Alcyone Therapeutics Announces Continued Enrollment Approval From FDA Of The PIERRE Pivotal IDE Clinical Study Of The ThecaFlex DRx System For Administration Of Nusinersen
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Alcyone Therapeutics has received FDA approval to continue enrollment in the PIERRE pivotal IDE clinical study of the ThecaFlex DRx System for administering nusinersen to SMA patients. The first stage of the trial showed no device-related adverse events, and the study will now expand to include 80 additional patients across 30 centers.
July 31, 2024 | 1:08 pm
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POSITIVE IMPACT
Biogen Inc. (BIIB), the company behind SPINRAZA® (nusinersen), may see positive short-term impact due to the FDA's approval for continued enrollment in the PIERRE study, which could enhance the delivery method of their drug.
The FDA's approval to continue the PIERRE study could improve the delivery method of SPINRAZA®, potentially increasing its adoption and sales, benefiting Biogen.
CONFIDENCE 90
IMPORTANCE 70
RELEVANCE 80
POSITIVE IMPACT
Ionis Pharmaceuticals Inc. (IONS), which developed nusinersen, may experience a positive short-term impact from the FDA's approval of the PIERRE study, as it could lead to increased usage of their drug.
The FDA's approval to continue the PIERRE study could lead to improved delivery of nusinersen, potentially increasing its usage and benefiting Ionis Pharmaceuticals.
CONFIDENCE 85
IMPORTANCE 60
RELEVANCE 70