Últimas noticias sobre vTv Therapeutics (NASDAQ:VTVT) Bolsa

vTv Therapeutics

vTv Therapeutics Inc is a clinical stage biopharmaceutical company focused on the development of orally administered treatments for metabolic and inflammatory diseases to minimize their long-term complications and improve the lives of patients. Itsproduct pipeline include TTP399, TTP273, HPP737, HPP593, Azeliragon, HPP971, HPP3033, and TTP-RA.

vTv Therapeutics Inc. - Class A Common Stock

vTv Therapeutics Inc

On Monday, the U.S. Food and Drug Administration (FDA) lifted the clinical hold on vTv Therapeutics Inc.&#8217;s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/VTVT#NASDAQ">VTVT</a>) cadisegliatin <a target="_blank" href="https://www.benzinga.com/general/biotech" rel="noreferrer noopener">clinical program</a>.
The program includes the CATT1 Phase 3 trial in type 1 diabetes (T1D).&nbsp;
Cadisegliatin&nbsp;is an oral, liver-selective glucokinase activator that has been generally well tolerated in over 500 subjects to date with up to <a target="_blank" href="https://www.benzinga.com/pressreleases/25/03/g44354662/vtv-therapeutics-announces-fda-has-lifted-clinical-hold-on-cadisegliatin-program-for-diabetes" rel="noreferrer noopener">six months of treatment</a>.
vTv Therapeutics expects to resume the trial following the submission of a protocol amendment to reduce the overall duration of the CATT1 trial from 12 months to 6 months. This will help expedite the initiation of required larger pivotal studies for future New Drug Application (NDA) submissions.
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The original primary endpoint of ascertaining level 2 and 3 hypoglycemia rates at 6 months will not change.
The planned amendment will not include the additional 6-month period to collect safety data. By shortening the trial from 12 to 6 months, the company will be able to obtain topline data from the study more quickly.
&#8220;We are pleased that the FDA has lifted the clinical hold on our cadisegliatin program and are eager to resume our Phase 3 trial. Importantly, we plan to submit a protocol amendment to reduce the time to topline data by 6-months, which will allow us to initiate our larger Phase 3 studies sooner to support our future NDA submission,&#8221; said Paul Sekhri, Chairman, President and Chief Executive Officer of vTv Therapeutics. 
&#8220;Cadisegliatin has the potential to be the first oral adjunctive therapy to insulin for T1D and we look forward to further evaluating the effects of cadisegliatin on glycemic control and incidence of hypoglycemia over insulin alone after reinitiating the CATT1 Phase 3 trial.&#8221;
In July 2024, the FDA placed a clinical hold on the <a target="_blank" href="https://www.benzinga.com/general/biotech/24/07/40015637/fda-puts-brake-on-vtv-therapeutics-diabetes-candidate-program-including-late-stage-study-stock-ta" rel="noreferrer noopener">cadisegliatin&nbsp;clinical program</a>.
The clinical hold was based on the discovery of a chromatographic signal in a recent human absorption, distribution, metabolism, and excretion (ADME) study of&nbsp;cadisegliatin&nbsp;that could not be resolved by standard mass spectroscopy.
The agency requires a single in vitro study to characterize this signal before the cadisegliatin&nbsp;program can resume.
Price Action: VTVT stock is up 66.70% at $24.76 at the last check Monday.
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VTVT

FDA Lifts Clinical Hold On vTv Therapeutics' Phase 3 Diabetes Trial, Stock Surges

<h3>Gainers</h3>
<ul>
<li>vTv Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/VTVT#NASDAQ">VTVT</a>) shares increased by 65.2% to $24.53 during Monday's regular session. The market value of their outstanding shares is at $64.0 million. </li>
<li>Monogram Technologies (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MGRM#NASDAQ">MGRM</a>) stock increased by 52.35% to $3.55. The company's market cap stands at $121.8 million. As per the news, the Q4 earnings report came out 3 days ago. </li>
<li>Regencell Bioscience (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/RGC#NASDAQ">RGC</a>) stock rose 46.67% to $18.51. The market value of their outstanding shares is at $240.8 million. </li>
<li>Scienture Holdings (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SCNX#NASDAQ">SCNX</a>) stock moved upwards by 42.95% to $2.13. The company's market cap stands at $18.3 million. </li>
<li>Hyperfine (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/HYPR#NASDAQ">HYPR</a>) shares increased by 34.92% to $1.24. The market value of their outstanding shares is at $96.0 million. As per the news, the Q4 earnings report came out today. </li>
<li>CervoMed (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CRVO#NASDAQ">CRVO</a>) shares moved upwards by 28.11% to $8.25. The company's market cap stands at $68.1 million. As per the press release, Q4 earnings came out today. </li>
</ul>
<h3>Losers</h3>
<ul>
<li>Revelation Biosciences (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/REVB#NASDAQ">REVB</a>) stock declined by 19.7% to $2.73 during Monday's regular session. The market value of their outstanding shares is at $2.4 million. </li>
<li>bioAffinity Technologies (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BIAF#NASDAQ">BIAF</a>) stock declined by 17.93% to $0.3. The market value of their outstanding shares is at $4.6 million. </li>
<li>Palisade Bio (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/PALI#NASDAQ">PALI</a>) stock decreased by 14.88% to $0.85. The company's market cap stands at $2.5 million. </li>
<li>Plus Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/PSTV#NASDAQ">PSTV</a>) stock decreased by 12.7% to $0.59. The market value of their outstanding shares is at $3.4 million. </li>
<li>NRX Pharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NRXP#NASDAQ">NRXP</a>) shares declined by 12.56% to $2.06. The market value of their outstanding shares is at $34.7 million. The company's, Q4 earnings came out today. </li>
<li>GRI Bio (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/GRI#NASDAQ">GRI</a>) stock declined by 12.14% to $5.26. The company's market cap stands at $2.7 million. 
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</ul>
This article was generated by Benzinga's automated content engine and reviewed by an editor.

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12 Health Care Stocks Moving In Monday's Intraday Session

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vTv Therapeutics shares are trading higher after the company announced the FDA has lifted the clinical hold on the cadisegliatin clinical program, which includes the CATT1 Phase 3 trial in type 1 diabetes.

vTv Therapeutics Says FDA Has Lifted Clinical Hold On Cadisegliatin Program For Diabetes, CATT1 Phase 3 Trial Expected To Resume Following Submission Of Protocol Amendment Shortening Overall Duration Of Trial From 12 To 6 Months

<h3>Gainers</h3>
<ul>
<li>Lipella Pharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/LIPO#NASDAQ">LIPO</a>) stock moved upwards by 49.5% to $4.56 during Tuesday's pre-market session. The market value of their outstanding shares is at $5.5 million. </li>
<li>IN8bio (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/INAB#NASDAQ">INAB</a>) shares increased by 49.46% to $0.4. The company's market cap stands at $29.2 million. </li>
<li>Ocean Biomedical (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/OCEA#NASDAQ">OCEA</a>) stock rose 38.58% to $0.21. The company's market cap stands at $7.1 million. </li>
<li>Firefly Neuroscience (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AIFF#NASDAQ">AIFF</a>) stock rose 38.06% to $4.28. The market value of their outstanding shares is at $34.2 million. </li>
<li>Travere Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TVTX#NASDAQ">TVTX</a>) stock rose 16.35% to $24.55. The company's market cap stands at $2.1 billion. </li>
<li>Enanta Pharma (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ENTA#NASDAQ">ENTA</a>) shares increased by 13.06% to $5.54. The company's market cap stands at $118.1 million. As per the press release, Q1 earnings came out yesterday. </li>
</ul>
<h3>Losers</h3>
<ul>
<li>T2 Biosystems (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TTOO#NASDAQ">TTOO</a>) shares declined by 43.4% to $0.11 during Tuesday's pre-market session. The market value of their outstanding shares is at $3.0 million. </li>
<li>Third Harmonic Bio (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/THRD#NASDAQ">THRD</a>) shares fell 29.25% to $3.29. The company's market cap stands at $148.2 million. </li>
<li>Aspira Womens Health (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AWH#NASDAQ">AWH</a>) stock declined by 26.7% to $0.26. The company's market cap stands at $4.4 million. </li>
<li>vTv Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/VTVT#NASDAQ">VTVT</a>) shares declined by 18.97% to $15.0. The market value of their outstanding shares is at $39.1 million. </li>
<li>Lixte Biotechnology (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/LIXT#NASDAQ">LIXT</a>) stock fell 17.54% to $1.88. The company's market cap stands at $4.2 million. </li>
<li>Hyperfine (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/HYPR#NASDAQ">HYPR</a>) stock decreased by 16.77% to $1.39. The company's market cap stands at $101.3 million. 
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</ul>
This article was generated by Benzinga's automated content engine and reviewed by an editor.

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Alliance Global Partners analyst James Molloy initiates coverage on vTv Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/VTVT#NASDAQ">VTVT</a>) with a Buy rating and announces Price Target of $35.

Price Target

Initiation

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Alliance Global Partners Initiates Coverage On vTv Therapeutics with Buy Rating, Announces Price Target of $35

vTv Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/VTVT#NASDAQ">VTVT</a>) reported quarterly losses of $(0.88) per share. This is a 72.41 percent increase over losses of $(3.19) per share from the same period last year.

Earnings

vTv Therapeutics Q3 EPS $(0.88) Up From $(3.19) YoY

vTv Therapeutics Q2 2024 EPS $(0.81)

U.S. stocks were mostly higher toward the end of trading, while the Dow Jones index traded slightly lower on Monday.
The Dow traded down 0.04% to 40,571.88 while the NASDAQ rose 0.16% to 17,385.52. The S&amp;P 500 also rose, gaining, 0.16% to 5,467.66.
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Leading and Lagging Sectors Consumer discretionary shares jumped by 1.8% on Monday.
In trading on Monday, energy shares fell by 1.2%.
Top Headline
The Dallas Fed Manufacturing index declined to -17.5 in July versus a reading of -15.1 in the prior month.
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>Lipella Pharmaceuticals Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/LIPO#NASDAQ">LIPO</a>) shares shot up 123% to $0.9265 after the company announced it commenced its Phase 2a trial for LP-310 in Oral Lichen Planus.</li>
<li>Shares of NLS Pharmaceutics AG (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NLSP#NASDAQ">NLSP</a>) got a boost, surging 38% to $0.2618 after the company announced a merger in which Kadimastem will become a wholly owned subsidiary of NLS.</li>
<li>Venus Concept Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/VERO#NASDAQ">VERO</a>) shares were also up, gaining 26% to $0.8169 after the company received a medical device license from Health Canada to market its Venus Bliss MAX system.</li>
</ul>
Equities Trading DOWN
<ul>
<li>vTv Therapeutics Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/VTVT#NASDAQ">VTVT</a>) shares dropped to $15.92 after the company announced the FDA has placed a clinical hold on the cadisegliatin clinical program.</li>
<li>Shares of Cognition Therapeutics, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CGTX#NASDAQ">CGTX</a>) were down 35% to $1.5350. Cognition Therapeutics reported that participants in the proof-of-concept Phase 2 ‘SHINE' study who were treated with CT1812 for six months showed a consistent trend in cognitive improvement compared to placebo across all cognitive measures.</li>
<li>Ventyx Biosciences, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/VTYX#NASDAQ">VTYX</a>) was down, falling 21% to $2.3350. The company released results from the Phase 2 trial of allosteric TYK2 inhibitor VTX958 in participants with moderately to severely active Crohn's disease, a type of inflammatory bowel disease that irritates and causes swelling in digestive tract.</li>
</ul>
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Commodities In commodity news, oil traded down 2.2% to $75.50 while gold traded down 0.2% at $2,376.50.
Silver traded down 1% to $27.75 on Monday, while copper fell 1% to $4.0820.
Euro zone
European shares closed mostly lower today. The eurozone's STOXX 600 fell 0.20%, Germany's DAX fell 0.53% and France's CAC 40 fell 0.98%. Spain's IBEX 35 Index fell 0.43%, while London's FTSE 100 rose 0.08%.
UK's net consumer credit increased by £1.2 billion over a month during June, a decline from the £1.5 billion gain recorded in May.
Asia Pacific Markets
Asian markets closed higher on Monday, with Japan's Nikkei 225 surging 2.13%, Hong Kong's Hang Seng Index gaining 1.28%, China's Shanghai Composite Index gaining 0.03% and India's S&amp;P BSE Sensex rising 0.03%.
Singapore's Domestic Supply Price Index increased by 4.3% year-over-year in June, accelerating from a revised 2.7% gain in the prior month. Producer prices in Malaysia increased to 1.6% year-over-year for June. Profits earned by Chinese industrial firms climbed by 3.5% year-over-year to CNY 3,511.03 billion during the first six months of 2024.
Economics
The Dallas Fed Manufacturing index declined to -17.5 in July versus a reading of -15.1 in the prior month.
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Shares of Bank of Marin Bancorp (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BMRC#NASDAQ">BMRC</a>) fell sharply during Monday's session after the company reported <a href="https://www.benzinga.com/quote/BMRC/earnings">worse-than-expected quarterly earnings.</a>
Bank of Marin reported quarterly earnings of 6 cents per share which missed the analyst consensus estimate of 18 cents per share. The company reported quarterly sales of $22.47 million which missed the analyst consensus estimate of $23.39 million, according to data from <a href="https://pro.benzinga.com/dashboard">Benzinga Pro</a>.
Bank of Marin Bancorp shares dipped 10.8% to $19.92 on Monday.
Here are some other stocks moving in today&#8217;s mid-day session.
<h3 class="wp-block-heading">Gainers</h3>
<ul>
<li>2U, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TWOU#NASDAQ">TWOU</a>) shares climbed 128% to $2.8535.</li>
<li>Lipella Pharmaceuticals Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/LIPO#NASDAQ">LIPO</a>) shares climbed 117.8% to $0.9039 after the company announced it commenced its Phase 2a trial for LP-310 in Oral Lichen Planus.</li>
<li>Planet Image International Limited (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/YIBO#NASDAQ">YIBO</a>) gained 61.6% to $4.75 after jumping around 56% on Friday.</li>
<li>NLS Pharmaceutics AG (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NLSP#NASDAQ">NLSP</a>) jumped 38% to $0.2644 after the company announced a merger in which Kadimastem will become a wholly owned subsidiary of NLS.</li>
<li>Tivic Health Systems, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TIVC#NASDAQ">TIVC</a>) shares gained 37.8% to $0.6232 after gaining 11% on Friday.</li>
<li>NIP Group Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NIPG#NASDAQ">NIPG</a>) gained 34.4% to $12.25.</li>
<li>Nisun International Enterprise Development Group Co., Ltd (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NISN#NASDAQ">NISN</a>) jumped 26.8% to $14.76.</li>
<li>Renalytix Plc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/RNLX#NASDAQ">RNLX</a>) jumped 24.2% to $0.4366.</li>
<li>Meta Data Limited (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/AIU#NYSE">AIU</a>) rose 23.5% to $2.9860.</li>
<li>Venus Concept Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/VERO#NASDAQ">VERO</a>) jumped 22.5% to $0.7936 after the company received a medical device license from Health Canada to market its Venus Bliss MAX system.</li>
<li>Nuwellis, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NUWE#NASDAQ">NUWE</a>) gained 21.3% to $2.8862. Roth MKM analyst Jonathan Aschoff initiated coverage on Nuwellis with a Buy rating and announced a price target of $17.</li>
<li>Longeveron Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/LGVN#NASDAQ">LGVN</a>) shares gained 19.8% to $4.1246 after the company disclosed study results from CLEAR MIND Phase 2a clinical trial of Lomecel-B in mild Alzheimer&#8217;s disease.</li>
<li>BurgerFi International, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BFI#NASDAQ">BFI</a>) gained 19.3% to $0.5021. BurgerFi shares jumped 97% on Friday after the company announced it reached a legal settlement agreement with Lion Point Capital. The company agreed to pay $1,350,000 and issue Lion Point 300,000 of preferred stock.</li>
<li>Oil States International, Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/OIS#NYSE">OIS</a>) climbed 18.8% to $5.63 after the company reported better-than-expected second-quarter financial results.</li>
<li>PolyPid Ltd. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/PYPD#NASDAQ">PYPD</a>) rose 18.4% to $4.19.</li>
<li>Cepton, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CPTN#NASDAQ">CPTN</a>) jumped 18.4% to $2.9950 after the company announced it will be acquired by Koito for $3.17 per share in cash.</li>
<li>CommScope Holding Company, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/COMM#NASDAQ">COMM</a>) rose 17.2% to $2.25 after reporting preliminary second quarter results.</li>
<li>Serve Robotics Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SERV#NASDAQ">SERV</a>) gained 16.1% to $15.35.</li>
<li>ON Semiconductor Corporation (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ON#NASDAQ">ON</a>) jumped 13.7% to $79.76 after the company reported better-than-expected second quarter financial results.</li>
<li>Koninklijke Philips N.V. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PHG#NYSE">PHG</a>) rose 13.1% to $29.14 after the company reported better-than-expected second quarter earnings.</li>
<li>Primega Group Holdings Limited (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/PGHL#NASDAQ">PGHL</a>) gained 9.5% to $5.09.</li>
<li>ZIM Integrated Shipping Services Ltd. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/ZIM#NYSE">ZIM</a>) rose 8.5% to $18.48. ZIM Integrated Shipping Services will release its second quarter financial results on Monday, Aug. 19.</li>
<li>Anavex Life Sciences Corp. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AVXL#NASDAQ">AVXL</a>) gained 6.4% to $7.18. Anavex Life Sciences presented comprehensive results from the Phase IIb/III study showing that blarcamesine, once daily orally, significantly slowed clinical decline in people with early Alzheimer&#8217;s disease.</li>
<li>Tesla, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TSLA#NASDAQ">TSLA</a>) gained 5.6% to $232.15. Morgan Stanley analyst Adam Jonas reiterated Tesla with an Overweight and maintained a $310 price target.</li>
</ul>
<h3 class="wp-block-heading">Losers</h3>
<ul>
<li>Cognition Therapeutics, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CGTX#NASDAQ">CGTX</a>) fell 34% to $1.5650 after the company reported Phase 2 results for Alzheimer&#8217;s drug.</li>
<li>vTv Therapeutics Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/VTVT#NASDAQ">VTVT</a>) shares dipped 31.4% to $14.55 after the company announced the FDA has placed a clinical hold on the cadisegliatin clinical program.</li>
<li>CERo Therapeutics Holdings, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CERO#NASDAQ">CERO</a>) shares fell 28.6% to $0.1830 after gaining 6% on Friday.</li>
<li>Centuri Holdings, Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/CTRI#NYSE">CTRI</a>) fell 26.4% to $14.90 following downbeat quarterly results.</li>
<li>Ventyx Biosciences, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/VTYX#NASDAQ">VTYX</a>) dipped 24.4% to $2.23. The company released results from the Phase 2 trial of allosteric TYK2 inhibitor VTX958 in participants with moderately to severely active Crohn's disease, a type of inflammatory bowel disease that irritates and causes swelling in digestive tract.</li>
<li>LuxUrban Hotels Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/LUXH#NASDAQ">LUXH</a>) shares fell 19.6% to $0.1536 after the company priced its $1.74 million public offering of 11,573,333 common shares at 15 cents per share.</li>
<li>NuScale Power Corporation (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/SMR#NYSE">SMR</a>) declined 18.5% to $8.84.</li>
<li>Ocean Power Technologies, Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/OPTT#NYSE">OPTT</a>) fell 17.5% to $0.2544.</li>
<li>Treasure Global Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TGL#NASDAQ">TGL</a>) shares fell 17% to $1.5243.</li>
<li>Integra Resources Corp. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/ITRG#NYSE">ITRG</a>) fell 16.6% to $0.8999. Integra Resources and Florida Canyon Gold entered into a definitive arrangement agreement, whereby Integra has agreed to acquire all of the issued and outstanding shares of FCGI pursuant to a court-approved plan of arrangement.</li>
<li>Phio Pharmaceuticals Corp. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/PHIO#NASDAQ">PHIO</a>) fell 16.6% to $3.3616. Phio Pharmaceuticals recently announced exercise of warrants for $3.1 million gross proceeds.</li>
<li>Integra LifeSciences Holdings Corporation (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/IART#NASDAQ">IART</a>) dipped 13.9% to $27.05 after the company lowered its FY24 guidance below estimates.</li>
<li>NANO Nuclear Energy Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NNE#NASDAQ">NNE</a>) fell 12.8% to $14.01.</li>
<li>Coursera, Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/COUR#NYSE">COUR</a>) fell 10.5% to $9.60.</li>
<li>Sunnova Energy International Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NOVA#NYSE">NOVA</a>) declined 10% to $7.24. Truist Securities analyst Jordan Levy maintained Sunnova Energy Intl with a Buy and raised the price target from $9 to $10.</li>
<li>Mesoblast Limited (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MESO#NASDAQ">MESO</a>) fell 7.4% to $6.85. Mesoblast, last week, announced that the FDA accepted its Biologics License Application resubmission for Ryoncil in the treatment of children with steroid-refractory acute graft versus host disease.</li>
<li>Arm Holdings plc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ARM#NASDAQ">ARM</a>) fell 6.3% to $139.61 after HSBC downgraded the stock from Hold to Reduce.</li>
<li>Tandem Diabetes Care, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TNDM#NASDAQ">TNDM</a>) fell 6.3% to $37.53.</li>
</ul>
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</ul>

AVXL

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MESO

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Why Bank of Marin Bancorp Shares Are Trading Lower? Here Are Other Stocks Moving In Monday's Mid-Day Session

U.S. stocks traded mostly higher midway through trading, with the Nasdaq Composite gaining around 0.4% on Monday.
The Dow traded up 0.02% to 40,598.43 while the NASDAQ rose 0.40% to 17,427.58. The S&amp;P 500 also rose, gaining, 0.28% to 5,474.27.
Check This Out: <a href="https://www.benzinga.com/trading-ideas/long-ideas/24/07/40007912/top-4-energy-stocks-that-may-rocket-higher-in-q3">Top 4 Energy Stocks That May Rocket Higher In Q3</a>
Leading and Lagging Sectors Consumer discretionary shares jumped by 1% on Monday.
In trading on Monday, energy shares fell by 1.3%.
Top Headline
ON Semiconductor Corp (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ON#NASDAQ">ON</a>) reported better-than-expected second quarter financial results.
ON Semiconductor reported a fiscal second-quarter 2024 revenue decline of 17.2% year-on-year to $1.74 billion, beating the analyst consensus estimate of $1.73 billion. The adjusted EPS of 96 cents beat the analyst consensus estimate of 92 cents per share, according to data from Benzinga Pro.
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>Lipella Pharmaceuticals Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/LIPO#NASDAQ">LIPO</a>) shares shot up 127% to $0.9334 after the company announced it commenced its Phase 2a trial for LP-310 in Oral Lichen Planus.</li>
<li>Shares of NLS Pharmaceutics AG (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NLSP#NASDAQ">NLSP</a>) got a boost, surging 54% to $0.2794 after the company announced a merger in which Kadimastem will become a wholly owned subsidiary of NLS.</li>
<li>Venus Concept Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/VERO#NASDAQ">VERO</a>) shares were also up, gaining 16% to $0.75 after the company received a medical device license from Health Canada to market its Venus Bliss MAX system.</li>
</ul>
Equities Trading DOWN
<ul>
<li>vTv Therapeutics Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/VTVT#NASDAQ">VTVT</a>) shares dropped 31% to $14.65 after the company announced the FDA has placed a clinical hold on the cadisegliatin clinical program.</li>
<li>Shares of Cognition Therapeutics, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CGTX#NASDAQ">CGTX</a>) were down 35% to $1.5499 after the company reported Phase 2 results for Alzheimer&#8217;s drug.</li>
<li>Ventyx Biosciences, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/VTYX#NASDAQ">VTYX</a>) was down, falling 25% to $2.22. The company released results from the Phase 2 trial of allosteric TYK2 inhibitor VTX958 in participants with moderately to severely active Crohn's disease, a type of inflammatory bowel disease that irritates and causes swelling in digestive tract.</li>
</ul>
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Commodities In commodity news, oil traded down 1.9% to $75.71 while gold traded down 0.4% at $2,371.10.
Silver traded down 1.6% to $27.575 on Monday, while copper fell 1.4% to $4.0670.
Euro zone
European shares were mostly lower today. The eurozone's STOXX 600 fell 0.23%, Germany's DAX fell 0.58% and France's CAC 40 fell 0.99%. Spain's IBEX 35 Index fell 0.48%, while London's FTSE 100 rose 0.17%.
UK's net consumer credit increased by £1.2 billion over a month during June, a decline from the £1.5 billion gain recorded in May.
Asia Pacific Markets
Asian markets closed higher on Monday, with Japan's Nikkei 225 surging 2.13%, Hong Kong's Hang Seng Index gaining 1.28%, China's Shanghai Composite Index gaining 0.03% and India's S&amp;P BSE Sensex rising 0.03%.
Singapore's Domestic Supply Price Index increased by 4.3% year-over-year in June, accelerating from a revised 2.7% gain in the prior month. Producer prices in Malaysia increased to 1.6% year-over-year for June. Profits earned by Chinese industrial firms climbed by 3.5% year-over-year to CNY 3,511.03 billion during the first six months of 2024.
Economics
The Dallas Fed Manufacturing index declined to -17.5 in July versus a reading of -15.1 in the prior month.
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Crude Oil Moves Lower; NLS Pharmaceutics Shares Jump

vTv Therapeutics Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/VTVT#NASDAQ">VTVT</a>) stock is trading lower on Monday. The FDA has placed a clinical hold on the cadisegliatin&nbsp;clinical program, which includes the ongoing CATT1 <a target="_blank" href="https://www.benzinga.com/pressreleases/24/07/g39993546/vtv-therapeutics-announces-cadisegliatin-program-for-type-1-diabetes-placed-on-clinical-hold" rel="noreferrer noopener">Phase 3 trial in type 1 diabetes</a>.&nbsp;
Cadisegliatin&nbsp;is an oral, liver-selective, glucokinase activator. The company says the drug candidate has been well-tolerated in over 500 subjects to date with up to six months of treatment.
Related: <a target="_blank" href="https://www.benzinga.com/general/biotech/24/02/37372919/why-is-diabetes-focused-vtv-therapeutics-stock-trading-higher-today" rel="noreferrer noopener">Why Is Diabetes Focused vTv Therapeutics Stock Trading Higher Today?</a>
Selectively acting on the liver,&nbsp;cadisegliatin&nbsp;increases the activity of glucokinase independently from insulin to improve glycemic control through hepatic glucose uptake and glycogen storage.
The clinical hold was based on the discovery of a chromatographic signal in a recent human absorption, distribution, metabolism, and excretion (ADME) study of&nbsp;cadisegliatin&nbsp;that could not be resolved by standard mass spectroscopy.
The agency requires a single in vitro study to characterize this signal before the cadisegliatin&nbsp;program can resume.
No patient had been dosed in CATT1 at the time of the clinical hold, and past clinical studies did not reveal any clinically concerning safety issues.
&#8220;We are working diligently with the agency to resolve the clinical hold and resume enrollment as quickly as possible,&#8221; said Paul Sekhri, Chairman, President, and CEO of vTv Therapeutics.
Price Action: VTVT stock is down 32.2% at $14.38&nbsp;at the last check on Monday.
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Don&#8217;t miss the opportunity to dominate in a volatile market at the&nbsp;<a target="_blank" href="https://www.benzinga.com/events/small-cap/global-small-cap-conference-2024/" rel="noreferrer noopener">Benzinga SmallCAP Conference</a>&nbsp;on Oct. 9-10 at the Chicago Marriott Downtown Magnificent Mile. Get exclusive access to CEO presentations, 1:1 meetings with investors, and valuable insights from top financial experts. Whether you&#8217;re a trader, entrepreneur, or investor, this event offers unparalleled opportunities to grow your portfolio and network with industry leaders. Secure your spot and get your tickets today!

FDA Puts Brake On vTv Therapeutics' Diabetes Candidate Program, Including Late-Stage Study, Stock Tanks

U.S. stocks traded higher this morning, with the Nasdaq Composite gaining around 1% on Monday.
Following the market opening Monday, the Dow traded up 0.06% to 40,612.10 while the NASDAQ rose 1% to 17,529.39. The S&amp;P 500 also rose, gaining, 0.50% to 5,486.56.
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Leading and Lagging Sectors Consumer discretionary shares jumped by 1.1% on Monday.
In trading on Monday, energy shares fell by 0.9%.
Top Headline
McDonald&#8217;s Corp (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/MCD#NYSE">MCD</a>) posted worse-than-expected second-quarter financial results.
McDonald&#8217;s reported a second-quarter FY24 sales decline of 0.12% year-on-year to $6.490 billion, missing the analyst consensus of $6.608 billion. Adjusted EPS of $2.97 missed the analyst consensus estimate of $3.07.
Global comparable sales decreased 1.0%, while U.S. comparable sales slipped 0.7%.
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>Lipella Pharmaceuticals Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/LIPO#NASDAQ">LIPO</a>) shares shot up 183% to $1.1741 after the company announced it commenced its Phase 2a trial for LP-310 in Oral Lichen Planus.</li>
<li>Shares of Planet Image International Limited (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/YIBO#NASDAQ">YIBO</a>) got a boost, surging 81% to $5.33 after jumping around 56% on Friday.</li>
<li>2U, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TWOU#NASDAQ">TWOU</a>) shares were also up, gaining 65% to $2.06.</li>
</ul>
Equities Trading DOWN
<ul>
<li>vTv Therapeutics Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/VTVT#NASDAQ">VTVT</a>) shares dropped 39% to $13.00 after the company announced the FDA has placed a clinical hold on the cadisegliatin clinical program.</li>
<li>Shares of Cognition Therapeutics, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CGTX#NASDAQ">CGTX</a>) were down 37% to $1.49 after the company reported Phase 2 results for Alzheimer&#8217;s drug.</li>
<li>CERo Therapeutics Holdings, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CERO#NASDAQ">CERO</a>) was down, falling 32% to $0.1742 after gaining 6% on Friday.</li>
</ul>
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Commodities In commodity news, oil traded up 0.1% to $77.18 while gold traded up 0.4% at $2,389.90.
Silver traded up 0.2% to $28.075 on Monday, while copper fell 1.1% to $4.0775.
Euro zone
European shares were mixed today. The eurozone's STOXX 600 gained 1%, Germany's DAX fell 0.2% and France's CAC 40 fell 0.8%. Spain's IBEX 35 Index fell 0.2%, while London's FTSE 100 rose 0.5%.
UK's net consumer credit increased by £1.2 billion over a month during June, a decline from the £1.5 billion gain recorded in May.
Asia Pacific Markets
Asian markets closed higher on Monday, with Japan's Nikkei 225 surging 2.13%, Hong Kong's Hang Seng Index gaining 1.28%, China's Shanghai Composite Index gaining 0.03% and India's S&amp;P BSE Sensex rising 0.03%.
Singapore's Domestic Supply Price Index increased by 4.3% year-over-year in June, accelerating from a revised 2.7% gain in the prior month. Producer prices in Malaysia increased to 1.6% year-over-year for June. Profits earned by Chinese industrial firms climbed by 3.5% year-over-year to CNY 3,511.03 billion during the first six months of 2024.
Economics
The Dallas Fed Manufacturing index will be released today.
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</ul>

Nasdaq Gains 1%; McDonald's Posts Downbeat Results

vTv Therapeutics shares are trading lower after the company announced the FDA has placed a clinical hold on the cadisegliatin clinical program.

Shares of Pitney Bowes Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PBI#NYSE">PBI</a>) shares rose sharply in today's pre-market trading following a report indicating that the company has sold a part of its <a href="https://www.benzinga.com/quote/PBI/news">e-commerce business to Stord</a>.
Pitney Bowes shares jumped 12.5% to $7.58 in pre-market trading.
Here are some other stocks moving in pre-market trading.
<h3 class="wp-block-heading">Gainers</h3>
<ul>
<li>Cognition Therapeutics, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CGTX#NASDAQ">CGTX</a>) gained 46% to $3.45 in pre-market trading after the company announced that it will host an investor presentation to discuss results from its phase 2 SHINE study of CT1812 on Monday July 29, 2024.</li>
<li>Longeveron Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/LGVN#NASDAQ">LGVN</a>) shares climbed 36.3% to $4.69 in pre-market trading after the company disclosed study results from CLEAR MIND Phase 2a clinical trial of Lomecel-B in mild Alzheimer&#8217;s disease.</li>
<li>Planet Image International Limited (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/YIBO#NASDAQ">YIBO</a>) rose 35.7% to $3.99 in pre-market trading after jumping around 56% on Friday.</li>
<li>DDC Enterprise Limited (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/DDC#NYSE">DDC</a>) shares gained 22.7% to $0.76 in pre-market trading after gaining 6% on Friday.</li>
<li>BurgerFi International, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BFI#NASDAQ">BFI</a>) gained 22.1% to $0.5133 in pre-market trading. BurgerFi shares jumped 97% on Friday after the company announced it reached a legal settlement agreement with Lion Point Capital. The company agreed to pay $1,350,000 and issue Lion Point 300,000 of preferred stock.</li>
<li>Tivic Health Systems, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TIVC#NASDAQ">TIVC</a>) shares gained 19.4% to $0.5395 in pre-market trading after gaining 11% on Friday.</li>
<li>Ambipar Emergency Response (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/AMBI#NYSE">AMBI</a>) gained 15.5% to $5.34 in pre-market trading after jumping 29% on Friday.</li>
<li>TransCode Therapeutics, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/RNAZ#NASDAQ">RNAZ</a>) shares gained 14.1% to $0.3371 in pre-market trading. TransCode Therapeutics 13G filing showed 3i, LP reported a 9.9% stake in the company, as of July 23.</li>
<li>Anavex Life Sciences Corp. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AVXL#NASDAQ">AVXL</a>) gained 11.4% to $7.51 in pre-market trading. Anavex Life Sciences presented comprehensive results from the Phase IIb/III study showing that blarcamesine, once daily orally, significantly slowed clinical decline in people with early Alzheimer&#8217;s disease.</li>
</ul>
<h3 class="wp-block-heading">Losers</h3>
<ul>
<li>vTv Therapeutics Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/VTVT#NASDAQ">VTVT</a>) shares fell 37.4% to $13.28 in pre-market trading after the company announced the FDA has placed a clinical hold on the cadisegliatin clinical program which includes the ongoing CATT1 phase 3 trial in type 1 diabetes.</li>
<li>CERo Therapeutics Holdings, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CERO#NASDAQ">CERO</a>) shares declined 34% to $0.1690 in pre-market trading after gaining 6% on Friday.</li>
<li>LuxUrban Hotels Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/LUXH#NASDAQ">LUXH</a>) shares fell 22.1% to $0.1488 in pre-market trading after the company priced its $1.74 million public offering of 11,573,333 common shares at 15 cents per share.</li>
<li>Treasure Global Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TGL#NASDAQ">TGL</a>) shares fell 19.6% to $1.48 in pre-market trading.</li>
<li>Globavend Holdings Limited (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/GVH#NASDAQ">GVH</a>) shares declined 13.1% to $0.63 in pre-market trading after surging 24% on Friday.</li>
<li>Phio Pharmaceuticals Corp. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/PHIO#NASDAQ">PHIO</a>) fell 12.6% to $3.53 in pre-market trading. Phio Pharmaceuticals recently announced exercise of warrants for $3.1 million gross proceeds.</li>
<li>INVO Bioscience, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/INVO#NASDAQ">INVO</a>) shares fell 11.6% to $0.7250 in pre-market trading after jumping 11% on Friday.</li>
<li>NuZee Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NUZE#NASDAQ">NUZE</a>) fell 9.7% to $3.40 in pre-market trading after surging around 25% on Friday.</li>
<li>EZCORP, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/EZPW#NASDAQ">EZPW</a>) shares dipped 8.8% to $9.41 in pre-market trading.</li>
<li>Abbott Laboratories (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/ABT#NYSE">ABT</a>) shares fell 6.6% to $98.29 in pre-market trading. A jury ordered Abbott to pay $495 million in compensation and damages in a baby-formula verdict, the Wall Street Journal reported.</li>
</ul>
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Pre-Market Outlook

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Why Pitney Bowes Shares Are Trading Higher By Over 12%; Here Are 20 Stocks Moving Premarket

vTv Therapeutics shares are trading lower after the company announced the FDA has placed a clinical hold on the cadisegliatin clinical program which includes the ongoing CATT1 phase 3 trial in type 1 diabetes.

vTv Therapeutics Shares Resume Trade

Trading Halt: Halt status updated at 4:30:00 PM ET: Quotation Resumption: News and Resumption Times

vTv Therapeutics Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/VTVT#NASDAQ">VTVT</a>), a late stage biopharmaceutical company with an innovative clinical portfolio of small molecules and lead program in diabetes, today announced that the United States Food and Drug Administration (FDA) has placed a clinical hold on the cadisegliatin clinical program which includes the ongoing CATT1 Phase 3 trial in type 1 diabetes. Cadisegliatin is an oral, liver selective, glucokinase activator that has been well-tolerated in over 500 subjects to date with up to six months of treatment.

vTv Therapeutics Announces FDA Has Placed A Clinical Hold On The Cadisegliatin Clinical Program Which Includes The Ongoing CATT1 Phase 3 Trial In Type 1 Diabetes

Trading Halt: Halted at 4:01:47 p.m. ET - Trading Halt: Halt News Pending

Press Releases

vTv Therapeutics Announces 2024 First Quarter Financial Results and Provides Corporate Update

CANTEX PHARMACEUTICALS RECEIVES FDA ORPHAN DRUG DESIGNATION FOR AZELIRAGON FOR THE TREATMENT OF PANCREATIC CANCER

CANTEX PHARMACEUTICALS ANNOUNCES FOUR ABSTRACTS TO BE PRESENTED FEATURING AZELIRAGON AT 2024 ASCO ANNUAL MEETING

vTv Therapeutics Announces Screening of First Patient in CATT1 Pivotal Trial Evaluating Cadisegliatin for Type 1 Diabetes

vTv Therapeutics Announces Cadisegliatin Program for Type 1 Diabetes Placed on Clinical Hold

vTv Therapeutics Announces 2024 Second Quarter Financial Results and Provides Corporate Update

vTv Therapeutics Announces 2024 Third Quarter Financial Results and Provides Corporate Update

vTv Therapeutics to Participate in 7th Annual Evercore HealthCONx Conference

CANTEX PHARMACEUTICALS RECEIVES FDA ORPHAN DRUG DESIGNATION FOR AZELIRAGON FOR THE TREATMENT OF BRAIN METASTASIS FROM BREAST CANCER

vTv Therapeutics Announces FDA has Lifted Clinical Hold on Cadisegliatin Program for Diabetes

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