12:00 AM
Jun 02, 2014
 |  BioCentury  |  Finance

Highlights of weekly biotech stock moves

Regulatory, clinical and other milestones
Regulatory milestones

Acura Pharmaceuticals Inc. (NASDAQ:ACUR) lost $0.17 (14%) to $1.06 last week after saying FDA advised the company that data from the Phase II Study 301 are "insufficient to support an intranasal abuse deterrence claim" for Acura's Vycavert, an oral, immediate-release formulation of hydrocodone with acetaminophen that uses the company's Aversion abuse-deterrent technology.

Acura previously said it expected to submit an NDA to FDA for the product this half. The company said it will determine a revised timeline following a meeting with FDA. At least one analyst downgraded the stock (see "Analyst Picks" A15).

The contingent value right for Genzyme Corp. was up $0.05 to $0.52 on Friday after Genzyme said FDA accepted for review a resubmitted sBLA for Lemtrada alemtuzumab to treat relapsing multiple sclerosis (MS). Genzyme said it expects a decision in 4Q14; the specific PDUFA date is not disclosed.

Genzyme said the resubmitted sBLA includes "supplemental analyses and additional information" to address FDA's issues from a December complete response letter.

Sanofi (Euronext:SAN; NYSE:SNY) acquired Genzyme in 2011 for $74 per share, or about $20.1 billion, plus a CVR worth up to $14. Sanofi missed the first $2 in milestones under the CVR; the remaining $12 is tied to Lemtrada sales thresholds.

The CVR, which trades on NASDAQ under the ticker symbol GCVRZ, was up $0.02 on the week.

InterMune Inc. (NASDAQ:ITMN) was off $0.36 to $39.62 last week after resubmitting an NDA to FDA for pirfenidone to...

Read the full 1209 word article

User Sign in

Trial Subscription

Get a 4-week free trial subscription to BioCentury

Article Purchase

$150 USD
More Info >