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

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

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

November 23, 2015 6:55 AM EST

Baird analyst, Brian Skorney, published a note this morning highlighting his interpretation of the FDA Briefing Documents on BioMarin's (NASDAQ: BMRN) drisapersen filed Friday. He still believes that Sarepta (NASDAQ: SRPT) has only a 35% chance of getting approval for eteplirsen... More

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

November 20, 2015 10:12 AM EST

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)

November 20, 2015 9:50 AM EST

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

Data does not support nod for BioMarin's DMD drug: FDA staff

November 20, 2015 9:12 AM EST

By Vidya L Nathan

(Reuters) - Data on BioMarin Pharmaceutical Inc's experimental treatment for a muscle-wasting disease did not warrant an approval of the drug at this time, the U.S. Food and Drug Administration's health regulator's staff reviewers said.

BioMarin's shares, which have lost a quarter of their value in the past four months, were down about 5 percent at $98.26 on Friday. Sarepta Therapeutics Inc, which is developing a rival treatment, jumped 28 percent to $33.37.

The FDA staff reviewers said the drug, drisapersen, did not improve the production of a protein called dystrophin, the lack of which causes Duchenne's muscular... More

Sarepta Therapeutics (SRPT) Surges 25% Following BioMarin (BMRN) Briefing Docs

November 20, 2015 8:36 AM EST

Sarepta Therapeutics (NASDAQ: SRPT) is trading up 25% following BioMarin Pharma's (NASDAQ: BMRN) FDA briefing docs on Drisapersen for treatment of DMD. Meanwhile, BMRN is down 7%.

... More

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

November 20, 2015 7:59 AM EST

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

... More

BioMarin Pharma (BMRN) FDA briefing docs released

November 20, 2015 7:59 AM EST

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

Related stocks:

Sarepta Therapeutics (NASDAQ: SRPT)

... More

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

November 19, 2015 3:28 PM EST

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

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

November 19, 2015 8:18 AM EST

Baird analyst, Brian Skorney, increasing belief is that the FDA is more likely to reject the NDA's for drisapersen and eteplirsen. He thinks the risk-reward is mildly skewed to the upside for BioMarin Pharma (NASDAQ: BMRN) (20% up/10% down) and massively so for Sarepta Therapeutics (NASDAQ: SRPT) (250%... More

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

November 19, 2015 7:42 AM EST

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