Stockwatch: Dynavax, CoLucid Investors Should Beware The Standard Of Care

 
• By Andy Smith
  
Generate a summary of this article
Listen to this article
Beta

Dynavax and CoLucid benefited from share price surges last week. But were investors throwing caution to the wind and overlooking the challenges and lessons presented by standard of care therapies? Meanwhile, bluebird bio’s stock soared again.

Dynavax Technologies Corp. saw its stock price climb by about 9% last week, against a drop in the NASDAQ Biotech Index of just just under 1%. In the last gasp of trading that preceded the Labor Day weekend, Dynavax’s announcement of the cancellation of its FDA Advisory Committee meeting for the HEPLISAV-B (recombinant hepatitis B vaccine) BLA had been described by the analysts from Cowen as "rather cryptic" and greeted with about a 30% stock price drop. (Also see "Heplisav-B Review Still On Track Even After Cancelled Advisory Cmte., Dynavax Says" - Pink Sheet, 6 September, 2016.)

However, subsequent support from investment bank analysts and the company’s clarification that it still expected the vaccine’s December PDUFA date...

Scrip Podcast

Keep up with the top pharma business news of the week. On the go.

Scrip brings you a weekly bulletin of top picks.

SpotifyApple PodcastsWebsite

More from Legal & IP

Scrip-Business (Free-1): Top-Selling Drugs 2024: Keytruda, Ozempic And Dupixent Dominate

 
• By Nabil

Merck’s immuno-oncology blockbuster was the world’s best-selling drugs by revenues for the second year in a row, with an almost $12bn lead over its closest rival, Novo Nordisk’s GLP-1 drug Ozempic.

MSN Put On Hold As DC Appeals Court Freezes Generic Entresto Approval

 
• By Dean Rudge

MSN Laboratories will be unable to move forward – for now – with any potential ‘at-risk’ launch for its generic version of Novartis’ Entresto blockbuster in the US after the originator won a stay on the firm’s ANDA pending appeal from the US Court of Appeals for the District of Columbia Circuit.

Investors Hit The Alarm Bells As Indivior Issues Profit Warning

 
• By Kevin Grogan

The UK group remains confident that the scale of the US opioid epidemic, driven by misuse of fentanyl, still represents a considerable opportunity but investors have reacted nervously to lower revenues coming from Sublocade.

SCOTUS' Mifepristone Decision Sets High Bar For US FDA Suits

 
• By Sarah Karlin-Smith

The unanimous decision that the Alliance for Hippocratic Medicine lacks standing to challenge the FDA’s relaxation of the abortion pill REMS leaves unclear whether the court would have deferred to the agency’s expertise on the merits. 

More from Business

How A New Healthcare Dialogue Is Driving Market Access In Mexico

Companies stand a better chance of securing public reimbursement in Mexico for innovative medicines if they understand changing approaches to healthcare. The shift means the emergence of managed entry agreements and a focus on economic impact, explains AMIIF, Mexico's research-based pharmaceutical industry association.

How Novartis Is Elevating CVD Outcomes, Driving ‘Personalized Access’ In APMA

Novartis’s APMA chief outlines the company’s tailored approach to deliver long-term outcomes, novel access solutions via innovative financing options and shape the CVD disease ecosystem in the extraordinarily diverse region. Partnering to build AI infrastructure is another key prong.

India Rare Diseases: Court Shows Path For Policy Action, Funding, Price Issues-- Test-2

A court order encompassing funding, drug pricing, clinical trials and overall policy implementation aspects is expected to bring about a paradigm shift in the treatment of rare diseases in India. Sarepta, Roche and Sanofi are among the key players that have been part of pricing discussions.