Merck (NYSE:MRK), known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted priority review for a new supplemental Biologics License Application (sBLA) seeking approval to update the U.S. product label based on the Phase 3 ZENITH trial for WINREVAIR™ (sotatercept-csrk). In 2024, WINREVAIR was approved for the treatment of adults with pulmonary arterial hypertension (PAH, Group 1 PH) to increase exercise capacity, improve WHO* functional class (FC), and reduce the risk of clinical worsening events. The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action date, of Oct. 25, 2025.
The sBLA is based on data from the Phase 3 ZENITH trial. The ZENITH trial was the first PAH Phase 3 outcome study to use a primary endpoint comprised entirely of major morbidity and mortality events. It was also the first PAH Phase 3 study stopped early by an independent data monitoring committee for overwhelming efficacy. In ZENITH, WINREVAIR demonstrated a 76% reduction in the risk of a composite of all-cause death, lung transplantation, and hospitalization for PAH ≥24 hours compared to placebo. Improvement was observed early in treatment with increasing benefit throughout the study. The safety profile of WINREVAIR in ZENITH was generally consistent with that observed in previous studies. These results were published in theNew England Journal of Medicine.
Women’s health company Organon’s endometriosis-related pain drug is being discontinued after it failed to improve pelvic pain in a Phase II trial.
Organon had been testing OG-6219, an oral 17β-hydroxysteroid dehydrogenase type 1 (HSD17B1) inhibitor, in the mid-stage proof-of-concept ELENA trial featuring patients who had been surgically diagnosed with endometriosis and who experienced moderate-to-severe pain. The drug did not meet the main goal of the trial, which was an improvement in that pain as compared to placebo.
OG-6219 will now be discontinued, but Organon pledged support to continuing to pursue new treatment options for women with endometriosis.
Organon spun out of Merck in 2020 with 60 products across women’s health, including reproductive health, biosimilars and other products. The company picked up OG-6219 in 2021 through the acquisition of Forendo Pharma, a Finnish company that focused on sex steroid physiology in women. Organon offered up to $954 million, most of which was in various developmental and regulatory milestones. The deal gave Organon a pipeline of new assets to explore.
Endometriosis is characterized by the growth of uterine tissues outside of the uterus. It can cause infertility, excessive menstrual cramps, heavy menstrual bleeding and pain during intercourse. The condition is diagnosed and can be treated by laproscopic surgery, while non-surgical options include pain management or hormone therapy.
But few companies have picked up the mantel to find new options for the condition, which effects about 2 to 10% of American women aged 24 to 40, according to Johns Hopkins Medicine. Organon is by far the largest player, with just a handful of small biotechs such as Ananda Pharma also in the game.
Eyenovia, Inc. (NASDAQ:EYEN), a micro-cap healthcare company currently valued at $63.55 million, announced Wednesday it is changing its corporate name to Hyperion DeFi, Inc. and will begin trading under the new ticker symbol "HYPD" on the Nasdaq Capital Market starting July 3, 2025.
The company, which describes itself as the first publicly-listed U.S. company to build a strategic treasury of HYPE tokens, said the rebranding reflects its cryptocurrency treasury reserve strategy focused on the native token of the Hyperliquid protocol. According to InvestingPro data, the stock has shown significant volatility, with a current price of $12.45 representing just 10% of its 52-week high.
"Our corporate name change to Hyperion DeFi, Inc. reflects our new vision for the company and represents the next important step in the evolution of our cryptocurrency treasury reserve strategy," said Michael Rowe, Chief Executive Officer, in a press release statement.
The company also announced that its co-branded validator "Kinetiq x Hyperion" is now officially live. Hyperion DeFi has begun staking its HYPE holdings to generate yield and prepare for its on-chain engagement strategies.
While pursuing its cryptocurrency strategy, the company continues to develop its Optejet User Filled Device (UFD), designed to work with topical ophthalmic liquids including artificial tears and lens rewetting products. InvestingPro analysts project 65.92% revenue growth for fiscal year 2025, though the company’s financial health score remains weak at 1.25. Get access to 12+ additional ProTips and comprehensive analysis with an InvestingPro subscription.
Anticipates Updating its Full Year 2025 Outlook for the Acquisition with Second Quarter 2025 Financial Results
Viemed Healthcare, Inc. (the "Company" or "Viemed") (NASDAQ: VMD), an in-home clinical care provider of post-acute respiratory healthcare equipment and services in the United States, announced that it has completed the previously disclosed acquisition of Illinois-based Lehan's Medical Equipment ("Lehan") for a base purchase price of $26 million, subject to customary adjustments, plus estimated contingent payments of $2.2 million.
"We are pleased to close the acquisition of Lehan and bring this talented and highly motivated team into the Viemed family," said Viemed Chief Executive Officer Casey Hoyt. "Lehan's 80-year track record and brand recognition in a large and fast-growing market along with its preferred contracts and fulfillment expertise make for a powerful combination with our national scale, unique care delivery model and existing payer relationships to serve a broader patient population."
In 2024, Lehan generated net revenues of approximately $25.7 million and Adjusted EBITDA of approximately $7.4 million. See "Non-GAAP Financial Measures" for a discussion of Adjusted EBITDA. Viemed funded the acquisition through a combination of cash on hand and borrowings from its existing credit facilities. Viemed anticipates increasing its previously issued full-year 2025 guidance range to account for the expected contribution from this acquisition when it reports earnings results for the quarter ended June 30, 2025.
Lehan's Medical Equipment is a healthcare provider offering home medical equipment and products for women's health, including breast pumps. The organization specializes in promoting wellness through a variety of healthcare services. Lehan also provides rental, sales, and resupply of CPAPs and other respiratory devices, as well as sales of other medical equipment. Lehan currently has three full-service locations in the Northern Illinois area and three sleep/CPAP set up locations in the West Chicagoland area, including one in Wisconsin.
Astrana Health (NASDAQ:ASTH) announced on Wednesday that it has completed the acquisition of Prospect Health, with a deal price of $708M, down from the previously stated $745M.
In light of the anticipated contributions from Prospect over the next six months, Astrana is revising its revenue projections for the full year 2025.
The company now expects total revenue to fall between $3.1B and $3.3B, with adjusted EBITDA anticipated to range from $215M to $225M.
Astrana said it is reaffirming its guidance for the second quarter of 2025.
The UK’s Financial Conduct Authority has clarified that serious bullying, harassment and violence in the work place qualify as misconduct at financial firms, behavior that could ultimately lead to a ban from the sector.
City firms reported a 72% surge in non-financial misconduct claims over the three years to October. That survey followed several high profile scandals, including sexual assault allegations made against hedge fund manager Crispin Odey and ex-Barclays Plc’s boss Jes Staley’s ties to disgraced financier Jeffery Epstein.
A Big Apple driving school paid off DMV examiners to fraudulently fast-track driver’s licenses for illegal immigrants — even if they had no clue how to drive, Staten Island prosecutors said Tuesday.
T&E Driving School in Queens took cash from Chinese immigrants — many of whom didn’t even speak English — and paid off a crew of Department of Motor Vehicles employees on Staten Island to illegally obtain driver’s licenses, District Attorney Michael McMahon said at a press conference.
The crackdown, dubbed Operation Road Test, took down the ring in a joint investigation with state investigators and the US Department of Homeland Security, prosecutors said.
Staten Island prosecutors said a Queens driving school ran a DMV pay-to-drive scam for illegal immigrants.Michael McWeeney
“Our investigation found that T&E Driving School blatantly flouted the laws and procedures that are necessary to ensure the public safety on the road,” George Ioannidis, assistant special agent in charge for Homeland Security Investigations in New York said Tuesday.
“As alleged T&E utilized social media and strategic advertising to Target exploited members of the Chinese community and guaranteed individual driver’s licenses regardless of their immigration status, language, and even their ability to operate a vehicle,” he said.
“Moreover these individuals were those who did not speak or understand English and may have believed that they all were taking necessary and legitimate steps.”
T&E owner Weixian Tan, secretary Weiwen Tan, employee Winnie Yang and school road test driver Wenfeng Yang set up the scam by paying off DMV examiners Aji Idicula, Tianna Rose Andolina and Edward Tarik Queen, according to the indictment.
Wenfend Yang and three other employees of T&E Driving School are charged with an illegal immigrant DMV scam.Michael McWeeney
The examiners would then rubber stamp the wanna-be drivers without even having them take a road test.
McMahon said the scam extends beyond the seven named indictments, with two dozen suspects in custody and another indicted DMV employee not identified in the 49-page document.
“The numbers, as we go through this investigation, as we go through the materials that have been seized, we think that we are going to find hundreds if not thousands of people that have been part of this scam,” the prosecutor said.
“The number of tests given by an individual examiner can be about 1,500 a year,” he said. “Two out of the three examiners have been working for four or five years, so we think this is just the tip of the iceberg.”
Staten Island prosecutors said DMV examiners took illegal payoffs to issue fraudulent licenses to immigrants.Getty Images
In a statement, McMahon called the pay-to-drive scheme a “corrosively corrupt” operation centered on DMV workers who “brazenly betrayed their oaths of office.”
The defendants were arraigned on a slew of fraud, tampering and theft charges and were released — the charges are not eligible for bail under the state’s controversial 2019 criminal justice reforms.
However, they were ordered to surrender their passports.
