Global Healthcare Analyst

Tina Banerjee

Thematic (Sector/Industry)

<ul>
<li>Daiichi Sankyo received EU approval for Enhertu in breast cancer. Kaken Pharmaceutical in-licensed hereditary angioedema drug candidate sebetralstat for Japan from KalVista Pharmaceuticals for an upfront payment of $11M.</li>
<li>ABL Bio signed £2B+ outlicensing licensing deal with GSK to develop novel medicines for neurodegenerative diseases. Samsung Biologics launched Epysqli, a biosimilar referencing Soliris in the U.S.</li>
<li>U.S. court ruled in favor of Sun Pharma regarding the launch of alopecia areata drug Leqselvi. Mayne Pharma has been involved in a legal proceeding in U.S., brought by TherapeuticsMD.</li>
</ul>


Daiichi Sankyo received EU approval for Enhertu in breast cancer. Kaken Pharmaceutical in-licensed hereditary angioedema drug candidate sebetralstat for Japan from KalVista Pharmaceuticals for an upfront payment of $11M.
ABL Bio signed £2B+ outlicensing licensing deal with GSK to develop novel medicines for neurodegenerative diseases. Samsung Biologics launched Epysqli, a biosimilar referencing Soliris in the U.S.
U.S. court ruled in favor of Sun Pharma regarding the launch of alopecia areata drug Leqselvi. Mayne Pharma has been involved in a legal proceeding in U.S., brought by TherapeuticsMD.


APAC Healthcare Weekly (April 13)- Daiichi Sankyo, Kaken, ABL Bio, Samsung Biologics, Sun Pharma

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>Since late-February (2/25/25 Compass) we expected an 8-10% pullback to provide a buying opportunity. But that all changed in last week's Compass (4/1/25), when we downgraded our outlook to bearish/cautious.</li>
<li>A historic selloff has ensued and significant damage has been done as market dynamics have worsened.</li>
<li>Until we see some base-building process develop alongside improving market dynamics, we remain cautious and we continue to favor defensives as long as the SPX is below its 200-day MA.</li>
</ul>


Since late-February (2/25/25 Compass) we expected an 8-10% pullback to provide a buying opportunity. But that all changed in last week's Compass (4/1/25), when we downgraded our outlook to bearish/cautious.
A historic selloff has ensued and significant damage has been done as market dynamics have worsened.
Until we see some base-building process develop alongside improving market dynamics, we remain cautious and we continue to favor defensives as long as the SPX is below its 200-day MA.


S&P 500 and Nasdaq 100 Testing Prior 2022 Highs; Still Bearish and Cautious

<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

Equity Bottom-Up

<ul>
<li>
<a href="https://www.smartkarma.com/entities/hlb-life-science-co-ltd" target="_blank" data-smartkarma-citation="entities:9830:1" rel="noopener">HLB Life Science (067630 KS)</a> shares lost ~20% since March 20 to trade near five-year lows after a group company, Elevar Therapeutics faced setback regarding a new cancer drug application.</li>
<li>FDA has rejected Elevar’s new drug application of its lead proprietary drug candidate, rivoceranib in combination with camrelizumab as a therapy for advanced or metastatic hepatocellular carcinoma.</li>
<li>This is the second time that the FDA declined to approve the drug combo. Elevar plans to promptly supplement the trial result and apply for reapproval to the FDA.</li>
</ul>



HLB Life Science (067630 KS) shares lost ~20% since March 20 to trade near five-year lows after a group company, Elevar Therapeutics faced setback regarding a new cancer drug application.
FDA has rejected Elevar’s new drug application of its lead proprietary drug candidate, rivoceranib in combination with camrelizumab as a therapy for advanced or metastatic hepatocellular carcinoma.
This is the second time that the FDA declined to approve the drug combo. Elevar plans to promptly supplement the trial result and apply for reapproval to the FDA.


HLB Life Science (067630 KS): FDA Rejects Oncology Drug AGAIN; What Lies Ahead

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>Trump’s pick for CDC director, former Congressman Dave Weldon, had his nomination withdrawn just hours before the Senate committee hearing.</li><li>Weldon lacked sufficient support from Republicans to clear the committee, as he adhered to his anti-vaccine views more strongly than RFK Jr.</li><li>While vaccine makers (PFE, MRNA, BNTX, NVAX) rebounded briefly on the news, other federal actions kept the space under pressure, including the termination of NIH grants for research on vaccine hesitancy and uptake. </li></ul>

Trump’s pick for CDC director, former Congressman Dave Weldon, had his nomination withdrawn just hours before the Senate committee hearing.Weldon lacked sufficient support from Republicans to clear the committee, as he adhered to his anti-vaccine views more strongly than RFK Jr.While vaccine makers (PFE, MRNA, BNTX, NVAX) rebounded briefly on the news, other federal actions kept the space under pressure, including the termination of NIH grants for research on vaccine hesitancy and uptake. 

Biopharma Week in Review - March 17, 2025

United States

Bristol-Myers Squibb Company is a global biopharmaceutical company. The Company develops, licenses, manufactures, markets, and sells pharmaceutical and nutritional products. Bristol Myers Squibb focuses on products and experimental therapies address cancer, heart disease, HIV and AIDS, diabetes, rheumatoid arthritis, hepatitis, organ transplant rejection, and psychiatric disorders.

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Bristol-Myers Squibb (BMY UN)

APAC Healthcare Weekly (April 13)- Daiichi Sankyo, Kaken, ABL Bio, Samsung Biologics, Sun Pharma

Daiichi got EU approval for Enhertu. Kaken Pharma signed inlicensing deal, while ABL stuck outlicensing deal. Sun Pharma's Leqselvi is now free to...

Tina Banerjee

S&P 500 and Nasdaq 100 Testing Prior 2022 Highs; Still Bearish and Cautious

$SPX and Nasdaq 100 $QQQ Testing Prior 2022 Highs; Upgrading Health Care $XLV; Downgrading Transportation $IYT; Still Bearish and Cautious; Sell...

Vermilion Research

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

HLB Life Science (067630 KS): FDA Rejects Oncology Drug AGAIN; What Lies Ahead

HLB Life Science shares dropped 20% as group company Elevar Therapeutics faces setback with FDA rejecting new cancer drug application for...

Tina Banerjee

Biopharma Week in Review - March 17, 2025

Trump’s pick for CDC director, former Congressman Dave Weldon, had his nomination withdrawn just hours before the Senate committee hearing.

Water Tower Research

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APAC Healthcare Weekly (April 13)- Daiichi Sankyo, Kaken, ABL Bio, Samsung Biologics, Sun Pharma

Daiichi got EU approval for Enhertu. Kaken Pharma signed inlicensing deal, while ABL stuck outlicensing deal. Sun Pharma's Leqselvi is now free to...

Tina Banerjee

S&P 500 and Nasdaq 100 Testing Prior 2022 Highs; Still Bearish and Cautious

$SPX and Nasdaq 100 $QQQ Testing Prior 2022 Highs; Upgrading Health Care $XLV; Downgrading Transportation $IYT; Still Bearish and Cautious; Sell...

Vermilion Research

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

HLB Life Science (067630 KS): FDA Rejects Oncology Drug AGAIN; What Lies Ahead

​HLB Life Science shares dropped 20% as group company Elevar Therapeutics faces setback with FDA rejecting new cancer drug application for...

Tina Banerjee

Biopharma Week in Review - March 17, 2025

Trump’s pick for CDC director, former Congressman Dave Weldon, had his nomination withdrawn just hours before the Senate committee hearing.

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...

HLB Life Science shares dropped 20% as group company Elevar Therapeutics faces setback with FDA rejecting new cancer drug application for...