Heron Therapeutics, Inc.

Heron Therapeutics has reached a settlement agreement with Mylan Pharmaceuticals to resolve ongoing patent litigations related to CINVANTI and APONVIE injectable emulsions.

Design Therapeutics has appointed Chris Storgard, M.D., as Chief Medical Officer, bringing over two decades of leadership in drug development with experience advancing multiple assets through global regulatory approvals.

The FDA has approved Heron Therapeutics' Prior Approval Supplement Application for the Zynrelef Vial Access Needle (VAN).

• Vanda Pharmaceuticals awaits FDA decision on tradipitant for gastroparesis, a condition affecting millions in the U.S., with a verdict expected by September 18. • Zevra Therapeutics anticipates potential approval of arimoclomol for Niemann-Pick disease type C (NPC) by September 21, following positive advisory committee support. • The FDA is set to decide on Heron Therapeutics' extended-release needle for Zynrelef by September 23, designed to simplify drug preparation and administration. • Merck seeks approval for Keytruda in pleural mesothelioma, with a decision due September 25, based on Phase II/III KEYNOTE-483 trial data showing improved survival. • Bristol Myers Squibb awaits FDA decision on KarXT for schizophrenia by September 26, potentially offering a novel mechanism of action targeting muscarinic receptors. • Sanofi and Regeneron anticipate a decision on Dupixent for COPD by September 27, supported by Phase III BOREAS and NOTUS trials demonstrating reduced exacerbations.

• The FDA is expected to decide on Vanda Pharmaceuticals' tradipitant for gastroparesis by September 18, potentially offering a novel NK-1R antagonist treatment option. • Zevra Therapeutics awaits a verdict by September 21 on arimoclomol for Niemann-Pick disease type C, an ultrarare neurodegenerative disorder with no approved therapies. • A decision is anticipated by September 26 on Bristol Myers Squibb's KarXT for schizophrenia, representing a new pharmacological approach targeting muscarinic receptors.