Why Agilon Health Shares Are Tumbling

 Agilon Health’s stock has seen a notable decline, primarily due to mixed analyst evaluations. While TD Cowen raised its price target, suggesting optimism for future growth, Baird lowered its target and downgraded the stock from Outperform to Neutral, expressing concerns over profitability and conservative revenue projections. These conflicting assessments have led to the stock’s recent volatility, reflecting differing views on the company’s financial health and growth strategy.

https://www.tipranks.com/news/catalyst/why-agilon-health-shares-are-tumbling

Adagio Medical’s Cryoablation System Earns FDA Breakthrough Tag

 Adagio Medical Holdings, Inc. (NASDAQ:ADGM), a micro-cap medical device company with a market capitalization of $14.2 million, known for its innovations in catheter ablation technologies, has been granted the Breakthrough Device designation by the U.S. Food and Drug Administration (FDA) for its vCLASTM Cryoablation System. The company maintains a strong liquidity position with more cash than debt on its balance sheet, though it’s currently experiencing rapid cash burn. This system is aimed at treating drug-refractory, recurrent, sustained monomorphic ventricular tachycardia (VT) in patients with ischemic or non-ischemic structural heart disease.

The FDA’s Breakthrough Device Program is designed to expedite the development and review process for medical devices that have the potential to provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases. To qualify, a device must either represent new technology, have no approved alternatives, offer significant advantages over existing alternatives, or its availability must be in the best interest of patients.

The vCLASTM Cryoablation System, which leverages Adagio’s proprietary Ultra-Low Temperature Cryoablation (ULTC) technology, is currently undergoing a study under an Investigational Device Exemption (IDE) known as FULCRUM-VT. This study enrolls patients with structural heart disease to evaluate the system’s safety and efficacy.

Todd Usen, CEO of Adagio, expressed the company’s excitement about the designation, highlighting that their system is the only technology granted the Breakthrough Device label for endocardial treatment of both ischemic and non-ischemic structural heart disease patients with sustained monomorphic VT.The company faces financial challenges, with a negative EBITDA of $33.57 million in the last twelve months. The stock has shown recent resilience with an 18% gain over the past week, though it remains significantly below its 52-week high.

https://www.investing.com/news/company-news/adagio-medicals-cryoablation-system-earns-fda-breakthrough-tag-93CH-3990766

Ligand Subsidiary Pelthos Therapeutics to Combine with Channel Therapeutics

 Proposed transaction will raise $50 million in equity capital and enhance a publicly traded biopharmaceutical company focused on launching Pelthos’ ZELSUVMI™

ZELSUVMI is an FDA-designated novel drug and the first and only prescription medication approved for the treatment of Molluscum contagiosum infections administered at home by parents, patients, and caregivers

Ligand is entitled to a 13% royalty on worldwide sales of ZELSUVMI

Transaction is expected to close in the summer of 2025

https://finance.yahoo.com/news/ligand-subsidiary-pelthos-therapeutics-combine-100000828.html

Evotec axes 30% of assets as cost-cutting push hits pipeline

Evotec’s cost-cutting drive has reached its pipeline. The biotech has axed around 30% of its asset portfolio and offloaded clinical program EVT 201 as part of a broader, ongoing attempt to correct its course.

Germany-based Evotec has a pipeline of assets that it co-owns with companies including Bristol Myers Squibb, Novo Nordisk and Sanofi. In addition to its partnered assets, the company has programs that are yet to be paired off with a drug developer. The future of the programs has been in doubt since Evotec unveiled a multi-year plan to get its business back on track.

Having started the second stage of the plan late last year, Evotec disclosed changes to its portfolio and strategy in its fourth quarter results Thursday. Evotec framed its pipeline changes as an attempt to focus on high-quality, high-potential assets. Christian Wojczewski, CEO of Evotec, said on the earnings call that the company stopped projects “which did not anymore meet our high quality, high potential criteria.”

Evotec’s pipeline is still vast. The company has more than 100 assets but around 70% of them are already partnered “with top pharma companies,” Wojczewski said. Evotec has worked on more than 30 assets for BMS alone. Six assets are in the clinic and another six are in preclinical development. Cord Dohrmann, chief scientific officer at Evotec, said on the earnings call that around 15 assets could reach the clinic over the next two years. The company plans to improve the quality of the pipeline over the next two to three years and make more selective bets on internal programs that could be the subject of deals in the future. 

“We will continue to do very selective investments in early stage, highly differentiated assets on our own behalf. Those serve as valuable proof points of the effectiveness of our technology and they open the door for strategic collaborations,” Wojczewski said. “We will only advance those assets beyond early stage as part of a strategic partnership.”

The company said it has divested EVT 201. Evotec wrapped up phase 2 trials of the candidate, which is also called dimdazenil, in insomnia and daytime sleepiness in 2007. Zhejiang Jingxin Pharmaceutical won approval for the drug in China in 2023. Evotec disclosed the divestiture in the slide deck for its earnings call without providing further details. 

Divesting EVT 201 ends Evotec’s foray into clinical development. Wojczewski said the company’s focus is now “sharply defined from target ID to IND” and confirmed “we will not be in clinical development.” The pipeline pullback could see Evotec’s R&D spending come in as low as 40 million euros this year, versus 51 million euros in 2024. 

Evotec is also exiting the equity stakes it acquired in some partners, starting with the divestiture of its 70 million euro holding in Recursion Pharmaceuticals. “Our strategy is not to act as a VC player,” Wojczewski said.

The changes follow earlier decisions to lay off 400 people and exit the gene therapy space. Evotec shared an update on the earlier cuts on its earnings call, revealing that it closed its gene therapy site last year and completed the layoffs in the first quarter of 2025. The shuttering of the gene therapy facility was part of a wider wave of site closures.

https://www.fiercebiotech.com/biotech/evotec-axes-30-assets-cost-cutting-push-hits-pipeline

UnitedHealth Group cuts profit outlook, citing higher-than-expected Medicare Advantage care costs

 UnitedHealth Group reported $6.29 billion in profit for the first quarter of 2025, or $6.85 a share, far exceeding its performance in the same quarter a year ago. In the first quarter of 2024, the healthcare giant reported a loss of $1.41 billion,  or a loss of $1.53 a share.

First-quarter 2025 revenue jumped 9.8% to reach $109.6 billion, up $9.8 billion from $99.8 billion a year ago.But UnitedHealth Group cut its earnings guidance after reporting higher-than-expected care costs in its Medicare Advantage businesses, "far above" the planned 2025 increase. The "heightened care activity indications within UnitedHealthcare’s Medicare Advantage businesses" became "visible as the quarter closed," the company said in an earnings press release issued Thursday morning.

"This activity was most notable within physician and outpatient services," the company said.

UnitedHealth Group cut its outlook to net earnings of $24.65 to $25.15 per share for the year and adjusted earnings of $26 to $26.50 per share for 2025. That's down from previous guidance of net earnings of $28.15 to $28.65 per share and adjusted net earnings of $29.50 to $30 per share.

The company also cited "unanticipated changes in the profile of Optum Health members impacting planned 2025 reimbursement due to unexpectedly minimal 2024 beneficiary engagement by plans exiting markets."

Further, executives cited "greater-than-expected impact to current and new complex patients from the ongoing Medicare funding reductions enacted by the previous administration."

“UnitedHealth Group grew to serve more people more comprehensively but did not perform up to our expectations, and we are aggressively addressing those challenges to position us well for the years ahead, and return to our long-term earnings growth rate target of 13 to 16%,” said Andrew Witty, CEO of UnitedHealth Group, in a statement.

"The company believes these factors to be highly addressable over the course of this year as well as it looks ahead to 2026," executives said in the press release.

UnitedHealth Group reported adjusted earnings of $7.20 a share for the quarter.

Both first-quarter revenue and earnings missed Wall Street analysts' expectations. Analysts had been expecting adjusted earnings of $7.29 per share for the quarter and revenue of $111.58 billion, according to FactSet.

UnitedHealth shares fell 19% in premarket trading Thursday.

The company is holding a call with investors at 8:45 am ET to review its first-quarter financial performance.

https://www.fiercehealthcare.com/payers/unitedhealth-group-cuts-profit-outlook-citing-higher-expected-medicare-advantage-care-costs

Lilly's oral GLP-1 drug delivers Ozempic-like efficacy in phase 3 diabetes trial

 Eli Lilly has met its goal of achieving semaglutide-like efficacy with an oral GLP-1 drug. The phase 3 study linked the oral GLP-1 drug orforglipron to similar reductions in blood glucose and body weight to Novo Nordisk’s injectable blockbuster, although the figures are down on Lilly’s midphase data. 

Speaking on an earnings call in February, Daniel Skovronsky, M.D., Ph.D., chief scientific officer at Lilly, was clear about the objectives for orforglipron. Lilly’s goal was to deliver an oral drug  with an “efficacy, safety and tolerability profile that is similar to that of an injectable single-acting GLP-1.” Semaglutide, which Novo sells as Ozempic and Wegovy, is the leading injectable single-acting GLP-1.

Lilly reported the first phase 3 data on orforglipron Thursday. The study randomized people with Type 2 diabetes to receive one of three doses of orforglipron or placebo. After 40 weeks of once-daily dosing, A1C, a measure of blood sugar, fell between 1.3% and 1.6% in the orforglipron cohorts, compared to a 0.1% drop in the placebo group. The result caused the trial to meet its primary endpoint.

Novo reported (PDF) A1C reductions of 1.4% to 1.6% after 30 weeks of dosing with Ozempic in a previous phase 3 trial. Lilly saw a steeper drop in A1C in its phase 2 trial, when it linked orforglipron to reductions of up to 2.1% after 26 weeks of treatment. Lilly didn’t take the highest dose from phase 2 into phase 3. 

ight loss was a key secondary endpoint in Lilly’s phase 3 orforglipron trial. After 40 weeks, patients on the oral GLP-1 drug candidate had lost between 4.7% and 7.9% of their body weight, with participants on the highest dose losing the most weight. At the top dose, patients lost an average of 7.3 kg of the 90.2 kg they weighed at the start of the trial. In Novo's phase 3 trial, patients on Ozempic lost up to 4.7 kg from mean starting weights of up to 96.9 kg. 

As with A1C, Lilly saw steeper reductions in body weight in its phase 2 trial, when the company posted mean weight loss of up to 10.1 kg after 26 weeks on orforglipron. Skovronsky has said Lilly expects weight loss seen in people with diabetes to be significantly less than in people living with obesity.  

The drugmaker also shared a snapshot of safety and tolerability data. The most common adverse events were diarrhea, nausea and indigestion, which respectively affected up to 26%, 18% and 20% of patients on the oral GLP-1 drug. For comparison, Novo reported rates of nausea and diarrhea of 20% and 9%, respectively, in its phase 3 trial.

The readout marks the start of a wave of data drops for orforglipron. Skovronsky has previously said Lilly expects to see data from up to five studies in Type 2 diabetes and two trials in obesity, with two phase 3 obesity readouts scheduled for the third quarter. Lilly plans to use the data to seek approval in obesity this year, with submissions in Type 2 diabetes penciled in for 2026.

Citi analysts said in a note this morning that the readout exceeded market expectations of around 5-6% weight loss for orforglipron, while the lack of liver toxicity will be a "sigh of relief to many" after Pfizer discontinued its oral GLP-1 earlier this week for this reason. Lilly stock was up 15% to $844.69 in the opening hour of trading Thursday from a Wednesday closing price of $734.90.

https://www.fiercebiotech.com/biotech/lillys-oral-glp-1-drug-delivers-ozempic-efficacy-phase-3-diabetes-trial

Regeneron gets FDA acceptance to review expanded label for Eylea HD

 Regeneron announces FDA review of sBLA for Eylea HD to treat macular edema and expand dosing

https://seekingalpha.com/news/4432107-regeneron-gets-fda-acceptance-to-review-expanded-label-for-eylea-hd