A tough spring has settled into a cruel summer for Fibrogen Inc. as the company has stumbled for the third time in two months. The newest problem is top-line results showing the phase III Zephyrus-1 study of pamrevlumab, a monoclonal antibody, missed its primary endpoint for treating idiopathic pulmonary fibrosis.
While investors focused on the top-line miss from Avalo Therapeutics Inc.’s phase II study of AVTX-002 (quisovalimab) in non-eosinophilic asthma, sending company shares (NASDAQ:AVTX) falling 89% to close at 50 cents June 26, the company pointed to promising trends seen in an exploratory analysis affirming the potential of targeting LIGHT.
Edding Group Co. Ltd. announced June 23 it filed for an IPO on the Hong Kong Exchange – news that comes amid a steep drop in China’s biopharma IPO market forecasting sluggish activity in a near-frozen “capital winter.”
Vicore Pharma Holding AB grossed about SEK500 million (US$46 million) in a directed share issue that will fund a phase IIb trial of its lead drug candidate, C-21, in idiopathic pulmonary fibrosis (IPF).
Less than two years ago, in October 2021, a group of investors bid at auction on a promising monoclonal antibody to treat asthma, chronic rhinosinusitis and other inflammatory conditions, winning the asset known as UPB-101, the sole focus of the then-newly launched Upstream Bio Inc.
Despite posting positive phase IIa data, Pliant Therapeutics Inc. stock (NASDAQ:PLRX) took a punch May 1 as shares closed 21% downward at $22.31 each. Still, the stock is in far better shape than it was a year ago when shares were going for about $5 each.
In its $2 billion acquisition of Bellus Health Inc., GSK plc is getting camlipixant, which is being developed to treat refractory chronic cough. The selective P2X3 receptor antagonist is currently in phase I and phase III studies. Bellus will be acquired by GSK for $14.75 per share in cash.
With no treatments available to effectively clear mucus, Aer Therapeutics Inc. secured $36 million in a series A financing to advance its novel inhaled small-molecule mucolytic treatment, AER-01, bringing optimism to about 5 million Americans with chronic obstructive pulmonary disease (COPD) who have a high burden of mucus plugs.
Dupixent (dupilumab) continues to expand its scope, this time potentially leading it and its developers into a new, multibillion dollar blockbuster market. Dupixent hit the primary and all key secondary endpoints in a phase III study of treating chronic obstructive pulmonary disease (COPD).
Mereo Biopharma Group plc said its path to approval for alvelestat is a phase III study that would preclude an additional confirmatory trial. After meetings with the U.S. FDA and the EMA to discuss next steps, Mereo said it is designing a single, 12- to 18-month, global phase III of the neutrophil elastase inhibitor for treating alpha-1-antitrypsin deficiency-associated lung disease.
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