Non-disclosure sees Ardelyx go down to the wire

Ardelyx’s lead project, tenapanor, got a highly damaging slapdown from the FDA last week, but the company sat on this information for as long as it possibly could before telling investors, it has emerged. According to an after-market statement yesterday the US regulator had on 13 July informed Ardelyx that tenapanor’s filing, for controlling serum phosphorus in chronic kidney disease, could not be reviewed owing to deficiencies relating to the treatment’s effect size and clinical relevance. The group did not issue an immediate market statement, but instead sought a meeting with the FDA, a request that was denied. US SEC rules state that most “significant events relevant to shareholders” must be disclosed via an 8-K filing within four business days, unless sudden stock movement suggests that the news has leaked out. Therefore, assuming that the initial FDA letter had come after hours on 13 July, Ardelyx did nothing technically wrong, merely waiting until the latest moment possible before disclosing. Investors are unlikely to be very pleased about this, however. Tenapanor has an odd history, and there is little doubt as to whether the deficiencies in its filing constitute a material event: Ardelyx stock crashed 70% this morning.

Rollercoaster: selected highlights from Ardelyx's development of tenapanor
3 Jun 2015 Astrazeneca hands back rights after two failures in chronic kidney conditions
12 May 2017 First ph3 IBS-C trial (T3MPO-1) raises concerns
11 Oct 2017 Second ph3 IBS-C trial (T3MPO-2) succeeds
12 Sep 2019 Tenapanor secures US approval for IBS-C, as Ibsrela
1 Mar 2021 Ibsrela is launched in Canada by Knight Therapeutics; apparently no commericial US launch yet
29 Apr 2021 US action date for controlling serum phosphorus in CKD is extended by 3mth after request for more info on mechanism of action
13 Jul 2021 FDA informs Ardelyx of deficiencies in phosphorus/CKD filing relating to effect size & clinical relevance
19 Jul 2021 Ardelyx informs the markets about 13 Jul FDA letter, saying this did not reflect a final decision
Source: company statements.

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