J&J & Glaxo Get FDA Approval For First Two-Drug HIV Regimen

By Zacks Investment ResearchStock MarketsNov 21, 2017 09:28PM ET

www.investing.com/analysis/jj--glaxo-get-fda-approval-for-first-twodrug-hiv-regimen-200267579

J&J & Glaxo Get FDA Approval For First Two-Drug HIV Regimen

By Zacks Investment Research | Nov 21, 2017 09:28PM ET

Saved. See Saved Items.

This article has already been saved in your Saved Items

GILD

-1.08%

Add to/Remove from Watchlist

AMZN

-0.60%

Add to/Remove from Watchlist

PFE

-1.90%

Add to/Remove from Watchlist

JNJ

-1.11%

Add to/Remove from Watchlist

GSK

+1.26%

Add to/Remove from Watchlist

Johnson & Johnson (NYSE:JNJ) and partner GlaxoSmithKline (NYSE:GSK) announced FDA approval for Juluca, a two-drug complete regimen of Tivicay/rilpivirine and Edurant/dolutegravir as a single tablet for the treatment of HIV-1 infection.

Tivicay, a novel investigational integrase strand transfer inhibitor (INSTI), is marketed by ViiV Healthcare, an HIV company majorly owned by Glaxo and Pfizer (NYSE:PFE) . Edurant, on the other hand, is a non-nucleoside reverse transcriptase inhibitor (NNRTI) marketed by Janssen, J&J’s pharma arm. Juluca has been developed under a partnership between ViiV Healthcare and Janssen.

This year so far, J&J’s share price is up 20.1%. This compares favorably with 14.1% increase witnessed by the industry.

Coming back to the latest news, Juluca’s approval was based on data from two phase III SWORD studies. Data from these studies published in February this year showed that the combination of dolutegravir/rilpivirine antiretroviral was as effective as a three- or four-drug antiretroviral regimen as a maintenance therapy in HIV patients who have already achieved viral suppression.

Juluca, the first two-drug regimen to be approved, reduces the number of medicines HIV patients take without compromising on the efficacy of a conventional three-drug regimen.

We remind investors that Gilead’s (NASDAQ:GILD) bictegravir single table regimen (STR) for HIV treatment is under priority review in the United States. The FDA is expected to announce its decision in February next year. The STR is a fixed-dose combination of bictegravir, an INSTI, and emtricitabine/tenofovir alafenamide (FTC/TAF), a dual-NRTI backbone. The combination is under review in the EU as well. Gilead’s HIV franchise is a major contributor to sales with approved drugs like Genvoya, Truvada, Atripla, Stribild, Descovy, Odefsey and Complera.

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

Wall Street’s Next Amazon (NASDAQ:AMZN)

Zacks EVP Kevin Matras believes this familiar stock has only just begun its climb to become one of the greatest investments of all time. It’s a once-in-a-generation opportunity to invest in pure genius.

Click for details >>

Pfizer, Inc. (PFE): Free Stock Analysis Report

Johnson & Johnson (JNJ): Free Stock Analysis Report

GlaxoSmithKline PLC (GSK): Free Stock Analysis Report

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

Original post

Walgreens' Future Could Be Reshaped by Sycamore’s $10 Billion Offer By Timothy Fries - Mar 04, 2025

Walgreens Boots Alliance Inc. (NASDAQ:WBA) is on the brink of a significant transformation as it nears a deal with Sycamore Partners to become a private entity. The transaction,...

Is the S&P 500 Road to 6400-6500 in Jeopardy? By Dr. Arnout ter Schure - Mar 04, 2025 2

Using the Elliott Wave Principle (EWP), we have been successfully tracking the most likely path forward for the S&P 500 (SPX) over several months. Although there are many ways...

These 3 Stocks Grew Dividends +50% Annually Over the Last 3 Years By Leo Miller - Mar 04, 2025

When looking for dividend stocks, high dividend yields are one important factor to consider. Even if a company’s dividend yield isn’t nearing double-digit percentages, finding...

Add a Comment

We encourage you to use comments to engage with other 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, don’t trash it.
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. Avoid profanity, slander or personal attacks directed at an author or another user. Racism, sexism and other forms of discrimination will not be tolerated.
Use standard writing style. Include punctuation and upper and lower cases. Comments that are written in all caps and contain excessive use of symbols will be removed.
NOTE: Spam and/or promotional messages and comments containing links will be removed. Phone numbers, email addresses, links to personal or business websites, Skype/Telegram/WhatsApp etc. addresses (including links to groups) will also be removed; self-promotional material or business-related solicitations or PR (ie, contact me for signals/advice etc.), and/or any other comment that contains personal contact specifcs or advertising will be removed as well. In addition, any of the above-mentioned violations may result in suspension of your account.
Doxxing. We do not allow any sharing of private or personal contact or other information about any individual or organization. This will result in immediate suspension of the commentor and his or her account.
Don’t monopolize the conversation. We appreciate passion and conviction, but we also strongly believe in giving everyone a chance to air their point of view. 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.
Any comment you publish, together with your investing.com profile, will be public on investing.com and may be indexed and available through third party search engines, such as Google.

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

I have read Investing.com's comments guidelines and agree to the terms described.

I Agree

Write your thoughts here

Are you sure you want to delete this chart?

Delete Cancel

Post

Post also to:

Replace the attached chart with a new chart ?

Replace Cancel

1000

Comment Guidelines

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.

<div id="comment">
				<div class="comment js-comment" data-comment-id="{commentID}" id="comment-{commentID}" data-user-id="">
    <div class="mainComment js-content">
       <div class="commentInnerWrapper">
        <a href="{userLink}" class="js-user-link"><img src="{userImage}" width="33" height="33" alt="{usernameAlt}" class="img" onerror="this.src='https://i-invdn-com.investing.com/defaultUserMaleTmp.png';"></a><div class="commentBody">
                					<span class="commentUsername">
                    	<a href="{userLink}" class="js-user-link js-user-name">{username}</a>
					</span>
                                <span class="js-date" comment-date="{dateFormat}" comment-date-formatted="{dateFormatted}" title="{dateTitle}">Just Now</span>
                <div class="commentDropDown js-commentDropDownWrapper " data-user-id="" data-cid="{commentID}">
	<a href="javascript:void(0);" class="threeDotsIconSmall js-thinDropdownArrow"></a>
	<div class="tooltipPopup commentActionsPop noHeader js-commentDropDownOptions displayNone">
		<div class="addRow js-option share">
			<a href="javascript:void(0);" class="js-commentSharePopup" data-cid="{commentID}" data-curl="{commentLink}"><span class="smallShareIcon middle"></span>Share</a>
		</div>

<div class="js-option addRow follow">
            <div class="js-follow-post-button" data-reg_ep="follow comment">
                <span class="alertfollowIcon middle"></span>Follow this post            </div>
            <div class="js-unfollow-post-button displayNoneImp">
                <span class="alertUnfollowIcon middle"></span>Unfollow this post            </div>
        </div>

<div class="addRow js-option save"  data-reg_ep="save comment">
		<a href="javascript:void(0);" class="js-save-item-btn" data-item-type="comments" data-item-id="{commentID}">
			<i class="saveItemBigIcon middle"></i>
			Save		</a>
	</div>
	<div class="addRow saveItemsConfirmation noHover displayNone js-saveItemResult">
		
<div class="content js-saveItemSuccess displayNone">
	<span class="mediumGreenSuccessIcon"></span><span>Saved. See <a href="/members-admin/saved-items" target="_blank">Saved Items</a>.</span>
	<a href="javascript:void(0);" class="bugCloseIcon js-close"></a>
</div>
<div class="content js-saveItemAlreadySaved saveItemAlreadySaved displayNoneImp">
	<span>This comment has already been saved in your <a href="/members-admin/saved-items" target="_blank">Saved Items</a></span>
	<a href="javascript:void(0);" class="bugCloseIcon js-close"></a>
</div>
	</div>

<div class="addRow shareButtons js-sharePopup displayNone">
			<div class="js-shareComment"><span class="js-shareCommentSpan"></span></div>
		</div>
	</div>
</div>
                 <div class="commentAuthor js-comment-by-author"><span class="commentAuthorIcon"></span>Author's response</div>             </div>
		<div id="commentText-{commentID}" class="js-text-wrapper commentText withImage">
							<div id="commentBigChart{commentID}" class="commentBigChart js-comment-chart" onclick="openViewChartPopup('{commentID}')">
					<img src="https://d1-invdn-com.investing.com/comments_images/{commentImage}" alt="{commentAlt}">
					<i class="newMagnifyChartIcon"></i>
				</div>
						<span class="js-text">{commentContent}</span>
			<div class="clear"></div>
							<div class="commentButtons js-not-master-user">
					<a href="javascript:void(0)" class="reply js-reply-btn" data-real-parent-id="{commentID}" data-to-user-name="{username}" data-to-user-id="">Reply</a>
					<div class="inlineblock likeDislikeBox js-like-dislike-box" data-item-id="{commentID}">
	<input class="js-like-checkbox" type="checkbox" name="option" value="Yes" id="like_{commentID}">
	<label for="like_{commentID}" class="like" title="I agree"></label>
	<span class="numOfLikes js-like-count lighterGrayFont">0</span>
	<input class="js-dislike-checkbox" type="checkbox" name="option" value="No" id="dislike_{commentID}">
	<label for="dislike_{commentID}" class="dislike" title="I disagree"></label>
	<span class="numOfDislikes js-dislike-count lighterGrayFont">0</span>
</div>

<div class="reportComment js-flag float_lang_base_2">
                            <a href="javascript:void(0);" id="commentFlag_{commentID}">
                                <span class="reportCommentIcon middle"></span><span class="inlineblock middle">Report</span>
                            </a>
                        </div>
                    				</div>
					</div>
	   </div>
	</div>
	</div>			</div>
			<div id="reply">
				
    <div class="commentReply js-comment js-comment-reply" data-comment-id="{commentID}" id="comment-{commentID}" data-user-id="">
		<div class="commentInnerWrapper"><a href="{userLink}" class="js-user-link"><img src="{userImage}" width="33" height="33" alt="{usernameAlt}" class="img" onerror="this.src='https://i-invdn-com.investing.com/defaultUserMaleTmp.png';"></a><div class="commentBody js-content">
            				<span class="commentUsername">
					<a href="{userLink}" class="commentUsername js-user-link js-user-name" onMouseOver="">{username}</a>
				</span>
                        <span class="js-date" comment-date="{dateFormat}" comment-date-formatted="{dateFormatted}" title="{dateTitle}">Just Now</span>
			 <div class="commentAuthor js-comment-by-author"><span class="commentAuthorIcon"></span>Author's response</div> 			<div class="commentDropDown js-commentDropDownWrapper " data-user-id="" data-cid="{commentID}">
	<a href="javascript:void(0);" class="threeDotsIconSmall js-thinDropdownArrow"></a>
	<div class="tooltipPopup commentActionsPop noHeader js-commentDropDownOptions displayNone">
		<div class="addRow js-option share">
			<a href="javascript:void(0);" class="js-commentSharePopup" data-cid="{commentID}" data-curl="{commentLink}"><span class="smallShareIcon middle"></span>Share</a>
		</div>

</div>
		<div id="commentText-{commentID}" class="js-text-wrapper commentText withImage">
							<div id="commentBigChart{commentID}" class="replyBigChart displayNone js-comment-chart">
					<img src="https://d1-invdn-com.investing.com/comments_images/{commentImage}" alt="{commentAlt}">
					<i class="newMagnifyChartIcon"></i>
				</div>
				<span id="commentSmallChart{commentID}" class="commentSmallChart pointer js-comment-chart" onclick="openViewChartPopup('{commentID}')">
                    <img src="https://d1-invdn-com.investing.com/comments_images/{commentImageSmall}" width="116" height="52" alt="{commentAlt}">
                    <span class="chartMagnifyOverlay displayNone"></span>
                    <span class="searchGlassIcon chartMagnify displayNone"></span>
                </span>
						<span class="js-text">{commentContent}</span>
			<div class="clear"></div>
							<div class="commentButtons js-not-master-user">
					<a href="javascript:void(0)" class="reply js-reply-btn" data-real-parent-id="{commentID}" data-to-user-name="{username}" data-to-user-id="">Reply</a>
					<div class="inlineblock likeDislikeBox js-like-dislike-box" data-item-id="{commentID}">
	<input class="js-like-checkbox" type="checkbox" name="option" value="Yes" id="like_{commentID}">
	<label for="like_{commentID}" class="like" title="I agree"></label>
	<span class="numOfLikes js-like-count lighterGrayFont">0</span>
	<input class="js-dislike-checkbox" type="checkbox" name="option" value="No" id="dislike_{commentID}">
	<label for="dislike_{commentID}" class="dislike" title="I disagree"></label>
	<span class="numOfDislikes js-dislike-count lighterGrayFont">0</span>
</div>

Are you sure you want to delete this chart?

Delete Cancel

Post

Replace the attached chart with a new chart ?

Replace Cancel

1000

Comment Guidelines

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.

I feel that this comment is:

Spam

Offensive

Thank You!

Your report has been sent to our moderators for review

Central Banks

Interest Rates

Next Meeting

FED

4.50%

Mar 19, 2025

ECB

2.90%

Mar 06, 2025

BOE

4.50%

Mar 20, 2025

SNB

0.50%

Mar 20, 2025

RBA

4.10%

Apr 01, 2025

BOC

3.00%

Mar 12, 2025

RBNZ

3.75%

Apr 09, 2025

BOJ

0.50%

Mar 19, 2025

CBR

21.00%

Mar 21, 2025

RBI

6.25%

Mar 10, 2025

PBOC

3.10%

BCB

13.25%

Mar 19, 2025

US 30	42,797.2	-394.8	-0.91%
US 500	5,823.5	-26.4	-0.45%
Dow Jones	42,521.66	-669.58	-1.55%
S&P 500	5,778.18	-71.54	-1.22%
Nasdaq	18,285.16	-65.03	-0.35%
S&P 500 VIX	23.51	+0.73	+3.20%
Dollar Index	105.530	-1.139	-1.07%

Crude Oil WTI	67.66	-0.71	-1.04%
Brent Oil	70.78	-0.84	-1.17%
Natural Gas	4.350	+0.228	+5.53%
Gold	2,925.30	+24.20	+0.83%
Silver	32.553	+0.242	+0.75%
Copper	4.5780	-0.0290	-0.63%
US Soybeans	1,001.75	-9.75	-0.96%

U.S. 10Y	4.247	+0.067	+1.60%
U.S. 30Y	4.537	+0.073	+1.64%
U.S. 5Y	4.017	+0.028	+0.70%
U.S. 3M	4.305	0.000	0.00%
US 10Y T-Note	111.14	-0.23	-0.21%
Euro Bund	129.82	-1.29	-0.98%
10-2 Yield Spread	19.92	-1.45	-6.79%

Apple	235.93	-2.10	-0.88%
NVIDIA	115.99	+1.93	+1.69%
Alphabet A	170.92	+3.91	+2.34%
Tesla	272.04	-12.61	-4.43%
Amazon.com	203.80	-1.22	-0.60%
Netflix	972.58	-1.12	-0.12%
Meta Platforms	640.00	-15.05	-2.30%

J&J & Glaxo Get FDA Approval For First Two-Drug HIV Regimen

Related Articles