Breaking News
Ad-Free Version. Upgrade your experience. Save up to 40% More details

Biotech Stock Roundup: ACAD Down on CRL, EBS Gets Additional Order & Other Updates

By Zacks Investment ResearchStock MarketsApr 07, 2021 03:13AM ET
Biotech Stock Roundup: ACAD Down on CRL, EBS Gets Additional Order & Other Updates
By Zacks Investment Research   |  Apr 07, 2021 03:13AM ET
Saved. See Saved Items.
This article has already been saved in your Saved Items

The biotech sector continues to be in focus as the development of vaccines for coronavirus continues to be the key focus. Other pipeline and regulatory updates also grabbed the spotlight.

Recap of the Week’s Most Important Stories:

Acadia Plunges on CRL: Shares of Acadia Pharmaceuticals, Inc. ACAD plummeted after it received a Complete Response Letter (CRL) from the FDA regarding its supplemental New Drug Application (sNDA) for Nuplazid (pimavanserin) for the treatment of hallucinations and delusions associated with dementia-related psychosis (DRP).

The CRL indicated that the regulatory body has completed its review of the application and decided that it cannot be approved in its present form as it lacks statistical significance in some of the subgroups of dementia. Moreover, there was an insufficient number of patients with certain less common dementia subtypes, which was considered as a lack of substantial evidence of effectiveness to support approval. The CRL also states that the phase II Alzheimer’s disease psychosis study, a supportive study in the sNDA filing, was found to be inadequate and not well controlled. The drug is already approved in the United States for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis.

Emergent Gets Additional $23M Order for Vaccine: Emergent Biosolutions (NYSE:EBS), Inc. EBS announced that it received a contract modification to increase the original task order by $23 million from the Biomedical Advanced Research and Development Authority (BARDA) to support further expansion of the manufacturing capacity for Johnson & Johnson’s JNJ COVID-19 vaccine. The amount will be used for the purchase of biologics manufacturing equipment specific to Johnson & Johnson’s COVID-19 vaccine for the potential expansion of manufacturing of that bulk drug substance to the third suite of Emergent’s Baltimore Bayview facility. In addition, Emergent plans to slow down the manufacturing of AstraZeneca’s COVID-19 vaccine bulk drug substance.

Separately, Emergent provided an update on its investigational SARS-CoV-2 Immune Globulin Intravenous (Human) (COVID-HIG) for the treatment of hospitalized patients with COVID-19. The phase III Inpatient Treatment with Anti-Coronavirus Immunoglobulin (ITAC) trial, also known as INSIGHT-013, evaluated the safety and efficacy of four immunoglobulin candidates plus standard of care versus placebo plus standard of care in hospitalized patients with COVID-19. Top-line data from the ITAC trial demonstrated that the addition of anti-SARS-CoV-2 hyperimmunoglobulin to standard of care, inclusive of Veklury, for hospitalized adult COVID-19 patients with symptoms for less than 12 days did not provide clinical benefit when compared to standard of care plus placebo. The study was sponsored and supported by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).

Emergent currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Dynavax (NASDAQ:DVAX) Gains on Partner’s Results: Shares of Dynavax Technologies Corporation DVAX gained after it announced that partner Valneva SE posted positive initial results in a phase I/II study evaluating the latter’s COVID-19 vaccine candidate, VLA2001. The vaccine candidate uses Dynavax's CpG 1018 adjuvant. Based on the initial data from the study, Valneva is planning to start a phase III study on the candidate by the end of this month, subject to regulatory approval. The adjuvant is also used in Dynavax’s marketed vaccine, Heplisav-B, for the prevention of hepatitis B in the United States. Valneva reported that VLA2001 was generally safe and well tolerated across all dose groups tested and was highly immunogenic with a seroconversion rate for S-protein binding IgG antibodies of 100% in the high dose group. The IgG antibody response was highly correlated with neutralization titers in a micro-neutralization assay.

Gilead’s Kite Submits sBLA for Tecartus: Gilead Sciences’ GILD Kite announced that it has submitted a supplemental biologics license application (sBLA) to the FDA for chimeric antigen receptor (CAR) T-cell therapy, Tecartus (brexucabtagene autoleucel). The sBLA is seeking approval of the therapy for the treatment of adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). The sBLA is supported by the data from the phase I/II ZUMA-3 trial. Tecartus was granted accelerated approval in July 2020 by the FDA for the treatment of relapsed or refractory mantle cell lymphoma, based on the overall response rate and durability of response.


The Nasdaq Biotechnology Index gained 3.27% in the last four trading sessions. Among the biotech giants, Incyte (NASDAQ:INCY) gained 3.68% during the period. Over the past six months, shares of Alexion (NASDAQ:ALXN) have surged 32.16%. (See the last biotech stock roundup here: Biotech Stock Roundup: BLUE/BMY's CAR T Therapy Nod, KLDO's COVID-19 Study News & More)

What's Next in Biotech?

Stay tuned for more pipeline and regulatory updates.

The Hottest Tech Mega-Trend of All

Last year, it generated $24 billion in global revenues. By 2020, it's predicted to blast through the roof to $77.6 billion. Famed investor Mark Cuban says it will produce "the world's first trillionaires," but that should still leave plenty of money for regular investors who make the right trades early.

See Zacks' 3 Best Stocks to Play This Trend >>

Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report

Johnson & Johnson (JNJ): Get Free Report

Dynavax Technologies Corporation (DVAX): Get Free Report

Gilead Sciences, Inc. (NASDAQ:GILD): Free Stock Analysis Report

Emergent Biosolutions Inc. (EBS): Free Stock Analysis Report

ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD): Free Stock Analysis Report

To read this article on click here.

Zacks Investment Research
Biotech Stock Roundup: ACAD Down on CRL, EBS Gets Additional Order & Other Updates

Related Articles

Michael Kramer
A Big Week For Stocks By Michael Kramer - May 17, 2021 2

This will be a big week for stocks, especially with the Fed minutes on Wednesday. Stocks had a volatile week, finishing lower but managing to catch a nice bounce on Thursday and...

Biotech Stock Roundup: ACAD Down on CRL, EBS Gets Additional Order & Other Updates

Add a Comment

Comment Guidelines

We encourage you to use comments to engage with users, share your perspective and ask questions of authors and each other. However, in order to maintain the high level of discourse we’ve all come to value and expect, please keep the following criteria in mind: 

  • Enrich the conversation
  • Stay focused and on track. Only post material that’s relevant to the topic being discussed.
  • Be respectful. Even negative opinions can be framed positively and diplomatically.
  •  Use standard writing style. Include punctuation and upper and lower cases.
  • NOTE: Spam and/or promotional messages and links within a comment will be removed
  • Avoid profanity, slander or personal attacks directed at an author or another user.
  • Don’t Monopolize the Conversation. We appreciate passion and conviction, but we also believe strongly in giving everyone a chance to air their thoughts. Therefore, in addition to civil interaction, we expect commenters to offer their opinions succinctly and thoughtfully, but not so repeatedly that others are annoyed or offended. If we receive complaints about individuals who take over a thread or forum, we reserve the right to ban them from the site, without recourse.
  • Only English comments will be allowed.

Perpetrators of spam or abuse will be deleted from the site and prohibited from future registration at’s discretion.

Write your thoughts here
Are you sure you want to delete this chart?
Post also to:
Replace the attached chart with a new chart ?
Your ability to comment is currently suspended due to negative user reports. Your status will be reviewed by our moderators.
Please wait a minute before you try to comment again.
Thanks for your comment. Please note that all comments are pending until approved by our moderators. It may therefore take some time before it appears on our website.
Are you sure you want to delete this chart?
Replace the attached chart with a new chart ?
Your ability to comment is currently suspended due to negative user reports. Your status will be reviewed by our moderators.
Please wait a minute before you try to comment again.
Add Chart to Comment
Confirm Block

Are you sure you want to block %USER_NAME%?

By doing so, you and %USER_NAME% will not be able to see any of each other's's posts.

%USER_NAME% was successfully added to your Block List

Since you’ve just unblocked this person, you must wait 48 hours before renewing the block.

Report this comment

I feel that this comment is:

Comment flagged

Thank You!

Your report has been sent to our moderators for review
Disclaimer: Fusion Media would like to remind you that the data contained in this website is not necessarily real-time nor accurate. All CFDs (stocks, indexes, futures) and Forex prices are not provided by exchanges but rather by market makers, and so prices may not be accurate and may differ from the actual market price, meaning prices are indicative and not appropriate for trading purposes. Therefore Fusion Media doesn`t bear any responsibility for any trading losses you might incur as a result of using this data.

Fusion Media or anyone involved with Fusion Media will not accept any liability for loss or damage as a result of reliance on the information including data, quotes, charts and buy/sell signals contained within this website. Please be fully informed regarding the risks and costs associated with trading the financial markets, it is one of the riskiest investment forms possible.
Continue with Google
Sign up with Email