DISCLAIMER — Not financial advice. Educational content only, not an offer or solicitation to buy or sell any security. Biotech and small/mid-cap stocks are highly speculative and volatile and can result in a partial or total loss of capital. Do your own research and consult a licensed advisor where appropriate. / Contenuti a solo scopo informativo e didattico, non costituiscono consulenza finanziaria né offerta o sollecitazione al pubblico risparmio ai sensi delle normative CONSOB e SEC. Le azioni biotech e le small/mid cap sono strumenti altamente speculativi e volatili e possono comportare la perdita parziale o totale del capitale investito. Si raccomanda di effettuare sempre le proprie ricerche e, se necessario, di rivolgersi a un consulente abilitato.

Merlintrader Trading Pub
Biotech catalyst news and analysis. FDA PDUFA tracker

Merlintrader Trading Pub
Biotech catalyst news and analysis. FDA PDUFA tracker
Category Uncategorized
Travere Therapeutics ( $TVTX ) after FILSPARI’s FDA approval in FSGS

Travere Therapeutics did not just clear another FDA box on April 13, 2026. It materially changed the shape of its equity story. FILSPARI, already commercial in IgA nephropathy, now has a second FDA-approved kidney disease indication: reduction of proteinuria in adults and pediatric patients aged 8 years and older with focal segmental glomerulosclerosis, or FSGS, without nephrotic syndrome. That is a narrower label than the most aggressive bulls had once hoped for, but it is still a real commercial approval, not a consolation prize, and it makes FILSPARI the first and only FDA-approved medicine for FSGS.
IOVANCE BIOTHERAPEUTICS (NASDAQ: $IOVA) March 27 2026 DD

Iovance enters the next stretch in a very different place than where the bull case used to live. The stock still has a powerful story behind it: AMTAGVI is already commercial, the TIL platform is no longer theoretical, and the company is trying to push that proof into larger and commercially more meaningful opportunities such as NSCLC. But this is also a company that the market punished hard when execution, European regulatory ambition and financing optics stopped matching the earlier narrative. That history matters because it explains why each new positive data point now has to pass a tougher test with investors.
Kodiak Sciences ( $KOD ): GLOW2 hits cleanly, Zenkuda clears the second major diabetic retinopathy hurdle
Positive GLOW2 topline data do more than add one more green headline to the tape. They materially strengthen the diabetic retinopathy package around Zenkuda, reduce the “one-study wonder” risk left after GLOW1, and push the KOD debate toward the next question that really matters: how much value the market should assign to a program that now looks BLA-ready across multiple retinal settings, while still carrying the memory of earlier setbacks and the need to deliver again in DAYBREAK.
Artelo Biosciences ( $ARTL ) — Final March 2026 Update: hard Nasdaq deadline, fragile balance sheet, and a real separation between pipeline promise and financing reality

Next Catalyst / Prossimo catalyst: March 30, 2026 Nasdaq compliance deadline on the stockholders’ equity rule, based on the company’s disclosed panel extension. EN / IT toggle inside the content area, with mirrored sections. EN IT Artelo Biosciences (ARTL) —…