| Over a week ago | ||||
Citi lowered the… Citi lowered the firm's price target on Larimar Therapeutics to $4.50 from $7 and keeps a Neutral rating on the shares. The analyst updated the model post the Q1 results. | ||||
Guggenheim analyst Yatin… Guggenheim analyst Yatin Suneja raised the firm's price target on Larimar Therapeutics to $14 from $12 and keeps a Buy rating on the shares after the company reported top-line results from the 25mg cohort of the ongoing Phase II trial testing CTI-1601. The results show "a consistent drug profile and very promising biomarker data," the analyst tells investors. | ||||
JMP Securities made no… JMP Securities made no change to the firm's Outperform rating and $15 price target on Larimar Therapeutics. While the expected greenlight decision from the FDA did not occur, safety data for CTI-1601 do not appear to have any findings that would preclude Larimar from moving to higher dosing, the analyst tells investors in a research note, adding that it would be a buyer on the weakness in shares. | ||||
Larimar Therapeutics… Larimar Therapeutics announced preliminary top-line data from the 25 mg cohort of its Phase 2, four-week, placebo-controlled, dose exploration trial of CTI-1601 in participants with Friedreich's ataxia. Participants in the trial's 25 mg cohort were randomized to receive subcutaneous injections of 25 mg CTI-1601 or placebo daily for 14 days and then every-other-day thereafter until day 28. Data from the cohort indicate CTI-1601 was generally well tolerated and showed increases in frataxin levels from baseline compared to placebo in all evaluated tissues at day 14. In skin, a median placebo-adjusted increase from baseline of 3.5 pg/microgram in frataxin levels was observed on day 14. Of the seven CTI-1601-treated participants with quantifiable levels of frataxin in skin at both baseline and day 14, all seven had increases in skin frataxin concentrations, compared to none of the four placebo participants with quantifiable levels of frataxin in skin at both baseline and day 14. In buccal cells, a median placebo-adjusted increase from baseline of 0.9 pg/microgram in frataxin levels was observed on day 14. Of the seven CTI-1601-treated participants with quantifiable levels of frataxin in buccal cells at both baseline and day 14, five had increases in buccal cell frataxin concentrations, compared to neither of the two placebo participants with quantifiable levels of frataxin in buccal cells at both baseline and day 14. In a non-interventional study that used the same sampling technique and assay as Larimar's Phase 2 trial to measure frataxin levels in 60 homozygous healthy volunteers, median frataxin concentrations observed in skin and buccal cells were 16 pg/microgram and 8 pg/microgram, respectively. Larimar therefore estimates phenotypically healthy heterozygous carriers of the FA-causing gene to have median frataxin concentrations of approximately 8 pg/microgram and 4 pg/microgram in skin and buccal cells, respectively, based on published literature indicating heterozygous carriers have frataxin levels that are approximately 50% of those of homozygous healthy people. Larimar's Phase 2 data and non-interventional study results follow Phase 1 data that showed dose-dependent increases in frataxin levels in peripheral tissue with daily dosing of 50 and 100 mg of CTI-1601 for at least 7 days, and no detectable increase in FXN levels with daily dosing of 25 mg of CTI-1601 for only 4 days. Larimar has submitted the data from the trial's 25 mg cohort to FDA and has a meeting scheduled with the Agency for later this quarter to discuss the information needed to gain clearance to initiate a 50 mg cohort in the Phase 2 trial. | ||||
"Our preliminary… "Our preliminary Phase 2 data provide the first clinical indication that a 25 mg dose of CTI-1601 can increase frataxin levels in peripheral tissues, building upon our proof-of-concept Phase 1 results," said Carole Ben-Maimon, MD, President and Chief Executive Officer of Larimar. "Importantly, the frataxin increases achieved with a relatively low 25 mg dose in our Phase 2 trial suggest a continuous daily dosing regimen is preferred for maintaining increases achieved with 25 mg CTI-1601. I would like to thank all those who participated in our trials and look forward to our upcoming meeting with the FDA later this quarter." | ||||
| Over a month ago | ||||
Analyst Minter holds a… Analyst Minter holds a conference call with CEO Ben-Maimon and CFO Celano on March 20 at 11 am hosted by William Blair. Webcast Link | ||||
Analyst Minter holds a… Analyst Minter holds a conference call with CEO Ben-Maimon and CFO Celano on March 20 at 11 am hosted by William Blair. Webcast Link | ||||
Analyst Minter holds a… Analyst Minter holds a conference call with CEO Ben-Maimon and CFO Celano on March 20 at 11 am hosted by William Blair. Webcast Link | ||||
"Our recent progress… "Our recent progress provides a strong foundation for growth as we work to develop CTI-1601 as the first FA therapy designed to potentially address frataxin deficiency, which is the underlying cause of the disease," said Carole Ben-Maimon, MD, President and Chief Executive Officer of Larimar. "The first cohort of our Phase 2 trial is fully enrolled, with an update that will outline the next steps for the trial anticipated in the second quarter. We also recently strengthened our balance sheet and leadership team with a financing and the appointment of long-time Johnson & Johnson veteran Dr. Gopi Shankar as our Chief Development Officer. Looking forward, we believe these accomplishments, together with our Phase 1 proof-of-concept data, leave us well positioned to build on our positive momentum as we seek to improve the therapeutic paradigm for patients with FA, who remain in need of a therapy that may address the root cause of the disease by increasing frataxin levels." | ||||
| Over a quarter ago | ||||
Citi analyst Samantha… Citi analyst Samantha Semenkow initiated coverage of Larimar Therapeutics with a Neutral rating and $4 price target. The clinical-stage biotech is focused on developing CTI-1601 for the treatment of rare neuromuscular disorder Friedreich's Ataxia, or FA, Semenkow tells investors. While news of the FDA having recently removed a full clinical hold on CTI-1601 is "a positive for Larimar," she continues to have questions surrounding the ability to identify a dose that is both safe and efficacious, keeping her on the sidelines. | ||||
