FINWIRES · TerminalLIVE
FINWIRES

Regeneron Says FDA Granted Accelerated Approval for Genetic Hearing Loss Therapy

By

Regeneron (REGN) said Thursday that the US Food and Drug Administration has granted accelerated approval for Otarmeni therapy indicated for the treatment of pediatric and adult patients with OTOF gene-related hearing loss.

FDA's approval was based on the ongoing Chord trial that showed 16 of 20 participants experienced hearing improvements per pure tone audiometry assessments, while 14 out of 20 demonstrated an auditory brainstem response, according to a statement.

Otarmeni's continued approval may be contingent upon verification and description of clinical benefit in the confirmatory portion of the Chord trial, Regeneron said.

The company said it will provide Otarmeni at no cost to clinically eligible individuals in the US.

Shares of the company were up 2% in Thursday trading.

Price: $761.47, Change: $+14.89, Percent Change: +1.99%

Related Articles

Wire

New Hope Completes AU$300 Million Convertible Notes Offering

New Hope (ASX:NHC) completed a AU$300 million issuance of 2.625% senior unsecured convertible notes due 2032 and the concurrent repurchase of AU$293.3 million of its existing 2029 convertible notes, according to a Thursday filing with the Australian bourse.The new notes are expected to be listed on the Singapore Exchange Securities Trading on or around Thursday, per the filing.The repurchased 2029 notes, which account for around 98% of the outstanding notes, will be cancelled under their terms, the filing said. The company also plans to redeem the remaining AU$6.7 million of notes at par plus accrued interest prior to maturity.

ASX:NHC
Wire

Telix Pharmaceuticals Settles Issue of $600 Million Convertible Notes

Telix Pharmaceuticals (ASX:TLX) said it settled the issue of $600 million in 1.50% convertible notes due 2031, according to a Thursday Australian bourse filing.The convertible notes are expected to be listed on the Official List of the Singapore Exchange Securities Trading on Thursday.In the same filing, the company said that the repurchase of around AU$637 million in principal of the AU$650 million worth of 2.375% convertible bonds due 2029 is "substantially complete."After the repurchase, given that less than 15% in aggregate principal amount of the existing bonds will remain outstanding, Telix said it plans to exercise its right to repurchase and cancel all of the remaining existing bonds at their principal amount.

ASX:TLX
Wire

Century Communities Q1 Adjusted Earnings, Revenue Fall

Century Communities (CCS) reported Q1 adjusted earnings late Wednesday of $0.88 per diluted share, down from $1.39 a year earlier.Three analysts polled by FactSet expected $0.59.Revenue for the three months ended March 31 fell to $789.7 million from $903.2 million a year earlier.Four analysts surveyed by FactSet expected $807.7 million.

$CCS