Biological Gossamer (NASDAQ:rumor) released Phase 2 data for the pulmonary arterial hypertension (PAH) candidate seralutinib on Tuesday, sending its stock to an all-time low during the Piper Sandler sell-off identified as a reactionary. overreact.
Top data from The TORREY study found that the dry powder inhaled version of the tyrosine kinase inhibitor hit the primary endpoint, showing a 14.3% improvement over placebo in pulmonary vascular resistance. (PVR) from baseline to week 24.
Meanwhile, the six-minute walking distance secondary endpoint (6MWD) showed a mean difference of 6.5 meters from baseline to Week 24, in favor of the seralutinib group.
Piper analysts led by Yasmeen Rahimi argued that Street overreacted to the readings because the PVR and 6MWD results were lower than expected even as seralutinib showed “a consistent association between the key effectiveness measure”, emphasizing its activity in PAH.
Quote by Gossamer (rumor) on today’s conference call, Rahimi and team noted management’s expectation that TORREY will allow them to properly power 6MWD as the primary endpoint in future Phase 3 testing.
Management rules out registration challenges for a key global study slated to begin in the second half of 2023 despite the possibility of US approval of the rival therapeutic sotatercept developed by Acceleron Pharma that Merck (A) is acquired in 2021.
“….as a global study, they do not foresee any registration issues, especially as older US geographies will still not have access to sotatercept,” the analysts said. reasoning with an Overweight rating and a $15 per share target on Gossamer (rumor).
Meanwhile, in response to sotatercept data, Aerovate Therapeutics (NASDAQ:AVTE), is developing inhalation dry powder formula for PAH called AV-101, fell even when BTIG upgraded the stock to Buy from Neutral, noting the strength of Gossamer’s (rumor) read aloud.
Analyst Julian Harrison argues that the TORREY data confirm the potential of tyrosine kinase inhibitor DPI formulations as a “technically feasible and safe approach” for the treatment of PAH.
However, seralutinib “may not put pressure on the AV-101 opportunity at this point,” given the roughly 14% drop in PVR in the study, analyst Julian Harrison wrote with a $27 target per share. on Aerovate (AVTE).
Wall Street remains bullish on Gossamer (rumor) stock, with a Average rating Buy from analysts, while looking for the author Alpha and SA’s Quantitative System, consistently beat the market, evaluate GOSS as a Hold.