LYTENAVA BLA Accepted by FDA; PDUFA Date Set for July 29, 2026.

研报英文原文证据摘录

LYTENAVA BLA Accepted by FDA; PDUFA Date Set for July 29, 2026.

line with Lucentis biosimilars yet still likely multiples higher than

the price point Outlook is expected to arrive at for LYTENAVA. Although compounded bevacizumab is estimated to cost less than

$100/injection, mgmt. estimates that the adjusted cost ends up closer to $1k/injection when rapid switching to more expensive TxRESEARCH options is accounted for. OTLK’s conversations with payors representing over 270 million lives indicate a high degree of willingness

to support a shift away from widespread use of compounded bevacizumab. Outside of payors, most doctors do not earn a profit

by prescribing off-label bevacizumab. If OTLK's eventual pricing strategy can allow doctors to profit more from LYTENAVA vs.

compounded bevacizumab, we think this could be an additional pull factor to opt for LYTENAVA rather than an off-label product.

Compounded bevacizumab could fall out of favor in the US if LYTENAVA is approved by the FDA. OTLK mgmt. believes that

compound pharmacists who choose to continue making compounded bevacizumab after LYTENAVA becomes commercially

available could put their entire operations at risk. Laws and regulations aside, high particulate counts, less-than-ideal storage

conditions, and lack of reachable/extractable testing are well-known shortcomings of compounded bevacizumab that LYTENAVA

significantly improves upon with higher manufacturing standards. Management has also noted that repackaging leads to protein

shearing and reaggregation, which likely is another source of high batch-to-batch variability in current off-label bevacizumab use.

Interestingly, OMIC (Private), the largest ophthalmic medical malpractice insurer in the US, has indicated that if a patient is being