KalVista Pharmaceuticals, Inc. (NASDAQ: KALV) shares closed up 115% to $33.50 following its announcement of positive top-line data from its Phase 2 trial of KVD900 as an oral on-demand treatment for hereditary angioedema (HAE) attacks. Attacks treated with KVD900 significantly reduced use of rescue treatment (p=0.001), with 15% of KVD900 treated attacks rescued compared to 30% on placebo at 12 hours. This efficacy benefit of KVD900 was maintained at 24 hours (p=0.0005). The company also announced after hours it intends to sell 4.5m shares in an underwritten public offering.
PDS Biotechnology Corporation (NASDAQ:PDSB) shares closed up 53% to $6.81 on no news. The company has mentioned that it is planning to initiate clinical trials of its COVID-19 vaccine during the first half of this year.
Heat Biologics, Inc. (NASDAQ:HTBX) shares closed up 50% on the back of updated data from its Phase 2 trial of HS-110, in combination with Opdivo (nivolumab) in advanced non-small cell lung cancer (NSCLC). In previously treated, checkpoint inhibitor naïve patients with advanced NSCLC, median progression free survival (PFS) of 1.8 months and a median overall survival (OS) of 24.6 months was observed.
Genfit (NASDAQ:GNFT) shares are trading up 97% after hours to $10.23 on news that data from its Phase 2 clinical trial evaluating elafibranor in patients with Primary Biliary Cholangitis (PBC) have been published in the Journal of Hepatology. Importantly, however, these data are not new and were released in April 2019 (press release).
Several companies announced public offerings. Brief details below:
Oncorus, Inc. (NASDAQ:ONCR) – Public offering of 3m shares.
Genprex, Inc. (NASDAQ:GNPX) - Registered direct offering of 4m at a purchase price of $6.25 per share for proceeds of $25m.
Codiak BioSciences, Inc. (NASDAQ:CDAK) - Public offering of 2.5m shares.
Adicet Bio, Inc. (NASDAQ:ACET) - Public offering of its common stock.
SQZ Biotechnologies Company (NYSE:SQZ) - Public offering of 3m shares.
Mereo BioPharma Group plc (NASDAQ:MREO) – Public offering of American Depositary Shares.
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Major price movers (stocks priced > $1.00, volume > 50k listed on NASDAQ/NYSE):
Refer to the BioPharmCatalyst Biotech Stocks page for Top 10 Gainers/Losers/Unusual Volume:
ADVANCERS:
Heat Biologics, Inc. (HTBX): $12.54; +50%.
Iterum Therapeutics plc (ITRM): $2.27; +47%.
Veru Inc. (VERU): $19.27; +38%.
Evoke Pharma, Inc. (EVOK): $4.41; +38%.
Rockwell Medical, Inc. (RMTI): $1.93; +30%.
DECLINERS:
Aeterna Zentaris Inc. (AEZS): $2.20; -34%.
Infinity Pharmaceuticals, Inc. (INFI): $4.19; -22%.
Ocugen, Inc. (OCGN): $12.61; -20%.
Summit Therapeutics Inc. (SMMT): $9.35; -16%.
Translate Bio, Inc. (TBIO): $29.27; -15%.
Pipeline updates below: