By the time you read this blog whether or not Robert F. Kennedy, Jr. will have been confirmed, or not, for the cabinet role overseeing the Department of Health and Human Services (HHS) will have been resolved. The uncertainty of his approach to how drugs and vaccines will be regulated is one of the biggest trends to watch in 2025. But there are other things happening in the Biopharma industry in 2025 beyond D.C.
Wall Street
A much-anticipated upswing in initial public offerings for biotech companies hasn’t materialized yet in 2025, but a Deloitte Center for Health Solutions study reported that 75% of C-suite executives in U.S., Europe and Asia biopharma predict a comeback for VC funding, M&A and IPOS. The Federal Reserve prime interest rate cut of .5% in September of 2024 should, as it has in the past, correlate with increased deal activity Sixteen companies went public on U.S. exchanges in the first three quarters of 2024 raising a combined $3 billion surpassing the $2.7 billon raised by 13 IP0s in all of 2023.
Gene Editing
Fyodor Urnov of the Innovative Genomics Institute wrote in a guest editorial in THE CRISPR Journal that far more revenue is expected to be generated from CRIPSR therapies through more treatments reaching the patients who need them. He urged drug developers to move beyond clinical programs that study just a single mutation in a given disease gene and asked for regulators to reform their reviews so that multiple guide RNAs could be considered within a single investigational new drug application.
Beam Therapeutics experimental sickle cell disease therapy, one of the most exciting trends to watch in 2025, is advancing in clinical trials. It is similar to an approved drug, Casgevy, but uses gene editing for DNA modification to hit its goal of offering a lasting benefit to patients with a single injection. Beam is also working on editing genes directly in the body therapeutically, specifically targeting a mutation that causes a genetic disease that damages the lungs and liver. Verve Therapeutics is using CRISPR gene editing to switch off genes associated with high cholesterol and preventing heart attacks for life with a single drug infusion.
Psychedelic Drugs
Confirmation of Kennedy as head of HHS could positively impact psychedelic drug research. He has pledged to encourage this research and stocks rose in the public companies doing this research after Kennedy was announced as the cabinet choice for HHS in the new administration. CBD, a component of weed and hemp, has already been approved by the FDA for treating seizures. Current clinical trials are pursuing potential therapeutic effects of CBD on severe psychiatric disorders like psychosis and schizophrenia-one of the trends to watch in 2025.
Weight Loss Juggernaut
The huge success of weight loss drugs is expanding to other areas of health. Eli Lilly’s drug Trulicity has already been proven to be effective at aiding cardiovascular health. Their other weight loss drug, Mounjaro, that it sells for diabetes, is also expected to be proven to help heart health. Incretins, Lilly’s tirzepatide and Novo Nordisk’s semaglutide (Wegovy), might even play a role in treating Alzheimer’s. Novo is conducting a clinical trial to show semaglutide can help slow the cognitive decline of Alzheimer’s.
Cancer Vaccines
Nicolas Poirier, CEO of OSE Immunotherapeutics says, “For cancer vaccines, there were decades of failure, but now we have seen new really intriguing data from Moderna and BioNTech in non-randomized trials, really promising. Others have generated really interesting data, and we are generating survival data in our randomized trial.” Leading developers of cancer vaccines, Moderna and Merck, launched their third Phase III trial for individualized neoantigen therapy. Lutetium-177, a radioisotope produced by NRG that is in multiple clinical trials as a cancer vaccine.
If the changes to the biopharma industry continue as dramatically as the appointment of Kennedy to head HHS, it could be a rocky year for the industry. If policies settle down, trends to watch in 2025 for the biopharma industry should become clearer.
