Research from Water Tower Research, Water Tower Research

Water Tower Research

Research from Water Tower Research

Water Tower Research is a leading equity research firm that provides research on micro, small and mid cap companies.

Water Tower Research was founded by Wall Street veterans after witnessing a fundamental shift in the investment research industry with the result being a declining knowledge base among investors, a lack of awareness and a shrinking pool of fundamental research being conducted on companies across the small-cap and micro-cap spectrum. The same issues are now increasingly occurring in the mid-cap space. This sea change within the investment community is impacting not only the companies themselves but also current shareholders and potential investors. With significantly less active sell-side sponsorship by Wall Street, a substantial information gap has developed between companies and various constituents in the financial community. The net result is fewer channels for insight and information to flow between companies and investors.

Equity Research Firm

Thematic (Sector/Industry)

<ul><li>Biotech fared better than pharma, as macro trends mostly favored growth stocks and LLY weakness pressured the large cap group.</li><li>M&amp;A activity also helped biotech, with NVS acquiring RLGS at a 108% premium and MKKGY buying SWTX after months of speculation.</li><li>Sentiment remained cautious among industry leaders, with another potential sign of regulatory disruption as the FDA missed Stealth’s (private) PDUFA date.</li></ul>

Biotech fared better than pharma, as macro trends mostly favored growth stocks and LLY weakness pressured the large cap group.M&amp;A activity also helped biotech, with NVS acquiring RLGS at a 108% premium and MKKGY buying SWTX after months of speculation.Sentiment remained cautious among industry leaders, with another potential sign of regulatory disruption as the FDA missed Stealth’s (private) PDUFA date.

Biopharma Week in Review - Macro and M&A Boost Biotech; NVO Moves to Slow LLY Obesity Lead

Research Coverage on Small and Micro-Cap Companies, Zacks Small Cap Research

Zacks Small Cap Research

Research Coverage on Small and Micro-Cap Companies

Zacks Small Cap Research provides research coverage on small- and micro-cap companies that are “under-followed” or “under-valued” by Wall Street. We produce high quality equity research for the institutional and retail investor on microcap firms we believe are well positioned for future growth. The Zacks SCR analyst team has an average of 20 years of experience in investment research. We conduct significant due diligence in an effort to maintain the highest quality small-cap universe.

Equity Bottom-Up

<ul><li>On November 14, 2024, Abeona Therapeutics, Inc. (ABEO) announced financial results for the third quarter of 2024 and provided a business update.</li><li>The company recently announced that the U.S. FDA has accepted the re-submission of the Biologics License Application (BLA) for pz-cel and set a PDUFA target action date of April 29, 2025.</li><li>The acceptance of the BLA by the FDA indicates that the resubmission includes all the necessary information that was found to be deficient in the original BLA filing and we are confident that the company has addressed all the issues identified in the CRL and the pre-license inspection.</li></ul>

On November 14, 2024, Abeona Therapeutics, Inc. (ABEO) announced financial results for the third quarter of 2024 and provided a business update.The company recently announced that the U.S. FDA has accepted the re-submission of the Biologics License Application (BLA) for pz-cel and set a PDUFA target action date of April 29, 2025.The acceptance of the BLA by the FDA indicates that the resubmission includes all the necessary information that was found to be deficient in the original BLA filing and we are confident that the company has addressed all the issues identified in the CRL and the pre-license inspection.

ABEO: FDA Accepts BLA Re-Submission for Pz-cel  PDUFA Date of April 29

<ul><li>On August 12, 2024, Abeona Therapeutics, Inc. (ABEO) announced financial results for the second quarter of 2024 and provided a business update.</li><li>The company recently completed a Type A meeting with the FDA in which data and reports addressing nearly all of the deficiencies cited in the complete response letter were shared and the FDA gave preliminary alignment pending formal review.</li><li>Two remaining outstanding items remain, however validation for those issues is currently ongoing under protocols that incorporate FDA feedback.</li></ul>

On August 12, 2024, Abeona Therapeutics, Inc. (ABEO) announced financial results for the second quarter of 2024 and provided a business update.The company recently completed a Type A meeting with the FDA in which data and reports addressing nearly all of the deficiencies cited in the complete response letter were shared and the FDA gave preliminary alignment pending formal review.Two remaining outstanding items remain, however validation for those issues is currently ongoing under protocols that incorporate FDA feedback.

ABEO: Type A Meeting with FDA Concluded  BLA Submission on Track for 2H24 

<ul><li>On May 15, 2024, Abeona Therapeutics, Inc. (ABEO) announced financial results for the first quarter of 2024 and provided a business update.</li><li>The company is planning to resubmit the Biologics License Application (BLA) for pz-cel for the treatment of patients with recessive dystrophic epidermolysis bullosa (RDEB) in the second half of 2024 following the receipt of a Complete Response Letter (CRL) in April 2024.</li><li>The CRL did not identify any deficiencies related to the clinical efficacy or clinical safety data but did request additional CMC information.</li></ul>

On May 15, 2024, Abeona Therapeutics, Inc. (ABEO) announced financial results for the first quarter of 2024 and provided a business update.The company is planning to resubmit the Biologics License Application (BLA) for pz-cel for the treatment of patients with recessive dystrophic epidermolysis bullosa (RDEB) in the second half of 2024 following the receipt of a Complete Response Letter (CRL) in April 2024.The CRL did not identify any deficiencies related to the clinical efficacy or clinical safety data but did request additional CMC information.

United States

Abeona Therapeutics Inc. is a leading clinical-stage biopharmaceutical company. The Company develops novel gene therapies for life-threatening rare diseases.

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Abeona Therapeutics (ABEO US)

Biopharma Week in Review - Macro and M&A Boost Biotech; NVO Moves to Slow LLY Obesity Lead

Biotech fared better than pharma, as macro trends mostly favored growth stocks and LLY weakness pressured the large cap group.

Water Tower Research

ABEO: FDA Accepts BLA Re-Submission for Pz-cel PDUFA Date of April 29

On November 14, 2024, Abeona Therapeutics, Inc. (ABEO) announced financial results for the third quarter of 2024 and provided a business...

Zacks Small Cap Research

ABEO: Type A Meeting with FDA Concluded BLA Submission on Track for 2H24

On August 12, 2024, Abeona Therapeutics, Inc. (ABEO) announced financial results for the second quarter of 2024 and provided a business...

Zacks Small Cap Research

ABEO: BLA Resubmission in 2H24

On May 15, 2024, Abeona Therapeutics, Inc. (ABEO) announced financial results for the first quarter of 2024 and provided a business update. The...

Zacks Small Cap Research

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