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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>Biopharma was heavily pressured by the appointment of Dr. Vinay Prasad as the FDA’s Center for Biologics Evaluation and Research (CBER) head and concerns over Most-Favored-Nation (MFN) drug pricing.</li><li>The group is again wary of the FDA with Prasad overseeing the regulation of biologics, including vaccines, cell and gene therapies, and blood supply.</li><li>While not anti-vaccine, Prasad’s ideology is closer to RFK Jr. than former CBER head Peter Marks.</li></ul>

Biopharma was heavily pressured by the appointment of Dr. Vinay Prasad as the FDA’s Center for Biologics Evaluation and Research (CBER) head and concerns over Most-Favored-Nation (MFN) drug pricing.The group is again wary of the FDA with Prasad overseeing the regulation of biologics, including vaccines, cell and gene therapies, and blood supply.While not anti-vaccine, Prasad’s ideology is closer to RFK Jr. than former CBER head Peter Marks.

Biopharma Week in Review - New CBER Head and MFN Headlines Renew Prior Fears

<ul><li>FDA Commissioner Martin Makary injected some regulatory optimism with his first public comments, advocating for accelerated drug approval pathways.</li><li>While biopharma headlines were a roller coaster, investors appeared ready to grasp any positive news, despite more signs of FDA dysfunction.</li><li>In an E&amp;Y report reviewed by Reuters, 25% pharma tariffs would increase drug costs by $51 billion, leading to either 12.9% higher prices or reductions in R&amp;D efforts and workforce. </li></ul>

FDA Commissioner Martin Makary injected some regulatory optimism with his first public comments, advocating for accelerated drug approval pathways.While biopharma headlines were a roller coaster, investors appeared ready to grasp any positive news, despite more signs of FDA dysfunction.In an E&amp;Y report reviewed by Reuters, 25% pharma tariffs would increase drug costs by $51 billion, leading to either 12.9% higher prices or reductions in R&amp;D efforts and workforce. 

Biopharma Week in Review: Makary Sparked FDA Optimism; Growing Pushback on HHS Changes

<ul><li>Academia was troubled last week by Trump’s broad pause on external communications from federal health agencies, disrupting study sections (NIH), public health publications (CDC), and treatment guidelines (FDA).</li><li>The pause remains in effect until February 1, which happens to be after RFK Jr.’s confirmation hearings for HHS secretary on January 29 and 30.</li><li>In industry news, NVO saw some redemption with positive amycretin obesity data, with a positive read-through for ZLDPF</li></ul>

Academia was troubled last week by Trump’s broad pause on external communications from federal health agencies, disrupting study sections (NIH), public health publications (CDC), and treatment guidelines (FDA).The pause remains in effect until February 1, which happens to be after RFK Jr.’s confirmation hearings for HHS secretary on January 29 and 30.In industry news, NVO saw some redemption with positive amycretin obesity data, with a positive read-through for ZLDPF

Biopharma Week in Review - January 27, 2025

<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, ADAP received the first TCR-T cell therapy approval in solid tumors. SNDX hit a minor regulatory speed bump, while VTVT got a clinical hold.</li><li>VTYX will move past Tyk2 after its Crohn’s failure. LLY succeeded in its heart failure trial with an obesity drug. </li></ul>

We review last week’s biopharma news for meaningful clinical data, regulatory updates, research innovation, and M&amp;A.Last week, ADAP received the first TCR-T cell therapy approval in solid tumors. SNDX hit a minor regulatory speed bump, while VTVT got a clinical hold.VTYX will move past Tyk2 after its Crohn’s failure. LLY succeeded in its heart failure trial with an obesity drug. 

United States

ALX Oncology Holdings Inc. operates as a clinical stage immuno-oncology company. The Company focuses on helping patients fight cancer by developing therapies that bridge the innate and adaptive immune system. ALX Oncology Holdings serves patients in the State of California.

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ALX Oncology Holdings (ALXO US)

Biopharma Week in Review - New CBER Head and MFN Headlines Renew Prior Fears

Biopharma was heavily pressured by the appointment of Dr. Vinay Prasad as the FDA’s Center for Biologics Evaluation and Research (CBER) head and...

Water Tower Research

Biopharma Week in Review: Makary Sparked FDA Optimism; Growing Pushback on HHS Changes

FDA Commissioner Martin Makary injected some regulatory optimism with his first public comments, advocating for accelerated drug approval pathways.

Water Tower Research

Biopharma Week in Review - January 27, 2025

Academia was troubled last week by Trump’s broad pause on external communications from federal health agencies, disrupting study sections (NIH),...

Water Tower Research

Biopharma Week in Review

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

Water Tower Research

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52-week Range

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