Gossamer Bio

Gossamer Bio has effected a 1-for-80 reverse split; the shares continue to trade on a post-split basis under the ticker symbol GOSS. Fractional shares were rounded up, and conversion ratios of convertible notes as well as exercisable option and stock-based compensation awards were adjusted proportionally. Authorized common shares and total authorized share capital were materially reduced. The measure aims to regain compliance with NASDAQ’s minimum bid price requirement of $1.00, but compliance by October 5, 2026, is not guaranteed. » Mais em de.investing.com

At the Cantor Fitzgerald Healthcare Conference, Gossamer Bio said the FDA gave a constructive signal for approval of seralutinib in pulmonary arterial hypertension and that it intends to submit the NDA at the end of September 2024. Although the Phase III trial missed the pre-specified alpha of 0.025 (p=0.032), the company points to a revised FDA guidance that supports 0.05 as a benchmark for rare diseases, as well as strong subgroup data and a favorable tolerability profile. Gossamer emphasized a strengthened balance sheet after refinancings and the repurchase of rights from Chiesi, expects to commercialize seralutinib on its own, but still sees regulatory and competitive risks. » Mais em de.investing.com

Gossamer Bio has entered into a purchase agreement for up to approximately $250 million in securities. Of that amount, $150 million is committed, including $25 million at the first closing and an additional $125 million contingent on FDA acceptance of the NDA for Seralutinib, which the company plans to submit in September 2026. In addition, exercisable warrants upon approval could raise up to roughly $100 million. Gossamer plans to use the proceeds for the clinical development and potential commercialization of Seralutinib and expects that revenues and existing cash will fund operations through 2028. » Mais em de.investing.com