Deep research.
An ephemeris maps positions and motion through time. Ephemeris maps the connections between evidence, arguments, and decisions across institutional records: FDA and SEC.
Companies after an FDA Complete Response Letter · 10
Nasdaq: ACHV · FDA letter Jun 20, 2026
Achieve Life Sciences
cytisinicline
- How does the company's 8-K compare with the FDA's letter?
- What has Achieve said about its manufacturer and resubmission timing?
- Why did the FDA reject cytisinicline?
- What remains unresolved?
36 findings · 4 source documents Open →
Nasdaq: REPL · FDA letters Jul 21, 2025 · Apr 10, 2026
Replimune
RP1 (vusolimogene oderparepvec)
- How did the RP1 efficacy estimate change through the FDA review?
- How did Replimune's 8-K characterize the FDA's concerns?
- What changed between the first and second FDA CRLs?
- Why did the FDA ultimately approve RP1?
- What remains unresolved in the clinical evidence?
45 findings · 6 source documents Open →
Nasdaq: ALDX · FDA letters Apr 2, 2025 · Mar 16, 2026
Aldeyra Therapeutics
Reproxalap ophthalmic solution
- How does the company's 8-K compare with the FDA's 2025 letter?
- What changed between the two letters?
- Why did the FDA reject reproxalap?
- What remains unresolved?
28 findings · 9 source documents Open →
Nasdaq: IRON · FDA letter Feb 13, 2026
Disc Medicine
Bitopertin (erythropoietic protoporphyria)
- How does the company's 8-K compare with the FDA's letter?
- What does the FDA need from APOLLO, and what did the earlier trials show?
- Why did the FDA reject bitopertin?
- What remains unresolved?
35 findings · 7 source documents Open →
Nasdaq: RGNX · FDA letter Feb 7, 2026
REGENXBIO
RGX-121 (clemidsogene lanparvovec)
- How does the company's 8-K compare with the FDA's letter?
- What did the company disclose about the brain tumor case?
- Why did the FDA reject RGX-121?
- What remains unresolved?
34 findings · 5 source documents Open →
Nasdaq: CORT · FDA letter Jan 28, 2026
Corcept Therapeutics
Relacorilant (hypercortisolism)
- How does the company's 8-K compare with the FDA's letter?
- What did the FDA tell Corcept before the decision?
- Why did the FDA reject relacorilant?
- What remains unresolved?
37 findings · 5 source documents Open →
NYSE: BHVN · FDA letter Nov 4, 2025
Biohaven
troriluzole (VYGLXIA)
- How does the company's 8-K compare with the FDA's letter?
- What does Biohaven's 10-K say about Study 206-RWE, beside the FDA's findings?
- Why did the FDA reject troriluzole?
- What remains unresolved?
42 findings · 5 source documents Open →
Nasdaq: SRRK · FDA letter Sep 22, 2025
Scholar Rock
apitegromab (ISEMBYLD)
- How does the company's 8-K compare with the FDA's letter?
- What happened at the fill-finish facility after the letter?
- Why did the FDA reject apitegromab?
- What remains unresolved?
34 findings · 11 source documents Open →
Nasdaq: CAPR · FDA letter Jul 9, 2025
Capricor Therapeutics
Deramiocel (CAP-1002)
- How does the company's 8-K compare with the FDA's letter?
- What do Capricor's filings say about the letter and its publication?
- Why did the FDA reject deramiocel?
- What remains unresolved?
39 findings · 11 source documents Open →
Nasdaq: RARE · FDA letter Jul 7, 2025
Ultragenyx
UX111 (rebisufligene etisparvovec)
- How does the company's 8-K compare with the FDA's letter?
- What did the company say about resubmission timing and the priority review voucher?
- Why did the FDA reject UX111?
- What happened next?
33 findings · 8 source documents Open →
Concept preview. Each company's answers were prepared from public FDA letters and SEC filings; every quoted passage and every “not in” search is checked against the original before it is shown. Not investment advice. EphemerisX Pro →