Larimar Therapeutics Inc
For the period ended Jun 30, 2024. Filed Aug 8, 2024.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Jun 30, 2024 · Filed Aug 8, 2024
What changed in Risk Factors?
Read the current filingPrevious report: 10-Q
Period ended 2024-03-31; filed 2024-05-09.
0000950170-24-056965
Item 1A. Risk FactorsUnregistered Sales of Equity Securities and Use of ProceedsDefaults Upon Senior SecuritiesMine Safety DisclosuresCurrent report: 10-Q
Period ended 2024-06-30; filed 2024-08-08.
0000950170-24-093733
Item 1A. Risk FactorsUnregistered Sales of Equity Securities and Use of ProceedsDefaults Upon Senior SecuritiesMine Safety DisclosuresThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 8 previous paragraphs and 10 current paragraphs.
8 unchanged; 0 reworded; 2 added; 0 removed; 0 previous and 0 current paragraphs rearranged.
Tables are not compared: 0 previous and 0 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (2)
Current report
We have been selected for participation in the START Pilot Program, however this may not lead to a faster development or regulatory review or approval process and does not increase the likelihood that we will receive marketing approval.
Current report
In May 2024, we announced that the FDA’s CDER had selected nomlabofusp as one of a few programs for participation in the START Pilot Program. The objective of the START Pilot Program is to accelerate the development of drugs for rare diseases that lead to significant disability or death by facilitating frequent advice and regular communication with the FDA staff to expedite the review process for biologics and drugs. As a pilot program, this expanded communication process will test if reducing wait times associated with the formal FDA meeting process accelerates the pace of development for products intended to address unmet medical needs. Because the START Pilot Program is newly launched by the FDA, its potential advantages are uncertain. While we anticipate that participation in this START Pilot Program may assist us in completing our BLA submission and approval timelines, there can be no assurance that the START Pilot Program will accelerate our development timelines or likelihood of approval for nomlabofusp. In addition, the FDA could withdraw our selection for participation in the START Pilot Program at any time.