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Bird Global Inc Class A

U.S. FDA issues clinical hold on EBVALLO&#x2122; (tabelecleucel) and ATA3219 studies linked to EBVALLO Complete Response Letter (CRL)
<a href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.atarabio.com%2F&amp;esheet=54183700&amp;newsitemid=20250121045791&amp;lan=en-US&amp;anchor=Atara+Biotherapeutics%2C+Inc.&amp;index=1&amp;md5=c7a54b9aad73e62bc9c74498767d641c">Atara Biotherapeutics, Inc.</a> (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ATRA#NASDAQ">ATRA</a>), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, today announced that the U.S. Food and Drug Administration (FDA) has placed a clinical hold on Atara's active Investigational New Drug (IND) applications. These INDs include the EBVALLOTM (tabelecleucel) program as monotherapy treatment for adult and pediatric patients two years of age and older with Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD), as well as ATA3219, an allogeneic CD19-targeted CAR-T therapy, for the treatment of non-Hodgkin's lymphoma and systemic lupus erythematosus. Specifically identified subjects currently enrolled in the clinical studies who have the potential to derive clinical benefit may continue to receive treatment in accordance with the ongoing study protocols. Screening and enrollment of new participants in both programs have been paused.
The clinical hold for EBVALLO is directly linked to inadequately addressed GMP compliance issues identified during the pre-license inspection of the third-party manufacturing facility referenced in the Complete Response Letter (CRL) for EBVALLO that was announced on January 16, 2025. While ATA3219 drug product is manufactured at a separate, fully compliant GMP-certified facility, the starting materials used in its production are affected by the compliance issues at the same third-party facility referenced in the CRL. These issues, which underlie both the CRL and the clinical hold, are specific to the referenced third-party manufacturing facility and do not affect Atara's second third-party manufacturer, FUJIFILM Diosynth Biotechnologies (FDB) facility in Thousand Oaks, California. The FDB facility remains a critical component of Atara's long-term manufacturing strategy for both assets.
Atara and FDA have discussed and agreed upon the actions necessary to release the clinical holds. The FDA has confirmed its commitment to working collaboratively and expeditiously with Atara to resolve the clinical holds.

Biotech

News

General

ATRA

FDA Places Clinical Hold On Atara Biotherapeutics' EBVALLO And ATA3219 Studies; Linked To Manufacturing Compliance Issues; Enrollment Paused; Existing Subjects May Continue Treatment; Co And FDA Discussed And Agreed Upon Actions For Resolution

Contracts

BWMN

Bowman Awarded Geodetic Survey Contract For An Infrastructure Company, Size Not Disclosed

Health Care

Dyne Therapeutics Given FDA Fast Track Designation For DYNE-101 To Treat Myotonic Dystrophy Type 1

Rosenblatt analyst Hans Mosesmann maintains Texas Instruments (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TXN#NASDAQ">TXN</a>) with a Buy and maintains $250 price target.

Price Target

Analyst Ratings

Rosenblatt Maintains Buy on Texas Instruments, Maintains $250 Price Target

Morgan Stanley analyst Brian Harbour maintains Sweetgreen (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/SG#NYSE">SG</a>) with a Equal-Weight and lowers the price target from $32 to $28.

Morgan Stanley Maintains Equal-Weight on Sweetgreen, Lowers Price Target to $28

Charles Schwab (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/SCHW#NYSE">SCHW</a>) reported quarterly earnings of $1.01 per share which beat the analyst consensus estimate of $0.91 by 10.99 percent. This is a 48.53 percent increase over earnings of $0.68 per share from the same period last year. The company reported quarterly sales of $5.33 billion which beat the analyst consensus estimate of $5.19 billion by 2.73 percent. This is a 19.51 percent increase over sales of $4.46 billion the same period last year.

Earnings

Earnings Beats

SCHW

Charles Schwab Q4 2024 Adj EPS $1.01 Beats $0.91 Estimate, Sales $5.33B Beat $5.19B Estimate

Top Wall Street analysts initiated coverage on these top names. For a complete view of all analyst rating changes, including upgrades, downgrades and initiations, please see our <a href="https://www.benzinga.com/analyst-stock-ratings">analyst ratings page</a>.
<ul>
<li>Keefe, Bruyette &amp; Woods analyst Wood Lay initiated coverage on FirstSun Capital Bancorp (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/FSUN#NASDAQ">FSUN</a>) with an Outperform rating and announced a price target of $46. Firstsun Capital shares closed at $39.49 on Friday. <a href="https://www.benzinga.com/quote/fsun/analyst-ratings">See how other analysts view this stock</a>.</li>
<li>China Renaissance analyst Colin Liu initiated coverage on MongoDB, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MDB#NASDAQ">MDB</a>) with a Buy rating and announced a price target of $351. MongoDB shares closed at $253.11 on Friday. <a href="https://www.benzinga.com/quote/msb/analyst-ratings">See how other analysts view this stock</a>.</li>
<li>Citigroup analyst Jason Gursky initiated coverage on Curtiss-Wright Corporation (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/CW#NYSE">CW</a>) with a Buy rating and announced a price target of $410. Curtiss-Wright shares closed at $366.92 on Friday. <a href="https://www.benzinga.com/quote/cw/analyst-ratings">See how other analysts view this stock</a>.</li>
<li>UBS analyst Priya Sachdeva initiated coverage on Penumbra, Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PEN#NYSE">PEN</a>) with a Buy rating and announced a price target of $305. Penumbra shares closed at $263.69 on Friday. <a href="https://www.benzinga.com/quote/pen/analyst-ratings">See how other analysts view this stock</a>.</li>
<li>Citigroup analyst Jason Gursky initiated coverage on V2X, Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/VVX#NYSE">VVX</a>) with a Buy rating and announced a price target of $64. V2X shares closed at $52.93 on Friday. <a href="https://www.benzinga.com/quote/vvx/analyst-ratings">See how other analysts view this stock.</a></li>
</ul>
Considering buying MDB stock? Here&#8217;s what analysts think: 
<figure class="wp-block-image size-large is-resized"><img loading="lazy" decoding="async" width="1024" height="494" src="https://editorial-assets.benzinga.com/wp-content/uploads/2025/01/21072846/image-135-1024x494.png" alt="" class="wp-image-742334" style="width:585px;height:auto" srcset="https://editorial-assets.benzinga.com/wp-content/uploads/2025/01/21072846/image-135-1024x494.png 1024w,https://editorial-assets.benzinga.com/wp-content/uploads/2025/01/21072846/image-135-300x145.png 300w,https://editorial-assets.benzinga.com/wp-content/uploads/2025/01/21072846/image-135-768x370.png 768w,https://editorial-assets.benzinga.com/wp-content/uploads/2025/01/21072846/image-135.png 1110w" sizes="(max-width: 1024px) 100vw, 1024px" /></figure>
Read This Next: 
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</ul>

Initiation

Pre-Market Outlook

Markets

Trading Ideas

FSUN

This MongoDB Analyst Begins Coverage On A Bullish Note; Here Are Top 5 Initiations For Monday

D. Boral Capital analyst Jason Kolbert maintains Reviva Pharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/RVPH#NASDAQ">RVPH</a>) with a Buy and maintains $15 price target.

RVPH

D. Boral Capital Maintains Buy on Reviva Pharmaceuticals, Maintains $15 Price Target

Morgan Stanley analyst John Glass maintains Sysco (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/SYY#NYSE">SYY</a>) with a Equal-Weight and lowers the price target from $82 to $79.

Morgan Stanley Maintains Equal-Weight on Sysco, Lowers Price Target to $79

<h2><a href="https://www.jnj.com/media-center/press-releases/european-commission-approves-lazcluze-lazertinib-in-combination-with-rybrevant-amivantamab-for-the-first-line-treatment-of-patients-with-egfr-mutated-advanced-non-small-cell-lung-cancer">https://www.jnj.com/media-center/press-releases/european-commission-approves-lazcluze-lazertinib-in-combination-with-rybrevant-amivantamab-for-the-first-line-treatment-of-patients-with-egfr-mutated-advanced-non-small-cell-lung-cancer</a></h2>
&nbsp;
<h2>&nbsp;</h2>
<h2>Latest topline data from the Phase 3 MARIPOSA study shows amivantamab plus lazertinib is the first regimen to demonstrate superior overall survival benefit compared to the current standard of care osimertinib1 Median overall survival improvement is expected to exceed one year1</h2>

Global

European Commission Approves LAZCLUZE In Combination With RYBREVANT For The first-Line Treatment Of Patients With EGFR-Mutated Advanced Non-Small Cell Lung Cancer

Morgan Stanley analyst Brian Harbour maintains Performance Food Gr (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFGC#NYSE">PFGC</a>) with a Equal-Weight and raises the price target from $94 to $96.

PFGC

Morgan Stanley Maintains Equal-Weight on Performance Food Gr, Raises Price Target to $96

Wells Fargo analyst Jared Shaw upgrades Bank OZK (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/OZK#NASDAQ">OZK</a>) from Underweight to Equal-Weight and raises the price target from $40 to $48.

Upgrades

Wells Fargo Upgrades Bank OZK to Equal-Weight, Raises Price Target to $48

Needham analyst Joshua Reilly reiterates AudioEye (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AEYE#NASDAQ">AEYE</a>) with a Buy and maintains $25 price target.

Reiteration

AEYE

Needham Reiterates Buy on AudioEye, Maintains $25 Price Target

Chinese smartphone maker Xiaomi&#8217;s (OTC:<a class="ticker" href="https://www.benzinga.com/stock/XIACF#OTC">XIACF</a>) first EV — the SU7 — outsold American EV giant Tesla Inc.&#8217;s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TSLA#NASDAQ">TSLA</a>) Model 3 sedan in China in December.
What Happened: Xiaomi chairman Lei Jun noted the achievement in a post on the social media platform Weibo.
While 25,815 Xiaomi SU7 vehicles were sold in December, only 21,046 Model 3s were sold. The best-selling EV in the month, however, was BYD Co.&#8217;s Seagull, of which the company sold 48,754 units.
Xiaomi launched its first EV — the SU7 sedan — in late March and started delivering the vehicles in April. 
The SU7 is available in three variants, namely Standard, Pro, and Max with the lower-end variant starting at 215,900 yuan ($29,500), lower than Tesla&#8217;s cheapest offering — the Model 3 — in China.
Why It Matters: Tesla hiked the price of the Model 3 in China earlier this month by 3,600 yuan. The vehicle now starts at 235,500 yuan in the country with the higher-end Performance variant priced at 339,500 yuan.
Tesla also launched a refreshed Model Y in China this month. The refreshed vehicle starts at&nbsp;<a href="https://www.benzinga.com/tech/25/01/42905406/tesla-launches-refreshed-model-y-in-china-amid-rising-competition" target="_blank" rel="noreferrer noopener">263,500 yuan on Tesla&#8217;s website</a>, nearly 5.4% pricier than the older version of the vehicle which started at 249,900 yuan.&nbsp;
China is an important market for Tesla. In 2024, the company reportedly&nbsp;<a href="https://www.benzinga.com/25/01/42782683/tesla-hits-record-ev-sales-in-china-despite-global-dip" target="_blank" rel="noreferrer noopener">sold around 657,000 vehicles in China</a>, marking a growth of 8.8% year-on-year, even while its global annual deliveries fell as compared to 2023.
Tesla reported global&nbsp;<a href="https://www.benzinga.com/trading-ideas/movers/25/01/42766117/tesla-stock-tumbles-on-q4-deliveries-whats-going-on" target="_blank" rel="noreferrer noopener">deliveries of 1.79 million</a>&nbsp;vehicles in 2024, down from full-year deliveries of 1.81 million in 2023, marking the first decline in over a decade.
Check out more of Benzinga&#8217;s Future Of Mobility coverage by&nbsp;<a href="https://www.benzinga.com/topic/mobility" target="_blank" rel="noreferrer noopener">following this link.</a>
Read Next:
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<li><a href="https://www.benzinga.com/tech/25/01/43090016/which-evs-might-lose-7500-ev-tax-credit-under-trump-administration" target="_blank" rel="noreferrer noopener">Here Are The EVs Which Could Lose $7,500 EV Tax Credit Under Trump Administration</a></li>
</ul>
Photo courtesy: Shutterstock

Tech

TSLA

XIACF

Tesla Model 3 Loses To Xiaomi SU7 In China's December Sales Showdown

Management

BIRK

Birkenstock Group Appoints Ivica Krolo As Finance Chief Effective February 1, 2025

Successfully treated atrial fibrillation (AF) in initial 30 patients with the Nanosecond PFA 360° Cardiac Catheter
Pulse Biosciences, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/PLSE#NASDAQ">PLSE</a>), a company leveraging its novel and proprietary Nanosecond Pulsed Field Ablation&#x2122; (nsPFA&#x2122;) technology, today announced the late-breaking data from its Nanosecond PFA 360° Cardiac Catheter System first-in-human feasibility study, which data were recently presented at the 30th Annual AF Symposium 2025 meeting.
The feasibility study is intended to assess the initial safety and efficacy of the Nanosecond PFA 360° Cardiac Catheter System for the treatment of AF (NCT06696170). To date, 77 patients have been treated by six investigators, including Dr. Vivek Reddy and Prof. Petr Neuzil, in cases performed at Na Holmolce Hospital in Prague and Dr. Johan Vijgen at Jessa Hospital in Hasselt. The initial cohort of the first 30 patients treated have been evaluated by remapping completed at ~3 months post ablation procedure.

PLSE

Pulse Biosciences Announces Nanosecond PFA 360° Cardiac Catheter Study Results, 92.4% Success At 3 Months In Initial 30 AF Patients; IDE Study Planned For 2025

Morgan Stanley analyst Brian Harbour maintains Portillos (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/PTLO#NASDAQ">PTLO</a>) with a Equal-Weight and lowers the price target from $15 to $13.

PTLO

Morgan Stanley Maintains Equal-Weight on Portillos, Lowers Price Target to $13

WIIM

HSDT

Helius Medical Technologies shares are trading higher after the company announced it exceeded its initial enrollment target for its stroke pivotal study.

Needham analyst Joshua Reilly reiterates Jamf Holding (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/JAMF#NASDAQ">JAMF</a>) with a Buy and maintains $25 price target.

JAMF

Needham Reiterates Buy on Jamf Holding, Maintains $25 Price Target

Guidance

BLRX

BioLineRx Outlines Vision For 2025: Plans New Oncology/Rare Disease In-Licensing, 1-For-40 Reverse Stock Split To Meet Nasdaq Compliance, $29.5M Cash, Runway Through H2 2026

Comments

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