BioMarin (BMRN) FDA Panel a 'Drisaster' - Oppenheimer

Oppenheimer analyst Christopher Marai weighed in on BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) following the FDA advisory panel, calling it a "Drisaster!" The panel, he said, puts accelerated approval at risk and DMD strategy in question.

Marai commented, "We attended the FDA advisory meeting for Kyndrisa yesterday. The panel was ultimately a disaster, dominated by a difficult discussion on sub-standard statistics and failed trial results that repeatedly resurfaced during the panel discussions among what appeared to be confused panel members. BMRN and key opinion leader discussion focused primarily on basic trial data, not discussion more relevant to DMD subset-analysis, patient heterogeneity or clinical outcome measures as we anticipated. Dr. McDonald and Dr. Goemans made note of surprising clinical benefit observed in their practices; however, this positive commentary was drowned out by questioning of discordant data sets across trials. Furthermore, public commentary was mixed. Positive patient outcomes were encouraging, but some highlighted switching from drisapersen to SRPT's eteplirsen due to AE's."

The firm maintained a Perform rating and price target of $115.

For an analyst ratings summary and ratings history on BioMarin Pharmaceutical Inc. click here. For more ratings news on BioMarin Pharmaceutical Inc. click here.

Shares of BioMarin Pharmaceutical Inc. closed at $97.80 yesterday.

You May Also Be Interested In

• UBS Reiterates Buy Rating on BioMarin Pharmaceutical Inc. (BMRN)
• Roth/MKM Upgrades Albertsons Companies Inc. (ACI) to Buy, 'Fundamental Floor and Improved Deal Likelihood'
• MetroCity Bankshares Inc. (MCBS) PT Raised to $28 at Keefe, Bruyette & Woods