Recent Funding:
Tempero Bio (SF) Raises $70M to Advance Addiction Treatment Candidate
Tempero Bio secured $70M in Series B funding, led by 8VC, Aditum Bio, and Khosla Ventures, to support Phase 2 trials of TMP-301 for alcohol and cocaine use disorders, with results expected by late 2025 and mid-2026, respectively. TMP-301, a next-generation mGluR5 inhibitor, aims to regulate brain reward pathways to reduce cravings and heavy substance use, positioning Tempero as a leader in addiction treatment amid growing pharma interest.
Recent Layoffs:
Cargo Therapeutics (SF) Lays Off 90% of Workforce, Ends CAR-T R&D
Following disappointing Phase 2 results for its lead CAR-T therapy firi-cel, Cargo Therapeutics is cutting 90% of its workforce, shelving all R&D programs, and exploring strategic alternatives, including a reverse merger or business combination. The biotech, which had $368M in cash at the end of 2024, will discontinue further development of CRG-023 despite receiving regulatory clearance for clinical testing.
Vaxart (SF) Lays Off 10% of Workforce After Government Halts COVID-19 Vaccine Trial
The U.S. Department of Health and Human Services (HHS) unexpectedly ordered Vaxart to stop work on its Phase 2b trial of an oral COVID-19 vaccine, despite prior funding commitments of up to $456M from BARDA and NIAID. With no reason provided for the directive, Vaxart laid off 10% of its workforce while continuing follow-up activities for the 400-patient cohort in the study. The company awaits a final decision within 90 days.
M&A, Deals, Partnerships:
Dren Bio (SF) Secures $600M Sanofi Deal for Autoimmune Therapy
Sanofi is acquiring Dren Bio’s bispecific myeloid cell engager, DR-0201, for $600M upfront, with up to $1.3B in additional milestone payments. The therapy aims to “reset” the immune system by depleting disease-causing B cells and is currently in Phase 1 testing. This deal strengthens Sanofi’s autoimmune pipeline, aligning with a broader industry trend toward immune system reset therapies. Dren Bio will continue advancing its oncology programs in collaboration with Pfizer and Novartis.
FDA Approvals:
Novartis’ Fabhalta Gains FDA Approval for C3 Glomerulopathy
Fabhalta, the first drug approved for C3 glomerulopathy (C3G), demonstrated a 35% reduction in proteinuria at six months in a Phase 3 study, with sustained benefits at one year. This marks Fabhalta’s third FDA approval, following prior nods for paroxysmal nocturnal hemoglobinuria and IgA nephropathy, as Novartis continues expanding its kidney disease portfolio.
Alnylam’s (MA) Amvuttra Wins FDA Approval for ATTR Cardiomyopathy
Amvuttra, already approved for a nerve-related form of transthyretin amyloidosis (ATTR), is now cleared for ATTR cardiomyopathy, reducing the risk of recurrent cardiovascular events or death by 28% in trials. The approval strengthens Alnylam’s position in the growing ATTR treatment market, where it will compete with Pfizer’s tafamidis and BridgeBio’s Attruby, with projected annual drug sales in the space expected to reach $15B-$20B.
Other Interesting News:
NIH Funding Cuts Threaten Medical Research and Hiring at Academic Institutions
NIH plans to cap indirect research cost reimbursements at 15%, cutting approximately $4 billion in annual funding, prompting hiring freezes at Stanford, UC, and Harvard, and potential layoffs in New York’s 17 medical schools. Researchers warn of long-term disruptions to innovation, with halted projects, fewer PhD student slots, and concerns over a “brain drain” as talent may move overseas for better opportunities.
CDC Vaccine Advisory Meeting Rescheduled Amid Policy Shifts
The ACIP meeting, originally set for February, is now scheduled for April 15-16 after being delayed following Robert F. Kennedy Jr.’s appointment as health secretary. The agenda includes discussions on measles, COVID-19, HPV, monkeypox, and RSV vaccines, but flu shot guidelines were removed. The delay follows the abrupt cancellation of an FDA meeting on flu shot composition, and the CDC is reportedly planning a large study on vaccines and autism, despite established evidence disproving a connection.
