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Monday, June 30, 2025

First China Weight Loss Drug Rival to Novo, Lilly Emerges

 


Novo Nordisk A/S and Eli Lilly & Co, the pharmaceutical giants dominating the global obesity drug market, now face their first serious rival in China.

Suzhou-based Innovent Biologics Inc. secured approval last week for its treatment mazdutide, a turning point in China’s efforts to combat rising obesity and diabetes rates with local innovation. With over 600 million Chinese adults projected to be overweight by 2050, the emergence of a viable local alternative to Novo and Lilly’s blockbuster GLP-1 treatments could make weight loss drugs more accessible in the world’s second-largest economy.

https://www.bloomberg.com/news/articles/2025-06-30/first-china-weight-loss-drug-rival-to-novo-lilly-emerges

Vor Biopharma stock rating upgraded to Buy by H.C. Wainwright on telitacicept deal

 H.C. Wainwright upgraded Vor Biopharma , Inc. (NASDAQ:VOR) from Neutral to Buy with a price target of $3.00 following the company’s exclusive licensing agreement with RemeGen Co., Ltd. The upgrade comes as Vor’s stock has surged over 265% in the past week, with the company currently valued at $132.46 million.

Vor announced on June 25 that it entered into an exclusive license agreement with RemeGen to develop and commercialize telitacicept, a recombinant fusion protein targeting BlyS and APRIL, in territories outside Greater China. Under the agreement, RemeGen will receive an upfront payment of $125 million, consisting of $45 million in cash and $80 million in warrants. 

The deal could potentially yield over $4 billion in regulatory and commercial milestone payments to RemeGen, along with tiered royalties upon successful commercialization. Telitacicept has already received marketing approvals in China for systemic lupus nephritis in November 2023, rheumatoid arthritis in July 2024, and generalized myasthenia gravis in May 2025.

RemeGen has initiated a randomized, double-blinded, placebo-controlled Phase 3 study with telitacicept for generalized myasthenia gravis in the U.S., EU, and South America, with initial data expected in the first half of 2027. If successful, Vor could potentially begin commercialization in the U.S. by mid-2028.

H.C. Wainwright cited the "quick resurrection of the company" and the acquisition of a "de-risked asset" as key factors in its upgrade decision, noting that the transaction strengthens Vor’s asset portfolio, finances, and management. 

https://www.investing.com/news/analyst-ratings/vor-biopharma-stock-rating-upgraded-to-buy-by-hc-wainwright-on-telitacicept-deal-93CH-4116771

Artelo Biosciences Positive First-in-Human Data for Novel Non-Opioid Treatment



Artelo Biosciences (Nasdaq: ARTL) has announced positive results from its first-in-human Phase 1 Single Ascending Dose (SAD) study of ART26.12, a novel non-opioid pain treatment candidate. The study, involving 49 subjects, demonstrated favorable safety and pharmacokinetic profiles for the first orally active Fatty Acid Binding Protein 5 (FABP5) inhibitor tested in humans.

Key findings from the study include excellent safety results with only mild, transient, and self-resolving adverse events, predictable pharmacokinetics with dose-dependent linear absorption, and a wide safety margin between therapeutic plasma concentrations and highest exposure levels. The drug represents a first-in-class approach targeting the multibillion-dollar pain management market.

The chronic pain therapeutics market exceeded $97 billion globally in 2023 and is projected to surpass $159 billion by 2030. A Multiple Ascending Dose study is planned to commence in Q4 2025 to further evaluate ART26.12's safety, tolerability, and pharmacokinetics with repeated dosing.

Eyenovia expands HYPE token holdings by over 265,000

 Eyenovia, Inc. (NASDAQ:EYEN), a $65 million market cap company currently trading near $12.74, has acquired an additional 265,872 HYPE tokens, bringing its total holdings to 1,306,452 tokens purchased at an average price of $34.83 per token, the company announced Monday. According to InvestingPro data, the company faces challenges with cash burn and liquidity, with short-term obligations exceeding liquid assets.

The ophthalmic technologies firm, which describes itself as the first publicly-listed U.S. company to build a strategic treasury of HYPE tokens, plans to use the expanded holdings to support ecosystem growth initiatives, including its validator operations and upcoming yield generation opportunities at the protocol level. While analysts project 65.92% revenue growth for fiscal year 2025, InvestingPro analysis indicates the company is not expected to achieve profitability this year.

"We continue to see strong signals from the market and prospective partners affirming the importance of HYPE’s role in next-generation financial infrastructure," said Hyunsu Jung, Chief Investment Officer of Eyenovia, in a press release statement.

HYPE is the native token of Hyperliquid, a layer one blockchain optimized for high-frequency trading that features onchain perpetual futures and spot order books. According to the company, the token has become the 12th-largest cryptocurrency by market capitalization as of June 2025.

Eyenovia maintains a dual focus on developing its proprietary Optejet User Filled Device (UFD) for topical eye treatments while building its HYPE token treasury. The company states this strategy aims to provide shareholders with exposure to the Hyperliquid ecosystem.

https://www.investing.com/news/company-news/eyenovia-expands-hype-token-holdings-by-over-265000-93CH-4116856

Biofrontera Restructuring Relationship With Biofrontera AG Backed By $11 Million Investment



Biofrontera Inc. (NASDAQ: BFRI) has announced a major restructuring agreement with Biofrontera AG, backed by an $11 million investment from Rosalind Advisors and AIGH Capital Management LLC. The company will acquire all US assets related to Ameluz® and RhodoLED®, including the New Drug Application (NDA) and associated patents.

Under the new agreement, Biofrontera Inc. will pay a significantly reduced royalty rate of 12% of net sales (increasing to 15% for revenue above $65 million), down from the previous 25-35% transfer pricing model. Biofrontera AG will receive a 10% post-money equity stake in Biofrontera Inc.

The $11 million investment will be funded in two tranches: $8.5 million with the signing of the royalty agreement and $2.5 million upon finalizing the asset transfer agreement by September 30, 2025. The capital will be provided as preferred shares convertible to common shares at $0.6249 per share.

AbbVie (ABBV) to Acquire Capstan Therapeutics for $2.1 B

 AbbVie (NYSE: ABBV) and Capstan Therapeutics, Inc. ("Capstan"), a clinical-stage biotechnology company dedicated to advancing in vivo engineering of cells through RNA delivery using tLNPs, today announced a definitive agreement under which AbbVie will acquire Capstan, including CPTX2309, a potential first-in-class in vivo tLNP anti-CD19 CAR-T therapy candidate, currently in Phase 1, in development for the treatment of B cell-mediated autoimmune diseases. Additionally, AbbVie will acquire Capstan's proprietary tLNP platform technology designed to deliver RNA payloads, such as mRNA, capable of engineering specific cell types in vivo.

"Scientific innovation is required to address not just the symptoms of autoimmune diseases, but also to resolve and potentially cure the underlying disease," said Roopal Thakkar, M.D., executive vice president, research and development and chief scientific officer, AbbVie. "By advancing CPTX2309 and utilizing Capstan's novel platform technology, AbbVie and Capstan aim to transform the care of those living with autoimmune diseases by developing treatments that have the potential to reset the immune system."

"In vivo CAR-T represents a potential new treatment modality in medicine – embodying the transformative power of cell therapy with the accessibility and scalability of an off-the-shelf biologic. This technology has the potential to become a first-in-class platform to treat a wide range of autoimmune diseases," said Laura Shawver, Ph.D., president and chief executive officer, Capstan. "Through AbbVie's world-leading expertise in immunology research, clinical development, and its commercialization capabilities, we believe that this transaction moves us closer to delivering on our shared mission to bring these innovative therapies to patients in need."

B cells contribute to the pathogenesis of autoimmune diseases. CD19 is a cell surface receptor expressed on B cells and is a clinically validated target for B cell depletion using ex vivo CAR-T cell therapy in autoimmune diseases. CPTX2309, a product of Capstan's proprietary technology platform that includes hepatic de-targeting, delivers an mRNA payload encoding an anti-CD19 CAR preferentially to reprogram CD8-expressing cytotoxic T cells. This process is achieved in vivo, without the need for lymphodepletion preconditioning and complex ex vivo manufacturing. The in vivo-modified CD8-expressing T cells will transiently express the CD19 CAR and deplete B cells in the periphery and tissues. Depletion of autoreactive antibody-producing pathogenic memory B cells and repopulation with naïve B cells, resulting in immune reset, has the potential to prevent disease progression and induce clinical remission.

Under the terms of the agreement, AbbVie will pay up to $2.1 billion in cash at closing to acquire Capstan, subject to certain customary adjustments. The transaction is subject to the satisfaction of customary closing conditions, including expiration of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act.

Advisors

Capstan's exclusive financial advisor was Centerview Partners LLC and Cooley LLP served as legal advisor.

https://www.streetinsider.com/Corporate+News/AbbVie+%28ABBV%29+to+Acquire+Capstan+Therapeutics+for+%242.1+Billion/24994814.html

INmune Crashes After Missing Cognitive Target in Phase II Alzheimer’s Trial

 

Digging into a prespecified analysis for the mid-stage study, INmune Bio identified some clinical and biological benefits of its TNF inhibitor in patients with early Alzheimer’s disease who have at least two biomarkers of inflammation.

INmune Bio’s investigational TNF inhibitor XPro showed no significant cognitive benefit in a mid-stage trial when used to treat patients with early Alzheimer’s disease who show signs of inflammation.

These findings come from the Phase II MINDFuL study, which enrolled some 200 patients with early-stage disease and biomarkers of neuroinflammation. In the trial’s modified intention-to-treat analysis, XPro over six months failed to significantly boost cognition over placebo, as measured by the Early Mild Alzheimer’s Cognitive Composite (EMACC), an assessment tool specifically meant for early Alzheimer’s disease (AD).

INmune was down by as much as 60% before the opening bell on Monday.

Despite falling short of its primary efficacy endpoint, the Florida-based biotech remained confident in the “potential” of XPro as a “promising treatment option” for Alzheimer’s, CEO RJ Tesi said in a statement.

Digging into a prespecified analysis of 100 patients who had at least two inflammatory biomarkers, INmune touted a “clinical benefit” for XPro over placebo on the EMACC. Results had an effect size of 0.27, which, according to Judith Jaeger, founder and president of CognitionMetrics and principal developer of EMACC, can be “considered preliminary evidence of potential therapeutic efficacy and are informative for signal detection in early phase studies.” Jaeger served as a consultant to INmune on the MINDFuL study.

Additionally, in this prespecified cohort, the company detected a “biological benefit” of XPro, as measured by a drop in the blood levels of the tau protein, which it called “the gold standard measure of AD pathology in blood.”

As for safety, INmune reported no instances of amyloid-related imaging abnormalities (ARIA) indicative of swelling or bleeding. Eight in 10 patients dosed with XPro developed injection-site reactions, as opposed to fewer than 20% of placebo counterparts. MINDFuL detected no deaths, organ system toxicities or drug-related hospitalizations.

Following Monday’s data drop, INmune plans to file for an FDA Breakthrough Therapy designation for XPro. An end-of-Phase II meeting with the agency is scheduled for the fourth quarter, after which the company expects to have more clarity on moving the drug forward.

Alzheimer’s remains a difficult disease to address. Currently, there are two FDA-approved therapies: Biogen and Eisai’s Leqembi and Eli Lilly’s Kisunla. While the drugs have been on the market since January 2023 and July 2024, respectively, their uptake has been slow amid continued criticism regarding their safety and efficacy.

In late March, for instance, the European Union’s Committee for Medicinal Products for Human Use (CHMP) refused to endorse Kisunla for approval in the region, citing safety concerns that the drug’s potential therapeutic benefits do not outweigh.

Meanwhile, while the CHMP has signed off on Leqembi, the U.K.’s National Institute for Health and Care Excellence has not—the agency in March did not recommend the antibody for coverage by the National Health Service, contending that its benefits are “too small to justify the cost.” Leqembi has also struggled to take off in the U.S., with Eisai being forced to lower its sales projection for the therapy again and again.

https://www.biospace.com/drug-development/inmune-crashes-after-missing-cognitive-target-in-phase-ii-alzheimers-trial