Milestone Pharmaceuticals downgraded to Hold from Buy at TD Cowen
TD Cowen downgraded Milestone Pharmaceuticals (MIST) to Hold from Buy and suspended the firm's price target after Milestone announced the FDA issued a Complete Response Letter regarding its New Drug Application for Cardamyst nasal spray for the conversion of acute episodes of PSVT to sinus rhythm in adults. The CRL is 'upending imminent launch plans' and timelines to NDA resubmission remain unclear given new concerns on FDA functionality, says the analyst, who adds that commercialization prospects are 'also constrained by limited capital.'
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Forbes
2 hours ago
- Forbes
Over 20 Million Eggs Recalled As Prices Fall
Even as egg prices drop, consumer confidence isn't cracking back so easily. Egg prices are finally falling. After two years of whiplash at the grocery store—first from avian flu, then inflation, then panic—the May Consumer Price Index showed eggs continuing their slow descent back toward affordability. But just as shoppers might be feeling a little more stable about their morning scramble, an egg recall due to has many doing a double take at the carton. It's the kind of moment that reminds us that food security isn't just about supply. It's about trust—and that part takes longer to repair. Earlier this month, August Egg Company recalled shell eggs distributed in Florida after environmental sampling revealed possible contamination with Salmonella Enteritidis, according to the FDA. The recall was relatively limited in geographic scope, but its timing was potent. Shoppers who have just begun to exhale after months of sticker shock were remindedthat lower prices don't always equal peace of mind. A product as simple and foundational as eggs—used for everything from morning meals to baking staples—is still carrying the baggage of the last two years. The CPI shows egg prices down year-over-year, following a dramatic run-up during 2022 and 2023. But the chart doesn't tell the whole story. On the shelf, prices have remained historically high compared to what consumers remember as 'normal,' and even modest relief doesn't erase the collective memory of limit signs and $7 cartons. The latest USDA Egg Market Report backs this up. While advertised retail prices for conventional caged large white eggs dropped 16% to $3.34 per dozen this month, the national average remains elevated. And price movements vary dramatically by region. California's benchmark for large shell eggs recently fell to $3.49 per dozen—but only after peaking above $10 earlier this year. Meanwhile, demand for shell eggs in early June was 'well below where it has been measured in the past,' according to the USDA's Livestock, Poultry, and Grain Market News division. It's not just economics. There's a feeling hanging in the air—and it's not entirely gone even as promotions return. We're not just buying eggs—we're still reacting to the possibility of not being able to. The recall is a reminder that stability is fragile. So is the supply chain itself. Despite the drop in consumer prices, egg producers are still under strain. Highly pathogenic avian influenza (HPAI) has wiped out over 36 million laying hens so far in 2025 alone, according to the USDA, representing a more than 10% loss in the national flock. That's after an already devastating 2024, when another 40 million birds were lost, half of them in the final quarter of the year. Those losses ripple far beyond the farms. They've reshaped retail inventory, shifted which eggs get featured in weekly grocery ads, and raised questions about the long-term resilience of both conventional and cage-free production systems. Even as the number of non-organic cage-free layers grow the system is still balancing recovery against consumer volatility. In some markets, wholesale prices are rising again as supply tightens. In some markets, carton prices dropped while loose egg prices climbed again—proof that 'falling prices' isn't the full story. Inventory levels are rising in some regions but are still down year-over-year in others. Supply is no longer in free fall, but it isn't steady either. For many shoppers, the egg case is more than just a line item—it's a gauge of how broken or mended our food system feels. And that sense of brokenness doesn't dissipate just because prices tick down. The contradiction of 'falling CPI, rising anxiety' is emblematic of a larger emotional lag in consumer behavior. We don't just remember the inflation—we remember what it felt like to not know if we could get what we needed. That's why food recalls still cut deep. They activate a muscle memory of uncertainty. And they complicate the story that government data is trying to tell us: that things are getting better. Some consumers have shifted their behavior permanently. Interest in backyard chickens surged during the worst of the egg crisis—and while not everyone stuck with it, the idea that food security can be homemade hasn't disappeared. Nor has the instinct to double-check expiration dates or skip eggs entirely when a headline breaks. Even large-scale food manufacturers are adjusting. Some have slowed production lines in response to carton demand spikes, while others are sitting on inventory, waiting for the next pricing swing. The market is active but also cautious—a reflection of the same sentiment many households are carrying. When consumers see eggs on sale again, it's tempting to believe the crisis has passed. It's one thing to see $3.49 on the shelf—it's another to remember when you had to call ahead to see if they had eggs at all. But price is only part of the picture. In the aftermath of both inflation and contamination, trust is a harder commodity to rebuild. From backyard coops to cautious cart swaps, shoppers are still negotiating their relationship with a product that was once a given. And while the CPI reports may offer economic relief, what consumers feel—in their habits, hesitations, and household rituals—tells the deeper story.
Yahoo
2 hours ago
- Yahoo
U.S. Food and Drug Administration Approves Nuvation Bio's IBTROZI™ (taletrectinib), a Next-Generation Oral Treatment for Advanced ROS1-Positive Non-Small Cell Lung Cancer
Approval follows Priority Review and is supported by the robust TRUST clinical program, in which IBTROZI treatment demonstrated high, durable response rates and brain-penetrant efficacy across different lines of therapy The safety and tolerability of IBTROZI have been well established in the pivotal program, with one of the largest safety datasets in ROS1+ NSCLC showing a favorable and consistent profile Company to host conference call tomorrow, June 12 at 7:30 a.m. EDT NEW YORK, June 11, 2025--(BUSINESS WIRE)--Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, today announced that the U.S. Food and Drug Administration (FDA) has approved IBTROZI™ (taletrectinib) for the treatment of adult patients with locally advanced or metastatic ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC). IBTROZI is a highly selective, next-generation oral ROS1 tyrosine kinase inhibitor (TKI) designed to address some of the outstanding challenges of treating ROS1+ NSCLC. It has demonstrated high response rates with durable benefit and intracranial activity and is generally well tolerated, providing a new treatment option for patients with advanced ROS1+ NSCLC. "The FDA approval of IBTROZI marks a major milestone in the evolution of targeted therapy for advanced ROS1-positive NSCLC," said David Hung, M.D., Founder, President and Chief Executive Officer of Nuvation Bio. "We believe one of the greatest threats to ROS1-positive lung cancer patients is disease progression, especially in the first-line setting. In pivotal trials, IBTROZI delivered high response rates with sustained durability—truly meaningful benefits for patients. With its clinically proven efficacy and safety profile, we believe IBTROZI has the potential to become a new standard for what targeted therapies can achieve in this type of lung cancer. With approvals for IBTROZI now in the U.S. and China, and additional global filings underway, we remain committed to delivering innovative therapies that help patients stay ahead of their disease." ROS1+ NSCLC is a rare and aggressive form of lung cancer, accounting for approximately 2% of new NSCLC cases, or about 3,000 new diagnoses of advanced disease annually in the U.S. The median age at diagnosis for patients with this type of lung cancer is approximately 50 years old, and the disease is more likely to occur in people who have never smoked. Brain metastases are common and a leading cause of disease progression and mortality in this population. "For people living with advanced ROS1-positive lung cancer, who tend to be diagnosed at a younger age, having another treatment option can make a real difference for them and their loved ones," said Janet Freeman-Daily, Co-Founder and President of The ROS1ders. "The approval of this new targeted therapy is a meaningful step forward for the advanced ROS1+ lung cancer community and offers hope for patients facing the added challenge of cancer spreading to the brain." The FDA approval of IBTROZI is supported by one of the largest global clinical trial programs in ROS1+ NSCLC to date, with over 300 patients enrolled in the pivotal TRUST-I and TRUST-II studies. In TRUST-I, IBTROZI achieved a confirmed overall response rate (cORR) of 90% in TKI-naïve patients. These findings were reinforced by the TRUST-II results, with a cORR of 85% in TKI-naïve patients. The median duration of response (DOR) was not yet reached for either trial, based on a cutoff date that is nearly five months later than that of the pooled TRUST-I and TRUST-II analysis published in April in the Journal of Clinical Oncology. For TRUST-I, with a median follow-up for responses of 40 months, the longest DOR was observed at 46.9 months and ongoing. For TRUST-II, with a median follow-up for responses of 19 months, the longest DOR was observed at 30.4 months and ongoing as of October 2024. Given the single-arm nature of the TRUST clinical studies, median progression-free survival (PFS) is not provided in the label. Across the pivotal studies, consistent results were also observed among patients who were previously treated with a ROS1 TKI (TKI-pretreated). In TRUST-I, treatment with IBTROZI achieved a cORR of 52% and median DOR of 13.2 months for TKI-pretreated patients, with median follow-up for responses of 33 months. In TRUST-II, treatment with IBTROZI achieved a cORR of 62%, and as of October 2024 the median DOR was 19.4 months in these patients, with a median follow-up for responses of 19 months. Brain metastases are among the most common and devastating complications in advanced ROS1+ NSCLC. IBTROZI was designed to penetrate the central nervous system (CNS) and has demonstrated consistent intracranial responses in patients with measurable brain metastases at baseline. An intracranial response was achieved in 73% of TKI-naive patients (11/15) and 63% of TKI-pretreated patients (15/24). "Patients living with advanced ROS1+ non-small cell lung cancer and their healthcare providers are in need of new treatment options," added Nathan Pennell, M.D., Ph.D., TRUST study investigator and Professor of Medicine at the Cleveland Clinic. "IBTROZI's durability of response and ability to effectively penetrate the brain, coupled with a well-characterized and manageable safety profile, further addresses these critical needs for patients. I believe this now-approved therapy offers providers and patients a promising new option for the treatment of advanced ROS1+ non-small cell lung cancer." Dr. Pennell is a compensated member of Nuvation Bio's advisory committee. IBTROZI was generally well-tolerated, with most adverse events being low grade, transient and manageable. Patients infrequently (7%) discontinued treatment due to treatment-emergent adverse events (TEAEs). The most common adverse reactions (≥20%) included diarrhea (64%), nausea (47%), vomiting (43%), dizziness (22%), rash (22%), constipation (21%), and fatigue (20%). Overall, the majority of CNS events were mild to moderate (~90%) and resolved within days, and dose modifications due to these events were low (~5%). Approximately 90% of reported cases of dizziness were Grade 1 (mild) and transient. Liver enzyme elevations (AST 87%/ALT 85%) and QT prolongation (19%) were manageable with standard monitoring and dose modifications. IBTROZI is approved as a 600 mg once-daily oral dose, supported by a half-life of approximately 66 hours and broad tissue distribution, including the brain, enabling sustained systemic and CNS exposure. Nuvation Bio also announced the launch of NuvationConnect, a program designed to support patients prescribed IBTROZI. The program will offer financial assistance, access to resources and personalized support for eligible patients. Prescribers can learn more at or by calling 1-877-NUV-CON1 (1-877-688-2661). Conference Call & Business Update Nuvation Bio will host a conference call on June 12, 2025 at 7:30 a.m. EDT / 4:30 a.m. PDT, where company executives will provide an overview of the FDA approval of IBTROZI and our plans to now bring this medicine to patients. As a reminder to investors, the approval, together with the first commercial sale, makes the funding secured from Sagard Healthcare Partners in March fully available to the company. Nuvation Bio expects that this finances the launch of IBTROZI in full and provides further resources to continue advancing our pipeline in areas of unmet need. Investors and the general public are invited to register and listen to a live webcast of the event through the company website at Those unable to register can access the live conference call by dialing +1 833-470-1428 (U.S. toll-free) and entering access code 783971. A replay of the event will be available shortly after the conclusion. About ROS1+ NSCLC Each year, more than one million people globally are diagnosed with non-small cell lung cancer (NSCLC), the most common form of lung cancer. It is estimated that approximately 2% of patients with NSCLC have ROS1+ disease. About 35% of patients newly diagnosed with metastatic ROS1+ NSCLC have tumors that have spread to their brain. The brain is also the most common site of disease progression, with about 50% of previously treated patients developing CNS metastases. Despite recent progress for patients with ROS1+ NSCLC, there remains a need for more effective and tolerable treatment options. About IBTROZI IBTROZI is an oral, potent, central nervous system-active, selective, next-generation ROS1 inhibitor therapy approved for the treatment of adult patients with advanced ROS1-positive non-small cell lung cancer. Learn more at About the TRUST Clinical Program The TRUST clinical program evaluating IBTROZI for the treatment of adult patients with advanced ROS1+ NSCLC included two Phase 2 single-arm pivotal studies: TRUST-I (NCT04395677) in China, which enrolled 173 patients, and TRUST-II (NCT04919811), a global study, which enrolled 164 patients. The primary endpoint of these registrational studies is confirmed objective response rate (cORR) as assessed by an independent review committee (IRC). Key secondary endpoints include intracranial cORR, duration of response, progression-free survival, and safety. Indication IBTROZI is indicated for the treatment of adult patients with locally advanced or metastatic ROS1+ non-small cell lung cancer (NSCLC). IMPORTANT SAFETY INFORMATION FOR IBTROZITM (taletrectinib) WARNINGS AND PRECAUTIONS Hepatotoxicity: Hepatotoxicity, including drug-induced liver injury and fatal adverse reactions, can occur. 88% of patients experienced increased AST, including 10% Grade 3/4. 85% of patients experienced increased ALT, including 13% Grade 3/4. Fatal liver events occurred in 0.6% of patients. Median time to first onset of AST or ALT elevation was 15 days (range: 3 days to 20.8 months). Increased AST or ALT each led to dose interruption in 7% of patients and dose reduction in 5% and 9% of patients, respectively. Permanent discontinuation was caused by increased AST, ALT, or bilirubin each in 0.3% and by hepatotoxicity in 0.6% of patients. Concurrent elevations in AST or ALT ≥3 times the ULN and total bilirubin ≥2 times the ULN, with normal alkaline phosphatase, occurred in 0.6% of patients. Interstitial Lung Disease (ILD)/Pneumonitis: Severe, life-threatening, or fatal ILD or pneumonitis can occur. ILD/pneumonitis occurred in 2.3% of patients, including 1.1% Grade 3/4. One fatal ILD case occurred at the 400 mg daily dose. Median time to first onset of ILD/pneumonitis was 3.8 months (range: 12 days to 11.8 months). ILD/pneumonitis led to dose interruption in 1.1% of patients, dose reduction in 0.6% of patients, and permanent discontinuation in 0.6% of patients. QTc Interval Prolongation: QTc interval prolongation can occur, which can increase the risk for ventricular tachyarrhythmias (e.g., torsades de pointes) or sudden death. IBTROZI prolongs the QTc interval in a concentration-dependent manner. In patients who received IBTROZI and underwent at least one post baseline ECG, QTcF increase of >60 msec compared to baseline and QTcF >500 msec occurred in 13% and 2.6% of patients, respectively. 3.4% of patients experienced Grade ≥3. Median time from first dose of IBTROZI to onset of ECG QT prolongation was 22 days (range: 1 day to 38.7 months). Dose interruption and dose reduction each occurred in 2.8% of patients. Significant QTc interval prolongation may occur when IBTROZI is taken with food, strong and moderate CYP3A inhibitors, and/or drugs with a known potential to prolong QTc. Administer IBTROZI on an empty stomach. Avoid concomitant use with strong and moderate CYP3A inhibitors and/or drugs with a known potential to prolong QTc. Hyperuricemia: Hyperuricemia can occur and was reported in 14% of patients, with 16% of these requiring urate-lowering medication without pre-existing gout or hyperuricemia. 0.3% of patients experienced Grade ≥3. Median time to first onset was 2.1 months (range: 7 days to 35.8 months). Dose interruption occurred in 0.3% of patients. Myalgia with Creatine Phosphokinase (CPK) Elevation: Myalgia with or without CPK elevation can occur. Myalgia occurred in 10% of patients. Median time to first onset was 11 days (range: 2 days to 10 months). Concurrent myalgia with increased CPK within a 7-day time period occurred in 0.9% of patients. Dose interruption occurred in 0.3% of patients with myalgia and concurrent CPK elevation. Skeletal Fractures: IBTROZI can increase the risk of fractures. ROS1 inhibitors as a class have been associated with skeletal fractures. 3.4% of patients experienced fractures, including 1.4% Grade 3. Some fractures occurred in the setting of a fall or other predisposing factors. Median time to first onset of fracture was 10.7 months (range: 26 days to 29.1 months). Dose interruption occurred in 0.3% of patients. Embryo-Fetal Toxicity: Based on literature, animal studies, and its mechanism of action, IBTROZI can cause fetal harm when administered to a pregnant woman. ADVERSE REACTIONS Among patients who received IBTROZI, the most frequently reported adverse reactions (≥20%) were diarrhea (64%), nausea (47%), vomiting (43%), dizziness (22%), rash (22%), constipation (21%), and fatigue (20%). The most frequently reported Grade 3/4 laboratory abnormalities (≥5%) were increased ALT (13%), increased AST (10%), decreased neutrophils (5%), and increased creatine phosphokinase (5%). DRUG INTERACTIONS Strong and Moderate CYP3A Inhibitors/CYP3A Inducers and Drugs that Prolong the QTc Interval: Avoid concomitant use. Gastric Acid Reducing Agents: Avoid concomitant use with PPIs and H2 receptor antagonists. If an acid-reducing agent cannot be avoided, administer locally acting antacids at least 2 hours before or 2 hours after taking IBTROZI. OTHER CONSIDERATIONS Pregnancy: Please see important information in Warnings and Precautions under Embryo-Fetal Toxicity. Lactation: Advise women not to breastfeed during treatment and for 3 weeks after the last dose. Effect on Fertility: Based on findings in animals, IBTROZI may impair fertility in males and females. The effects on animal fertility were reversible. Pediatric Use: The safety and effectiveness of IBTROZI in pediatric patients has not been established. Photosensitivity: IBTROZI can cause photosensitivity. Advise patients to minimize sun exposure and to use sun protection, including broad-spectrum sunscreen, during treatment and for at least 5 days after discontinuation. Please see accompanying full Prescribing Information. About Nuvation Bio Nuvation Bio is a global oncology company focused on tackling some of the toughest challenges in cancer treatment by developing therapies that create a profound, positive impact on patients' lives. Our diverse pipeline includes IBTROZI (taletrectinib), a next-generation ROS1 inhibitor; safusidenib, a brain-penetrant IDH1 inhibitor for glioma; NUV-1511, an innovative drug-drug conjugate (DDC) designed for targeted cancer treatment; and NUV-868, a BD2-selective BET inhibitor. Nuvation Bio was founded in 2018 by biopharma industry veteran David Hung, M.D., who previously founded Medivation, Inc., which brought to patients one of the world's leading prostate cancer medicines. Nuvation Bio has offices in New York, San Francisco, Boston, and Shanghai. For more information, visit or follow the company on LinkedIn and X (@nuvationbioinc). Forward-Looking Statements Certain statements included in this press release that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements are sometimes accompanied by words such as "believe," "may," "will," "estimate," "continue," "anticipate," "intend," "expect," "should," "would," "plan," "predict," "potential," "seem," "seek," "future," "outlook" and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, our expectations regarding IBTROZI's therapeutic potential in advanced ROS1+ NSCLC and its potential to become a new standard of care. These statements are based on various assumptions, whether or not identified in this press release, and on the current expectations of the management team of Nuvation Bio and are not predictions of actual performance. These forward-looking statements are subject to a number of risks and uncertainties that may cause actual results to differ from those anticipated by the forward-looking statements, including but not limited to the challenges associated with conducting drug discovery and initiating or conducting clinical studies due to, among other things, difficulties or delays in the regulatory process, enrolling subjects or manufacturing or acquiring necessary products; the emergence or worsening of adverse events or other undesirable side effects; risks associated with preliminary and interim data, which may not be representative of more mature data; and competitive developments. Risks and uncertainties facing Nuvation Bio are described more fully in its Form 10-Q filed with the SEC on May 7, 2025 under the heading "Risk Factors," and other documents that Nuvation Bio has filed or will file with the SEC. You are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date of this press release. Nuvation Bio disclaims any obligation or undertaking to update, supplement or revise any forward-looking statements contained in this press release. View source version on Contacts Media and Investor ContactsNuvation Bio Investor Contact ir@ Nuvation Bio Media Contact media@ Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
3 hours ago
- Yahoo
FedEx bumps up fuel surcharge rates
This story was originally published on Supply Chain Dive. To receive daily news and insights, subscribe to our free daily Supply Chain Dive newsletter. FedEx increased its fuel surcharge calculations on Monday, adding to the list of fee adjustments the logistics giant has made so far this month. The fuel surcharge hikes — generally around 200 basis points — apply to FedEx Ground, Home Delivery, International Ground, domestic package services and international imports and exports. Additionally, U.S. express freight services now have a higher per-pound surcharge rate. FedEx sets its fuel fee prices each week, adjusting it based on average diesel and jet fuel costs. With the calculation changes, if the per-gallon price of diesel fuel is $3.74, a FedEx Ground shipment now incurs a 20.5% surcharge on fuel instead of an 18.5% surcharge. FedEx's fuel surcharge adjustments build upon ongoing pricing pressures that parcel shippers have seen over the past year. Frequent fee additions, increases and changes among major carriers are eating into rate discounts shippers have secured in a competitive market. "Over the past 18 months, FedEx and UPS have pursued a different strategy as they fight for revenue in a low demand environment, with more frequent, subtle pricing changes that take effect more quickly," according to April's TD Cowen/AFS Freight Index. Fuel surcharge calculations tweaks have been common during this stretch. From Q1 2024 to Q1 2025, FedEx's ground fuel surcharge jumped 12% as a result of the changes, despite diesel fuel prices falling by 8.4% over the same period, per the index. Beyond fuel fee tweaks, FedEx increased its late payment fee from 8% to 9.9% of the total past-due invoice balance on June 1. The following day, FedEx also changed which ZIP codes its delivery area surcharge applies to. Now, deliveries to several ZIP codes in communities such as Abilene, Texas, and the Oregon cities of Eugene and Salem will be subject to the per-package surcharge. FedEx's moves follow similar actions by rival UPS, which has increased its fuel surcharges, changed where its delivery area surcharge applies and announced upcoming tweaks to how fees on bulky packages are calculated. Recommended Reading UPS surcharge updates impact fuel fees, bulky packages and more Error while retrieving data Sign in to access your portfolio Error while retrieving data Error while retrieving data Error while retrieving data Error while retrieving data
