Aquestive Therapeutics (AQST) shares ended the last trading session 7.9% higher at $6.69. The jump came on an impressive volume with a higher-than-average number of shares changing hands in the session. This compares to the stock's 27.1% gain over the past four weeks.The surge in stock price is likely due to positive expectations regarding the company’s key product candidate, Anaphylm, which is currently under review with the FDA for treating severe allergic reactions. Earlier this week, the United States P ...

Shares of Aquestive Therapeutics (NASDAQ:AQST) rose on Wednesday after the company announced that the U.S. regulators had issued two new patents covering its allergy therapy Anaphylm, which is currently under FDA review. The Warren, New Jersey-based biopharma said that the U.S. Patent ...

Core Insights - Several small-cap stocks experienced significant gains in after-hours trading due to corporate updates, clinical developments, and strategic shifts Company Summaries MEDIROM Healthcare Technologies Inc. (MRM) - Shares surged 282.8% to $5.55 after announcing plans to double the installation of its biometric authentication device "Orb" to 200 stores in collaboration with "World" [2] - Closed at $1.45 during regular trading, down 7.05%, with a trading volume of over 31.5 million shares [3] - The stock has a 52-week range of $0.34 to $5.30, highlighting the scale of its overnight move [3] Lexaria Bioscience Corp. (LEXX) - Shares rose 45.75% to $2.23 following renewed interest in its DehydraTECH drug delivery platform, which enhances GLP-1 drug delivery [4] - Closed at $1.53, up 7.75%, with a volume exceeding 7.5 million shares [5] - The stock's 52-week range is $0.775 to $3.392, with Thursday's close near the midpoint [5] Safety Shot, Inc. (SHOT) - Shares increased 12% to $0.28 after announcing a partnership with Monarq Asset Management to manage its BONK Holdings Treasury [6] - Closed at $0.25, down 9.06%, with a trading volume of over 15.4 million shares [7] - The stock has a 52-week range of $0.23 to $1.35, with the after-hours price near the lower end [7] Aquestive Therapeutics, Inc. (AQST) - Shares rose 11.41% to $5.86 following favorable regulatory news regarding its oral epinephrine candidate, Anaphylm [8] - Closed at $5.26, down 2.95%, with a volume of over 3.6 million shares [9] - The stock's 52-week range is $2.12 to $6.00, with the after-hours price near the upper end [9] Ovid Therapeutics Inc. (OVID) - Shares increased 4.26% to $1.47 after reaching a 52-week high during regular trading, driven by progress in its neurological pipeline [10] - Closed at $1.41, up 0.71%, with a trading volume of over 2.4 million shares [11] - The stock has a 52-week range of $0.2430 to $1.47, with Thursday's close at the top end of its recent performance band [11]

Company Overview - Aquestive Therapeutics (AQST) shares increased by 14.8% to close at $5.67, with notable trading volume compared to typical sessions, and a total gain of 26.3% over the past four weeks [1][2] Regulatory Developments - The stock price surge is attributed to positive investor expectations regarding the FDA approval filing for its key product candidate, Anaphylm, aimed at treating severe allergic reactions. The FDA waived the advisory committee meeting, indicating a lower perceived risk associated with the treatment, with a final decision expected by January 31, 2026 [2] Financial Performance Expectations - The company is projected to report a quarterly loss of $0.13 per share, unchanged from the previous year, with expected revenues of $13.36 million, reflecting a 1.3% decline from the year-ago quarter [3] - The consensus EPS estimate for the quarter has been revised 24.4% higher over the last 30 days, suggesting a potential for price appreciation [4] Industry Comparison - Aquestive Therapeutics operates within the Zacks Medical - Drugs industry. In contrast, USANA Health Sciences (USNA) closed 3.6% lower at $29.74, with a 0.7% return over the past month. USANA's consensus EPS estimate remains unchanged at $0.47, representing a 16.1% decline from the previous year [4][5]

Aquestive Therapeutics, Inc. (NASDAQ:AQST) is one of the stocks Jim Cramer recently gave takes on. Cramer said that the stock “has found new life” over the past few years and remarked: “For the past few years, this stock has found new life, climbing back to the mid single digits, mostly thanks to the growing excitement about their EpiPen replacement that can be taken by mouth for emergency allergy treatments… I think people are right to be excited. If this drug can be approved, I think it could be huge. T ...

Core Insights - Several small-cap stocks experienced significant gains in after-hours trading, driven by strategic updates, leadership changes, and pipeline developments, indicating renewed investor interest [1] Adaptimmune Therapeutics plc (ADAP) - ADAP's stock surged 30% in after-hours trading, reaching $0.2020 after a 98% gain during the regular session, closing at $0.16 [2] - The company reported a net loss of $30.3 million for Q2 2025, with total revenue of $13.7 million, primarily from product sales of TECELRA, which saw over 150% growth compared to Q1 [3] - In August, Adaptimmune sold several cell therapies to US WorldMeds for $55 million upfront, with potential future milestone payments of up to $30 million, allowing the company to repay its debt and restructure [4] Butterfly Network Inc. (BFLY) - BFLY's stock rose 10.58% in after-hours trading to $2.09, following a 15.95% increase during the regular session [4] - The company was recognized in TIME's list of the World's Top HealthTech Companies for 2025, and appointed a new Chief Technology Officer, enhancing its focus on innovation [5] - A recent study confirmed that Butterfly-enabled POCUS programs significantly reduce hospital stays and costs, validating its clinical impact [5] Aquestive Therapeutics Inc. (AQST) - AQST's stock increased 7.69% in after-hours trading to $5.32, continuing a year-to-date rise of nearly 39% [6] - The FDA confirmed it will not require an advisory committee meeting for AQST's NDA for Anaphylm, streamlining the regulatory process with a PDUFA date set for January 2026 [7] - The company secured a $75 million strategic funding agreement to support the potential launch of Anaphylm, reinforcing its commercial readiness [7] ALX Oncology Holdings Inc. (ALXO) - ALXO's stock rose 9.17% in after-hours trading to $1.19, following a 3.81% increase during the regular session [8] - Insider buying activity, particularly by CEO Jason Lettmann, who purchased 92,233 shares, has boosted investor confidence [9] - The company's lead candidate, Evorpacept, is in multiple Phase 1 and Phase 2 trials across various cancers, collaborating with major partners [9] Ekso Bionics Holdings Inc. (EKSO) - EKSO's stock increased 5.37% in after-hours trading to $4.51, following a 9.74% gain during the regular session [10] - The company's inclusion in the NVIDIA Connect Program has spotlighted its efforts to integrate AI into its technologies [11] - EKSO launched Virtual eksoUniversity to support continuing education for physical therapists, potentially broadening adoption of its rehabilitation devices [11] CEL-SCI Corp. (CVM) - CVM's stock rose 5.27% in after-hours trading to $9.39, after a 1.02% increase during the regular session [12] - The company completed a $10 million public offering to support ongoing clinical and regulatory efforts [13] - CEL-SCI filed for Breakthrough Medicine Designation in Saudi Arabia for its lead candidate, Multikine, which could expedite patient access and reimbursement [13]

Core Thesis - ARS Pharmaceuticals, Inc. is positioned favorably in the epinephrine delivery market with its nasal spray Neffy, supported by a robust patent portfolio and strong management, despite facing legal challenges and competition [2][4][5] Patent and Legal Landscape - ARS Pharmaceuticals holds a portfolio of patents covering various aspects of Neffy, with protections extending to 2039, but is currently facing a lawsuit from Lupin, a major generic manufacturer, which could lead to generic competition [2] - The litigation against Lupin triggers a 30-month delay on generic entry, providing a temporary shield for Neffy [2] - Historical data indicates that generics succeed in patent infringement cases about 45% of the time, but ARS's strong patent position and cash reserves enhance its defensive capabilities [2] Market Dynamics and Competition - Insurance coverage for Neffy is expanding, currently at 60% and projected to reach 80% by the end of 2025, which is expected to support market adoption [3] - The competitive landscape includes Aquestive Therapeutics' Anaphylm, which has an 80% probability of FDA approval and may enter the market in early 2026, presenting a faster-acting alternative to Neffy [3] - Neffy benefits from a first responder-friendly nasal delivery method, while mouth films like Anaphylm face challenges in certain emergency scenarios [3] Management and Market Position - The management of ARS Pharmaceuticals has a proven track record, having previously captured 95% of the Narcan market, although current adoption of Neffy is slower at around 5% [4] - Brand awareness for Neffy stands at 49%, and the company has established international licensing agreements, providing a competitive edge [4] - Despite the market advantages and growth potential, the uncertain outcome of patent litigation and competition from AQST suggest a cautious approach to investment [4][5]

Core Insights - The article discusses the performance and future outlook of Aquestive Therapeutics (NASDAQ: AQST), noting a 2% decline in the stock price over the past six months since the last analysis [2]. Company Focus Areas - The company is focusing on five key areas for 2025, including the potential FDA approval of Anaphylm, which is a significant catalyst for future growth [2]. Investment Group Features - The investment group Compounding Healthcare offers several features such as model healthcare portfolios, a weekly newsletter, a daily watchlist, and a platform for dialogue and questions among members [2].

Group 1 - The company has a strong academic foundation with an MBA in Finance and an MD, enhancing its expertise in the financial sector [1] - The firm specializes in income investing and biotech/pharma investing, with nearly a decade of experience in these areas [2] - The organization focuses on identifying both short-term catalyst-driven opportunities and long-term investment strategies in the biotech sector [3] Group 2 - Subscribers receive regular portfolio trade alerts and have access to an interactive chat feature, promoting engagement and addressing inquiries [4] - The company has published a best-selling book on biotech investing and offers an online course, showcasing its commitment to educating investors [4] - The firm provides custom biotech analysis upon request, ensuring tailored insights for its audience [3][4]

Financial Data and Key Metrics Changes - Total revenue decreased to $11.9 million in Q4 2024 from $13.2 million in Q4 2023, a 10% decrease primarily due to declines in license and royalty revenue [31] - For the full year 2024, total revenues increased to $57.6 million from $50.6 million in 2023, a 14% increase driven by increases in license and royalty revenue [32] - Net loss for Q4 2024 was $17.1 million or $0.19 per share, compared to a net loss of $8.1 million or $0.12 per share in Q4 2023 [36] - Non-GAAP adjusted EBITDA loss was $11 million in Q4 2024 compared to $2.8 million in Q4 2023 [38] Business Line Data and Key Metrics Changes - Manufacture and supply revenue decreased to $10.7 million in Q4 2024 from $11 million in Q4 2023, primarily due to a decrease in Suboxone revenues [31] - License and royalty revenue decreased to $0.8 million in Q4 2024 from $1.9 million in Q4 2023, mainly due to prior year milestone royalty revenue [31] - Research and development expenses increased to $4.9 million in Q4 2024 from $2.9 million in Q4 2023, driven by clinical trial costs for Anaphylm [34] Market Data and Key Metrics Changes - The company plans to submit applications for Anaphylm in international markets including the EU, UK, and Canada [22] - The estimated market opportunity for JAK inhibitors, which are existing therapies for alopecia areata, is over $1 billion [24] Company Strategy and Development Direction - The company has begun the filing process with the FDA for Anaphylm and expects to launch in Q1 2026 if approved [9][10] - Plans to focus on international markets and partnerships for Anaphylm post-FDA submission [22] - The company is preparing for a potential advisory committee meeting for Anaphylm, expected in the second half of 2025 [15] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in Anaphylm's profile and its potential to be preferred by patients due to its rapid absorption and ease of use [48] - The company anticipates total revenues of approximately $47 million to $56 million for 2025, including some erosion in Suboxone demand [41] - Management remains committed to ensuring access to Libervant for young patients despite recent legal challenges [26][66] Other Important Information - The company raised over $78 million in capital from institutional investors to support strategic priorities [30] - Cash and cash equivalents were $71.5 million as of December 31, 2024, with a pro forma adjustment to approximately $93 million after recent fundraising [39] Q&A Session Summary Question: Key topics for FDA advisory committee meeting - Management discussed confidence in Anaphylm's profile and the importance of rapid epinephrine uptake during allergic reactions [44][45] Question: Early adopters of Anaphylm - Management believes that anyone at risk of anaphylaxis will be an early adopter, with a focus on teenagers and young adults [49][50] Question: Commercialization strategy - The company is prepared to launch Anaphylm independently but is open to partnerships if beneficial [54][60] Question: Libervant's future - Management emphasized the importance of Libervant for patients and the ongoing efforts to ensure access despite legal challenges [66][102] Question: Market seasonality for epinephrine products - Management highlighted the seasonal nature of the epinephrine market, with a peak in demand during summer months [72][73] Question: Safety profile of Anaphylm - Management expressed confidence in the safety and efficacy data supporting Anaphylm, noting a robust clinical package submitted to the FDA [77][78]