Recent Funding:
Alto Neuroscience (SF) Raises $50 Million to Advance Precision Psychiatry Program
Alto secured $50M in private financing led by Perceptive Advisors, with participation from Vivo Capital, Commodore Capital, and others. Funds will accelerate ALTO-207, a combo therapy for treatment-resistant depression, with a Phase 2b trial planned for mid-2026 and a Phase 3 expected by early 2027.
NewLimit (SF) Raises $45 Million, Nears $1.6B Valuation for Anti-Aging Programs
The anti-aging biotech, co-founded by Coinbase CEO Brian Armstrong, secured $45M from investors including Lilly Ventures and S32, bringing its valuation cap to $1.6B. Funding supports preclinical work on reversing liver cell aging, with plans to select a lead candidate by year-end and begin IND-enabling studies in 2026.
Faeth Therapeutics (SD) Raises $25 Million to Advance Cancer Metabolism Trials
Faeth secured $25M led by S2G Ventures to fund a Phase 2 trial combining PI3K and mTOR inhibitors in endometrial cancer, exploring how metabolism and diet influence outcomes. Early data showed strong responses, including complete remissions, and Faeth aims for potential accelerated approval while expanding studies into food allergies and asthma.
Pelage Pharmaceuticals (LA) Raises $120 Million to Advance Hair Loss Drug to Phase 3
Pelage secured $120M in a Series B led by GV and ARCH Venture Partners to fund two Phase 3 trials of its small-molecule topical PP405, which activates dormant hair follicle stem cells. The UCLA-born biotech’s treatment showed improved hair density in Phase 2a and aims to commercialize independently as awareness of hair loss treatments grows.
Kardigan (SF) Raises $254 Million to Advance Precision Heart Therapies
The cardiovascular biotech secured $254M led by Fidelity, T. Rowe Price, ARCH, and Sequoia Heritage to advance three clinical-stage drugs licensed from Sanofi, Ionis, and Bristol Myers’ MyoKardia. CEO Tassos Gianakakos, formerly of MyoKardia, is developing “cardiac intelligence” tools to personalize treatments for cardiomyopathy, valve disease, and severe hypertension.
Siren Biotechnology (SF) Raises $4.2 Million Through Community Round
Siren took an uncommon path for biotechs, raising $4.2M from community investors to support its immuno-gene therapy platform. Backed by $28M in seed funding and a $4M CIRM grant, its first program targets brain cancer.
Recent Layoffs:
Kezar Life Sciences (SF) Plans Layoffs After FDA Meeting Cancellation on Autoimmune Hepatitis Drug
Kezar is cutting staff and exploring strategic alternatives after the FDA canceled a key meeting on next steps for its immunoproteasome inhibitor zetomipzomib, delaying the program by up to two years. The agency requested an additional pharmacokinetic study in liver-impaired patients, which Kezar says it lacks resources to complete, prompting a strategic review despite holding $90M in cash.
M&A, Deals, Partnerships:
Rani Therapeutics (SF) Secures $1.08 Billion Partnership with Chugai and $60M Financing
Rani inked a deal with Chugai to pair its robotic oral pill delivery system with Chugai’s experimental rare disease antibody, worth up to $1.08B in milestones and royalties. The biotech also raised $60.3M in new funding led by Samsara BioCapital, extending its cash runway into 2028 as it advances oral biologic therapies.
Kite Pharma (LA) and Pregene Biopharma Ink $1.52 Billion In Vivo Cell Therapy Deal
Gilead’s Kite Pharma partnered with China’s Pregene Biopharma in a deal worth up to $1.52B to co-develop next-generation in vivo CAR-T, CAR-NK, and TCR-T therapies. Pregene will receive $120M upfront, with additional milestone and royalty potential, as the companies aim to accelerate cell therapy innovation in oncology and autoimmune diseases.
insitro (SF) Extends ALS Collaboration with Bristol Myers Squibb
Bristol Myers extended its AI-driven ALS research partnership with insitro by one year, adding up to $20M in funding to advance a small molecule program based on a newly identified ALS target. insitro will use its ChemML platform and DNA-encoded library technology to design potential drugs, marking a shift from target discovery to molecule development.
Protagonist Therapeutics (SF) Reportedly in Acquisition Talks with Johnson & Johnson
J&J is in discussions to acquire its partner Protagonist, developer of icotrokinra, an oral IL-23 drug projected to exceed $5B in annual sales; the therapy has completed Phase 3 trials in plaque psoriasis and entered Phase 3 in ulcerative colitis. Protagonist also has rusfertide, a Takeda-partnered rare blood disorder drug with positive Phase 3 data, plus several preclinical oral immunology and metabolic programs.
Xoma (SF) Lowers Offer in Lava Therapeutics Acquisition After Pipeline Setbacks
Xoma cut its cash offer to $1.04 per share for Lava Therapeutics and reduced the required closing cash to $24.5M, with shareholders still eligible for milestone-based CVR payments. The adjustment follows Lava’s failed Phase 1 prostate cancer trial and workforce reductions, though partnered programs with J&J and Pfizer remain active.
Other Interesting News:
Iambic Therapeutics (SD) Reports Encouraging Early Human Data for AI-Designed HER2 Drug
Iambic shared first-in-human results for IAM1363, a HER2-targeting small molecule, showing tumor shrinkage in 28% of evaluable patients with HER2-related cancers. The AI-designed drug was well-tolerated with mostly mild side effects; next steps include dose optimization and further studies planned for 2026.
RAPT Therapeutics (SF) Reports Positive Phase 2 Data for Anti-Itch Antibody
Partner Shanghai Jeyou’s Phase 2 trial of RAPT’s anti-IgE antibody RPT904 showed stronger itch reduction than standard therapy Xolair, with no serious side effects. RAPT plans to discuss next steps with the FDA, while Jeyou moves toward Phase 3 trials in China and explores additional studies in food allergies and asthma.
Vivace Therapeutics (SF) Reports Strong Phase 1/2 Results in Mesothelioma, Plans Phase 3 Launch
Vivace’s small molecule VT3989 shrank tumors in 32% of patients with treatment-resistant mesothelioma and more than doubled median progression-free survival compared to standard chemotherapy. The drug, which targets the Hippo pathway to control tumor growth, showed a strong safety profile and will move into a Phase 3 trial in the first half of 2026.
Exelixis (SF) Reports Phase 3 Success for Oral Cancer Drug Zanzalintinib
Exelixis’ TKI zanzalintinib, combined with Roche’s Tecentriq, cut the risk of death by 20% in patients with advanced colorectal cancer versus Bayer’s Stivarga combo. The result marks the first TKI–immunotherapy combo to improve survival in this setting, with FDA submission planned this year and broader “franchise” ambitions beyond colorectal cancer.
Summit Therapeutics (SF) and Akeso Report Phase 3 Win for Ivonescimab in Lung Cancer
In China’s HARMONi-6 trial, ivonescimab plus chemo cut the risk of tumor progression or death by 40% versus another PD-1 combo, extending median progression-free survival to 11.1 months in first-line squamous NSCLC. The bispecific PD-1×VEGF antibody outperformed across all PD-L1 subgroups and showed a manageable safety profile, bolstering its potential as a new immunotherapy backbone ahead of Summit’s global studies.
Denali Therapeutics (SF) Faces FDA Decision Delay for Hunter Syndrome Drug
The FDA extended its review of Denali’s enzyme replacement therapy tividenofusp by three months to April 2026, after classifying updated pharmacology info as a “major amendment.” The delay stems from a technical correction to the drug’s molecular weight and isn’t expected to affect approval prospects for the therapy, which aims to treat Hunter syndrome by crossing the blood-brain barrier.
Trump Administration Announces IVF Drug Discount Deal and Broader Drug Pricing Push
President Trump unveiled an agreement with EMD Serono to cut IVF drug costs by 42–79%, with products launching in 2026 through the administration’s new TrumpRx platform; CVS Caremark and Express Scripts will also lower distribution fees. The White House is expanding its “most favored nation” pricing model to include fertility and GLP-1 weight-loss drugs, while the FDA’s new National Priority Voucher program will fast-track reviews (by up to 10 months) for affordable, U.S.-made medicines meeting major health needs.
CBO Nearly Doubles Cost of Orphan Drug Loophole Under Trump’s Tax Law
The Congressional Budget Office now estimates the 10-year cost of Trump’s orphan drug exemption at $8.8 billion, up from $4.9 billion, after finding it shields blockbuster drugs Keytruda, Opdivo, and Darzalex from Medicare price negotiations. Lawmakers criticized the provision as a “sweetheart deal” for pharma, while CBO noted uncertainty over whether subcutaneous vs. IV formulations will be treated separately could push total costs as high as $10.9 billion through 2034.
