Needham & Company Reiterates a 'Buy' on Regeneron Pharma (REGN); Priority, Shmyriority - 90 More Days to Prepare for Launch - Remain Positively Inclined
Tweet
Share
E-mailGet Alerts REGN Hot Sheet
Price: $803.48 -0.31%
Rating Summary:
29 Buy, 19 Hold, 0 Sell
Rating Trend: = Flat
Today's Overall Ratings:
Up: 13 | Down: 14 | New: 11
Rating Summary:
29 Buy, 19 Hold, 0 Sell
Rating Trend: = Flat
Today's Overall Ratings:
Up: 13 | Down: 14 | New: 11
Join SI Premium – FREE
Needham & Company reiterates a 'Buy' on Regeneron Pharma (NASDAQ: REGN) price target of $60.00.
Needham analyst says, "This morning, Regeneron hosted a conference call to discuss the extension by the FDA of the PDUFA date for the priority review of the EYLEA BLA for wet AMD from August 20 to November 18. This 90-day extension was triggered by the agency’s classification of the company’s recent response to questions regarding the CMC section as a major amendment to the BLA. According to the Company, the questions raised by the FDA are typical CMC questions. No additional work is needed from the Company at this time."
"We are positively inclined to the approval of EYLEA by the new November 18 PDUFA date. Given that the FDA did not issue a complete response letter (as we are proximal to the August 20 PDUFA date), we are inferring that there are no major issues with the CMC, but rather the situation reflects a typical administrative delay which is often associated with priority review applications."
For more ratings news on Regeneron Pharma click here and for the rating history of Regeneron Pharma click here.
Shares of Regeneron Pharma closed at $57.42 yesterday.
Needham analyst says, "This morning, Regeneron hosted a conference call to discuss the extension by the FDA of the PDUFA date for the priority review of the EYLEA BLA for wet AMD from August 20 to November 18. This 90-day extension was triggered by the agency’s classification of the company’s recent response to questions regarding the CMC section as a major amendment to the BLA. According to the Company, the questions raised by the FDA are typical CMC questions. No additional work is needed from the Company at this time."
"We are positively inclined to the approval of EYLEA by the new November 18 PDUFA date. Given that the FDA did not issue a complete response letter (as we are proximal to the August 20 PDUFA date), we are inferring that there are no major issues with the CMC, but rather the situation reflects a typical administrative delay which is often associated with priority review applications."
For more ratings news on Regeneron Pharma click here and for the rating history of Regeneron Pharma click here.
Shares of Regeneron Pharma closed at $57.42 yesterday.
Serious News for Serious Traders! Try StreetInsider.com Premium Free!
You May Also Be Interested In
- Regeneron Pharma (REGN) PT Raised to $756 at Bernstein SocGen Group
- Nu Holdings (Nubank) (NU) PT Raised to $19 at Needham
- NANO Nuclear Announces Participation in Several Investor Conferences
Create E-mail Alert Related Categories
Analyst CommentsRelated Entities
Needham & CompanySign up for StreetInsider Free!
Receive full access to all new and archived articles, unlimited portfolio tracking, e-mail alerts, custom newswires and RSS feeds - and more!
