Stock Market News 2025-09-19
269 news published.
Biotech and Pharma: approvals, guidelines and pivotal data
KalVista Pharmaceuticals (KALV) scored a regulatory win as the European Commission and Swissmedic approved EKTERLY®, the first oral on‑demand treatment for hereditary angioedema — opening EU/Swiss commercial channels and creating early revenue optionality.
Nuvation Bio (NUVB) received approval from Japan’s Ministry of Health for IBTROZI™ in advanced ROS1‑positive non‑small cell lung cancer, widening market footprint and reducing regulatory risk for the asset.
Sprout Therapeutics (SPRY) saw its neffy® epinephrine nasal spray approved in Japan as the first needle‑free emergency treatment for anaphylaxis, a format that could expand adoption in emergency settings and among needle‑averse patients.
Clinical data and near‑term readouts
Johnson & Johnson (JNJ) had a busy day: its TECVAYLI® plus DARZALEX FASPRO® induction showed strong responses in transplant‑eligible newly diagnosed multiple myeloma, and separately TREMFYA® (guselkumab) earned U.S. approval for subcutaneous induction in adult ulcerative colitis — making it the first IL‑23 inhibitor with a fully subcutaneous regimen. Together, these moves broaden J&J’s immunology and oncology franchise levers and could prompt analyst revisions on peak sales and market outlook.
United Therapeutics (UTHR) will review data from the TETON‑2 pivotal study of nebulized Tyvaso® in idiopathic pulmonary fibrosis; a positive readout could materially shift revenue forecasts.
MBX Biosciences (MBX) will release topline data Monday, Sept. 22 from its Phase 2 study of once‑weekly canvuparatide for hypoparathyroidism. Investors will watch efficacy and safety signals that determine partnering or commercialization timelines.
Moderna (MRNA) announced its first made‑in‑Canada mRNA vaccines were delivered to provinces and territories, marking a step in decentralizing supply chains and potentially accelerating local immunization programs.
Medtech and device approvals
Medtronic (MDT) secured FDA approval for the Altaviva™ device to treat urge urinary incontinence. New device approvals often translate into faster commercial adoption and recurring procedure revenue.
Verrica Pharmaceuticals (VRCA) said partner Torii received approval for YCANTH® in Japan, a partner approval that can deliver milestone income without direct commercialization risk.
Treasury moves, crypto and post‑quantum security
FG NEXUS (FGNX) accelerated its total ETH holdings to 49,715 ETH — a material crypto treasury that increases earnings sensitivity to ETH price swings and treasury accounting moves.
ZOOZ (ZOOZ) shareholders approved a $180 million private placement and a formal Bitcoin treasury reserve strategy, tying balance‑sheet volatility to BTC price action while funding operations.
Flora Growth Corp. (FLGC) announced $401 million of funding including a $22.88 million strategic investment that will seed an AI zero‑gravity coin treasury strategy. For investors, this raises treasury‑management risk and crypto‑exposure questions amid volatile token markets.
SEALSQ (LAES) plans to launch the Quantum Shield QS7001 mid‑November, positioning post‑quantum cryptography for custody and treasury security.
Financial results, capital raises and shareholder actions
CEA Industries (BNC) board authorized a $250 million stock buyback program, a clear signal of capital return focus that can lift EPS and support the share price if executed.
Five Point (FPH) announced pricing terms for a cash tender offer on its 10.500% Initial Rate Senior Notes due 2028. Debt tendering can change capital structure and short‑term liquidity profiles, so bondholders and equity investors should note the terms.
Pintec (PT) released unaudited H1 2025 results, with investors focused on originations, margin trends and regulatory headwinds in fintech lending.
Franklin Templeton (BEN) announced a plan to liquidate the Putnam BioRevolution™ ETF. ETF closures can force portfolio rebalancing and create transient flow into related biotech stocks.
Mergers, deals and strategic moves
The9 (NCTY) announced a JV acquisition to run proprietary mobile games including Ultraman titles — owning IP and live‑ops can boost margins and recurring revenue visibility.
Xponential Fitness (XPOF) announced the divestiture of Lindora, narrowing focus toward core fitness brands and recurring membership revenue.
InterCure (INCR) announced a strategic acquisition of ISHI, accelerating U.S. market entry with premium cannabis tech and brands.
Qualigen Therapeutics (QLGN) announced a $41 million strategic investment from Faraday Future via a PIPE tied to its crypto business. For QLGN, that’s an unusual cross‑sector move that raises questions about dilution, governance and the use of proceeds.
Market structure, governance and corporate actions
Vaxart (VXRT) withdrew its reverse stock split proposal, altering short‑term delisting risk calculus and investor sentiment.
SU Group Holdings (SUGP) received a Nasdaq notice of delisting for minimum publicly held share deficiency and is appealing. Delisting risk can sharply reduce liquidity and requires close monitoring by shareholders.
Patterson‑UTI Energy (PTEN) noted Leslie Beyer’s confirmation as Assistant Secretary for Land and Minerals Management at Interior and her resignation from the board, creating a near‑term governance watchpoint.
Global Medical REIT Inc. (GMRE) completed a one‑for‑five reverse stock split, a common step to regain listing compliance but one that reduces float and can affect index eligibility.
Tenaris (TS) saw its controlling shareholder file an amendment to Schedule 13D amid the company’s ongoing share buyback program. That filing could signal intent to increase influence and warrants attention from investors tracking ownership shifts and buyback impact on supply.
Heritage Distilling (CASK) announced a ticker symbol change to “IPST”, a technical update investors should note for trading and filings.
Defense, government orders and contract wins
AeroVironment (AVAV) was awarded a new firm‑fixed‑price option for two BADGER phased array systems, strengthening production and delivery plans for the SCAR program.
Emergent BioSolutions (EBS) secured $29 million in MCM product orders from an international government partner — predictable government demand supports near‑term revenue.
Energy, materials and sustainability
Constellation Energy (CEG) highlighted near‑perfect summer reliability from its clean energy centers and cited $7 billion of investments over the past decade — underscoring the capital intensity behind reliable clean infrastructure.
Sunrise New Energy (EPOW) broke ground on a 20,000‑ton high‑end graphite anode production line, accelerating its scale‑up in battery materials and improving supply chain positioning for EV makers.
Other operational updates to note
- Esperion partner Otsuka (ESPR) received approval to market NEXLETOL® in Japan, extending the cholesterol drug’s reach through a local partner.
- AMC Theatres (AMC) and Cinemark (CNK) are both running Taylor Swift | The Official Release Party of A Showgirl in theaters worldwide, a box‑office event that can boost concession sales and short‑term foot traffic for exhibitors.
Regulatory commentary and investor protections
RBI (QSR) recommended shareholders reject Ocehan’s “mini‑tender offer”, a reminder that small tender proposals can undercut shareholder value and warrant scrutiny by boards and regulators.
Tevogen (TVGNW) commended HHS for addressing long COVID and highlighted TVGN‑489’s potential to help an estimated 20 million Americans — policy focus can accelerate development incentives and trial enrollment for long‑COVID therapeutics.
Market signals investors should watch today
Track upcoming clinical readouts and tender‑offer outcomes for immediate share‑price catalysts. Monitor delisting appeals and governance shifts that affect liquidity. Watch changes to corporate treasuries and new crypto treasury strategies, as they influence leverage and balance‑sheet volatility. Finally, keep an eye on index actions — Reynolds Consumer Products is set to join the S&P SmallCap 600 — since index inclusion can drive demand and short‑term price moves.
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