Shares of Pharvaris N.V. (Nasdaq: PHVS) surged over 10% in pre-market trading after the clinical-stage company announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold on its Investigational New Drug (IND) application for deucrictibant, a potential treatment for Hereditary Angioedema (HAE). This positive development allows Pharvaris to advance the development of PHVS416(deucrictibant immediate-release capsules), specifically for on-demand treatment of HAE.

While progress is being made on the on-demand treatment, Pharvaris is actively addressing the remaining hold on the IND application for deucrictibant for prophylactic treatment of HAE. Data from the ongoing 26-week nonclinical study will be submitted to the FDA by the end of 2023 to address this issue.

During pre-market, $PHVS is currently trading at $13.52, up $1.92 (16.55%).

In contrast, shares of Avalo Therapeutics, Inc. (Nasdaq: AVTX) experienced a significant decline of over 80% as its Phase 2 PEAK Trial evaluating AVTX-002 (quisovalimab) in patients with non-eosinophilic asthma failed to meet the primary endpoint of reducing asthma-related events compared to placebo.

$AVTX is currently trading at $0.61, down $3.80 (86.03%) in pre-market following this announcement.

Similarly, FibroGen, Inc.'s (Nasdaq: FGEN) shares witnessed a sharp drop of over 70% as it reported disappointing results from its Phase 3 ZEPHYRUS-1 trial, which evaluated the safety and efficacy of pamrevlumab in patients with idiopathic pulmonary fibrosis. Due to the failure to meet the primary endpoint in the ZEPHYRUS-2 Phase 3 study, it will be discontinued.

To extend its cash runway into 2026, FibroGen plans to implement significant cost reduction measures in the U.S.

During pre-market trading, $FGEN is currently valued at $3.80, down $12.25 (76.32%).

THIS IS NOT A RECOMMENDATION TO BUY OR SELL ANY SECURITY OR DIGITAL ASSET. Please consult with a professional investment advisor before purchasing or selling any securities viewed on or mentioned herein. (Read Full Disclaimer)