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Pasithea Therapeutics Corp. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/KTTA#NASDAQ">KTTA</a>) is trading higher in the premarket session on Tuesday with a session volume of 22.14 million compared to the average volume of 2.81 million as per data from <a href="https://www.benzinga.com/pro/feature/newsfeed" target="_blank" rel="noreferrer noopener">Benzinga Pro</a>.
The clinical-stage biotechnology company released interim pharmacodynamic (PD) data from its ongoing Phase 1 trial of PAS-004 in <a target="_blank" href="https://www.benzinga.com/general/health-care" rel="noreferrer noopener">advanced cancer patients</a>.
The data includes results from cohorts 3 and 4A, evaluating 8mg and 15mg capsules, and cohort <a target="_blank" href="https://www.benzinga.com/pressreleases/25/05/g45217154/pasithea-therapeutics-reports-positive-pharmacodynamic-results-demonstrating-robust-target-engagem" rel="noreferrer noopener">4B evaluating 4mg tablets</a>.
The data demonstrates strong target engagement consistent with PAS-004&#8217;s favorable pharmacological profile.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/25/05/45217506/exclusive-mira-pharmaceuticals-lead-program-ketamir-2-shows-no-brain-toxicity-in-fda-mandated-study" rel="noreferrer noopener">EXCLUSIVE: MIRA Pharmaceuticals Lead Program Ketamir-2 Shows No Brain Toxicity In FDA-Mandated Study</a>
Inhibition of ERK phosphorylation (pERK) is widely recognized as a gold-standard PD biomarker for assessing MEK inhibitor activity. To evaluate target engagement, pERK levels were measured in peripheral blood mononuclear cells (PBMCs) collected from patients at baseline and steady-state at day 22.
Preliminary results demonstrate robust pERK inhibition, with reductions in pERK levels of up to 91% even at the 8mg dose level, in line with a previously developed PK/PD model. This confirms substantial target engagement in patients receiving PAS-004.
Pharmacodynamic activity is supported by encouraging preliminary clinical observations, with several patients achieving stable disease and tumor shrinkage while on PAS-004 treatment.
Notably, one patient in cohort 4A (15mg capsule) with stage 4 KRAS G12R-mutated pancreatic cancer, having progressive disease while on three prior lines of therapy, achieved a tumor volume reduction of -9.8% over 5 months of PAS-004 treatment and currently remains on study.
In April, the external Safety Review Committee recommended that the company&#8217;s Phase 1 clinical trial of PAS-004 in advanced cancer should proceed to Cohort 6, 30mg capsule, without modification.
This recommendation was based on the review of the safety data from three patients from Cohort 5 and the absence of any <a target="_blank" href="https://www.benzinga.com/pressreleases/25/04/g44730908/pasithea-therapeutics-announces-positive-safety-review-committee-src-recommendation-from-its-ongoi" rel="noreferrer noopener">dose-limiting toxicities (DLTs)</a>.
In late April, Pasithea Therapeutics completed enrollment and initial dosing of three subjects in Cohort 6 with 30 mg <a target="_blank" href="https://www.benzinga.com/pressreleases/25/04/g45062430/pasithea-therapeutics-announces-completion-of-enrollment-and-initial-dosing-of-patients-in-cohort-" rel="noreferrer noopener">capsules of PAS-004</a>.&nbsp;
In September 2024, Pasithea Therapeutics announced safety, tolerability, pharmacokinetic (PK), and preliminary efficacy data from the first two cohorts of patients (n=6) in its Phase 1 trial of PAS-004 in patients with MAPK pathway-driven advanced solid tumors with a documented RAS, NF1 or RAF mutation or patients who have failed&nbsp;<a target="_blank" href="https://www.benzinga.com/general/biotech/24/09/41046115/why-is-pasithea-therapeutics-stock-surging-on-thursday" rel="noreferrer noopener">BRAF/MEK inhibition</a>.
Price Action: KTTA stock is up 62.7% at $2.33 during the premarket session at last check Tuesday.
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Photo: Shutterstock

Biotech

News

Health Care

Movers

Trading Ideas

General

KTTA

Pasithea Therapeutics Drug Shows Tumor Reduction In Pancreatic Cancer, Strong Early Trial Results

Wells Fargo analyst Vik Chopra maintains Henry Schein (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/HSIC#NASDAQ">HSIC</a>) with a Equal-Weight and lowers the price target from $80 to $75.

Price Target

Analyst Ratings

HSIC

Wells Fargo Maintains Equal-Weight on Henry Schein, Lowers Price Target to $75

Upstream Bio (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/UPB#NASDAQ">UPB</a>) reported quarterly losses of $(0.51) per share which missed the analyst consensus estimate of $(0.49) by 4.08 percent. The company reported quarterly sales of $566.00 thousand which beat the analyst consensus estimate of $327.50 thousand by 72.82 percent.

Earnings

Earnings Beats

Earnings Misses

Upstream Bio Q1 EPS $(0.51) Misses $(0.49) Estimate, Sales $566.00K Beat $327.50K Estimate

<a href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.bioaffinitytech.com&amp;esheet=54249602&amp;newsitemid=20250506249474&amp;lan=en-US&amp;anchor=bioAffinity+Technologies%2C+Inc.&amp;index=1&amp;md5=3432b844d8ff9585cba1757103d06d76">bioAffinity Technologies, Inc.</a> (NASDAQ:<a href="https://www.benzinga.com/stock/BIAF#NASDAQ">BIAF</a>, BIAFW)) a biotechnology company focused on the need for noninvasive tests for the detection of early-stage cancer, today announced that it has priced a best efforts offering of securities as described below for aggregate gross proceeds to the Company of $3.25 million, before deducting agent fees and other estimated expenses payable by the company.
The offering consists of 10,156,250 shares (the "Shares") of our Common Stock (or pre-funded warrants), together with warrants to initially purchase up to 15,234,375 shares of Common Stock, (the "May 2025 Warrants"). The combined public offering price for each share of common stock (or pre-funded warrant) and accompanying May 2025 Warrant is $0.32.
The closing of the offering is expected to occur on or about May 7, 2025, subject to the satisfaction of customary closing conditions.
WallachBeth Capital, LLC is acting as sole placement agent for the offering.

Offerings

BIAF

bioAffinity Technologies Announces Pricing Of $3.25M Offering Of 10,156,250 Shares Of Our Common Stock, Together With Warrants To Initially Purchase Up To 15,234,375 Shares Of Common Stock; The Combined Price For Each Share Of Common Stock And Accompanying May 2025 Warrant Is $0.32

Wells Fargo analyst Cerena Chen maintains Axsome Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AXSM#NASDAQ">AXSM</a>) with a Overweight and raises the price target from $160 to $165.

AXSM

Wells Fargo Maintains Overweight on Axsome Therapeutics, Raises Price Target to $165

WIIM

Transdigm Group shares are trading lower after the company reported a Q2 sales miss and announced its CEO will retire this year.

Oppenheimer analyst Michael Tames maintains Denny's (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/DENN#NASDAQ">DENN</a>) with a Outperform and lowers the price target from $7 to $6.

DENN

Oppenheimer Maintains Outperform on Denny's, Lowers Price Target to $6

Wells Fargo analyst Larry Biegelsen maintains Zimmer Biomet Holdings (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/ZBH#NYSE">ZBH</a>) with a Equal-Weight and lowers the price target from $113 to $98.

Wells Fargo Maintains Equal-Weight on Zimmer Biomet Holdings, Lowers Price Target to $98

Benchmark analyst Mark Zgutowicz maintains Shopify (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SHOP#NASDAQ">SHOP</a>) with a Buy and lowers the price target from $150 to $125.

SHOP

Benchmark Maintains Buy on Shopify, Lowers Price Target to $125

<ul>
<li>The WRAPSODY CIE is designed to help physicians prolong functional vascular access in hemodialysis patients.</li>
<li>Approval was supported by superior 12-month target lesion primary patency (70.1%) and access circuit primary patency (58.1%) in the randomized arm of the trial.</li>
</ul>
SOUTH JORDAN, Utah, May 06, 2025 (GLOBE NEWSWIRE) -- Merit Medical Systems, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MMSI#NASDAQ">MMSI</a>), a global leader of healthcare technology, announced today that the Wrapsody Cell-Impermeable Endoprosthesis (CIE) received regulatory approval from Health Canada. With this approval, Merit intends to begin immediate commercialization of the device throughout Canada with devices shipped from Merit's Toronto distribution center.

MMSI

Merit Medical Systems Receives Health Canada Regulatory Approval For Wrapsody Cell-Impermeable Endoprosthesis

Wells Fargo analyst Larry Biegelsen maintains Inspire Medical Systems (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/INSP#NYSE">INSP</a>) with a Equal-Weight and lowers the price target from $195 to $174.

INSP

Wells Fargo Maintains Equal-Weight on Inspire Medical Systems, Lowers Price Target to $174

TSLA

Tesla shares are trading lower amid reports that new car sales in the UK and Germany hit two-year lows. An additional report stated the company has over 10,000 units of Cybertruck inventory.

Wells Fargo analyst Stephen Baxter maintains CVS Health (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/CVS#NYSE">CVS</a>) with a Overweight and raises the price target from $76 to $84.

Wells Fargo Maintains Overweight on CVS Health, Raises Price Target to $84

Gartner Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/IT#NYSE">IT</a>) reported first-quarter FY25 revenue growth of 4.2% year-on-year to $1.53 billion, which is in line with the analyst consensus estimate.
Global Contract Value climbed 6.7% to $5.1 billion. Global Technology Sales Contract Value (GTS CV) increased 5.5% Y/Y to $3.9 billion and Global Business Sales Contract Value (GBS CV) jumped 10.8% to $1.2 billion.
Selling, general and administrative expenses increased 5.8% to $730.3 million. Operating income for the quarter increased 1.4% to $278 million and the operating margin contracted 50 basis points to 18.1%.
Also Read: <a href="https://www.benzinga.com/analyst-ratings/price-target/25/05/45205131/peloton-profit-push-faces-subscriber-setbacks-and-tariff-troubles">Peloton Faces Subscriber Setbacks, Tariff Troubles Despite Profit Push</a>
Adjusted EBITDA for the quarter increased 0.7% to $385 million with an adjusted EBITDA margin of 24.9%. Adjusted EPS of $2.98 <a href="https://www.benzinga.com/earnings">beat the consensus </a>estimate of $2.72.
The company<a href="https://www.sec.gov/ix?doc=/Archives/edgar/data/0000749251/000074925125000028/it-20250331.htm"> held $2.1 billion in cash</a> and equivalents as of March 31, 2025.
Operating cash flow for the quarter was $314 million, with a free cash flow of $288 million.
&#8220;In a dynamic world, we are managing our costs to deliver Adjusted EBITDA Margin ahead of our initial guidance while also investing for future growth,&#8221; Gene Hall, Gartner's CEO said. &#8220;We continue to provide significant value to our clients and will emerge from the current environment even stronger."
Price Action: IT shares traded lower by 0.23% at $426.00 in premarket at last check Tuesday.
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Photo: Shutterstock

Consulting Firm Gartner Q1 Earnings Beat Estimates As Contract Value Climbs

Keybanc analyst Philip Gibbs maintains Olympic Steel (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ZEUS#NASDAQ">ZEUS</a>) with a Overweight and lowers the price target from $43 to $41.

ZEUS

Keybanc Maintains Overweight on Olympic Steel, Lowers Price Target to $41

Wells Fargo analyst Elyse Greenspan maintains Everest Group (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/EG#NYSE">EG</a>) with a Equal-Weight and lowers the price target from $362 to $361.

Wells Fargo Maintains Equal-Weight on Everest Group, Lowers Price Target to $361

Oppenheimer analyst Tyler Batory maintains Invitation Homes (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/INVH#NYSE">INVH</a>) with a Outperform and raises the price target from $39 to $41.

INVH

Oppenheimer Maintains Outperform on Invitation Homes, Raises Price Target to $41

Wells Fargo analyst Elyse Greenspan maintains Allstate (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/ALL#NYSE">ALL</a>) with a Equal-Weight and lowers the price target from $200 to $197.

Wells Fargo Maintains Equal-Weight on Allstate, Lowers Price Target to $197

Top Wall Street analysts changed their outlook on these top names. For a complete view of all analyst rating changes, including upgrades, downgrades and initiations, please see our <a href="https://www.benzinga.com/analyst-stock-ratings">analyst ratings page</a>.
<ul>
<li>Hovde Group analyst Brendan Nosal upgraded the rating for Lakeland Financial Corporation (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/LKFN#NASDAQ">LKFN</a>) from Market Perform to Outperform. Lakeland Financial shares closed at $59.22 on Monday. <a href="https://www.benzinga.com/quote/LKFN/analyst-ratings">See how other analysts view this stock</a>.</li>
<li>Hovde Group analyst Brendan Nosal upgraded HBT Financial, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/HBT#NASDAQ">HBT</a>) from Market Perform to Outperform. HBT Finl shares closed at $23.57 on Monday. <a href="https://www.benzinga.com/quote/HBT/analyst-ratings">See how other analysts view this stock</a>.</li>
<li>Hovde Group analyst Brendan Nosal upgraded First Savings Financial Group, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/FSFG#NASDAQ">FSFG</a>) from Market Perform to Outperform. First Savings Financial shares closed at $27.50 on Monday. <a href="https://www.benzinga.com/quote/FSFG/analyst-ratings">See how other analysts view this stock</a>.</li>
<li>Hovde Group analyst Brendan Nosal upgraded Bank First Corporation (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BFC#NASDAQ">BFC</a>) from Market Perform to Outperform. Bank First shares closed at $114.52 on Monday. <a href="https://www.benzinga.com/quote/BFC/analyst-ratings">See how other analysts view this stock</a>.</li>
</ul>
Considering buying LKFN stock? Here&#8217;s what analysts think:
<figure class="wp-block-image is-resized"><img decoding="async" src="blob:https://editorial.benzinga.com/d1be1c3c-8bb9-462a-835f-7e263251e645" alt="" style="width:660px;height:auto" /></figure>
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<li><a href="https://www.benzinga.com/markets/25/05/45192607/jim-cramer-applied-materials-is-an-excellent-company-but-likes-this-tech-stock-more">Jim Cramer Says Applied Materials Is An &#8216;Excellent&#8217; Company, But Likes This Tech Stock More</a> </li>
</ul>
Photo via Shutterstock

Upgrades

Markets

FSFG

LKFN

This Lakeland Financial Analyst Turns Bullish; Here Are Top 4 Upgrades For Tuesday

Keybanc analyst John Vinh maintains Lattice Semiconductor (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/LSCC#NASDAQ">LSCC</a>) with a Overweight and lowers the price target from $75 to $70.

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