Sanofi ouster opens can of worms
Sanofi (Euronext:SAN; NYSE:SNY) shares touched a 52-week low of $44.50 in New York on Wednesday before its ADSs closed down $2.85 (6%) to $45.22, on the news that Christopher Viehbacher had been removed as CEO, a move that leaves several loose ends affecting the industry.
FDA approves Pfizer's meningitis B vaccine
FDA granted accelerated approval for Trumenba from Pfizer Inc. (NYSE:PFE) to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroup B in individuals aged 10-25. The bivalent meningococcal B vaccine targeting LP2086 (factor H binding protein) had breakthrough therapy and Priority Review designations, and was approved ahead of its Feb. 14 PDUFA date.
Xencor revises XmAb5871 deal with Amgen
Xencor Inc. (NASDAQ:XNCR) renegotiated its deal with Amgen Inc. (NASDAQ:AMGN) related to autoimmune candidate XmAb5871. Xencor terminated the companies' original deal in which the bellwether had an option to license exclusive, worldwide rights to XmAb5871 upon completion of a Phase II trial to treat rheumatoid arthritis (RA).
Regulus raises $75M in follow-on
Regulus Therapeutics Inc. (NASDAQ:RGLS) wasted little time cashing in on a recent stock surge, as the microRNA company raised $75 million through the sale of 4.4 million shares at $17 in a follow-on underwritten by Deutsche Bank; BMO; Needham; Wedbush; and FBR.
Vanda raises $58M in follow-on
Vanda Pharmaceuticals Inc. (NASDAQ:VNDA) raised $58 million through the sale of 5 million shares at $11.60 in a follow-on underwritten by Jefferies; Piper Jaffray; JMP Securities; and Canaccord. The neurology company proposed the offering on Tuesday, when its share price was $12.03.
Chimerix planning $105M follow-on
Chimerix Inc. (NASDAQ:CMRX) said it plans to raise about $105 million in a follow-on underwritten by Morgan Stanley; JP Morgan; Cowen; Piper Jaffray; and Stifel, Nicolaus.
Synergy raises $175M in note deal
Synergy Pharmaceuticals Inc. (NASDAQ:SGYP) raised $175 million through the sale of senior unsecured convertible notes. The notes bear 7.5% interest, mature in 2019 and initially convert at $3.11.
POLITICS & POLICY
Rep. McCaul outlines compassionate access bill
Rep. Michael McCaul (R-Texas) plans to introduce compassionate access legislation that would impose new requirements on drug developers and establish rights for patients. McCaul summarized the legislation and his reasons for introducing it in a white paper submitted to the House Energy & Commerce Committee's 21st Century Cures initiative.
EMA could allow extrapolation for biosimilars
EMA's final guidance outlining general principles for developing biosimilars in the EU suggests that regulators may allow extrapolation of evidence of biosimilarity from one indication to others. The detail is among a handful of changes from draft guidance issued in May 2013 (see BioCentury Extra, May 2, 2013).
Senators seek to incentivize Ebola research
Sens. Tom Harkin (D-Iowa) and Lamar Alexander (R-Tenn.) plan to introduce a bill that would add Ebola to the list of eligible diseases under FDA's Priority Review voucher program for tropical diseases.