Bayer's treatment of Alport syndrome granted FDA orphan designation
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Yahoo
an hour ago
- Yahoo
What's Behind Hologic's Positive Long-Term Outlook for Cytology Unit?
Hologic HOLX is a leading name in the cytology space, with its Cytology business, part of its Diagnostics franchise, primarily focusing on screening for cervical cancer. The company has pioneered the first FDA-approved liquid-based cytology test — the ThinPrep Pap test — and the first FDA-approved mRNA-based HPV test — the Aptima HPV Assay. Co-testing — combining a Pap test with an HPV test — is the most sensitive testing option for cervical cancer screening compared to either test used alone. While this business of Hologic has historically been a flattish to single-digit grower, the company has continued to invest in it, like the 2024 launch of the Genius digital cytology system. It was a significant introduction, marking the only FDA-cleared digital cytology system that combines deep-learning-based AI with advanced volumetric imaging technology to help identify pre-cancerous lesions and cervical cancer cells. HOLX management noted that if not for the sales headwinds in China, Cytology would have grown in low single digits in the second quarter of fiscal 2025, driven by the rollout of its Genius digital diagnostics system, instead of reporting a 2.2% decline. With more labs around the world implementing this in-house innovation, Hologic has received strong positive feedback. Genius replaces the traditional manual review of path slides, which was previously conducted on glass under a microscope, by capturing a digital image of the slide, which can be reviewed remotely from anywhere in the customer's network on the company's review station. These workflow advantages not only address their growing labor shortages but also enable cervical cancer screening in regions with limited infrastructure. Because the Genius system requires an overhaul of the traditional pet screening workflow, Hologic expects the full rollout to be a multi-year process, serving as a growth driver for the next several quarters. HOLX's Peers in Cervical Cancer Screening Quest Diagnostics DGX offers a complete menu of solutions for screening and diagnosing cervical cancer. In April this year, DGX introduced a new solution aimed at expanding access to human papillomavirus (HPV) screening to help identify women who are at risk of developing cervical cancer. With this new offering, physicians can offer patients the option to collect their specimen for HPV screening in a physician's office or other healthcare setting. Quest Diagnostics' latest test uses the FDA-cleared HPV self-collection solution from Roche, approved for use with Roche Holding AG's RHHBY cobas HPV test in May 2024. Roche's cervical cancer portfolio includes three clinically validated tests to help identify women at risk and improve the detection of high-grade disease in a single round of screening. The cobas HPV test is the first clinically validated, FDA-approved, CE-IVD marked HPV DNA test for all cervical screening indications — primary screening, ASC-US triage and co-testing. The CINtec PLUS Cytology test is the only FDA-approved triage test that uses dual biomarker technology to simultaneously detect p16 and Ki-67 in women with HPV-positive results. Roche's CINtec Histology test uses advanced p16 biomarker technology to confirm cervical lesions due to transforming HPV infections. HOLX Stock Performance, Valuation and Estimates In the past six months, Hologic shares have risen 5.2% against the industry's 11.9% fall. Image Source: Zacks Investment Research Hologic is trading at a forward three-year price-to-earnings of 15.23X, lower than the industry average of 28.67X. The stock carries a Value Score of B at present. Image Source: Zacks Investment Research Consensus estimates for Hologic's fiscal 2025 earnings are showing a mixed trend. Image Source: Zacks Investment Research HOLX stock currently carries a Zacks Rank #3 (Hold).You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Roche Holding AG (RHHBY) : Free Stock Analysis Report Quest Diagnostics Incorporated (DGX) : Free Stock Analysis Report Hologic, Inc. (HOLX) : Free Stock Analysis Report This article originally published on Zacks Investment Research ( Zacks Investment Research
Boston Globe
an hour ago
- Boston Globe
How hurricanes, fires, and floods put drugs and medical supplies at risk
Advertisement These threats are especially pressing as the Trump administration makes a push to ramp up US drug manufacturing, say the authors of the new research. As part of a broader effort to increase US pharmaceutical factories, President Donald Trump has threatened to impose tariffs on imported medicines, a move that could make the country more reliant on domestically produced supplies. Roughly 40% of finished medications and 80% of active pharmaceutical ingredient components come from abroad, according to US Food and Drug Administration estimates. Get Starting Point A guide through the most important stories of the morning, delivered Monday through Friday. Enter Email Sign Up 'Climate change-driven extreme weather events impose new threats to established vulnerabilities in the US drug supply,' the study's authors wrote. 'Those threats must be examined to be appropriately mitigated.' The analysis used FDA and Federal Emergency Management Agency databases to find drug production facilities in counties with major fire, hurricane, storm, tornado and flood events between 2019 and 2024. California, Florida and North Carolina were home to the largest numbers of facilities in counties with presidential disaster declarations. Advertisement Hurricanes were the most common of the climate-related disasters in areas with pharmaceutical facilities, according to the research. In 2017, Hurricane Maria hit Puerto Rico and disrupted Baxter's saline solution manufacturing facility there. Baxter is a major manufacturer of the sterile salt water widely used in hospitals to deliver medications and keep patients hydrated. The company didn't have backup facilities manufacturing smaller bags of the saline solution, which compounded pre-existing supply issues. Baxter has said it's learned from Maria and now has a more resilient supply chain, citing manufacturing investments and FDA clearance to produce saline outside of the US if needed. Even resilient supply chains are prone to climate shocks, though. Helene flooded Baxter's North Carolina facility, which made 60% of the IV fluid bags used in US hospitals for various functions, including to deliver medicine. Baxter reported earlier this year that the North Carolina plant was back at pre-hurricane production levels, and the FDA said this month that the shortages had resolved. Sarah Ryan, a spokesperson for pharmaceutical industry group PhRMA, says that the industry works with government regulators to avoid shortages. The new research did not determine how often such disasters result in shortages, saying that data wasn't readily available. ©2025 Bloomberg L.P.
Business Insider
2 hours ago
- Business Insider
The big buydown bet
Good morning. If you bought the Great Value raw frozen shrimp at Walmart, throw it away. The FDA says a possible contamination from Cesium-137, a radioactive isotope, has been detected. Don't sell it, don't serve it, and definitely don't eat it — no matter how much BI's Katie Notopoulos may want to. In today's big story, homebuyers made a big bet on lower mortgage rates. They're paying a high price. What's on deck: Markets: Bank of America thinks these 10 cheap stocks are poised for big gains. Tech: This party is the surest sign yet that the tech dating scene is a mess. Business: In its latest hardcore turn, AT&T is hitting some managers with an ultimatum. But first, betting the house. If this was forwarded to you, sign up here. The big story The big buydown bet For homebuilders, it represented a silver bullet. For buyers, it can be a mousetrap. Rick Palacios Jr., the director of research at John Burns Research and Consulting, has been sounding the alarm since last summer about a dangerous gamble tempting Americans: " mortgage rate buydowns." They seemed to offer an elegant solution. With mortgage rates sky-high, your dream home might feel out of reach. That's not good for you, nor for the homebuilders stuck with inventory. But what if a homebuilder shaved a percentage point off your monthly payments, even just for the first couple of years? Surely, rates must drop soon. When the deal runs out, you could refinance. Easy. The cost to builders is the upfront cash to lower the rate via their in-house lenders. Matt Hutton, a millennial homebuyer, told BI his builder threw in $30,000 in incentives — including the buydown — to close the deal. You buy your house. They sell theirs. Crucially, the official listing price doesn't change, so home values remain inflated. That was the wager a few years ago. Today, rates are typically still above 6.5% — right where buyers had hoped not to end up. Their gamble has failed spectacularly, BI's James Rodriguez writes. Andre Rucker for BI There's an even more dire scenario, Palacios warns. What if you need to sell? Life happens — a new job, a marriage, a divorce — and you may have to move. But today's sellers face a weak market. In many parts of the US, more homes are sitting unsold than at any point since the pandemic. Buyers a few years ago may have accepted inflated prices in exchange for monthly savings — but they can't usually pass those savings along to the next buyer. To close a deal, they may have to take a loss. Just ask Hutton. After five years, he and his wife sold their first home for a $150,000 profit and upgraded to a bigger, brand-new home for nearly $800,000. A few months later, they wanted out. They ended up selling it for roughly what they paid for it, after dropping their asking price by $50,000. In addition, the buyer asked them to cover a $40,000 buydown to match the builder's ongoing incentives for nearby homes. They agreed. Today, Hutton and his wife are back in an apartment, waiting for another shot at the dream. 3 things in markets 1. Wage growth isn't keeping up with prices. However, some industries have enjoyed more growth than others. Business services and financial activities have less purchasing power than they did in 2021, while hospitality and healthcare workers have more. 2. Bank of America shares 10 ultra-cheap stocks primed to rebound. The bank thinks the days of large-cap stock dominance are numbered. If the US enters a recovery phase alongside rate cuts, beaten-down stocks could surge. 3. A short-seller explains why he thinks Palantir is overvalued. In a new note, Andrew Left's firm Citron Research used OpenAI's $500 billion valuation as a benchmark to measure the defense tech giant against. Even if Palantir fell to $40 a share, it'd still be expensive, the firm said. 3 things in tech 1. Inside San Francisco's "enforced ratio" party in a Tesla showroom. Fed up with male-dominated spaces in SF, two women who work in the tech industry threw a bash centered around "feminine energy." It offered a rare chance to dress up and a strictly enforced 50/50 gender ratio — which, of course, left hundreds of men on the waitlist. 2. Another W for Tim Cook. The Apple CEO notched a win in his fight with the UK government, which had ordered the company to make encrypted user data accessible to it. Apple enjoyed the backing of the US government, which said that the UK had agreed to drop the order. 3. Do you miss the old internet? There's an app for that. Perfectly Imperfect is a newsletter and social network that's designed to feel like the old version of the internet, reminiscent of Tumblr and MySpace. Its founder told BI it's betting on events and community-focused tools to grow. 3 things in business 1. AT&T tells some managers: Relocate or get laid off. The telecom company is consolidating 22 internal help-desk centers into six US locations. Affected managers get two weeks to decide whether to move or lose their jobs and get severance, BI's Tim Paradis and Dominick Reuter exclusively report. 2. Spike Lee's Colin Kaepernick doc is officially game over. The acclaimed director has no plans to shop around his scrapped ESPN docuseries about the retired football player to other platforms. "That thing fell apart a year ago," Lee said in an interview with BI's Jason Guerrasio. " I've moved on." 3. We still don't know if Trump is getting free ads from Paramount. Trump says Larry and David Ellison promised him millions in free ads, but Paramount CEO David Ellison doesn't want to comment on it. We shouldn't be left guessing about what's true, writes BI's Peter Kafka. In other news Meta CTO gives his short-term and long-term predictions for AI's impact on software engineering. Wall Street bosses want junior bankers to come clean about PE jobs. It won't be easy. A CPA couple who invest in real estate on the side share the investment mistake that cost them about six-figures worth of 401(k) money. What investors should be listening for in Jerome Powell's Jackson Hole speech. OpenAI chairman compares AI to the dot-com boom: There's lots of "snake oil" but some " real value being created." What the " hidden job market" really is and how to make it work for you. What's happening today Federal Open Market Committee meeting minutes published. Lowe's and Target report earnings. Made by Google event to launch latest devices, including Pixel smartphone. Hallam Bullock, senior editor, in London. Meghan Morris, bureau chief, in Singapore. Akin Oyedele, deputy editor, in New York. Amanda Yen, associate editor, in New York. Lisa Ryan, executive editor, in New York. Kiera Fields, editor, in London. Dan DeFrancesco, deputy editor and anchor, in New York (on parental leave).
