Avail

Strong

Optimism

Safety

<div class="textg" style="text-align: justify; font-weight: lighter; line-height: 1.3em; font-size: 15px; border-radius: 3px; color: #80909a; padding: 10px; background-color: #F4F6F9; margin-bottom: 15px;">
 Neither the author, Tim Fries, nor this website, The Tokenist, provide financial advice. Please consult our&nbsp;<a href="https://tokenist.com/terms-of-service/" style="text-decoration:underline;color:#3c7b7b" target="_blank" rel="noreferrer noopener" class="deco-link">website policy</a>&nbsp;prior to making financial decisions.
</div> 
<p class="has-drop-cap">MBX Biosciences, Inc. (NASDAQ: MBX) shares surged dramatically in <a href="https://tokenist.com/investing/how-to-trade-after-hours/" rel="dofollow" class="deco-link">premarket trading</a> Monday following the announcement of clinically meaningful and statistically significant <a href="https://investors.mbxbio.com/news-releases/news-release-details/mbx-biosciences-announces-once-weekly-canvuparatide-achieved" target="_blank" aria-label="results (opens in a new tab)" rel="noreferrer noopener nofollow" class="deco-link">results</a> from its Phase 2 trial of once-weekly canvuparatide for chronic hypoparathyroidism. The stock jumped 139.10% to $23.91 in premarket trading after closing at $10.00 on Friday, representing one of the most significant single-day gains for the clinical-stage biopharmaceutical company. The positive trial results exceeded expectations and positioned the company to advance to Phase 3 development in 2026.</p> 
<h3 id="mbx-phase-2-trial-shows-strong-efficacy-and-safety">MBX Phase 2 Trial Shows Strong Efficacy and Safety</h3> 
<p>The Phase 2 Avail trial demonstrated remarkable efficacy with 63% of canvuparatide-treated patients meeting the primary composite endpoint at 12 weeks, compared to just 31% in the placebo group (p=0.042). The study achieved statistical significance with zero contribution from rescue therapy, indicating the drug’s standalone effectiveness. All 64 patients completed the 12-week study, with an impressive 94% choosing to continue in the open-label extension, demonstrating strong patient confidence in the treatment.</p> 
<p>The open-label extension results were even more encouraging, with 79% of patients achieving responder status at 6 months. Responders were defined as patients who maintained normal serum calcium levels (8.2-10.6 mg/dL) while remaining independent from conventional therapy including active vitamin D and high-dose calcium supplements. The drug showed positive effects on bone and kidney biomarkers, with bone turnover markers increasing consistent with enhanced bone remodeling, and urine calcium levels reduced by 48% in treated patients compared to 33% on placebo.</p> 
<p>The safety profile remained favorable throughout the study, with canvuparatide being generally well-tolerated across all doses. No treatment-related serious adverse events or discontinuations occurred during the 12-week trial period, and most adverse events were categorized as mild to moderate. The pharmacokinetic findings supported the once-weekly dosing schedule, consistent with earlier Phase 1 results.</p> 
<div class="cta-referral"> 
 <img src="https://tokenist.com/wp-content/themes/thetokenist/assets/img/del/cta-referral-1.png" alt="" class="cta-referral__img" loading="lazy" decoding="async"> 
 <div class="cta-referral__text"> 
  <p>Join our <a href="https://t.me/thetokenist" target="_blank" rel="nofollow">Telegram group</a> and never miss a breaking digital asset story.</p> 
 </div> 
</div> 
<h3 id="stock-surge-reflects-optimism-for-long-term-strategy">Stock Surge Reflects Optimism for Long-Term Strategy</h3> 
<p>The stock’s dramatic premarket surge reflects investor enthusiasm for the potential of canvuparatide as a best-in-class treatment for hypoparathyroidism, a rare endocrine disorder affecting over 250,000 individuals in the U.S. and Europe. MBX’s market capitalization of $335.94 million positions the company well for the anticipated Phase 3 trial initiation in 2026. The 1-year analyst target estimate of $37.71 suggests continued upside potential, though the stock has shown high volatility with a 52-week range of $4.81 to $27.50.</p> 
<p>The current treatment landscape for hypoparathyroidism relies primarily on high doses of oral calcium and active vitamin D supplements, which fail to address the underlying PTH deficiency and often result in unpredictable calcium level swings. Canvuparatide’s once-weekly administration schedule and continuous infusion-like PTH exposure could represent a significant improvement over existing therapies. The company’s Precision Endocrine Peptide platform technology underlies this promising drug candidate, which has already received orphan drug designation from the FDA.</p> 
<p>MBX plans to present additional data from the trial at an upcoming medical meeting while preparing for Phase 3 development. The company’s pipeline also includes other candidates in development, including imapextide for post-bariatric hypoglycemia and MBX 4291 for obesity treatment. With $224.91 million in total cash and minimal debt, the company appears well-positioned financially to advance canvuparatide through the next development phase.</p> <iframe src="https://tokenist.substack.com/embed" width="100%" height="320" style="border:1px solid #EEE; background:white;" frameborder="0" scrolling="no"></iframe> 
<p><em>Disclaimer: The author does not hold or have a position in any securities discussed in the article.</em> <em>All stock prices were quoted at the time of writing.</em></p> 
<p>The post <a rel="nofollow" href="https://tokenist.com/mbx-biosciences-stock-skyrockets-after-announcing-significant-phase-2-results/">MBX Biosciences Stock Skyrockets After Announcing Significant Phase 2 Results</a> appeared first on <a rel="nofollow" href="https://tokenist.com">Tokenist</a>.</p>

MBX Biosciences Stock Skyrockets After Announcing Significant Phase 2 Results

Table of Contents

Tokenist

Other articles published on Sep 22, 2025

Arthur Hayes Dumps $5.1M HYPE Bag Weeks After 126x Call, Says He is Buying a Ferrari

September Altcoin Rally: XRP, Tron, and Solana Join the Surge

Plasma One Launches Stablecoin Neobank for Emerging Markets

AI Capital Connect: Event For Investors and Innovators in Singapore

Oracle’s Strategic Leap: New Co-CEOs Drive AI Infrastructure Dominance

Seoul Exchange, One of Only Two Licensed Platforms For Unlisted Securities, Will Exclusively Use ...

Join our free newsletter for daily crypto updates!