tw0122
6 시간 전
........….We ...believe the durable effects observed following 28 days of dosing suggest potential opportunities to introduce lower dose regimens following an initial induction of weight loss. We plan to discuss with the FDA the clinical path forward for injectable VK2735 later this quarter and we expect to initiate a Phase 2 study of the oral tablet formulation of VK2735 by the end of this year."
Details of the Phase 3 injectable and Phase 2 oral study designs will be provided closer to study initiation dates.
About GLP-1 and Dual GLP-1/GIP Agonists
Activation of the glucagon-like peptide 1 (GLP-1) receptor has been shown to decrease glucose, reduce appetite, lower body weight, and improve insulin sensitivity in patients with type 2 diabetes, obesity, or both. Semaglutide is a GLP-1 receptor agonist that has been approved by the U.S. Food and Drug Administration and is currently marketed in various dosage strengths and forms as Ozempic®, Rybelsus®, and Wegovy®. More recently, research efforts have explored the potential co-activation of the glucose-dependent insulinotropic peptide (GIP) receptor as a means of enhancing the therapeutic benefits of GLP-1 receptor activation. Tirzepatide is a dual GLP-1/GIP receptor agonist that has been approved by the U.S. Food and Drug Administration and is currently marketed in various dosage strengths and forms as Mounjaro®and Zepbound®.
We believe the durable effects observed following 28 days of dosing suggest potential opportunities to introduce lower dose regimens following an initial induction of weight loss. We plan to discuss with the FDA the clinical path forward for injectable VK2735 later this quarter and we expect to initiate a Phase 2 study of the oral tablet formulation of VK2735 by the end of this year."
Details of the Phase 3 injectable and Phase 2 oral study designs will be provided closer to study initiation dates.
About GLP-1 and Dual GLP-1/GIP Agonists
Activation of the glucagon-like peptide 1 (GLP-1) receptor has been shown to decrease glucose, reduce appetite, lower body weight, and improve insulin sensitivity in patients with type 2 diabetes, obesity, or both. Semaglutide is a GLP-1 receptor agonist that has been approved by the U.S. Food and Drug Administration and is currently marketed in various dosage strengths and forms as Ozempic®, Rybelsus®, and Wegovy®. More recently, research efforts have explored the potential co-activation of the glucose-dependent insulinotropic peptide (GIP) receptor as a means of enhancing the therapeutic benefits of GLP-1 receptor activation. Tirzepatide is a dual GLP-1/GIP receptor agonist that has been approved by the U.S. Food and Drug Administration and is currently marketed in various dosage strengths and forms as Mounjaro®and Zepbound®…..
Monksdream
1 월 전
Snag This Biotech Stock Before November, Here's Why
Anushka Mukherji - Barchart - Sat Sep 21, 11:15AM CDT
Healthcare - pills in a petri dish and syringe by LightStock via iStock
Healthcare - pills in a petri dish and syringe by LightStock via iStock
The weight-loss drug market has exploded over the past year, fueled by blockbuster GLP-1 breakthroughs from pharma giants. With projections calling for the global weight-loss drug market to expand at an astonishing 43.7% compound annual growth rate (CAGR) from 2024 to 2032, the niche is transforming into one of the most high-stakes and lucrative arenas in healthcare.
As the appetite for the next game-changing weight-loss solutions skyrockets, pharmaceutical companies are locked in fierce competition to deliver breakthrough treatments. Amidst this high-stakes race, Viking Therapeutics, Inc. (VKTX) has emerged as a rising contender, ready to challenge the dominance of industry heavyweights like Eli Lilly (LLY) and Novo Nordisk (NVO) in this rapidly expanding market.
As retail investors flock to Viking Therapeutics, the biotech firm is also catching the eye of billionaire fund managers like Jeff Yass and Israel Englander. During Q2, Yass ramped up his fund’s stake in VKTX stock by 1.1 million shares, while Englander’s fund snapped up 326,000 shares.
With the excitement around VKTX stock growing, analysts at JPMorgan recently advised investors to scoop up the stock before a November catalyst event, anticipating even greater gains ahead.
About Viking Therapeutics Stock
Founded in 2012, San Diego-based Viking Therapeutics, Inc. (VKTX) is a cutting-edge clinical-stage biopharma company that is advancing a range of innovative therapies targeting metabolic and endocrine disorders.
Leading the charge is VK2735, a dual GLP-1/GIP agonist for obesity, which has demonstrated strong safety and clinical benefits in early trials, with both injectable and oral formulations under development. The company also recently completed Phase 2 trials on VK2809, an oral drug for treating non-alcoholic steatohepatitis (NASH) and fibrosis.
With a focus on game-changing therapies and a strong pipeline, Viking is positioning itself as a key player in the biotech world. Valued at a market cap of around $7.6 billion, this innovative biotech firm has exploded higher in 2024, largely thanks to optimism over the possibilities for its oral weight-loss formulation.
Shares of Viking have delivered stunning returns of roughly 421.9% over the past year and 278.3% on a YTD basis, even as the shares trade down about 31.4% from their year to date highs, set in February.
www.barchart.com
A Dig Into Viking’s Q2 Financials
Viking Therapeutics sparked excitement with its Q2 update, which sent its shares soaring over 28% on July 25. The pre-revenue company reported a narrower-than-forecast loss of $0.20 per share, which rose slightly from the year ago period on higher research and development expenses.
During the quarter, R&D expenses hit $23.8 million, up from $13.9 million during the same period last year. The company wrapped up the quarter with a strong balance sheet, with $942 million in cash, cash equivalents, and short-term investments, up from just $362 million as of Dec. 31, 2023.
This cash cushion should support Viking’s cash burn for long enough to achieve critical milestones across its diverse pipeline. With this solid foundation, Viking appears well-positioned for exciting growth as it continues to drive innovation and transform the future of metabolic health.
Viking’s Advancements In Weight Loss Drug Arena
In Q1, Viking achieved remarkable milestones with its weight-loss drug candidate VK2735, positioning itself to challenge the dominance of industry titans like Novo Nordisk and Eli Lilly in the obesity market. While Lilly and Novo offer injectable GLP-1 treatments, enthusiasm around Viking’s offering centers around its oral formulation, which is expected to receive a warmer reception from patients.
In the Phase 2 VENTURE study released in February, VK2735 demonstrated impressive results, with patients losing up to 15% of their body mass in just 13 weeks, well ahead of the year-long timelines seen with current therapies.
This remarkable finding established Viking's obesity option as a serious contender against blockbuster obesity medications like Novo’s Wegovy and Lilly’s Zepbound, signaling a potential shift in the competitive landscape. Following the impressive results from its Phase 2 trials, analysts anticipated a Phase 2b trial for VK2735.
However, in its Q2 earnings release, management announced a game-changing decision. After talks with FDA officials, management revealed that VK2735 would skip straight to Phase 3 and is preparing for an end-of-Phase 2 meeting by the conclusion of this year. This groundbreaking announcement ignited massive attention from investors in the aftermath of the Q2 earnings release.
Adding to the momentum, management also revealed that the Phase 1 trial of the oral tablet formulation of VK2735 showed encouraging safety and clinical activity, with participants losing an average of 5.3% of their weight in just 28 days of daily dosing. Plus, the Phase 2 trial for this formulation is expected to be launched in the final quarter of this year.
What Do Analysts Expect For Viking Stock?
Shares of Viking rallied 11.3% on Sep. 11 after JPMorgan launched coverage with an “Overweight” rating on VKTX stock. With an upcoming early-stage trial readout for the company’s oral obesity therapy VK2735 set for early November at Obesity Week in San Antonio, analyst Hardik Parikh placed Viking under a positive catalyst watch.
“We recommend being long into the upcoming readout for oral-2735, which we think should lead to substantial up move for shares,” wrote Parikh, who thinks Viking can capture roughly 10% of the oral obesity drug market. He set an $80 price target for the shares.
Overall, Wall Street has a unanimous “Strong Buy” rating on the biotech stock, with all 12 analysts in coverage giving VKTX their highest recommendation.
www.barchart.com
The average analyst price target is $110.82, indicating expected upside potential of 56.7% from current levels.
vinmantoo
3 월 전
For my little friend who hates VKTX but knows nothing about clinical trials or science.
Final Rule (42 CFR Part 11) for the Food and Drug Administration Amendments Act of 2007 (FDAAA)
Overview
What is it? U.S. Federal regulation implementing FDAAA 801 effective in 2017
Which clinical trials must follow it? Clinical trials of FDA-regulated drug, biological, or device products other than Phase 1 trials of drug/biological products or small feasibility studies of device products
Does it require registration? Yes
Does it require results submission? Yes
As I said, results from phase I trial data is not required to be reported.
https://clinicaltrials.gov/policy/reporting-requirements#final-rule
The primary completion date for the phase 2 trial of VK2735 weekly sub-cutaneous administration was Feb 27, 2024. VKTX has a year to SUBMIT the data not publish the data.
When must clinical trial results information be submitted for applicable clinical trials subject to §?11.42?
(a)
Standard submission deadline.
In general, for applicable clinical trials subject to §?11.42, clinical trial results information specified in sections 402(j)(3)(C) and 402(j)(3)(I) of the Public Health Service Act (42 U.S.C. 282(j)(3)(C) and 42 U.S.C. 282(j)(3)(I)) or in §?11.48, as applicable, must be submitted no later than 1 year after the primary completion date of the applicable clinical trial.
https://www.federalregister.gov/documents/2016/09/21/2016-22129/clinical-trials-registration-and-results-information-submission#p-1440
vinmantoo
3 월 전
What you don't understand is that short term investments can be impaired. It doesn't mean they have $900 million in assets. That is similar to looking at the Balance Sheet and the Goodwill is listed as $100 million as an Asset - when reading a financial statement I disregard Goodwill and Intangible Assets.
You are grasping at straws. It make me laugh.
Plus, Viking didn't publish the results on ClinicalTrials.gov for Phase 1 and Phase 2. That is a huge red flag.
Thanks for showing us you don't know anything about biotech or publishing in Scientific Journals. First, companies don't usually publish Phase I results as the data set is too small, and phase I trials are usually just about safety and dosage escalation. Second, the phase 2 data for VK2735 was released at the very end of February. It takes several months just to assemble the data and write the manuscript into publication form. Then the manuscript is submitted and reviewers have to be found who have the time and expertise to review the manuscript. Then the reviewers read the manuscript with a fine tooth comb. This can take 1-2 months or in some cases, more. The reviewers provide their comments on the manuscript on and suggestions for writing and data presentation. The manuscript is then sent back to the authors for revisions, well assuming the journal editor thinks it merits publication is. The people who submitted the manuscript make revisions based on reviewer critiques. They can also explain why they disagree with suggestions. Depending on what the reviewers say and what the editor decided, the manuscript can be accepted with the proviso that certain minor changes be made, which might take only a few weeks and not require further input from reviewers are needed. In that case, the manuscript might be published in a month or two more. Alternatively, or a major revision might be required and the manuscript re-reviewed. It isn't uncommon for it to take a year or more until publication.
There is a lack of transparency from Viking.
Nonsense. Again your inexperience in biotech is showing
I generally am skeptical of Short Term Investments.
Feel however you like.
The Viking corporate headquarters is a virtual office - another huge red flag.
Not sure what you are talking about VKTX has 28 full time employees.
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