization agreement under which Philochem granted RayzeBio exclusive worldwide rights to develop, manufacture, and commercialize its radiopharmaceutical agent OncoACP3 for prostate cancer Under the agreement, Philochem will receive $350M up front and is eligible for up to $1B in development, regulatory, and commercial milestones, plus…

ByPrince GiriJune 11, 2025

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Cullinan Therapeutics Enters a ~$712M Licensing Deal with Genrix Bio for Velinotamig

Shots: Genrix Bio has granted Cullinan exclusive global license to velinotamig, excl. Greater China for all indications, with Cullinan planning to develop it in autoimmune diseases As per the deal, Genrix will receive $20M upfront, ~$292M in development & regulatory milestones & ~$400M in sales-based milestones, with net sales-based tiered royalties from mid-single digits up to…

ByRidhi RastogiJune 5, 2025

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The EC Approves Roche’s Evrysdi Tablet for Spinal Muscular Atrophy

Shots: The EC has approved label extension of Evrysdi (5mg oral tablet) for pts with spinal muscular atrophy (SMA) Approval was based on P-I study assessing Evrysdi 5mg tablet vs oral solution, showing bioequivalence with comparable efficacy & safety; data was presented at SMA Europe 2024 Evrysdi, an SMN2 splicing modifier, treats SMA caused by…

ByRidhi RastogiJune 5, 2025

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MavriX Bio Reports the US FDA’s IND Clearance of MVX-220 for Angelman Syndrome

Shots: The US FDA has approved IND application of MVX-220 for the treatment of Angelman Syndrome (AS) to initiate P-I/II (ASCEND-AS) trial, with first pts dosing expected in H2’25 The P-I/II trial will evaluate the safety, tolerability, & effectiveness of MVX-220 in both adult & pediatric pts with multiple AS genotypes, incl. rare types like uniparental…

ByRidhi RastogiMay 13, 2025

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UTR Therapeutics Seeks the US FDA’s IND Clearance of UTRxM1-18 to Target c-MYC-Driven Cancers

Shots: The US FDA has received the IND application for UTRxM1-18, a novel therapy targeting c-MYC-driven cancers, to initiate P-I trial in 2026 pending approval, focusing on c-MYC driven tumors incl. triple-negative breast, pancreatic, colorectal, & ovarian cancer UTRxM1-18 has demonstrated strong, dose-dependent efficacy against human-derived tumors from multiple cancer subtypes, with no dose-limiting toxicities…

ByRidhi RastogiMay 9, 2025

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FDA Grants Verastem Oncology’s Avmapki + Fakzynja Accelerated Approval for KRAS-Mutated Low-Grade Serous Ovarian Cancer (LGSOC)

Shots: This accelerated approval for the combination of Avmapki (avutometinib) + Fakzynja (defactinib) was granted in advance to the planned PDUFA of Jun 30, 2025, which will be available in the US within a week as a co-pack Approval was based on P-II (RAMP 201) trial assessing Avmapki (3.2mg, twice weekly) + Fakzynja (200 mg,…

ByDipanshu DixitMay 9, 2025

News

Eli Lilly Enters a ~$415M Licensing Agreement with Alchemab Therapeutics for ATLX-1282 to Treat Amyotrophic Lateral Sclerosis (ALS)

Shots: Eli Lilly has entered into a licensing agreement with Alchemab for ATLX-1282 to treat ALS & other neurodegenerative conditions As per the deal, Alchemab will receive ~$415M, incl. an upfront payment, potential discovery, development, & commercial payments, as well as royalties, plus will handle early P-I trial activities, with Lilly leading further development &…

ByRidhi RastogiMay 6, 2025

Libertas Bio Licenses Gusacitinib to Sanofi

Merck and Daiichi Sankyo Report First Patient Dosing with Ifinatamab DXd in P-III (IDeate-Prostate01) Trial for mCRPC

NextCure Signs a ~$745M Licensing Agreement with Simcere Zaiming for SIM0505

Philochem and RayzeBio Enter Into a Development and Commercialization Deal of ~$1.35B

Cullinan Therapeutics Enters a ~$712M Licensing Deal with Genrix Bio for Velinotamig

The EC Approves Roche’s Evrysdi Tablet for Spinal Muscular Atrophy

MavriX Bio Reports the US FDA’s IND Clearance of MVX-220 for Angelman Syndrome

UTR Therapeutics Seeks the US FDA’s IND Clearance of UTRxM1-18 to Target c-MYC-Driven Cancers

FDA Grants Verastem Oncology’s Avmapki + Fakzynja Accelerated Approval for KRAS-Mutated Low-Grade Serous Ovarian Cancer (LGSOC)

Eli Lilly Enters a ~$415M Licensing Agreement with Alchemab Therapeutics for ATLX-1282 to Treat Amyotrophic Lateral Sclerosis (ALS)

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