Science, Regulation And Access
Several forces are lining up in biotech’s favor: advances in the lab, a clearer proposed development path for individualized gene editing, and a push to get more cell and gene therapies paid for.
Karim Mikhail was selected in September to lead the FDA’s biologics division. On October 27th, the FDA proposed a framework allowing one approval application to cover multiple patient-specific gene-editing variants within defined design boundaries. CMS also plans to expand its access model for cell and gene therapies beyond sickle cell disease, using outcomes-based payment agreements with manufacturers.
The research tools are advancing too. Twist Bioscience launched an antibody screening service Wednesday designed to assess thousands of candidates a day, with turnaround starting at five days. That gives AI-assisted drug discovery more experimental capacity to test its ideas.
For the companies we follow, faster testing, clearer development pathways and broader access to payment can help move promising science toward commercial products. We’re looking for the milestones that can make that progress visible to investors.
The Record Behind Our Top Names
Our Top Names are the Portfolio Armor system’s highest-ranked stocks by estimated potential return, net of hedging cost. Across 174 completed weekly cohorts, they averaged a six-month unhedged return of 17.93%, versus 9.90% for SPY over the same periods. The full Top Names record shows every weekly cohort:
Glaukos, which develops drugs and devices for eye diseases, ranked 10th on our September 15th Top Names list. Its stock closed Thursday at $242.48, about 41% above the $171.68 selection-day close. Thursday’s nearly 34% jump followed quarterly sales growth of 58% and a higher full-year outlook:
Our full trade exits record tracks the outcomes of our closed trades.
Today’s Three Trade Plans
Today’s alert combines a new Top Names idea with two biotech retries from our Multibaggers research, which tracks outside analysts with multiple recent 100%+ winners. The retries retain the same structures, with entry limits set for Friday’s conditions.
Get today’s trade plans before we enter, with the exact orders and our follow-up as we manage the positions.
To see how we select, structure and manage our trades, start here:
Top Names
Commerce infrastructure
RSI: 55
Chartmill ratings: Technical: 9 · Setup: 8 · Fundamental: 7
