Shares of Heartbeam Inc (NASDAQ: BEAT ) rose sharply in pre-market trading after announcing its regulatory strategy following the Food and Drug Administration’s Not Substantially Equivalent (NSE) decision on its 12-lead Electrocardiogram Synthesis Software.
The Santa Clara-based medical technology company is pursuing multiple options, including an appeal process or a 510(k) resubmission, a premarket FDA filing showing the device is equivalent to legally marketed products.
Heartbeam shares jumped 43.3% to $0.86 in the pre-market trading session.
Here are some other stocks moving in pre-market trading.
Gainers
SMX (Security Matters) PLC (NASDAQ: SMX ) surged 73.1% to $30.12 in pre-market trading after jumping 194% on Wednesday. Zenta Group Co Ltd (NASDAQ: ZGM ) gained 26.7% to $3.18 in pre-market trading after rising 4% on Wednesday. Waton Financial Ltd (NASDAQ: WTF ) gained 21.1% to $3.74 in pre-market trading after rising 10% on Wednesday. CDT Equity Inc (NASDAQ: CDT ) rose 22.1% to $2.53 in pre-market trading after gaining over 12% on Wednesday. Top KingWin Ltd (NASDAQ: WAI ) rose 11.2% to $2.87 in pre-market trading after gaining 18% on Wednesday. Verrica Pharmaceuticals Inc (NASDAQ: VRCA ) rose 9.7% to $7.36 in pre-market trading after gaining 31% on Wednesday. Verrica Pharmaceuticals recently announced a $50 million private placement to retire debt and extend its cash runway. TMC the metals company Inc (NASDAQ: TMC ) gained 15.3% to $6.72 in pre-market trading after rising 7% on Wednesday. Standard Biotools Inc (NASDAQ: LAB ) gained 11.2% to $1.59 in pre-market trading. Beyond Meat Inc (NASDAQ: BYND ) gained 5% to $1.07 in pre-market trading after jumping 19% on Wednesday.Losers
FBS Global Ltd (NASDAQ: FBGL ) tumbled 24.3% to $0.51 in pre-market trading. Tilray Brands Inc (NASDAQ: TLRY ) declined 15% to $0.88 in pre-market trading after the company announced a 1-for-10 reverse stock split. Solo Brands Inc (NYSE: SBDS ) shares dipped 14.4% to $7.19 in pre-market trading after gaining 5% on Wednesday. Solo Brands recently reported worse-than-expected third-quarter financial results. Zynex Inc (NASDAQ: ZYXI ) fell 12.6% to $1.39 in pre-market trading after gaining more than 115% on Wednesday. Zynex recently reported worse-than-expected third-quarter financial results. Pasithea Therapeutics Corp (NASDAQ: KTTA ) fell 12.3% to $0.93 in pre-market trading after jumping 117% on Wednesday. Direct Digital Holdings Inc (NASDAQ: DRCT ) dipped 11.5% to $0.13 in pre-market trading. The company filed a Form 8-K with the Securities and Exchange Commission (SEC) on Wednesday, revealing it reached a settlement agreement last week with Continuation Capital Inc. ECD Automotive Design Inc (NASDAQ: ECDA ) fell 9.8% to $0.48 in pre-market trading after declining 4% on Wednesday. Tevogen Bio Holdings Inc (NASDAQ: TVGN ) fell 8.1% to $0.44 in pre-market trading after gaining 10% on Wednesday. Inventiva ADR (NASDAQ: IVA ) fell 7.4% to $4.26 in pre-market trading after gaining 4% on Wednesday. Anglogold Ashanti PLC (NYSE: AU ) dipped 5.5% to $83.97 in pre-market trading after gaining over 5% on Wednesday.Now Read This:
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Loading... Loading... AU Anglogold Ashanti PLC $84.00 -4.55% Overview BEAT HeartBeam Inc $0.8730 44.6% BYND Beyond Meat Inc $1.07 4.90% CDT CDT Equity Inc $2.46 19.1% DRCT Direct Digital Holdings Inc $0.1300 -11.4% ECDA ECD Automotive Design Inc $0.4770 -10.9% FBGL FBS Global Ltd $0.5059 -24.3% IVA Inventiva SA $4.22 -8.26% KTTA Pasithea Therapeutics Corp $0.9320 -12.1% LAB Standard BioTools Inc $1.59 11.2% SBDS Solo Brands Inc $7.19 -14.4% SMX SMX (Security Matters) PLC $30.18 73.5% TLRY Tilray Brands Inc $0.8806 -14.5% TMC TMC The Metals Co Inc $6.71 15.1% TVGN Tevogen Bio Holdings Inc $0.4420 -8.11% VRCA Verrica Pharmaceuticals Inc $7.37 9.84% WAI Top KingWin Ltd $2.99 10.7% WTF Waton Financial Ltd $3.74 21.0% ZGM Zenta Group Co Ltd $3.18 38.9% ZYXI Zynex Inc $1.40 -11.9% Market News and Data brought to you by Benzinga APIs© 2025 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
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