Novartis upgraded at Morgan Stanley on stock pullback, Rhapsido launch

 

• Morgan Stanley has upgraded Novartis (NVS) to overweight from equal-weight, citing a valuation pullback after the Swiss drugmaker missed on the bottom line in its Q3 results in late October as well as optimism over the upcoming launch of Rhapsido (remibrutinib) for chronic spontaneous urticaria (hives).
• The bank has upped its price target to CHF 110 from CHF 108 (~2% upside based on Wednesday's close on the SIX Swiss Exchange.
• The Q3 miss "was driven by a negative one-off on Cosentyx and faster-than-expected erosion for legacy/LOE products (Tasigna, Promacta, Taf/Mek, Xolair), while key growth drivers (Kesimpta, Pluvicto, Scemblix, Fabhalta) beat expectations," wrote analyst Thibault Boutherin.
• He expects modest 2026 sales growth of 2% followed by 5% from 2027-2029, adding he sees the company projecting a 5% CAGR from 2025-2030.

• Boutherin wrote that he anticipates $5B in risk adjusted potential sales for Rhapsido assuming additional indications, adding that the launch in chronic spontaneous urticaria is likely to surpass the consensus estimate.

https://www.msn.com/en-us/money/companies/novartis-upgraded-at-morgan-stanley-on-stock-pullback-rhapsido-launch/ar-AA1RDZ5M

'Microsoft erases some losses as it denies report it cut sales quotas tied to AI'

 

• Microsoft (MSFT) shares erased some of its losses on Wednesday after it denied a report that it was cutting software sales quotas tied to artificial intelligence.
• Microsoft told CNBC it has not lowered its sales quotas or targets for its salespeople. In a statement provided to Seeking Alpha, a Microsoft spokesperson said report was incorrect. “The Information’s story inaccurately combines the concepts of growth and sales quotas, which shows their lack of understanding of the way a sales organization works and is compensated,” the spokesperson said. “Aggregate sales quotas for AI products have not been lowered, as we informed them prior to publication.”
• Shares fell on Wednesday after The Information reported that the tech giant is cutting software sales quotas tied to artificial intelligence. The Windows maker has lowered its forecast for how fast customers will be able to spend money on AI agents, after a number of salespeople missed their goals, the news outlet added, citing people familiar with the matter. The quotas have been missed across multiple divisions, two salespeople in Microsoft's Azure unit told the news outlet.

https://www.msn.com/en-us/money/companies/microsoft-erases-some-losses-as-it-denies-report-it-cut-sales-quotas-tied-to-ai/ar-AA1RDxMW

Micron Announces Exit from Crucial Consumer Business

Micron (Nasdaq: MU) announced it will exit the Crucial consumer business, ending consumer-branded product sales through retailers, e-tailers and distributors worldwide.

Micron will continue Crucial consumer shipments through the end of fiscal Q2 (February 2026), and will provide continued warranty service and support for Crucial products. The company said it will keep selling Micron-branded enterprise products to commercial customers globally.

Micron framed the move as part of a portfolio transformation to prioritize enterprise and commercial segments, improve supply and support for strategic customers driven by AI data-center demand, and pursue redeployment opportunities for affected team members.

https://www.stocktitan.net/news/MU/micron-announces-exit-from-crucial-consumer-z3b5itrx9uih.html

Regeneron downgraded at Morgan Stanley on valuation

 Morgan Stanley has downgraded Regeneron Pharmaceuticals (REGN) from overweight to equal-weight, stating that the stock is fairly valued. The price target remains at $767, indicating a potential 3% upside. Despite recent gains from Eylea HD's new indication and strong Dupixent sales, analyst Terence Flynn emphasizes the need for pipeline diversification. Upcoming catalysts include phase 3 melanoma and phase 2 lung cancer data, and decisions on COPD development in collaboration with Sanofi. Flynn projects 2026 revenues at $14.89 billion and EPS at $45.19, close to consensus estimates.

https://www.gurufocus.com/news/3232370/morgan-stanley-downgrades-regeneron-regn-citing-fair-valuation

German, French, Spanish ministers to meet on on next-gen fighter December 11, says source

 Defence ministers from Germany, France and Spain ​are set to meet on ‌December 11 to discuss FCAS, Europe's next-generation fighter ‌jet project, a source familiar with the matter told Reuters on Wednesday.

The 100-billion-euro ($117 billion) Future Combat Air System (FCAS), ⁠floated more ‌than eight years ago, has been mired in disputes between ‍the companies involved over workshare and prized technology.

At stake ​is the next phase of ‌plans to deliver a fighter flanked by drones for France, Germany and Spain by 2040, mirroring a UK-Italian-Japanese initiative called GCAP.

However, disagreements between France's ⁠Dassault Aviation and Airbus ​mean the project has ​hit an impasse.

Last month, French President Emmanuel Macron and German ‍Chancellor Friedrich ⁠Merz discussed the project in a bid to try to make ⁠progress.

https://uk.finance.yahoo.com/news/german-french-spanish-ministers-meet-160935660.html

Harmony’s Dravet Drug Halves Monthly Seizures in Late-Stage Study

 

The Phase III, open-label extension study suggests EPX-100 has a “positive” risk/benefit profile for the treatment of Dravet syndrome, analysts at H.C. Wainwright & Co. said Tuesday.

Harmony Biosciences’ EPX-100 reduced monthly seizures by about half in a Phase III study of patients with Dravet syndrome.

“These results increase our confidence in the EPX-100 program,” analysts at H.C. Wainwright & Co. said in a note to investors on Tuesday. The analysts called the drug “a cornerstone of Harmony’s strategy” to complement the company’s excessive sleepiness drug Wakix.

The readout, H.C. Wainwright added, “represents a de-risking event for a key pipeline asset” for the biotech.

Tuesday’s data come from the open-label extension stage of the Phase III ARGUS study, a randomized, double-blinded and placebo-controlled trial that compared EPX-100 against placebo, looking at countable motor seizures per 28 days, a metric called CMS-28. Results showed that in patients who had been taking EPX-100 for at least 6 months in this extension phase, there was an “approximately 50% reduction” in CMS-28 from baseline.

All 29 patients who had completed the double-blind portion of the study continued on to the open-label extension phase, which H.C. Wainwright said is indicative of “a positive patient and physician view of the drug’s risk/benefit profile.”

More detailed data from the trial is scheduled to be presented on Dec. 8 at the American Epilepsy Society’s annual conference.

Aside from EPX-100’s preliminary efficacy, the ARGUS open-label phase also assessed the drug’s safety profile. There were 28 drug-related side effects and 11 serious adverse events, of which one was “possibly” linked to EPX-100, according to the study investigator. The H.C. Wainwright analysts called the drug’s safety profile “favorable” overall.

“While from a small, open-label cohort, this clinically meaningful efficacy signal provides strong validation for the program” in Dravet syndrome, H.C. Wainwright added. Harmony is also running the Phase III LIGHTHOUSE study for EPX-100, this time in Lennox-Gastaut syndrome, a rare and severe type of epilepsy in childhood. Both studies are pivotal, the analysts said, and are set to read out next year.

The Dravet win on Tuesday breaks somewhat of a losing streak for Harmony, which in September announced that its cannabidiol candidate ZYN002 failed a late-stage study in fragile X syndrome. In the Phase III RECONNECT trial, patients treated with ZYN002 showed no significant improvement in social avoidance. And though the biotech did not provide specific data at the time, it blamed the miss on a “higher than expected placebo response rate.”

In February, the FDA refused to accept Harmony’s supplemental application to expand Wakix into idiopathic hypersomnia. The biotech at the time did not reveal the reasoning behind the refusal.

https://www.biospace.com/drug-development/harmonys-dravet-drug-halves-monthly-seizures-in-late-stage-study

BMS Delays Cobenfy Alzheimer’s Psychosis Data After ‘Irregularities’ in Phase III Study

 

Analysts had noted “unease” from investors regarding the state of the Phase III ADEPT-2 trial, with BMS at one point telling Leerink Partners that the reopening of enrollment would be a “significant development.”

A closely watched readout for Bristol Myers Squibb’s Cobenfy in Alzheimer’s disease psychosis has been delayed to 2026 after the pharma was forced to recruit additional patients into the trial.

In a press announcement on Wednesday, BMS said it detected “irregularities” in the Phase III ADEPT-2 study linked to the execution of the trial “at a small number of study sites.”

The pharma did not specify what these irregularities were, which sites were affected and how these anomalies could affect the integrity of the collected data.

BMS nevertheless excluded data from these compromised sites and, after consulting with the FDA and with an external monitoring committee, decided to enroll more patients into the trial. The company remains blinded to study data.

Analysts appear to have had an inkling that ADEPT-2 had run into some trouble. According to an Oct. 30 note from Leerink Partners, BMS executives were asked during their Q3 earnings call whether they had reopened enrollment for the study at certain sites. A spokesperson, however, told the firm later that “there has been no clinical trial update on ADEPT-2, and any reopening of enrollment would be a significant development.”

At the time, Leerink expected ADEPT-2 to read out by the end of 2025.

On Wednesday, however, BMS noted that “additional trial results from the ADEPT program,” which includes ADEPT-2, as well as ADEPT-1 and ADEPT-4, “are expected to read out by the end of 2026.”

BMO Capital Markets, writing in a note to investors Wednesday morning, likewise alluded to the “feelings of unease from investors” regarding the ADEPT-2 readout. “Shifting commentary from management has prompted concern from some investors that the ADEPT-2 trial would fail,” the analysts wrote, however noting that relative to an outright failure, the news of the delay “is likely to be viewed a positive.”

Cobenfy, a muscarinic antipsychotic, is the main prize BMS acquired when it bet $14 billion in December 2023 to buy Karuna Therapeutics. While this investment paid off less than a year later with the FDA’s approval of the drug for schizophrenia in September 2024, Cobenfy has since run into a rough patch.

In April this year, the pharma reported disappointing findings from the Phase III ARISE study, which tested Cobenfy as a supplement to atypical antipsychotics. While add-on Cobenfy showing improvements on a scoring scale for assessing schizophrenia symptoms, its treatment effect fell short of statistical significance.

For Leerink, that late-stage stumble cast doubt on Cobenfy’s profile as a product, with analysts writing in an April 23 note that the drug could have “far less potential than we originally anticipated.” At the time of the ARISE fail, BMS said it would discuss the path forward for Cobenfy in this indication, but the pharma revealed in late July that no such talks with health regulators had yet occurred.

https://www.biospace.com/drug-development/bms-delays-cobenfy-alzheimers-psychosis-data-after-irregularities-in-phase-iii-study