Shots:
The US FDA has accepted sNDA & granted Priority Review to Kerendia (finerenone) for the treatment of chronic kidney disease (CKD) associated with type 1 diabetes (T1D)
sNDA was supported by the global P-III (FINE-ONE) trial assessing Kerendia (10 or 20mg, QD) + SoC vs PBO in 242 pts with CKD associated with T1D
Kerendia…
Shots:
The US FDA has granted Priority Review to Bayer’s Hyrnuo (sevabertinib) for the 1L treatment of adults with locally advanced or metastatic NSCLC harboring HER2 (ERBB2) TKD-activating mutations & no prior systemic therapy
sNDA was supported by preliminary data from Cohort F of the P-I/II (SOHO-01) trial evaluating the efficacy & safety of Hyrnuo…
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…
Shots:
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…
Shots:
The biopharma industry is a multi-hundred-billion-dollar market, with a projected compound annual growth rate (CAGR) of 8.6%, the global biopharma market is expected to reach $1.41T by 2034. Eli Lilly and Co. ranked first with $65.17B, followed by Pfizer ($61.19B) and AbbVie ($61.16B), reflecting strong market concentration among large-cap innovators with diversified, high-value portfolios …
Shots:
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…
Shots:
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…
Shots:
The Top 20 Radiopharma Companies of 2026, ranked by market capitalization, represent a powerful mix of global pharmaceutical leaders and agile innovators transforming radioligand therapies, alpha-emitters, and copper-based theranostics into pillars of modern oncology. What was once niche science is now redefining precision cancer care.
Flagship therapies such as Lutathera, Pluvicto, Pylarify, Illuccix/Gozellix, Xofigo,…
Shots:
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 &…
Shots:
Zydus Lifesciences has launched Anyra (aflibercept 2 mg), a biosimilar version of Eylea. Zydus has inked an agreement with Regeneron and Bayer
Aflibercept is a Vascular endothelial growth factor-A (VEGF-A) and placental growth factor (PlGF), which are members of the VEGF family of angiogenic factors that can act as mitogenic, chemotactic, and vascular permeability…

