Ensysce Biosciences Inc falls amid sector rotation
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jul 26 2024
0mins
Should l Buy ENSC?
Source: SeekingAlpha
Ensysce Biosciences Inc's stock price dropped by 19.92% in pre-market trading as it crossed below the 5-day SMA.
The decline occurred amid sector rotation, as the broader market showed mixed signals with the Nasdaq-100 slightly up and the S&P 500 down. This indicates that while some sectors are performing well, others, like Ensysce, are experiencing significant downward pressure.
Investors may be cautious as the stock's performance diverges from the overall market trend, suggesting a need for further analysis of the company's fundamentals and market position.
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Analyst Views on ENSC
About ENSC
Ensysce Biosciences, Inc. is a clinical-stage pharmaceutical company. The Company develops solutions for severe pain relief while reducing the potential for opioid misuse, abuse, and overdose. Its pipeline includes two new drug platforms: an abuse-resistant opioid prodrug technology, the Trypsin Activated Abuse Protection (TAAP) platform, and an over-dose protection opioid prodrug technology, the Multi-Pill Abuse Resistant (MPAR) platform. Its lead product, PF614, is a TAAP extended-release oxycodone and a potential analgesic to treat severe pain. Its second product, PF614-MPAR, is to treat severe pain with the added benefit of oral overdose protection, is a combination product of the TAAP prodrug PF614 with a trypsin inhibitor. Additionally, nafamostat, which is an ingredient in its overdose protection combination products, is also being developed for the intended purpose of treating infection and pulmonary lung diseases.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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- Significant Year-over-Year Growth: The company anticipates over 200% year-over-year growth in the current fiscal year, reflecting its competitive position in the industry and rapid market share expansion.
- Quarterly Growth Outlook: Credo also expects mid-single-digit sequential revenue growth to round out the year, suggesting continued strong performance in the coming months, which enhances investor confidence.
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- Technological Innovation: The application of MPAR® technology in Ensysce's opioids is expected to significantly reduce abuse potential and prevent overdose, enhancing patient safety without compromising pain relief, showcasing the transformative potential of its platforms.
- Market Expansion: This patent not only extends Ensysce's protection in North America and the EU but also strengthens its competitive position in the South American market, aiding the company's global strategy in the analgesic sector.
- Strategic Vision: Ensysce's CEO highlighted that this patent approval complements its recent patent for ADHD and opioid use disorder products, marking a significant step towards developing safer and more effective therapeutic options.
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- IP Expansion: The newly granted U.S. patent extends the protection for Ensysce's MPAR® overdose-prevention platform until 2042, strengthening the company's competitive moat in the field of safe opioid therapeutics.
- Regulatory Milestone: The FDA's endorsement of PF614's Chemistry, Manufacturing, and Controls strategy provides a clear pathway for commercial-scale production, reducing regulatory risks and enhancing the likelihood of successful approval.
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- Clinical Milestone: Ensysce Biosciences announced the enrollment of the first patient in the PF614 Phase 3 study, marking a significant step towards commercialization, which is expected to enhance its competitiveness in the safer opioid market.
- IP Expansion: The newly granted U.S. patent extends the protection of Ensysce's MPAR® overdose-prevention platform until 2042, strengthening the company's competitive moat in opioid safety and supporting its future market positioning.
- FDA Regulatory Milestone: The FDA's agreement on PF614's Chemistry, Manufacturing, and Controls strategy provides a clear pathway to commercial production, reducing regulatory risks and enhancing Ensysce's competitiveness at key clinical and regulatory inflection points.
- Financing Strengthens Capital: Ensysce closed a $4 million convertible preferred stock financing, with potential access to an additional $16 million, significantly enhancing the company's financial flexibility to support PF614's Phase 3 development and other initiatives.
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- Positive FDA Feedback: Ensysce Biosciences received written responses from the FDA confirming the appropriateness of its regulatory starting materials and specifications for PF614. This feedback provides Ensysce with a direct path to commercial production, marking a significant milestone in its drug development journey.
- Strengthened Partnerships: Ensysce is initiating commercial production of PF614 in collaboration with Purisys, LLC. This partnership will accelerate the market launch of the new analgesic, addressing the growing demand for safer pain relief options.
- Innovative Product Outlook: PF614 is Ensysce's TAAP™ oxycodone analogue and the leading product in its next-generation analgesic pipeline. Designed to provide safer pain relief while minimizing the risk of abuse and overdose, it holds significant market potential.
- Increased Executive Confidence: Ensysce CEO Dr. Lynn Kirkpatrick stated that the FDA's feedback enables the company to expedite PF614's market pathway, further solidifying its leadership in the analgesic market. This progress will help improve patient quality of life and meet the urgent market demand for safe pain medications.
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- Revenue Guidance Increase: Credo Technology expects to report revenue between $404 million and $408 million, significantly up from prior guidance of $335 million to $345 million, indicating strong market demand and business growth potential.
- Significant Year-over-Year Growth: The company anticipates over 200% year-over-year growth in the current fiscal year, reflecting its competitive position in the industry and rapid market share expansion.
- Quarterly Growth Outlook: Credo also expects mid-single-digit sequential revenue growth to round out the year, suggesting continued strong performance in the coming months, which enhances investor confidence.
- Positive Stock Reaction: In pre-market trading, Credo Technology shares jumped 17.4% to $144.87, reflecting market optimism regarding its financial outlook and potentially attracting more investor interest.
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- Patent Approval: Ensysce received a Notice of Allowance from the Brazilian Patent Office for its TAAP™ and MPAR® technologies applied to additional opioid families, further strengthening its intellectual property and supporting the global development of safer analgesics.
- Technological Innovation: The application of MPAR® technology in Ensysce's opioids is expected to significantly reduce abuse potential and prevent overdose, enhancing patient safety without compromising pain relief, showcasing the transformative potential of its platforms.
- Market Expansion: This patent not only extends Ensysce's protection in North America and the EU but also strengthens its competitive position in the South American market, aiding the company's global strategy in the analgesic sector.
- Strategic Vision: Ensysce's CEO highlighted that this patent approval complements its recent patent for ADHD and opioid use disorder products, marking a significant step towards developing safer and more effective therapeutic options.
See More
Ensysce Initiates PF614 Phase 3 Enrollment, Advancing Towards Commercialization
- Clinical Milestone: Ensysce Biosciences announced the enrollment of the first patient in the PF614 Phase 3 trial, marking a significant step towards commercialization and expected to enhance its competitive position in the safe opioid market.
- IP Expansion: The newly granted U.S. patent extends the protection for Ensysce's MPAR® overdose-prevention platform until 2042, strengthening the company's competitive moat in the field of safe opioid therapeutics.
- Regulatory Milestone: The FDA's endorsement of PF614's Chemistry, Manufacturing, and Controls strategy provides a clear pathway for commercial-scale production, reducing regulatory risks and enhancing the likelihood of successful approval.
- Capital Financing: Ensysce secured $4 million in convertible preferred stock financing, with the potential for an additional $16 million, significantly enhancing the company's financial flexibility as it advances the PF614 Phase 3 program.
See More
Ensysce Initiates PF614 Phase 3 Enrollment, Advancing Towards Commercialization
- Clinical Milestone: Ensysce Biosciences announced the enrollment of the first patient in the PF614 Phase 3 study, marking a significant step towards commercialization, which is expected to enhance its competitiveness in the safer opioid market.
- IP Expansion: The newly granted U.S. patent extends the protection of Ensysce's MPAR® overdose-prevention platform until 2042, strengthening the company's competitive moat in opioid safety and supporting its future market positioning.
- FDA Regulatory Milestone: The FDA's agreement on PF614's Chemistry, Manufacturing, and Controls strategy provides a clear pathway to commercial production, reducing regulatory risks and enhancing Ensysce's competitiveness at key clinical and regulatory inflection points.
- Financing Strengthens Capital: Ensysce closed a $4 million convertible preferred stock financing, with potential access to an additional $16 million, significantly enhancing the company's financial flexibility to support PF614's Phase 3 development and other initiatives.
See More
Ensysce Secures FDA Approval for PF614 Commercial Production Pathway
- Positive FDA Feedback: Ensysce Biosciences received written responses from the FDA confirming the appropriateness of its regulatory starting materials and specifications for PF614. This feedback provides Ensysce with a direct path to commercial production, marking a significant milestone in its drug development journey.
- Strengthened Partnerships: Ensysce is initiating commercial production of PF614 in collaboration with Purisys, LLC. This partnership will accelerate the market launch of the new analgesic, addressing the growing demand for safer pain relief options.
- Innovative Product Outlook: PF614 is Ensysce's TAAP™ oxycodone analogue and the leading product in its next-generation analgesic pipeline. Designed to provide safer pain relief while minimizing the risk of abuse and overdose, it holds significant market potential.
- Increased Executive Confidence: Ensysce CEO Dr. Lynn Kirkpatrick stated that the FDA's feedback enables the company to expedite PF614's market pathway, further solidifying its leadership in the analgesic market. This progress will help improve patient quality of life and meet the urgent market demand for safe pain medications.
See More
Ensysce Biosciences Under Review: Zacks Small-Cap Research Assigns $16.45 Price Target
Real-time Intelligence: Benzinga Pro offers traders the fastest news alerts to stay updated on market movements.
Exclusive Content: The platform provides exclusive stories and insights generated by Benzinga reporters for its users.
Community Engagement: Over 10,000 serious traders are part of the Benzinga Pro community, enhancing collaboration and information sharing.
Market Winning Tools: Benzinga Pro is designed to help traders gain an edge in the markets with accurate stock market intelligence.
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