Global Healthcare Analyst

Tina Banerjee

Thematic (Sector/Industry)

<ul>
<li>CHMP has recommended five medicines for approval at its March 2025 meeting, including two innovative drugs and three biosimilars.</li>
<li>The Committee Recommended not granting a marketing authorization for Eli Lilly’s Kisunla (donasemab), a medicine intended for the treatment of early Alzheimer’s disease.</li>
<li>The committee recommended extensions of indication for seven medicines that are already authorized in the EU, while recommended to refuse extending the marketing authorisation for Pemazyre for myeloid/lymphoid neoplasms.</li>
</ul>


CHMP has recommended five medicines for approval at its March 2025 meeting, including two innovative drugs and three biosimilars.
The Committee Recommended not granting a marketing authorization for Eli Lilly’s Kisunla (donasemab), a medicine intended for the treatment of early Alzheimer’s disease.
The committee recommended extensions of indication for seven medicines that are already authorized in the EU, while recommended to refuse extending the marketing authorisation for Pemazyre for myeloid/lymphoid neoplasms.


CHMP Meeting Update: Five New Medicines Recommended for Approval, Rejects Kisunla Application

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

Equity Bottom-Up

<ul>
<li>In 4Q24, <a href="https://www.smartkarma.com/entities/beigene-ltd" target="_blank" data-smartkarma-citation="entities:27352:1" rel="noopener">BeiGene (6160 HK)</a> reported U.S. sales of Brukinsa of $616M, up 97% YoY and 22% QoQ, with 60%+ of demand growth coming from expanded use in CLL. </li>
<li>Brukinsa holds 25% market share in new patient starts in the U.S. in CLL, followed by Calquence (20%). For the first time, Brukinsa’s quarterly U.S. revenue outpaced that of Calquence.</li>
<li>Beigene has guided for 2025 revenue of $4.9–5.3B (up 29–39% YoY), driven by Brukinsa’s U.S. leadership position and continued global expansion in both Europe and other markets.</li>
</ul>


In 4Q24, BeiGene (6160 HK) reported U.S. sales of Brukinsa of $616M, up 97% YoY and 22% QoQ, with 60%+ of demand growth coming from expanded use in CLL. 
Brukinsa holds 25% market share in new patient starts in the U.S. in CLL, followed by Calquence (20%). For the first time, Brukinsa’s quarterly U.S. revenue outpaced that of Calquence.
Beigene has guided for 2025 revenue of $4.9–5.3B (up 29–39% YoY), driven by Brukinsa’s U.S. leadership position and continued global expansion in both Europe and other markets.


BeiGene (6160 HK): Brukinsa Outpaces Competitor in 4Q US Sales; Solid Guidance for 2025

Technical Analyst, Vermilion Research

Joe Jasper

Technical Analyst

Technical and Quantitative Research

Vermilion Research

Vermilion’s objective is to deliver timely, actionable, and unique technical research to professional investors through the application of our various technical indicators.

Our research strategists seek to highlight securities which we believe are at major inflection points, based on our various technical and quantitative indicators, and offer asymmetric risk/return profiles. Our unique research methodology, centered on relative strength, enables our strategists to deliver superior investment recommendations.

Our process begins by organizing the universe of actively traded stocks into discrete sectors, then into industry groups. We then apply our technical and quantitative tools to identify developing price trends. Once attractive trends are identified within a selected sector or group, we screen for individual stocks which we believe offer the best risk/reward profile. We provide a historical perspective that often reveals, through our long-term charts, how price patterns often repeat themselves over time.

Technical Analysis

<ul>
<li>Our long-term outlook remains bullish as long as the S&amp;P 500 remains above 5770-5850 and 5600-5670 (worst case), and we are buyers at these levels.</li>
<li>With that said, we see potential for near-term downside based on several developments discussed below.  It likely means at least another 2-4 weeks of consolidation</li>
<li>If SPX remains below 6100 and 6150 resistances, do not be surprised if there is a test of the bottom of the range at either 5770-5850 or 5600-5670</li>
</ul>


Our long-term outlook remains bullish as long as the S&amp;P 500 remains above 5770-5850 and 5600-5670 (worst case), and we are buyers at these levels.
With that said, we see potential for near-term downside based on several developments discussed below.  It likely means at least another 2-4 weeks of consolidation
If SPX remains below 6100 and 6150 resistances, do not be surprised if there is a test of the bottom of the range at either 5770-5850 or 5600-5670


Near-Term Downside Likely Following False Breakouts; Targeting 5770-5850; Long-Term Still Bullish

<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, PBMs were targeted by Congress, NAMS had a CV outcomes preview, and CADL showed prostate cancer benefit.</li><li>LLY partnered GLP-1 access with telehealth Ro and presented oral SERD data in breast cancer, rattling HIMS, LFMD, ARVN, and OLMA. </li></ul>

We review last week’s biopharma news for meaningful clinical data, regulatory updates, research innovation, and M&amp;A.Last week, PBMs were targeted by Congress, NAMS had a CV outcomes preview, and CADL showed prostate cancer benefit.LLY partnered GLP-1 access with telehealth Ro and presented oral SERD data in breast cancer, rattling HIMS, LFMD, ARVN, and OLMA. 

Biopharma Week in Review - December 16, 2024

United States

AbbVie Inc. researches and develops pharmaceutical products. The Company produces pharmaceutical drugs for specialty therapeutic areas such as immunology, chronic kidney disease, hepatitis C, women's health, oncology, and neuroscience. AbbVie also offers treatments for diseases including multiple sclerosis, parkinson's, and alzheimer's disease.

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AbbVie (ABBV UN)

CHMP Meeting Update: Five New Medicines Recommended for Approval, Rejects Kisunla Application

CHMP recommends approval for five medicines, but rejects marketing authorization for Eli Lilly's Kisunla for early Alzheimer's disease. It also...

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

BeiGene (6160 HK): Brukinsa Outpaces Competitor in 4Q US Sales; Solid Guidance for 2025

BeiGene's Brukinsa sees significant growth in U.S. sales, surpassing Calquence for the first time, with 60%+ demand growth from expanded use in...

Tina Banerjee

Near-Term Downside Likely Following False Breakouts; Targeting 5770-5850; Long-Term Still Bullish

Near-Term Downside Likely After False Breakouts $SPX $QQQ; Long-Term Still Bullish; Major Tops on $DXY, 10-Year Treasury Yield. If < 6100 and 6150...

Vermilion Research

Biopharma Week in Review - December 16, 2024

LLY partnered GLP-1 access with telehealth Ro and presented oral SERD data in breast cancer, rattling HIMS, LFMD, ARVN, and OLMA.

Water Tower Research

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52-week Range

Market Cap (USDm)

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CHMP Meeting Update: Five New Medicines Recommended for Approval, Rejects Kisunla Application

​CHMP recommends approval for five medicines, but rejects marketing authorization for Eli Lilly's Kisunla for early Alzheimer's disease. It also...

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

BeiGene (6160 HK): Brukinsa Outpaces Competitor in 4Q US Sales; Solid Guidance for 2025

​BeiGene's Brukinsa sees significant growth in U.S. sales, surpassing Calquence for the first time, with 60%+ demand growth from expanded use in...

Tina Banerjee

Near-Term Downside Likely Following False Breakouts; Targeting 5770-5850; Long-Term Still Bullish

Near-Term Downside Likely After False Breakouts $SPX $QQQ; Long-Term Still Bullish; Major Tops on $DXY, 10-Year Treasury Yield. If < 6100 and 6150...

Vermilion Research

Biopharma Week in Review - December 16, 2024

LLY partnered GLP-1 access with telehealth Ro and presented oral SERD data in breast cancer, rattling HIMS, LFMD, ARVN, and OLMA.

Water Tower Research

CHMP recommends approval for five medicines, but rejects marketing authorization for Eli Lilly's Kisunla for early Alzheimer's disease. It also...

BeiGene's Brukinsa sees significant growth in U.S. sales, surpassing Calquence for the first time, with 60%+ demand growth from expanded use in...