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Wire

Definium Therapeutics' Upcoming Phase 3 Data on DT120 to De-Risk Program, Back FDA Approval, RBC Says

Definium Therapeutics' (DFTX) upcoming phase 3 data on DT120 in generalized anxiety disorder or GAD is likely to further de-risk the program and back potential approval, RBC Capital Markets said in a Friday note.The first phase 3 trial in GAD met its primary endpoint and a positive data readout from the second phase 3 trial should ease residual regulatory uncertainty on the therapy's approvability, the brokerage said. Data from the second phase 3 trial is due for release "any day now," RBC noted.Trial results are likely to support approval from the US Food and Drug Administration given DT120's robust efficacy data, well-powered studies, and the FDA's flexibility for neuropsychiatric drugs, according to the investment firm.RBC has an outperform rating on Definium Therapeutics, with a $66 price target.Price: $38.53, Change: $+0.80, Percent Change: +2.12%

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Wire

Definium Therapeutics' DT120 Data Boosts Confidence in Future Trials, RBC Capital Markets Says

Definium Therapeutics' (DFTX) phase 3 data for DT120 in generalized anxiety disorder looked better than the stock's muted reaction suggests, with the results increasing confidence in future studies and the drug's regulatory path, RBC Capital Markets said in a note Wednesday.The investment firm said baseline characteristics were largely balanced, while safety data showed typical transient hallucinogenic effects and no new or concerning adverse events.RBC expects the ongoing Panorama and Ascend trials in GAD and major depressive disorder to deliver positive results, noting that the 50-microgram arm did not separate from placebo in the prior GAD trial and was included mainly to reduce expectation bias and meet regulatory guidance.The firm said it estimates peak sales of about $1.3 billion in MDD and $1.2 billion in GAD, with psychedelic treatment centers expected to ramp quickly to meet launch demand, while patients may require three to four annual DT120 doses versus more than 50 Spravato administrations.RBC Capital Markets maintained its outperform, speculative risk rating on the stock and raised its price target to $66 from $57.Definium Therapeutics shares were up 3% in Thursday trading.Price: $44.08, Change: $+1.29, Percent Change: +3.01%

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Sectors

Sector Update: Healthcare Stocks Advance Late Afternoon

Healthcare stocks were higher late Wednesday afternoon, with the NYSE Healthcare Index up 0.2% and the State Street Health Care Select Sector SPDR ETF (XLV) adding 0.3%.The iShares Biotechnology ETF (IBB) rose 0.5%.In corporate news, Merck (MRK) shares rose 2.4% after Daiwa upgraded the stock to outperform from neutral and raised its price target to $143 per share from $120.Cencora (COR) said that certain Walgreens volume that was being serviced by the company, separate from the prime vendor agreement, has started moving outside the company from July 1. Meanwhile, Cencora said its prime vendor agreement remains unchanged and accounts for the majority of its business with Walgreens. Cencora shares fell past 5%.Legend Biotech (LEGN) could see pressures from competition and recent leadership change, potentially weighing on Carvykti myeloma therapy strategy, Oppenheimer said. It downgraded Legend to perform from outperform. Shares fell 5.2%.Definium Therapeutics (DFTX) shares rose 5% after the firm said its phase 3 trial of DT120 orally disintegrating tablets in adults with generalized anxiety disorder met its primary endpoint.

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Sectors

Sector Update: Healthcare Stocks Ease in Afternoon Trading

Healthcare stocks edged lower Wednesday afternoon, with the NYSE Healthcare Index and the State Street Health Care Select Sector SPDR ETF (XLV) each down 0.1%.The iShares Biotechnology ETF (IBB) rose 0.4%.In corporate news, Legend Biotech (LEGN) could see pressures from competition and its recent leadership change, potentially weighing on its Carvykti myeloma therapy strategy, Oppenheimer said in a note. The firm downgraded Legend to perform from outperform and cut the price target to $40 from $75. Legend shares fell nearly 6%.Arbutus Biopharma (ABUS) shares dropped 2.5% after the company reported that it swung to a Q2 loss as revenue fell during the period.Definium Therapeutics (DFTX) shares jumped 6% after it said Wednesday its phase 3 trial of DT120 lysergide orally disintegrating tablets in adults with generalized anxiety disorder met its primary endpoint.

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Wire

Top Midday Stories: Consumer Prices Rise 3.4% YoY in July; CoreWeave Q2 Loss Narrower Than Expectations

The S&P 500 Index and Nasdaq Composite were up slightly, while the Dow Jones Industrial Average was roughly flat in late-morning trading Wednesday, after the consumer price index for July matched expectations.The US seasonally adjusted CPI rose by 0.1% in July, as expected and following a 0.4% decrease in June, the Bureau of Labor Statistics said Wednesday. Core CPI, which excludes food and energy prices, rose by 0.2%, matching expectations and after holding steady in June.The year-over-year rates for overall CPI decreased to 3.4% in July from 3.5% in the previous month and that for core CPI fell to 2.5% from 2.6% in the previous month.In company news, CoreWeave (CRWV) reported a Q2 loss late Tuesday of $1.14 per diluted share, widening from a loss of $0.60 a year earlier but narrower compared with the FactSet consensus estimate of a loss of $1.46. Second-quarter revenue was $2.58 billion, up from $1.21 billion a year ago and above the FactSet consensus of $2.55 billion. CoreWeave shares were up 17.9% around midday.Blackstone (BX) and La Caisse are leading a 2.5 billion Canadian dollars ($1.8 billion) minority equity investment in Air Canada's Aeroplan loyalty program, valuing the business at CA$10 billion, the airline said Tuesday. Blackstone shares were down 0.8%.Goldman Sachs (GS) said Wednesday it has agreed to buy exchange-traded fund provider NEOS Investments for up to $2.25 billion in cash and equity. Goldman shares were up 1%.Alphabet's (GOOG, GOOGL) Google introduced its newest line of Pixel devices, including four phones, a watch and its first-ever tag. The phones are designed for Gemini Intelligence, are more durable and include major camera upgrades, the company said Wednesday. Pixel Watch 5 features proactive Gemini Intelligence capabilities, personalized strength coaching and Google's most accurate GPS route tracking. It also includes Health Guardian features that track blood pressure and insulin resistance trends, as well as Breathing Emergency Detection, the company said. Alphabet's Class C and Class A shares were both down 0.5%.Home Depot (HD) said Wednesday that Chair, President and Chief Executive Ted Decker is taking a temporary medical leave of absence and is expected to return within the next few months. Senior Executive Vice President Ann-Marie Campbell and Chief Financial Officer and EVP Richard McPhail will oversee the operations of the office of the CEO during Decker's absence, the company said. Greg Brenneman, the board's independent lead director, will chair the board while Decker is away, the company said. Home Depot shares were down 2.4%.Definium Therapeutics (DFTX) said Wednesday its phase 3 study of DT120 lysergide orally disintegrating tablets in adults with generalized anxiety disorder met its primary endpoint. Definium shares were up 7.3%.Price: $106.46, Change: $+16.14, Percent Change: +17.87%

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Commodities

Exchange-Traded Funds, Equity Futures Gain Pre-Bell Wednesday Amid In-Line Consumer Inflation Data, Tech Gains

The broad market exchange-traded fund SPDR S&P 500 ETF Trust (SPY) was up 0.2%, and the actively traded Invesco QQQ Trust (QQQ) was 0.7% higher in Wednesday's premarket activity as investors welcomed a July consumer inflation reading that matched forecasts and continued strength in AI-related technology shares.US stock futures were also higher, with S&P 500 Index futures up 0.3%, Dow Jones Industrial Average futures advancing 0.1%, and Nasdaq futures gaining 0.7% before the start of regular trading.Mortgage applications rose by 3.6% in the week ended Aug. 7 after a 2.9% decline in the previous week as 30-year fixed mortgage rates declined, according to Mortgage Bankers Association data released Wednesday.The US seasonally adjusted consumer price index, a measure of inflation, gained 0.1% in July, as expected and following a 0.4% decrease in June, according to data released by the Bureau of Labor Statistics on Wednesday.Weekly crude oil stocks data will be released at 10:30 am ET.The US Treasury is due to publish its monthly budget statement for July at 2 pm ET.In premarket activity, bitcoin was up by 1.1%. Among cryptocurrency ETFs, the cryptocurrency fund ProShares Bitcoin Strategy ETF (BITO) was 1.2% higher, Ether ETF (EETH) advanced 2%, and Bitcoin & Ether Market Cap Weight ETF (BETH) was down 0.7%.Power Play:Health CareThe State Street Health Care Select Sector SPDR ETF (XLV) retreated 0.2%, the Vanguard Health Care Index Fund (VHT) was 0.02% lower, while the iShares US Healthcare ETF (IYH) was flat. The iShares Biotechnology ETF (IBB) advanced 0.1%Definium Therapeutics (DFTX) stock was up more than 17% premarket after the company said its phase 3 Voyage study of DT120 lysergide orally disintegrating tablets in adults with generalized anxiety disorder met its primary endpoint.Winners and Losers:TechnologyThe State Street Technology Select Sector SPDR ETF (XLK) rose 1%, the iShares US Technology ETF (IYW) was 1% higher, and the iShares Expanded Tech Sector ETF (IGM) was inactive. Among semiconductor ETFs, the State Street SPDR S&P Semiconductor ETF (XSD) was up 2.1%, while the iShares Semiconductor ETF (SOXX) rose by 2.1%.Octave Intelligence (OCTV) shares were down more than 14% in premarket activity after the company posted lower Q2 revenue.FinancialThe State Street Financial Select Sector SPDR ETF (XLF) retreated 0.03%. Direxion Daily Financial Bull 3X Shares (FAS) was up 0.2%, while its bearish counterpart, Direxion Daily Financial Bear 3X Shares (FAZ), was 0.1% higher.Marex Group (MRX) shares were up 8% in early-hours activity after the company reported higher Q2 adjusted earnings and revenue.IndustrialThe State Street Industrial Select Sector SPDR ETF (XLI) advanced 0.3%, while the Vanguard Industrials Index Fund (VIS) was flat and the iShares US Industrials ETF (IYJ) was inactive.Firefly Aerospace (FLY) stock was up more than 3% before the opening bell after the company reported a narrower Q2 adjusted loss and higher year-over-year revenue.EnergyThe iShares US Energy ETF (IYE) was inactive, while the State Street Energy Select Sector SPDR ETF (XLE) was down by 0.4%.Fervo Energy (FRVO) stock was up more than 2% before market open after the company reported a narrower Q2 net loss.ConsumerThe State Street Consumer Staples Select Sector SPDR ETF (XLP) was up 0.03%, the Vanguard Consumer Staples Index Fund ETF Shares (VDC) retreated 0.01%, and the iShares US Consumer Staples ETF (IYK) was down 1.3%. The State Street Consumer Discretionary Select Sector SPDR ETF (XLY) lost 0.03%. The VanEck Retail ETF (RTH) was inactive, while the State Street SPDR S&P Retail ETF (XRT) gained 0.02%.Kontoor Brands (KTB) shares were down more than 1% pre-bell following the company's Q2 financial results.CommoditiesFront-month US West Texas Intermediate crude oil advanced by 0.6% to $83.69 per barrel on the New York Mercantile Exchange. Natural gas was 1.3% higher at $2.80 per 1 million British Thermal Units. The United States Oil Fund (USO) increased by 0.1%, while the United States Natural Gas Fund (UNG) was 2% higher.Gold futures for November gained by 0.7% to reach $4,472.20 an ounce on the Comex. Silver futures retreated 2.3% to $66.44 an ounce. SPDR Gold Shares (GLD) was up by 0.8%, and the iShares Silver Trust (SLV) was 2% higher.

Dow JonesNasdaq CompositeS&P 500$BETH$BITO$DFTX$EEM$EETH$EXI$FAS$FAZ$FLY$FRVO$GLD$IBB$IGM$IGV$IPK$IVV$IWM$IYE$IYH$IYJ$IYK$IYW$MRX$OCTV$PMR$QQQ$RTH$SLV$SOXX$SPY$UNG$USO$VDC$VHT$VIS$XLE$XLF$XLI$XLK$XLP$XLV$XLY$XRT$XSD
Sectors

Sector Update: Healthcare Stocks Lean Lower Premarket Wednesday

Healthcare stocks were leaning lower premarket Wednesday, with the State Street Health Care Select Sector SPDR ETF (XLV) declining by 0.4% and the iShares Biotechnology ETF (IBB) down 0.1%.Definium Therapeutics (DFTX) shares were up more than 16% after the company said its phase 3 Voyage study of DT120 lysergide orally disintegrating tablets in adults with generalized anxiety disorder met its primary endpoint.Arbutus Biopharma (ABUS) stock was down more than 3% after the company reported that it swung to a Q2 loss as revenue fell during the period.Natera's (NTRA) Latitude tissue-free assay for molecular residual disease detection will be used by Kupando Therapeutics in a phase 1 clinical trial of its lead immunotherapy candidate, KUP-101, Natera said. Shares of Natera were up more than 1% pre-bell.

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Sectors

Sector Update: Healthcare

Healthcare stocks were leaning lower premarket Wednesday, with the State Street Health Care Select Sector SPDR ETF (XLV) declining by 0.2% and the iShares Biotechnology ETF (IBB) down 0.1%.Definium Therapeutics (DFTX) shares were up more than 16% after the company said its phase 3 Voyage study of DT120 lysergide orally disintegrating tablets in adults with generalized anxiety disorder met its primary endpoint.

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Research

Wells Fargo Initiates Definium Therapeutics at Overweight

Definium Therapeutics, Inc. (DFTX) has an average rating of buy and mean price target of $60, according to analysts polled by FactSet.

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Wire

Top Midday Gainers

Nexentis Technologies (NXTS) said Monday its subsidiary, MitoCareX Bio, has entered into an engagement with Boltz, an AI research lab, to accelerate the identification of novel small-molecule scaffolds targeting selected solute carrier proteins of interest to MitoCareX's pipeline.Shares jumped over 200% as trading volume catapulted to over 55 million from a daily average of about 208,000.AbbVie (ABBV) agreed to acquire Apogee Therapeutics (APGE) for $135.11 per share in cash for a total equity value of $10.9 billion, the companies said Monday.Shares of Apogee soared 47%, with intraday trading volume of over 47.1 million against a daily average of about 975,000.Definium Therapeutics (DFTX) reported positive topline results from a phase 3 Emerge study of DT120 orally disintegrating tablet in major depressive disorder.RBC Capital raised its price target to $57 from $36, while maintaining its outperform rating.Shares surged 52% amid a jump in intraday trading volume to over 16 million from a daily average of roughly 1.9 million.Price: $15.55, Change: $+10.47, Percent Change: +206.08%

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Sectors

Sector Update: Healthcare Stocks Rise Monday Afternoon

Healthcare stocks were higher Monday afternoon, with the NYSE Healthcare Index rising 1.4% and the State Street Health Care Select Sector SPDR ETF (XLV) adding 1.2%.The iShares Biotechnology ETF (IBB) rose 1.9%.In corporate news, AbbVie (ABBV) has agreed to acquire Apogee Therapeutics (APGE) in an all-cash deal worth about $10.9 billion, as the drugmaker looks to boost its immunology portfolio and accelerate its clinical presence in the respiratory segment. AbbVie shares jumped past 7%, and Apogee surged 46%.Jaguar Health (JAGX) shares climbed up past 9% after the firm said Monday its board has started a process to explore strategic alternatives to maximize shareholder value.Definium Therapeutics (DFTX) shares soared 55% after the firm said the phase 3 Emerge trial of a single 100-microgram dose of DT120 orally disintegrating tablet in major depressive disorder met the primary endpoint, and all key secondary endpoints.

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Wire

RBC Capital Adjusts Price Target on Definium Therapeutics to $57 From $36, Maintains Outperform Rating

Definium Therapeutics, Inc. (DFTX) has an average rating of buy and mean price target of $42, according to analysts polled by FactSet.Price: $38.10, Change: $+13.62, Percent Change: +55.64%

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Sectors

Sector Update: Healthcare Stocks Flat to Lower Premarket Monday

Healthcare stocks were flat to lower premarket Monday, with the State Street Health Care Select Sector SPDR ETF (XLV) down 0.1% and the iShares Biotechnology ETF (IBB) inactive.AbbVie (ABBV) has agreed to acquire Apogee Therapeutics (APGE) for $135.11 per share in cash for a total equity value of $10.9 billion. Shares of Apogee Therapeutics were up nearly 47% pre-bell, while AbbVie rose 2.3%.Definium Therapeutics (DFTX) shares were up more than 60% after the company said the phase 3 Emerge trial of a single 100-microgram dose of DT120 orally disintegrating tablet in major depressive disorder met the primary endpoint, along with all key secondary efficacy endpoints.MapLight Therapeutics' (MPLT) phase 2 trial of ML-004 in autism spectrum disorder failed to meet its primary endpoint in social communication, the company said. MapLight Therapeutics stock was up 1.6% premarket.

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Wire

Definium Therapeutics Reports Positive Phase 3 Data for DT120 ODT in Major Depressive Disorder

Definium Therapeutics' (DFTX) Phase 3 Emerge trial of a single 100-microgram dose of DT120 orally disintegrating tablet in major depressive disorder met the primary endpoint along with all key secondary efficacy endpoints, the company said Monday.The study showed an 8.1-point placebo-adjusted decline in Montgomery-Asberg Depression Rating Scale scores at Week 6 (pThe company also reported a 14.2-point placebo-adjusted improvement at Week 1 (pDT120 ODT was generally well tolerated, with mostly mild to moderate adverse events, no serious adverse events and no new safety signals, including no increase in suicidal ideation or behavior, Definium said.Definium Therapeutics shares were up 32% in premarket trading.

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Wire

FDA Fast-Tracks Psychedelic Drug Research Following Trump Directive; Psychedelic Drug Makers Gain

Shares of some psychedelic drug companies gained Friday morning after the US Food and Drug Administration said it was launching regulatory actions to back the development of psychedelic therapies to treat mental illness.Cybin (HELP) shares jumped past 4%, Psyence Biomedical (PBM) shares climbed 7%, and Clearmind Medicine (CMND) shares were up 2.4%.The FDA's move builds on President Donald Trump's recent executive order directing the Department of Health and Human Services to accelerate access to treatments for people with serious mental illness, the FDA said.The drugs have the potential to address mental health diseases like treatment-resistant depression, alcoholism and substance abuse, said FDA Commissioner Marty Makary.The agency said it is issuing national priority vouchers to three companies researching psilocybin for treatment-resistant depression, psilocybin for major depressive disorder, and methylone for post-traumatic stress disorder.The agency said it is also allowing an early-phase trial of noribogaine hydrochloride to proceed following an investigational new drug filing. The sponsor is investigating noribogaine to potentially treat alcohol use disorder, the FDA said, adding the move will allow the company developing the new drug, DemeRx NB, to start a phase 1 trial in the US.The agency said it will release final guidance "imminently" to provide recommendations to sponsors developing psychedelic medications.Price: $8.89, Change: $-0.27, Percent Change: -2.90%

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Wire

Oppenheimer Adjusts Definium Therapeutics PT to $40 From $25, Maintains Outperform Rating

Definium Therapeutics, Inc. (DFTX) has an average rating of Buy and mean price target of $38.87, according to analysts polled by FactSet.Price: $22.79, Change: $-0.29, Percent Change: -1.26%

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Research

Stifel Initiates Definium Therapeutics at Buy With $30 Price Target

Definium Therapeutics, Inc. (DFTX) has an average rating of buy and mean price target of $36.67, according to analysts polled by FactSet.

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