Shots:
Bayer has reported topline P-III (REVEAL) trial data assessing PET/CT radiotracerI 124 evuzamitide (IV) vs clinical SoC diagnosis in 170 adults with suspected cardiac amyloidosis
Trial met its 1EPs of sensitivity & specificity for the diagnosis of cardiac amyloidosis based on visual scan; data will be discussed with regulators, presented in future & submitted…
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Bayer has entered into an agreement to fully acquire Perfuse Therapeutics, incl. its asset PER-001, complementing Bayer’s pipeline & expertise in ophthalmology
As per the deal, Bayer will acquire Perfuse for ~$2.45B, incl. $300M upfront payment & additional development, regulatory, & commercial milestone payments;
PER-001 (intravitreal implant), a small molecule endothelin receptor antagonist, is…
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Formycon has signed a settlement and license agreement with Regeneron and Bayer for the commercialization of FYB203, a biosimilar version of Eylea 2 mg (aflibercept 0.05 ml of 40 mg/mL solution), in the EU
Under the agreement, both products may launch in the EU and other regions, including LATAM and Asia-Pacific, from May 2026. Earlier, in October 2025, Formycon secured…
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Bayer has reported the P-III (FIND-CKD) trial data assessing Kerendia (finerenone; 10 or 20mg) vs PBO, both in addition to SoC, in >1,500 adults with non-diabetic chronic kidney disease
Trial met its 1EP, showing a statistically significant improvement in eGFR slope, defined as the mean annual change in eGFR from baseline to Month 32; data…
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Bayer has reported the P-III (PEACE-3) trial assessing Xofigo (radium-223 dichloride; 55kBq/kg, IV, QM for 6 cycles) + enzalutamide (160mg, PO, QD) vs enzalutamide in asymptomatic or mildly symptomatic pts (Brief Pain Inventory score <4) with mCRPC & ≥2 bone metastases
Trial showed improved OS (2EP), with a 24% reduction in death risk &…
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The P-III (OCEANIC-STROKE) trial assessed asundexian (50mg, QD, PO) vs PBO, both in combination with antiplatelet therapy, in pts (n=12,327) for prevention of ischemic stroke after a non-cardioembolic ischemic stroke or high-risk transient ischemic attack
Trial showed a 26% reduction in recurrent ischemic stroke without increased ISTH major bleeding across all subgroups, met key…
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Samsung Bioepis has signed a settlement and license agreement with Regeneron and Bayer for the commercialization of SB15, a biosimilar version of Eylea 2 mg (aflibercept 40 mg/mL solution), in markets excluding the US and Canada
The agreement allows Samsung Bioepis to launch SB15 in the UK from Jan 2026, across the EU from Apr 2026,…
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Alvotech has signed a settlement and license agreement with Regeneron and Bayer for Eylea 2 mg (aflibercept) biosimilar. With prior US rights effective Q4’26, Alvotech now holds worldwide manufacturing and supply rights for its commercial partners
The settlement enables Alvotech and partners to launch the biosimilar from Jan 1, 2026, in the UK and Canada, May 1, 2026,…
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Genethon has entered into an exclusive, worldwide licensing agreement with AskBio for the use of a patented component of AskBio’s investigational gene therapy AB-1009 for the treatment of Pompe disease
The licensed component is based on a transgene encoding a truncated form of GAA, developed by Genethon, which demonstrated preclinical efficacy in correcting glycogen…
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Biocon Biologics has signed a settlement and license agreement with Regeneron and Bayer for Yesafili (Biosimilar, Eylea) in the EU and globally, following a prior US and Canada settlement
Biocon Biologics, Regeneron, and Bayer settled all pending litigation, allowing Yesafili’s UK launch in Jan’26 and other countries by Mar’26 or earlier. YESAFILI launched in Canada in 2024, and US market entry secured in April…

