Recent Funding:
Circle Pharma (SF) raises $92.5M Series E for first-in-class cyclin D1 program
Closed an oversubscribed $92.5 million Series E led by The Column Group, with RA Capital, Nextech, Euclidean and Eli Lilly participating. Funds advance CID-165, an oral macrocyclic cyclin D1 inhibitor, toward a Q1 2027 clinical start in ER-positive breast cancer.
M&A, Deals, Partnerships:
Iambic Therapeutics (SD) signs multi-year AI drug-discovery pact with AbbVie
Entered a multi-year collaboration with AbbVie to discover small molecules across immunology, neuroscience and oncology, taking undisclosed upfront cash plus potential milestones and royalties. The deal showcases Iambic’s newly unveiled Enchant v3 model (41 billion parameters, 6,000+ molecular properties) built to predict a program’s clinical viability from the earliest discovery stages.
Roche taps Dualitas Therapeutics (SF) in bispecific deal worth up to $1B
Licensed its DualScreen discovery engine to Roche to find next-generation bispecific antibodies for immune and inflammatory diseases. Took a $36.5 million upfront payment, with research, development and commercial milestones plus tiered royalties bringing potential value to $1 billion.
Marea Therapeutics (SF) goes public via reverse merger with Lisata
Reverse-merged into Lisata Therapeutics alongside a $225 million private placement — one of two reverse-merger deals that week carrying $405 million in combined backing. The financing advances MAR001, an ANGPTL4 antibody in Phase 2b for severe hypertriglyceridemia, plus a second program in acromegaly.
IPOs:
ADARx (SD) sets terms for IPO of up to $371.9M
Set a Nasdaq IPO range implying up to $371.9 million (about $319 million at the midpoint) and a valuation near $1.74 billion, with AbbVie taking a roughly 4.9% concurrent stake. Proceeds fund a pipeline of siRNA drugs for rare immune, kidney, cardiovascular and neurological diseases.
TRexBio (SF) files for Nasdaq IPO
Filed to go public, joining the IPO queue as the biotech listing window stays open. Develops tissue-targeted regulatory T-cell (Treg) therapies for immunology and inflammation.
Electra Therapeutics (SF) closes upsized $350M IPO
Priced and closed an upsized IPO raising about $350 million — following last week’s launch of terms — to fund the transition toward a commercial company. Proceeds push its SIRP-targeting antibody ipsoprubart through late-stage development in the rare hyperinflammatory syndrome sHLH.
FDA Approvals:
Ultragenyx (SF) wins FDA approval for Fayuvi, the first Sanfilippo Type A therapy
Secured FDA approval for Fayuvi (UX111), the first-ever treatment for Sanfilippo syndrome Type A, a fatal childhood neurodegenerative disease. Priced at $3.95 million — among the costliest gene therapies ever — and the approval also earned a Priority Review Voucher worth an estimated $200 million.
Other Interesting News:
Gilead (SF) expands global access agreements for once-yearly lenacapavir HIV PrEP
Widened its six royalty-free voluntary licenses to cover once-yearly lenacapavir for HIV prevention across 120 high-incidence countries, and struck a PAHO deal to speed access across Latin America and the Caribbean. Also raised its no-profit supply commitment by 50%, targeting up to 3 million people through 2028.
Gilead’s (SF) O’Day eyes company’s next chapter with cancer and inflammation push
CEO Daniel O’Day laid out a strategy to reach “critical mass” beyond virology, expanding into oncology and inflammation as the company’s next growth chapter. A signal of sustained hiring and pipeline build-out at one of the West Coast’s largest biopharmas.
FDA hearing on therapeutic psychedelics weighs access vs. safety
The FDA held a landmark public hearing on the future therapeutic use of psychedelic drugs — 1,800+ registrants and 80 speakers — weighing how to expand patient access against safety concerns. Sets the tone for how the agency may handle a coming wave of psychedelic therapies; held Sept. 14, just ahead of this week’s window. Macro item for the whole sector.
FDA launches expedited IND pilot to speed up Phase 1 trials (macro / industry-wide)
The FDA opened an expedited IND pilot under “Operation Trial Blazer,” pairing sponsors with qualified research institutions to shave 6–12 months off Phase 1 timelines and keep pace with China and Australia; applications are open through Oct. 30. Macro item affecting all biotech — broke Sept. 15, just ahead of this week’s window; included per your preference to track FDA news.
