On the same day that FDA Commissioner Martin Makary spoke in a fireside chat during the 2025 Biotechnology Innovation Organization’s International Convention, the agency unveiled a pilot commissioner’s national priority voucher program that will enable companies to receive a shortened FDA review time of one to two months. “We have got to try new things. We are seeing an increasingly competitive landscape internationally,” Makary told BIO CEO John Crowley before a full audience of biopharma executives and staff in Boston June 17. In a separate fireside chat, Pennsylvania Governor Josh Shapiro also recapped efforts in his commonwealth to attract life sciences companies, while calling out Trump administration decisions affecting the industry.

Newly launched Draig targeting depression with $140M series A

Draig Therapeutics Ltd. launched with a $140 million series A and an AMPA receptor modulator program that has completed phase I and will start a phase II trial in major depressive disorder later in 2025. The series A also will enable the company to advance two small-molecule GABA receptor modulators that have the potential to treat a range of neuropsychiatric disorders, into the clinic in 2026.

An early stage 85% remissions rate in AML drives Aptevo’s stock surge

An 85% remissions rate was found in results from Aptevo Therapeutics Inc.’s ongoing phase Ib/II Ranier study of mipletamig in one of the toughest blood cancers to treat. The potentially first-in-class CD123 x CD3 bispecific antibody, combined with standard-of-care venetoclax and azacitidine, was administered to front-line patients who were newly diagnosed with acute myeloid leukemia and who weren’t fit for intensive chemotherapy. The rate was seen in evaluable front-line patients in both studies. The company’s investors were enthusiastic about the results, as the stock (NASDAQ:APVO) was up 114% at midday to $6.03 per share.

Pancreatic cancer still a therapeutic hurdle, Immuneering unveils phase II data

Immuneering Corp.’s phase IIa data this week with oral, once-daily MEK inhibitor atebimetinib (IMM-1-104) in pancreatic cancer (PC) put the notoriously tough indication at the forefront. Immuneering has hopes for atebimetinib in combination with modified gemcitabine/nab-paclitaxel against first-line disease. A number of other developers have rolled out PC results in recent weeks.

US universities developing alternative to cover indirect costs

Indirect costs are the real, unavoidable costs of conducting research, but there may be a better way for U.S. agencies like the NIH to cover them. Instead of the flat 15% cap the Trump administration put forward or the decades-old university-by-university negotiated rate that can exceed 50% of a grant, the recently formed Joint Associations Group on Indirect Costs is developing an alternative for Congress and the administration to consider. The coalition plans, by the end of the month, to finalize its model, which would provide an auditable, transparent process for covering essential research costs. The goal is a model that “will enable our country to continue leading the world in research and innovation while upholding the highest standards of ethics and accountability to American taxpayers,” according to the group, which consists of several university associations.

Avata, Oceanus partner on cannabidiol for epilepsy, schizophrenia

Avata Biosciences Holdings Ltd. and Oceanus Bio Inc. have inked a drug discovery and development deal worth up to $95 million for two of Avata’s cannabidiol (CBD) compounds. Under terms of the deal, Oceanus gains exclusive rights to develop CBD candidates AVAT-021 and AVAT-022 in Japan and Asia, excluding China and India. In exchange, Avata is eligible to receive up to $95 million in co-development contributions, regulatory and sales milestone payments plus sales-based royalties. AVAT-021 is a solid-dose CBD for treatment-resistant epilepsy and schizophrenia, and AVAT-022 is a water-soluble CBD powder in development for pediatric patients.

Jyong’s $20M US IPO to help refile NDA of urological botanic drug

Jyong Biotech Ltd. raised $20 million from its Nasdaq debut June 17 to advance a pipeline of botanical drugs targeting male urinary disorders. The company’s shares began trading under the ticker MENS, and closed at $10.11 apiece at the bell – up 34.80% from its listing price of $7.50 per share. The stock sale included about 2.66 million ordinary shares offered at the lower end of the $7.50 to $8.50 price range. The offering is expected to close June 18, 2025, with an additional overallotment option of 400,000 shares. 

Holiday notice

BioWorld's offices will be closed in observance of Juneteenth in the U.S. No issue will be published Thursday, June 19.

Also in the news

Acurx, Adial, Aldeyra, Alligator, Alzecure, Arima, Avata, Azitra, Capricor, CSL, Dyne, Enliven, Escugen, Ferrer, Fibrobiologics, Geovax, Glykos, GSK, Hemogenyx, Hemostemix, Immedica, Immuneering, Intact, Jyong, Lyell, Maxion, Mineralys, Mineralys, Nodthera, Orion, Oceanus, Polypid, Processa, Quiver, Recce, Relmada, Sanofi, Sunrock, Spyre, Tharimmune, Theralase, Tisento, Ventyx, Zyus