Shots:In this second installment of Dealmaker 2024, PharmaShots presents an insightful guide to the top M&A deals ranked by deal value
This report highlights Novo Nordisk’s remarkable achievements, including 24 collaborations spanning acquisitions, company formations, contract services, development and commercialization agreements, facility purchases, licensing options, and platform/product purchases. Collectively, these deals amount to…
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Shots:REGENXBIO & Nippon have partnered to develop RGX-121 (Hunter syndrome; FDA’s accelerated approval expected in late 2025, with ongoing rolling BLA filing) & RGX-111 (P-I/II study for Hurler syndrome) in the US & Asia. The closing is expected in Q1’25
REGENXBIO will get $110M upfront, ~$700M milestones ($40M development & regulatory + $660M…
Shots:The NMPA has granted sNDA approval of Orpathys to treat locally advanced or metastatic NSCLC with MET exon 14 skipping alterations, expanding its indication to include both treatment-naïve & experienced patients. Previous conditional approval is also converted to full approval
Approval was based on P-IIIb study, with preliminary data from the first line…
Shots:Neurogen Biomarking partnered with Linus Health to form a unified platform by incorporating the latter’s digital cognitive assessments with the Neurogen Biomarking ecosystem, commercially available in Q1’25
The new platform will integrate early detection & care for patients with MCI or dementia related to AD with Linus Health’s scientifically validated assessments to identify…
Shots:The P-III (C-POST) trial assessed Libtayo adj. (n=205; 350mg, IV, Q3W for first 12wks. followed by 700mg, IV, Q6W for 36wks.) vs PBO (n=204) to treat high-risk CSCC patients (N=415) for ~48wks.
Study met its first prespecified interim analysis, showing 68% reduced disease occurrence & death risk at 24mos. median follow-up, with additional…
Shots:AbbVie & Simcere Zaiming (subsidiary Simcere Pharma) have signed an option to license agreement for developing SIM0500, being assessed in P-I for r/r multiple myeloma (MM) in the US & China
As per the terms, Simcere will get an upfront, up to $1.055B option fees & milestones plus net-sales-based tiered royalties outside Greater China…
Shots:FDA has accepted & granted priority review to the BLA of datopotamab deruxtecan (Dato-DXd) for treatment-experienced patients with LA/M EGFR-mutated NSCLC (PDUFA: Q3’25) which also received BTD from US FDA
BLA & designation were based on P-II (TROPION-Lung05) & P-III (TROPION-Lung01) trials along with supporting data from P-I (TROPION-PanTumor01) study. The combined findings…
Shots:Eli Lilly to acquire Scorpion, plus its leading asset STX-478, for ~2.5B in cash, incl. upfront, regulatory & sales milestones through a definitive agreement
As per the terms, Scorpion will form an independent company owned by its current shareholders with Lilly’s minority stake to hold its employees & non-PI3Kα pipeline assets
STX-478 (oral,…
Shots:The US FDA has granted 510(k) Clearance for Aptiva’s APS IgG & APS IgM reagents, expanding its portfolio from Celiac Diseases & CTD essential reagents to 18 FDA-cleared analytes
The APS reagents semi-quantitatively detect anti-cardiolipin (aCL), plus anti-β2 glycoprotein 1 (aβ2GP1) IgG & IgM in serum levels, aiding in diagnoses of 1° & 2° APS…
Shots:Teva Pharmaceuticals International secured semi-exclusive marketing rights for FYB203, a biosimilar of Eylea (aflibercept), in Europe (excl. Italy) & Israel via a deal with Klinge & Formycon, boosting Teva’s biosimilar portfolio
The deal combines Teva’s commercial expertise & distribution network with Formycon’s biosimilar development capabilities, following their successful collaboration on marketing FYB201, a…
