HHS Secretary Robert F. Kennedy Jr. says Moderna (MRNA) has agreed to do another clinical trial to back its newly approved next-gen COVID-19 vaccine.
https://seekingalpha.com/news/4455331-rfk-jr-says-moderna-another-trial-new-covid-shot
Wednesday, June 4, 2025
Anaptys Positive Rosnilimab Data Updated Through 6 Months in Robust Phase 2b Trial in RA
AnaptysBio (ANAB) announced positive 6-month data for rosnilimab in Phase 2b trial for moderate-to-severe rheumatoid arthritis. The drug demonstrated JAK-like efficacy with monthly dosing, achieving significant improvements in disease activity measures. The 424-patient trial showed 69% of patients achieved low disease activity (LDA) across all doses at Week 14, with responses lasting at least 2 months after treatment. The drug showed favorable safety with no treatment-related serious adverse events. In b/tsDMARD-naive patients, LDA rates reached up to 72% at Week 28, while b/tsDMARD-experienced patients showed up to 56% LDA. The drug demonstrated ~50% reduction in CRP levels and ~90% reduction in PD-1high T cells, indicating strong anti-inflammatory effects. Rosnilimab targets the ~$20 billion U.S. RA market, with potential for extended dosing intervals during maintenance treatment.
Bayer gains key FDA expansion for fast-rising prostate cancer drug Nubeqa
Bayer has taken another step toward achieving its €3 billion peak sales estimate for androgen receptor inhibitor Nubeqa, scoring an FDA approval to expand its use to all patients with metastatic castration-sensitive prostate cancer (mCSPC), also known as metastatic hormone-sensitive prostate cancer (mHSPC).
The label expansion comes three years after the FDA signed off on Nubeqa in combination with androgen deprivation therapy (ADT) and the chemotherapy docetaxel to treat patients with mCSPC. The new nod allows Nubeqa to be used along with ADT by those who can’t tolerate chemo.
The FDA endorsement was based on results of a phase 3 trial, ARANOTE, which showed that Nubeqa significantly extended the time before tumor progression or death in patients with mCSPC compared with ADT alone. In the study of 669 patients who were randomized 2 to 1 to receive 600 mg of Nubeqa plus ADT or placebo plus ADT, Nubeqa reduced the risk of radiographic progression or death (rPFS) by 46%, allowing the trial to achieve its primary endpoint.
The result demonstrated Nubeqa’s “powerful efficacy,” according to the trial’s principal investigator Dr. Fred Saad, M.D., of the University of Montreal Hospital Center.
“Today’s approval further expands physicians’ options for using Nubeqa with and without docetaxel in this setting, providing a potential new choice for patients,” Saad added in a release.
Nubeqa was originally approved in 2019 in combination with ADT to treat patients with non-metastatic castration-resistant (nmCRPC) who are at risk of developing metastatic disease.
Last year, Nubeqa achieved blockbuster status for the first time with global sales of 1.52 billion euros ($1.65 billion), an increase of 78% from the prior year. With first-quarter sales of 515 million euros ($574 million), Nubeqa is on its way to generating more than $2 billion in 2025.
In addition to the two existing tumor settings, Bayer is running the phase 3 trial to evaluate if the addition of Nubeqa could improve upon ADT in non-metastatic hormone-sensitive prostate cancer at high risk of biochemical recurrence. The study has an estimated primary completion date of early 2027.
Other androgen receptor inhibitors on the market are Pfizer and Astellas’ powerhouse Xtandi, which was approved 13 years ago and generated sales of $5.4 billion in 2024, as well as Johnson & Johnson’s Erleada, which reached the market in 2018 and achieved $784 million in sales last year.
With Nubeqa and kidney disease treatment Kerendia—which achieved an 89% increase in sales to 161 million euros ($179 million) in the first quarter—Bayer has a pair of fast-rising drugs that allowed its pharma sector to post a surprising 4.4% increase in revenue in Q1.
“These gains more than offset the declines we’re seeing on Xarelto,” Bayer CEO Bill Anderson said last month of the aging blood thinner, which saw its sales tumble by 31% to 633 million euros ($706 million).
Roche’s Evrysdi tablet OKd by European Commission as first and only for Spinal Muscular Atrophy
Roche (RHHBY) has received European Commission approval for a new tablet formulation of Evrysdi (risdiplam), marking a significant advancement in Spinal Muscular Atrophy (SMA) treatment. The 5mg tablet, which can be swallowed whole or dispersed in water, offers room-temperature stability and doesn't require refrigeration. This new formulation maintains the same efficacy and safety as the original oral solution, as demonstrated in bioequivalence studies. Evrysdi, the only non-invasive disease-modifying SMA treatment, has treated over 18,000 patients globally. The tablet is approved for patients aged two years or older, weighing 20kg or more, who can swallow without a feeding tube. The original oral solution will remain available for patients requiring different doses or preferring that format.
'Microsoft Launches Free Cybersecurity Support For European Governments'
The free European Security Program will enhance AI-driven cyber threat intelligence, strengthen partnerships with law enforcement, and boost digital defenses across EU countries.
Microsoft Corp. (MSFT) has launched a European Security Program aimed at bolstering the continent's defenses against escalating cyber threats, especially those involving artificial intelligence (AI).
The initiative, announced in Berlin, is designed to enhance collaboration between Microsoft and European governments in combating sophisticated cyberattacks.
Microsoft’s President Brad Smith remarked that as artificial intelligence and digital innovations progress, the cyber threat environment in Europe is rapidly changing, creating new obstacles that demand tighter collaboration and improved defenses.
Ransomware gangs and government-backed hackers from Russia, China, Iran, and North Korea are expanding their reach and increasing in complexity, making it crucial for Europe’s cybersecurity efforts to keep pace.
Neogen stock tumbles on genomics business divestiture plans
Shares of Neogen Corporation (NASDAQ:NEOG) plummeted 20.4% following the company’s announcement at William Blair’s Growth Stock Conference of its plans to divest its genomics business. The divestiture is part of a broader strategy to mitigate the impact of tariffs and focus more intently on its food safety testing segment.
Neogen’s CFO and COO David Naemura conveyed the company’s intention to streamline operations by shedding its cleaners and disinfectants and genomics businesses by fiscal year 2025. This strategic move is expected to result in a revenue reduction of $150 million and a decrease in EBITDA by a low twenties million in fiscal 2026. Naemura emphasized the company’s commitment to improving execution and driving better results amidst challenging conditions.
The decision to sell the genomics business, which had not been previously specified, comes as Neogen aims to enhance its growth acceleration and margin expansion. The company has also undertaken measures to counterbalance the financial repercussions of tariffs, which are projected to have a nominal full-year impact of approximately $5 million based on current rates, thanks to mitigation efforts, agricultural exemptions, pricing adjustments, and supply chain redirection.
Neogen’s focus on operational improvement includes three key areas: growth acceleration, margin expansion, and improved execution. The company is actively marketing the genomics platform, which is a part of its animal safety business, with the sale of the cleaners and disinfectants business already announced.
Investors reacted to the news by selling off Neogen shares, reflecting concerns over the near-term revenue and earnings impact resulting from the divestitures. Despite the company’s strategic rationale for the move, the market’s response underscores the challenges Neogen faces in navigating tariff impacts and refocusing its business portfolio.
Medicare expands coverage for Natera’s Signatera MRD test
Natera, Inc. (NASDAQ: NTRA), a pioneer in cell-free DNA testing and precision medicine, has announced that Medicare will now cover its Signatera MRD (molecular residual disease) assay for a wider range of cancers. The decision, effective under LCD L38779, includes Medicare beneficiaries with colorectal, breast, bladder, ovarian, and lung cancers, as well as patients undergoing pan-cancer immunotherapy monitoring.
This expanded coverage follows the presentation of a pan-cancer study involving 392 patients at the recent 2025 American Society of Clinical Oncology (ASCO) Annual Meeting earlier this week. The study highlighted the clinical utility of the Signatera Genome assay, which utilizes Natera’s proprietary multiplex PCR-NGS technology for deep sequencing of targeted high-quality variants.
Subscribe to:
Comments (Atom)