FLORHAM PARK, N.J., July 02, 2025 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (Nasdaq: CLRB) (the “Company”), a late-stage clinical biopharmaceutical company focused on the discovery and development of drugs for the treatment of cancer, today announced the closing of its previously announced underwritten public offering for gross proceeds of approximately $6.9 million prior to deducting underwriting commissions and offering expenses. The offering includes participation from healthcare dedicated funds an ...

Proceeds to drive development of ONP-002, the Company’s lead intranasal drug candidate for mild traumatic brain injurySARASOTA, Fla., July 02, 2025 (GLOBE NEWSWIRE) -- Oragenics, Inc. (NYSE American: OGEN), a clinical-stage biotechnology company pioneering intranasal therapeutics for neurological disorders, today announced the successful closing of its previously announced public offering of Series H Convertible Preferred Stock and Warrants. The Company secured total gross proceeds of approximately $16.5 mi ...

Core Insights - Inventiva, a clinical-stage biopharmaceutical company, announced the publication of results from the Phase 2b NATIVE clinical trial and preclinical study on lanifibranor for treating metabolic dysfunction-associated steatohepatitis (MASH) [1][10] Group 1: Clinical Trial Results - The Phase 2b NATIVE trial demonstrated that lanifibranor can reduce liver sinusoidal endothelial cell (LSEC) capillarization, which is associated with fibrosis and inflammation in patients with MASH [2][3] - CD34 staining in liver biopsies indicated a higher density in patients with MASLD or MASH compared to those without, and treatment with lanifibranor for 24 weeks resulted in a dose-dependent reduction in CD34 staining [3][6] - Histological evaluations showed that LSEC capillarization occurs early in the disease, suggesting that lanifibranor may help prevent progression to cirrhosis [6][7] Group 2: Mechanism of Action - Lanifibranor acts as a pan-PPAR agonist, targeting all three PPAR isoforms, which may contribute to its anti-fibrotic and anti-inflammatory effects [9] - Preclinical models indicated that lanifibranor not only reverses capillarization but also normalizes intrahepatic vascular resistance and portal vein pressure, outperforming single PPAR agonists [4][7] Group 3: Company Overview - Inventiva is focused on developing oral therapies for MASH and is currently evaluating lanifibranor in the pivotal Phase 3 NATiV3 clinical trial [10] - The FDA has granted Breakthrough Therapy and Fast Track designations to lanifibranor, highlighting its potential in treating MASH [9]

NEW YORK, July 02, 2025 (GLOBE NEWSWIRE) -- Wolf Haldenstein Adler Freeman & Herz LLP announces that a class action lawsuit has been filed in the U.S. District Court for the Southern District of New York on behalf of investors who purchased or otherwise acquired Sarepta Therapeutics, Inc. (“Sarepta” or the “Company”) (NASDAQ: SRPT) securities between June 22, 2023 and June 24, 2025, inclusive (the “Class Period”). Investors who purchased or otherwise acquired shares of Sarepta should contact the Firm prior ...

A c t i o n | 29 Jun 2025 20:44:48 ET │ 13 pages Innovent (1801.HK) R&D Day Takeaways: Leading the Development of Next-Generation IO + ADC CITI'S TAKE During the R&D day, KoLs highlighted promising data of IBI363 in NSCLC, mucosal/acral melanoma and MSS CRC, and its potential to become a cornerstone product for next-generation IO treatment. Innovent is leading the development of next generation of IO+ADC combinations, which could bring broader-spectrum, highly-potent, less-toxic, innovative cancer treatment ...

Financial Performance and Guidance - Ligand's total revenue guidance for 2024 is $160-$165 million[21], with royalty revenue expected to be $105-108 million[22], representing a 27% increase from 2023[30] - The company anticipates adjusted EPS of $550-$570 in 2024[22], a 38% growth[30] - For 2025, Ligand forecasts total revenue of $180-$200 million[34], with royalty revenue growing by 30% over 2024[35] - Ligand projects royalty receipts to grow at a CAGR of 22% from 2024 to 2029[24, 40] Investment and Portfolio Activity - Ligand deployed $192 million across 8 different investments in 2024[21] - The company's Q4 pipeline includes over 30 actionable opportunities, representing over $1 billion of potential investments[61] - Ligand acquired Apeiron Biologics in July 2024 for approximately $100 million, gaining rights to Qarziba royalties[70] Key Products and Platforms - Ligand's Captisol platform is used in 16 approved products[99, 104] - Verona's Ohtuvayre, in which Ligand has royalty rights, achieved over $11 million in sales in the first 4 months following approval[75] - Travere's Filspari generated $356 million in Q3 2024, with 31% growth from Q2 2024[80] - Merck's Capvaxive, another royalty asset for Ligand, protects against strains that cause 84% of invasive pneumococcal disease[88]

BERKELEY HEIGHTS, N.J., July 02, 2025 (GLOBE NEWSWIRE) -- Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; “Cyclacel” or the “Company”), a biopharmaceutical company developing innovative medicines, today announced that it expects to implement a 1-for-15 reverse stock split on its shares of common stock effective July 7, 2025, with trading to begin on a split-adjusted basis at the market open on that day. Trading in the shares of common stock will continue on The Nasdaq Capital Market under the s ...

Core Viewpoint - A lawsuit has been filed against Organon & Co. and its senior executives for potential violations of federal securities laws, particularly related to misleading statements about the company's dividend policy following a significant acquisition [1][2][3]. Group 1: Lawsuit Details - The lawsuit is pending in the U.S. District Court for the District of New Jersey, titled Hauser v. Organon & Co., et al., No. 25-cv-05322, and investors have until July 22, 2025, to seek lead plaintiff status [2]. - The complaint alleges violations under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 on behalf of investors who purchased Organon securities [2]. Group 2: Company Background and Acquisition - Organon is a global healthcare company focused on women's health, known for rewarding shareholders with dividends [3]. - In October 2024, Organon completed a $1.2 billion acquisition of Dermavant, a biopharmaceutical company, which increased the company's debt [3]. Group 3: Dividend Policy and Stock Performance - Following the acquisition, Organon assured investors it would maintain its dividend, claiming it was the "1 capital allocation priority," but later shifted focus to debt reduction, leading to a significant dividend cut [3]. - On May 1, 2025, Organon announced a reduction in its dividend payout from $0.28 per share to $0.02 per share, resulting in a stock price decline of approximately 27%, from $12.93 to $9.45 per share [4].

Core Viewpoint - A lawsuit has been filed against Iovance Biotherapeutics, Inc. and certain senior executives for potential violations of federal securities laws, with claims under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 [1][2]. Company Overview - Iovance Biotherapeutics is a commercial-stage biopharmaceutical company focused on developing treatments for melanoma and other solid tumor cancers [3]. - The company launched its key melanoma treatment, Amtagvi, in February 2024, administered at authorized treatment centers (ATCs) [3]. Allegations and Issues - The lawsuit alleges that Iovance misrepresented the effectiveness of its ATCs as a driver of demand for Amtagvi, while in reality, these centers faced long timelines for patient treatment and high patient drop-off rates due to ineffective patient identification and selection [4]. - Following disappointing financial results for Q1 2025, Iovance revised its full-year 2025 revenue guidance, citing slow treatment timelines and high patient drop-off as contributing factors [5]. Stock Performance - On May 8, 2025, Iovance's stock price fell over 44%, dropping from $3.17 per share to $1.75 per share the following day, in response to the negative news regarding its financial performance and operational challenges [6].

Core Viewpoint - VYNE Therapeutics Inc. is advancing its VYN202 program for treating moderate-to-severe plaque psoriasis after the FDA lifted a clinical hold for female patients on lower doses, while further data is needed for male subjects [1][2][4] VYN202 Program Update - The FDA placed a clinical hold on the Phase 1b trial due to testicular toxicity observed in dogs, but has now lifted the hold for female patients on 0.25 mg and 0.5 mg doses [2] - The 1 mg dose was excluded from the revised protocol due to a lower safety margin [2] - A 12-week non-clinical toxicology study is required to resume trials in male subjects, with the study design agreed upon with the FDA [2] Clinical Data Insights - The clinical data from the Phase 1b trial included 7 enrolled subjects, with 6 treated with VYN202 and 1 with placebo [3][5] - No serious adverse events or treatment discontinuations were reported, and all subjects treated with VYN202 showed improvement in psoriasis symptoms [7] - PASI scores improved by approximately 27% after 1 week and up to 90% by week 8 [7] - Significant reductions in serum cytokine levels were observed in subjects treated with VYN202, while no changes were noted in the placebo group [7] Future Plans and Financial Outlook - The company will not enroll new patients in the Phase 1b psoriasis study, extending its expected cash runway into Q4 2026 [4] - Further updates on the VYN202 program will follow the release of top-line results from the ongoing Phase 2b study of repibresib gel for non-segmental vitiligo [4] About VYN202 - VYN202 is an oral small molecule BET inhibitor with potential class-leading selectivity and potency for BD2, aimed at providing a non-biologic treatment option for immuno-inflammatory conditions [10] About VYNE Therapeutics Inc. - VYNE is focused on developing differentiated therapies for chronic inflammatory and immune-mediated conditions, leveraging its proprietary BET inhibitors to overcome limitations of earlier generations [11]