- The FDA has instituted a clinical hold on Larimar Therapeutics Inc’s (NASDAQ: LRMR) CTI-1601 clinical program as a treatment for Friedreich’s Ataxia (FA), a neurodegenerative movement disorder.
- The clinical hold follows the previous notification by Larimar to the FDA of mortalities that occurred at the highest dose levels in an ongoing 180-day non-human primate toxicology study, which is designed to support extended dosing of patients with CTI-1601.
- The clinical hold letter cited that the agency would need a full study report from the ongoing NHP study.
- Larimar will not initiate additional clinical trials until the submission of the report and receiving a go-ahead from the agency for the additional trials.
- Due to the additional regulatory requirements, the company expects to initiate Jive and pediatric multiple ascending dose trials in 2022
- Recently announced data from these trials indicate that repeated subcutaneous administration of CTI-1601 resulted in dose-dependent increases in frataxin (FXN) levels from baseline compared to placebo controls.
- The company also terminated the previously announced private placement financing of $95 million.
- As of March 31, the company has $81.4 million in cash and investments, which provides cash runway through the first half of 2022.
- Price Action: LRMR shares are 37.8% at $8.41 during the premarket session on the last check Wednesday.
- Related content: Benzinga’s Full FDA Calendar
Twilio Is Nearing A Key Support Level: What’s Next?
Twilio Inc. (NYSE: TWLO) shares gapped down Thursday after EPS guidance came in below estimates. The company issued second-quarter adjusted EPS guidance of $(0.16) to $(0.13), versus the $(0.05) estimate.
