Medical technology stocks don't usually pop 43% because things are going well with the FDA. But sometimes the market just wants to hear you have a plan.
Heartbeam Inc. (BEAT) shares rocketed higher in premarket trading after the Santa Clara-based company laid out its regulatory strategy following what sounds like a setback: the Food and Drug Administration issued a Not Substantially Equivalent decision on its 12-lead Electrocardiogram Synthesis Software. That's FDA-speak for "we're not convinced this is similar enough to what's already out there."
The company isn't throwing in the towel. Heartbeam said it's pursuing multiple pathways forward, including an appeal process or potentially filing a new 510(k) submission. For context, a 510(k) is the FDA filing that shows your medical device is essentially equivalent to products already legally on the market. It's typically the faster route to approval compared to a full premarket approval process.
Heartbeam shares climbed 43.3% to $0.86 in premarket action.
But Heartbeam wasn't alone in making premarket moves. Here's a look at the other notable gainers and losers before the opening bell.
Stocks Climbing Higher
SMX (Security Matters) PLC (SMX) continued its absolutely wild run, surging another 73.1% to $30.12 in premarket trading. This comes after the stock already exploded 194% on Wednesday. Whatever's driving this momentum, traders are clearly still buying in.
Zenta Group Co Ltd (ZGM) added 26.7% to $3.18 premarket after rising 4% on Wednesday.
Waton Financial Ltd (WTF) gained 21.1% to $3.74 in premarket trading, building on Wednesday's 10% advance.
CDT Equity Inc (CDT) climbed 22.1% to $2.53 premarket after gaining over 12% the previous day.
Top KingWin Ltd (WAI) rose 11.2% to $2.87 in early trading after an 18% jump on Wednesday.
Verrica Pharmaceuticals Inc (VRCA) gained 9.7% to $7.36 premarket, extending Wednesday's impressive 31% rally. The pharmaceutical company recently announced a $50 million private placement aimed at retiring debt and extending its cash runway, giving investors some confidence about its financial runway.
TMC the metals company Inc (TMC) rose 15.3% to $6.72 premarket after a 7% gain on Wednesday.
Standard Biotools Inc (LAB) climbed 11.2% to $1.59 in early trading.
Beyond Meat Inc (BYND) gained 5% to $1.07 premarket, adding to Wednesday's substantial 19% surge.
Stocks Under Pressure
FBS Global Ltd (FBGL) tumbled 24.3% to $0.51 in premarket trading.
Tilray Brands Inc (TLRY) dropped 15% to $0.88 premarket after announcing a 1-for-10 reverse stock split. Reverse splits are typically viewed negatively by traders, as they're often seen as a last-ditch effort to boost a falling share price and maintain exchange listing requirements.
Solo Brands Inc (SBDS) fell 14.4% to $7.19 in premarket trading after gaining 5% on Wednesday. The decline follows the company's recently reported third-quarter results, which missed analyst expectations.
Zynex Inc (ZYXI) dropped 12.6% to $1.39 premarket, giving back some of Wednesday's spectacular 115% surge. The company recently reported third-quarter financial results that came in below expectations, which may be prompting some profit-taking after the previous session's explosive move.
Pasithea Therapeutics Corp (KTTA) fell 12.3% to $0.93 premarket after rocketing 117% on Wednesday. Like Zynex, this looks like a classic case of momentum reversal after an outsized gain.
Direct Digital Holdings Inc (DRCT) dipped 11.5% to $0.13 in premarket trading. The company filed a Form 8-K with the Securities and Exchange Commission on Wednesday, disclosing that it reached a settlement agreement last week with Continuation Capital Inc.
ECD Automotive Design Inc (ECDA) fell 9.8% to $0.48 premarket after declining 4% on Wednesday.
Tevogen Bio Holdings Inc (TVGN) dropped 8.1% to $0.44 in early trading after gaining 10% on Wednesday.
Inventiva ADR (IVA) fell 7.4% to $4.26 premarket after rising 4% the previous day.
Anglogold Ashanti PLC (AU) dipped 5.5% to $83.97 in premarket trading after climbing over 5% on Wednesday.
