Capricor Therapeutics Shares Rise on FDA Priority Review

 Capricor Therapeutics' shares rose after its biologics license application for deramiocel to treat a form of muscular dystrophy was given priority review by the Food and Drug Administration.

Shares climbed 10% to $14.99 Tuesday morning. The stock has more than tripled over the past year.

The FDA accepted Capricor's application for approval of its cell therapy deramiocel for patients with Duchenne muscular dystrophy cardiomyopathy, the San Diego company said Tuesday.

The FDA plans to take action on the application by Aug. 31.

https://www.morningstar.com/news/dow-jones/202503046547/capricor-therapeutics-shares-rise-on-fda-priority-review

Wave Life Sciences Initiates Dosing in INLIGHT Trial for WVE-007 in Obesity, Reports

 Wave Life Sciences Ltd. has initiated dosing in its INLIGHT trial for WVE-007, aimed at treating obesity, with clinical data expected in the second half of 2025. The company has also completed enrollment for the first single-dose cohort and is currently conducting multi-dosing in the RestorAATion-2 trial for WVE-006, targeting alpha-1 antitrypsin deficiency (AATD), with anticipated data later this year. Wave is on track to release 48-week data for its DMD treatment WVE-N531 in early 2025 and plans to submit an IND application for a Phase 2/3 study of WVE-003 in Huntington’s disease in the latter half of 2025. As of December 31, 2024, the company reported cash and cash equivalents totaling $302.1 million, expected to sustain operations into 2027.

Potential Positives

• Initiation of dosing in the INLIGHT trial with WVE-007, targeting the obesity market, which represents a significant global health challenge.
• Progress in RestorAATion-2 clinical trial for WVE-006, with positive multi-dosing data expected in 2025, which may enhance treatment options for Alpha-1 antitrypsin deficiency (AATD).
• Strong financial position with cash and cash equivalents of $302.1 million as of December 31, 2024, providing funding runway into 2027.
• Upcoming delivery of clinical data from multiple trials, including FORWARD-53 for Duchenne Muscular Dystrophy (DMD) and feedback from regulators on accelerated approval pathways, indicating a proactive regulatory engagement strategy.

Potential Negatives

• Despite increasing cash reserves, the company reported a significant net loss of $97.0 million for the full year 2024, worsening from a loss of $57.5 million in 2023, indicating ongoing financial challenges.
• Research and development expenses increased substantially to $159.7 million in 2024 from $130.0 million in the prior year, raising concerns about the sustainability of its spending relative to revenue generation.
• The company's revenue decreased slightly to $108.3 million in 2024 compared to $113.3 million in 2023, suggesting potential difficulties in maintaining or growing revenue streams amid high operating expenses.

https://www.nasdaq.com/articles/wave-life-sciences-initiates-dosing-inlight-trial-wve-007-obesity-reports-fourth-quarter

Tiziana Submits IND For Phase 2 ALS Trial

 Tiziana Life Sciences Ltd. (TLSA) announced the submission of its Investigational New Drug or IND application to the FDA for a Phase 2 clinical trial of intranasal foralumab, a fully human anti-CD3 monoclonal antibody, aimed at treating Amyotrophic Lateral Sclerosis or ALS.

The submission follows the receipt of a grant from the ALS Association, supporting the company's commitment to advancing new treatment approaches for ALS.

Tiziana plans to initiate a 20-patient trial evaluating the safety and early-stage efficacy of intranasal foralumab upon FDA clearance of the IND application.

The trial will assess the safety profile and disease improvement in ALS patients, with the primary goal to evaluate early-stage parameters of disease progression.

Intranasal foralumab is expected to offer a novel immunomodulatory approach to treat ALS, a disease with limited treatment options and a rapid progression.

Tiziana's lead candidate, intranasal foralumab, is currently being studied in other neurodegenerative diseases, including Multiple Sclerosis and Alzheimer's disease.

https://www.nasdaq.com/articles/tiziana-life-sciences-submits-ind-phase-2-als-trial-intranasal-foralumab-trial-start-soon

Acelyrin doubles down on Alumis merger after deciding Concentra’s surprise offer 'not superior'

 Acelyrin has declined a surprise offer from Concentra Biosciences, and is instead pushing ahead with plans to merge with immune-mediated disease specialist Alumis.

Los Angeles-based Acelyrin consulted with independent financial and legal advisors and came to the conclusion that the unsolicited interest from Tang Capital Partners-owned Concentra was “not reasonably expected to result in a superior proposal to the planned merger with Alumis,” according to a March 4 release.

In late February, Concentra offered to buy all outstanding shares of Acelyrin for $3 per share in cash, along with a contingent value right for Acelyrin’s current shareholders to receive 80% of the net proceeds from the sale or out-license of any of the biotech's development programs.

The proposition followed an announcement earlier in the month that laid out plans for an Alumis-Acelyrin merger, in which the resulting company would continue under the Alumis name at the biotech’s South San Francisco headquarters under Alumis’ leadership. Stockholders of Alumis—which went public last year—would own 55% of the company, with Acelyrin’s shareholders comprising the remaining 45%.

The two California biotechs are now reaffirming the merger plans, with the deal expected to close in the second quarter of this year, subject to approval by stockholders from both companies, according to a separate March 4 release.

“The Acelyrin board of directors is confident that the all-stock transaction with Alumis maximizes long-term value for Acelyrin stockholders and continues to recommend that stockholders support the planned merger,” CEO Mina Kim said in the release. “We chose to enter into the merger agreement with Alumis after a comprehensive assessment of strategic alternatives and believe this is the best outcome for Acelyrin stockholders.”

The expanded Alumis will take its pick from the two companies’ pipelines. This includes continuing with its own ESK-001, an allosteric tyrosine kinase 2 inhibitor in a phase 3 plaque psoriasis trial, as well as the TYK2 inhibitor A-005, which is being lined up for a phase 2 trial in multiple sclerosis later this year.

The company will also take forward Acelyrin’s anti-IGF-1R monoclonal antibody lonigutamab, which is in a phase 2 trial for thyroid eye disease. 

Recent months have proved tough for Acelyrin, which laid off a third of its workforce last summer as the biotech shifted attention from its former lead asset izokibep to lonigutamab, with hopes that the latter could rival Amgen's eye disease blockbuster Tepezza.

After Acelyrin threw in the towel on izokibep, the company returned the drug back to its former partner Affibody, which claimed that Acelyrin hadn’t “been able to fully capitalize” on izokibep’s potential.

But now Acelyrin is anticipating brighter days upon merging, with the new entity expected to have about $737 million on hand. That estimate combines Alumis’ $289 million and Acelyrin’s $448 million in cash, cash equivalents and marketable securities as of Dec. 31, 2024. The combined cash runway is expected to carry the merged biotech into 2027.

Alumis brought in one of biotech’s biggest venture capital fundraises of last year when it secured a $259 million series C financing in March 2024. Less than three months after the series C, Alumis revealed plans for a $274 million IPO, downsizing the offer a few days later to debut on the Nasdaq with a $250 million offering.

Concentra’s parent company Tang Capital Partners has a track record of swooping in to try to acquire struggling biotechs—with mixed results. The company bought Jounce Therapeutics and Theseus Pharmaceuticals in 2023 but had its advances rejected by Atea Pharmaceuticals, Rain Oncology, LianBio and Kezar Life Sciences.

https://www.fiercebiotech.com/biotech/acelyrin-doubles-down-alumis-merger-after-deciding-concentras-surprise-offer-isnt-better

UnitedHealth shares rise after Medicare fraud case update

 UnitedHealth Group (NYSE: NYSE:UNH) stock climbed 2% following news that a special master recommended rejecting a Department of Justice case that sought billions from the company, signaling a favorable outcome in a Medicare fraud case.

The recommendation, which still requires a federal judge’s ruling to determine if the case will proceed, was reported by Bloomberg. The news led to a positive reaction in UnitedHealth’s stock during the trading session, as investors responded to the potential removal of a significant legal overhang.

The case revolves around allegations of Medicare fraud, a serious charge that could have led to substantial financial penalties for UnitedHealth. However, with the special master’s recommendation to dismiss the DOJ’s case, the company may avoid these penalties, pending the final decision by the judge.

While this development is a positive step for UnitedHealth, the final outcome remains in the hands of the federal judiciary. Investors and market observers will be closely watching for the judge’s ruling, which will ultimately determine the case’s impact on the company’s financial and reputational standing.

Today’s stock movement reflects the immediate market response to the special master’s recommendation, which, if followed by a judge’s ruling in the same vein, could provide relief to UnitedHealth and its shareholders. As the situation unfolds, further updates are anticipated to influence the company’s stock performance.

https://www.investing.com/news/stock-market-news/unitedhealth-shares-rise-after-medicare-fraud-case-update-93CH-3906566

Wellvana expands with CVS Health’s Medicare business

 Wellvana, a value-based care enablement company, has recently acquired the Medicare Shared Savings Program (MSSP) business from CVS Health (NYSE: NYSE:CVS), as announced today. CVS Health, a prominent player in the Healthcare Providers & Services industry with annual revenue of $370.66 billion, continues to demonstrate strong financial health according to InvestingPro analysis. The company’s shares currently appear undervalued based on InvestingPro’s Fair Value assessment. This strategic move not only provides CVS Health with a minority investment in Wellvana but also strengthens Wellvana’s position as a leading company in the value-based care sector, now supporting healthcare providers across 40 states and serving an estimated 1 million Medicare patients. For investors following this development, InvestingPro data shows CVS Health maintains a solid 4.1% dividend yield and has maintained dividend payments for 55 consecutive years, demonstrating long-term financial stability.

The acquisition enhances Wellvana’s capabilities by diversifying its Accountable Care Organization (ACO) presence, extending its network of affiliated hospitals and physicians, and incorporating a team with extensive experience in value-based care and technology from CVS Health’s MSSP business.

Kyle Wailes, President and CEO of Wellvana, emphasized the importance of primary care in reducing costs and improving community health. He stated that the addition of CVS Health’s MSSP business amplifies Wellvana’s impact and fast-tracks their mission to deliver more valuable care to patients.

CVS Health reaffirmed its commitment to value-based care, noting the continuation of its efforts through Oak Street Health®, MinuteClinic®, and accountable care contracts between Aetna and network providers. Sree Chaguturu, MD, President of Health Care Delivery at CVS Health, expressed pride in the CVS Health team’s contribution to the MSSP business and ensured a seamless transition to support ongoing services to clients, providers, and patients.

Physicians joining Wellvana’s network through this acquisition will gain access to resources such as scheduling, administrative support, and value-based care education. Over time, these physicians may also qualify for Wellvana’s Foundational Care™, offering additional medical management support for patients between appointments and post-hospitalization.

While the detailed terms of the transaction have not been publicly disclosed, the acquisition signifies a significant development in the value-based care landscape, with potential implications for the administration and delivery of care to Medicare patients nationwide. This report is based on a press release statement from Wellvana. With CVS Health’s impressive YTD return of 46.41% and strong market position, investors can access detailed analysis and 10 additional exclusive tips through InvestingPro’s comprehensive research reports.

In other recent news, CVS Health reported its fourth-quarter earnings for 2024, surpassing consensus expectations with an adjusted earnings per share of $1.19, which was 29% higher than anticipated. This performance was supported by a favorable medical loss ratio and better-than-expected net investment income. Additionally, Bernstein SocGen Group raised CVS Health’s stock price target to $71, reflecting increased confidence in the company’s earnings potential, particularly from its Aetna segment. Meanwhile, CVS Health is facing scrutiny as part of a broader Department of Justice investigation into Medicare billing practices, which has affected the healthcare sector’s market performance.

In a strategic move, CVS Pharmacy introduced a new 3-in-1 test for Influenza A, Influenza B, and COVID-19, available at around 1,600 locations across 37 states, enhancing its testing and treatment capabilities. The company also offers at-home testing options and emphasizes the importance of vaccinations, providing flu and updated COVID-19 vaccines at its pharmacy and MinuteClinic locations. Furthermore, CVS Health’s former CEO, Karen S. Lynch, joined the board of Thermo Fisher Scientific (NYSE:TMO), bringing her extensive healthcare sector experience to the company. Lastly, CVS Health director Michael F. Mahoney’s $2 million share purchase has been seen as a sign of confidence in the company’s future, positively influencing investor sentiment.

https://www.investing.com/news/company-news/wellvana-expands-with-cvs-healths-medicare-business-93CH-3906751

Charles River, LabCorp upgraded, Quest downgraded at Citi on valuation

 Citi upgraded Charles River Laboratories (NYSE:CRL) and LabCorp (NYSE:LH) while downgrading Quest Diagnostics (NYSE:DGX), citing valuation-related arguments as the main reasons for the rating revisions.

Analyst Patrick Donnelly upgraded contract research organization Charles River (NYSE:CRL) to Neutral from Buy, noting that his negative thesis for the company has largely played out and the stock adequately reflects his concerns.

However, he raised his price target on CRL to $175 from $155 per share, noting that “we think the recent DSA (and manufacturing) revenue and margin headwinds are appropriately modeled by the Street and adequately reflected in valuation.”

Meanwhile, Donnelly upgraded Labcorp (NYSE:LH) to Buy from Neutral and raised its price target to $300 from $250. The analyst argued that the stock’s multiple has yet to fully reflect the improvements in utilization and recovery in early development.

Donnelly downgraded Quest Diagnostics (NYSE:DGX) to Neutral from Buy but maintained his price target at $185 per share. “Our positive thesis has largely played out with the core diagnostics business and elevated utilization rates fully appreciated in the multiple, leaving limited room for potential upside,” Bloomberg reported, quoting the analyst.

https://www.msn.com/en-us/money/companies/charles-river-labcorp-upgraded-quest-downgraded-at-citi-on-valuation/ar-AA1Af8fU