Regulatory - REDFILED

PALI

FDA Clears PALISADE BIO IND for PALI-2108 in Crohn's Disease

Palisade Bio can start the Phase 2 ASCENTRA-CD trial of its oral PDE4 prodrug, with first dosing targeted for Q1 2027 and a primary readout in Q1 2028.

Filana Therapeutics is preparing a Phase 2a trial of simufilam in patients with drug-resistant seizures linked to tuberous sc

FLNA

FDA Lifts Clinical Hold on FILANA's Simufilam in TSC Epilepsy

Filana Therapeutics can start a 40-patient Phase 2a study of simufilam in TSC-related epilepsy, with screening expected by the first quarter of 2027.

Susan Galbraith leads AstraZeneca's oncology R&D efforts behind the Enhertu breast cancer program.

AZN

ASTRAZENECA'S Enhertu Wins EU CHMP Backing in Early Breast Cancer

CHMP recommended Enhertu for adjuvant use in HER2-positive early breast cancer after Phase III trial cut recurrence risk by 53%.

InMed develops small molecule drug candidates targeting the CB1 and CB2 receptors.

INM

INMED (INM) Falls Short of Nasdaq Equity Rule Ahead of Mentari Merger

InMed reported shareholders' equity of $1.08 million, below Nasdaq's $2.5 million minimum, and says its pending merger with Mentari should restore compliance.

BeyondSpring is a clinical-stage biopharmaceutical company based in Florham Park, New Jersey.

BYSI

BEYONDSPRING (BYSI) Files 8-K on Nasdaq Listing Compliance Issue

The clinical-stage biotech filed an Item 3.01 disclosure covering a delisting notice or failure to meet a continued listing standard.

Amneal is launching a prefilled-syringe version of lanreotide in the United States.

AMRX

FDA Approves AMNEAL (AMRX) Generic of $983M Somatuline Depot, Launch Immediate

Amneal won FDA approval for lanreotide injection 120 mg/0.5 mL with Competitive Generic Therapy designation and is launching the product immediately.

Cosentyx is aimed at adults with polymyalgia rheumatica who relapse as steroids are tapered.

NVS

NOVARTIS (NVS) Wins Positive CHMP Opinion for Cosentyx in Polymyalgia Rheumatica

The EMA committee recommends Cosentyx for adults with PMR who fail steroids, which would make it the first IL-17A inhibitor cleared for the disease in Europe.

A dispute over a sold life insurance portfolio has moved to the US courts.

Regulatory

RESS LIFE INVESTMENTS Sues Buyer of Life Portfolio Over $129M Earn-Out

The Danish fund has terminated the sale of its legacy life insurance portfolio and filed US court complaints alleging fraud and breach of contract.

ABEO

FDA Approval of Ultragenyx Gene Therapy Triggers ABEONA Royalties

Abeona is eligible for commercial milestone payments and royalties after the FDA approved FAYUVI, the Sanfilippo type A gene therapy it out-licensed in 2022.

RARE

FDA Clears ULTRAGENYX (RARE) Gene Therapy Fayuvi for Sanfilippo Syndrome Type A

The FDA approved Fayuvi (rebisufligene etisparvovec-hopf), the first treatment for pediatric patients with MPS IIIA, a rare inherited disorder.

RARE

FDA Approves ULTRAGENYX (RARE) Gene Therapy for Sanfilippo Syndrome Type A

Ultragenyx wins full FDA approval for FAYUVI, the first treatment ever cleared for MPS IIIA, and receives a Priority Review Voucher.

Frehemgo is delivered through a single-use pre-filled pen for subcutaneous injection.

NVO

CHMP Backs EU Approval of NOVO NORDISK Haemophilia Drug Frehemgo

European regulators' advisory committee recommended marketing authorisation for denecimig, with first European launches planned for the fourth quarter of 2026.