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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.

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<ul><li>We review last week’s biopharma news for meaningful clinical data, regulatory updates, research innovation, and M&amp;A.</li><li>Last week, ALDX completed the additional study needed to resubmit dry eye NDA.</li><li>Kidney disease drugs continue to benefit from regulatory tailwinds, as NVS gained IgAN approval and APLS succeeded in a pivotal biomarker study in C3G/IC- MPGN.</li></ul>

We review last week’s biopharma news for meaningful clinical data, regulatory updates, research innovation, and M&amp;A.Last week, ALDX completed the additional study needed to resubmit dry eye NDA.Kidney disease drugs continue to benefit from regulatory tailwinds, as NVS gained IgAN approval and APLS succeeded in a pivotal biomarker study in C3G/IC- MPGN.

Biopharma Week in Review - August 12, 2024

<ul><li>Last week, IONS matched Ultragenyx’s Angelman benefit, with maybe better safety.</li><li>PFE and SGMO had approvable gene therapy results in hemophilia A, but durability remains a question.</li><li>BIIB had a bad week, as SAGE-partnered essential tumor trial failed and ESAIY-partnered lecanemab in Alzheimer’s hit an EU regulatory wall. </li></ul>

Last week, IONS matched Ultragenyx’s Angelman benefit, with maybe better safety.PFE and SGMO had approvable gene therapy results in hemophilia A, but durability remains a question.BIIB had a bad week, as SAGE-partnered essential tumor trial failed and ESAIY-partnered lecanemab in Alzheimer’s hit an EU regulatory wall. 

<ul><li>We review last week’s biopharma news for meaningful clinical data, regulatory updates, research innovation, and M&amp;A.</li><li>Roche Holding Ltd. (RHHBY) reported initial Phase 1 data for oral GLP-1R agonist CT-996 in obesity patients, showing a 6.1% placebo-adjusted weight loss (p&lt;0.001) at four weeks.</li><li>While the weight loss compares favorably with approved injectables at four weeks (1-3% adjusted), the lack of details in the CT996 data, like baseline body weight, limits any cross-trial comparison. </li></ul>

We review last week’s biopharma news for meaningful clinical data, regulatory updates, research innovation, and M&amp;A.Roche Holding Ltd. (RHHBY) reported initial Phase 1 data for oral GLP-1R agonist CT-996 in obesity patients, showing a 6.1% placebo-adjusted weight loss (p&lt;0.001) at four weeks.While the weight loss compares favorably with approved injectables at four weeks (1-3% adjusted), the lack of details in the CT996 data, like baseline body weight, limits any cross-trial comparison. 

<ul><li>We review last week’s biopharma news for meaningful clinical data, regulatory updates, research innovation, and M&amp;A.</li><li>Morphic Holding, Inc. (MORF) agreed to be acquired by Eli Lilly and Co. (LLY) for $3.2 billion or $57/share in cash, with value primarily driven by lead drug MORF-057, an oral α4β7 integrin inhibitor, in Phase 2s for inflammatory bowel disease (IBD). MORF-057 looks to compete against injectable biologics in the large UC and Crohn’s markets, aiming for similar efficacy, better safety, and oral convenience.</li><li>Morphic’s novel drug shares the same target as Takeda’s Entyvio, a successful anti-α4β7 antibody. MORF was up 75% last Monday.</li></ul>

We review last week’s biopharma news for meaningful clinical data, regulatory updates, research innovation, and M&amp;A.Morphic Holding, Inc. (MORF) agreed to be acquired by Eli Lilly and Co. (LLY) for $3.2 billion or $57/share in cash, with value primarily driven by lead drug MORF-057, an oral α4β7 integrin inhibitor, in Phase 2s for inflammatory bowel disease (IBD). MORF-057 looks to compete against injectable biologics in the large UC and Crohn’s markets, aiming for similar efficacy, better safety, and oral convenience.Morphic’s novel drug shares the same target as Takeda’s Entyvio, a successful anti-α4β7 antibody. MORF was up 75% last Monday.

<ul><li>We review last week’s biopharma news for meaningful clinical data, regulatory updates, research innovation, and M&amp;A.</li><li>Eli Lilly and Company (LLY) received FDA approval for donanemab (Kisunla) in early Alzheimer’s, which was largely expected following unanimous support from the June AdComm and multiple delays.</li><li>The cost of Kisunla is $32K/year, which is at a premium to Leqembi (Biogen, Inc. [BIIB]/Eisai Co., Ltd. [ESAIY]) at $26.5K/year, but total cost per patient should be lower for Kisunla, as treatment can be stopped with amyloid clearance.</li></ul>

We review last week’s biopharma news for meaningful clinical data, regulatory updates, research innovation, and M&amp;A.Eli Lilly and Company (LLY) received FDA approval for donanemab (Kisunla) in early Alzheimer’s, which was largely expected following unanimous support from the June AdComm and multiple delays.The cost of Kisunla is $32K/year, which is at a premium to Leqembi (Biogen, Inc. [BIIB]/Eisai Co., Ltd. [ESAIY]) at $26.5K/year, but total cost per patient should be lower for Kisunla, as treatment can be stopped with amyloid clearance.

Denmark

Novo Nordisk A/S develops, produces, and markets pharmaceutical products. The Company focuses on diabetes care and offers insulin delivery systems and other diabetes products. Novo Nordisk also works in areas such as haemostatis management, growth disorders, and hormone replacement therapy. The Company offers educational and training materials. Novo Nordisk markets worldwide.

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Novo Nordisk (NVO US)

Biopharma Week in Review - August 12, 2024

We review last week’s biopharma news for meaningful clinical data, regulatory updates, research innovation, and M&A.

Water Tower Research

Biopharma Week in Review - Jul 29, 2024

Last week, IONS matched Ultragenyx’s Angelman benefit, with maybe better safety. PFE and SGMO had approvable gene therapy results in hemophilia A,...

Water Tower Research

Biopharma Week in Review - Jul 22, 2024

Roche Holding Ltd. (RHHBY) reported initial Phase 1 data for oral GLP-1R agonist CT-996 in obesity patients, showing a 6.1% placebo-adjusted weight...

Water Tower Research

Biopharma Week in Review - July 15, 2024

We review last week’s biopharma news for meaningful clinical data, regulatory updates, research innovation, and M&A.

Water Tower Research

Biopharma Week in Review - Jul 8, 2024

The cost of Kisunla is $32K/year, which is at a premium to Leqembi (Biogen, Inc. [BIIB]/Eisai Co., Ltd. [ESAIY]) at $26.5K/year, but total cost per...

Water Tower Research

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