Recent Funding:
Ridge Biotechnologies (SF) Launches with $25M Seed to Improve ADCs and Biologics
Ridge Bio, backed by Sutter Hill Ventures and advised by Nobel laureate Carolyn Bertozzi and MIT’s Sangeeta Bhatia, will use AI to design enzymes for better antibody-drug conjugates and biologics. Led by Weston Kightlinger, the startup is already partnered with an ADC-focused biotech and aims to create safer, more effective therapies across ADCs, radiopharmaceuticals, RNA delivery, and in vivo CAR-T.
Wellcome Leap and Pivotal Commit $100M to Women’s Health Research
Backed by Melinda French Gates, the funding will launch programs in 2026 targeting women’s health gaps in cardiovascular disease, autoimmune disorders, and mental health. The initiative aims to help close decades of underinvestment in women’s health, with Leap targeting $1B in philanthropic capital for breakthroughs by 2040.
IPOs:
LB Pharmaceuticals (SD) Launches $285M IPO to Fund Schizophrenia Drug
LB raised $285M in its IPO, the first biotech listing in seven months, to fund Phase 3 trials of its schizophrenia drug LB-102. The company had just $14M in cash mid-year and aims for FDA approval by 2026, betting on recent mid-stage trial results.
Other Interesting News:
aTyr Pharma (SD) Stock Drops 80% After Phase 3 Trial Failure
aTyr’s drug efzofitimod failed to show significant benefit in reducing steroid use for pulmonary sarcoidosis patients in a 268-person Phase 3 trial. Despite missing its primary endpoint, the company plans to share results with the FDA and highlight quality-of-life improvements, though analysts remain doubtful.
Avidity Biosciences (SD) Shares Fall 20% After $500M Offering
Avidity announced a $500M public raise, signaling plans to launch drugs independently despite Novartis buyout rumors. The company expects to file three FDA applications by 2026, including accelerated approval for its Duchenne muscular dystrophy therapy, with three launches targeted by 2027.
Summit Therapeutics (SF) Sees Stock Drop After Mixed Lung Cancer Data
Summit’s drug ivonescimab showed weaker results in Western patients, causing shares to fall ~20%. Despite the setback, company leaders say physicians remain interested and further development continues in the PD-1/VEGF bispecific space.
Capsida Biotherapeutics (LA) Pauses Gene Therapy Trial After Patient Death
A patient died after receiving Capsida’s first-in-human gene therapy for STXBP1 developmental and epileptic encephalopathy, leading the company to halt the trial and notify the FDA. Capsida, which partners with AbbVie and Eli Lilly, is pioneering IV-delivered gene therapies that can cross the blood-brain barrier without surgery.
Arrowhead Pharmaceuticals (LA) Sues Ionis Over Rare Disease Drug Patent
Arrowhead filed a lawsuit claiming Ionis’ APOC3 patent is invalid and doesn’t apply to its RNAi therapy plozasiran, now under FDA review for familial chylomicronemia syndrome. If approved by Nov. 18, plozasiran would compete with Ionis’ Tryngolza, the first FDA-approved treatment for FCS, setting up a high-stakes market clash.
FibroGen (SF) Pays $1.25M SEC Settlement Over Roxadustat Data Manipulation
The SEC alleged former CMO Peony Yu altered Phase 3 analyses to make anemia drug roxadustat appear more effective than it was, misleading investors and regulators. FibroGen agreed to settle for $1.25M; while FDA rejected U.S. approval, the drug is sold in Europe and Asia through partners Astellas and AstraZeneca.
MEI Pharma (SD) Rebrands as Lite Strategy, Shifts to Crypto Treasury Model
After a failed merger, MEI Pharma has rebranded as Lite Strategy, securing $100M in Litecoin and becoming the first U.S.-listed company to adopt it for corporate treasury. While pivoting to digital assets, the company says it will still evaluate its preclinical biotech pipeline, including programs in leukemia and B-cell malignancies.
Capricor Therapeutics (SD) Responds to FDA Rejection of Duchenne Cell Therapy
The FDA rejected Capricor’s BLA for deramiocel, citing concerns with trial data, and made the rejection letter public under a new transparency policy. Capricor defended its Phase 2 results as statistically significant and plans to resubmit after topline HOPE-3 data in late 2025.
Trump Administration Weighs Restrictions on Chinese Biotech Drug Deals
A draft executive order reportedly proposes stricter U.S. oversight of licensing drugs from Chinese biotechs, including national security reviews and tougher FDA scrutiny of China trial data. The move reflects growing concern over China’s rising influence in biotech, with nearly one-third of global out-licensing deal value coming from China in early 2025.
FDA Moves to Tighten Oversight of Drug Ads Under White House Order
The FDA will crack down on direct-to-consumer pharma ads, ending a loophole that allowed companies to disclose only limited risk information on TV or radio. The agency plans to issue 100+ cease-and-desist letters and thousands of warnings, signaling tougher enforcement that could impact how biotech and pharma market their therapies going forward.
