Recent Funding:
Kopra Bio (SF) raised $9.1M Seed Round to Advance Glioblastoma Virus Therapy
UCSF spinout Kopra Bio raised $9.1M (co-led by Andreessen Horowitz and Boutique Venture Partners) to advance KB-516, a replicating retrovirus (RRV) that integrates into brain tumor cells and drives sustained IL-15 immune expression directly within the tumor microenvironment.
The company, founded by neurosurgeon-researcher Dr. Alexander Haddad and serial entrepreneur Andrew Bartynski, will use the seed capital to advance KB-516 into a Phase 1 first-in-human trial for glioblastoma, to be conducted through China’s regulatory pathway.
Nura Bio (SF) raises $73.8M Series B to Advance SARM1 Inhibitors for Neurodegeneration
Nura Bio raised a $73.8M Series B — backed in part by Eli Lilly — to fund two oral SARM1 inhibitor programs through early clinical trials: NB-4746 for ALS and NB-9402 for a broader neurodegeneration indication.
SARM1 is a pro-degenerative signaling enzyme that drives Wallerian axon degeneration; Nura’s oral small molecules aim to inhibit this pathway directly, offering a novel disease-modifying approach in conditions with high unmet need and historically failed drug development track records.
Spot Biosystems emerged from stealth June 17 with $40M raised to advance KB-516 — a non-viral, extracellular vesicle-based gene delivery platform — reporting early human data showing dystrophin restoration in two children with Duchenne muscular dystrophy; the company has operations in California and China.
Unlike viral gene therapy vectors, Spot’s platform uses engineered extracellular vesicles for nucleic acid delivery, aiming to sidestep the immunogenicity and manufacturing limitations associated with AAV; the company intends to advance its lead DMD program into broader human studies using the data gathered to date.
M&A, Deals, Partnerships:
Biogen to Acquire RayThera (SD) for Up to $1B
Biogen announced a definitive agreement on June 17 to acquire RayThera Inc., a private San Diego biotech developing small-molecule anti-inflammatory therapies for immune-mediated conditions, for up to $1 billion in upfront cash plus contingent milestone payments.
RayThera’s lead candidate is expected to enter Phase 1 development in early Q3 2026; the transaction is anticipated to close in Q3 2026, pending regulatory approvals, and adds multiple immunology assets to Biogen’s pipeline in its ongoing effort to diversify beyond neuroscience.
Iambic Therapeutics (SD) and Bayer AI Drug Discovery Collaboration for Hard-to-Drug Small Molecules
Iambic Therapeutics and Bayer announced a drug discovery collaboration on June 22 in which Bayer will use Iambic’s AI-driven platform — including flagship models Enchant and NeuralPLexer — to identify novel small molecule drug candidates against hard-to-drug targets and strengthen Bayer’s early R&D portfolio.
Under the agreement, Iambic receives an upfront payment plus milestone and royalty payments; the deal is the latest validation of Iambic’s molecular superintelligence platform, which previously advanced a novel drug candidate to the clinic in roughly one-third of industry-standard time, and marks Iambic’s second consecutive year on the CNBC Disruptor 50.
Protillion Biosciences and Merck Inks $510M Biobucks Data Generation Partnership
AI drug design specialist Protillion Biosciences announced a $510M biobucks collaboration and license agreement with Merck & Co. on June 16, centered on Protillion’s Prot-MaP platform — a high-throughput protein library data generation technology designed to produce training sets for protein design AI and enable quantitative analysis of large protein libraries.
The partnership targets biologics with sophisticated therapeutic profiles — such as pH-dependent sweeping and multi-target specificity — that are difficult to achieve via traditional methods; Protillion receives an undisclosed upfront payment plus research, development, and commercial milestones tied to multiple potential therapies.
IPOs:
Kardigan (SF) Raises $400M in Upsized Nasdaq IPO
Kardigan (KARD), a South San Francisco and Princeton-based cardiovascular biotech led by former MyoKardia executives, priced 25 million shares at $16 and began trading June 18, closing its first day at $22 (+37.5%); the $400M raise was upsized from initial terms targeting $373M.
The company’s three clinical-stage pipeline assets — danicamtiv for dilated cardiomyopathy, ataciguat for calcific aortic valve stenosis, and tonlamarsen (an ASO) for hypertension — were all licensed from established programs, positioning Kardigan as a de-risked platform in an increasingly capital-favorable cardio IPO market.
Other Interesting News:
Denali Therapeutics (SF) Sells Rare Pediatric Disease Priority Review Voucher for $195M
Denali Therapeutics announced June 18 it has sold its rare pediatric disease PRV — earned following the March 2026 FDA accelerated approval of AVLAYAH (tividenofusp alfa) for Hunter syndrome (MPS II) — for gross proceeds of $195M in a non-dilutive transaction to an undisclosed buyer.
The $195M sale reflects a meaningful rebound in PRV market pricing (previously compressed to ~$100–150M) and will fund Denali’s TransportVehicle blood-brain barrier platform pipeline, including DNL126 (Sanfilippo A), DNL593 (GRN-FTD), DNL952 (Pompe disease), and DNL628 (Alzheimer’s disease).
Exelixis (SF) STELLAR-303 NLM Subgroup OS Analysis Falls Short; NDA on Track for Dec. 2026
Exelixis announced June 22 that the final OS analysis in the non-liver metastases (NLM) subpopulation of the Phase 3 STELLAR-303 trial — evaluating zanzalintinib plus atezolizumab vs. regorafenib in previously treated metastatic colorectal cancer — did not reach statistical significance (HR 0.83; 95% CI: 0.66–1.05; p=0.1185), with median OS of 15.9 vs. 12.7 months.
The NLM miss is incremental; the ITT population already demonstrated a statistically significant OS improvement (published in The Lancet at ESMO 2025), and the FDA has accepted the NDA for zanzalintinib + atezolizumab with a PDUFA date of December 3, 2026 — leaving the regulatory path intact.
Calidi Biotherapeutics reported on June 16 that it received positive pre-IND feedback from the FDA for CLD-401 — its lead RedTail virotherapy asset, a systemically delivered oncolytic virus engineered to replicate selectively in tumor cells and express high concentrations of IL-15 superagonist — with the agency agreeing on the IND-enabling preclinical strategy.
The regulatory alignment accelerates Calidi’s timeline toward an IND submission by year-end 2026, representing a meaningful validation of the RedTail platform as the company pursues a first-in-human Phase 1 study in patients with metastatic solid tumors; a CRO partnership for trial initiation was also previously announced.
MapLight Therapeutics (SF) ML-004 Misses Phase 2 Primary Endpoint in Autism; FDA Meeting Planned
MapLight Therapeutics reported June 22 that ML-004 — its lead autism drug candidate — failed to reach its Phase 2 primary endpoint on social communication; however, the drug showed meaningful improvement in irritability in teenagers, prompting the company to seek an FDA meeting to discuss a potential path forward.
MapLight is pursuing the regulatory discussion rather than shelving the program, citing the secondary irritability signal as a clinically meaningful outcome in a patient population with very limited treatment options; the outcome of the FDA meeting will determine whether and how ML-004 continues into later-stage development.
GondolaBio (SF) PORT-77 Hits Phase 2a Primary Endpoint with 79% Plasma PPIX Reduction in EPP
GondolaBio (Palo Alto, a BridgeBio sister company) announced June 22 that PORT-77 — an oral, small molecule ABCG2 inhibitor — met the primary endpoint of the Phase 2a GATEWAY trial in erythropoietic protoporphyria (EPP), achieving a mean 79% reduction in plasma protoporphyrin IX (PPIX) in the high-dose cohort (300 mg BID) and 63% in the low-dose cohort (180 mg QD), with reductions observed within hours of dosing.
PORT-77 was well tolerated with no serious adverse events or discontinuations; based on these results and End-of-Phase 2 FDA alignment this month, GondolaBio plans to initiate the global Phase 2b/3 PATHWAY trial in EPP and X-linked protoporphyria (XLP) in Q3 2026 — targeting a patient population of 25,000+ in the U.S. and EU with no approved disease-modifying treatment.
HHS/FDA/NIH — Operation Trial Blazer Aims to Cut Phase 1 Timelines by 6–12 Months
Announced June 22 at the BIO International Convention in San Diego, HHS launched ‘Operation Trial Blazer’ — a department-wide initiative led by Acting FDA Commissioner Kyle Diamantas and NIH Director Jay Bhattacharya — to reduce Phase 1 trial timelines by 6–12 months, directly responding to the growing share of Phase 1 studies moving to China and Australia.
Key reforms include an expedited IND pilot program, updated guidance on AI/computational dose selection models and master protocols, a new FDA Phase 1 sponsor portal and call center, and plans to clarify CMC requirements for first-in-human studies — with the initiative explicitly framed as a competitiveness measure to keep early clinical research in the U.S.
