Search This Blog

Monday, June 16, 2025

Teva, Fosun Partner on Novel Anti-PD1-IL2 Therapy (TEV-56278) in Immuno-Oncology

 

  • Teva-engineered TEV-56278 is an anti-PD1-IL2 ATTENUKINE™ therapy in Phase 1 for the treatment of various forms of cancer, including melanoma

  • Fosun Pharma-Teva collaboration agreement established with goal of accelerating clinical data generation for TEV-56278

  • Partnership leverages strategic relationships to enable research and development of innovative treatments to advance Teva's Pivot to Growth strategy

Stocks Rise on Reports Iran Wants to Restart Talks

 


Relative calm returned to global markets, with stocks climbing and oil sinking alongside gold as fears subsided that Israel’s war against Iran would escalate into a wider conflict. Equities extended gains on news reports Iran is signaling it wants to restart talks over nuclear programs.

Equities bounced after Friday’s slide, with the S&P 500 up over 1%. West Texas Intermediate crude slid 4%, erasing an earlier rally. Treasuries moved away from session lows as the drop in oil eased inflation angst just days ahead of the Federal Reserve decision. Before that, the market will face a demand test during a $13 billion sale of 20-year bonds. The dollar fell.

Phathom: FDA Confirms 10 Years of Regulatory Exclusivity for VOQUEZNA

Phathom Pharmaceuticals (NASDAQ: PHAT) announced that the FDA has corrected the Orange Book listing for VOQUEZNA® (vonoprazan) tablets, confirming its 10-year New Chemical Entity (NCE) exclusivity period through May 3, 2032. VOQUEZNA, a first-in-class potassium-competitive acid blocker (PCAB), is approved for treating heartburn associated with Non-Erosive GERD and Erosive GERD in adults. The product is also available as VOQUEZNA TRIPLE PAK and DUAL PAK for H. pylori infection treatment. This correction reinforces the long-term commercial potential for this novel GI treatment, ensuring market protection for the full statutory period.

FDA clears Ocugen’s phase 2/3 trial for Stargardt disease therapy

 Ocugen, Inc. (NASDAQ: OCGN), a $330 million market cap biotechnology company whose stock has surged over 33% in the past six months, announced Monday that the U.S. Food and Drug Administration has cleared an Investigational New Drug amendment to begin a Phase 2/3 pivotal confirmatory trial of OCU410ST, a modifier gene therapy for Stargardt disease. According to InvestingPro data, the company maintains a healthy liquidity position with a current ratio of 2.6, though it faces significant R&D expenses.

The therapy has previously received Rare Pediatric Disease Designation and Orphan Drug Designation from the FDA for treating ABCA4-associated retinopathies, including Stargardt disease.

The planned Phase 2/3 trial will enroll 51 participants with Stargardt disease. Of these, 34 will receive a one-time subretinal injection of OCU410ST in the eye with poorer visual acuity, while 17 will serve as untreated controls. The primary endpoint will measure reduction in atrophic lesion size, with secondary endpoints including improvements in visual acuity.

According to the company’s press release, Phase 1 trial data showed a favorable safety profile with no serious adverse events related to the treatment. The data also indicated 48% slower lesion growth at 12 months in treated eyes compared to untreated eyes, and a statistically significant improvement in visual function.

https://www.investing.com/news/company-news/fda-clears-ocugens-phase-23-trial-for-stargardt-disease-therapy-93CH-4096942

AbbVie's Venetoclax Doesn't Meet Primary Endpoint for Higher-Risk Myelodysplastic Syndrome

 AbbVie said its Phase 3 trial evaluating venetoclax in combination with azacitidine to treat higher-risk myelodysplastic syndrome didn't meet the primary endpoint of overall survival.

The drugmaker said data from the trial doesn't impact any current approved indications for venetoclax.

Venetoclax is being developed by AbbVie and Roche. It is jointly commercialized by AbbVie and Genentech, a member of the Roche Group.

https://www.morningstar.com/news/dow-jones/202506164170/abbvies-venetoclax-doesnt-meet-primary-endpoint-in-trial-for-higher-risk-myelodysplastic-syndrome-treatment

Oncology precision medicine platform Caris ups range to $19 to $20 ahead of $459M IPO

 Caris Life Sciences, which offers an AI-powered molecular diagnostics platform focused on oncology, raised the proposed deal size for its upcoming IPO on Monday.


The Irving, TX-based company now plans to raise $459 million by offering 23.5 million shares at a price range of $19 to $20. It had previously filed to offer the same number of shares at a range of $16 to $18. Insiders intend to purchase $75 million worth of shares in the offering (16% of the deal). At the midpoint of the revised range, Caris Life Sciences will raise 15% more in proceeds than previously anticipated.

The company is developing and commercializing a platform meant to incorporate next-generation sequencing, artificial intelligence, and machine learning technologies to develop precision medicine diagnostic solutions meant to treat cancer. Caris Life Sciences states that its platform is based off of a data set with more than 6.5 million tests, run on over 849,000 cases, and has generated measurements of over 38 billion molecular markers. Its current commercial product portfolio is focused on oncology and consists of MI Profile, a tissue-based molecular profiling solution that has generated the majority of its revenue to date, and Caris Assure, a blood-based molecular profiling solution that was broadly launched in the first quarter of 2024 for therapy selection.

Caris Life Sciences was founded in 2008 and booked $452 million in revenue for the 12 months ended March 31, 2025. It plans to list on the Nasdaq under the symbol CAI. BofA Securities, J.P. Morgan, Goldman Sachs, Citi, TD Cowen, Evercore ISI, and Guggenheim Securities are the joint bookrunners on the deal. It is expected to price during the week of June 16, 2025.

Truist starts on diabetes device makers, sees glucose monitor, insulin pump growth

 Truist Securities launched coverage on four diabetes technology companies, saying there is a long-term growth potential for continuous glucose monitors (CGM) and insulin pumps amid rising adoption in both type 1 and type 2 diabetes patients.

The firm started Dexcom (NASDAQ:DXCM), Insulet (NASDAQ:PODD), and Beta Bionics with Buy ratings, while initiating Tandem Diabetes Care (NASDAQ:TNDM) at Hold.

Truist already covers Medtronic’s diabetes business, which it rates “Hold.”

Truist said the diabetes device sector is positioned for double-digit growth over the next several years, driven by expanding use in underpenetrated global markets and a shift toward more patient-centric care.

Survey feedback from physicians suggested stronger adoption of pumps and CGMs in type 2 diabetes, particularly among patients using insulin.

Among the large-cap names, the firm favored Dexcom and Insulet, citing strong profitability and leadership in the growing CGM and patch pump segments.

While Truist said that Insulet’s recent CEO change may introduce some near-term uncertainty, it said the company’s growth trajectory remains intact.

Dexcom, which has faced concerns following mid-2024 execution missteps and rising competition from Abbott’s Libre system, still offers a favorable risk-reward, Truist said, pointing to a lower relative valuation and catalysts such as guideline updates and expanding reimbursement for type 2 diabetes.

In the small-cap space, Truist preferred Beta Bionics over Tandem.

It noted both firms face challenges in the slower-growing durable pump market but said Beta Bionics’ iLet system has a potential ease-of-use advantage and a head start in transitioning to more profitable pharmacy distribution channels.

Regarding potential volatility in shares of both Beta Bionics and Tandem, Truist said the broader diabetes device market remains one of the most attractive growth areas in medtech, supported by technology innovation, evolving reimbursement, and increased patient engagement.

https://finance.yahoo.com/news/truist-starts-diabetes-device-makers-142143828.html