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Regulatory pipeline in HIV prevention (oral long-acting formulation)
Gilead said the FDA accepted its supplemental New Drug Application for Yeztugo (lenacapavir) 300-mg tablets as a potential once-weekly oral PrEP option for HIV prevention. The FDA set a...
M&A and financing for inflammatory bowel disease (IBD) programs
Adial agreed to buy Azora in a $64 million deal structured as an equity exchange, bringing Azora’s lead IBD candidate AT177 into Adial’s pipeline. The oral, colon-targeted prodrug is designed to...
Biotech dealflow and private funding in genomics/AI (seed)
Radical Numerics launched with $50 million in seed funding to build multimodal AI models trained across DNA, RNA, and proteins for cancer diagnostics, drug target identification, and biosecurity...
Biotech IPOs and capital markets momentum (large fundraising)
Parabilis priced and closed the largest-ever IPO by a drug developer, raising $770.5 million in gross proceeds and establishing a new Wall Street record for the category. The company sold 33.5...
EU regulatory shift: clinical trial administration changes under EU Biotech Act
The European Medicines Agency (EMA) said it is preparing for major Clinical Trials Regulation updates tied to the upcoming EU Biotech Act. EMA management board will allocate resources to update...
Company funding and commercialization expansion (Germany depression assets)
HMNC Brain Health raised €50 million (Series B) to advance two depression programs into mid-stage development, with family-owned German healthcare firm Medice leading the financing. HMNC said the...
Clinical trial readouts and trial strategy shifts (depression, late-stage failures)
Neumora said it is discontinuing navacaprant development after two additional Phase 3 misses in major depressive disorder and plans to lay off about 35% of staff. The Koastal-2 and Koastal-3...
Clinical pharmacovigilance and biology finding (neural risk across time)
A new study challenges the assumption behind conventional clinical trial averaging by showing that a nasal spray’s brain impact varies by week, potentially explaining why a promising drug...
AI-enabled biotech infrastructure and instruments (autonomous labs)
Researchers at UC Berkeley described how an “A-Lab” autonomous setup runs experiments overnight using AI-enabled robotic platforms, generating iterative material data without continuous human...
Regulatory milestone for HIV prevention oral lenacapavir
Gilead Sciences said the U.S. FDA accepted its supplemental New Drug Application for Yeztugo (lenacapavir) 300 mg tablets as a potential once-weekly oral PrEP option for HIV prevention. The agency...
Oncology approval expands Merck combo in early kidney cancer
Merck & Co. won FDA approval for Welireg (belzutifan) plus Keytruda (pembrolizumab) in an adjuvant setting for high-risk clear cell renal cell carcinoma after surgery. The June 12 nod marks the...
Deal: Adial to acquire Azora to advance colon-targeted UC therapy
Adial said it will buy Azora for $64 million to fund early clinical development of Azora’s lead ulcerative colitis asset AT177. The program is an oral, colon-targeted drug designed to selectively...
Immuno-oncology pipeline setback: Elicio abandons KRAS vaccine after Phase 2 miss
Elicio Therapeutics disclosed that its KRAS-mutation-driven pancreatic cancer vaccine ELI-002 7P failed to meet the primary endpoint in its randomized Phase 2 Amplify-7P study conducted in the...
Clinical trial failures in depression spur staffing reductions at Neumora
Neumora Therapeutics said its Phase 3 trials for navacaprant in major depressive disorder failed to achieve statistical significance on primary and key secondary endpoints, prompting the company...
Clinical-stage depression biotech raises funds via Series B
HMNC Brain Health announced a $50 million Series B led by Medice, paired with a European commercialization licensing arrangement for its two depression therapies. The financing supports...
Molecular glue expansion: Novartis partners with Orionis
Novartis entered a second partnership with Orionis Biosciences to advance induced proximity approaches described as “molecular glue” work. The companies cited a prior relationship that included a...
Gene editing startup financing: Radical Numerics raises seed
Radical Numerics launched with $50 million in seed funding to build multimodal AI models trained on biological data spanning DNA, RNA, and proteins. The round was led by Emergence Capital with...
FDA review resourcing: EU prepares for Biotech Act clinical trial changes
The European Medicines Agency said it is preparing for major clinical trial regulation changes expected under the EU Biotech Act. In comments shared ahead of full adoption later this year, the EMA...
Antibiotic resistance diagnostics: Fleming Initiative evaluates Cepheid molecular screening for CPE
The Fleming Initiative partnered with Cepheid to evaluate real-time PCR-based molecular screening using the Xpert Carba-R assay to identify patients with antibiotic-resistant...
Regulatory approvals – oncology
The FDA approved Merck & Co.’s Welireg (belzutifan) in combination with Keytruda (pembrolizumab) for adjuvant clear cell renal cell carcinoma (ccRCC), marking the first approval for a PD-1 plus...