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breaking MIRM

Mirum's Brelovitug Meets Phase 3 Endpoint in Hepatitis D

Mirum's brelovitug hit the AZURE-1 primary endpoint in chronic hepatitis delta, with 56% of the weekly-dose arm achieving virologic response plus ALT normalization versus 0% on delayed treatment.

September 28, 2026 · Rare disease · $MIRM
breaking

AZN Etcamah Misses SERENA-4 First-Line Endpoint

AstraZeneca's Etcamah missed the SERENA-4 first-line breast cancer endpoint, capping the oral SERD to the ESR1-mutant niche. Its accelerated approval is intact.

September 25, 2026
breaking

KYTX Miv-cel CAR-T: One-Year Durability in SPS

Kyverna's CD19 CAR-T miv-cel held up at one year in stiff person syndrome, with a rolling BLA due Q4 2026. It could be the first CAR-T for autoimmune disease.

September 24, 2026
breaking

ITM 177Lu-Edotreotide CRL: Manufacturing Only

The FDA issued a CRL for ITM 177Lu-edotreotide in GEP-NETs on Aug 7, citing only manufacturing and facility items. The Phase 3 COMPETE win still stands.

August 22, 2026
breaking

VOGX IPO Surges 127% on Mizagliflozin for PBH

Vogenx (VOGX) priced an $81M IPO at $13 and ran to $29.52 as mizagliflozin, an oral SGLT1 inhibitor for post-bariatric hypoglycemia, rode the Amylyx wave.

August 22, 2026
breaking BMY

BMY Zenbexus: First CELMoD Approval in Myeloma

The FDA approved Bristol Myers Squibb's Zenbexus (iberdomide) for relapsed multiple myeloma, the first CELMoD. MRD-negative response hit 41% versus 21%.

August 21, 2026 · Oncology · $BMY
breaking

IPHA Lacutamab: $540M Sobi Deal Funds Phase 3

Sobi pays Innate $75M upfront for lacutamab, a first-in-class antibody for Sézary syndrome. The deal funds the Phase 3 trial toward accelerated approval.

August 10, 2026
breaking

Elevar Gets Third CRL for Rivoceranib in HCC

FDA issued a third CRL for Elevar's rivoceranib in liver cancer. The 23.8-month OS was never the problem. Manufacturing failures killed an approvable drug.

July 25, 2026
breaking

GSK Lynavoy CHMP: First PBC Itch Drug for EU

The EMA's CHMP recommended GSK's Lynavoy (linerixibat), the first IBAT inhibitor for cholestatic pruritus in PBC, setting up EU approval within 67 days.

July 25, 2026
breaking

JNJ Icotyde: First Oral IL-23 Pill Wins CHMP

The EMA's CHMP backed J&J's Icotyde (icotrokinra), the first oral IL-23 receptor antagonist, for moderate-to-severe plaque psoriasis in adults and teens 12+.

July 25, 2026
breaking OTLK

FDA Approves Lytenava for Wet AMD on Fourth Attempt

FDA approved Lytenava for wet AMD on July 24, five days early. First approved ophthalmic bevacizumab after three prior CRLs. OTLK at $1.32, cap $247M.

July 24, 2026 · Ophthalmology · $OTLK