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Noticias de PYXS
Eventos de PYXS
Pyxis Oncology Plans to Initiate Global Phase 3 Trial in 2027
"The September monotherapy data reinforce our confidence in MICVO's potential to serve a significant population of patients with previously treated recurrent/metastatic head and neck cancer," said Tom Civik, Chief Executive Officer and Chairman of Pyxis Oncology. "We have aligned with feedback received from the U.S. Food and Drug Administration and the European Medicines Agency on the design of the global Phase 3 Headliner trial and plan to initiate it in mid-2027, with FDA feedback on dose selection expected in the first quarter of 2027. We look forward to presenting MICVO monotherapy data, along with two preclinical posters, at the EORTC-NCI-AACR Symposium in November, and providing a comprehensive update on our head and neck cancer strategy in December, including updated efficacy and safety data from MICVO in combination with pembrolizumab in the first-line setting. Our strengthened balance sheet positions us to execute on these priorities, continue evaluating MICVO's broader potential and advance toward becoming a pre-commercial organization."
Pyxis Oncology Closes $110 Million Public Offering
Pyxis Oncology announced that it closed its previously announced registered public offering on October 1, 2026. The Offering generated approximately $110.0 million in upfront gross proceeds, before deducting underwriting discounts and commissions and other offering expenses. The Offering consisted of 36,047,919 shares of common stock at a public offering price of $2.90 per share and, in lieu of common stock to certain investors, pre-funded warrants to purchase 1,883,121 shares of common stock at a public offering price of $2.899 per pre-funded warrant, in each case, accompanied by common warrants to purchase an aggregate of 49,310,352 shares of common stock. The clinical milestone-linked common warrants are tied to Pyxis Oncology's public disclosure of overall survival data rom its ongoing Phase 1 monotherapy study of micvotabart pelidotin in second-line and beyond recurrent/metastatic head and neck squamous cell carcinoma, which is expected to occur in the first half of 2027. The warrants have an exercise price of $3.50 per common share, a 21% premium to the $2.90 public offering price. If all milestone-linked warrants are exercised in full for cash, the Offering would provide Pyxis Oncology with approximately $172.6 million in additional gross proceeds, for a total of approximately $282.6 million in gross proceeds, before deducting applicable expenses. Leerink Partners, Guggenheim Securities and Wells Fargo Securities acted as joint bookrunning managers for the Offering. Pyxis Oncology intends to use the net proceeds from the Offering to advance its lead clinical program, MICVO, through key clinical milestones, including Headliner, its planned Phase 3 trial in 2L+ R/M HNSCC, and for working capital and general corporate purposes.
Leerink, Guggenheim and Wells Fargo Jointly Manage Offering
Leerink, Guggenheim and Wells Fargo acted as joint book running managers for the offering.
Apple Shares Drop Nearly 3% as Market Focuses on New CEO
The major averages slipped for the second consecutive day despite the decline in oil prices as rising treasury yields remain top of mind for investors. Utilities was the best-performing area of the market, though the sector has been a major laggard within the S&P 500 over the past few months as rising interest rates in fixed income offset its dividend-paying appeal. Energy was the worst-performing sector in the benchmark as WTI crude oil fell below $90 per barrel. Within tech, semiconductor equipment stocks traded firmly but Semis were more mixed.Ahead of its earnings tomorrow, Micronwas up 1% on Tuesday. Applesaw a notable retreat of nearly 3% after a Bloomberg report that its new CEO Ternus is pushing to accelerate product development to become more competitive in the AI arena, with investors taking that as a sign that the company may shed its tendency to be more cautious on the capex front.In the opening hour of the evening session, index futures are marginally higher, with S&P e-minis and Nasdaq 100 contracts both up 0.2%.Check out this evening's top movers from around Wall Street, compiled by The Fly.HIGHER -Vanda Pharmaceuticalsup 29.4% after results from pivotal Phase III study of HETLIOZYYForceup 5.6% after contract announcementAmeriprise Financialup 2.6% after announcing $5.5B buybackBoeingup 2.3% after being selected for 6th generation F/A-XX Strike Fighter deal for over $20B by Pentagon; Northrop Grummandown 3.6%GameStopup 1.7% after insider buyTalen Energyup 1.0% after announcing CEO transition, $1.5B accelerated share repurchase planDOWN AFTER EARNINGS -Concentrixdown 10.6%ALSO LOWER -Pyxis Oncologydown 8.6% after equity offering
Pyxis Oncology Launches Public Offering to Advance Clinical Programs
Pyxis Oncology announced that it has commenced a registered public offering of (i) shares of its common stock, or in lieu of common stock to certain investors, pre-funded warrants to purchase shares of common stock, and (ii) accompanying common warrants to purchase shares of common stock. Each share of common stock and each pre-funded warrant will be sold together with a common warrant to purchase one share of common stock. Pyxis Oncology intends to use the net proceeds from the offering to advance its lead clinical program, MICVO, through key clinical milestones, including Headliner, its planned Phase 3 trial in 2L+ R/M HNSCC, and for working capital and general corporate purposes. Leerink Partners, Guggenheim Securities and Wells Fargo Securities are acting as joint bookrunning managers for the proposed offering.
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