On July 30, 2025 Vivace Therapeutics, Inc., a small molecule discovery and development company developing first-in-class cancer therapies targeting the Hippo pathway, reported that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to VT3989 for the treatment of mesothelioma in the United States (Press release, Vivace Therapeutics, JUL 30, 2025, View Source [SID1234654656]). VT3989, the company’s first-in-class and best-in-class transcriptional enhanced associate domain (TEAD) autopalmitoylation inhibitor, is a novel investigational small molecule cancer therapeutic that is designed to target the Hippo pathway by inhibiting palmitoylation of members of the TEAD protein family.

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"The granting of Orphan Drug Designation to VT3989 underscores the critical need for new, effective therapies for mesothelioma, an aggressive cancer with limited treatment options. The benefits provided by this important designation will support our continued advancement of VT3989, which has already generated compelling clinical trial data, a first for this promising therapeutic class," said Sofie Qiao, Ph.D., president and chief executive officer of Vivace Therapeutics. "We are committed to continuing clinical development of VT3989 and discussing a move into a registrational Phase 3 study in mesothelioma with FDA by the end of 2025."

VT3989 has been evaluated in more than 200 patients to date in an ongoing, open-label Phase 1 clinical study and, to the company’s knowledge, is the first and only member of the TEAD autopalmitoylation inhibitor class for which compelling clinical efficacy data have been publicly reported. In addition to the promising data to date, VT3989 has demonstrated a positive safety profile in the Phase 1 trial, which supports its best-in-class potential.

Clinical findings for VT3989 have been particularly notable in patients with mesothelioma who have failed chemotherapy and immuno-oncology combination regimens, which represent the only approved therapies in this indication. These results will be presented at a major medical conference in the second half of 2025.

Orphan Drug Designation is granted by FDA and is intended to support the development and evaluation of treatments for rare diseases affecting fewer than 200,000 people in the U.S. The designation provides drug developers with potential benefits including tax credits for qualified clinical trials, exemptions from certain FDA fees for clinical trials, and the potential for seven years of market exclusivity following drug approval.

About Phase 1 study of VT3989
The Phase 1 study of VT3989 (View Source) is a multi-center, open label trial designed to evaluate the safety, tolerability, pharmacokinetics (PK) and biological activity of VT3989 in patients with refractory metastatic solid tumors, including refractory pleural and non-pleural malignant mesothelioma.

On July 30, 2025 PharmaMar Group (MSE: PHM) reported an 18% increase in total revenue in the first six months of the year, reaching €95.3 million. Recurring revenue, resulting from the sum of net sales plus royalties received from our partners, grew by 5% as of June 30th, 2025, reaching €72.5 million (Press release, PharmaMar, JUL 30, 2025, View Source [SID1234654640]).

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At the end of the first half of this year, total oncology sales amounted to €45.8 million, representing a 9% increase over the same period last year. These sales include commercial sales of Yondelis (trabectedin) in Europe, sales of raw materials to our partners for both trabectedin and lurbinectedin, distribution of Zepzelca (lurbinectedin) under the compassionate use program ("accès compassionnel"), and commercial sales of lurbinectedin in Switzerland. The increase, during the first half of the year, was driven by the positive performance of lurbinectedin revenues in Europe, where revenues recorded under the compassionate use program – mainly in France – increased by 26% to €15.4 million, as well as commercial sales of lurbinectedin in Switzerland amounting to €8.4 million, representing a growth of 75% compared to the same period in 2024.

At the end of the first half of 2025, oncology royalty income stood at €26.4 million, compared to €26.5 million recorded on June 30th, 2024. This amount corresponds mainly to royalties received from sales of lurbinectedin by our partners Jazz Pharmaceuticals in the US and Luye in China, which together amount to €21.0 million[1], as well as royalties from sales of trabectedin by our partners in the US and Japan, amounting to €5.4 million.

Regarding non-recurring income from licensing agreements, at the end of the first half of 2025, this increased by 87% to €23.0 million, compared to €12.3 million recorded on June 30th, 2024. The increase is driven by the lurbinectedin licensing agreement for Japan signed with Merck for €20.7 million, together with €2.0 million in deferred revenue from the 2019 agreement signed with Jazz Pharmaceuticals in relation to lurbinectedin.

During the first half of the year, €14.7 million was recognized as other net income/(expenses) corresponding to the completed portion of the Syoligo project, for which Sylentis was awarded a grant under the European IPCEI (Important Projects of Common European Interest) ‘Med4Cure’ program for the period January 2023 to August 2026. The total amount of the grant is €21.1 million.

The PharmaMar Group’s investment in R&D amounted to €47.5 million, representing a 7% reduction compared to the first half of 2024, due to the completion of two Phase 3 clinical trials.

Of the total R&D investment for the period, the oncology segment recorded €44.8 million, compared to €46.7 million as of June 30th, 2024. This variation is mainly due to the completion in December 2024 of recruitment for the Phase 3 LAGOON clinical trial with lurbinectedin in small cell lung cancer.

For its part, the RNAi segment recorded €2.7 million in R&D as of June 30th, 2025, compared to €4.6 million for the same period last year. This variation is due to the completion in the first months of 2024 of the Phase 3 PIVO1 clinical trial with tivanisiran for dry eye.

In addition, the Company continues to invest in the clinical development of other molecules at earlier stages. In this regard, two Phase 2 clinical trials are underway with ecubectedin, as well as Phase 1 clinical trials with PM534 and PM54, all for the treatment of solid tumors.

As a result, the PharmaMar Group’s EBITDA reached €25.1 million as of June 30th, 2025, compared to -€0.8 million in the first half of 2024.

The Group’s net profit as of June 30th, 2025, stands at €19.4 million, compared to €3.5 million in the same period last year.

At the end of the first half of the year, the PharmaMar Group had cash and cash equivalents of €128.9 million, with a total financial debt of €48.3 million.

PharmaMar management will host a conference call and webcast for investors and analysts on July 31st, 2025, at 13:00 CET (07:00 AM, New York time) as follows: The numbers to connect to the teleconference are +34 91 901 16 44 (from Spain), +1 646 664 1960 (from USA or Canada), and +44 20 3936 2999 (other countries). Participants’ access code: 883194. Interested parties can also follow the conference call live via the following link: View Source

The recording of the teleconference will be available for thirty days and it can be accessed on PharmaMar’s website by visiting the Events Calendar section of the Company’s website www.pharmamar.com

On July 30, 2025 Akeso, Inc. (9926.HK) ("Akeso" or the "Company") reported that the first patient has been dosed in its pivotal Phase III clinical study (AK112-305/HARMONi-8A) of ivonescimab (PD-1/VEGF bispecific antibody) in combination with docetaxel for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) that has progressed following PD-1/L1 inhibitors and platinum-based chemotherapy (Press release, Akeso Biopharma, JUL 30, 2025, View Source;therapy-for-immunotherapy-resistant-nsclc-302518092.html [SID1234654657]).

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Ivonescimab is the only bispecific immunotherapy antibody currently undergoing Phase III registration trials for IO-resistant lung cancer.

In recent years, immunotherapy has achieved significant progress in the treatment of NSCLC. PD-1/L1 inhibitors, whether used as monotherapy or in combination with platinum-based chemotherapy, have become the standard first-line treatment for advanced NSCLC in patients without driver mutations. However, despite these advances, 60%-70% of patients experience disease progression within the first year of treatment.

Currently, there are no approved standard treatment options for IO-resistant NSCLC. Docetaxel is recommended in both China’s and international treatment guidelines for immunotherapy-resistant (IO-resistant) NSCLC. However, docetaxel’s monotherapy efficacy in the IO-resistant NSCLC patients remains limited. Several Phase III clinical trials investigating IO-resistant lung cancer, including immunotherapy combination therapies studies and ADC therapy studies, have failed to demonstrate positive results.

Mechanistic studies suggest that PD-1 therapy can restore the immune system’s anti-tumor activity, while anti-VEGF therapy alleviates VEGF-mediated immune suppression and promotes T-cell infiltration. When combined, these two therapies may produce synergistic effects. Ivonescimab simultaneously targets both PD-1 and VEGF pathways, reversing the immune-suppressive tumor microenvironment and reactivating anti-tumor immune responses. These synergistic mechanisms provide a scientific rationale for using ivonescimab to treat IO-resistant tumors. Furthermore, the positive efficacy and safety data demonstrated in a Phase II study in this indication underscore the significant therapeutic potential of ivonescimab in this difficult to treat patient population.

The ivonescimab regimen has demonstrated remarkable efficacy and excellent safety across multiple tumor types. The ongoing AK112-305/HARMONi-8A Phase III study targeting IO-resistant NSCLC is expected to offer a novel and highly effective treatment option for patients with IO-resistant NSCLC, in line Akesos ‘ ‘Immuno-2.0’ strategy.

As the world’s leading PD-1/VEGF bispecific antibody, ivonescimab has achieved extensive population coverage for core indications in NSCLC and is positioned across multiple lines of treatment, with the potential to reshape the overall treatment landscape for advanced NSCLC.

On July 30, 2025 Takeda reported financial report for the quarter ended June 30, 2025 (Presentation, Takeda, JUL 30, 2025, View Source [SID1234654685]).

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On July 30, 2025 Phio Pharmaceuticals Corp. (NASDAQ: PHIO), a clinical-stage siRNA biopharmaceutical company developing therapeutics using its proprietary INTASYL gene silencing technology to eliminate cancer, reported the entry into definitive agreements to exercise certain outstanding warrants to purchase up to an aggregate of 928,596 shares of common stock of the Company originally issued in December 2024 and January 2025, having exercise prices between $2.00 and $3.00 per share (Press release, Phio Pharmaceuticals, JUL 30, 2025, View Source [SID1234654641]). Warrants to purchase 100,000 shares of common stock at the existing exercise price of $2.00 per share will be exercised at their existing exercise price of $2.00 per share and warrants to purchase 828,596 shares of common stock will be exercised at a reduced exercise price of $2.485 per share. The shares of common stock issuable upon exercise of the warrants are registered pursuant to effective registration statement on Form S-1 (No. 333-284381). The gross proceeds to the Company from the exercise of the warrants are expected to be approximately $2.5 million, prior to deducting placement agent fees and offering expenses.

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H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

In consideration for the immediate exercise of the warrants for cash and the payment of additional $0.125 per new unregistered warrant (additional $232,149 in the aggregate, which are included in the gross proceeds to the Company), the exercising holders will receive new unregistered warrants to purchase shares of common stock in a private placement pursuant to Section 4(a)(2) of the Securities Act of 1933, as amended (the "1933 Act"). The new warrants will be exercisable for an aggregate of up to 1,857,192 shares of common stock, at an exercise price of $2.485 per share and will be immediately exercisable upon issuance and (i) will have a term of twenty-four months with respect to new warrants to purchase up to 1,538,596 shares of common stock and (ii) will have a term of five years with respect to new warrants to purchase up to 318,596 shares of common stock, in each case, following the effective date of the resale registration statement registering the shares of common stock issuable upon exercise of the new warrants.

The offering is expected to close on or about July 28, 2025, subject to satisfaction of customary closing conditions. The Company intends to use the net proceeds from the offering for working capital and other general corporate purposes.

The new warrants described above were offered in a private placement pursuant to an applicable exemption from the registration requirements of the 1933 Act and, along with the shares of common stock issuable upon their exercise, have not been registered under the 1933 Act, and may not be offered or sold in the United States absent registration with the SEC or an applicable exemption from such registration requirements. The securities were offered only to accredited investors. The Company has agreed to file a registration statement with the SEC covering the resale of the shares of common stock issuable upon exercise of the new warrants.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.