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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>In a week of bad industry news, biopharma surprisingly held onto its bounce from recent two-year lows.</li><li>With pharma tariffs now expected by June and federal health agencies’ prospects looking worse, we may be close to peak negativity, but too much uncertainty remains for any confidence in a bottom.</li><li>In obesity, LLY had a win for an oral GLP-1, while PFE lost, affecting NVO, GPCR, VKTX, AMGN, MTSR, ALT, and TERN. VERV gained on CVD data and BMY’s heart drug failed, affecting CYTK and EWTX, while MURA stopped development.</li></ul>

In a week of bad industry news, biopharma surprisingly held onto its bounce from recent two-year lows.With pharma tariffs now expected by June and federal health agencies’ prospects looking worse, we may be close to peak negativity, but too much uncertainty remains for any confidence in a bottom.In obesity, LLY had a win for an oral GLP-1, while PFE lost, affecting NVO, GPCR, VKTX, AMGN, MTSR, ALT, and TERN. VERV gained on CVD data and BMY’s heart drug failed, affecting CYTK and EWTX, while MURA stopped development.

Biopharma Week in Review Shrugging Off Constant Bad News; LLY Winning Obesity Drug Race

Global Healthcare Analyst

Tina Banerjee

<ul>
<li>EMA’s human medicines committee (CHMP) recommended three new medicines for approval and adopted positive opinion for one generic medicine at its February 2025 meeting. </li>
<li>The committee recommended extending the therapeutic indications of 16 existing medicines, including two cystic fibrosis medicines, KAFTRIO and KALYDECO and oncology drugs CALQUENCE, DARZALEX, ENHERTU, and RINVOQ . </li>
<li>The CHMP concluded that its opinion recommending a marketing authorization for Eisai's Alzheimer’s disease drug Leqembi does not need to be updated.</li>
</ul>


EMA’s human medicines committee (CHMP) recommended three new medicines for approval and adopted positive opinion for one generic medicine at its February 2025 meeting. 
The committee recommended extending the therapeutic indications of 16 existing medicines, including two cystic fibrosis medicines, KAFTRIO and KALYDECO and oncology drugs CALQUENCE, DARZALEX, ENHERTU, and RINVOQ . 
The CHMP concluded that its opinion recommending a marketing authorization for Eisai's Alzheimer’s disease drug Leqembi does not need to be updated.


CHMP Meeting Update: 4 New Medicines Recommended For Approval, Reinstates Previous Leqembi Decision

Equity Bottom-Up

<ul>
<li>
<a href="https://www.smartkarma.com/entities/telix-pharmaceuticals-ltd" target="_blank" data-smartkarma-citation="entities:26052:1" rel="noopener">Telix Pharmaceuticals (TLX AU)</a> reported 1H26 revenue of $477M, up 22% YoY, driven by Precision Medicine, tracking in line with the upper end of full year guidance of $950–970M.</li>
<li>Pixclara, an investigational PET imaging agent for the characterization of recurrent or progressive glioma (brain cancer), has been granted a PDUFA goal date by the FDA of September 11, 2026.</li>
<li>With two‑product PSMA imaging strategy (Illuccix and Gozellix) differentiated clinical positioning, and expanding commercial presence globally, Telix is well-positioned for continued growth.</li>
</ul>



Telix Pharmaceuticals (TLX AU) reported 1H26 revenue of $477M, up 22% YoY, driven by Precision Medicine, tracking in line with the upper end of full year guidance of $950–970M.
Pixclara, an investigational PET imaging agent for the characterization of recurrent or progressive glioma (brain cancer), has been granted a PDUFA goal date by the FDA of September 11, 2026.
With two‑product PSMA imaging strategy (Illuccix and Gozellix) differentiated clinical positioning, and expanding commercial presence globally, Telix is well-positioned for continued growth.


Telix Pharmaceuticals (TLX AU): Stellar H1 Financial Performance; Eye on Upcoming Approval

<ul>
<li>In its January 2025 meeting, EMA’s human medicines committee (CHMP) recommended eight medicines for approval, including four innovative, three biosimilars, and one generic drugs.</li>
<li>The committee has also recommended extensions of indication for eight medicines that are already authorized in the EU.</li>
<li>Marketing applications for two medicines were withdrawn. Among them, withdrawal of Daiichi Sankyo’s datopotamab deruxtecan for non-squamous non-small cell lung cancer is noteworthy.</li>
</ul>


In its January 2025 meeting, EMA’s human medicines committee (CHMP) recommended eight medicines for approval, including four innovative, three biosimilars, and one generic drugs.
The committee has also recommended extensions of indication for eight medicines that are already authorized in the EU.
Marketing applications for two medicines were withdrawn. Among them, withdrawal of Daiichi Sankyo’s datopotamab deruxtecan for non-squamous non-small cell lung cancer is noteworthy.


CHMP Meeting Update: Eight New Medicines Recommended For Approval

<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, SGMO got an even faster FDA path for Fabry gene therapy, VKTX built more anticipation for upcoming oral <span style="font-size: var(--content-font-size);">GLP-1 data, and ITRM crossed the antibiotic finish line at last. </span></li><li>AMGN showed at-risk confidence with a favorable court ruling versus REGN, VRTX pain data was as expected, NVO’s oral GLP- 1 in diabetes also benefited CVD, and ZLAB was lifted by niche lung cancer data. </li></ul>

We review last week’s biopharma news for meaningful clinical data, regulatory updates, research innovation, and M&amp;A.Last week, SGMO got an even faster FDA path for Fabry gene therapy, VKTX built more anticipation for upcoming oral GLP-1 data, and ITRM crossed the antibiotic finish line at last. AMGN showed at-risk confidence with a favorable court ruling versus REGN, VRTX pain data was as expected, NVO’s oral GLP- 1 in diabetes also benefited CVD, and ZLAB was lifted by niche lung cancer data. 

Biopharma Week in Review - October 28, 2024

United States

Regeneron Pharmaceuticals, Inc. is a biopharmaceutical company that discovers, develops, and commercializes pharmaceutical products for the treatment of serious medical conditions. The Company has therapeutic candidates in clinical trials for the potential treatment of cancer, eye diseases, and inflammatory diseases, and has preclinical programs in other diseases and disorders.

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Regeneron Pharmaceuticals (REGN US)

Biopharma Week in Review Shrugging Off Constant Bad News; LLY Winning Obesity Drug Race

With pharma tariffs now expected by June and federal health agencies’ prospects looking worse, we may be close to peak negativity, but too much...

Water Tower Research

CHMP Meeting Update: 4 New Medicines Recommended For Approval, Reinstates Previous Leqembi Decision

EMA’s CHMP recommended three new and one generic medicines for approval at its February 2025 meeting. The committee concluded that its positive...

Tina Banerjee

Telix Pharmaceuticals (TLX AU): Stellar H1 Financial Performance; Eye on Upcoming Approval

Telix wins FDA approval for Pixclara, a radioactive diagnostic drug indicated for use with positron emission tomography for imaging gliomas (brain...

Tina Banerjee

CHMP Meeting Update: Eight New Medicines Recommended For Approval

In its January 2025 meeting, CHMP recommended 8 drugs for approval, including 4 innovative, 3 biosimilars, and 1 generic drugs. The committee has...

Tina Banerjee

Biopharma Week in Review - October 28, 2024

Last week, SGMO got an even faster FDA path for Fabry gene therapy, VKTX built more anticipation for upcoming oral GLP-1 data, and ITRM crossed the...

Water Tower Research

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