Needham & Company Weighs in on Brexit Biotech Impact (ACAD) (GILD0 (ICPT) (SGEN)

Needham & Company analyst Alan Carr highlighted Brexit impact on biotech companies they cover:

• Acadia (NASDAQ: ACAD) is in discussions with EMA around Pediatric Investigation Plan for Nuplazid, which has led to a delay in MAA submission. We assume an MAA will be submitted either late this year or in 2017.
• Celator (NASDAQ: CPXX) plans to submit an MAA for Vyxeos in 1Q17. As a reminder, Jazz recently announced plans to acquire Celator.
• Cempra (NASDAQ: CEMP) plans to submit an MAA for Solithera in Jun 2016.
• Gilead's (NASDAQ: GILD) Sofosbuvir/Velpatasvir (Epclusa) is currently under review by the MAA. A positive CHMP opinion was adopted in May 2016.
• Intercept's (NASDAQ: ICPT) Ocaliva is currently under review by the EMA and has guided for a review decision in 2H16.
• Lexicon's (NASDAQ: LXRX) collaborator Ipsen plans to submit an MAA for telotristat in mid-2016.
• Seattle Genetics (NASDAQ: SGEN) and collaborator Takeda announced in May 2016 that a positive CHMP opinion was adopted for Adcetris label expansion in post-transplant Hodgkin’s lymphoma.
• We expect Progenics (NASDAQ: PGNX) and collaborator Valeant (NYSE: VRX) to submit an MAA for oral Relistor sometime after their July PDUFA.

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