Global Healthcare Analyst

Tina Banerjee

Thematic (Sector/Industry)

<ul>
<li>EMA’s human medicines committee (CHMP) recommended sixteen medicines for approval at its April 2025 meeting. CHMP also adopted positive opinion for nine biosimilar medicines.</li>
<li>Among the new medicines, Vertex’s triple combination cystic fibrosis drug Alyftrek, Amgen’s Thyroid eye disease drug Tepezza, and Jazz Pharmaceutical’s billiary tract cancer drug Ziihera have potential to become blockbusters.</li>
<li>The Agency has recommended the refusal of the marketing authorization for Eli Lilly’s Alzheimer’s Disease drug Kisunla. Eli Lilly may ask for a re-examination of the opinion within 15 days.</li>
</ul>


EMA’s human medicines committee (CHMP) recommended sixteen medicines for approval at its April 2025 meeting. CHMP also adopted positive opinion for nine biosimilar medicines.
Among the new medicines, Vertex’s triple combination cystic fibrosis drug Alyftrek, Amgen’s Thyroid eye disease drug Tepezza, and Jazz Pharmaceutical’s billiary tract cancer drug Ziihera have potential to become blockbusters.
The Agency has recommended the refusal of the marketing authorization for Eli Lilly’s Alzheimer’s Disease drug Kisunla. Eli Lilly may ask for a re-examination of the opinion within 15 days.


CHMP Meeting Update April 2025: Sixteen New Medicines Recommended For Approval

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

<ul><li>Market uncertainty and further disruptions at health agencies led to continued divergence between SMID-cap and large biopharma, as investors sought shelter in lower- <span style="font-size: var(--content-font-size);">risk, higher-quality names. </span></li><li><span style="font-size: var(--content-font-size);">Trump nominees, Martin Makary for </span>the FDA and Jay Bhattacharya for the NIH, appeared on course for Senate confirmations after relatively uncontentious hearings, but both provided little confidence that they would stop or reverse the draconian changes at these agencies.</li><li>NIH grant funding has not resumed despite a judge ruling against the cuts. RFK Jr. changed his stance on the measles outbreak, from not unusual to deeply concerned, as the second death occurred in an unvaccinated adult.</li></ul>

Market uncertainty and further disruptions at health agencies led to continued divergence between SMID-cap and large biopharma, as investors sought shelter in lower- risk, higher-quality names. Trump nominees, Martin Makary for the FDA and Jay Bhattacharya for the NIH, appeared on course for Senate confirmations after relatively uncontentious hearings, but both provided little confidence that they would stop or reverse the draconian changes at these agencies.NIH grant funding has not resumed despite a judge ruling against the cuts. RFK Jr. changed his stance on the measles outbreak, from not unusual to deeply concerned, as the second death occurred in an unvaccinated adult.

Biopharma Week in Review - March 10, 2025

<ul><li>We review last week’s biopharma news for meaningful clinical data, regulatory updates, research innovation, and M&amp;A.</li><li>The short holiday week saw another controversial name picked for NIH head, PSTX was acquired by RHHBY, AMGN underwhelmed with obesity data, and Medicare proposed to cover LLY and NVO obesity drugs.</li><li>In addition, SRPT filled its pipeline with ARWR assets, BHVN’s poor SMA results benefited SRRK, and MRK expanded its PAH drug benefit.</li></ul>

We review last week’s biopharma news for meaningful clinical data, regulatory updates, research innovation, and M&amp;A.The short holiday week saw another controversial name picked for NIH head, PSTX was acquired by RHHBY, AMGN underwhelmed with obesity data, and Medicare proposed to cover LLY and NVO obesity drugs.In addition, SRPT filled its pipeline with ARWR assets, BHVN’s poor SMA results benefited SRRK, and MRK expanded its PAH drug benefit.

Biopharma Week in Review - December 2, 2024

<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, the CDC and CMS picks aligned with President- elect Donald Trump’s agenda, while the FDA choice felt like a compromise.</li><li>NTLA had competitive biomarker data in ATTR-CM but was still behind ALNY and BBIO (approved late Friday). </li></ul>

We review last week’s biopharma news for meaningful clinical data, regulatory updates, research innovation, and M&amp;A.Last week, the CDC and CMS picks aligned with President- elect Donald Trump’s agenda, while the FDA choice felt like a compromise.NTLA had competitive biomarker data in ATTR-CM but was still behind ALNY and BBIO (approved late Friday). 

Biopharma Week in Review - November 25, 2024

Independent research on the U.S. markets, Baptista Research

Baptista Research

Independent research on the U.S. markets

Baptista Research is an independent financial research house focused on the U.S. markets. We provide equity research as well as credit research reports on the top-listed U.S. companies with most of our focus on technology, consumer goods and services, automobiles, industrials, oil and gas, pharma, and healthcare. Our research has served more than 3000 institutional investors including mutual funds, hedge funds, banks, family offices, and various buy-side firms. We operate a research subscription service where institutions, as well as retail investors, can have priority access to all our research. We also have a wide distribution of our research reports across some of the top global financial platforms. Apart from equity research and credit research, we also provide advisory services with respect to mergers & acquisitions (M&A), private equity/ venture capital fundraising, valuation reports, and investment management services for corporates.
Baptista Research is owned and managed by Ishan Majumdar, an ex-Venture Capitalist/ Investment Banker, a Chartered Accountant, and a Masters’ degree holder in Management from HEC Paris. Ishan has nearly a decade of experience in Mergers and Acquisitions, Leveraged Buyouts (LBOs), Venture Capital Investing, Corporate Strategy, and Valuation in front-office roles at the likes of BNP Paribas CIB, Credit Agricole CIB, Groupe Danone, and TIW Private Equity. He has worked on and closed multiple acquisition deals, leveraged buyouts, and start-up investment transactions.

Equity Bottom-Up

<ul><li>Jazz Pharmaceuticals recently reported its third quarter 2024 financial results, reflecting a period of noteworthy commercial growth and strategic progression, particularly in its neuroscience and oncology business units.</li><li>The company recorded a total revenue exceeding $1.05 billion, a 9% increase compared to the same quarter in 2023.</li><li>This growth was primarily fueled by the continued strong performance of Xywav and Epidiolex in the neuroscience segment, with both products achieving record quarterly sales and double-digit year-over-year growth.</li></ul>

Jazz Pharmaceuticals recently reported its third quarter 2024 financial results, reflecting a period of noteworthy commercial growth and strategic progression, particularly in its neuroscience and oncology business units.The company recorded a total revenue exceeding $1.05 billion, a 9% increase compared to the same quarter in 2023.This growth was primarily fueled by the continued strong performance of Xywav and Epidiolex in the neuroscience segment, with both products achieving record quarterly sales and double-digit year-over-year growth.

Jazz Pharmaceuticals Plc: Its Efforts Towards Zepzelca Frontline Therapy Expansion & Other Major Drivers

Ireland

Jazz Pharmaceuticals plc is a specialty biopharmaceutical company focused on improving patients' lives by identifying, developing and commercializing innovative products that address unmet medical needs. The company has a diverse portfolio of products in the areas of narcolepsy, oncology, pain and psychiatry.

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Jazz Pharmaceuticals (JAZZ US)

CHMP Meeting Update April 2025: Sixteen New Medicines Recommended For Approval

Among the new medicines, Vertex’s triple combination CF drug Alyftrek, Amgen’s Thyroid eye disease drug Tepezza, and Jazz Pharmaceutical’s cancer...

Tina Banerjee

Biopharma Week in Review - March 10, 2025

Market uncertainty and further disruptions at health agencies led to continued divergence between SMID-cap and large biopharma, as investors sought...

Water Tower Research

Biopharma Week in Review - December 2, 2024

The short holiday week saw another controversial name picked for NIH head, PSTX was acquired by RHHBY, AMGN underwhelmed with obesity data

Water Tower Research

Biopharma Week in Review - November 25, 2024

Last week, the CDC and CMS picks aligned with President- elect Donald Trump’s agenda, while the FDA choice felt like a compromise.

Water Tower Research

Jazz Pharmaceuticals Plc: Its Efforts Towards Zepzelca Frontline Therapy Expansion & Other Major Drivers

Jazz Pharmaceuticals recently reported its third quarter 2024 financial results, reflecting a period of noteworthy commercial growth and strategic...

Baptista Research

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