NVIV +13% on announcement that two spinal cord injury patients in the INSPIRE study who received its Neuro-Spinal Scaffold have improved from sensory incomplete AIS B status to motor incomplete AIS C, the second and third patients to reach this level.
GBT +9% on announcement that the European Medicines Agency determined that lead product candidate GBT440 is eligible for its Priority Medicines program.
Sinovac Biotech (NASDAQ:SVA) says it will be unable to file its 2016 20-F by end of the extension period allowed under Nasdaq's late filing rules. The delay is due to additional time required for the Board's Audit Committee to complete its internal investigation into allegations raised in a report published by Geoinvesting.
On May 10, it received written notice from Nasdaq that it was no longer in compliance with listing requirements. The company has 60 days to submit a plan to address the deficiency.
In a statement, Sinovac Biotech (NASDAQ:SVA) says its Audit Committee has authorized the start of an internal investigation into possible criminal behavior by its CEO related to alleged bribes paid to a Chinese regulatory official to enhance the review process for its vaccines.
Sinovac Biotech: Court Documents Show CEO Bribed Chinese FDA, Buyout Offers Could Be In Jeopardy, penned by long-time Contributor GeoInvesting, cites Chinese court documents that appear to confirm that Chairman and CEO Yin Weidong funneled brides to Chinese Food and Drug Administration (CFDA) Deputy Director General Yin Hongzhang through Mr. Hongzhang's wife. Mr. Hongzhang was removed from his position in June 2015 on the heels of a government investigation that sent his wife, Guo, to prison for three years for accepting bribes totaling over 1.5M RMB from a number of vaccine makers. Details about the investigation only became available recently.
GeoInvesting says the pending go-private offers of $6.18 and $7.00 are at risk due to possible violations of the U.S. Foreign Corrupt Practices Act and Mr. Weidong's potential criminal prosecution.
According to the company, the decline in sales was due to the suspension of vaccine deliveries to the private-pay market pending the interpretation of new regulations by the Chinese Food and Drug Administration (CFDA). The Ministry of Health and CFDA issued a joint statement in mid-June clarifying the new requirements. Vaccine sales to private payers have since resumed.
The FDA approves Holly Springs, NC-based Seqirus' FLUCELVAX QUADRIVALENT, the firs four-strain, cell culture-derived, inactivated seasonal influenza vaccine for people at least four year old. The vaccine helps protect individuals against two influenza A and two B viruses for the current flu season.
The traditional flu vaccine is trivalent, consisting of two influenza A viruses and one influenza B strain, although Sanofi's (NYSE:SNY) quadrivalent flu vaccine was approved by the FDA in December 2014 for use in adults.
Each year, about 200K Americans are hospitalized due to flu complications.
Seqirus was created in July 2015 when bioCSL and Novartis' (NYSE:NVS) influenza vaccines business combined, creating the second largest influenza vaccine company in the world. Novartis sold the business to Australian blood products firm CSL Ltd. in October 2014 for $275M.
Related tickers: (NYSE:GSK)(NASDAQ:NVAX)(NASDAQ:SVA)(NYSEMKT:HEB)
Sinovac (NASDAQ:SVA) received a preliminary non-binding proposal yesterday from a group of Chinese investors who seek to acquire the company for $7 per share in cash. The competing bid follows one received on January 30 from an investor group led by Chairman, President & CEO Weidong Yin for $6.18 per share.
A special committee of the firm's independent directors will evaluate the offers.