Baird Expects FDA Rejection for Drisapersen and Eteplirsen (BMRN) (SRPT)

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

Despite Harsh BioMarin (BMRN) Briefing Docs, the Jury is Still Out - Leerink Partners

Leerink Partners analyst Joseph Schwartz weighed in on BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) following today's FDA briefing docs, noting they were even more harsh then expected. That said, the analyst said the jury is still out.

Schwartz commented, "FDA briefing documents for... 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

BioMarin Pharma (BMRN) FDA briefing docs released

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

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Sarepta Therapeutics (NASDAQ: SRPT)

Buy Sarepta (SRPT) Into Kyndrisa Briefing Documents and Panel Outcome - Oppenheimer

Oppenheimer analyst Christopher Marai said they would be buyers of Sarepta Therapeutic (NASDAQ: SRPT) into Kyndrisa briefing documents and panel outcome. The firm reiterated an Outperform rating and price target of $45.

"Tomorrow morning, the FDA will make available briefing documents (here) pertaining to the... More

Jefferies Survey Suggests Positive Expectations for BioMarin (BMRN) Ahead of Data on 11/24

In a turn of events, Jefferies analyst, Gena Wang, surveyed 58 investors to find out expectations for upcoming therapy results and found the buy-sides expectations of 62/28/10% probability for positive/mixed/negative outcomes for BioMarin Pharma's (NASDAQ: BMRN) Kyndrisa (drisapersen). The results are expected... More

Sarepta Therapeutics (SRPT) Issues Publication of Positive Eteplirsen Phase 2b Long-Term Data in DMD

Sarepta Therapeutics (Nasdaq: SRPT) announced that the Annals of Neurology published online [link to final article] positive efficacy and safety results from a Phase IIb long-term open-label extension study of eteplirsen in patients with Duchenne muscular dystrophy (DMD) amenable to exon 51 skipping. The study found that at three years of treatment, patients experienced a slower rate of disease progression when compared to untreated matched historical controls and the investigational drug continued to be well-tolerated.

This analysis used historical data from the Italian Telethon Network and the Leuven Neuromuscular Reference Group for comparative... More