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

<ul>
<li>FDA has confirmed the primary endpoints for Neuren Pharmaceuticals’ planned Phase 3 pivotal clinical trial of NNZ-2591 in Phelan-McDermid syndrome. Eisai has ultimately received its long-waited European approval for Leqembi.</li>
<li>Chugai Pharmaceutical’s outlicensed oral GLP-1 drug candidate orforglipron has shown positive topline Phase 3 results. Telix announced preliminary results from the Phase 2 study of TLX101 in recurrent high-grade glioma.</li>
<li>Biocon secured market entry date for Yesafili, an interchangeable biosimilar to Eylea in the U.S. FDA has issued Form 483 with 11 observations for Aurobindo Pharma’s North Carolina inhaler plant.</li>
</ul>


FDA has confirmed the primary endpoints for Neuren Pharmaceuticals’ planned Phase 3 pivotal clinical trial of NNZ-2591 in Phelan-McDermid syndrome. Eisai has ultimately received its long-waited European approval for Leqembi.
Chugai Pharmaceutical’s outlicensed oral GLP-1 drug candidate orforglipron has shown positive topline Phase 3 results. Telix announced preliminary results from the Phase 2 study of TLX101 in recurrent high-grade glioma.
Biocon secured market entry date for Yesafili, an interchangeable biosimilar to Eylea in the U.S. FDA has issued Form 483 with 11 observations for Aurobindo Pharma’s North Carolina inhaler plant.


APAC Healthcare Weekly (April 20)- Neuren, Chugai, Eisai, Telix, Biocon, Aurobindo Pharma

<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

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>After two rejections, Mesoblast has finally received FDA approval for its first drug. Celltrion has received FDA approval for its Stelara biosimilar, which will be launched in February 2025.</li>
<li>Peptidream has become eligible for a milestone payment. Sumitomo Pharma is strengthening R&amp;D for regenerative medicine and cell therapy business. Astellas Pharma in-licenses technology for developing neurology drugs.</li>
<li>Hansoh Pharmaceutical granted an exclusive global license to Merck for its pre-clinical drug candidate. Lupin received FDA approval to market generic version of blockbuster Descovy tablets.</li>
</ul>


After two rejections, Mesoblast has finally received FDA approval for its first drug. Celltrion has received FDA approval for its Stelara biosimilar, which will be launched in February 2025.
Peptidream has become eligible for a milestone payment. Sumitomo Pharma is strengthening R&amp;D for regenerative medicine and cell therapy business. Astellas Pharma in-licenses technology for developing neurology drugs.
Hansoh Pharmaceutical granted an exclusive global license to Merck for its pre-clinical drug candidate. Lupin received FDA approval to market generic version of blockbuster Descovy tablets.


APAC Healthcare Weekly (Dec 22)- Mesoblast, Celltrion, Peptidream, Astellas, Hansoh, Lupin

United States

Eli Lilly and Company discovers, develops, manufactures, and sells pharmaceutical products for humans and animals.  The Company's products are sold in countries around the world.  Eli Lilly's products include neuroscience products, endocrine products, anti-infectives, cardiovascular agents, oncology products, and animal health products.

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Eli Lilly & Co (LLY 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

APAC Healthcare Weekly (April 20)- Neuren, Chugai, Eisai, Telix, Biocon, Aurobindo Pharma

Neuren is a step closer to P3 trial in PMS. Chugai’s oral GLP-1 drug candidate shows promise in P3 trial. Eisai got Leqembi approval in EU. Biocon...

Tina Banerjee

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

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

APAC Healthcare Weekly (Dec 22)- Mesoblast, Celltrion, Peptidream, Astellas, Hansoh, Lupin

Mesoblast got FDA approval for its first drug, while Betta Pharma, Celltrion, and Lupin also received some major FDA approvals. Pharma companies...

Tina Banerjee

Price Gauge

52-week Range

Market Cap (USDm)

P/E

Dividend (Yield)

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

APAC Healthcare Weekly (April 20)- Neuren, Chugai, Eisai, Telix, Biocon, Aurobindo Pharma

Neuren is a step closer to P3 trial in PMS. Chugai’s oral GLP-1 drug candidate shows promise in P3 trial. Eisai got Leqembi approval in EU. Biocon...

Tina Banerjee

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

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

APAC Healthcare Weekly (Dec 22)- Mesoblast, Celltrion, Peptidream, Astellas, Hansoh, Lupin

Mesoblast got FDA approval for its first drug, while Betta Pharma, Celltrion, and Lupin also received some major FDA approvals. Pharma companies...

Tina Banerjee

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