Ultime notizie per ESSA Pharma (NASDAQ:EPIX) Azioni

ESSA Pharma

ESSA Pharma Inc is a pharmaceutical company. The company is focused on the development of small molecule drugs for the treatment of castration-resistant prostate cancer. The company is developing drugs that selectively block the amino-terminal domain of the androgen receptor, potentially overcoming the known AR-dependent resistance mechanisms of CRPC and providing CRPC patients with the potential for increased progression-free and overall survival.

ESSA Pharma Inc

General

EPIX

ESSA Pharma shares are trading lower after Oppenheimer downgraded the stock from Outperform to Perform. Piper Sandler downgraded its rating from Overweight to Neutral and cut its price target from $15 to $2.

Piper Sandler analyst Joseph Catanzaro downgrades ESSA Pharma (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/EPIX#NASDAQ">EPIX</a>) from Overweight to Neutral and lowers the price target from $15 to $2.

News

Downgrades

Price Target

Analyst Ratings

Piper Sandler Downgrades ESSA Pharma to Neutral, Lowers Price Target to $2

Oppenheimer analyst Leland Gershell downgrades ESSA Pharma (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/EPIX#NASDAQ">EPIX</a>) from Outperform to Perform.

Oppenheimer Downgrades ESSA Pharma to Perform

U.S. stocks traded higher toward the end of trading, with the Nasdaq Composite gaining more than 100 points on Friday.
The Dow traded up 0.67% to 42,043.38 while the NASDAQ surged 0.75% to 18,230.53. The S&amp;P 500 also rose, gaining, 0.47% to 5,732.21.
Check This Out: <a href="https://www.benzinga.com/news/24/10/41653495/top-2-real-estate-stocks-you-may-want-to-dump-this-quarter">Top 2 Real Estate Stocks You May Want To Dump This Quarter</a>
Leading and Lagging Sectors Consumer discretionary shares rose by 2.3% on Friday.
In trading on Friday, utilities shares fell by 2.1%.
Top Headline
Apple Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AAPL#NASDAQ">AAPL</a>) shares fell around 2% on Friday after the company reported results for the fourth quarter.
The company reported fiscal fourth-quarter revenue of $94.9 billion, beating analyst estimates of $94.56 billion. The iPhone maker reported fourth-quarter adjusted earnings of $1.64 per share, beating analyst estimates of $1.60 per share.
<h3 class="wp-block-heading">Equities Trading UP &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;</h3>
<ul>
<li>ChromaDex Corporation (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CDXC#NASDAQ">CDXC</a>) shares shot up 53% to $5.34 after the company reported a year-over-year increase in third-quarter EPS results and raised its FY24 revenue guidance.</li>
<li>Shares of Proto Labs, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/PRLB#NASDAQ">PRLB</a>) got a boost, surging 33% to $36.42 after the company reported better-than-expected third-quarter financial results and issued fourth-quarter adjusted EPS guidance with its midpoint above estimates.</li>
<li>Interface, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TILE#NASDAQ">TILE</a>) shares were also up, gaining 33% to $23.23 after the company reported better-than-expected third-quarter financial results and raised its FY24 net sales guidance above estimates.</li>
</ul>
Equities Trading DOWN
<ul>
<li>ESSA Pharma Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/EPIX#NASDAQ">EPIX</a>) shares dropped 71% to $1.51 after the company announced it terminated its Phase 2 study evaluating masofaniten combined with enzalutamide in patients with mCRPC.</li>
<li>Shares of Myriad Genetics, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MYGN#NASDAQ">MYGN</a>) were down 21% to $17.30. Myriad Genetics will hold its third quarter earnings conference call on Thursday, Nov. 7.</li>
<li>Lexicon Pharmaceuticals, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/LXRX#NASDAQ">LXRX</a>) was down, falling 37% to $1.2250. Lexicon Pharmaceuticals announced the outcome of the FDA's Endocrinologic and Metabolic Drugs Advisory Committee Meeting to review the company's New Drug Application (NDA) for Zynquista (sotagliflozin). The company is seeking approval for the oral SGLT1/SGLT2 inhibitor as an adjunct to insulin therapy for glycemic control in adults with type 1 diabetes (T1D) and chronic kidney disease (CKD).</li>
</ul>
Commodities In commodity news, oil traded up 0.8% to $69.79 while gold traded down 0.1% at $2,745.60.
Silver traded down 0.7% to $32.555 on Friday, while copper rose 0.3% to $4.3520.
Euro zone
European shares were higher today. The eurozone's STOXX 600 gained 1.09%, Germany's DAX gained 0.93% and France's CAC 40 gained 0.80%. Spain's IBEX 35 Index surged 1.46%, while London's FTSE 100 rose 0.83%.
Asia Pacific Markets
Asian markets closed mostly lower on Friday, with Japan's Nikkei 225 falling 2.63%, Hong Kong's Hang Seng Index gaining 0.93%, China's Shanghai Composite Index declining 0.24% and India's BSE Sensex falling 0.27%.
Economics
<ul>
<li>The U.S. economy added 12,000 jobs in October compared to a revised 223,000 gain in September and versus market estimates of 113,000.</li>
<li>Average hourly earnings increased by 0.4% over a month to $35.46 in October, while unemployment rate came in unchanged at 4.1% in October.</li>
<li>U.S. construction spending increased by 0.1% month-over-month to an annual rate of $2,148.8 billion in September.</li>
<li>The S&amp;P Global Flash manufacturing PMI was revised upward to 48.5 in October versus a preliminary reading of 47.8.</li>
<li>The ISM manufacturing PMI declined to 46.5 in October versus 47.2 in the previous month and down from estimates of 47.6.</li>
<li>The total number of active U.S. oil rigs fell by one to 479 rigs this week, Baker Hughes Inc reported.</li>
</ul>
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</ul>

Earnings

Equities

Eurozone

Commodities

Markets

Trading Ideas

AAPL

CDXC

LXRX

MYGN

PRLB

TILE

Crude Oil Moves Higher; Apple Shares Slide After Q4 Results

U.S. stocks traded higher midway through trading, with the Nasdaq Composite gaining more than 200 points on Friday.
The Dow traded up 1.18% to 42,254.81 while the NASDAQ surged 1.31% to 18,332.35. The S&amp;P 500 also rose, gaining, 0.95% to 5,759.63.
Check This Out: <a href="https://www.benzinga.com/news/24/10/41653495/top-2-real-estate-stocks-you-may-want-to-dump-this-quarter">Top 2 Real Estate Stocks You May Want To Dump This Quarter</a>
Leading and Lagging Sectors Consumer discretionary shares rose by 2.9% on Friday.
In trading on Friday, utilities shares fell by 1.1%.
Top Headline
Amazon.com Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AMZN#NASDAQ">AMZN</a>) shares surged 7% on Friday after the copany posted stronger-than-expected results for the third quarter.
Amazon reported third-quarter net sales of $158.9 billion, up 11% year-over-year. The total beat a Street consensus estimate of $157.2 billion, according to data from Benzinga Pro. The company said it sees fourth-quarter net sales to come in a range of $181.5 billion to $188.5 billion, up 7% to 11% year-over-year.
Equities Trading UP &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;
<ul>
<li>ChromaDex Corporation (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CDXC#NASDAQ">CDXC</a>) shares shot up 55% to $5.41 after the company reported a year-over-year increase in third-quarter EPS results and raised its FY24 revenue guidance.</li>
<li>Shares of Proto Labs, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/PRLB#NASDAQ">PRLB</a>) got a boost, surging 31% to $36.54 after the company reported better-than-expected third-quarter financial results and issued fourth-quarter adjusted EPS guidance with its midpoint above estimates.</li>
<li>Interface, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TILE#NASDAQ">TILE</a>) shares were also up, gaining 33% to $23.15 after the company reported better-than-expected third-quarter financial results and raised its FY24 net sales guidance above estimates.</li>
</ul>
Equities Trading DOWN
<ul>
<li>ESSA Pharma Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/EPIX#NASDAQ">EPIX</a>) shares dropped 70% to $1.58 after the company announced it terminated its Phase 2 study evaluating masofaniten combined with enzalutamide in patients with mCRPC.</li>
<li>Shares of Myriad Genetics, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MYGN#NASDAQ">MYGN</a>) were down 21% to $17.24. Myriad Genetics will hold its third quarter earnings conference call on Thursday, Nov. 7.</li>
<li>Lexicon Pharmaceuticals, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/LXRX#NASDAQ">LXRX</a>) was down, falling 36% to $1.2550. Lexicon Pharmaceuticals announced the outcome of the FDA's Endocrinologic and Metabolic Drugs Advisory Committee Meeting to review the company's New Drug Application (NDA) for Zynquista (sotagliflozin). The company is seeking approval for the oral SGLT1/SGLT2 inhibitor as an adjunct to insulin therapy for glycemic control in adults with type 1 diabetes (T1D) and chronic kidney disease (CKD).</li>
</ul>
Commodities In commodity news, oil traded up 1.1% to $70.04 while gold traded up 0.2% at $2,753.70.
Silver traded down 0.1% to $32.755 on Friday, while copper rose 0.5% to $4.3635.
Euro zone
European shares were higher today. The eurozone's STOXX 600 gained 1.25%, Germany's DAX gained 1.10% and France's CAC 40 gained 1.05%. Spain's IBEX 35 Index surged 1.42%, while London's FTSE 100 rose 1.06%.
Asia Pacific Markets
Asian markets closed mostly lower on Friday, with Japan's Nikkei 225 falling 2.63%, Hong Kong's Hang Seng Index gaining 0.93%, China's Shanghai Composite Index declining 0.24% and India's BSE Sensex falling 0.27%.
Economics
<ul>
<li>The U.S. economy added 12,000 jobs in October compared to a revised 223,000 gain in September and versus market estimates of 113,000.</li>
<li>Average hourly earnings increased by 0.4% over a month to $35.46 in October, while unemployment rate came in unchanged at 4.1% in October.</li>
<li>U.S. construction spending increased by 0.1% month-over-month to an annual rate of $2,148.8 billion in September.</li>
<li>The S&amp;P Global Flash manufacturing PMI was revised upward to 48.5 in October versus a preliminary reading of 47.8.</li>
<li>The ISM manufacturing PMI declined to 46.5 in October versus 47.2 in the previous month and down from estimates of 47.6.</li>
</ul>
Now Read This: 
<ul>
<li><a href="Top%202%20Utilities%20Stocks%20That%20May%20Crash%20This%20Quarter">Top 2 Utilities Stocks That May Crash This Quarter</a></li>
</ul>

AMZN

Nasdaq Surges Over 200 Points; Amazon Shares Jump After Strong Results

U.S. stocks traded higher this morning, with the Dow Jones index gaining more than 400 points on Friday.
The Dow traded up 1% to 42,182.88 while the NASDAQ surged 1.18% to 18,309.37. The S&amp;P 500 also rose, gaining, 0.98% to 5,761.25.
Check This Out: <a href="https://www.benzinga.com/news/24/10/41653495/top-2-real-estate-stocks-you-may-want-to-dump-this-quarter">Top 2 Real Estate Stocks You May Want To Dump This Quarter</a>
Leading and Lagging Sectors Consumer discretionary shares rose by 3.1% on Friday.
In trading on Friday, utilities shares fell by 0.1%.
Top Headline
The U.S. economy added 12,000 jobs in October compared to a revised 223,000 gain in September and versus market estimates of 113,000.
Average hourly earnings increased by 0.4% over a month to $35.46 in October, while unemployment rate came in unchanged at 4.1% in October.
Equities Trading UP &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;
<ul>
<li>ChromaDex Corporation (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CDXC#NASDAQ">CDXC</a>) shares shot up 55% to $5.38 after the company reported a year-over-year increase in third-quarter EPS results and raised its FY24 revenue guidance.</li>
<li>Shares of Proto Labs, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/PRLB#NASDAQ">PRLB</a>) got a boost, surging 33% to $36.54 after the company reported better-than-expected third-quarter financial results and issued fourth-quarter adjusted EPS guidance with its midpoint above estimates.</li>
<li>Interface, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TILE#NASDAQ">TILE</a>) shares were also up, gaining 32% to $23.04 after the company reported better-than-expected third-quarter financial results and raised its FY24 net sales guidance above estimates.</li>
</ul>
Equities Trading DOWN
<ul>
<li>ESSA Pharma Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/EPIX#NASDAQ">EPIX</a>) shares dropped 70% to $1.5450 after the company announced it terminated its Phase 2 study evaluating masofaniten combined with enzalutamide in patients with mCRPC.</li>
<li>Shares of Elevai Labs Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ELAB#NASDAQ">ELAB</a>) were down 45% to $0.0325.</li>
<li>Lexicon Pharmaceuticals, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/LXRX#NASDAQ">LXRX</a>) was down, falling 34% to $1.2790. Lexicon Pharmaceuticals announced the outcome of the FDA's Endocrinologic and Metabolic Drugs Advisory Committee Meeting to review the company's New Drug Application (NDA) for Zynquista (sotagliflozin). The company is seeking approval for the oral SGLT1/SGLT2 inhibitor as an adjunct to insulin therapy for glycemic control in adults with type 1 diabetes (T1D) and chronic kidney disease (CKD).</li>
</ul>
Commodities In commodity news, oil traded up 1.5% to $70.39 while gold traded up 0.4% at $2,761.30.
Silver traded up 0.3% to $32.890 on Friday, while copper rose 0.4% to $4.3575.
Euro zone
European shares were higher today. The eurozone's STOXX 600 gained 1%, Germany's DAX gained 0.8% and France's CAC 40 gained 0.7%. Spain's IBEX 35 Index surged 1.2%, while London's FTSE 100 rose 0.8%.
Asia Pacific Markets
Asian markets closed mostly lower on Friday, with Japan's Nikkei 225 falling 2.63%, Hong Kong's Hang Seng Index gaining 0.93%, China's Shanghai Composite Index declining 0.24% and India's BSE Sensex falling 0.27%.
Economics
<ul>
<li>The U.S. economy added 12,000 jobs in October compared to a revised 223,000 gain in September and versus market estimates of 113,000.</li>
<li>Average hourly earnings increased by 0.4% over a month to $35.46 in October, while unemployment rate came in unchanged at 4.1% in October.</li>
<li>U.S. construction spending increased by 0.1% month-over-month to an annual rate of $2,148.8 billion in September.</li>
<li>The S&amp;P Global Flash manufacturing PMI was revised upward to 48.5 in October versus a preliminary reading of 47.8.</li>
<li>The ISM manufacturing PMI declined to 46.5 in October versus 47.2 in the previous month and down from estimates of 47.6.</li>
</ul>
Now Read This: 
<ul>
<li><a href="Top%202%20Utilities%20Stocks%20That%20May%20Crash%20This%20Quarter">Top 2 Utilities Stocks That May Crash This Quarter</a></li>
</ul>

ELAB

Dow Jumps 400 Points; US Adds 12,000 Jobs In October

On Thursday, ESSA Pharma Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/EPIX#NASDAQ">EPIX</a>) announced its plans to terminate the Phase 2 trial of masofaniten combined with enzalutamide versus enzalutamide single agent in patients with metastatic castration-resistant prostate cancer (mCRPC) naïve to <a target="_blank" href="https://www.benzinga.com/pressreleases/24/10/n41669391/essa-pharma-announces-termination-of-phase-2-study-evaluating-masofaniten-combined-with-enzalutami" rel="noreferrer noopener">second-generation antiandrogens</a>.
This decision was based on a protocol-specified interim review of the safety, PK, and efficacy data, which showed a much higher rate of PSA90 response in patients treated with Pfizer Inc&#8217;s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>) Xtandi (enzalutamide) monotherapy (which is the standard of care for this patient population) than expected based on historical data.
In addition, there was no clear efficacy benefit seen with the combination of masofaniten plus enzalutamide compared to enzalutamide single agent.
A futility analysis determined a low likelihood of meeting the prespecified primary endpoint of the study.
The combination of masofaniten plus enzalutamide was well-tolerated with no new safety signals and a safety profile similar to that seen in Phase 1 studies.
&#8220;We made the difficult decision to terminate this Phase 2 study following the interim analysis because we concluded that the emerging efficacy profile of masofaniten combined with enzalutamide would not likely meet the primary endpoint of the study, nor our internal requirements for a prostate cancer therapy candidate,&#8221; said&nbsp;David Parkinson, President, and CEO.
As part of the effort to focus its resources, ESSA is also planning to terminate the other remaining company-sponsored and investigator-sponsored clinical studies evaluating masofaniten either as a monotherapy or in combination <a target="_blank" href="https://www.benzinga.com/pressreleases/24/09/n40862721/essa-pharma-presents-updated-phase-12-masofaniten-epi-7386-clinical-data-at-the-2024-esmo-congress" rel="noreferrer noopener">with other agents</a>.
As of&nbsp;September 30, 2024, the company had available cash reserves and short-term investments of&nbsp;$126.8 million&nbsp;and net working capital of&nbsp;$124.3 million.
In September, ESSA Pharma announced the presentation of updated dose escalation data from its Phase 1/2 study of masofaniten (formerly EPI-7386) in combination with enzalutamide at the 2024 European Society for Medical Oncology (ESMO) Congress.
Across all dose cohorts, 88% of patients (14 of 16) achieved PSA50, 88% of patients (14 of 16) achieved PSA90, 69% of patients (11 of 16) achieved PSA90 in less than 90 days, and 63% of patients (10 of 16) achieved PSA &lt;0.2ng/mL.
Price Action: EPIX stock was down 69.80% at $1.57 during the premarket session at the last check on Friday.
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Biotech

Health Care

Movers

Cancer-Focused ESSA Pharma Ends Prostate Cancer Trial Due to Insufficient Efficacy From Combination Therapy

Shares of Charter Communications, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CHTR#NASDAQ">CHTR</a>) rose sharply in today's pre-market trading after the company reported better-than-expected <a href="https://www.benzinga.com/news/earnings/24/11/41684534/charter-communications-beats-q3-estimates-on-strong-mobile-growth-expanding-margins">third-quarter EPS and revenues.</a>
Charter Communications reported fiscal third-quarter 2024 revenue growth of 1.6% year-on-year to $13.8 billion, beating the analyst consensus estimate of $13.7 billion. EPS of $8.82 beat the analyst consensus estimate of $8.67
Charter Communications shares rose 11.1% to $364.01 in the pre-market trading session.
Here are some other stocks moving in pre-market trading.
<h3 class="wp-block-heading">Gainers</h3>
<ul>
<li>Globalstar, Inc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GSAT#NYSE">GSAT</a>) gained 41.9% to $1.49 in pre-market trading after the company announced a proposed public offering.</li>
<li>Theriva Biologics, Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/TOVX#NYSE">TOVX</a>) rose 41.1% to $2.06 in pre-market trading after the company announced it was selected as a finalist for Merck KGaA&#8217;s EMEA Advance Biotech Grant.</li>
<li>Athira Pharma, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ATHA#NASDAQ">ATHA</a>) shares surged 31.1% to $0.5610 in pre-market trading.</li>
<li>VS MEDIA Holdings Limited (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/VSME#NASDAQ">VSME</a>) climbed 30% to $1.43 in pre-market trading after declining 11% on Thursday.</li>
<li>Atlassian Corporation (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TEAM#NASDAQ">TEAM</a>) gained 22.5% to $231.06 in pre-market trading after the company reported better-than-expected first-quarter financial results and issued second-quarter revenue guidance above estimates.</li>
<li>Nuburu, Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BURU#NYSE">BURU</a>) gained 18.6% to $0.5340 in pre-market trading.</li>
<li>Proto Labs, Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PRLB#NYSE">PRLB</a>) gained 18.3% to $32.43 in pre-market trading after the company reported better-than-expected third-quarter financial results and issued fourth-quarter adjusted EPS guidance with its midpoint above estimates.</li>
<li>comScore, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SCOR#NASDAQ">SCOR</a>) shares rose 17.3% to $6.45 in pre-market trading.</li>
<li>Halozyme Therapeutics, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/HALO#NASDAQ">HALO</a>) gained 12.8% to $57.04 in pre-market trading after the company reported better-than-expected third-quarter financial results and issued FY24 adjusted EPS guidance above estimates.</li>
</ul>
<h3 class="wp-block-heading">Losers</h3>
<ul>
<li>ESSA Pharma Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/EPIX#NASDAQ">EPIX</a>) shares dipped 69.2% to $1.60 in pre-market trading. ESSA Pharma terminated Phase 2 study evaluating Masofaniten combined with Enzalutamide in patients with mCRPC.</li>
<li>Lexicon Pharmaceuticals, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/LXRX#NASDAQ">LXRX</a>) fell 37.4% to $1.2207 in pre-market trading.</li>
<li>Elevai Labs Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ELAB#NASDAQ">ELAB</a>) fell 35% to $0.0383 in pre-market trading.</li>
<li>MultiMetaVerse Holdings Limited (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MMV#NASDAQ">MMV</a>) declined 24.1% to $0.3331 in pre-market trading.</li>
<li>Arbe Robotics Ltd. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ARBE#NASDAQ">ARBE</a>) declined 18.7% to $1.4800 in pre-market trading after the company announced a public offering.</li>
<li>Advent Technologies Holdings, Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/ADN#NYSE">ADN</a>) fell 15.8% to $1.9899 in pre-market trading after jumping around 34% on Thursday.</li>
<li>ASP Isotopes Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ASPI#NASDAQ">ASPI</a>) fell 8.4% to $6.40 in pre-market trading after the company announced a proposed public offering.</li>
<li>BJ&#8217;s Restaurants, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BJRI#NASDAQ">BJRI</a>) fell 6.3% to $34.75 in today's pre-market trading after the company announced worse-than-expected third-quarter EPS results.</li>
<li>nVent Electric plc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVT#NYSE">NVT</a>) shares fell 6.1% to $70.00 in pre-market trading after the company reported third-quarter results.</li>
<li>DigitalBridge Group, Inc.  (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/DBRG#NASDAQ">DBRG</a>) declined 6% to $14.75 in pre-market trading after the company reported weaker-than-expected third-quarter results.</li>
</ul>
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</ul>

Pre-Market Outlook

ARBE

ASPI

ATHA

BJRI

BURU

CHTR

DBRG

GSAT

HALO

Eaton Vance Massachusetts Municipal Income Trust

SCOR

TEAM

TOVX

VSME

Why Charter Communications Shares Are Trading Higher By Around 11%; Here Are 20 Stocks Moving Premarket

Jones Trading analyst Soumit Roy downgrades ESSA Pharma (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/EPIX#NASDAQ">EPIX</a>) from Buy to Hold.

Jones Trading Downgrades ESSA Pharma to Hold

WIIM

ESSA Pharma shares are trading lower after the company announced it terminated its Phase 2 study evaluating masofaniten combined with enzalutamide in patients with mCRPC

Efficacy signals observed will not achieve ESSA's target product profile in patients with metastatic castration-resistant prostate cancer naïve to second-generation antiandrogens
&nbsp;A futility analysis conducted as part of a protocol-specified interim review of the safety, PK and efficacy data showed the single-agent enzalutamide control arm performing better than historical controls and similar to the combination of masofaniten and enzalutamide and therefore, unlikely to achieve the primary endpoint of the study&nbsp;
Additional clinical studies with masofaniten including the combination study with abiraterone acetate and apalutamide as well as the remaining investigator sponsored trials will also be terminated and the IND and CTAs in different geographies will be withdrawn
Company will initiate a process to explore and review strategic options focused on maximizing shareholder value

Reported Earlier, ESSA Pharma Terminates Phase 2 Study Evaluating Masofaniten Combined With Enzalutamide In Patients With mCRPC

ESSA Pharma shares are trading higher after the company announced it presented data on prostate cancer therapy Masofaniten at ESMO 2024.

ESSA Pharma Inc. ("ESSA", or the "Company") (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/EPIX#NASDAQ">EPIX</a>), a clinical-stage pharmaceutical company focused on developing novel therapies for the treatment of prostate cancer, today announced the presentation of updated dose escalation data from its Phase 1/2 study evaluating masofaniten (formerly EPI-7386) in combination with enzalutamide at the 2024 European Society for Medical Oncology (ESMO) Congress, taking place September 13-17, 2024, in Barcelona, Spain. Masofaniten is a first-in-class N-terminal domain androgen receptor ("AR") inhibitor that suppresses androgen activity through a novel mechanism of action and is being developed for the treatment of prostate cancer. The poster presentation is available on the "Publications" section of the Company's website at&nbsp;www.essapharma.com.
"We are pleased to be sharing more mature data from the Phase 1 dose escalation study evaluating masofaniten in combination with enzalutamide today at ESMO 2024. The combination continues to be well tolerated with prolonged reductions in circulating prostate-specific antigen ("PSA") levels in patients with metastatic castration-resistant prostate cancer ("mCRPC"). After 15.2 months of follow up, neither median time to PSA progression nor radiographic progression free survival have been reached. These data compare favorably to historical data for single agent enzalutamide treatment in the mCRPC patient population," said David Parkinson, MD, President and CEO of ESSA. "We continue to focus on the enrollment of the Phase 2 dose expansion study evaluating masofaniten in combination with enzalutamide, with 33 sites activated in the US,&nbsp;Canada&nbsp;and&nbsp;Australia&nbsp;and an additional 22 sites anticipated in&nbsp;Europe. We look forward to providing further updates in 2025."
Poster presentation details:
&nbsp;
Title:&nbsp;Phase 1/2 trial of oral EPI-7386 (masofaniten) in combination with enzalutamide (Enz) compared with Enz alone in subjects with metastatic castration-resistant prostate cancer (mCRPC): Phase 1 results and Phase 2 design
Presenting Author:&nbsp;Christos Kyriakopoulos, MD, University of Wisconsin-Madison Carbone Cancer Center
Presentation #: 1641P Date and time: Sunday, September 15, 2024; 12:00-1:30 p.m. CEST/ 6:00-7:30 a.m. ET

Prior Reported, ESSA Pharma Presents Data on Prostate Cancer Therapy Masofaniten at ESMO 2024, Shows Prolonged PSA Reduction

Oppenheimer analyst Leland Gershell maintains ESSA Pharma (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/EPIX#NASDAQ">EPIX</a>) with a Outperform and maintains $17 price target.

Oppenheimer Maintains Outperform on ESSA Pharma, Maintains $17 Price Target

ESSA Pharma (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/EPIX#NASDAQ">EPIX</a>) reported its Q1 earnings results on Tuesday, February 13, 2024 at 07:00 AM.
Here's what investors need to know about the announcement.
<h3>Earnings</h3>
ESSA Pharma beat estimated earnings by 17.65%, reporting an EPS of $-0.14 versus an estimate of $-0.17.
Revenue was down $0 from the same period last year.
<h3>Past Earnings Performance</h3>
Last quarter the company beat on EPS by $0.09 which was followed by a 0.36% increase in the share price the next day.

&#x2A;&#x2A; Listen to the earnings announcement yourself by <a href="">clicking here</a>. &#x2A;&#x2A;
To track all earnings releases for ESSA Pharma <a href="https://www.benzinga.com/quote/EPIX/earnings">visit their earnings calendar here.</a> 
This article was generated by Benzinga's automated content engine and reviewed by an editor.

ESSA Pharma: Q1 Earnings Insights

ESSA Pharma (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/EPIX#NASDAQ">EPIX</a>) has outperformed the market over the past 5 years by 3.09% on an annualized basis producing an average annual return of 15.65%. Currently, ESSA Pharma has a market capitalization of $297.22 million. 
Buying $1000 In EPIX: If an investor had bought $1000 of EPIX stock 5 years ago, it would be worth $2,060.30 today based on a price of $6.73 for EPIX at the time of writing.
<h3>ESSA Pharma's Performance Over Last 5 Years</h3>
<img src="https://www.benzinga.com/files/images/story/2024/1706634367_0.png" alt="comp_fig" />
Finally -- what's the point of all this? The key insight to take from this article is to note how much of a difference compounded returns can make in your cash growth over a period of time.
This article was generated by Benzinga's automated content engine and reviewed by an editor.

$1000 Invested In This Stock 5 Years Ago Would Be Worth $2,100 Today

U.S. stocks traded mixed, with the Dow Jones gaining around 80 points on Friday.
Shares of Booz Allen Hamilton Holding Corporation (NYSE: <a class="ticker" href="https://www.benzinga.com/stock/bah#NYSE">BAH</a>) rose sharply during Friday&rsquo;s session after the company reported better-than-expected third-quarter financial results, increased its quarterly dividend and <a href="https://www.benzinga.com/quote/BAH/earnings">raised FY24 guidance</a>.
Booz Allen Hamilton posted adjusted earnings of $1.41 per share, beating market estimates of $1.14 per share. The company&rsquo;s quarterly sales came in at $2.57 billion versus expectations of $2.54 billion, according to data from <a href="https://pro.benzinga.com/">Benzinga Pro</a>.
Booz Allen Hamilton shares jumped 13.2% to $145.90 on Friday.
Here are some other big stocks recording gains in today&rsquo;s session.
<ul>
<li>AppFolio, Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/appf#NASDAQ">APPF</a>) surged 25.7% to $219.23 after the company reported better-than-expected fourth-quarter financial results and issued guidance.</li>
<li>Vera Therapeutics, Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/vera#NASDAQ">VERA</a>) gained 20.6% to $30.54. Raymond James analyst Steven Seedhouse upgraded Vera Therapeutics from Outperform to Strong Buy and raised the price target from $29 to $37.</li>
<li>eHealth, Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/ehth#NASDAQ">EHTH</a>) jumped 19.8% to $6.70 after the company announced preliminary results for the fourth quarter.</li>
<li>Tellurian Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/tell#NASDAQ">TELL</a>) shares rose 16.6% to $0.6067 following a report suggesting the company hired Lazard to explore a possible sale.</li>
<li>Cipher Mining Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/cifr#NASDAQ">CIFR</a>) climbed 11.8% to $2.64.</li>
<li>Lumen Technologies, Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/lumn#NASDAQ">LUMN</a>) gained 11.2% to $1.5350 after the company announced that it entered into an amended and rested transaction support agreement with a group of creditors.</li>
<li>ESSA Pharma Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/epix#NASDAQ">EPIX</a>) gained 11% to $7.55.</li>
<li>Mereo BioPharma Group plc (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/mreo#NASDAQ">MREO</a>) rose 10.5% to $4.0207.</li>
<li>Freedom Holding Corp. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/frhc#NASDAQ">FRHC</a>) gained 8.5% to $84.98 after the company announced the conclusion of an external review of allegations made in a short-seller report.</li>
<li>CleanSpark, Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/clsk#NASDAQ">CLSK</a>) climbed 7.8% to $7.88.</li>
<li>Repligen Corporation (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/rgen#NASDAQ">RGEN</a>) rose 7.3% to $199.07.</li>
<li>American Express Company (NYSE: <a class="ticker" href="https://www.benzinga.com/stock/axp#NYSE">AXP</a>) climbed 7.2% to $201.61 after the company posted quarterly results and plans to increase the regular quarterly dividend by 17%.</li>
<li>Avid Bioservices, Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/cdmo#NASDAQ">CDMO</a>) rose 7.2% to $7.42.</li>
<li>First Financial Bankshares, Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/ffin#NASDAQ">FFIN</a>) rose 6.9% to $32.29 after the company reported fourth-quarter financial results.</li>
<li>The Bancorp, Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/tbbk#NASDAQ">TBBK</a>) climbed 6.6% to $43.18 after the company reported better-than-expected fourth-quarter sales results.</li>
<li>Gentex Corporation (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/gntx#NASDAQ">GNTX</a>) surged 6% to $33.74 after the company reported better-than-expected fourth-quarter financial results and issued guidance.</li>
<li>Olin Corporation (NYSE: <a class="ticker" href="https://www.benzinga.com/stock/oln#NYSE">OLN</a>) gained 6% to $54.89 following strong results.</li>
<li>Avantor, Inc. (NYSE: <a class="ticker" href="https://www.benzinga.com/stock/avtr#NYSE">AVTR</a>) rose 5.2% to $23.07 after Raymond James maintained an Outperform rating on the stock and raised its price target from $22.5 to $26.</li>
</ul>
&nbsp;
Now Read This: <a href="https://www.benzinga.com/news/earnings/24/01/36796404/how-to-earn-500-a-month-from-pfizer-stock-ahead-of-q4-earnings-print"> How To Earn $500 A Month From Pfizer Stock Ahead Of Q4 Earnings Print </a>

Penny Stocks

Small Cap

Intraday Update

APPF

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CDMO

CIFR

CLSK

EHTH

FFIN

FRHC

GNTX

LUMN

MREO

RGEN

TBBK

TELL

VERA

Booz Allen Hamilton Posts Upbeat Results, Joins AppFolio, Gentex And Other Big Stocks Moving Higher On Friday

Thursday,&nbsp;ESSA Pharma Inc&nbsp;(NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/EPIX#NASDAQ">EPIX</a>) shares closed 22.6% lower at $6.80. According to data from&nbsp;<a target="_blank" href="https://www.benzinga.com/pro/feature/newsfeed" rel="noreferrer noopener">Benzinga Pro</a>, session volume stands at 447.615K compared to the average volume (100 days) of 132.003K.
The company announced the presentation of updated dose escalation data from its Phase 1/2 study evaluating masofaniten (formerly EPI-7386) in combination with enzalutamide at the 2024 ASCO&nbsp;<a target="_blank" href="https://www.benzinga.com/pressreleases/24/01/n36781818/essa-pharma-presents-updated-phase-1-masofaniten-epi-7386-clinical-data-at-the-2024-asco-genitouri" rel="noreferrer noopener">Genitourinary Cancers Symposium</a>.
Masofaniten is a first-in-class N-terminal domain androgen receptor inhibitor that suppresses androgen activity through a novel mechanism of action and is being developed for prostate cancer.&nbsp;
In the patients evaluable for efficacy (n=16), rapid, deep, and durable reductions in prostate-specific antigen (PSA) were observed, regardless of previous chemotherapy status, including in patients who received lower than the full dose of enzalutamide (120 mg).&nbsp;
Across all dose cohorts, 88% of patients (14 of 16) achieved PSA50, 81% of patients (13 of 16) achieved PSA90, 69% of patients (11 of 16) achieved PSA90 in less than 90 days, and 63% of patients (10 of 16) achieved PSA &lt;0.2ng/mL.&nbsp;
While the data for disease PSA progression are still maturing with a current median follow-up of 11.1 months, the median time to PSA progression is 16.6 months.
The randomized, open-label, two-arm, Phase 2 dose expansion portion of the study is underway to evaluate the combination of masofaniten and enzalutamide versus single-agent enzalutamide in patients with metastatic castration-resistant prostate cancer (mCRPC) naïve to second-generation anti-androgens.&nbsp;
At September 30, 2023, ESSA Pharma had available cash reserves and short-term investments of $148.1 million. The company&#8217;s cash position is expected to be sufficient to fund current and planned <a href="https://www.benzinga.com/pressreleases/23/12/n36192713/essa-pharma-provides-corporate-update-and-reports-financial-results-for-fiscal-fourth-quarter-and-" target="_blank" rel="noreferrer noopener">operations through 2025</a>.
Price Action: EPIX stock is down 1.03% at $6.73 premarket Friday.
Photo via Shutterstock

What's Going On With Prostate Cancer Focused ESSA Pharma Stock Today?

Shares of Humana Inc. (NYSE: <a class="ticker" href="https://www.benzinga.com/stock/hum#NYSE">HUM</a>) fell sharply during Thursday&rsquo;s session after the company reported fourth-quarter FY23 earnings and issued 2024 guidance.
The company reported a Q4 adjusted loss of 11 cents per share, a turnaround from EPS income of $1.97 per share a year ago, missing the consensus for a loss of 5 cents per share. The insurer reported adjusted revenue of $25.73 billion, compared to $21.30 billion a year ago and the consensus of $25.55 billion.
Humana shares dipped 11.3% to $356.93 on Thursday.
Here are some other stocks moving in today&#39;s mid-day session.
<h3>Gainers</h3>
<ul>
<li>Onconetix, Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/onco#NASDAQ">ONCO</a>) shares surged 137% to $0.3519 after falling over 4% on Wednesday.</li>
<li>Processa Pharmaceuticals, Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/pcsa#NASDAQ">PCSA</a>) gained 97% to $4.0527 after the company announced the completion of the safety tolerability evaluation in its Phase 1b trial of Next Generation Capecitabine.</li>
<li>Enviva Inc. (NYSE: <a class="ticker" href="https://www.benzinga.com/stock/eva#NYSE">EVA</a>) climbed 47.4% to $0.5239.</li>
<li>Vera Therapeutics, Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/vera#NASDAQ">VERA</a>) shares jumped 46% to $24.84 after the company announced 72-week data from the OLE period of its Phase 2b ORIGIN clinical trial. Also, Oppenheimer initiated coverage on the stock with an Outperform rating and announced a $26 price target.</li>
<li>Rail Vision Ltd. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/rvsn#NASDAQ">RVSN</a>) gained 43.8% to $7.78. Foresight&#39;s affiliate Rail Vision&#39;s Main Line System secured EU Railway Standards approval and certifications.</li>
<li>LAVA Therapeutics N.V. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/lvtx#NASDAQ">LVTX</a>) rose 37.4% to $2.13 after the company announced a clinical trial collaboration and supply agreement with Merck &amp; Co. to evaluate LAVA-1207 in combination with KEYTRUDA.</li>
<li>Acutus Medical, Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/afib#NASDAQ">AFIB</a>) shares climbed 30.6% to $0.29. Acutus Medical has been granted European patent number EP3043701 titled &quot;Devices and Methods for Determination of Electrical Dipole Densities on a Cardiac Surface (And Methods for Diagnosing Tissue Health).&quot;</li>
<li>Prairie Operating Co. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/prop#NASDAQ">PROP</a>) gained 28.8% to $8.17.</li>
<li>American Superconductor Corporation (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/amsc#NASDAQ">AMSC</a>) shares climbed 28.4% to $12.52 after the company reported better-than-expected third-quarter financial results and issued fourth-quarter revenue guidance above estimates.</li>
<li>CCSC Technology International Holdings Limited (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/cctg#NASDAQ">CCTG</a>) rose 26.6% to $18.82.</li>
<li>Clearmind Medicine Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/cmnd#NASDAQ">CMND</a>) gained 25.8% to $1.4601.</li>
<li>Cyngn Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/cyn#NASDAQ">CYN</a>) gained 23.3% to $0.2256 after the company disclosed a strategic shift to Nvidia AI computers that will transform the technology powering its fleet of DriveMod autonomous industrial vehicles.</li>
<li>Richtech Robotics Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/rr#NASDAQ">RR</a>) rose 21.3% to $9.10. Richtech Robotics signed a Letter of Intent with Ghost Kitchens International.</li>
<li>AlTi Global, Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/alti#NASDAQ">ALTI</a>) surged 20.8% to $6.82 after Raymond James upgraded the stock from Market Perform to Strong Buy and announced a $9 price target.</li>
<li>C3is Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/ciss#NASDAQ">CISS</a>) jumped 19.1% to $0.1579. Aegis Capital Corp. acted as sole bookrunner on an upsized $7.0 million underwritten public offering for C3is.</li>
<li>Hut 8 Corp. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/hut#NASDAQ">HUT</a>) climbed 14.7% to $7.28.</li>
<li>Charge Enterprises, Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/crge#NASDAQ">CRGE</a>) rose 13.6% to $0.1672 following a 6% decline on Wednesday.</li>
<li>Biomea Fusion, Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/bmea#NASDAQ">BMEA</a>) gained 12.8% to $16.92</li>
<li>United Rentals, Inc. (NYSE: <a class="ticker" href="https://www.benzinga.com/stock/uri#NYSE">URI</a>) gained 12.7% to $649.95 after the company reported better-than-expected fourth-quarter financial results and issued FY24 revenue guidance.</li>
<li>Alpine Immune Sciences, Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/alpn#NASDAQ">ALPN</a>) jumped 12.4% to $20.88</li>
<li>Nokia Oyj (NYSE: <a class="ticker" href="https://www.benzinga.com/stock/nok#NYSE">NOK</a>) gained 12.3% to $3.8299 after the company reported fourth-quarter financial results.</li>
<li>Xerox Holdings Corporation (NYSE: <a class="ticker" href="https://www.benzinga.com/stock/xrx#NYSE">XRX</a>) gained 12.3% to $18.47 following quarterly results.</li>
<li>ADT Inc. (NYSE: <a class="ticker" href="https://www.benzinga.com/stock/adt#NYSE">ADT</a>) gained 10.2% to $6.81 after the company announced it will exit its residential solar business. The company also said it would increase its dividend and authorize a $350 million share repurchase program.</li>
<li>International Business Machines Corporation (NYSE: <a class="ticker" href="https://www.benzinga.com/stock/ibm#NYSE">IBM</a>) shares gained 9.9% to $191.19 as the company reported reported stronger-than-expected results for its fourth quarter.</li>
<li>American Airlines Group Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/aal#NASDAQ">AAL</a>) jumped 9.6% to $15.27 after the company reported better-than-expected fourth-quarter results.</li>
<li>NextEra Energy Partners, LP (NYSE: <a class="ticker" href="https://www.benzinga.com/stock/nep#NYSE">NEP</a>) climbed 9.3% to $29.35 after the company reported quarterly financial results.</li>
<li>W. R. Berkley Corporation (NYSE: <a class="ticker" href="https://www.benzinga.com/stock/wrb#NYSE">WRB</a>) gained 7.2% to $83.30 after the company reported better-than-expected quarterly financial results.</li>
<li>TAL Education Group (NYSE: <a class="ticker" href="https://www.benzinga.com/stock/tal#NYSE">TAL</a>) gained 6.5% to $12.03 following a third-quarter revenue beat. Additionally, JP Morgan upgraded the stock to Overweight.</li>
<li>Alaska Air Group, Inc. (NYSE: <a class="ticker" href="https://www.benzinga.com/stock/alk#NYSE">ALK</a>) rose 5.1% to $37.63 following upbeat earnings.</li>
</ul>
<h3>Losers</h3>
<ul>
<li>RedHill Biopharma Ltd. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/rdhl#NASDAQ">RDHL</a>) shares dropped 44.4% to $0.6009 after the company announced an $8 million registered direct offering.</li>
<li>VS MEDIA Holdings Limited (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/vsme#NASDAQ">VSME</a>) shares fell 22.1% to $0.5049 after jumping around 98% on Wednesday.</li>
<li>Columbia Banking System, Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/colb#NASDAQ">COLB</a>) fell 21.9% to $19.98 after the company reported worse-than-expected fourth-quarter financial results.</li>
<li>Polished.com Inc. (NYSE: <a class="ticker" href="https://www.benzinga.com/stock/pol#NYSE">POL</a>) fell 21.8% to $3.71.</li>
<li>Akoustis Technologies, Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/akts#NASDAQ">AKTS</a>) shares fell 21.8% to $0.5508 after the company announced pricing of a public offering of $10 million of common stock.</li>
<li>MarineMax, Inc. (NYSE: <a class="ticker" href="https://www.benzinga.com/stock/hzo#NYSE">HZO</a>) dipped 19.9% to $26.61 after the company reported worse-than-expected first-quarter adjusted EPS results and issued FY24 adjusted EPS guidance below estimates.</li>
<li>Marpai, Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/mrai#NASDAQ">MRAI</a>) fell 17.3% to $1.43.</li>
<li>Inseego Corp. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/insg#NASDAQ">INSG</a>) fell 16.6% to $2.0362.</li>
<li>Concentrix Corporation (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/cnxc#NASDAQ">CNXC</a>) fell 16.2% to $87.10 after the company issued first-quarter and FY24 guidance below consensus estimates.</li>
<li>Immix Biopharma, Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/immx#NASDAQ">IMMX</a>) declined 16.2% to $3.92.</li>
<li>Tesla, Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/tsla#NASDAQ">TSLA</a>) shares fell 13.1% to $180.61 after the company reported downbeat earnings and sales results for its fourth quarter.</li>
<li>Rackspace Technology, Inc. (NYSE: <a class="ticker" href="https://www.benzinga.com/stock/rxt#NYSE">RXT</a>) fell 12.8% to $1.6750.</li>
<li>ESSA Pharma Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/epix#NASDAQ">EPIX</a>) fell 11.2% to $7.81. ESSA Pharma presented updated Phase 1 masofaniten clinical data at the 2024 ASCO Genitourinary Cancers Symposium.</li>
<li>Phunware, Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/phun#NASDAQ">PHUN</a>) declined 11.1% to $0.3075 after dipping around 20% on Wednesday.</li>
<li>Virtu Financial, Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/virt#NASDAQ">VIRT</a>) fell 9.6% to $17.35 after the company reported worse-than-expected fourth-quarter financial results.</li>
<li>Old Republic International Corporation (NYSE: <a class="ticker" href="https://www.benzinga.com/stock/ori#NYSE">ORI</a>) fell 9.6% to $27.43 as the company reported worse-than-expected fourth-quarter results.</li>
<li>Carpenter Technology Corporation (NYSE: <a class="ticker" href="https://www.benzinga.com/stock/crs#NYSE">CRS</a>) fell 7.4% to $61.08 following mixed quarterly earnings.</li>
<li>Marine Products Corporation (NYSE: <a class="ticker" href="https://www.benzinga.com/stock/mpx#NYSE">MPX</a>) declined 7% to $ 10.27 following fourth-quarter results.</li>
<li>ATI Inc. (NYSE: <a class="ticker" href="https://www.benzinga.com/stock/ati#NYSE">ATI</a>) fell 6.4% to $40.18.</li>
<li>Hexcel Corporation (NYSE: <a class="ticker" href="https://www.benzinga.com/stock/hxl#NYSE">HXL</a>) shares declined 6.4% to $66.98 after reporting weak quarterly results.</li>
<li>LG Display Co., Ltd. (NYSE: <a class="ticker" href="https://www.benzinga.com/stock/lpl#NYSE">LPL</a>) shares fell 3% to $4.5250 after the company reported fourth-quarter financial results.</li>
</ul>
&nbsp;
Now Read This: <a href="https://www.benzinga.com/trading-ideas/long-ideas/24/01/36776429/jim-cramer-this-healthcare-stock-is-too-risky-but-shares-jumped-64-over-past-month"> Jim Cramer: This Healthcare Stock Is &#39;Too Risky,&#39; But Shares Jumped 64% Over Past Month </a>

AFIB

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ALTI

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CCTG

CISS

CMND

CNXC

COLB

CRGE

IMMX

INSG

LVTX

MRAI

ONCO

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PHUN

PROP

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RVSN

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Combination of masofaniten plus enzalutamide continues to be well tolerated with deep and durable reductions in PSA in patients with mCRPC
Phase 2 dose expansion currently underway at the RP2CDs of masofaniten 600 mg BID in combination with enzalutamide 160 mg QD
Across all dosing cohorts, 81% of patients achieved PSA90, 69% of patients achieved PSA90 in less than 90 days, and 63% of patients achieved&nbsp;PSA &lt;0.2ng/mL. While the data are still maturing, median time to PSA progression is currently at 16.6 months.
SOUTH SAN FRANCISCO, California and VANCOUVER, Canada, Jan. 25, 2024 /CNW/ - ESSA Pharma Inc. ("ESSA", or the "Company") (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/EPIX#NASDAQ">EPIX</a>), a clinical-stage pharmaceutical company focused on developing novel therapies for the treatment of prostate cancer, today announced the presentation of updated dose escalation data from its Phase 1/2 study evaluating masofaniten (formerly EPI-7386) in combination with enzalutamide at the 2024 ASCO Genitourinary Cancers Symposium, taking place January 25 - 27, 2024, in San Francisco, CA. Masofaniten is a first-in-class N-terminal domain androgen receptor ("AR") inhibitor that suppresses androgen activity through a novel mechanism of action and is being developed for the treatment of prostate cancer. The poster presentation is available on the "Publications" section of the Company's website at&nbsp;<a href="http://www.essapharma.com/">www.essapharma.com</a>.
"The maturing data from the Phase 1 dose escalation study evaluating masofaniten in combination with enzalutamide continue to demonstrate that the combination is well tolerated, accompanied by deep and durable reductions in circulating prostate-specific antigen ("PSA") levels. While the data are still immature, the durability of the PSA responses is encouraging with a median time to PSA progression currently at 16.6 months. The Phase 2 dose expansion head-to-head portion of the study is underway and is designed to evaluate the proportion of patients with a PSA decline on combination therapy compared to single agent enzalutamide," said David Parkinson, MD, President and CEO of ESSA. "We look forward to evaluating the potential long-term benefits of masofaniten in patients with metastatic castration-resistant prostate cancer ("mCRPC") and to providing future updates."
Poster presentation details:
Title:&nbsp;Phase 1/2 trial of oral EPI-7386 (masofaniten) in combination with enzalutamide (Enz) compared to Enz alone in patients with metastatic castration-resistant prostate cancer (mCRPC): Phase 1 (P1) results and phase 2 (P2) design. Presenting Author:&nbsp;Christos Kyriakopoulos, MD, University of Wisconsin-Madison Carbone Cancer Center Abstract #:&nbsp;141 Date and time: Thursday, January 25, 2024; 11:30-1:00 p.m. PT
Data summary: This Phase 1/2 multicenter, open-label clinical trial enrolled patients with mCRPC who have received androgen deprivation therapy and who are naïve to second-generation antiandrogens but may have been treated previously with one line of prior chemotherapy in the metastatic hormone-sensitive prostate cancer setting. The data presented today include 18 patients across four cohorts in the Phase 1 dose escalation portion of the study. Masofaniten has no effect on enzalutamide exposure, thus allowing the use of full dose per label (160mg) of enzalutamide in combination. Enzalutamide reduces masofaniten exposure but twice daily dosing of masofaniten appears to mitigate the reduction and maintains clinically relevant drug exposures.
In patients evaluable for safety (n=18), masofaniten combined with enzalutamide, continues to be well-tolerated at the dose levels tested through 25 cycles of dosing in some patients. Most frequent adverse events were Grades 1 and 2, related to either AR inhibition or gastrointestinal tract irritation. In Cohort 4, one patient experienced a Grade 3 rash, which was observed immediately following administration of masofaniten combined with enzalutamide and deemed probably related, resulting in the expansion of the cohort from four to seven patients. No additional dose-limiting toxicities (DLTs) were observed, therefore the maximum tolerated dose (MTD) was not reached. The recommended Phase 2 combination doses (RP2CDs) were identified as masofaniten 600 mg twice daily (BID) in combination with enzalutamide 160 mg once daily (QD).
In the patients evaluable for efficacy (n=16), rapid, deep and durable reductions in PSA were observed, regardless of previous chemotherapy status, including in patients who received lower than the full dose of enzalutamide (120 mg). Across all dose cohorts, 88% of patients (14 of 16) achieved PSA50, 81% of patients (13 of 16) achieved PSA90, 69% of patients (11 of 16) achieved PSA90 in less than 90 days, and 63% of patients (10 of 16) achieved PSA &lt;0.2ng/mL. While the data for disease PSA progression are still maturing with a current median follow up of 11.1 months, the median time to PSA progression is at 16.6 months.
The randomized, open-label, two arm, Phase 2 dose expansion portion of the study is underway and is designed to evaluate the combination of masofaniten and enzalutamide versus single agent enzalutamide in patients with mCRPC naïve to second generation anti-androgens. The study is currently enrolling at approximately 25 sites in the USA, Canada and Australia. Expansion to European sites is in progress.
About Masofaniten
Masofaniten (formerly known as EPI-7386) is a first-in-class investigational, highly selective, oral, small molecule inhibitor of the N-terminal domain ("NTD") of the androgen receptor ("AR"). Masofaniten's unique mechanism of action disrupts the AR signaling pathway, the primary pathway that drives prostate cancer growth, by selectively binding to the NTD, a region of the AR that is not currently targeted by other therapies. Masofaniten is currently being studied in an open-label, randomized Phase&nbsp;2 clinical trial (NCT05075577) in combination with&nbsp;enzalutamide in patients with metastatic castration-resistant prostate cancer (mCRPC) naïve to second-generation antiandrogens. ESSA is also conducting a Phase 1 monotherapy study (NCT04421222) in patients with mCRPC whose tumors have progressed on standard-of-care therapies. The U.S. Food and Drug Administration has granted Fast Track designation to masofaniten for the treatment of adult male patients with mCRPC resistant to standard-of-care treatment. ESSA retains all rights to masofaniten worldwide.

Events

ESSA Pharma Presents Updated Phase 1 Masofaniten Clinical Data At The 2024 ASCO Genitourinary Cancers Symposium

In a report released today, Joseph Catanzaro from Piper Sandler maintained a Buy rating on ESSA Pharma (EPIX – Research Report), with a price targe...

ESSA Pharma (EPIX) Gets a Buy from Piper Sandler

JonesResearch analyst Soumit Roy downgraded Essa Pharma (EPIX) to Hold from Buy with no price target after the board decided to terminate all trial...

Essa Pharma downgraded to Hold from Buy at JonesResearch

Essa Pharma (EPIX) announced that it has made the decision to terminate the Phase 2 clinical trial evaluating in a 2:1 randomization masofaniten co...

Essa Pharma terminates Phase 2 study of masofaniten combo in mCRPC

ESSA Pharma tanks after terminating trial for its prostate cancer treatment

Jefferies downgraded Essa Pharma (EPIX) to Hold from Buy with a price target of $1.70, down from $16. The company announced that it is discontinuin...

Essa Pharma downgraded to Hold from Buy at Jefferies

In a report released on November 1, Maury Raycroft from Jefferies downgraded ESSA Pharma (EPIX – Research Report) to a Hold, with a price target of...

ESSA Pharma Faces Uncertainty After Discontinuing Masofaniten Programs, Receives Hold Rating

Piper Sandler analyst Joseph Catanzaro downgraded the rating on ESSA Pharma (EPIX – Research Report) to a Hold today, setting a price target of $2....

ESSA Pharma Downgraded to Hold Amid Masofaniten Trial Termination and Revised Financial Outlook

Oppenheimer analyst Leland Gershell downgraded Essa Pharma (EPIX) to Perform from Outperform without a price target The company announced that it w...

Essa Pharma downgraded to Perform from Outperform at Oppenheimer

Piper Sandler analyst Joseph Catanzaro downgraded Essa Pharma (EPIX) to Neutral from Overweight with a price target of $2, down from $15. The compa...

Essa Pharma downgraded to Neutral from Overweight at Piper Sandler

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Press Releases

ESSA Pharma Provides Corporate Update and Reports Financial Results for Fiscal Second Quarter Ended March 31, 2024

ESSA Pharma to Present at the Jefferies Global Healthcare Conference

ESSA Pharma to Present at the JonesHealthcare Seaside Summit

ESSA Pharma Provides Corporate Update and Reports Financial Results for Fiscal Third Quarter Ended June 30, 2024

ESSA Pharma to Present at the 2024 Cantor Global Healthcare Conference

ESSA Pharma Presents Updated Phase 1/2 Masofaniten (EPI-7386) Clinical Data at the 2024 ESMO Congress

ESSA Pharma Announces Termination of Phase 2 Study Evaluating Masofaniten Combined with Enzalutamide in Patients with Metastatic Castration-Resistant Prostate Cancer

Piper Sandler

Oppenheimer

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