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Deep-pocketed investors have adopted a bearish approach towards Viking Therapeutics (NASDAQ:VKTX), and it’s something market players shouldn’t ignore. Our tracking of public options records at Benzinga unveiled this significant move today. The identity of these investors remains unknown, but such a substantial move in VKTX usually suggests something big is about to happen.

We gleaned this information from our observations today when Benzinga’s options scanner highlighted 15 extraordinary options activities for Viking Therapeutics. This level of activity is out of the ordinary.

The general mood among these heavyweight investors is divided, with 26% leaning bullish and 66% bearish. Among these notable options, 3 are puts, totaling $99,420, and 12 are calls, amounting to $690,874.

Expected Price Movements

Taking into account the Volume and Open Interest on these contracts, it appears that whales have been targeting a price range from $41.0 to $75.0 for Viking Therapeutics over the last 3 months.

Insights into Volume & Open Interest

Looking at the volume and open interest is a powerful move while trading options. This data can help you track the liquidity and interest for Viking Therapeutics’s options for a given strike price. Below, we can observe the evolution of the volume and open interest of calls and puts, respectively, for all of Viking Therapeutics’s whale trades within a strike price range from $41.0 to $75.0 in the last 30 days.

Viking Therapeutics 30-Day Option Volume & Interest Snapshot

Significant Options Trades Detected:

Symbol	PUT/CALL	Trade Type	Sentiment	Exp. Date	Ask	Bid	Price	Strike Price	Total Trade Price	Open Interest	Volume
VKTX	CALL	TRADE	BEARISH	01/16/26	$19.1	$16.0	$16.0	$75.00	$240.0K	358	5
VKTX	CALL	SWEEP	BEARISH	08/16/24	$5.6	$5.5	$5.5	$65.00	$76.4K	699	20
VKTX	CALL	SWEEP	BEARISH	09/20/24	$5.9	$5.7	$5.7	$70.00	$47.3K	1.8K	506
VKTX	CALL	SWEEP	BEARISH	09/20/24	$5.7	$5.7	$5.7	$70.00	$47.3K	1.8K	356
VKTX	CALL	SWEEP	BEARISH	09/20/24	$5.8	$5.7	$5.7	$70.00	$47.3K	1.8K	256

About Viking Therapeutics

Viking Therapeutics Inc is a healthcare service provider. The company specializes in the area of biopharmaceutical development focused on metabolic and endocrine disorders. The company’s clinical program pipeline consists of VK2809, VK5211, VK0214 products. VK2809 and VK0214 are orally available, tissue and receptor-subtype selective agonists of the thyroid hormone receptor beta. VK5211 is an orally available, non-steroidal selective androgen receptor modulator.

Having examined the options trading patterns of Viking Therapeutics, our attention now turns directly to the company. This shift allows us to delve into its present market position and performance

Viking Therapeutics’s Current Market Status

• With a trading volume of 818,180, the price of VKTX is up by 1.42%, reaching $53.48.
• Current RSI values indicate that the stock is may be oversold.
• Next earnings report is scheduled for 42 days from now.

Trading options involves greater risks but also offers the potential for higher profits. Savvy traders mitigate these risks through ongoing education, strategic trade adjustments, utilizing various indicators, and staying attuned to market dynamics. Keep up with the latest options trades for Viking Therapeutics with Benzinga Pro for real-time alerts.

Semiconductor company Broadcom Inc (NASDAQ:AVGO) is set to report second-quarter financial results after market close Wednesday, June 12.

Here are the earnings estimates, what analysts are saying and key items to watch ahead of the report.

Earnings Estimates: Analysts expect Broadcom to post second-quarter revenue of $12.03 billion according to data from Benzinga Pro.

The company reported $8.73 billion in revenue in last year’s second quarter. Broadcom has beaten analysts’ estimates for revenue in nine of the last 10 quarters.

Analysts expect the company to report earnings per share of $10.84 for the second quarter compared to $10.32 in last year’s second quarter. The company has beaten analysts’ estimates for earnings per share in 10 straight quarters.

Related Link: Top 10 Highest Paid CEOs In 2023: Elon Musk Nowhere To Be Found, Where Tim Cook, Ted Sarandos Rank

What Analysts Are Saying: Broadcom’s growth in the artificial intelligence sector and upside synergies from the acquisition of VMWare led to Morgan Stanley analyst Joe Moore resuming an Overweight rating on the stock.

The analyst, who has a $1,658 price target, said Broadcom is one of the strongest AI plays.

Moore said Broadcom is set to grow faster than many other AI alternatives.

Bank of America analyst Vivek Arya expects Broadcom to report a beat in the second quarter on Wednesday.

The analyst, who has a Buy rating and $1,680 price target, said strength in AI could offset headwinds in the company’s legacy businesses.

JPMorgan analyst Harlan Sur recently highlighted deals for Broadcom with Alphabet Inc (NASDAQ:GOOG)(NASDAQ:GOOGL) and Meta Platforms Inc. (NASDAQ:META).

The partnerships are helping Broadcom estimate that its AI-related revenue will reach $11 billion in 2024.

Sur said Broadcom could have over $12 billion in AI-related revenue in 2024 and $14 to $15 billion or more in 2025.

The analyst, who has an Overweight rating and $1,700 price target, said Broadcom is the top market share leader in custom (ASIC) chip designs.

Here are other analyst ratings on Broadcom and their price targets:

Citigroup: Buy rating, $1,560 price target

Jefferies: Buy rating, lowered price target from $1,616 to $1,550

Barclays: Overweight rating, raised price target from $1,405 to $1,500

Key Items to Watch: The AI-related revenue, as mentioned by analysts above, will likely be the key item for investors to watch in the second-quarter results.

“We are pleased to have two strong drivers of revenue growth for Broadcom in the first quarter and fiscal year 2024. First, our acquisition of VMware is accelerating revenue growth in our infrastructure software segment, as customers deploy VMware Cloud Foundation,” Broadcom CEO Hock Tan said after first-quarter results. “Second, strong demand for our networking products in AI data centers, as well as custom AI accelerators from hyperscalers, are driving growth in our semiconductor segment.”

The company’s guidance will be another area analysts and investors are watching. The company is guiding for a full-year 2024 revenue of $50 billion. With the added excitement of AI-related revenue, some may expect a raise to the estimates for the full year after a strong first-quarter report and continued momentum in the second quarter.

One area of concern to watch on is AI chip export restrictions, which could impact Broadcom and other semiconductor stocks.

AVGO Price Action: Broadcom shares trade at $1,442.58 on Tuesday at publication versus a 52-week trading range of $795.09 to $1,454. Broadcom stock is up 69% in the last year and up 29% year-to-date in 2024.

Read Next: Broadcom, Marvell Capitalize On Generative AI Demand With Custom ASIC Solutions

Photo: Dennis Diatel, Shutterstock

Spotify Technology (NYSE:SPOT) has a new, more expensive premium plan for music lovers.

What Happened: According to Bloomberg, subscribers would pay at least $5 more monthly for the plan.

The new offering, set for later this year, features access to improved audio. It also offers new capabilities for making playlists and managing song libraries.

Spotify did not immediately respond to Benzinga’s request for comment.

Spotify expects to offer the upgraded plan as an add-on for existing customers. That means most users will stay on their current Spotify plans while those who buy the upgrade will create more revenue for the company and its partners.

Also read: Decoding Spotify Technology’s Options Activity: What’s the Big Picture?

Why It Matters: Spotify is just the latest streaming company to raise prices, seemingly justifying the decision by offering more to its customers.

Other content providers — Netflix (NASDAQ:NFLX), Warner Bros Discovery‘s (NASDAQ:WBD) Max, and Comcast Corp‘s (NASDAQ:CMCSA) Peacock — are all raising prices.

The premium plan could generate hundreds of millions of dollars in additional revenue. That money would go toward music rights holders.

Pricing will vary based on users’ base plans. It will result in a roughly 40% higher cost for the feature — dubbed a “Supremium” plan.

Tactics like these have been discussed for years. Companies see higher-quality audio as an opportunity to upsell and/or implement tier pricing. Competitors like Amazon Music and Apple Music have already started offering improved audio as part of their standard plans.

Last week, Spotify adjusted the cost of its monthly individual plan to $11.99 from $10.99. The duo plan went from $14.99 to $16.99. The family plan went from $16.99 to $19.99 in the U.S.

Price action: Spotify’s shares have declined 0.9% to $312.18 in early-morning trading on Tuesday.

Read Now: Spotify Stock Is Surging Today: Here’s Why

Image: Shutterstock

Software company Oracle Corporation (NYSE:ORCL) is set to report fourth-quarter financial results after the market close on Tuesday, June 11, 2024.

Here is a look at the earnings estimates and key items to watch.

Earnings Estimates: Analysts expect Oracle to report fourth-quarter revenue of $14.59 billion according to data from Benzinga Pro.

The revenue estimate represents an increase over last year’s fourth-quarter total of $13.84 billion.

Oracle has missed analysts’ revenue estimates in three straight quarters and missed estimates in five of the last 10 quarters.

Analysts estimate Oracle will report fourth-quarter earnings per share of $1.65 compared to $1.67 in last year’s fourth quarter. The company has beaten analysts’ earnings per share estimates in six straight quarters and eight of the past 10 quarters.

What Analysts Are Saying: Momentum around large and long-term deals could help Oracle continue momentum in the fourth quarter, Morgan Stanley analyst Keith Weiss said.

The analyst, who has an Equal-weight rating and $155 price target, said forward estimates for Oracle have been largely unchanged year-to-date.

Weiss said investors have hope Oracle can capitalize on the scarcity of AI hardware in the current cycle.

The analyst sees a positive near-term outlook for Oracle and said the shares could be rewarded. The analyst calls the valuation of 22x CY24 P/E as “reasonable.”

Multiple analysts raised their price targets on Oracle in March after the third-quarter financial results.

Related Link: Oracle’s Options Frenzy: What You Need to Know

Key Items to Watch: The momentum of Oracle’s cloud infrastructure business remains a key item to watch in the fourth-quarter earnings results. Overall cloud revenue was up 25% year-over-year in the third quarter with cloud infrastructure revenue up 49% year-over-year.

“We expect to continue receiving large contracts reserving cloud infrastructure capacity because the demand for our Gen2 AI infrastructure substantially exceeds supply — despite the fact we are opening new and expanding existing cloud datacenters very, very rapidly,” Oracle CEO Safra Catz said after third quarter financial results.

Another item to watch will be any update or official announcement of a reported collaboration between Oracle and xAI, the AI startup from Elon Musk.

A report from The Information previously said xAI was finalizing a $10 billion contract with Oracle for cloud services.

Oracle also announced plans to open two Oracle Cloud Regions in Morocco to expand its enterprise cloud services across Africa.

The growth of international revenue and any government contracts for AI business could be in the spotlight during fourth-quarter results.

Oracle was a popular stock pick of institutional investors in the first quarter. The fourth-quarter results could show if Oracle being a top 10 holding of several institutions in the first quarter was a wise move going forward.

ORCL Price Action: Oracle shares trade at $124.28 on Monday at publication versus a 52-week trading range of $99.26 to $132.77. Oracle stock is up 20% over the last year.

Read Next: Oracle Stock Climbs On Reports Of Deal With Musk’s xAI: Is There More Upside Ahead?

Photo: Michael Vi/Shutterstock

As of June 10, 2024, five stocks in the financial sector could be flashing a real warning to investors who value momentum as a key criteria in their trading decisions.

The RSI is a momentum indicator, which compares a stock’s strength on days when prices go up to its strength on days when prices go down. When compared to a stock’s price action, it can give traders a better sense of how a stock may perform in the short term. An asset is typically considered overbought when the RSI is above 70, according to Benzinga Pro.

Here’s the latest list of major overbought players in this sector.

UP Fintech Holding Ltd (NASDAQ:TIGR)

• On June 5, UP Fintech Holding reported a year-over-year increase in first-quarter sales results. Mr. Wu Tianhua, Chairman and CEO of UP Fintech stated, “Market backdrop was more active in the first quarter, total revenue in the first quarter was US$78.9 million, representing a 12.8% increase sequentially and 19.0% increase compared to the same quarter last year. Benefiting from our brand strength and R&D capabilities, both GAAP and non-GAAP net income experienced significant growth.” GAAP The company’s stock gained around 11% over the past five days and has a 52-week high of $5.80.
• RSI Value: 72.85                              
• TIGR Price Action: Shares of UP Fintech gained 5.9% to close at $4.75 on Friday.

PennantPark Investment Corp. (NYSE:PNNT)

• On May 8, Pennant Park Investment posted downbeat quarterly results. “We are pleased to announce an increase in our monthly dividend based on the continued strong underlying credit performance of our portfolio,” said Arthur Penn, Chairman and CEO.  “Our earnings stream continues to be robust and is driven in part by the  excellent returns generated by our PSLF Joint Venture.” The company’s stock gained around 6% over the past month and has a 52-week high of $7.73.
• RSI Value: 72.03
• PNNT Price Action: Shares of PennantPark Investment rose 0.8% to close at $7.72 on Friday.

Saratoga Investment Corp (NYSE:SAR)

• On May 23, Saratoga Investment raised its quarterly dividend from 73 cents to 74 cents per share. The company’s stock gained around 5% over the past month and has a 52-week high of $28.15.
• RSI Value: 71.18
• SAR Price Action: Shares of Saratoga Investment gained 0.4% to close at $24.29 on Friday.

FS KKR Capital Corp (NYSE:FSK)

• On June 6, FSK completed public offering of $600 million 6.875% unsecured notes due 2029. The company’s stock jumped around 4% over the past month and has a 52-week high is $20.99.
• RSI Value: 71.12
• FSK Price Action: Shares of FS KKR Capital gained 0.2% to close at $20.62 on Friday.

Hagerty Inc (NYSE:HGTY)

• On May 7, Hagerty posted mixed quarterly results. “We are off to a great start in 2024 as the initiatives undertaken in 2023 powered strong top-line momentum and significant margin expansion,” said McKeel Hagerty, Chief Executive Officer and Chairman of Hagerty. The company’s stock jumped around 14% over the past month and has a 52-week high of $10.10.
• RSI Value: 75.30
• HGTY Price Action: Shares of Hagerty rose 3% to close at $10.10 on Friday.

Read More: Jim Cramer Is ‘Worried’ About Palo Alto Networks, Calls Monday.com ‘Really Good‘

Elon Musk‘s SpaceX on Thursday successfully completed the fourth flight test of its Starship launch vehicle, checking all its test flight goals, and the CEO is already outlining future launch objectives.

What Happened: The vehicle lifted off at 7:50 a.m. CT from Starbase in Texas on Thursday. The two stages of the vehicle- the Starship spacecraft and the Super Heavy booster- separated and the booster subsequently had a soft splashdown in the Gulf of Mexico. The spacecraft ignited its own engines and went on to space, made a controlled re-entry to Earth, and had a soft splashdown in the Indian Ocean. The entire flight lasted one hour and six minutes from launch.

The key objective of this test flight was to re-enter Earth. The mission achieved it but lost many hexagonal heat-shield tiles designed to protect against the extreme heat of reentry to Earth’s atmosphere in the process.

“Despite loss of many tiles and a damaged flap, Starship made it all the way to a soft landing in the ocean!” Musk wrote on social media platform X afterward.

“A fully and immediately reusable orbital heat shield, which (as you know) has never been made before, is the single toughest problem remaining,” he wrote in another post.

Past Flight Tests: SpaceX has launched the Starship thrice before. During Starship’s previous flight test on March 14, the spacecraft lost contact and broke apart while re-entering the atmosphere instead of splashing down in the Indian Ocean as planned. The booster also lost contact before achieving a soft splashdown in the Gulf of Mexico. The entire flight lasted about an hour.

Starship did not reach space at all on its first flight test. On the second flight, it reached space but blew up soon afterward.

Looking Forward: Starship is still in its development phase and will require further testing before it takes humans back to the surface of the Moon as part of NASA’s Artemis mission. In March, Musk said that the company will ‘hopefully’ have at least six flights of the Starship this year.

Hopefully, at least 6 more flights this year

— Elon Musk (@elonmusk) March 12, 2024

For upcoming flights, Musk said that SpaceX will further hone its SX300 alloy to withstand higher temperatures. A newer version of the vehicle also has the forward flaps shifted leeward to help improve reliability and ease of manufacturing, he added.

Speaks to the incredible resilience of stainless steel at temperature.

We will further hone our SX300 alloy to withstand even higher temperatures.

— Elon Musk (@elonmusk) June 6, 2024

“I think we should try to catch the booster with the mechazilla arms next flight!,” Musk said, hinting that on the next flight, the company will attempt to land the booster back at the Starbase launch tower instead of splashing it down into the Gulf of Mexico in what would be a significant demonstration of its reusability.

SpaceX’s Falcon rocket is about 80% reusable, and the company is currently looking to ensure full reusability for its Starship rocket. Reuse of rockets, the company believes, is integral to bringing down the costs of spaceflight as the most cost is taken up in building the launch vehicle.

Starship is touted as the world’s most powerful launch vehicle, standing 121 meters tall and weighing approximately 5,000 tonnes. NASA is currently relying on the success of Starship to land humans back on the moon as part of its Artemis program. The last crewed lunar mission occurred in 1972 with Apollo 17. Since then, no crew has traveled beyond low-Earth orbit.

Check out more of Benzinga’s Future Of Mobility coverage by following this link.

Read More: Forget Tesla And Rivian: America’s Iconic School Bus Maker Smokes EV, Auto Giants With 117% Stock Surge

Image: Created with artificial intelligence on MidJourney and Official SpaceX Photos on Flickr

Adobe Inc‘s (NASDAQ:ADBE) recent update to its terms and conditions has caused a backlash from professional users, who are concerned about the company’s rights to access and use their content.

What Happened: According to 9to5Mac, Adobe has updated the terms and conditions for its apps, including Photoshop, requiring users to agree to the new terms to continue using the software. This change has sparked outrage among professionals, who fear that Adobe is claiming extensive rights over their content.

The new terms state that Adobe may access user content through both automated and manual methods for content review. Users must grant Adobe a non-exclusive, worldwide, royalty-free sublicensable license to use, reproduce, publicly display, distribute, modify, create derivative works and translate the content.

See Also: Jeff Bezos Once Picked Up The Phone And Called Amazon Customer Support To Make A Point

Designer Wetterschneider, who works with clients like DC Comics and Nike, voiced strong objections on X, formerly known as Twitter, urging professionals to cancel their Adobe subscriptions and posting a screenshot of Adobe’s terms of use.

“Here it is. If you are a professional, if you are under NDA with your clients, if you are a creative, a lawyer, a doctor or anyone who works with proprietary files – it is time to cancel Adobe, delete all the apps and programs,” the X user said. “Adobe can not be trusted.”

Benzinga contacted Adobe for comment on the company’s terms and conditions update.

Here it is. If you are a professional, if you are under NDA with your clients, if you are a creative, a lawyer, a doctor or anyone who works with proprietary files – it is time to cancel Adobe, delete all the apps and programs. Adobe can not be trusted. pic.twitter.com/LFnBbDKWLC

— Wetterschneider (@Stretchedwiener) June 5, 2024

Movie director Duncan Jones also expressed frustration, questioning the new agreement on Twitter.

Concept artist Sam Santala highlighted that users cannot raise support requests or uninstall the apps without agreeing to the new terms. Some are speculating the terms might be intended for the creation of thumbnails or CSAM scanning.

Why It Matters: The controversy surrounding Adobe’s new terms and conditions has been escalating. According to 80.lv, users of Photoshop and Substance 3D are now required to provide Adobe with unlimited access to their creations. This includes projects under NDA, which has raised significant privacy concerns.

Jérémie Noguer, product director for Substance 3D, said that Adobe is “not accessing or reading Substance users’ projects in any way, shape or form nor are we planning to or have any means to do it in the first place,” 80.lv reports. Despite this, the community remains skeptical and dissatisfied.

The backlash from Adobe users highlights the growing tension between tech companies and their users over data privacy and control.

Read Next: ‘So Much Is Wrong:’ Short-Seller Andrew Left Says ‘Roaring Kitty’ Trying To Take Advantage Of Retail Traders

This content was partially produced with the help of AI tools and was reviewed and published by Benzinga editors.

Photo: Shutterstock.

In response to last week’s announcement of a bipartisan amendment to the Farm Bill seeking to ban intoxicating hemp products from the market, the Wine & Spirits Wholesalers of America (WSWA) sent a message to Congress — prohibition isn’t the answer.

“Now is the time for federal regulation – not prohibition,” said WSWA president & CEO Francis Creighton in a press release. “Lawmakers need not look too far back in history to learn from the beverage alcohol marketplace and know, without a doubt, that prohibition isn’t the answer. Congress should be focused on protecting public safety and empowering states to regulate the sale of these products – just as federal regulations for alcohol have done for 90-plus years.”

WSWA, which supports the regulation of THC whether it comes from hemp or cannabis, is the first alcohol industry trade association to publicly support the legalization of adult-use cannabis, and to brief Congress on comprehensive federal regulations for those products based upon the success and efficacy of the U.S. alcohol regulatory model. 

The amendment in question seeks to ban intoxicating hemp products by eliminating them from the definition of legal hemp. If enacted, this would likely lead to the removal of these products from shelves across the country.

“I have doubts about the ability to eliminate all of these products any more than they’ve eliminated the cannabis marketplace. There’s several ways to skin the cat, so to speak, and in our view the cleanest is to essentially try to replicate what we have in the alcohol space,” said Dawson Hobbs, WSWA’s executive VP of Government Affairs, reported Politico in late May. 

“We’ve just completed the first lap of a long-distance race. There are a lot of mileposts along the way where this can be changed. One of the benefits of this amendment is that it brought the conversation to the forefront,” Hobbs said in the recent press release.

WSWA’s framework is built on four principles drawing on long-established federal laws governing the alcohol industry. The Associations’ principles for comprehensive federal legalization and oversight of the adult-use cannabis supply chain are rooted in four pillars:

• The federal permitting of cannabis producers, importers, testing facilities and distributors.
• The federal approval and regulation of “cannabis products and product labels.”
• The efficient and effective collection of federal excise tax.
• Effective federal measures to ensure public safety.

Now Read: Over $20 Billion In Green: Cannabis Is A Lucrative Harvest For Legal Weed States

Lead image generated by AI

Keith Gill, popularly known as Roaring Kitty, has amassed a substantial position in GameStop Corp. (NYSE:GME), through call options. However, cashing in on these options could prove challenging, according to experts.

What Happened: Trade Alert data revealed that the number of open contracts in GameStop rose to 145,000 by the end of May, a significant increase from the 15,000 recorded on May 19. With an average trading price of $5.52 during this period, a buyer of 120,000 options contracts could have made around $54 million by Monday, based on the contracts’ closing price of $10 each, Reuters reported

However, exiting this options trade could pose a challenge. The size of the position and the attention on GameStop could make selling the options or taking delivery of the underlying shares problematic. This could potentially reduce the price of the options and the underlying stock, industry experts noted.

See Also: Rapper 50 Cent Accepted Bitcoin For His Album ‘Animal Ambition’ 10 Years Ago: Here’s How Much He Earned I

Steve Sosnick, Chief Strategist at Interactive Brokers and a former options market maker, pointed out the difficulty in selling a large chunk of the options position without attracting attention.

“It’s much easier to sell 10 to 12 million shares than if you sold 120,000 call options,” he said.

Garrett DeSimone, Head of Quantitative Research at OptionMetrics, suggested that taking delivery of the 12 million shares that the disclosed options contracts command may require hundreds of millions in capital.

“Unless he is super committed to being a long term investor and taking delivery of (the shares), it’s going to be challenging to monetize this without moving the market just because everybody’s hyper aware of this now,” DeSimone added

Why It Matters: The Roaring Kitty saga has been a major focus in the market. Gill, a significant figure in the GameStop “meme stock” frenzy, revealed on Reddit that he owns over $115.7 million worth of GameStop shares and has $65.7 million in call options expiring on June 21 with a strike price of $20 each. This disclosure came at a time when Morgan Stanley’s E*Trade was considering banning Gill from its platform due to allegations of his involvement in manipulating meme stock prices through his social media activities.

Meanwhile, Citron Research founder Andrew Left raised doubts about Gill’s intentions, accusing him of trying to take advantage of retail traders after revealing his huge GameStop position.

Price Action: GameStop was trading 1.6% lower at $27.55 at the time of publication Tuesday, according to Benzinga Pro.

Read Next: Crypto Analyst Predicts Huge Surge In Dogecoin’s Value: ‘Market Sentiment … Is As Bearish As It Was In Early February’

Image: Shutterstock/ Hansonl

This story was generated using Benzinga Neuro and edited by Pooja Rajkumari

MDMA, the drug commonly known as ecstasy and declared illegal by the DEA in 1985, is nearing a landmark moment in its journey toward becoming a legal and approved treatment for PTSD. Lykos Therapeutics Inc., a company that emerged from the nonprofit Multidisciplinary Association for Psychedelic Studies (MAPS), has spearheaded this effort, bringing the first new PTSD treatment in over two decades to the brink of FDA approval.

FDA Review And Potential Approval Timeline

On Tuesday, the FDA’s Psychopharmacologic Drugs Advisory Committee will meet to discuss the drug application submitted by Lykos, providing the first clear indication of the FDA’s stance on this treatment and possibly paving the way for a final decision by August. According to Bloomberg, the treatment involves administering MDMA in conjunction with 42 hours of therapy, a method aimed at addressing the deep-seated trauma experienced by PTSD patients which has shown promising results in clinical trials.

As the FDA nears a decision on MDMA for PTSD treatment, it’s crucial to stay informed about the implications for the future of psychedelic medicine. Hear directly from top experts, researchers, and policymakers at the 19th Benzinga Cannabis Capital Conference, coming to Chicago this Oct. 8-9. Get your tickets now before prices surge by following this link.

Controversies And Concerns Raised By ICER

While Lykos, supported by high-profile donors and a recent $100 million investment, is confident in the therapy’s potential, the journey has not been without controversy. The Institute for Clinical and Economic Review (ICER) recently issued a report raising concerns about the validity of Lykos’ trial results, questioning the reliability of non-blind trials and the potential for bias.

Additionally, the report cited instances of alleged misconduct and underreporting of adverse effects, leading to a near-unanimous vote from ICER advisers against the proven benefit of MDMA-assisted therapy compared to standard talk therapy.

Urgent Need For Effective PTSD Treatments

Despite these concerns, the urgency for new and effective PTSD treatments is undeniable. Current medications often fall short though MDMA’s phase three trials showed substantial symptom reduction in two-thirds of participants, noted Bloomberg. “We’re on the precipice of integrating psychedelic medicine into mainstream medicine,” Lykos chairman Jeff George said at a recent conference.

Highlighting the treatment’s potential impact, the Department of Veterans Affairs, managing a vast PTSD patient population, is already preparing to adopt the treatment if approved. Former Army Ranger Jesse Gould, who leads a nonprofit assisting veterans with PTSD called Heroic Hearts Project emphasized the critical need for effective treatments. “If not MDMA, there’s nothing out there in the pipeline,” he stated. Yet, ICER’s outside advisers caution against hastily embracing MDMA therapy without addressing the raised concerns fully.

Challenges Ahead For MDMA Legalization And Accessibility

Even if the FDA grants approval, MDMA’s legalization faces further challenges, including DEA rescheduling and ensuring therapists receive specialized training. Furthermore, the therapy’s high cost, estimated by ICER at over $12,000 per patient, might deter insurance coverage and pose additional barriers to its widespread adoption.

Photo: Benzinga edit with photo by Yuriy Golub and Bacsica on Shutterstock.