Latest news with #biotech
Yahoo
29 minutes ago
- Business
- Yahoo
1 Analyst Thinks This Former Pandemic Winner Could Surge 500% This Year
Moderna (MRNA), once an unknown biotech firm, quickly rose to the top of the global vaccine market during the COVID-19 pandemic. Its mRNA technology platform created one of the world's first and most widely used COVID-19 vaccines. Investors who recognized its potential early saw a dramatic increase in share price, with MRNA stock rising by 1,226.9% between 2020 and 2022. More News from Barchart Tesla Just Signed a Chip Supply Deal with Samsung. What Does That Mean for TSLA Stock? Here's What Happened the Last Time Novo Nordisk Stock Was This Oversold Dear Microsoft Stock Fans, Mark Your Calendars for Aug. 1 Our exclusive Barchart Brief newsletter is your FREE midday guide to what's moving stocks, sectors, and investor sentiment - delivered right when you need the info most. Subscribe today! Now, in this post-pandemic era, vaccine demand is no longer at its peak. The question is whether the company can move beyond its COVID-19 legacy and become a sustainable, diversified biotech company with long-term growth potential. Moderna will report its second-quarter earnings on Aug. 1. The stock is down 22% year-to-date, underperforming the overall market. Let us see if the stock is a buy now on the dip. A Deep and Ambitious Pipeline Valued at $13.1 billion, Moderna is a biotechnology company that develops messenger RNA (mRNA)-based medicines and vaccines. It uses synthetic mRNA to instruct human cells to produce proteins that can aid in disease prevention, treatment, and cure. Its primary areas of focus include infectious diseases, oncology, rare diseases, autoimmune diseases, and cardiovascular diseases. Moderna's revenue increased dramatically during the peak pandemic years, owing primarily to sales of its COVID-19 vaccine, Spikevax. However, as global vaccination rates stabilized, the company's revenue began to decline. Total revenue fell by 35.3% in the first quarter of 2025 to $108 million, owing to lower net product sales. Spikevax sales totaled $84 million, versus $167 million in Q1 2024. This revenue decline has been difficult for investors accustomed to massive pandemic-era revenue. The company's second commercial product is its standalone RSV vaccine, mRESVIA, which received FDA approval in mid-2024 for adults aged 60 and up. It generated $2 million in sales in the first quarter. Moderna is also testing a combined COVID-19/flu vaccine (mRNA-1083), which is currently in phase 3 trials. If approved, this combination has the potential to streamline millions of annual booster shots while also significantly reducing healthcare logistics and costs. Beyond respiratory viruses, Moderna's oncology pipeline is a daring bet on personalized cancer vaccines. Its collaboration with Merck (MRK) has received significant attention, particularly for mRNA-4157, a personalized cancer vaccine for melanoma. Phase 3 trials are currently underway, and if successful, this approach could provide a new edge in immunotherapy. Further down the pipeline are vaccines for rare metabolic diseases like propionic acidemia and methylmalonic acidemia, as well as autoimmune conditions like multiple sclerosis. While these are early stage and speculative, they show the company's desire to become a multi-franchise biotech powerhouse. Despite short-term revenue challenges, Moderna has been aggressively investing in research and development. As of 2025, the company has over 21 mRNA-based programs in development, including Zika, HIV, HSV, Influenza, and Lyme vaccines, among others. R&D spending totalled $856 million in Q1, with a target of $4.1 billion for the year, reflecting the cost of conducting numerous late-stage trials. Moderna's business model is currently losing money due to a dramatic drop in revenue following the pandemic, as well as an increase in expenses. Its net loss stood at $2.52 per share, compared to $3.07 per share in the year-ago quarter. The company expects to return to profitability by 2026, assuming regulatory approvals and successful commercial launches for its next-generation vaccines. However, this may take time. Clinical setbacks, slower-than-expected market adoption, or pricing pressures may all cause a delay in returning to profitability. Nonetheless, Moderna maintains a strong financial position. At the end of the first quarter, the company had more than $8.4 billion in cash and cash equivalents. This strong liquidity position allows for ongoing investment in clinical development, infrastructure expansion, and strategic acquisitions. Analysts expect the company to report a loss of $3 per share in the second quarter, down from $3.33 the previous year. Revenue could fall by 53%, to $112.56 million. Analysts predict $2.07 billion in revenue for the year, which is consistent with management's forecast of $1.5 to $2.5 billion. However, revenue is expected to climb by 16.3% to $2.41 billion in 2026. Moderna has surpassed the earnings consensus four times in the last two years, with six revenue beats. Is Moderna a Buy, Hold, or Sell on Wall Street? The consensus on Moderna stock is an overall 'Hold.' Of the 26 analysts covering the stock, three rate it a 'Strong Buy,' 19 rate it a 'Hold,' one says it is a 'Moderate Sell,' and three rate it a 'Strong Sell.' The average target price of $42.95 implies the stock can rally 30% from current levels. Additionally, its high price estimate of $198 from Brookline Capital Markets suggests upside potential of more than 500% over the next 12 months. While the upside appears unattainable in light of declining vaccine sales, Moderna stock has a track record of delivering outsized gains. A successful clinical trial result or an FDA approval can send a biotech stock skyrocketing. Rebuilding After the Peak Moderna faces the demanding task of reinventing itself for the post-COVID-19 era. This means transitioning from a single-product blockbuster to a diversified innovator with recurring revenues and pipeline-driven growth. Whether the stock has 'legs' in the long run will depend on its ability to introduce new products to the market and expand its reach. It will also have to convince investors that its post-pandemic story is just as interesting as the one that brought it to global prominence in the first place. This risky biotech is a good buy now if you still believe in the company's potential to turn its story around. On the date of publication, Sushree Mohanty did not have (either directly or indirectly) positions in any of the securities mentioned in this article. All information and data in this article is solely for informational purposes. This article was originally published on
Yahoo
2 hours ago
- Business
- Yahoo
Regeneron (REGN) Q2 Earnings: What To Expect
Biotech company Regeneron (NASDAQ:REGN) will be reporting earnings this Friday before market open. Here's what investors should know. Regeneron missed analysts' revenue expectations by 6.1% last quarter, reporting revenues of $3.03 billion, down 3.7% year on year. It was a disappointing quarter for the company, with a miss of analysts' EPS estimates. Is Regeneron a buy or sell going into earnings? Read our full analysis here, it's free. This quarter, analysts are expecting Regeneron's revenue to decline 6.9% year on year to $3.30 billion, a reversal from the 12.3% increase it recorded in the same quarter last year. Adjusted earnings are expected to come in at $8.43 per share. Heading into earnings, analysts covering the company have grown increasingly bearish with revenue estimates seeing 13 downward revisions over the last 30 days (we track 14 analysts). Regeneron has missed Wall Street's revenue estimates twice over the last two years. Looking at Regeneron's peers in the biotechnology segment, some have already reported their Q2 results, giving us a hint as to what we can expect. Incyte delivered year-on-year revenue growth of 16.5%, beating analysts' expectations by 5.5%, and United Therapeutics reported revenues up 11.7%, falling short of estimates by 0.5%. Incyte traded up 10.5% following the results. Read our full analysis of Incyte's results here and United Therapeutics's results here. The euphoria surrounding Trump's November win lit a fire under major indices, but potential tariffs have caused the market to do a 180 in 2025. While some of the biotechnology stocks have shown solid performance in this choppy environment, the group has generally underperformed, with share prices down 3.9% on average over the last month. Regeneron is up 3% during the same time and is heading into earnings with an average analyst price target of $721.52 (compared to the current share price of $550.97). Unless you've been living under a rock, it should be obvious by now that generative AI is going to have a huge impact on how large corporations do business. While Nvidia and AMD are trading close to all-time highs, we prefer a lesser-known (but still profitable) semiconductor stock benefiting from the rise of AI. Click here to access our free report on our favorite semiconductor growth story. StockStory is growing and hiring equity analyst and marketing roles. Are you a 0 to 1 builder passionate about the markets and AI? See the open roles here.
Bloomberg
7 hours ago
- Business
- Bloomberg
AbbVie in Talks to Acquire Gilgamesh in $1 Billion Deal
AbbVie Inc. is in talks to acquire mental health therapeutics company Gilgamesh Pharmaceuticals in a deal highlighting growing takeover interest in the sector, according to people familiar with the matter. A potential deal could value privately held Gilgamesh at about $1 billion, the people said, asking not to be identified because the information is private. An announcement could be made in the coming weeks, the people said.
News.com.au
8 hours ago
- Business
- News.com.au
Doubling up: How ASX biotechs are multiplying their impact
ASX companies finding smarter ways to stretch value of existing assets and launch into broader clinical areas LTR Pharma leveraging proven intranasal platform for erectile dysfunction treatment to target non-invasive relief for patients with swallowing difficulties From concussion to Alzheimer's the CogState Cognigram digital cognitive assessment system is used by physicians to monitor brain function As global biotech faces increasing pressure to deliver more with less, several ASX-listed healthcare companies are working to find smarter ways to stretch the value of their existing assets. Whether it's repurposing a drug delivery platform, extending the reach of a diagnostic tool or developing next-generation compounds that act on the same biological pathway to treat other conditions, these companies are using proven science as a launchpad into broader clinical territory. The strategy is playing out globally, with Novo Nordisk and Eli Lilly providing high-profile examples of repurposing GLP-1 drugs – originally developed for type 2 diabetes – for weight loss. Blockbusters like Ozempic/Wegovy (Novo Nordisk) and Mounjaro/Zepbound (Eli Lilly) are now reshaping treatment for obesity and related conditions. It's a compelling demonstration of how one well-validated mechanism of action can be leveraged across multiple disease areas in turn lowering development risk, tapping into existing safety and efficacy data, and accelerating time to market. For ASX healthcare companies navigating tighter capital conditions, similar strategies are proving to be a smart and resourceful way to unlock broader clinical value from their existing platforms. LTR Pharma rises above ED with nasal spray tech targeting broader conditions Developer of a nasal spray treatment for erectile dysfunction (ED), LTR Pharma (ASX:LTP) has turned to a secondary program using its innovative intranasal delivery platform but this time for oesophageal motility disorders (OMD). In May, LTR Pharma announced it had inked a collaborative development agreement with US-based Strategic Drug Solutions (SDS) to develop Oroflow a spray for OMD – a group of conditions that cause impaired swallowing (dysphagia). The program leverages LTR's proven proprietary intranasal delivery platform and foundational work from its Spontan and Roxus ED treatments to target rapid symptom relief for patients with swallowing difficulties, potentially offering a non-invasive alternative to current treatments. Oroflow aims to deliver relief in 10 minutes, bypassing swallowing barriers and offering a compelling althernative to treatments including invasive procedures such as pneumatic dilation, surgery, or botulinum toxin injections. LTR Pharma is addressing a $4.5 billion OMD market projected to reach $8.1 bn by 2034 with the company announcing in its latest quarterly report that proof-of-concept testing preparations were underway. LTR Pharma executive chairman Lee Rodne said Oroflow represented an exciting expansion of its nasal spray platform. "For patients with swallowing difficulties, oral medications present obvious challenges for patients," he said. "Our nasal spray technology is designed to offer a patient-friendly solution that avoids the need to swallow medications, have surgery or undergo other problematic treatments while providing rapid symptom relief. Neuren targeting broad set of neurological conditions Neuren Pharmaceuticals (ASX:NEU) is another standout. The company and US partner Acadia was in 2023 granted the first US Food and Drug Administration (FDA) approval for a drug to treat Rett syndrome, a rare neurological disorder mostly affecting girls and emerging in infancy. Trofinetide, marketed as Daybue, is a synthetic analog of part of the hormone insulin-like growth factor 1 (IGF-1), which is a potent regulator of central nervous system development. Neuren is now advancing NNZ-2591, which also targets IGF-1. Building on the scientific foundation of trofinetide, NNZ-2591 is structurally optimised to improve brain penetration, enhance tolerability, and expand therapeutic reach across a broader set of neurodevelopmental conditions. Using a strategy that targets multiple indications from one compound, Neuren aims to accelerate development while reducing R&D expenses. Currently in phase II trials, NNZ-2591 could open new treatment avenues for other underserved neurodevelopmental conditions like Phelan-McDermid, Angelman, and Pitt-Hopkins syndromes. The company is preparing to start a phase III study of NNZ-2591 for its most advanced program Phelin McDermid. It also plans to consult with the FDA this year to establish a clinical path for NNZ-2591 to treat hypoxic-ischemic encephalopathy (HIE), which results from a baby's brain not getting enough oxygen or blood flow before, or shortly after, birth. "We believe the mechanism of action of NNZ-2591 can be broadly applicable to neurodevelopmental disorders, independent of the genetic origin," CEO Jon Pilcher told Stockhead. "We are striving to be successful in multiple settings, for the benefit of both the impacted families and our shareholders." Tracking cognition from concussion to Alzheimer's From footy fields to neurology clinics, the CogState (ASX:CGS) Cognigram digital cognitive assessment system is used by physicians to monitor key aspects of brain function – including processing speed, attention, visual learning, working memory and executive function. The test can assess cognition at a single point in time or track changes over multiple assessments. You may have heard of it referred to as the Cogstate concussion test in footy coverage. However, Cognigram has since evolved into a widely used tool in healthcare and research. Cogstate is riding a wave of global demand for cognition-related clinical trials, particularly in the race to treat Alzheimer's disease and related dementias. The company recently upgraded its financial guidance for FY25, reflecting strong performance and improved outlook across key financial metrics. Full-year profit before tax is forecast to be in the range of $12-14m, an improvement of 69% to 97% on FY24. "We are now using Cognigram, which is the same cognitive assessment used to assess AFL footballers for concussion, to prescreen for clinical trials in the earlier stages of Alzheimer's," CEO Brad O'Connor told Stockhead. "We have a contract with a large pharmaceutical company screening for 20,000 patients in the community to find those that might be appropriate to include in their very early stage Alzheimer's trials.
Wall Street Journal
8 hours ago
- Health
- Wall Street Journal
Why Vinay Prasad Had to Go at FDA
Vinay Prasad has left the building. The hematologist and Bernie Sanders acolyte is stepping down as head of the Food and Drug Administration's gene therapy and vaccine shop after only three months on the job. This is welcome news, but there's still reason to keep a cautious eye on the agency that could assist or stymie U.S. drug innovation in this era of great biotech advances. A Health and Human Services Department spokesperson said Tuesday night that Dr. Prasad is resigning because he doesn't want to 'be a distraction.' The truth is that he was under heavy criticism from patients and these pages for undermining the Administration's goal of fast-tracking life-saving treatments.
