- Thursday afternoon, the FDA announced holding an advisory committee meeting related to Sarepta Therapeutics Inc’s (NASDAQ:SRPT) SRP-9001 (delandistrogene moxeparvovec) marketing application.
- On the call, management highlighted that the decision was solely to discuss the surrogate endpoint and that there were no new outstanding issues and no new data or analyses that triggered the change in decision.
- William Blair writes that the fall in share price is an overreaction given that Ad Com was expected before the company updated its fourth-quarter call.
- Sarepta’s vector is clean, especially compared to competitors, which have all seen major safety issues, including signs of complement activation, writes William Blair’s analyst.
- Needham writes that the committee will focus on the relationship between micro-dystrophin expression and clinical benefit.
- The analyst expects potential approval positively but also acknowledges the increased risk that there will not be an accelerated approval of SRP-9001.
- The analyst reiterated the Buy Rating but lowered the price target to $160 from $200.
- Price Action: SRPT shares are down 17.80% at $123.05 on the last check Friday.
Setback Strikes Alabama’s Medical Cannabis Industry, Licenses On Hold Yet Again
The issuance of licenses for medical cannabis businesses in Alabama has been temporarily halted by a judge. Montgomery Circuit Judge James Anderson issued a temporary restraining order on Thursday, preventing the Alabama Medical Cannabis Commission (AMCC) from granting licenses for dispensaries. The order followed a legal battle brought by a group of medical cannabis operators against the AMCC. The operators accused the commission of procedural violations and failing to follow its own grading and ranking guidelines when awarding licenses. The AMCC had previously granted 20 licenses for the production and distribution of medical marijuana on 1 December, part of an attempt to establish a medical cannabis industry in the state. However, Anderson's ruling upheld a request by Yellowhammer Medical Dispensaries to halt issuance of licenses in the dispensary category.
