Clears the way to finalize Phase 3 protocol and recruit sites for U.S.
Phase 3 substantially funded by $17.0 million CPRIT grant and $8.5 million Company match
regarding the protocol for the planned registrational Phase 3 study of eRapa in familial adenomatous polyposis (“FAP”).
Sonoma Pharmaceuticals, Inc. (Nasdaq:SNOA), a global healthcare leader developing and producing patented Microcyn® technology based stabilized hypochlorous acid (HOCl) products for a wide range of applications, including wound care, eye, oral and nasal care, dermatological conditions, podiatry, and animal health care, today announced that it will be exhibiting at the 2025 American Academy of Dermatology (AAD) Annual Meeting in Orlando, Florida, March 7-11, 2025.
Amgen’s anti-OX40 antibody rocatinlimab vindicated itself this weekend, with new Phase III data pointing to its strong efficacy in moderate to severe atopic dermatitis.
These findings come from the ROCKET-IGNITE study, one of eight trials under Amgen’s late-stage ROCKET clinical development program for rocatinlimab. Results showed that 42.3% of patients given 300-mg rocatinlimab once every four weeks saw at least a 75% reduction from baseline in Eczema Area and Severity Index scores (EASI-75) at 24 weeks. This treatment effect represented a significant 29.5% difference versus placebo, according to Amgen’s news release.
At this dose level, 23.6% of patients achieved clear or almost-clear skin at 24 weeks, representing a 14.9% advantage over placebo. Amgen presented these data Saturday at the 2024 annual meeting of the American Academy of Dermatology
Analysts at Leerink Partners called these findings “surprisingly positive” in an investor note on Sunday, pointing to a prior readout from ROCKET-HORIZON. Released in September 2024, data from the HORIZON trial found that 32.8% of rocatinlimab-treated patients achieved EASI-75, representing a 19.1% difference from placebo.
While Amgen at the time declared victory in HORIZON, calling rocatinlimab’s effect a “statistically significant improvement” in disease severity, analysts were unconvinced. Jefferies called the magnitude of effect “modest,” while BMO Capital Markets said the data “appear to fall short of agents like Ebglyss/Dupixent.” Leerink, in its note on Sunday, said it found HORIZON’s results to be “underwhelming.”
Meanwhile, IGNITE’s outcomes were “more compelling,” according to the Leerink analysts, despite testing a similar dose as HORIZON.
Still, the analysts flagged instances of pyrexia (fever) and chills—which they called an “adverse event of interest”—that occurred more frequently in rocatinlimab-treated patients. Amgen explained these side effects as “mainly a first dose effect and therefore not commonly seen on subsequent doses,” as per the Leerink note.
Amgen on Saturday also released data from two other ROCKET studies. The first, dubbed SHUTTLE, showed that rocatinlimab can elicit significant rates of EASI-75 when combined with topical corticosteroids or topical calcineurin inhibitors. The second, named VOYAGER, found that rocatinlimab does not interfere with response to tetanus and meningococcal vaccines.
Concentra®, the nation’s leader in occupational medicine, today announced the acquisition of the assets of Physicians Health Center (PHC) and OM Management (OMM).
“This acquisition will make it easier for employers in the Miami area to utilize Concentra services,” said Janet Cobb, MD, senior vice president of Concentra medical operations. “We’re excited to expand in Miami and look forward to building relationships with more Miami employers.”
Concentra will provide work injury care, physical therapy, drug testing, DOT physical exams, pre-placement exams, and other employer-related health services from its new locations in Miami. Telemedicine for minor work injuries will also be available via Concentra Telemed®, Concentra’s proprietary telemedicine platform.
Shares of Trevi Therapeutics, Inc. (NASDAQ:TRVI) surged 32% following the announcement of positive topline results from their Phase 2a RIVER trial of Haduvio. The clinical-stage biopharmaceutical company reported that Haduvio met its primary endpoint, showing a significant reduction in chronic cough frequency among patients with refractory chronic cough (RCC) and idiopathic pulmonary fibrosis (IPF).
The RIVER trial, which tested the efficacy, safety, and tolerability of Haduvio in RCC patients, demonstrated a 67% reduction in 24-hour cough frequency from baseline and a 57% reduction on a placebo-adjusted basis. These results were bolstered by significant improvements in both patient-reported outcomes and other secondary endpoints. Notably, Haduvio is the first therapy to show a statistically significant reduction in chronic cough across both RCC and IPF patient groups.
The RIVER trial’s design was a randomized, double-blind, placebo-controlled, crossover study, which included titration assessments of Haduvio at multiple dosages. The primary endpoint focused on the mean change in 24-hour cough frequency, with the Haduvio group achieving a 67% reduction compared to a 10% reduction in the placebo group.
In addition to the primary endpoint, Haduvio showed a 66% reduction in 24-hour cough frequency in the severe cough subgroup and a 55% difference in the proportion of patients achieving at least a 30% reduction in 24-hour cough frequency compared to placebo. Improvements were observed as early as Day 7 of the trial, and the safety results were generally consistent with the known safety profile of Haduvio.
China's Ministry of Finance slapped retaliatory tariffs on key Canadian exports, including rapeseed oil, pork, and seafood, escalating trade tensions between Beijing and Ottawa. The long-anticipated measures come in response to Canadian tariffs imposed last year on Chinese-made electric vehicles, steel, and aluminum. Escalating trade wars add growth scares and sparked turmoil for global equity markets as President Trump advances his "America First" agenda, reshaping economic alliances and complex supply chains in friend-shoring and reshoring efforts.
On Saturday, the Ministry of Finance issued a statement announcing that Beijing would enact retaliatory measures in response to the Canadian government's 100% tariffs on electric vehicles imported from China, effective October 1, 2024, and 25% tariffs on Chinese steel and aluminum products, effective on October 22, 2024.
MoF said these tariffs are "protectionist practices" that "seriously violate the rules of the World Trade Organization" and "damage China's legitimate rights and interests."
In response, Beijing imposed a 100% tariff on rapeseed oil, oil cake, and peas and a 25% tariff on pork and seafood products.
Canada is one of the world's largest rapeseed producers, so Beijing's tariffs on these products directly hits North America's agricultural export market.
Canola futures in New York fell 6% by the exchange limit on Sunday evening.
"Canadian canola farmers are facing an unprecedented situation of trade uncertainty from our two largest export markets only weeks before planting begins," Rick White, the president and CEO of the Canadian Canola Growers Association, said in a statement, quoted by Bloomberg.
Anilkumar Bagani, research head of Mumbai-based vegetable oil broker Sunvin Group, told Reuters:
"China has alternative origins for rapeseed oil such as Russia and the EU and also the Chinese import duty hike could pressure Canadian canola prices, resulting in a sharp decline in product prices.
"It also needs to be noted that China has huge rapeseed oil stocks at the moment and the crush capacity utilisation is also considerably high."
The trade dispute comes as globalist Mark Carney prepares to take over as leader of Canada's ruling Liberal Party and succeed Justin Trudeau as prime minister, at a time when the country to America's north is experiencing significant political and economic turmoil.
