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KPTI 資訊
KPTI 事件
Karyopharm Submits sNDA for Accelerated Approval of XPOVIO
Karyopharm Therapeutics announced that it has submitted a supplemental New Drug Application, sNDA, to the U.S. Food and Drug Administration, FDA, seeking Accelerated Approval for XPOVIO in combination with ruxolitinib for patients with myelofibrosis. Karyopharm requested Priority Review of the application, which, if granted, could result in a six-month review process. "Today's submission is an important step toward our goal of bringing the combination of selinexor plus ruxolitinib to patients with myelofibrosis who continue to face a significant unmet need," said Reshma Rangwala, M.D., Ph.D., Chief Medical Officer and Head of Research of Karyopharm. "The SENTRY trial generated compelling and consistent results, including rapid, deep and sustained spleen responses across a broad range of patients, together with a promising overall survival signal and important evidence of disease modification. We believe the strength of these data underscores the potential of this novel combination to deliver meaningful long-term benefits and fundamentally change the treatment of patients with myelofibrosis."
Significant Increases in Borrow Rates for Liquid Options
Latest data shows the largest indicative borrow rate increases among liquid option names include: T-REX 2X LONG MSTR DAILY TARGET (MSTU) 28.04% +1.54, Critical Metals Corp (CRML) 11.84% +0.89, iShares Global Clean Energy (ICLN) 23.68% +0.65, Welltower (WELL) 0.74% +0.49, -1X SHORT VIX FUTURES ETF (SVIX) 9.05% +0.37, GraniteShares 2x Long NOW Daily ETF (NOWL) 9.48% +0.29, Karyopharm (KPTI) 17.14% +0.26, DIREXION DAILY MSFT BULL 1.5X SHARES ETF (MSFU) 10.87% +0.21, Terrestrial Energy Inc. (IMSR) 2.01% +0.18, and Direxion Daily TSLA Bull 1.5X Shares (TSLL) 4.18% +0.18.
Karyopharm Reports Q2 Revenue of $33.4M, Beating Expectations
Reports Q2 revenue $33.4M, consensus $32.19M. "Our planned submission under the Accelerated Approval pathway represents the beginning of an important new chapter for Karyopharm and an important milestone for the myelofibrosis community," said Richard Paulson, President and Chief Executive Officer of Karyopharm. "If approved, selinexor plus ruxolitinib would become the first approved combination therapy for patients with myelofibrosis, introducing a novel therapeutic mechanism for the treatment of this disease within the multi-billion-dollar U.S. marketplace. Our planned submission follows productive engagements with the FDA and reflects the speed, focus, urgency and extraordinary commitment of our teams. We look forward to continuing to work closely with the FDA."
U.S. XPOVIO Net Product Revenue Expected to Reach $115M-$130M
Total revenue consists of U.S. XPOVIO net product revenue and license, royalty and milestone revenue earned from partners. U.S. XPOVIO net product revenue to be in the range of $115M-$130M.
Company Evaluates Financing Opportunities to Extend Cash Runway
The company, together with its financial advisor Centerview Partners and other advisors, is actively evaluating a range of financing opportunities and strategic alternatives with the objective of maximizing both near- and long-term value for stakeholders while preserving strategic flexibility as it advances its myelofibrosis program. The company expects its existing liquidity, including cash, cash equivalents and investments, together with anticipated cash flow from net product revenue and license and other revenue, to fund its current operating plans into September 2026. As discussed above, the company is actively evaluating a range of financing opportunities and strategic alternatives with the objective of extending its cash runway, preserving strategic flexibility and maximizing long-term shareholder value as it advances its myelofibrosis program. On September 10, 2026, a $15.8M principal payment is due under the company's senior secured term loan facility. If that payment is made without additional financing or a waiver from the company's lenders, the company expects its cash, cash equivalents and investments would fall below its $10M minimum liquidity covenant, which would constitute an event of default under the term loan.
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