FDA Briefing Docs Offer Positives and Negatives for Sarepta (SRPT) - Baird

Why BioMarin FDA Panel is Positive for Sarepta (SRPT) - Oppenheimer

On Nov. 24, the FDA held an Advisory Committee panel for BioMarin's (NASDAQ: BMRN) Kyndrisa a potential competitor to eteplirsen. The panel highlighted Kyndrisa's significant liabilities and the panel focus included safety concerns then difficult-to-interpret efficacy data.

Why is this a positive for Sarepta... More

Sarepta Therapeutics (SRPT) on Watch as BioMarin's (BMRN) Kyndrisa Adcom Set to Kickoff

Sarepta Therapeutics (NASDAQ: SRPT) was on watch Tuesday morning ahead of competitor BioMarin's (Nasdaq: BMRN) Kyndrisa FDA committee review. The advisory meeting runs from 8:00 a.m. to 5:30 p.m. EST.

BioMarin (BMRN) PT Cut to $100 at Baird; Sees Drisapersen Approval 'Near-Zero'

Baird analyst Brian Skorney reiterated a Neutral rating and lowered his price target on BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) to $100.00 (from $147.00) following Friday's drisapersen FDA riefing documents.

"The documents are in, and they aren't good," Skorney comments. "This comes as no surprise... More

BioMarin (BMRN) PT Trimmed at Wedbush Following Briefing Docs; Sees Positive Read-Thru to SRPT, None to PTCT

Wedbush analyst Heather Behanna lowered her price target on BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) to $125.00 (from $137.00) following today's FDA briefing documents. The firm maintained a Neutral rating.

Behanna said the briefing docs for drisapersen efficacy were in line with their expectation. Meanwhile, the FDA has unleashed its view point on BioMarin's drisapersen for DMD including the focus on potential unblinding of studies due to injection site reactions. "Things that were new to us include analysis that boys in the 6 mg/kg continuous arm of the one successful 24-week Phase II study may have... More

Concerns on Drisapersen Positive for Sarepta's (SRPT) Eteplirsen - Needham & Company

Needham & Company analyst Chad Messer said FDA concerns on BioMarin's drisapersen should be a positive for Sarepta Therapeutic (NASDAQ: SRPT) Eteplirse. The firm reiterated a Buy rating and price target of $55.

Messer commented, "The FDA released briefing documents for BioMarin's drisapersen this... More

BioMarin (BMRN) Has Good Risk/Reward Despite Cautious FDA Briefing Documents for Drisapersen, Says RBC

BioMarin Pharmaceutical's (NASDAQ: BMRN) long-term positive thesis remains unchanged, said RBC Capital analyst Michael J. Yee. Comments follow the release of FDA advisory committee briefing documents for drisapersen, which were said to have a "cautious tone." While documents appear cautious, Yee thinks approval is possible and risk/reward is good.

"Notably, unlike most panels, the FDA does not specifically ask this panel to vote on the potential approval of the drug so for investors today it's not clear we'll get a great "answer" to satisfy any confidence on the approval debate by... More

BioMarin Pharma (BMRN) Briefing Docs 'Ugly' - Baird (SRPT)

Baird analyst Brian Skorney weighed in on BioMarin Pharma (NASDAQ: BMRN) after today's Drisapersen briefing docs, calling them "ugly"

Skorney commented, "The FDA isn't even offering voting questions to the panelist and the review on risk benefit states: The benefit of drisapersen in exon... More

FDA Posts Breifing Docs for BioMarin Pharma's (BMRN) Drisapersen

BioMarin Pharma (NASDAQ: BMRN) posted briefing documents for its advisory committee meeting on Drisapersen for treatment of DMD.

BioMarin Pharma (BMRN) FDA briefing docs released

BioMarin Pharma (NASDAQ: BMRN) FDA briefing docs released. LINK

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