Apple Inc. (NASDAQ:AAPL) is losing its mojo in China’s crucial market as its domestic players gain ground. The uncertainty regarding the availability of the Apple Intelligence feature in the country is an additional downer.
The iPhone maker’s market share in China plunged to sixth place from third in the second quarter of 2024. According to Canalys, Apple had a market share of 14%, down by two basis points year-on-year.
Also Read: China’s Markets Still Manage To Get Nvidia AI Chips Via Smuggling: Report
China’s smartphone shipment grew 10% year-on-year to over 70 million units in the second quarter. Vivo emerged as the number one with a 19% market share by shipping 13.1 million units, up by 15% year-on-year, driven by solid performance in offline channels and robust online sales during the Chinese e-commerce festival.
OPPO remained in second position with a 16% market share after shipping 11.3 million units. HONOR came third with a market share of 15%, backed by shipments of 10.7 million units, implying a 4% growth year-on-year.
Huawei Technologies Co bagged the fourth position with a 15% market share supported by shipments of 10.6 million units, which grew by 41% year-on-year. Xiaomi Corp (OTC:XIACF) (OTC:XIACY) came fifth with a market share of 14%, backed by a 17% year-on-year shipment increase to 10 million units.
Canalys attributed the local brands’ success to the early significant discounts and promotions backed by offline channel enhancements.
The local brands continue to tap the Chinese premium smartphone market by integrating generative artificial intelligence, and their deep collaboration with regional supply chains is a significant advantage, Canalys noted.
Canalys also flagged Apple’s struggle to maintain adequate inventory levels, keep retail prices in check, and maintain the margins of channel partners.
Huawei’s $2,800 Mate XT trifold phone launching on September 20 coincides with the release of the iPhone 16 models. Apple’s iPhone 16 Pro Max starts at $1,199, while the standard iPhone 16 is $799.
International Data Corporation (IDC) expects global smartphone shipments to increase by 5.8% to 1.23 billion units in 2024, marking a recovery with generative AI posing as a significant catalyst.
However, due to higher competition in China, Android growth is expected to beat Apple iOS. As per IDC, Apple’s success hinges on its capability to forge local AI partnerships in China.
Ivan Lam, senior analyst at Counterpoint Research told SCMP that iPhone market share in the premium segment will likely decline as Huawei and other Chinese brands gain traction.
Apple has not yet revealed its plans for AI integration in China, which could place it at a disadvantage in the race to implement AI, SCMP cites Canalys analyst Lucas Zhong. However, Lam noted that pent-up demand for iPhone upgrades may still boost sales in China.
Price Action: AAPL stock closed at $222.66 on Wednesday.
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UnitedHealth Group Inc. (NYSE:UNH) reportedly announced on Tuesday that it will remove AbbVie Inc.’s (NYSE:ABBV) blockbuster drug Humira from some of its preferred reimbursement lists starting January 1, 2025. The company will recommend lower-cost biosimilar versions instead.
This move is part of a larger trend in the U.S. pharmaceutical market, as health plans seek to cut costs by promoting alternatives to high-priced drugs.
Reuters highlights that Amgen Inc’s (NASDAQ:AMGN) Amjevita, managed by its pharmacy benefits unit, Optum Rx, is among the biosimilars covered under UnitedHealth’s lists for commercial health plans.
With this decision, Optum becomes the last of the three largest U.S. pharmacy benefit managers (PBMs) to exclude Humira.
Cigna Corporation (NYSE:CI) announced last month that it would remove Humira from some of its lists in 2025, following a similar decision by CVS Health Inc’s (NYSE:CVS) Caremark unit in April.
CVS’s action led to a swift shift, with more patients transitioning to Sandoz Group AG’s (OTC:SDZNY) (OTC:SDZXF) biosimilar version of Humira in just three weeks than in the previous 15 months combined.
Cigna plans to cover biosimilars like Boehringer Ingelheim’s Cyltezo, Simlandi from Teva Pharmaceutical Industries Ltd (NYSE:TEVA), and Alvotech’s (NASDAQ:ALVO) products, including an unbranded version of Sandoz’s Hyrimoz, as replacements for Humira.
UnitedHealth noted that patients would still have access to Humira until the FDA designates the preferred biosimilars as interchangeable with the original drug, per the report. The FDA is expected to make this designation in 2025.
Despite the growing competition, AbbVie has managed to retain a dominant share of the U.S. Humira market throughout 2023. This has been achieved through favorable negotiations with PBMs, even as biosimilar alternatives from companies like Pfizer Inc (NYSE:PFE) entered the market.
As per a Reuters report, Humira has still managed to retain over 80% of its patients even after facing lower-priced rivals in the U.S. over the past year.
Following their launch last year, pharmacy benefit managers largely influenced patient access, with minimal incentive for doctors to switch to these alternatives.
In May, Cantor Fitzgerald said AbbVie had positioned itself to absorb Humira biosimilar erosion and achieve modest operational revenue growth.
Price Action: UNH stock is down 2% at $587.07 at last check Wednesday.
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Disclaimer: This content was partially produced with the help of AI tools and was reviewed and published by Benzinga editors.
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Piper Sandler downgraded Supernus Pharmaceuticals Inc (NASDAQ:SUPN), saying that the anticipated surge in Qelbree prescriptions during the back-to-school season has not materialized as expected.
“That has us rethinking our assumptions regarding the longer-term (LT) sales/volume growth trajectory of the product,” the analyst adds.
Qelbree (viloxazine) is indicated to treat attention deficit hyperactivity disorder in children and adults.
In the second quarter of 2024, net sales of Qelbree increased 92% year over year to $59.4 million, and total IQVIA prescriptions were 184,342, up 26%.
Piper writes that the management’s focus on optimizing Qelbree’s net economics, such as reducing copay assistance, suggests that future volume growth may be more modest. While initial estimates projected peak sales nearing $500 million, Piper writes that $400 million is a more realistic target.
The Piper analyst writes that Qelbree is growing and highlights that YTD prescriptions increased 91% in 2023 compared to 2022.
Piper has downgraded Supernus Pharmaceuticals to Neutral from Overweight, with a price target of $36, down from $41.
Quarter-to-date prescriptions have grown by about 1% in the third quarter of 2024 compared to the second quarter, following a 4% increase in the second quarter over the first quarter. In contrast, prescriptions for all ADHD products have declined sequentially by around 2% quarter-to-date in the third quarter.
A Piper analyst expects volume growth for Qelbree to accelerate during the back-to-school season but anticipates a slower growth trajectory than initially expected, prompting a reassessment of the drug’s peak sales potential.
In August, the FDA acknowledged the resubmission of the new drug application (NDA) for the company’s apomorphine infusion device (SPN-830) for the continuous treatment of motor fluctuations (OFF episodes) in Parkinson’s disease.
The resubmission is now filed, with a user fee goal date (PDUFA date) of February 1, 2025.
In April, the FDA issued a Complete Response Letter related to SPN-830, requiring additional information regarding the product quality and the master file for the infusion device.
Price Action: SUPN stock is down 7.17% at $31.09 at last check Wednesday.
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The FDA is addressing concerns about tampon safety following a 2024 study that discovered metals in tampons during laboratory testing.
Some of the tampon makers include Procter & Gamble Co (NYSE:PG), Johnson & Johnson (NYSE:JNJ), Edgewell Personal Care (NYSE:EPC), and Kimberly-Clark Corporation (NYSE:KMB).
A study published in July found a variety of metals, including arsenic, cadmium, and lead, in more than a dozen brands of tampons.
The researchers said they evaluated the concentrations of 16 metal(loid)s in 30 tampons from 14 tampon brands and 18 product lines.
The FDA reassured the public that all tampons must meet strict safety and effectiveness requirements before they can be legally sold in the U.S. Tampon manufacturers are required to conduct thorough tests of their products and component materials throughout the manufacturing process.
This includes pre-market biocompatibility testing, which the FDA evaluates.
While the study identified the presence of metals in certain tampons, it did not examine whether these metals are released during use or absorbed by the vaginal lining, nor did it explore the potential for metals entering the bloodstream.
In response, the FDA has launched two initiatives to investigate the issue further.
- First, the FDA has commissioned an independent review of the available literature on tampon safety. This review aims to enhance the agency’s understanding of existing data on the chemicals found in tampons and any associated health risks.
- Second, the FDA has begun its internal laboratory study to measure how much metals are released from tampons under conditions mimicking typical use.
The findings from these studies will contribute to a comprehensive risk assessment of metal exposure from tampons. The FDA plans to share the results of its literature review and lab tests with the public once they have been peer-reviewed.
Additionally, the FDA emphasized that it will continue to monitor tampon safety as part of its total product lifecycle approach to medical devices.
Disclaimer: This content was partially produced with the help of AI tools and was reviewed and published by Benzinga editors.
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Johnson & Johnson (NYSE:JNJ) is reportedly facing a lawsuit for allegedly using copyrighted instrumental music without permission in numerous YouTube and Facebook videos.
The legal action, filed by Associated Production Music (APM) in a Los Angeles federal court, accuses the pharmaceutical giant of “rampant infringement” involving nearly 80 videos featuring unlicensed tracks.
These videos were distributed online without obtaining proper music licenses from APM, which specializes in producing music for various media.
Also Read: Johnson & Johnson’s Mid-Stage Lung Cancer Trial Reveals Fewer Infusion-Related Reactions
APM, a joint venture between Sony Music Publishing and Universal Music Publishing, claims that despite repeated attempts to notify Johnson & Johnson of the unlicensed use, the company neither obtained the necessary licenses nor acknowledged any wrongdoing, the Billboard report adds.
According to APM, Johnson & Johnson failed to secure authorization to synchronize APM’s music with the videos in question, violating copyright law.
The lawsuit highlights the scope of the infringement, listing 30 different APM songs used by Johnson & Johnson. The legal action suggests that even though these songs are not mainstream hits, using them without a license could lead to significant financial penalties.
Under federal copyright law, Johnson & Johnson could face substantial damages. If the court finds that the company’s actions were willful, the pharmaceutical firm could be fined up to $150,000 per song, amounting to nearly $12 million for the 79 videos involved.
Price Action: JNJ stock is down 1.50% at $164.87 at the last check on Wednesday.
Disclaimer: This content was partially produced with the help of AI tools and was reviewed and published by Benzinga editors.
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Advanced Micro Devices, Inc (NASDAQ:AMD) client Oracle Corp (NYSE:ORCL) acknowledged the chip designer gaining traction in the data center chip market for artificial intelligence despite Nvidia Corp’s moat.
Oracle cloud business executive Karan Batta told the Information regarding customers’ openness to multiple vendors for inference computing implying opportunities for AMD and rivals.
Recent reports indicated AMD is currently ditching the premium gaming GPU market for the mainstream and mid-range GPUs. The update followed after AMD hired Nvidia’s Keith Strier to helm AMD’s AI vision.
BofA Securities analyst Justin Post hailed the recent Oracle and Amazon.Com Inc (NASDAQ:AMZN) partnership. This partnership offers cloud providers a sizable opportunity to unlock demand for infrastructure and applications, which in turn implies demand for Nvidia and AMD AI chips.
Mai Capital Management portfolio manager Chris Grisanti, in a CNBC interview, cold-shouldered the recent semiconductor and AI chip stock selloff, citing sustained AI ambitions of cash-rich Big Tech giants.
JPMorgan analyst Harlan Sur projects AMD’s revenue from data center GPUs to grow by $5 billion in the current fiscal year.
AMD stock gained 35% in the last 12 months. Investors can gain exposure to AMD through iShares Core S&P 500 ETF (NYSE:IVV) and Vanguard Total Stock Market ETF (NYSE:VTI).
Price Actions: AMD stock is up 2.32% at $156.15 at the last check Wednesday.
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Nano Nuclear Energy Inc. (NASDAQ:NNE) shares are trading higher on Wednesday.
The company revealed that it has entered into an agreement with GNS Gesellschaft für Nuklear-Service mbH to develop an advanced transportation system for HALEU.
This project will utilize NANO Nuclear’s proprietary fuel transportation basket design.
The agreement includes a study on transporting various HALEU nuclear fuel types, such as uranium oxide, TRISO particles, uranium-zirconium hydride, uranium mononitride, and salt fuel for molten salt reactors.
Also Read: What’s Going On With Ford Motor Stock Today?
GNS’s expertise is pivotal in rapidly developing a compliant solution. GNS is a German specialist in radioactive material management with a strong track record in developing, licensing, and manufacturing transport and storage casks as well as waste processing and dismantling technology.
The agreement outlines the development of a new HALEU transportation solution specifically designed to meet the requirements of various fuel types.
This study will be conducted under the NRC Quality Assurance program to ensure regulatory compliance and alignment with NANO Nuclear’s commitment to safe and efficient fuel transportation.
Additionally, the agreement provides an option for GNS to perform an in-depth analysis of four specific fuel types: TRISO pebbles, uranium-zirconium hydride (U-ZrHx), uranium mononitride (UN), and molten salt reactor fuel salt.
“In addition to enhancing safety and efficiency of our fuel transportation designs, this agreement with GNS represents a critical step towards our goal of achieving full self-sufficiency in transporting nuclear fuel across the country for each of our deployed microreactor systems,” said James Walker, Chief Executive Officer and Head of Reactor Development of NANO Nuclear Energy.
Yesterday, Nano Nuclear Energy announced that, effective September 23, 2024, it has been selected as one of only 12 companies for inclusion into the broad-market Russell 3000 Index.
Price Action: NNE shares are trading higher by 27.5% to $11.21 at last check Wednesday.
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On Tuesday, BridgeBio Pharma, Inc. (NASDAQ:BBIO) released topline results from the Phase 1/2 open-label ADventure study of BBP-631, an investigational adeno-associated virus (AAV) 5 gene therapy, for congenital adrenal hyperplasia (CAH).
CAH is a rare, inherited disorder that affects the adrenal glands and causes a hormone imbalance. The adrenal glands are on top of the kidneys and produce hormones that help the body function.
Also Read: Why Is BridgeBio Pharma Stock Trading Higher On Friday?
To date, key results from the study include:
- Increased endogenous cortisol production was achieved in all patients at higher doses.
- At the two highest dose levels, a maximum change from the baseline post-ACTH stimulation test of 4.7 μg/dL and 6.6 μg/dL was observed, respectively, with cortisol levels as high as 11 μg/dL achieved.
- Substantial and durable increases in 11-deoxycortisol, the product of 21-hydroxylase, and reductions in 17-hydroxyprogesterone (17-OHP), the substrate of 21-hydroxylase, provide compelling evidence of durable BBP-631 transgene activity. At the highest dose levels, sustained 11-deoxycortisol averaged a 55-fold increase from baseline, with a maximum of 99-fold increase. These represent an average maximum of 23-fold the upper limit of normal.
- Robust reduction in 17-hydroxyprogesterone, with most patients reaching a reduction of ≥50%, with a max reduction of 95%.
BBP-631 has been well tolerated, with only mild to moderate treatment-emergent adverse events (TEAEs), and no treatment-related SAEs have been reported.
“While the data to date are not yet transformational, the study showed for the first time that people living with CAH can indeed make their own cortisol, and that gene therapy can be safely administered in this patient population…” said Neil Kumar, CEO and Founder of BridgeBio.
BridgeBio also said it will no longer be pursuing development of BBP-631 for CAH and is seeking partnership opportunities to support future development of BBP-631 or next-generation gene therapies for the treatment of CAH.
Price Action: BBIO stock is down 3.07% at $29.07 at the last check on Wednesday.
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Stryker Corporation (NYSE:SYK) shares are trading marginally lower on Wednesday.
The company announced the addition of two new products to its Foot & Ankle portfolio – the Osteotomy Truss System and Ankle Truss System, recently acquired from 4WEB Medical.
The new Ankle Truss System, featuring Arthrosphere and Arthrocube implants, is a groundbreaking solution for restoring limb length and ensuring structural stability during tibiotalocalcaneal fusions.
“The addition of the ATS and the integration of Artelon reflects our commitment to providing surgeons with enhanced orthopaedic solutions to achieve the best possible patient outcomes,” said Michael Rankin, vice president of marketing and medical education of Stryker’s Foot & Ankle business.
Utilizing Truss Implant Technology, the ATS implants have an open architecture designed to deliver robust support and facilitate successful fusion.
The Osteotomy Truss System includes Cotton, Evans, and Utility wedges, providing a complete solution for various osteotomy procedures. Designed for internal bone fixation and osteotomies in the foot and ankle, this system is now available for clinical use.
Yesterday, Piper Sandler analyst Matt O’Brien maintained Stryker with an Overweight rating and a $380 price target.
In addition, Wolfe Research analyst Mike Polark initiates coverage on Stryker with an Outperform rating and announces a $405 price forecast.
According to Benzinga Pro, SYK stock has gained over 10% in 2023. Investors can gain exposure to the stock via iShares U.S. Medical Devices ETF (NYSE:IHI) and Trust for Professional Managers Jensen Quality Growth ETF (NYSE:JGRW).
Price Action: SYK shares are trading lower by 0.22% to $364.25 at last check Wednesday.
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On Wednesday, Adobe Inc. (NASDAQ:ADBE) unveiled its advancements in generative AI video capabilities powered by the Adobe Firefly Video Model.
Notably, Firefly has already generated over 12 billion images globally.
This new model, which extends Adobe’s Firefly suite that includes Image, Vector, and Design Models, is set to enhance video editing by helping professionals fill timeline gaps and add new elements to footage.
The upcoming features, available later this year, will include Text to Video and Image to Video capabilities on Firefly.Adobe.com and within Premiere Pro. Text to Video will allow users to generate video from text prompts and adjust elements like camera angle and zoom, while Image to Video will animate still shots into live-action clips.
Ashley Still, senior vice president, Creative Product Group at Adobe, said, “Building upon our foundational Firefly models for imaging, design and vector creation, our Firefly foundation video model is designed to help the professional video community unlock new possibilities, streamline workflows and support their creative ideation.”
In August, Adobe launched Adobe Journey Optimizer (AJO) B2B Edition, using generative AI to boost customer engagement and drive growth for B2B companies.
The company is set to release third-quarter FY24 results on September 12.
Investors can gain exposure to the stock via REX FANG & Innovation Equity Premium Income ETF (NASDAQ:FEPI) and IShares Expanded Tech-Software Sector ETF (BATS:IGV).
Price Action: ADBE shares are down 0.41% at $572.13 at the last check Wednesday.
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Disclaimer: This content was partially produced with the help of AI tools and was reviewed and published by Benzinga editors.
Boeing Company (NYSE:BA) shares are trading lower on Wednesday. On Tuesday, Boeing stated that it delivered 40 commercial jets in August, five more than in the same month of 2023 when a manufacturing defect affected 737 MAX production.
Of total count, Boeing delivered 32 MAX aircraft in August (up from 31 in July), which includes nine deliveries to customers in China, reported Reuters.
Goldman Sachs analyst Noah Poponak writes that deliveries stayed higher in August, following low levels earlier in the year due to a focus on product quality controls.
The analyst anticipates continued delivery increases in the second half of 2024, reflecting improved performance in the third quarter.
Also, Airbus SE (OTC:EADSY) CEO Guillaume Faury announced that the company plans to launch a new aircraft program by the end of the decade, reported Reuters.
BofA Securities analyst Ronald J. Epstein says that Faury estimated that the next-generation aircraft would reduce fuel consumption by 25% compared to the A320, suggesting that an open-rotor engine design could be an option.
Epstein adds that the “A220XLR” has been a topic of speculation, and this announcement adds credibility to the program.
If Boeing responds to Airbus’ announcement, it could have significant implications for the company and impact Boeing’s balance sheet, writes the analyst.
Apart from this, on Tuesday, Boeing informed suppliers of a six-month delay in a key production milestone for its 737 MAX. The new target is to reach a monthly output of 42 jets by March 2025.
Truist Securities analyst Michael Ciarmoli says that consensus estimates of around 32 MAX aircraft per month in fourth-quarter suggest that the delay in production rate increases was anticipated.
The analyst added that this delay, while not unexpected by the supply chain, is likely to strain suppliers who are already managing substantial inventory related to the program.
Investors can gain exposure to the stock via IShares U.S. Aerospace & Defense ETF (BATS:ITA) and Gabelli Commercial Aerospace and Defense ETF (NYSE:GCAD).
Price Action: BA shares are down 1.21% at $158.13 at the last check Wednesday.
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At a trade fair in Frankfurt, almost 900 Chinese auto suppliers and several electric vehicle makers are reportedly displaying their offerings.
The country’s automotive sector is striving to enhance its global presence and counteract declining domestic profits despite looming trade barriers, reported Reuters.
Chinese automakers such as BYD Co., Ltd. (OTC:BYDDY), Geely Automobile Holdings Ltd. (OTC:GELYF), Hongqi, and GAC International are set to showcase their vehicles at the Automechanika fair, which traditionally emphasizes suppliers but is now featuring cars as a highlight.
Also Read: US Ally Urges EU To ‘Reconsider’ Tariffs On Chinese EVs: ‘We Don’t Need Another War’
“Even if some in Europe turn against us, we will never turn against the European market,” said Victor Yang, senior vice-president at Geely, the only carmaker to host a press conference at the fair.
According to the report, Geely, which reportedly sold approximately 200,000 cars in Europe during the first half of this year, will encounter tariffs of up to 19.3% on its China-made EVs under the European Commission’s current plans—a move the company has previously called “disappointing.”
China’s auto sector is making significant investments in expanding overseas despite Europe and North America imposing trade barriers to curb the influx of China-made EVs, which they claim benefit from unfair subsidies.
The “EV Expo,” opening in collaboration with the China Council for the Promotion of International Trade, adds a focus on electric vehicles to an event traditionally centered on suppliers, Reuters added.
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Disclaimer: This content was partially produced with the help of AI tools and was reviewed and published by Benzinga editors.
UBS Group AG (NYSE:UBS) shares are trading lower on Wednesday.
Sabine Keller-Busse, UBS’s Switzerland country head, affirmed the bank’s steadfast commitment to its domestic market, addressing public concerns about its plans, reported Reuters.
Keller-Busse told a conference in northern Switzerland, “Underpinning this commitment, we aim to maintain our loan book in Switzerland at around 350 billion Swiss francs [$411 million].”
The loans include corporate loans, private loans and mortgages.
UBS has faced intense scrutiny since its acquisition of Credit Suisse last year, which followed the rival’s financial troubles and eventual collapse.
UBS leadership criticized Credit Suisse’s unsustainable business model and low credit terms, suggesting a need for re-pricing. This has fueled speculation that UBS might reduce its loan portfolio in Switzerland.
However, Keller-Busse noted that Switzerland accounts for about 30% of UBS’s capital and revenues, underscoring its importance to the bank.
Last month, UBS placed a real estate fund from its former competitor Credit Suisse, valued at over $2 billion, into “orderly liquidation.”
In August, UBS reported second-quarter FY24 sales of $11.9 billion, up 25% Y/Y, beating the consensus of $11.3 billion and EPS of $0.34, beating the consensus of $0.12.
Investors can gain exposure to the stock via Avantis International Equity ETF (NYSE:AVDE) and American Century ETF Trust Avantis Responsible International Equity ETF (NYSE:AVSD).
UBS Price Action: UBS Group shares are up 0.52% at $28.78 at publication Wednesday.
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Disclaimer: This content was partially produced with the help of AI tools and was reviewed and published by Benzinga editors.
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Mullen Automotive, Inc. (NASDAQ:MULN) shares are trading higher on Wednesday.
The company announced that its unit, Bollinger Motors, has appointed Affinity Truck Center as an official dealer.
Affinity operates sales locations in Bakersfield and Fresno, California, and service centers in Paso Robles and Salinas, California. Affinity Truck Center is certified under the California Hybrid and Zero-Emission Truck and Bus Voucher Incentive Project.
The Bollinger B4 chassis cab is a newly designed, all-electric Class 4 commercial truck developed with extensive input from fleets and upfitters.
Serial production of the B4 starts on September 16, 2024, with deliveries to customers beginning in October 2024.
Also Read: What’s Going On With Dell Technologies Shares Today?
“The addition of Affinity Truck Center gives Bollinger Motors a strong foothold in California’s Central Valley,” said Jim Connelly, chief revenue officer for Bollinger Motors. “Affinity has a rich history providing a variety of transportation options and is well positioned to help our team bring electrification and customer support to this critical market.”
The addition of Affinity Truck Center is part of a series of recent milestones for Bollinger Motors, including new dealer and service center partnerships with TEC Equipment, Nacarato Truck Centers, Nuss Truck & Equipment, and LaFontaine Automotive Group.
Recent achievements also include full warranty coverage for the B4 chassis cab, an EPA Certificate of Conformity, a 145-vehicle sale to Momentum Group, a 70-vehicle sale to Doering Fleet Management, a 50-vehicle sale to EnviroCharge, a partnership with Our Next Energy in Novi, Michigan for battery packs, and the engagement of Amerit Fleet Solutions as a mobile service provider.
Price Action: MULN shares are trading higher by 16% to $0.1637 at last check Wednesday.
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Disclaimer: This content was partially produced with the help of AI tools and was reviewed and published by Benzinga editors.
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GSK Plc (NYSE:GSK) shelved on Wednesday its herpes simplex virus (HSV) vaccine development program.
The recombinant protein vaccine, dubbed GSK3943104, did not meet the study’s primary efficacy objective.
GSK added that the vaccine candidate will not progress to phase three studies.
No safety concern was observed. The TH HSV REC-003 study will continue for routine safety monitoring and to generate follow-up.
“Given the unmet medical need and burden associated with genital herpes, innovation in this area is still needed,” the company said. “GSK intends to evaluate the totality of all these data and other studies to progress future research and development of its HSV program.”
There are no approved vaccines for HSV, and GSK’s decision to stop developing GSK3943104 eliminates a key contender in the race to market.
Moderna Inc (NASDAQ:MRNA) is developing mRNA-1608, an investigational vaccine for herpes simplex virus type 2. The candidate is currently in phase 1/2 trial that is fully enrolled with 300 participants in the U.S. Data is expected in June 2025.
Pfizer Inc. (NYSE:PFE) partner BioNTech SE (NASDAQ:BNTX) is developing BNT163, a prophylactic vaccine candidate being studied in a phase one clinical trial.
The German company initiated the phase one trial in December 2022, with an estimated enrollment of 248 participants. Data is expected in 2025.
There are an estimated four billion people globally infected with HSV.
GSK Price Action: GSK stock is down 1.12% at $43.61 at last check Wednesday.
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