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ZYME 资讯
ZYME 事件
BeOne Medicines' TEVIMBRA Approved by FDA for HER2 Positive Gastric Cancer
BeOne Medicines (ONC) announced that the U.S. FDA has approved the supplemental Biologics License Application for TEVIMBRA in combination with ZIIHERA and chemotherapy for the first-line treatment of adult patients with unresectable locally advanced or metastatic HER2-positive gastric, gastroesophageal junction, or esophageal adenocarcinoma. The approval is supported by results from the Phase 3 HERIZON-GEA-01 trial, which were published in The New England Journal of Medicine earlier this year. The approval is based on data from HERIZON-GEA-01, the global Phase 3 clinical trial evaluating ZIIHERA plus chemotherapy, with and without TEVIMBRA, compared with trastuzumab plus chemotherapy as first-line treatment for advanced or metastatic HER2+ GEA. Key findings from the trial include: Overall survival: TEVIMBRA plus ZIIHERA and chemotherapy demonstrated a statistically significant improvement in OS, with median OS of 26.4 months compared with 19.2 months in the control arm. Progression-free survival: TEVIMBRA plus ZIIHERA and chemotherapy demonstrated a statistically significant and clinically meaningful improvement in PFS, with a median PFS of 12.4 months compared with 8.1 months in the control arm.
Zymeworks' Partner Jazz Receives FDA Approval for Ziihera Regimens
Zymeworks (ZYME) announced that its partner, Jazz Pharmaceuticals, has received U.S. Food and Drug Administration approval for two Ziihera-containing regimens for the first-line treatment of adults with unresectable locally advanced or metastatic HER2-positive gastroesophageal adenocarcinoma: Ziihera plus Tevimbra and fluoropyrimidine- and platinum-containing chemotherapy, and Ziihera plus fluoropyrimidine- and platinum-containing chemotherapy. This is the second FDA approval for zanidatamab in less than two years, further validating Zymeworks' proprietary Azymetric platform and its ability to discover and develop differentiated multifunctional antibodies for patients with difficult-to-treat cancers. The FDA approval of zanidatamab in GEA following its accelerated approval in biliary tract cancer, and with additional clinical trials underway by Jazz Pharmaceuticals (JAZZ) and BeOne Medicines (ONC) across other tumor types, together underscores the potential of Zymeworks' partnered drug development and royalty strategy to expand the potential reach of this important medicine to more patients across multiple tumor types. Each additional indication has the potential to increase the clinical impact of zanidatamab, while creating incremental value through our royalty interest and commercial milestone payments. "We believe this approach of supporting the development of innovative medicines while leveraging the resources and expertise of our partners, provides a capital-efficient pathway to participate in long-term patient benefit, and value creation for our shareholders." The approval is supported by results from the Phase 3 HERIZON-GEA-01 trial, which demonstrated the benefit of zanidatamab in combination with immunotherapy and chemotherapy in the first-line treatment of HER2+ GEA. Results from the study were published in the New England Journal of Medicine and first presented at ASCO GI 2026. The trial remains ongoing, with additional analyses planned. Under the terms of its collaboration with Jazz Pharmaceuticals, Zymeworks has earned a $250M milestone payment upon this approval, bringing total upfront and milestone payments received from Jazz to $650M. The company remains eligible to receive up to $1.3B in additional regulatory and commercial milestones, as well as tiered royalties of 10% to 20% on Jazz's net sales of zanidatamab in Jazz's licensed territories. Separately, under its collaboration with BeOne Medicines, Zymeworks has received $81M in upfront and milestone payments to date and remains eligible for up to $144M in additional milestones, plus tiered royalties of up to 19.5% on net sales in BeOne's licensed territories. Together, these collaborations provide significant non-dilutive capital and long-term royalty potential, supporting Zymeworks' disciplined capital allocation strategy, including investment in its wholly-owned R&D pipeline, strategic business development opportunities, and return of capital to shareholders.
Zymeworks Reports Q2 Revenue of $4.6M
Reports Q2 revenue $4.6M, consensus $10.90M. The decrease in revenue was driven mainly by the absence of significant non-recurring collaboration revenue recognized in the prior year, as well as continued declines in development support and drug supply revenue from Jazz. "The first half of 2026 has been a transformative period for Zymeworks, demonstrating the continued evolution of our business into a diversified, revenue-generating biotechnology business. While scientific innovation remains our foundation, we believe long-term value is created not only through discovering new medicines, but also through disciplined capital allocation, creative business development and thoughtful partnership structures that maximize the impact of that innovation for patients and shareholders," said CEO Kenneth Galbraith.
Nasdaq Futures Rise, PetMed Express Stock Soars 32%
Stock futures are higher before the open, with the Nasdaq leading gains as investors move back toward growth and technology names after last week's pressure. Oil prices are also easing from recent highs, reducing fears that a geopolitical shock could spill into inflation expectations.The key theme this week is shifting from geopolitics back toward macro data. Investors are watching labor market releases, including JOLTS and Thursday's payroll report, for clues on the Federal Reserve path. Markets continue to weigh a resilient economy against concerns that sticky inflation could keep the Fed more restrictive than expected.In pre-market trading, S&P 500 futures rose 0.76%, Nasdaq futures rose 1.03% and Dow futures rose 0.41%.Check out this morning's top movers from around Wall Street, compiled by The Fly.HIGHER -PetMed Expressup 32% after SilverCape Investments released an open letter to its board of directors calling on the board to engage with SilverCape on a revised proposal to acquire all outstanding shares of common stock of PetMed for $3.00 per share in cash with no financing contingencyCharterand SpaceXand up 24% and 2%, respectively, after a report that the companies discussed partnering on a consumer mobile phone offeringComcastup 21% after announcing its intention to separate into two independent publicly traded companies through a tax-free spin-off of NBCUniversal and SkyIridiumand Rocket Labup 22% and 9%, respectively, after Rocket Lab agreed to acquire all the outstanding shares of Iridium common stock for $54 per share in a cash and stock transactionLOWER -Zymeworksand Theravance Biopharmaboth down 2% after Zymeworks entered into a definitive agreement to acquire Theravance Biopharma for $17.00 per shareMartin Mariettadown 2% after entering into a definitive agreement to combine with Lhoist North America, a subsidiary of Lhoist Group, for $13.5B in cash and shares of Martin Marietta common stockBritish American Tobaccodown 1% after reporting its Fit2Win cost-cutting initiatives will impact 9,000 jobsVerizondown 1% after BT Groupand the company announced the signing of an agreement to combine their respective international enterprise operations into a 50:50 joint venture
Zymeworks to Acquire Theravance Biopharma for $17.00 per Share
Theravance Biopharma (TBPH) announced that it has entered into a definitive agreement pursuant to which Zymeworks (ZYME) will acquire the company for $17.00 per share in cash, representing an equity value of approximately $929M. In addition to the cash consideration, Theravance Biopharma shareholders will receive a CVR entitling them to 80% of net proceeds realized from any future license, divestiture or other monetization of ampreloxetine over the next ten years, with the remaining 20% to Zymeworks. Under the terms of the definitive agreement, Theravance Biopharma shareholders will receive $17.00 in cash for each outstanding ordinary share of Theravance Biopharma. Theravance Biopharma shareholders will also receive a contingent value right entitling them to 80% of net proceeds realized from any future license, divestiture or other monetization transaction involving ampreloxetine over the next ten years, with the remaining 20% to Zymeworks. In addition, if a license, divestiture or monetization transaction involving ampreloxetine is not executed by the closing, a designee from Theravance Biopharma will explore potential opportunities to license, divest or otherwise monetize ampreloxetine on behalf of Zymeworks for 12-months following closing. The strategic review committee, comprised solely of independent directors, unanimously recommended the transaction to the board of directors. The board of directors unanimously approved the transaction and recommends that Theravance Biopharma shareholders vote in favor of the transaction. The transaction is expected to close in the second half of 2026, subject to approval by Theravance Biopharma shareholders, receipt of applicable regulatory approvals and satisfaction of other customary closing conditions.
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