quantumup
2週前
USITC reply dates coming up (February 28, 2025 and March 7, 2025) for $VKTX Re: #VK2809
and
$ASCLF's #ASC41 & #ASC43F,
at The UNITED STATES INTERNATIONAL TRADE COMMISSION, Washington, D.C..
Remedy could come ≤60 days after dates.
https://www.usitc.gov/system/files/secretary/fed_reg_notices/337/337_1352_notice02122025sgl.pdf
$MDGL $AMGN
NOTICE OF A COMMISSION DETERMINATION TO REVIEW A FINAL INITIAL DETERMINATION FINDING A VIOLATION OF SECTION 337; REQUEST FOR WRITTEN SUBMISSIONS ON REMEDY, THE PUBLIC INTEREST, AND BONDING
The initial written submissions and proposed remedial orders must be filed no later than close of business on February 28, 2025. Reply submissions must be filed no later than the close of business on March 7, 2025. No further submissions on these issues will be permitted unless otherwise ordered by the Commission.
If the Commission orders some form of remedy, the U.S. Trade Representative, as delegated by the President, has 60 days to approve, disapprove, or take no action on the Commission’s determination.
TheFinalCD
2月前
The feedback on the Viking Therapeutics $VKTX presentation today at the J.P. Morgan Healthcare Conference has been mixed:
Some noted that the presentation did not bring much new information, with expectations that more details on Phase 3 trial designs or outcomes from FDA meetings might have been shared but were not. This left some feeling that the presentation was underwhelming in terms of new insights or announcements.
On the positive side, the CEO, Brian Lian, mentioned key points such as the completion of the End of Phase 2 meeting with the FDA in December, the initiation of a Phase 2 oral study with doses ranging from 15mg to 120mg, and plans for two Phase 3 studies for the injectable drug in the first half of 2025. There was also mention of ongoing supplier discussions and high interest from potential partners, which could be seen as positive developments.
However, there were criticisms regarding the delivery of the presentation, with some describing the speaker's style as not being engaging enough.
Despite the mixed feedback on the content and delivery, there's an underlying sentiment of patience among some investors, believing that the foundation laid by VKTX is strong, and they are moving forward with their drug development plans.
Overall, while some were looking for more substantial updates or breakthroughs, the presentation still conveyed ongoing progress in the company's clinical pipeline
DewDiligence
3月前
WSJ take on NVO, LLY et al:
https://www.wsj.com/health/pharma/theres-a-new-obesity-king-ef5a4c8a “The easier money has already been made,” says [Kevin Gade of Bahl & Gaynor]. “Reaching initial projections of $50 billion in annual sales was doable. But achieving the $150 billion projections some analysts are putting out there will require some gymnastics to make the numbers work.”
Novo’s disappointing [CagriSema] data, and its subsequent market value drop [-21% today], suggests Wall Street doesn’t believe those numbers will work—at least not for Novo. Lilly, however, has a better shot. Yet, as recent events show, the stakes are higher now, and the margin for error is shrinking.
I-Glow
4月前
Viking only has 34 employees. Eli Lilly has 45,150 employees.
Novo Nordisk has 66,000 employees.
Novo Nordisk had a R&D budget of $4.711 billion in 2023.
Eli Lilly had a R&D budget of $9,313 Billion budget 2023.
Viking had a R&D budget of $63.8 Million in 2023.
The results of the clinical trials for VK2735 (for weight loss) weren't published.
"It's known that Ozempic underwent extensive testing through multiple clinical trials before receiving approval. For instance, the U.S. Food and Drug Administration (FDA) considered data from seven clinical trials involving 4,087 patients with type 2 diabetes, conducted across 536 sites in 33 countries. ??
While the specific expenses for Ozempic's trials remain confidential, it's important to note that clinical trials, especially those of this magnitude, are typically costly. These expenses encompass various aspects, including research and development, patient recruitment, data analysis, and regulatory compliance. Novo Nordisk reported spending nearly $5 billion on research and development in a recent year, which includes costs for multiple projects beyond Ozempic. ??
Given the scale and complexity of Ozempic's clinical trials, it's reasonable to infer that a significant portion of Novo Nordisk's R&D budget was allocated to this drug's development.??"
Looking at the financials of Viking they don't have the Capital to compete in the weight loss drug development.
IG
tw0122
4月前
........….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
6月前
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.
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