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NS Pharma, Inc. (NS Pharma), a subsidiary of Nippon Shinyaku Co., Ltd. (Nippon Shinyaku) announced today that the U.S. Food and Drug Administration has accepted for review the Biologics License Application (BLA) submission by REGENXBIO Inc. (REGENXBIO, Headquarters: Rockville, Maryland, USA, CEO: Curran M. Simpson, (REGENXBIO; Headquarters: Rockville, Maryland, USA; CEO: Curran M. Simpson, NASDAQ:<a href="https://www.benzinga.com/stock/RGNX#NASDAQ">RGNX</a>) for RGX-121 (clemidsogene lanparvovec), a potential first-in-class, investigational gene therapy for the treatment of Mucopolysaccharidosis II (MPS II).&nbsp;The FDA granted REGENXBIO's BLA Priority Review with a Prescription Drug User Fee Act ("PDUFA") target action date of November 9, 2025.

News

FDA Accepts Biologics License Application For Mucopolysaccharidosis II Treatment

Federal regulators are pressing Tesla Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TSLA#NASDAQ">TSLA</a>) for details on how its driverless taxis will operate safely in challenging conditions as the electric vehicle maker prepares for a pivotal robotaxi launch in Austin next month.
What Happened: The National Highway Traffic Safety Administration (NHTSA) has requested information on how Tesla&#8217;s autonomous vehicles will handle fog, sun glare, rain, and other low-visibility situations linked to previous accidents involving the company&#8217;s driver-assistance software, according to a nine-page letter, according to an Associated Press <a href="https://apnews.com/article/testla-robotaxi-cybercab-austin-musk-regulators-waymo-236331b75aa8fae687fbb7d3ad527842">report</a> on Wednesday.
CEO Elon Musk has reassured investors the Austin launch will proceed as planned, laying the groundwork for &#8220;millions of robotaxis&#8221; nationwide by year-end. &#8220;Can you go to sleep in our cars and wake up at your destination?&#8221; 
Musk asked during an April earnings call. &#8220;I&#8217;m confident that will be available in many cities in the U.S. by the end of this year.&#8221;
The federal inquiry comes amid Tesla&#8217;s intensive &#8220;Project Rodeo&#8221; testing in Austin, where approximately 300 operators have been <a href="https://www.benzinga.com/tech/25/04/45028007/tesla-prepares-for-robotaxi-reveal-in-june-insiders-share-secrets?utm_source=chatgpt.com">secretly evaluating prototype self-driving software</a>, Business Insider reported. 
See Also: <a href="https://www.benzinga.com/25/05/45400104/elon-musk-says-mohammed-bin-salman-and-trump-were-impressed-with-tesla-optimus-as-the-humanoid-robot-danced-to-ymca">Elon Musk Says Mohammed Bin Salman And Trump Were &#8216;Impressed&#8217; With Tesla Optimus As The Humanoid Robot Danced To &#8216;YMCA&#8217;</a>
Why It Matters: The company has been accumulating &#8220;critical miles,&#8221; conducting training with local first responders, and testing its robotaxi app <a href="https://www.benzinga.com/tech/25/04/45028007/tesla-prepares-for-robotaxi-reveal-in-june-insiders-share-secrets?utm_source=chatgpt.com">ahead of a targeted June 1 launch</a>.
Industry veterans remain skeptical of Tesla&#8217;s readiness. Former Waymo CEO John Krafcik publicly questioned whether the company&#8217;s Cybercab concept <a href="https://www.benzinga.com/markets/equities/25/03/44488029/tesla-teases-robotaxi-launch-in-texas-but-industry-veterans-question-safety-and-readiness-if-a-company-were-serious?utm_source=chatgpt.com">incorporates necessary safety features</a>, stating a &#8220;serious robotaxi would demonstrate the primacy of safety.&#8221;
Tesla&#8217;s stock has risen 45% since Musk announced he was <a href="https://www.benzinga.com/news/management/25/05/45140155/musk-shifts-focus-back-to-tesla-says-doge-will-endure-without-him-is-buddha-needed-for-buddhism">stepping back from his role</a> in President Donald Trump&#8216;s administration to focus on the company, though shares remain down 17% year-to-date. With first-quarter profits down 71%, the success of the robotaxi initiative has become increasingly critical to justify Tesla&#8217;s valuation.
Read Next:
<ul class="wp-block-list">
<li><a href="https://www.benzinga.com/general/market-summary/25/05/45399940/warren-buffett-shows-how-patience-pays-98-of-his-160-billion-wealth-came-after-turning-65-thanks-the-power-of-compound-interest">Warren Buffett Shows How Patience Pays: 98% Of His $160 Billion Wealth Came After Turning 65, Thanks The Power Of &#8216;Compound Interest&#8217;</a></li>
</ul>
Disclaimer:&nbsp;This content was partially produced with the help of AI tools and was reviewed and published by Benzinga editors.
Image Via Shutterstock

Equities

Markets

TSLA

Tesla's Robotaxi Plans Under Federal Scrutiny Ahead Ff Austin Launch As Elon Musk Vows Nationwide Rollout By Year-End

Milestone Pharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MIST#NASDAQ">MIST</a>) reported quarterly losses of $(0.31) per share which missed the analyst consensus estimate of $(0.18) by 72.22 percent. This is a 47.62 percent decrease over losses of $(0.21) per share from the same period last year.

Earnings

Earnings Misses

MIST

Milestone Pharmaceuticals Q1 EPS $(0.31) Misses $(0.18) Estimate

Climb Bio (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CLYM#NASDAQ">CLYM</a>) reported quarterly losses of $(0.31) per share which missed the analyst consensus estimate of $(0.15) by 106.67 percent. This is a 416.67 percent decrease over losses of $(0.06) per share from the same period last year.

CLYM

Climb Bio Q1 EPS $(0.31) Misses $(0.15) Estimate

Benchmark analyst Cody Acree reiterates Silicon Laboratories (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SLAB#NASDAQ">SLAB</a>) with a Buy and maintains $160 price target.

Price Target

Reiteration

Analyst Ratings

SLAB

Benchmark Reiterates Buy on Silicon Laboratories, Maintains $160 Price Target

SRRK

Scholar Rock Holding Q1 EPS $(0.67) Misses $(0.65) Estimate

Live Nation To Anchor New 5,300-Seat Venue at Atlanta's $5B Centennial Yards District

DAVA

Endava And AlixPartners Form Strategic Partnership To Deliver End-To-End Technology-Driven Solutions And Accelerate Digital Transformation Globally

Foghorn Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/FHTX#NASDAQ">FHTX</a>) reported quarterly losses of $(0.30) per share which beat the analyst consensus estimate of $(0.31) by 3.23 percent. This is a 49.15 percent increase over losses of $(0.59) per share from the same period last year. The company reported quarterly sales of $5.95 million which beat the analyst consensus estimate of $5.82 million by 2.34 percent. This is a 17.86 percent increase over sales of $5.05 million the same period last year.

Earnings Beats

FHTX

Foghorn Therapeutics Q1 EPS $(0.30) Beats $(0.31) Estimate, Sales $5.95M Beat $5.82M Estimate

MRCY

Mercury Launches ROCK3 Mission Computer To Power AI, 5G-Enabled Military And Urban Air Platforms

WIIM

SEPN

Septerna shares are trading higher after the company announced an exclusive global collaboration and license agreement with Novo Nordisk to develop oral small molecule medicines for obesity, type 2 diabetes, and other cardiometabolic diseases.

Radcom (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/RDCM#NASDAQ">RDCM</a>) raises FY2025 sales outlook from $69.20 million to $71.10 million vs $68.75 million estimate.

Guidance

RDCM

Radcom Raises FY2025 Sales Guidance from $69.20M to $71.10M vs $68.75M Est

CalciMedica (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CALC#NASDAQ">CALC</a>) reported quarterly losses of $(0.36) per share which missed the analyst consensus estimate of $(0.31) by 16.13 percent. This is a 3700 percent decrease over earnings of $0.01 per share from the same period last year.

CALC

CalciMedica Q1 EPS $(0.36) Misses $(0.31) Estimate

Aeluma, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ALMU#NASDAQ">ALMU</a>), a semiconductor company specializing in high-performance, scalable technologies for mobile, automotive, AI, defense and aerospace, communication, and quantum computing, announced today it will participate in two key upcoming industry conferences: the 2025 International Conference on Compound Semiconductor Manufacturing Technology (CS Mantech) and the 2025 IEEE Optical Interconnects and Packaging Conference (OIP).
At the conferences, Aeluma will present technical advancements in shortwave infrared photodetectors, high-speed optical interconnects, and quantum dot lasers for silicon photonics, core technologies engineered to meet the growing performance and scale requirements of AI infrastructure, quantum, and sensing systems.
At <a href="https://pr.report/ae75">CS Mantech</a>, being held May 19-22, 2025 in New Orleans, Louisiana, Aeluma will deliver a talk titled: "Heterogeneous Integration of Large-Area InGaAs SWIR Photodetectors on 300mm CMOS-Compatible Si Substrates." This session will spotlight Aeluma's novel approach to wafer-scale manufacturing of high-performance photodetector arrays enabling compact, energy-efficient solutions for mobile and consumer, AR/VR, defense and aerospace, and industrial automation.
At the <a href="https://pr.report/ae76">IEEE OIP</a>, being held June 16-18, 2025 in Fort Collins, Colorado, Aeluma will present:
"Heterogeneous Integration of InGaAs PIN and APD Photodetectors for High-Speed Interconnects," focusing on data center, AI infrastructure, and aerial systems.
"Scalable and Monolithic Integration of Quantum Dot Lasers for Silicon Photonics," addressing critical bottlenecks in next-generation optical interconnects, AI infrastructure, quantum, and sensing.

ALMU

Aeluma to Showcase Breakthrough AI and Quantum Tech at Key Semiconductor Conferences

Telsey Advisory Group analyst Dana Telsey maintains VF (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/VFC#NYSE">VFC</a>) with a Market Perform and lowers the price target from $27 to $17.

Telsey Advisory Group Maintains Market Perform on VF, Lowers Price Target to $17

Toyota Adds 20th Electrified Model With 2026 C-HR BEV: High Power, Long Range, Striking Looks

BRKR

Bruker And 10x Genomics Settle Patent Disputes And Enter Global Cross-License Agreement, Dismissing All Ongoing Litigations

Needham analyst Charles Shi maintains Camtek (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CAMT#NASDAQ">CAMT</a>) with a Buy and lowers the price target from $110 to $80.

CAMT

Needham Maintains Buy on Camtek, Lowers Price Target to $80

Verve Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/VERV#NASDAQ">VERV</a>) reported quarterly losses of $(0.35) per share which beat the analyst consensus estimate of $(0.67) by 47.76 percent. This is a 40.68 percent increase over losses of $(0.59) per share from the same period last year. The company reported quarterly sales of $32.98 million which beat the analyst consensus estimate of $9.38 million by 251.72 percent. This is a 479.03 percent increase over sales of $5.70 million the same period last year.

VERV

Verve Therapeutics Q1 EPS $(0.35) Versus $(0.59) YoY, Sales $32.98M

AVEA

Aeva Inks Strategic Collaboration With Global Tech Affiliate, Secures Up To $50M Investment Including Equity Stake

BlackRock iShares USD TIPS 0-5 UCITS ETF USD (Dist)

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