Global Healthcare Analyst

Tina Banerjee

Thematic (Sector/Industry)

<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

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.

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<ul><li>Biopharma lagged as Trump’s pending pharma tariffs loom.</li><li>The 90-day pause in reciprocal tariffs was a short-lived reprieve for biopharma, as Trump later clarified pharma tariffs were not part of the pause.</li><li>After a second unvaccinated child died from measles (three deaths total), RFK Jr. endorsed the vaccine as the most effective way of prevention. </li></ul>

Biopharma lagged as Trump’s pending pharma tariffs loom.The 90-day pause in reciprocal tariffs was a short-lived reprieve for biopharma, as Trump later clarified pharma tariffs were not part of the pause.After a second unvaccinated child died from measles (three deaths total), RFK Jr. endorsed the vaccine as the most effective way of prevention. 

Biopharma Week in Review : Pharma Tariffs Overhang; Worrying Vaccine Comments from RFK Jr.

<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

<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

Research from ACF Equity Research, ACF Equity Research

ACF Equity Research

Research from ACF Equity Research

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ACF was set up to improve the effectiveness of capital markets for smaller and mid-sized companies. The majority of jobs are created by smaller companies not global companies. If we can help improve companies use of capital markets more projects will be completed, more jobs created, more global GDP grown, which in turn helps create more resources for education, leading to equality and opportunity for those who are still oppressed by ignorance and poverty.

ACF Equity Research is an independent research house specialising in the highest specification independent equity research for corporate clients.

We deliver premium independent corporate sponsored equity research characterised by its accuracy, clarity and foresight based upon a fundamental valuation approach.

Our independent research is designed to educate our professional investor readers about your company, with an emphasis on clear and accurate explanations. Our mission is to improve company’s liquidity through credible equity research services, excellent international distribution and reliable access for investment managers.

We believe in the importance and value of clarity, the careful articulation of technical ideas, concepts and solutions.

Our team of analysts are independently minded individuals who believe in thoroughness, technical competence and clear punchy communications.

<ul>
<li>Diabetes mellitus, Type 1 (T1D) and Type 2 (T2D, 85-90% of cases), is a USD ~75bn global therapy market.</li>
<li>Global economic costs of diabetes may exceed USD1 trn today and USD 450bn in the US, suggesting a pressing global health challenge.</li>
<li>Diabetes is a chronic metabolic disorder characterized by high blood sugar levels.</li>
</ul>


Diabetes mellitus, Type 1 (T1D) and Type 2 (T2D, 85-90% of cases), is a USD ~75bn global therapy market.
Global economic costs of diabetes may exceed USD1 trn today and USD 450bn in the US, suggesting a pressing global health challenge.
Diabetes is a chronic metabolic disorder characterized by high blood sugar levels.


ACF Thematic Research Regenerative Medicine Diabetes Treatment & Innovation 13032025

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)

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

Biopharma Week in Review : Pharma Tariffs Overhang; Worrying Vaccine Comments from RFK Jr.

The 90-day pause in reciprocal tariffs was a short-lived reprieve for biopharma, as Trump later clarified pharma tariffs were not part of the pa

Water Tower 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

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

ACF Thematic Research Regenerative Medicine Diabetes Treatment & Innovation 13032025

Global economic costs of diabetes may exceed USD1 trn today and USD 450bn in the US, suggesting a pressing global health challenge.

ACF Equity Research

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52-week Range

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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

Biopharma Week in Review : Pharma Tariffs Overhang; Worrying Vaccine Comments from RFK Jr.

The 90-day pause in reciprocal tariffs was a short-lived reprieve for biopharma, as Trump later clarified pharma tariffs were not part of the pa

Water Tower 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

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

ACF Thematic Research Regenerative Medicine Diabetes Treatment & Innovation 13032025

Global economic costs of diabetes may exceed USD1 trn today and USD 450bn in the US, suggesting a pressing global health challenge.

ACF Equity Research

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