Gossamer Bio (GOSS) is proceeding toward a September new drug application submission for seralutinib as a potential treatment for patients with pulmonary arterial hypertension, the company said Monday.
The plans follow a "productive" pre-application meeting with the U.S. Food and Drug Administration, the company said.
Gossamer has also reacquired worldwide development and commercial rights to seralutinib from Chiesi, eliminating a previous 50/50 profit share deal and requiring Chiesi to make a one-time $5 million payment, it said.
Its shareholders have also approved proposals related to a convertible note exchange and authorized it to effect a reverse stock split, to take effect after Q3 2026, the company said.
The company also reported that cash, cash equivalents and marketable securities totaled approximately $57 million as of June 30.
Shares of the company were up more than 20% in recent premarket trading.
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