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NVO News
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Novo Nordisk's Wegovy Tablet Application Accepted
The official website of the Center for Drug Evaluation of China's National Medical Products Administration, NMPA, shows that Novo Nordisk's application for the marketing of Wegovy tablets, semaglutide tablets, for long-term weight management has been officially accepted. This registration application is based on the extensive OASIS clinical research program. Dr. Yan Cai, Senior Vice President of Novo Nordisk Global and President of Greater China, stated: "With over thirty years of dedicated experience in obesity, Novo Nordisk continues to lead innovation, offering a wider range of treatment options to meet patients' individualized treatment needs, driving obesity treatment from focusing on changes in weight numbers to focusing on overall health and long-term outcomes, creating longer-term health benefits for patients."
Major Averages Rise as Chip Stocks Benefit from Nvidia Earnings
The major averages advanced, with chip stocks moving higher ahead of Nvidia's upcoming earnings print as well as key inflation data due Wednesday. The U.S. has begun imposing tougher sanctions on Iran, but crude prices have eased, continuing a downward trend that began late last week. In other geopolitical news, the North American trade war heated up as Canada is matching Trump's weekend tariff escalation with a sweeping package of counter tariffs that directly targets U.S. steel, aluminum and downstream manufacturing.Get caught up quickly on the top news and calls moving stocks with these five Top Five lists.1. STOCK NEWS:Dick's Sportingreportedand cut its FY26 earnings and revenue guidanceUnited Airlinesaddedacross Europe and AsiaMcKessonPrecision Medicine Group for roughly $2.25BTeslahas increased U.S. Cybertruck prices,Anthropic is preparing to pitch a more than $30T total addressable market in its IPO, surpassing SpaceX's$28.5T estimate,2. WALL STREET CALLS:AMDto Strong Buy from Outperform at Raymond JamesLoop CapitalFive Belowwith bullish view priced inDynatraceto Overweight at Morgan StanleyKlarnato Peer Perform at Wolfe ResearchShift4 Paymentsto Overweight at Wells Fargo3. AROUND THE WEB:Appleis set to introduce a foldable iPhone at a launch event on or around September 9, Bloomberg reportsSome PepsiCoemployees were notified this week that weight-loss drugs such as Novo Nordisk'sWegovy and Eli Lilly'sZepbound will no longer be covered by their company health insurance as of October, Bloomberg saysSoftBankis planning a record Y1T, or $6.3B, retail bond sale to raise funds for its investment commitments to OpenAI, Bloomberg saysShellhas attracted interest from ExxonMobiland LyondellBasellfor its underperforming U.S. chemicals assets, including the $14B Monaca complex, as it seeks to streamline its portfolio, FT saysJack Ma, the founder of Alibaba, has bought more than HK$600M worth of the company's Hong Kong-listed shares on consecutive days, SCMP reports4. MOVERS:Richtech Roboticsincreased after announcing aMadison Airgained after announcing aModernawas higher after Wolfe Researchthe stock to Peer PerformGorilla Technologyfell in New York afterand providing guidance for FY27Targetwas lower after issuing a statement related to its5. EARNINGS/GUIDANCE:Vipshopand provided guidance for Q3Scotiabank, with EPS and revenue beating consensusCiti Trendsand raised its outlook for FY26SelectQuote, with CEO Tim Danker commenting, "It was a highly successful 4th quarter and full-year fiscal 2026 for our business"Marzetti, with EPS beating consensusINDEXES:The Dow rose 160.24, or 0.30%, to 53,577.40, the Nasdaq gained 171.11, or 0.66%, to 26,151.30, and the S&P 500 advanced 24.42, or 0.32%, to 7,677.28.
Lexicon Earns $10M Milestone Payment from Novo Nordisk
Lexicon (LXRX) announced that it has earned a third $10M milestone payment in 2026 from Novo Nordisk (NVO) following the achievement of a patient dosing milestone in the ongoing Phase 1 clinical development program for LX9851. LX9851 is being advanced by Novo Nordisk under the companies' exclusive worldwide license agreement signed in 2025. Under the terms of the agreement, Novo Nordisk obtained an exclusive, worldwide license to develop, manufacture and commercialize LX9851 in all indications. With the achievement of this milestone, Lexicon has now earned $75M of the $1B in potential upfront, development, regulatory and commercial milestone payments available under its collaboration with Novo Nordisk. In addition, Lexicon is entitled to receive tiered royalties on future net sales of LX9851.
Scholar Rock Removes Catalent Indiana as Apitegromab Commercial Fill-Finish Facility
Scholar Rock (SRRK) announced it has removed Catalent Indiana (NVO) as a commercial fill-finish facility from its apitegromab Biologics License Application for the treatment of spinal muscular atrophy in the U.S., under guidance from FDA. FDA review of the BLA is progressing well with the Company's alternate fill-finish facility, and Scholar Rock continues to expect an FDA approval decision by the September 30 Prescription Drug User Fee Act date. Scholar Rock also announced that, following the August 7 customer notification that FDA classified the Catalent Indiana April 2026 general site inspection as Official Action Indicated, the Company has withdrawn its apitegromab Marketing Authorisation Application via written procedure with the Committee for Medicinal Products for Human Use, which concluded on August 20. Scholar Rock will remove Catalent Indiana as a commercial fill-finish facility from the apitegromab MAA and resubmit the application with the alternate fill-finish facility to facilitate the most expeditious path to a CHMP opinion. In addition, Scholar Rock announced that it is now on track to submit a Japanese New Drug Application for apitegromab for the treatment of children and adults with SMA by year end 2026, following alignment with Japan's Pharmaceuticals and Medical Devices Agency that no additional clinical studies are required. This alignment is based on PMDA's assessment of the ability of apitegromab to meet the criteria as described in recent guidelines on core conditions for filing without Japanese clinical data. In Japan, clinical studies in the Japanese population are typically required to support a JNDA filing. Scholar Rock engaged with PMDA regarding recent guidelines allowing JNDA submissions for specific orphan and rare disease drugs without domestic Japanese clinical trial data. The core conditions include a pivotal trial successfully completed outside of Japan, impractical patient recruitment due to small target patient populations, and available scientific and clinical evidence strongly indicating favorable benefit-risk profile for Japanese patients. Based on these criteria, the PMDA has agreed that an apitegromab JNDA may be filed without clinical data in Japanese patients. Scholar Rock's alternate fill-finish facility for apitegromab is a U.S.-based facility producing numerous commercial products with a strong track record of regulatory compliance, including recent successful FDA and EMA inspections. Robust supply of apitegromab commercial vials from the alternate fill-finish facility is available to support the global launch of apitegromab following regulatory approvals.
Novo Nordisk Shares Up 1.32%, Active Options Trading
Moderately bullish activity in Novo Nordisk (NVO), with shares up 60c, or 1.32%, near $46.31. Options volume running well above average with 83k contracts traded and calls leading puts for a put/call ratio of 0.34, compared to a typical level near 0.58. Implied volatility (IV30) is higher by 1.1 points near 31.57,in the lowest 10% of observations over the past year, suggesting an expected daily move of $0.92. Put-call skew steepened, indicating increased demand for downside protection, following a downgrade to Hold at Berenberg.
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