Neuphoria Therapeutics Inc.’s phase III study of social anxiety disorder has missed its primary and secondary endpoints, prompting the company to stop the program’s development. Neuphoria also is evaluating its development plans for using the same drug, BNC-210, to treat post-traumatic stress disorder. The company is collaborating with Merck & Co. Inc. to develop two positive allosteric modulators. One, MK-1167, is in a phase II study for treating Alzheimer’s disease. Neuphoria’s stock (NASDAQ:NEUP) was taking a hammering at midday, with shares dropping 66% to $5.21 each.

Celcuity nears NDA filing with gedatolisib breast cancer win

Detailed Viktoria-1 results of Celcuity Inc.’s gedatolisib positions the pan-PI3K/mTORC1/2 inhibitor as a top contender for second-line treatment of HR+/HER2- PIK3CA wild-type advanced breast cancer – an indication that represents a multibillion-dollar opportunity. In contrast with phase III data from Roche Holding AG’s Evera breast cancer study of giredestrant, disclosed alongside the Celcuity data Oct. 18 at the European Society for Medical Oncology (ESMO) Congress in Berlin, gedatolisib came out ahead, removing giredestrant’s competitive overhang. Celcuity’s stock (NASDAQ:CELC) rose 36%, or $18.62, to close at $70.58, on Oct. 20, the first trading day following the Saturday presentations. Roche’s Evera data showed its drug was effective in patients with ESR1 mutations, about 15% of the patient population, Brian Sullivan, Celcuity’s co-founder, chairman and CEO, said on an investor call, but gedatolisib has potential to address “roughly 85% of patients.” The company is working to complete a rolling NDA by year-end.

ADC space has plenty of room to grow, say ESMO 2025 panelists

Antibody-drug conjugates (ADCs) are a mature technology. The first ADC, Mylotarg, was initially approved in 2000, and there are now 14 approved agents in both leukemias and solid tumors. According to Clarivate’s Cortellis Drug Discovery & Intelligence, those drugs collectively accounted for $13.55 billion in sales in 2024 – a figure that Cortellis projects will rise to $16 billion in 2025. At the 2025 Congress of the European Society for Medical Oncology (ESMO) in Berlin this past weekend, there was much buzz around Enhertu’s (trastuzumab deruxtecan, Astrazeneca plc./Daiichi Sankyo Co. Ltd.) success in early stage cancers – another typical milestone as new treatment modalities mature. But exciting times or mature technology does not mean ADCs have yet reached their full potential.

Step closes €38M series C to advance CTPS1 inhibitor in cancer

Step Pharma is financed to move its pipeline-in-a-product strategy forward on a broad front, after raising a €38 million (US$44.2 million) series C. That will see three ongoing trials testing the company’s potentially first-in-class, orally available cytidine triphosphate synthase 1 (CTPS1) inhibitor, dencatistat, through to phase II in T-cell and B-cell lymphoma, in an ovarian, endometrial and lung cancer study, and in essential thrombocythemia, a rare blood cancer in which the bone marrow produces too many platelets leading to a risk of blood clots. The breadth of these programs is a reflection of the central role that CTPS1 plays in DNA synthesis, as a key component of the pyrimidine synthesis pathway.

Post spinoff, Samsung Bioepis inks first ADC deal with Phrontline

Samsung Bioepis Co. Ltd. announced Oct. 21 the signing of a license deal to codevelop, manufacture and commercialize two of Phrontline Biopharma Suzhou Co. Ltd.’s novel bispecific dual-payload antibody-drug conjugate (ADC) candidates. Specific financial terms were not disclosed, but Samsung Bioepis agreed to codevelop two of Phrontline’s investigational ADC assets, including TJ-108, a preclinical EGFR/HER3-targeting bispecific dual-payload ADC that combines a topoisomerase-1 inhibitor (TOP1i) and a microtubule inhibitor as cytotoxic payloads. Samsung Bioepis will identify a second asset for co-development through the ongoing collaboration. The deal also grants Samsung Bioepis an exclusive license to apply one of Phrontline’s TOP1i payloads to its other oncology candidates.

Radiopharm Theranostics raises AU$35M to advance pipeline

Radiopharm Theranostics Ltd. completed a AU$35 million (US$22.77 million) placement to advance six of its radiopharmaceutical candidates for both diagnostic and therapeutic uses. The funds raised will go toward clinical trials, drug manufacturing and working capital to extend Radiopharm’s funding runway into 2027. The placement consisted of 1.167 billion new fully paid ordinary shares priced at AU3 cents per share. A share purchase plan for eligible shareholders in Australia and New Zealand is expected to raise a further AU$5 million at the same offer price. Fellow radiopharma company Lantheus Holdings Inc. invested AU$7.6 million in the placement, increasing its shareholding to 14.5% of Radiopharm Theranostics.

Delcath’s Chemosat plus ICIs triples PFS in uveal melanoma

While positive results from the investigator-led phase II CHOPIN trial at the 2025 European Society of Medical Oncology (ESMO) meeting being held in Berlin failed to get investors dancing, they were no doubt music to management’s ears, particularly with Delcath System Inc.’s third-quarter earnings report missing a beat. The study demonstrated that combining immune checkpoint inhibitors with Delcath’s Chemosat hepatic delivery system with melphalan percutaneous hepatic perfusion (PHP), a combination marketed as the Hepzato Kit, more than tripled one-year progression-free survival and more than doubled two-year overall survival in patients with metastatic uveal melanoma compared to percutaneous hepatic perfusion (PHP) alone. Further, it showed that the “practice changing” combination does not require delaying initiation of systemic therapy while waiting to schedule PHP, a concern that has affected the company’s revenues.

SK Bio, Eurofarma launch Mentis Care for digital epilepsy care

SK Biopharmaceuticals Co. Ltd. and Eurofarma Laboratórios SA launched a new joint venture called Mentis Care Inc. Oct. 21, dedicated to developing an AI-powered platform for epilepsy management. "SK Biopharmaceuticals is expanding beyond pharmaceuticals into digital health care to open new possibilities in patient care," Donghoon Lee, CEO of SK Biopharmaceuticals, said. "Through Mentis Care, we will advance toward patient-centered innovation by integrating AI and clinical data to improve epilepsy treatment."

Also in the news

Abeona, Achieve, Aicuris, Alto Neuroscience, Amgen, Astrazeneca, Aurion, Cardiol, Cogent, Contera, Corbus, Corcept, Cumberland Pharma, Cyclana, Disc Medicine, Exelixis, Genmab, Glaukos, H. Lundbeck, IO, ITM, Lava, Leap, Merck, Mosaic, Novo Nordisk, Olema Oncology, Radiopharm, Redhill, Replimune, Roche, Salvat, Sanofi, Silver Creek, Valink, Valitor Vivace, Xbrane, Xoma Royalty