Tag: Biotech

Release – Data and Safety Monitoring Board Reviews Interim Safety Data of Phase 2 Subjects of OCU410 ArMaDa Clinical Trial for Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration

Posted on by aweinsoff@channelchek.com

Research News and Market Data on OCGN

December 19, 2024

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  • OCU410 has a very favorable safety and tolerability profile
  • No serious adverse events related to the study drug have been reported, such as exudation, infectious endophthalmitis, intraocular Inflammation, anterior ischemic optic neuropathy, or vasculitis

MALVERN, Pa., Dec. 19, 2024 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines, today announced that the Data and Safety Monitoring Board (DSMB) for the OCU410 ArMaDa clinical trial recently convened and approved continuation of the second phase of the Phase 1/2 study. OCU410 (AAV5-hRORA) is a novel modifier gene therapy candidate being developed for geographic atrophy (GA) secondary to dry age-related macular degeneration (dAMD).

“The DSMB assessed data on 15 subjects from Phase 2. Initial data indicates that OCU410 appears to be safe and well-tolerated,” said Peter Chang, MD, FACS, Co-President and Partner of the Massachusetts Eye Research and Surgery Institution (MERSI). “No serious adverse events (SAEs) related to OCU410 have been reported to date.”

The ArMaDa clinical trial will assess the safety and efficacy of unilateral subretinal administration of OCU410 in subjects with GA. Phase 2 is an ongoing, randomized, outcome assessor-blinded, dose-expansion study in which 45 subjects are randomized in a 1:1:1 ratio to either one of two OCU410 treatment groups (5×1010 vg/mL or 1.5 ×1011 vg/mL) or an untreated control group.

“Currently approved treatments for GA require 6-12 intravitreal injections annually and frequent injections are a burden on patients and caregivers,” said Huma Qamar, MD, MPH, CMI, Chief Medical Officer of Ocugen. “We are very enthusiastic about the potential of OCU410 to serve as a game-changing, one-time treatment for life for patients with GA.”

Positive preliminary efficacy and safety data from the Phase 1 dose-escalation portion of the ArMaDa clinical trial demonstrated: no drug-related serious adverse events, reduced lesion growth, preservation of retinal tissue, and—most importantly—there was a positive effect on the functional visual measure of low luminance visual acuity (LLVA).

dAMD is a multifactorial disease involving genetic and environmental factors that is one of the world’s leading causes of blindness in people aged 50 years and older. Four cellular pathways drive the pathology of dry AMD: lipid metabolism, inflammation, oxidative stress, and complement. Currently approved therapies target only the latter, while OCU410 addresses all four and thereby helps reestablish retinal homeostasis.

The ArMaDa clinical trial is currently being performed at 13 leading retinal surgery centers across the U.S. Dosing in the OCU410 ArMaDa clinical trial will be completed in early 2025 and the Company will continue to provide 9- and 12-month efficacy updates from Phase 1.  

About dAMD and GA
dAMD affects approximately 10 million Americans and more than 266 million people worldwide. It is characterized by the thinning of the macula. The macula is the part of the retina responsible for clear vision in one’s direct line of sight. dAMD involves the slow deterioration of the retina with submacular drusen (small white or yellow dots on the retina), atrophy, loss of macular function and central vision impairment. dAMD accounts for 85-90% of the total AMD population.

About OCU410
OCU410 utilizes an AAV delivery platform for the retinal delivery of the RORA (RAR Related Orphan Receptor A) gene. The RORA protein plays an important role in lipid metabolism, reducing lipofuscin deposits and oxidative stress, and demonstrates an anti-inflammatory role in vitro and in vivo (animal model) studies. These results demonstrate the ability of OCU410 to target multiple pathways linked with dAMD pathophysiology. Ocugen is developing AAV5–hRORA as a one-time gene therapy for the treatment of GA.

About Ocugen, Inc.
Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines that improve health and offer hope for patients across the globe. We are making an impact on patient’s lives through courageous innovation—forging new scientific paths that harness our unique intellectual and human capital. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with a single product, and we are advancing research in infectious diseases to support public health and orthopedic diseases to address unmet medical needs. Discover more at www.ocugen.com and follow us on X and LinkedIn.

Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, including, but not limited to, strategy, business plans and objectives for Ocugen’s clinical programs, plans and timelines for the preclinical and clinical development of Ocugen’s product candidates, including the therapeutic potential, clinical benefits and safety thereof, expectations regarding timing, success and data announcements of current ongoing preclinical and clinical trials, the ability to initiate new clinical programs; statements regarding qualitative assessments of available data, potential benefits, expectations for ongoing clinical trials, anticipated regulatory filings and anticipated development timelines, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations, including, but not limited to, the risks that preliminary, interim and top-line clinical trial results may not be indicative of, and may differ from, final clinical data; that unfavorable new clinical trial data may emerge in ongoing clinical trials or through further analyses of existing clinical trial data; that earlier non-clinical and clinical data and testing of may not be predictive of the results or success of later clinical trials; and that that clinical trial data are subject to differing interpretations and assessments, including by regulatory authorities. These and other risks and uncertainties are more fully described in our annual and periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release.

Contact:
Tiffany Hamilton
Head of Communications
Tiffany.Hamilton@ocugen.com 

Cara Therapeutics and Tvardi Therapeutics to Merge, Forming New Biopharma Leader

Posted on by slightbourne@noblecapitalmarkets.com
Key Points:
– Cara Therapeutics and Tvardi Therapeutics announce an all-stock merger, set to create a Nasdaq-listed biopharmaceutical company.
– Tvardi’s recent $28 million financing strengthens the combined company’s financial outlook, funding operations into 2026.
– The new entity will focus on developing STAT3 inhibitors for fibrosis-driven diseases, with Phase 2 data expected in 2025.

Cara Therapeutics (Nasdaq: CARA) and Tvardi Therapeutics have announced a definitive merger agreement, marking a significant step in the development of innovative treatments for fibrosis-driven diseases. The all-stock transaction will combine Cara’s resources with Tvardi’s promising pipeline, including its lead candidate, TTI-101, a small-molecule STAT3 inhibitor. The combined entity will be Nasdaq-listed under the name Tvardi Therapeutics, Inc. and is expected to trade under the ticker symbol “TVRD” once the deal closes in the first half of 2025, subject to regulatory and shareholder approvals.

The merger will give pre-merger Cara stockholders an estimated 17% stake in the new company, while Tvardi investors will own around 83%, assuming Cara’s cash balance at closing falls within the expected range. This transaction comes after Tvardi completed a $28 million private financing round, which, alongside the combined company’s cash, will provide funding into 2026, supporting clinical development through critical data readouts expected in 2025.

Tvardi’s pipeline, which is focused on fibrosis-driven diseases, will be the cornerstone of the merged company’s future. The lead candidate, TTI-101, is currently in Phase 2 trials for idiopathic pulmonary fibrosis (IPF) and Phase 1b/2 trials for hepatocellular carcinoma (HCC). The drug is designed to inhibit STAT3, a central transcription factor involved in the progression of these diseases. Early-stage data from the clinical trials is expected to be reported in the second half of 2025, potentially marking significant inflection points for the company.

In addition to TTI-101, Tvardi is developing TTI-109, another STAT3 inhibitor that is set to enter clinical trials in 2025. Tvardi’s innovative approach to targeting STAT3 positions the combined company as a key player in addressing serious, chronic diseases with significant unmet medical need.

The new company will be headquartered in Houston, Texas, and led by Tvardi CEO Imran Alibhai, Ph.D. The board will consist of members from both Cara and Tvardi, with six directors from Tvardi and one from Cara. This leadership structure is expected to ensure a seamless transition as the combined company moves forward with its mission to develop novel, oral therapies for fibrosis-driven diseases.

This merger comes at a time when the biopharmaceutical sector is increasingly focused on addressing complex diseases with limited treatment options. With a strong financial foundation, a promising pipeline, and a leadership team well-versed in the challenges of drug development, the combined company is poised to make significant strides in the field.

As the merger progresses, investors and industry watchers will be closely monitoring upcoming clinical trial results and further developments in the company’s pipeline, which could position Tvardi Therapeutics as a leader in the treatment of fibrosis-driven diseases.

Quanterix Advances Scientific Innovation with Strategic Acquisition of EMISSION

Posted on by slightbourne@noblecapitalmarkets.com
Key Points
– Quanterix acquires EMISSION for $10M, expanding its technological capabilities and entering the OEM market.
– EMISSION’s bead technology enhances Quanterix’s Simoa platform for high-multiplex and multi-omic assays.
– The acquisition is expected to drive revenue growth and improve margins by 2026.

Quanterix Corporation (NASDAQ: QTRX), a company advancing scientific discovery through ultrasensitive biomarker detection, has announced the acquisition of EMISSION iNC., a Georgetown, TX-based manufacturer of proprietary magnetic beads and mid-plex assay platforms. The transaction, expected to close in January 2025, aims to vertically integrate EMISSION’s bead technology into Quanterix’s next-generation platform and drive a new multi-plex segment targeting OEM customers.

Masoud Toloue, Quanterix’s CEO, emphasized the importance of controlling core components to expand their technology stack and capabilities. “EMISSION’s proprietary bead technology has already been validated on our upcoming new Simoa platform and will enable us to provide OEM beads to other non-Quanterix platforms. We look forward to welcoming EMISSION’s innovations and colleagues to the Quanterix team,” he stated.

EMISSION’s magnetic beads are designed for low and mid-plex assays, offering high uniformity and scalability. Their integration into Quanterix’s platform will enhance multi-plex and multi-omic capabilities, ensuring greater control over critical components. EMISSION CEO Van Chandler expressed enthusiasm about the partnership, noting that their high-quality bead technology aligns with Quanterix’s vision to make advanced multi-plex assays accessible to all labs.

The acquisition involves an upfront cash payment of $10 million, with an additional $10 million contingent on the completion of technical milestones. EMISSION may also earn up to $50 million in performance-based payouts, expected to be funded through cash generated from meeting those milestones. Quanterix anticipates the deal will positively impact revenue and gross margins by 2026.

This strategic move reinforces Quanterix’s commitment to innovation in biomarker detection and diagnostics. By integrating EMISSION’s technology, the company strengthens its position in the multi-plex assay market while opening new revenue streams through OEM partnerships. With Simoa technology already setting industry standards for ultrasensitive biomarker detection, the acquisition marks a significant step toward broadening the reach of Quanterix’s tools and solutions.

Quanterix’s focus on neurology, oncology, immunology, and infectious disease research continues to fuel breakthroughs in disease understanding and management. With nearly two decades of experience, the company remains a trusted partner for researchers, boasting over 2,900 peer-reviewed publications featuring its technology. The integration of EMISSION’s beads is expected to enhance Quanterix’s ability to deliver precise, flexible solutions to researchers and clinicians worldwide, further cementing its leadership in the field.

Furthermore, the acquisition aligns with Quanterix’s strategy of vertical integration, which is increasingly critical in the competitive field of diagnostics. By bringing key components in-house, Quanterix not only enhances its technological control but also reduces dependence on external suppliers, paving the way for faster innovation cycles and cost efficiencies. This approach is expected to drive long-term growth and maintain the company’s edge in a rapidly evolving industry.

The addition of EMISSION’s proprietary bead technology also has implications for the broader scientific community. By targeting third-party OEM customers, Quanterix is fostering collaboration and expanding access to advanced diagnostic tools. This could accelerate the adoption of multi-plex assays across various laboratories and research institutions, driving progress in disease diagnostics and personalized medicine.

As the demand for high-sensitivity biomarker detection continues to grow, Quanterix’s ability to deliver scalable, high-quality solutions becomes increasingly vital. The integration of EMISSION’s technology not only reinforces Quanterix’s position as a market leader but also underscores its commitment to empowering scientists with cutting-edge tools to address complex healthcare challenges. With this acquisition, Quanterix is poised to play a pivotal role in shaping the future of diagnostics and research.

Release -MAIA Biotechnology Granted FDA Rare Pediatric Disease Designation for THIO as a Treatment for Pediatric High-Grade Gliomas

Posted on by aweinsoff@channelchek.com

Research News and Market Data on MAIA

December 16, 2024 8:37am EST Download as PDF

CHICAGO–(BUSINESS WIRE)– MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, today announced that the FDA has designated THIO for the treatment of pediatric-type diffuse high-grade gliomas (PDHGG) as a drug for a “rare pediatric disease.”

“THIO is a versatile anti-cancer agent that has demonstrated positive results in multiple difficult to treat cancer types, including pediatric high-grade glioma, which is among the most treatment-resistant cancers in children. THIO is shown to activate the immune system while evading tumor immunosuppression, a novel therapeutic approach for this devastating childhood disease,” said MAIA Chairman and Chief Executive Officer Vlad Vitoc, M.D. “We are proud to receive the FDA’s Rare Pediatric Disease designation for THIO, which significantly bolsters our plans for continuing research in the PDHGG indication.”

MAIA’s Vice President and Head of Regulatory and Quality K. Robinson Lewis added, “Rare pediatric disease designation also offers a highly valuable incentive for MAIA. Upon FDA approval of a future new drug application in PDHGG, MAIA would be eligible to receive a priority review voucher that can be redeemed or sold as an asset at a very high valuation.”

Rare pediatric disease priority review vouchers (PRVs) can be redeemed by drug developers for FDA priority review of a different product or transferred or sold to another sponsor. Since 2015, FDA priority review vouchers have sold as assets at an average amount of $100 million.1

Previous research showcased THIO’s potency as a treatment for a PDHGG subtype known as diffuse intrinsic pontine glioma (DIPG). A research collaboration between MAIA and Nationwide Children’s Hospital found that THIO combined with ionizing radiation (IR) resulted in significantly decreased cell proliferation and produced potent anticancer effects in highly aggressive DIPG. The data was presented in April 2024 at the American Association for Cancer Research (AACR) Annual Meeting.

MAIA collaborated with Only Orphans Cote for THIO’s designation request. Only Orphans Cote is a foremost provider of regulatory services and strategies for FDA orphan drug designations and marketing authorization.

In addition to its rare pediatric disease designation in PDHGG, THIO holds orphan drug designations (ODD) in three cancer types: hepatocellular carcinoma (HCC), small cell lung cancer (SCLC) and glioblastoma. MAIA believes that THIO is the only direct telomere-targeting agent currently in clinical development.

About THIO

THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in Non-Small Cell Lung Cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine (THIO) induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. THIO-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment with THIO followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. THIO is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

About MAIA Biotechnology, Inc.

MAIA is a targeted therapy, immuno-oncology company focused on the development and commercialization of potential first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer. Our lead program is THIO, a potential first-in-class cancer telomere targeting agent in clinical development for the treatment of NSCLC patients with telomerase-positive cancer cells. For more information, please visit www.maiabiotech.com.

Forward Looking Statements

MAIA cautions that all statements, other than statements of historical facts contained in this press release, are forward-looking statements. Forward-looking statements are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels or activity, performance or achievements to be materially different from those anticipated by such statements. The use of words such as “may,” “might,” “will,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,” “future,” “potential,” or “continue,” and other similar expressions are intended to identify forward looking statements. However, the absence of these words does not mean that statements are not forward-looking. For example, all statements we make regarding (i) the initiation, timing, cost, progress and results of our preclinical and clinical studies and our research and development programs, (ii) our ability to advance product candidates into, and successfully complete, clinical studies, (iii) the timing or likelihood of regulatory filings and approvals, (iv) our ability to develop, manufacture and commercialize our product candidates and to improve the manufacturing process, (v) the rate and degree of market acceptance of our product candidates, (vi) the size and growth potential of the markets for our product candidates and our ability to serve those markets, and (vii) our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates, are forward looking. All forward-looking statements are based on current estimates, assumptions and expectations by our management that, although we believe to be reasonable, are inherently uncertain. Any forward-looking statement expressing an expectation or belief as to future events is expressed in good faith and believed to be reasonable at the time such forward-looking statement is made. However, these statements are not guarantees of future events and are subject to risks and uncertainties and other factors beyond our control that may cause actual results to differ materially from those expressed in any forward-looking statement. Any forward-looking statement speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. In this release, unless the context requires otherwise, “MAIA,” “Company,” “we,” “our,” and “us” refers to MAIA Biotechnology, Inc. and its subsidiaries.

1 Pharmaceutical Technology, GlobalData Pharma Intelligence Centre, January 2024

Investor Relations Contact
+1 (872) 270-3518
ir@maiabiotech.com

Source: MAIA Biotechnology, Inc.

Released December 16, 2024

Candel Therapeutics Stock Skyrockets 172% After Promising Phase III Prostate Cancer Trial Results

Posted on by slightbourne@noblecapitalmarkets.com
Key Points:
– Candel Therapeutics’ stock surged 172% after its Phase III trial of CAN-2409 for localized prostate cancer met its primary endpoint.
– The trial showed a 14.5% relative improvement in disease-free survival compared to placebo, with promising long-term results.
– The company plans to use Phase III data to seek regulatory approval from the FDA for CAN-2409.

Candel Therapeutics (CADL) has seen its stock price surge by 172% following the announcement of positive results from its Phase III clinical trial of CAN-2409, a viral immunotherapy designed for localized prostate cancer. This breakthrough was announced on December 11, 2024, signaling the potential of CAN-2409 as a new treatment option for patients battling prostate cancer.

The Phase III trial, conducted under a Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration (FDA), tested CAN-2409 in combination with radiation therapy and the antiviral drug valacyclovir. The trial showed a statistically significant improvement in disease-free survival, with patients experiencing a 14.5% relative increase in survival compared to the placebo group after 54 months of observation. These results demonstrate the treatment’s ability to improve long-term outcomes for prostate cancer patients.

In addition to the survival benefit, the study also found an increased proportion of patients achieving a prostate-specific antigen (PSA) level associated with remission, further supporting CAN-2409’s potential as a promising treatment. The therapy works by stimulating the immune system to attack prostate cancer cells, offering a novel approach compared to traditional treatments, which often rely on chemotherapy or radiation alone. Importantly, the treatment demonstrated no new safety concerns, with a safety profile similar to that of existing therapies.

The company’s CEO, Paul Peter Tak, expressed confidence in the results, emphasizing that the Phase III trial validated earlier observations of CAN-2409’s effectiveness in hard-to-treat tumors. Tak noted that the study’s design, agreed upon by the FDA, could allow Candel to seek regulatory approval for CAN-2409 as a treatment for localized prostate cancer.

Dr. Glen Gejerman, the principal investigator of the study, highlighted the clinical significance of the results, noting that the improvement in disease-free survival could mark a major advancement in prostate cancer care. Gejerman also pointed out that CAN-2409 offers a treatment option without introducing substantial toxicity, which is a key concern for many prostate cancer therapies.

Candel Therapeutics now plans to use the data from this Phase III trial to advance its marketing application to the FDA. If approved, CAN-2409 could provide a much-needed treatment alternative for patients with localized prostate cancer, transforming the current treatment paradigm.

This success positions Candel as a leader in the prostate cancer space, with investors reacting positively to the trial’s results. The company’s stock price has risen significantly, reflecting growing confidence in its future prospects.

Candel’s success comes at a time when other companies in the prostate cancer field, such as Arvinas and Pfizer, are also advancing their own treatments. However, the dramatic stock increase following the Phase III results highlights the excitement surrounding CAN-2409 and its potential to change the landscape of prostate cancer treatment.

As the company moves toward FDA approval, the oncology community will be watching closely. If successful, CAN-2409 could become a game-changing option for prostate cancer patients, offering new hope and a more effective treatment strategy.

Release – Ocugen CEO to Present at NobleCon20 – Noble Capital Markets’ 20th Annual Emerging Growth Equity Conference

Posted on by aweinsoff@channelchek.com

Research News and Market Data on OCGN

November 27, 2024

PDF Version

MALVERN, Pa., Nov. 27, 2024 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines, today announced that Dr. Shankar Musunuri, Chairman, CEO, and Co-Founder of Ocugen will present at NobleCon20 – Noble Capital Markets’ 20th Annual Emerging Growth Equity Conference at Florida Atlantic University, Executive Education Complex, in Boca Raton, FL—taking place December 3 – 4, 2024.

“Every year, NobleCon showcases emerging growth companies from a variety of industries to a relevant investor audience,” said Dr. Musunuri. “I look forward to sharing an update on our clinical programs for attendees who may not yet be familiar with the Ocugen story.”

Details regarding the presentation and moderated Q&A are as follows:

Date: Tuesday, December 3, 2024

Location: Presentation Room 3

Time: 1:30 p.m. ET  
 

In addition to Dr. Musunuri’s session, members of Ocugen’s executive team will conduct one-on-one meetings with investors to highlight the Company’s business and clinical development strategy across its unique modifier gene therapy platform.
 

A high-definition video webcast of the presentation will be available the following day in the Events section of the Company’s website, and as part of a complete catalog of presentations available at Noble Capital Markets’ Conference website and on Channelchek the investor portal created by Noble. The webcast will be archived on the Company’s website, the NobleCon website, and Channelchek.com for 90 days following the event. 
 

About Ocugen, Inc. 
Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines that improve health and offer hope for patients across the globe. We are making an impact on patients’ lives through courageous innovation—forging new scientific paths that harness our unique intellectual and human capital. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with a single product, and we are advancing research in infectious diseases to support public health and orthopedic diseases to address unmet medical needs. Discover more at www.ocugen.com and follow us on X and LinkedIn.
 

About Noble Capital Markets, Inc. 
Established in 1984, Noble Capital Markets is an SEC / FINRA registered full-service investment bank and advisory firm with an award-winning research team and proprietary investor distribution platform. We deliver middle market expertise to entrepreneurs, corporations, financial sponsors, and investors. Over the past 40 years, Noble has raised billions of dollars for companies and published more than 45,000 equity research reports. Noble launched www.channelchek.com in 2018 – an investor community dedicated exclusively to public emerging growth and their industries. Channelchek is the first service to offer institutional-quality research to the public, for FREE at every level without a subscription. More than 7,000 public emerging growth companies are listed on the site, and content including equity research, webcasts, and industry articles.
 

Cautionary Note on Forward-Looking Statements 
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release.

Contact:
Tiffany Hamilton
Head of Communications
Tiffany.Hamilton@ocugen.com

How Trump’s DOGE Initiative Could Reshape Biotech’s Future

Posted on by slightbourne@noblecapitalmarkets.com

The Department of Government Efficiency (DOGE), spearheaded by Donald Trump with the involvement of Elon Musk and Vivek Ramaswamy, promises sweeping changes to federal operations, including deregulation efforts targeting agencies like the FDA. For the biotech industry, these potential reforms could significantly impact drug development, approval processes, and market dynamics.

Faster Approvals: A Biotech Catalyst

The FDA’s rigorous drug approval process ensures safety and efficacy but often takes years and billions of dollars to navigate. By streamlining these regulations, DOGE could shorten timelines for bringing therapies to market. This shift would lower barriers for smaller biotech firms, enhance their ability to innovate, and reduce costs for large pharmaceutical companies.

For investors, expedited approvals would translate to quicker revenue streams for new drugs, driving valuations and fueling confidence in the sector. This environment could spur a rally in biotech stocks, particularly for companies with promising pipelines awaiting FDA clearance.

Risks of Deregulation

However, deregulation comes with significant challenges. The FDA exists to ensure public safety, and relaxing oversight could lead to unintended consequences. If subpar drugs enter the market, public trust in the industry might erode, and companies could face litigation or reputational damage. These risks could temper investor enthusiasm, particularly if deregulation is perceived as compromising safety.

Additionally, deregulation might benefit well-established players disproportionately. Large pharmaceutical firms with the resources to navigate even a reduced regulatory framework may thrive, while smaller biotech startups could struggle to compete despite faster approvals.

Investor Implications

DOGE’s initiatives might catalyze investment in biotechnology, particularly in areas like gene therapy, oncology, and rare diseases. Sectors with high unmet needs and long development cycles stand to gain the most from expedited approvals. Furthermore, the promise of reduced R&D costs could attract private equity and venture capital to early-stage biotech firms.

In the stock market, the potential for reform could trigger bullish sentiment in biotech ETFs and sector-specific indices. Companies with late-stage trials or pending FDA decisions might see the greatest benefit. However, volatility is likely as the industry adapts to new regulations, and investors should be cautious of overvaluations driven by speculative enthusiasm.

Industry Innovators at the Forefront

As these potential regulatory shifts emerge, a select group of biotech pioneers are positioning themselves to capitalize on the DOGE initiative’s promising landscape. At the upcoming NobleCon conference, a plethora of healthcare companies will showcase their innovative approaches and strategic vision, offering investors and industry observers a glimpse into how they might leverage potential FDA streamlining and accelerated approval processes. These organizations represent the cutting edge of biotech innovation, each poised to potentially benefit from the proposed regulatory reforms.

Broader Impacts on Healthcare

Beyond the biotech sector, DOGE’s focus on efficiency could reshape the broader healthcare landscape. Cheaper and faster drug approvals might improve patient access to innovative treatments. Yet, balancing speed with safety will be critical to achieving long-term success.

The initiative also highlights the growing intersection of politics and business, with leaders like Musk and Ramaswamy advocating for entrepreneurial approaches to governance. Whether DOGE delivers on its promises remains to be seen, but its potential to disrupt traditional industries, including biotechnology, is undeniable.

DOGE represents both opportunity and risk for biotech investors. If executed thoughtfully, its reforms could unlock unprecedented growth in the sector by fostering innovation and reducing costs. However, ensuring safety and maintaining public trust will be critical to its long-term success. Investors should monitor regulatory developments closely, as the outcomes of these reforms will shape the biotech landscape for years to come.

The biotech rally might already be on the horizon—if DOGE achieves its ambitious goals, this sector could see transformative growth.

Sonnet BioTherapeutics Announces $5 Million Offering and Surge in Trading Volume

Posted on by slightbourne@noblecapitalmarkets.com
Key Points:
– Sonnet BioTherapeutics priced a $5 million public offering to fund research and trials.
– The offering sparked a significant increase in Sonnet’s trading volume.
– Sonnet advances its FHAB platform with promising cancer treatments like SON-1411 and SON-1010.

Sonnet BioTherapeutics (NASDAQ: SONN), a clinical-stage biotech company specializing in oncology-focused immunotherapies, has priced a $5.0 million underwritten public offering. The offering includes 1,111,111 shares of common stock, each sold with one common warrant for the purchase of an additional two shares, at a combined price of $4.50 per share. This offering is set to close on or around November 7, 2024, and is expected to generate gross proceeds of approximately $5.0 million before underwriting discounts and commissions.

The proceeds from this offering are intended to fund Sonnet’s ongoing research and development, clinical trials, working capital, and liability repayments, advancing the company’s mission to develop novel biologic therapies for cancer treatment. While the offering is an exciting opportunity for the company to secure necessary funding, it also brings with it potential risks, including the possibility of shareholder dilution through the issuance of new shares and warrants.

Notably, Sonnet’s share price has seen increased volatility today, with trading volume significantly surging. This rise in trading activity follows the announcement of the offering and its anticipated closure. As is often the case with at-the-market offerings under Nasdaq rules, the pricing of the shares could pressure the stock value in the short term. However, investors may also be reacting positively to the financial backing that will enable Sonnet to accelerate the clinical development of its promising drug pipeline.

Sonnet is known for its proprietary FHAB (Fully Human Albumin Binding) platform, which enables the development of biologic drugs designed to target tumor and lymphatic tissues more efficiently. This technology utilizes a human single-chain antibody fragment (scFv) to hitch a ride on human serum albumin, guiding the drug directly to the target tissue for improved therapeutic effectiveness. The FHAB platform is adaptable, enabling the creation of a wide range of therapeutic candidates, including cytokines, peptides, antibodies, and vaccines.

One of Sonnet’s leading therapeutic candidates is SON-1411, a novel bifunctional fusion protein designed to enhance the efficacy of the immune response against cancer. SON-1411 combines IL-18BPR (a receptor that binds IL-18) with IL-12 and is linked to the FHAB platform. This innovative approach is aimed at overcoming limitations observed in previous IL-18-based therapies, which suffered from poor efficacy due to the presence of IL-18 binding protein (IL-18BP) in the tumor microenvironment. By modifying the IL-18 domain, SON-1411 seeks to bypass this issue and enhance the therapeutic potential of IL-18 in cancer treatment.

In addition to SON-1411, Sonnet is also advancing SON-1010, an IL-12-FHAB fusion protein, through clinical trials for solid tumors and ovarian cancer. The company is evaluating SON-1010 in collaboration with Roche, in combination with the immune checkpoint inhibitor atezolizumab, for the treatment of platinum-resistant ovarian cancer. Moreover, Sonnet is working on SON-1210, a combination of IL-12-FHAB and IL-15, for the treatment of solid tumors like pancreatic cancer.

Despite the potential dilution concerns stemming from the offering, the announcement underscores the company’s strategic commitment to advancing its promising drug candidates. As Sonnet BioTherapeutics progresses through clinical trials and secures additional funding, the surge in trading volume today suggests strong market interest in the company’s future prospects. The funding from the offering will be crucial in supporting Sonnet’s clinical trials and advancing the company’s vision of delivering targeted, effective treatments for cancer patients.

Release – PDS Biotech to Announce Third Quarter Financial Results on November 14, 2024 at 8:30 a.m. Eastern Time

Posted on by aweinsoff@channelchek.com

Research News and Market Data on PDSB

PRINCETON, N.J., Nov. 06, 2024 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB) (“PDS Biotech” or the “Company”), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers and the development of infectious disease vaccines, today announced that the Company will host a conference call to report financial results for the quarter ended September 30, 2024, and provide a clinical program update on Thursday, November 14, 2024, at 8:30 a.m. Eastern Time.

Conference Call Details

Date: November 14, 2024
Time: 8:30 a.m. Eastern Time
Dial-in: 1-877-704-4453 or 1-201-389-0920
Webcast Registration: Click Here
Call MeTM Registration: Click Here (Available 15 minutes prior to call)

About PDS Biotechnology
PDS Biotechnology is a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers and the development of infectious disease vaccines. The Company plans to initiate a pivotal clinical trial in 2024 to advance its lead program in advanced HPV16-positive head and neck squamous cell cancers. PDS Biotech’s lead investigational targeted immunotherapy Versamune® HPV is being developed in combination with a standard-of-care immune checkpoint inhibitor, and also in a triple combination including PDS01ADC, an IL-12 fused antibody drug conjugate (ADC), and a standard-of-care immune checkpoint inhibitor. We believe that proof-of-concept long-term data have shown positive survival results and tumor shrinkage with these combinations and indicate favorable tolerability.

We believe that the novel investigational mechanisms of action of Versamune® HPV and the combination of Versamune® HPV and PDS01ADC have resulted in compelling results with potential to successfully disrupt a tumor’s internal defenses, while also generating potent, targeted killer T-cells to attack the tumor. We also believe that data from more than 350 patients, as well as ongoing clinical trials across multiple tumor types and standard treatment regimens, have validated the potential for both platforms and point to potential broad utility.

For more information, please visit www.pdsbiotech.com.

Forward Looking Statements
This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast,” “guidance”, “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to initiate the planned clinical trials for Versamune® HPV, PDS01ADC, and other Versamune® and Infectimune® based product candidates; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning Versamune® HPV, PDS01ADC and other Versamune® and Infectimune® based product candidates and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund its disclosed clinical trials, which assumes no material changes to the Company’s currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim or preliminary results (including, without limitation, any preclinical results or data), which are not necessarily indicative of the final results of the Company’s ongoing clinical trials; any Company statements about its understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs and any collaboration studies; the Company’s ability to continue as a going concern; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the other risks, uncertainties, and other factors described under “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in the documents we file with the U.S. Securities and Exchange Commission. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.  

Versamune® and Infectimune® are registered trademarks of PDS Biotechnology Corporation.

Investor Contact:
Mike Moyer
LifeSci Advisors
Phone +1 (617) 308-4306
Email: mmoyer@lifesciadvisors.com

Media Contact:
Janine McCargo
6 Degrees
Phone +1 (646) 528-4034
Email: jmccargo@6degreespr.com

AbbVie Expands Alzheimer’s Pipeline with $1.4B Acquisition of Aliada Therapeutics

Posted on by slightbourne@noblecapitalmarkets.com
Key Points:
– AbbVie acquires Aliada Therapeutics, adding ALIA-1758 and its unique drug-delivery platform.
– Expands AbbVie’s neuroscience pipeline with advanced Alzheimer’s treatments.
– Aliada’s MODEL platform enhances drug delivery across the blood-brain barrier.

AbbVie has strategically bolstered its Alzheimer’s portfolio by acquiring Boston-based Aliada Therapeutics in a deal valued at $1.4 billion. The acquisition brings AbbVie ALIA-1758, a Phase I anti-amyloid antibody targeting Alzheimer’s disease, along with Aliada’s novel Modular Delivery (MODEL) platform. This technology aims to improve the delivery of therapeutics across the blood-brain barrier (BBB), a significant challenge in developing drugs for the central nervous system.

With Alzheimer’s becoming a critical area for biotech and pharma innovation, AbbVie’s acquisition comes amid heightened interest in anti-amyloid therapies. The recent successes of Biogen and Eisai’s Leqembi and Eli Lilly’s Kisunla, the first FDA-approved disease-modifying treatments for Alzheimer’s, have demonstrated the potential of anti-amyloid treatments, though they come with risks. ALIA-1758 is designed to target pyroglutamate amyloid beta, an epitope similar to that in Kisunla, and leverages Aliada’s MODEL platform to improve therapeutic delivery.

The MODEL platform is engineered to transport therapeutic agents across the BBB by targeting transferrin and CD98 receptors, both of which are abundantly expressed in brain endothelial cells. The technology effectively carries antibodies across the BBB, allowing higher therapeutic concentrations in the brain to address amyloid plaques associated with Alzheimer’s. This targeted approach has the potential to provide superior treatment efficacy compared to previous approaches.

This acquisition aligns with AbbVie’s strategy of expanding its presence in neuroscience. The company already has a robust portfolio that includes experimental therapies like ABBV-916, another anti-amyloid antibody; ABBV-552, which targets nerve terminals to enhance synaptic function; and AL002, an antibody developed in partnership with Alector Therapeutics. With the addition of ALIA-1758, AbbVie strengthens its position in the field and continues to invest in innovation that could transform the treatment landscape for neurodegenerative diseases.

While the Alzheimer’s market is promising, AbbVie’s expansion comes with some caution. Analysts have noted that investor sentiment in anti-amyloid drugs is mixed, given the high cost and developmental challenges. However, AbbVie’s investment signals confidence in the MODEL platform’s potential to enhance drug delivery, particularly in addressing diseases with significant unmet needs like Alzheimer’s. AbbVie is optimistic that Aliada’s technology will complement its existing assets and support long-term growth in the neuroscience sector.

Expected to close by the end of 2024, the acquisition of Aliada Therapeutics is subject to regulatory approvals and standard closing conditions. The deal underscores AbbVie’s ongoing commitment to innovation and its mission to bring novel treatments to patients suffering from Alzheimer’s and other neurological disorders.

Three Biotech Companies Price Their IPOs, Raising Significant Capital for Future Growth

Posted on by cpatches
Key Points:
– Upstream Bio raised $255 million to fund advanced trials for its respiratory disease drug verekitug, achieving a valuation of $830 million.
– Ceribell raised $180 million to further develop its AI-powered EEG platform, focusing on diagnosing serious neurological conditions.
– CAMP4 Therapeutics raised $75 million to continue its work in gene expression therapies, pricing its IPO below expectations at $11 per share.

Three biotech companies priced their initial public offerings (IPOs) on Thursday, securing substantial funding to advance their innovative therapies and technologies. The companies—Upstream Bio, Ceribell, and CAMP4 Therapeutics—collectively raised millions, with plans to use the proceeds for various clinical trials and product developments.

Upstream Bio: Raising $255 Million for Respiratory Therapies Upstream Bio led the day by raising $255 million, with its shares priced at the higher end of the expected range. Initially planning to sell 12.5 million shares between $15 and $17 each, the company increased the offering to 15 million shares due to high demand, pricing them near $17. This could further rise if underwriters exercise their option to purchase an additional 2.25 million shares. The company, which now has a valuation of around $830 million, will trade on the NASDAQ under the ticker symbol UPB.

Upstream Bio is using the capital to advance clinical trials for its lead drug, verekitug, which is being tested for severe asthma and chronic rhinosinusitis with nasal polyps. The drug targets a receptor for thymic stromal lymphopoietin, a key player in inflammatory diseases. Proceeds will also help initiate a phase 3 trial for severe asthma.

Ceribell: Secures $180 Million for AI-Powered Neurological Diagnostics Ceribell, a commercial-stage medical technology company, raised $180 million through its IPO, with 10.6 million shares priced at $17 each, giving the company a valuation of $578 million. Like Upstream, Ceribell also granted underwriters the option to purchase additional shares—up to 1.6 million more. The company will trade on the NASDAQ under the symbol CBLL.

Ceribell specializes in AI-powered neurological diagnostic tools, notably its point-of-care electroencephalography (EEG) platform, designed to help in the diagnosis and management of critical neurological conditions. The technology is expected to revolutionize the way healthcare providers address neurological emergencies.

CAMP4 Therapeutics: Raises $75 Million Despite Pricing Below Expectations CAMP4 Therapeutics saw its IPO priced below expectations, at $11 per share, compared to an initial range of $14 to $16. Despite this, the company managed to sell 6.8 million shares, surpassing its original goal of 5 million, for total gross proceeds of $75 million. CAMP4 will begin trading on the NASDAQ under the ticker symbol CAMP.

CAMP4 focuses on regulatory RNA-targeting therapeutics, aiming to upregulate gene expression in genetic diseases. The proceeds will be used to further develop its drug pipeline, including its recent collaboration with BioMarin to target RNA sequences for therapeutic applications.

Bio-Path Surges on Expansion into Obesity Market

Posted on by cpatches
Key Points:
– Stock Surge: Bio-Path Holdings’ stock rose 30% after announcing BP1001-A, its new obesity treatment program, with trading volume significantly higher than average.
– New Focus: The company plans preclinical studies for BP1001-A by Q4 2024, marking its first use of DNAbilize technology for non-cancer applications.
– Market Opportunity: A September report projects the obesity treatment market could reach $200 billion by 2031, with up to 16 new drugs expected by 2029, presenting a lucrative opportunity for Bio-Path.

Shares of Bio-Path Holdings (NASDAQ: BPTH) surged by 30% as of 11 a.m. Tuesday, driven by significantly increased trading volume of 57 million shares, far exceeding its average volume of 329,000. The rally follows the company’s announcement of a new therapeutic program aimed at addressing obesity and related metabolic diseases using its DNAbilize® technology. This marks the company’s first foray into non-cancer applications, potentially opening the door to a new growth avenue for the biotech firm.

Bio-Path initiated the development of BP1001-A, targeting insulin sensitivity to treat obesity and type 2 diabetes, with plans to begin preclinical studies as soon as the fourth quarter of 2024. In a statement, Bio-Path’s President and CEO, Peter Nielsen, expressed enthusiasm about the expansion into obesity treatments, citing the growing epidemic as a critical health issue. “Developing BP1001-A for the treatment of obesity should have a high probability of success as its mechanism of action has the potential to treat insulin resistance, which is the underpinning of obesity, Type 2 diabetes, and other related diseases,” Nielsen said.

The company’s announcement also coincided with the completion of patient enrollment in the third dosing cohort of its ongoing Phase 1 clinical trial for BP1002, a treatment for acute myeloid leukemia (AML).

In a September report from analysts at Morningstar and Pitchbook, the obesity treatment market was forecast to see as many as 16 new drugs by 2029, vying for a slice of this lucrative and rapidly expanding market, currently dominated by industry giants Novo Nordisk and Eli Lilly. The same report projected that the global market for obesity treatments could balloon to $200 billion by 2031, highlighting the significant commercial potential in addressing obesity and related metabolic diseases.

Bio-Path Holdings is primarily known for its DNAbilize® technology, which uses RNAi nanoparticle drugs that can be administered via simple intravenous infusion. The company’s lead product candidate, prexigebersen (BP1001), is currently in a Phase 2 trial for blood cancers, while BP1001-A is being studied for solid tumors in a Phase 1 trial.

As Bio-Path explores the obesity space, this expansion could represent a major opportunity for growth, particularly as the market for obesity treatments continues to evolve at a rapid pace.

Viking’s Surprise Move in the $150 Billion Weight Loss Race

Posted on by slightbourne@noblecapitalmarkets.com
Key Points:
– Viking Therapeutics stock surges 20% after announcing early advancement to late-stage trials for weight loss drug
– Company’s experimental injection VK2735 shows promising results, potentially rivaling industry giants
– Decision to skip additional mid-stage trial could accelerate drug’s market entry by a year
– Viking also developing a convenient monthly injection and oral version of the drug

In a stunning turn of events, the relatively unknown biotech company Viking Therapeutics has suddenly become the talk of Wall Street. The San Diego-based firm saw its stock price soar by over 20% on Thursday, following a game-changing announcement that has investors and health enthusiasts alike sitting up and taking notice.

The catalyst for this dramatic surge? Viking Therapeutics revealed its plans to fast-track its experimental weight loss injection, VK2735, directly into late-stage trials. This bold move, which comes earlier than expected, has positioned the company as a potential dark horse in the fiercely competitive GLP-1 market, currently dominated by pharmaceutical giants Novo Nordisk and Eli Lilly.

The GLP-1 market, projected to balloon to a staggering $150 billion by the end of the decade, has been a battlefield for drug companies seeking to capitalize on the growing demand for effective weight loss solutions. Viking’s unexpected leap forward has not only caught the attention of investors but also sent ripples through the industry, with shares of both Novo Nordisk and Eli Lilly dipping more than 1% in response.

What makes Viking’s VK2735 so promising? In a phase two trial, patients receiving weekly doses of the injection lost up to 14.7% of their body weight over just 13 weeks – an impressive figure that puts it in the same league as its more established competitors. But Viking isn’t stopping there. The company is also developing a monthly injection version of VK2735, which could offer a more convenient option for patients compared to the weekly regimens of current market leaders.

Adding another layer of intrigue, Viking is simultaneously working on an oral version of VK2735. In early-stage trials, this pill form demonstrated a 3.3% weight loss compared to placebo, opening up the possibility of a non-injectable alternative in the future.

The decision to skip an additional mid-stage trial and move directly to phase three could shave off a significant amount of time from Viking’s development timeline. Analysts now estimate that this strategic move could accelerate the drug’s market entry by as much as a year, potentially launching in 2028 instead of the previously projected 2029.

Viking’s CEO, Brian Lian, expressed confidence in the company’s direction during a recent earnings call, citing positive feedback from the Food and Drug Administration as a key factor in their decision to expedite the development process. The company is now preparing for a crucial meeting with the FDA in the fourth quarter to discuss the design and timing of the phase three trial.

As Viking Therapeutics gears up for this next critical phase, the biotech world watches with bated breath. Could this underdog company be on the verge of disrupting the weight loss drug market? With its promising results and aggressive development strategy, Viking is certainly positioning itself as a formidable contender in the race to capture a slice of the lucrative GLP-1 pie.

For investors and health-conscious individuals alike, the message is clear: keep a close eye on Viking Therapeutics. This small biotech firm might just be holding the key to the next big breakthrough in weight loss treatment.