Global Healthcare Analyst

Tina Banerjee

Equity Bottom-Up

<ul>
<li>
<a href="https://www.smartkarma.com/entities/nippon-shinyaku-co-ltd" target="_blank" data-smartkarma-citation="entities:6634:1" rel="noopener">Nippon Shinyaku (4516 JP)</a> and <a href="https://www.smartkarma.com/entities/capricor-therapeutics-inc" target="_blank" data-smartkarma-citation="entities:37671:1" rel="noopener">Capricor Therapeutics (CAPR US)</a> announced positive topline results from its pivotal Phase 3 HOPE-3 trial evaluating Deramiocel.  </li>
<li>Capricor plans to submit its response to the Complete Response Letter incorporating HOPE-3 data, following prior alignment with FDA.</li>
<li>The next big trigger for the stock would be the approval of Deramiocel and RGX-121 by FDA followed by their commercialization.</li>
</ul>



Nippon Shinyaku (4516 JP) and Capricor Therapeutics (CAPR US) announced positive topline results from its pivotal Phase 3 HOPE-3 trial evaluating Deramiocel.  
Capricor plans to submit its response to the Complete Response Letter incorporating HOPE-3 data, following prior alignment with FDA.
The next big trigger for the stock would be the approval of Deramiocel and RGX-121 by FDA followed by their commercialization.


Nippon Shinyaku (4516 JP): Deramiocel Data Positive, Approval and Commercialization Next Big Trigger

Thematic (Sector/Industry)

<ul>
<li>Simcere entered into license agreement with Vigonvita for new indications of Deuterated Remdesivir Hydrobromide. Kelun Biotech inked partnership with Crescent Biopharma to develop and commercialize oncology therapeutics, including novel combinations.</li>
<li>Samsung Biologics is acquiring land for third campus in Songdo, Icheon for KRW249B. SK Biopharmaceutical signed supply agreement with Eckert &amp; Ziegler for actinium-225 for the development of next-generation radiopharmaceutical.</li>
<li>Daiichi Sankyo won a court appeal for its long-running legal battle with Seagen. Biocon made settlement agreement with Amgen clearing commercialization path for its Denosumab biosimilars in Europe and RoW.</li>
</ul>


Simcere entered into license agreement with Vigonvita for new indications of Deuterated Remdesivir Hydrobromide. Kelun Biotech inked partnership with Crescent Biopharma to develop and commercialize oncology therapeutics, including novel combinations.
Samsung Biologics is acquiring land for third campus in Songdo, Icheon for KRW249B. SK Biopharmaceutical signed supply agreement with Eckert &amp; Ziegler for actinium-225 for the development of next-generation radiopharmaceutical.
Daiichi Sankyo won a court appeal for its long-running legal battle with Seagen. Biocon made settlement agreement with Amgen clearing commercialization path for its Denosumab biosimilars in Europe and RoW.


APAC Healthcare Weekly (December 7) – Simcere, Kelun Bio, Samsung Biologics, Daiichi Sankyo, Biocon

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>Biopharma was heavily pressured by the appointment of Dr. Vinay Prasad as the FDA’s Center for Biologics Evaluation and Research (CBER) head and concerns over Most-Favored-Nation (MFN) drug pricing.</li><li>The group is again wary of the FDA with Prasad overseeing the regulation of biologics, including vaccines, cell and gene therapies, and blood supply.</li><li>While not anti-vaccine, Prasad’s ideology is closer to RFK Jr. than former CBER head Peter Marks.</li></ul>

Biopharma was heavily pressured by the appointment of Dr. Vinay Prasad as the FDA’s Center for Biologics Evaluation and Research (CBER) head and concerns over Most-Favored-Nation (MFN) drug pricing.The group is again wary of the FDA with Prasad overseeing the regulation of biologics, including vaccines, cell and gene therapies, and blood supply.While not anti-vaccine, Prasad’s ideology is closer to RFK Jr. than former CBER head Peter Marks.

Biopharma Week in Review - New CBER Head and MFN Headlines Renew Prior Fears

<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>Last week, BMY received landmark antipsychotic approval, while BHVN finally scored a win in rare genetic SCA.</li>
<li>AMGN had approvable data in atopic dermatitis and gMG, but not enough to dethrone REGN and ARGX. </li>
</ul>


We review last week’s biopharma news for meaningful clinical data, regulatory updates, research innovation, and M&amp;A.
Last week, BMY received landmark antipsychotic approval, while BHVN finally scored a win in rare genetic SCA.
AMGN had approvable data in atopic dermatitis and gMG, but not enough to dethrone REGN and ARGX. 


Biopharma Week in Review - September 30, 2024

United States

Capricor Therapeutics, Inc. operates as a clinical stage biotechnology company. The Company focuses on the development and commercialization of biological therapies for the treatment of duchenne muscular dystrophy (DMD) and other rare disorders. Capricor Therapeutics serves healthcare sector in the United States and Canada.

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Capricor Therapeutics (CAPR US)

Nippon Shinyaku (4516 JP): Deramiocel Data Positive, Approval and Commercialization Next Big Trigger

Nippon Shinyaku and Capricor announce positive Phase 3 results for Deramiocel, with potential FDA approval and commercialization on the horizon....

Tina Banerjee

APAC Healthcare Weekly (December 7) – Simcere, Kelun Bio, Samsung Biologics, Daiichi Sankyo, Biocon

Simcere stuck license pact with Vigonvita. Kelun Bio inked partnership with Crescent Biopharma. Samsung Biologics is acquiring land for third...

Tina Banerjee

Biopharma Week in Review - New CBER Head and MFN Headlines Renew Prior Fears

Biopharma was heavily pressured by the appointment of Dr. Vinay Prasad as the FDA’s Center for Biologics Evaluation and Research (CBER) head and...

Water Tower Research

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 - September 30, 2024

We review last week’s biopharma news for meaningful clinical data, regulatory updates, research innovation, and M&A. Last week, BMY received...

Water Tower Research

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52-week Range

Market Cap (USDm)

P/E

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Nippon Shinyaku (4516 JP): Deramiocel Data Positive, Approval and Commercialization Next Big Trigger

​Nippon Shinyaku and Capricor announce positive Phase 3 results for Deramiocel, with potential FDA approval and commercialization on the horizon....

Tina Banerjee

APAC Healthcare Weekly (December 7) – Simcere, Kelun Bio, Samsung Biologics, Daiichi Sankyo, Biocon

Simcere stuck license pact with Vigonvita. Kelun Bio inked partnership with Crescent Biopharma. Samsung Biologics is acquiring land for third...

Tina Banerjee

Biopharma Week in Review - New CBER Head and MFN Headlines Renew Prior Fears

Biopharma was heavily pressured by the appointment of Dr. Vinay Prasad as the FDA’s Center for Biologics Evaluation and Research (CBER) head and...

Water Tower Research

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 - September 30, 2024

We review last week’s biopharma news for meaningful clinical data, regulatory updates, research innovation, and M&A. Last week, BMY received...

Water Tower Research

Nippon Shinyaku and Capricor announce positive Phase 3 results for Deramiocel, with potential FDA approval and commercialization on the horizon....