Detailed data are expected later, but partners Biontech SE and Duality Biologics Co. Ltd. are celebrating a phase III interim analysis readout demonstrating that HER2-targeting antibody-drug conjugate (ADC) trastuzumab pamirtecan (BNT-323/DB-1303) hit the primary endpoint of progression-free survival in patients with HER2-positive unresectable or metastatic breast cancer who have previously received trastuzumab and a taxane-based chemotherapy. For Biontech, it marks the company’s first phase III success in oncology. For Dualitybio, which conducted the phase III study in China, it could lead to a BLA submission with China’s NMPA.

Braveheart licenses Hengrui's heart drug HRS-1893 in $1B+ deal

New company Braveheart Bio Inc. is paying $65 million up front to license Jiangsu Hengrui Pharmaceuticals Co. Ltd.’s oral hypertrophic cardiomyopathy (HCM) drug candidate called HRS-1893. Under the terms of the deal, Jiangsu, China-based Hengrui granted Delaware-based Braveheart, which was founded in 2024, exclusive worldwide rights to develop, manufacture and commercialize HRS-1893, excluding mainland China, Hong Kong, Macau and Taiwan. Braveheart will pay Hengrui an up-front payment of $65 million, a near-term milestone payment of up to $10 million upon completion of the technology transfer, and development and sales milestone payments of up to $1.013 billion, plus royalties.

Neurology biopharmas rebound on trial catalysts and Q2 gains

The BioWorld Neurological Diseases Index showed signs of recovery in August, narrowing its year-to-date decline to 14.31%, compared to a steeper drop of 22.34% at the end of May. Momentum shifted notably over the summer, with 17 of the 20 component companies posting gains between June and August. Cognition Therapeutics Inc. surged nearly tenfold, largely on regulatory momentum for its Alzheimer’s candidate. Ovid Therapeutics Inc. followed with a 374% climb after its second-quarter (Q2) financials. Neumora Therapeutics Inc. rebounded strongly, and Supernus Pharmaceuticals Inc. also saw solid growth on the back of strong Q2 earnings.

FDA aims for transparency with ‘real-time release’ of CRLs

After July’s first-ever release of more than 200 complete response letters (CRLs) by the U.S. FDA, the agency now says it will release letters shortly after sponsors receive them. In addition, the FDA released a new batch of 89 CRLs from 2024 to now that are tied to pending or withdrawn applications. When an application is approved, the FDA added, it will also release any CRLs that are associated with the application. More CRL releases are pending as the agency said it plans to publish batches of previously issued letters associated with withdrawn or abandoned applications.

Ascendis’ Yorvipath path may be one to follow in hypoparathyroidism

Last summer’s U.S. FDA clearance of Ascendis Pharma A/S’ hormone replacement therapy Yorvipath (palopegteriparatide) to treat hypoparathyroidism (hypoPT) – the first and only treatment for adults with the rare endocrine disease – planted a stake with regard to efficacy and safety. A number of other players are aiming to match or surpass the compound. Recent scientific findings have shown that the risk of chronic kidney disease goes up by 11% every year that hypoPT goes untreated.

2025 funding aligns with post-COVID normalization with $40B raised

Biopharma financing activity has continued to remain low compared to the highs seen in recent years, with a total of $39.83 billion raised across IPOs, follow-on offerings, public/other and private financings in the first eight months of 2025. This is nearly a 50% decline from the same period in 2024, when $77.52 billion was raised, and puts 2025 more in line with 2022 to 2023 levels.

Also in the news

AC Immune, AL-S, Agios, Aquestive, Arcutis, Artelo, Ashvattha, Atara, Atlas, Avadel, Beacon, Biocytogen, Blue Cell, Boehringer Ingelheim, Congruence, Eli Lilly, Enveda, Hinge, Immunovant, Kuros, Longeveron, Merck KGaA, Mesoblast, Novavax, Orbital, Pulmovant, Sangamo, Sanofi, Sibylla, Sol-Gel, Syantra, Takeda, Tegoven, Vyome, Xwpharma, Zevra