Shots:
Alvotech and Teva reached a settlement and license agreement with Regeneron, allowing the US launch of AVT06, a biosimilar version of Eylea (aflibercept) in Q4’26 or earlier under certain conditions
AVT06 is an aflibercept (Eylea) biosimilar that inhibits VEGF and has been approved as Mynzepli in the UK and EEA and as Aflibercept BS in Japan
On…
Shots:
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…
Shots:
Lynozyfic is emerging as a standout in heavily pre-treated multiple myeloma. In the pivotal LINKER-MM1 trial, it delivered early, deep, and durable responses, offering renewed hope for patients with limited options. Its response-adapted dosing regimen further reduces treatment burden and enhances convenience
Regeneron is accelerating progress with a broad development strategy, advancing Lynozyfic across multiple therapy lines, combination regimens, precursor conditions, and global markets. The program…
Shots:
Regeneron has entered into a global collaboration with Tessera Therapeutics to develop & commercialize TSRA-196 as a one-time gene editing treatment of AATD
As per the deal, Tessera & Regeneron will equally share global development costs & potential future profits for TSRA-196. Tessera will receive $150M in upfront & equity investment plus $125M in near…
Shots:
The EC has approved Dupixent to treat mod. to sev. CSU pts (≥12yrs.), who were symptomatic despite H1 antihistamine treatment & naïve to anti-IgE therapy based on 2 P-III (Study A & C) trials from LIBERTY-CUPID program
Study A & C (N=284) assessed Dupixent + SoC antihistamines (loading dose then 300mg Q2W; pts weighing <60kg…
Shots:
ModeX & Regeneron entered into a license & collaboration agreement to develop multispecific antibodies across cancer and metabolic, combining ModeX’s MSTAR platform with Regeneron’s antibody binders
Regeneron will fund & lead all development & commercialization in exchange for $7M upfront, plus future product selection, clinical, regulatory, & commercial milestones over $200M per molecule, with…
Shots:
The CHMP has recommended Libtayo (cemiplimab) as an adj. treatment for CSCC adults who are at high risk for recurrence after surgery & radiation
Opinion was based on the P-III (C-POST) trial assessing Libtayo adj. (350mg, IV, Q3W for first 12wks. followed by 700mg, IV, Q6W for 36wks.; n=209) vs PBO (n=206) to treat…
Shots:
The US FDA has approved Libtayo (cemiplimab-rwlc) under priority review as an adj. treatment for CSCC adults who are at high risk for recurrence after surgery & radiation; application under EMA’s review, with decision expected in H1’26
Approval was based on the P-III (C-POST) trial assessing Libtayo adj. (350mg, IV, Q3W for first 12wks.…
Shots:
The P-III (EMPOWER-Lung 3) trial assessed Libtayo (350mg, Q3W for 108wks.; n=312) vs PBO (n=154), both with Pt-based CT (Q3W ×4 cycles), in 466 adults with LA/M NSCLC harboring no EGFR, ALK, or ROS1 alteration
At mFU of 60.9mos., trial showed a 34% reduction in death risk (mOS: 21.1 vs 12.9mos.; 5yr. survival probability:…
Shots:
The P-III NIMBLE trial enrolled adults with symptomatic gMG & anti-AChR antibodies, randomizing them to cemdisiran (600mg, SC, Q12W, n=64), cemdi-poze (SC, Q4W, n=67), or PBO (n=59), with completion rates of 100%, 96%, & 90%, respectively; FDA’s filing is expected in Q1’26, pending discussions
Trial met its 1EP of improved MG-ADL total score, showing…

