Group 1 - U.S. stocks experienced an upward trend, with the Dow Jones index increasing by over 200 points on Friday [1] - Crinetics Pharmaceuticals, Inc. saw a significant stock price increase of 23.7%, reaching $44.41, following FDA approval of PALSONIFY [1] - Baird and JMP Securities raised their price targets for Crinetics Pharmaceuticals [1] Group 2 - Aquestive Therapeutics, Inc. stock rose by 21.2% to $6.38 [3] - Perpetua Resources Corp. increased by 18% to $22.43 after providing an update on securing the American antimony supply chain [3] - Robo.ai Inc. gained 14% to $2.77 [3] - Quantum Computing Inc. saw a 13% increase to $23.15 [3] - SkyWater Technology, Inc. shares jumped 12% to $17.23 [3] - Scholar Rock Holding Corporation surged 10.8% to $38.23, despite receiving a Complete Response Letter from the FDA regarding its treatment for spinal muscular atrophy [3] - Avino Silver & Gold Mines Ltd. gained 9.2% to $5.24 [3] - New Found Gold Corp. rose 9.1% to $2.3347, confirming high-grade core in its sampling program [3] - Gorilla Technology Group Inc. increased by 7% to $20.10 after signing a $1.4 billion deal for AI data centers in Southeast Asia [3] - BlackBerry Limited rose 6.6% to $4.9596 after reporting better-than-expected second-quarter EPS and sales, along with raising its FY2026 adjusted EPS guidance [3] - Carpenter Technology Corporation increased by 6.6% to $247.84 [3]

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 ...

Group 1 - U.S. stocks experienced an upward trend, with the Nasdaq Composite increasing by over 100 points on Friday [1] - CoreWeave, Inc. (CRWV) saw a significant rise in shares, jumping 4.8% to $127.15 after Loop Capital initiated coverage with a Buy rating and set a price target of $165 [1] - Quantum Computing Inc. (QUBT) shares surged by 22.5% to $22.47, indicating strong market interest [3] Group 2 - WhiteFiber, Inc. (WYFI) gained 17.6% to $27.53, with Roth Capital analyst maintaining a Buy rating and raising the price target from $25 to $28 [3] - Serve Robotics Inc. (SERV) rose 17% to $15.09, reflecting positive investor sentiment [3] - Aquestive Therapeutics, Inc. (AQST) increased by 16.5% to $5.75 after receiving news from the FDA that an advisory committee meeting is not required for its product [3] Group 3 - PureTech Health plc (PRTC) gained 16.2% to $17.08, showing strong performance in the market [3] - NANO Nuclear Energy Inc. (NNE) rose 15.3% to $44.10, indicating robust investor confidence [3] - Newegg Commerce, Inc. (NEGG) jumped 15% to $53.51, reflecting a positive market reaction [3] Group 4 - Oklo Inc. (OKLO) gained 14.4% to $120.13, continuing a remarkable 60% rally over the past month [3] - NuScale Power Corporation (SMR) rose 12.6% to $42.99, indicating strong market interest [3] - Centrus Energy Corp. (LEU) gained 9.4% to $287.38, reflecting positive investor sentiment [3] Group 5 - Symbotic Inc. (SYM) shares rose 8.5% to $55.59, indicating strong market performance [3] - Rigetti Computing, Inc. (RGTI) gained 8.5% to $26.98 after being awarded a three-year $5.8 million contract from the Air Force Research Laboratory [3] - Barrick Mining Corporation (B) rose 7% to $32.17, with B of A Securities analyst maintaining a Neutral rating and raising the price target from $29 to $34 [3] Group 6 - FedEx Corporation (FDX) gained 2.4% to $231.98 after reporting better-than-expected first-quarter EPS and sales, leading multiple analysts to raise their price targets [3]

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]

Summary of Aquestive Therapeutics FY Conference Call Company Overview - **Company Name**: Aquestive Therapeutics - **Ticker**: AQST - **Industry**: Biotechnology - **Established**: Over 20 years, public for 8 years - **FDA Approvals**: 6 approvals - **Revenue**: Approximately $50 million annually - **Headquarters**: R&D in New Jersey, manufacturing in Indiana [2][3] Core Technology - **PharmFilm® Technology**: A polymeric matrix for buccal or sublingual absorption - **Adrenaverse™ Technology**: An epinephrine prodrug technology aimed at improving absorption profiles [3][4] Key Products - **Anaphylm™**: - A sublingual film for anaphylaxis, currently under FDA review with a PDUFA date of January 31, 2026 - Projected to be a billion-dollar product globally [5][6] - **AQST-108**: An undisclosed prodrug in topical gel form for alopecia areata [5] Market Opportunity - **Epinephrine Market Size**: Estimated at $800 million to $1 billion in the U.S., with potential growth to $2 billion due to increased awareness and promotion of non-needle-based products [7][9] - **Prevalence**: 30 to 40 million Americans should carry a rescue product, but only 5 million prescriptions are filled annually [9] Competitive Advantage - **Unique Value Proposition**: Anaphylm™ is designed to be easy to carry, easy to use, and provides rapid relief, with peak absorption in 12 minutes and therapeutic levels in as little as 5 minutes [11][16] - **Market Readiness**: The company has established relationships with payers and distributors, and is focused on educating healthcare providers about Anaphylm™ [21][22] Financial Position - **Recent Funding**: Raised $85 million in new equity and secured a $75 million revenue-sharing agreement, totaling over $200 million available for product launch and promotion [10] Launch Strategy - **Timing**: Launch planned for spring 2026, coinciding with increased prescriptions for seasonal allergies [20] - **Sales Focus**: Targeting allergists and pediatricians, who prescribe an average of 200 epinephrine prescriptions annually [20] Patient Access and Support - **Patient Services**: Emphasis on ensuring patient access through support services for both patients and healthcare providers [22] Conclusion - **Excitement for Launch**: The company is optimistic about the upcoming launch of Anaphylm™ and believes it will significantly impact the epinephrine market [23]

If you are interested in keeping up to date with stocks making moves within the biotech, pharma, and healthcare industries and understanding the key trends and catalysts driving valuations ahead of the market, why not subscribe to my weekly newsletter via my Investing Group, Haggerston BioHealth ?The share price of Aquestive Therapeutics, Inc. (NASDAQ: AQST ) was soaring yesterday, as the Warren, New Jersey-headquartered biotech, focused on "advancing medicines to bring meaningful improvement to patients' l ...

Core Viewpoint - The FDA has informed Aquestive Therapeutics that no advisory committee meeting is required for the NDA of Anaphylm, indicating the target action date remains January 31, 2026 [1][5][7]. Company Developments - Shares of Aquestive Therapeutics rose by 28.1% following the FDA announcement [2][7]. - The stock has increased by 42.2% year-to-date, outperforming the industry average increase of 11.7% [4]. - The NDA for Anaphylm was accepted by the FDA in June 2025, with the target action date set for January 31, 2026 [5][7]. - Anaphylm is being developed as a non-invasive oral epinephrine product for treating severe allergic reactions, including anaphylaxis [6][8]. Market Potential - If approved, Anaphylm would be the first non-invasive, orally delivered epinephrine product approved by the FDA for severe allergic reactions [6][8]. - The management believes Anaphylm offers greater convenience compared to traditional autoinjectors [7]. - The company has secured $160 million in financing to support the potential launch of Anaphylm in the U.S. in Q1 2026 [8].

Financial Data and Key Metrics Changes - The company announced a successful financing round of $160 million to support the launch of ANNAFILM, indicating a strong financial position for upcoming operations [52][68]. - The recent funding includes an $85 million equity raise and a $75 million revenue interest financing, providing sufficient runway through 2026 and into 2027 [68][69]. Business Line Data and Key Metrics Changes - ANNAFILM, the lead product, is a prodrug of epinephrine designed to improve the delivery and usability for patients at risk of severe allergic reactions [8][12]. - The company is also developing AQST-108 for alopecia areata, showcasing a commitment to expanding its product pipeline beyond ANNAFILM [9][65]. Market Data and Key Metrics Changes - The potential market for ANNAFILM includes over 30 million individuals at risk of severe allergic reactions, with only 5 million prescriptions written annually, indicating a significant opportunity for market penetration [12]. - The company plans to target college-age individuals, teenagers, and parents concerned about their children's safety as early adopters of ANNAFILM [52][53]. Company Strategy and Development Direction - The company aims to leverage its unique oral administration of epinephrine to differentiate itself from existing injectable products, focusing on convenience and accessibility [23][50]. - Plans for international expansion include outreach to key markets such as Europe, Canada, and Japan, with ongoing discussions with regulatory bodies like EMA and Health Canada [60][62]. Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding the FDA's decision not to require an advisory committee meeting, viewing it as a positive sign for the approval process [42][46]. - The company is preparing for a robust commercial launch and anticipates a strong market response to ANNAFILM, particularly among demographics that prefer non-injectable options [51][52]. Other Important Information - The company has conducted extensive studies to ensure the safety and efficacy of ANNAFILM, including unique studies to assess its performance in various scenarios [23][40]. - The management emphasized the importance of transparency in their interactions with the FDA, which has been consistent and constructive throughout the review process [22][46]. Q&A Session Summary Question: What items would you say that you had in common with the Nefi product, and what are the key differences? - The company acknowledged similarities in the goal of helping patients but emphasized the unique aspects of their product and the thoroughness of their FDA submission process [16][18]. Question: How do you think about the time it takes to actually take the product compared to an EpiPen? - Management believes that the oral product will be used more quickly than an EpiPen due to behavioral factors and the convenience of not using a needle [36]. Question: What is the plan for ex-US markets? - The company is prioritizing outreach in Europe, Canada, and Japan, with plans to submit filings in these regions as they progress [60][62]. Question: Why should an investor own Aquestive now versus waiting for approval? - Management highlighted the momentum and readiness of the company for commercial launch, suggesting that now is an opportune time for investment [66]. Question: What is your DTC strategy and social media strategy? - The company plans to utilize social media for cost-effective marketing while reserving traditional DTC advertising for later stages of the product lifecycle [72][74].