PoZdroweek 4/2025: Prasad's nomination as FDA head for vaccines and gene therapy terrified investors

The biotechnology index from the American stock exchange NASDAQ collapsed almost 7% on Tuesday after information leaked to the market about the nomination of Vinay Prasad as the FDA director responsible for the vaccine and gene therapy segment. He has an approach, especially in the vaccine area, that most of science does not share. Poland was an oasis of peace in this context. WIGmed gained, and shareholders of Diagnostyka have reasons to be happy, whose share price set a record.

This week we had a two-vector healthcare sector. In Poland , WIGmed went up by 1.8% . This was not the case in the world and in Europe. There was a negative sentiment there, which resulted in a drop in the sector indices – the global MSCI World Health Care lost 2.5% , and its European counterpart MSCI Europe Health Care fell by 3.5% .

The result of the divergence in the direction of the behavior of these three indices was the growing advantage of the domestic WIGmed, which has gained almost 3% since the beginning of this year . Its foreign competitors at that time were sinking deeper and deeper into negative areas. This is most visible in the case of the global index, which recorded a loss of over 10%.

Source: TradingView

The group of those pledging allegiance to America is growing

Time is running out, and the great unknown is what the Republican administration led by President Donald Trump will finally decree regarding tariffs on the healthcare industry. The big players in the sector are racing against time, declaring new investments in the US every now and then. The goal of the efforts is clear - to placate the president so that he doesn't accidentally go off the deep end (and behind the scenes, there are increasingly intense whispers about differentiated import tariffs of 50-200% ).

According to calculations by politykazdrowia.com, by last week commitments from biopharmaceutical companies to invest in the United States amounting to approximately USD 170 billion had been put on the table - Johnson & Johnson (55), Roche (50), Eli Lilly (27), Novartis (23) and AbbVie (10).

This is already outdated. More than 70 billion dollars have been added to the pool. The latest to pledge allegiance to America on Wednesday was Gilead Sciences. The California giant from Foster City declared that it wants to invest up to 32 billion dollars in drug production in the US (a day earlier, Bristol Myers Squibb added 40 billion dollars to the general investment pool).

As a result, the healthcare sector wants to charm Trump with $240 billion , green on the pile of money that the industry intends to invest in the United States. And that's probably not the end of it, because although many of the giants of Big Pharma have already said their piece, some are still missing from this circle. We are talking about Merck, Pfizer, Amgen, Vertex Pharmaceuticals and Regeneron Pharmaceuticals, not to mention the corporations headquartered outside America.

According to our estimates, it is likely that the bidding war to encourage Trump to be lenient on tariffs will end at around $300 billion.

Prasad's nomination has terrified the healthcare industry

The NASDAQ biotech index fell 6.6% on Tuesday after Vinay Prasad was named director of the FDA's Center for Biologics Evaluation and Research (CBER), which is tasked with overseeing regulations for vaccines and gene therapy.

Vinay Prasad, a hematologist-oncologist and professor of epidemiology at the University of California, San Francisco, filled the vacancy left by CBER’s previous director, Peter Marks , who resigned in March. Marks’ resignation was mired in controversy as insider details about the decision emerged.

Peter Marks did not want to allow Department of Health and Human Services (HHS) officials to interfere with the FDA's database of measles vaccine-related deaths .

He believes HHS officials wanted to edit data on adverse events following vaccination. Why they wanted to do that remains a matter of speculation, some of which leads in troublesome directions for the administration.

The new CBER director has been a critic of many of the institution’s health care policies. He posted on X in March about Sarepta’s Elevidys gene therapy for Duchenne muscular dystrophy, which was approved on an accelerated schedule in 2023 based on data showing increased expression of microdystrophin. In his post, Prasad wrote about causing the death of a 16-year-old boy who was given Elevidys. Sarepta shares fell 26% Tuesday in response to the nomination, as investors fear the gene therapy’s approval could be challenged.

Moreover, the new head of CBER is not only concerned about the case of Elevidys – he has repeatedly criticized the approval of genetic medicine preparations via the accelerated approval path.

Vinay Prasad also spoke negatively about protective measures related to COVID-19. He was outraged by what he considered the wrong policies of the Centers for Disease Control and Prevention during the pandemic, because he did not like, among others, the recommendation to maintain a distance of 6 feet, wearing masks by small children, vaccination mandates, annual booster doses, failure to take into account natural immunity in health policy.

At the same time, the current head of CBER seemed to downplay the harmfulness of the COVID-19 infection in one of his posts on X, writing that it is now a cold.

As if that were not enough, the Association for Immunization Managers released a report in 2023 that found that Prasad, along with Marty Makary (current head of the entire FDA) and his assistant Tracy Beth Høeg, were the three largest purveyors of disinformation about pediatric COVID-19 vaccines.

The study noted that Prasad claimed that " vaccines are more dangerous to children than COVID-19 , even though he never treated children for COVID-19 and was not a pediatrician."

Investors are dismayed by Prasad's appointment because they now have to factor into their financial models that value many health care companies a new risk that FDA policies will not be based on evidence-based medicine alone.

And the scale of their terror can be clearly seen if you look at the infographic below, which shows the changes in the prices of shares of the leading twenty from the MSCI World Health Care index in the last week. The color red is striking, which clearly illustrates the significant declines in the prices of representatives of the world's health care.

Source: own study based on stooq.pl

Red did not dominate Polish stock exchange shares associated with the WIGmed index. Voxel (+9.1%), Captor Therapeutics (+8.7%) and Diagnostyka (+7.0%) had a successful week.

The third company in particular deserves closer attention. The share price of the national leader in traditional laboratory diagnostics has reached its maximum quotation (PLN 170).

Diagnostyka's securities were sold in a public offering at the turn of January and February 2025 at PLN 105 per share. The lucky ones who caught this price have reason to be happy. The price of the Krakow-based company is already over 60% higher , which is more than a decent profit in such a short time.

Source: own study based on stooq.pl

POLAND

Monday (5/5/2025)

- PolTREG has positively assessed the results from the in vivo part of the study conducted on animals using CAR-Tregs therapy. According to the company's management , the data are sufficient to apply for permission to conduct a phase I clinical trial in multiple sclerosis and amyotrophic lateral sclerosis using CAR-TREGS lymphocytes.

Tuesday (6.5.2025)

- Celon Pharma has concluded an agreement with the Medical Research Agency (ABM) to support the project "SimOn - increasing drug safety by developing a scalable production process for a biosimilar monoclonal antibody anti-PD-1 for use in cancer immunotherapy". ABM has granted funding in an amount not exceeding PLN 9.7 million (65% of total eligible costs) for the project worth nearly PLN 15 million. It is to be completed by the end of March 2026.

- PolTREG has received a positive opinion from the Paediatric Committee of the European Medicines Agency (PDCO) regarding the paediatric investigation plan for the development of a polyclonal Treg somatic cell therapy product for the indication of preventing symptomatic type 1 diabetes in children.

- President Andrzej Duda has vetoed the health insurance contribution act and has referred the regulation to the Sejm for reconsideration. Andrzej Domański, the Minister of Finance, commented on the matter, explaining on Friday on TVN that the government will return to this solution.

Wednesday (7.5.2025)

- NanoGroup has signed a letter of intent to acquire, directly or through another legal person, a block of shares in Auxilius Pharma by purchasing existing securities or taking up a new issue. Auxilius Pharma is developing AUX-001, a drug candidate based on nicorandil, which is to be used in the treatment of angina pectoris. NanoGroup did not provide more detailed information on the planned transaction, although it admitted that it is in talks with investors who would provide financing for the planned transaction.

Thursday (8.5.2025)

- The subsidiary Synektik will supply NH Hospital in the Czech Republic (for the Hořovice hospital) with a da Vinci robotic system along with an accompanying package - the net value of the contract is approximately USD 3.4 million.

Friday (9.5.2025)

- Medinice has concluded an agreement with the Board of the Mazowieckie Voivodeship to co-finance the AtriClamp project in the amount of PLN 8.7 million. The total cost of the project will amount to PLN 17.4 million. The aim of the project is to build a medical device for the prevention of strokes by performing a procedure to close the left atrial appendage of the heart. The initiative is to be completed by December 24, 2027.

- Genomtec has secured funds for over a year of operations and does not plan to issue shares. Miron Tokarski, CEO of the company, explained that the M&A process started in July 2023 is ongoing, and recently also on the Asian market.

- Bacteromic, a subsidiary of Scope Fluidics , has submitted a pre-submission to the US FDA for the Bacteromic System with Rapid UNI Panel under the 510(k) pathway.

WORLD

Monday (5/5/2025)

PTC Therapeutics said its Huntington's disease drug candidate PTC518 (votoplam) met its primary endpoint in a mid-stage trial, but the results appeared to disappoint investors as the company's shares fell nearly 19% on Monday. Investors likely believe PTC518 fell short of earlier promises that prompted Novartis to make an up-front payment of $1 billion late last year to participate in the drug's development.

Tuesday (6.5.2025)

- Donald Trump signed an executive order aimed at increasing U.S. prescription drug production by reducing regulatory hurdles related to building and approving new sites. The decision is expected to shorten the current time it takes to build additional manufacturing capacity from five years to 10 years.

The new presidential legislation also calls on the FDA to increase fees and inspections of foreign manufacturing facilities. According to Marty Makary, the agency’s commissioner, the change will involve moving from announced to surprise inspection visits to factories owned by foreign investors.

Wednesday (7.5.2025)

- Many investors could not believe their eyes when Novo Nordisk lowered its financial forecast for this year for the first time in 4 years . Lars Fruergaard Jørgensen, the company's CEO, noted that about 1/3 of the American obesity drug market had been "captured" by pharmacies, which "slowed down" the company's development.

In 2025, Novo Nordisk expects sales growth in the range of 13-21%, assuming a constant exchange rate of the Danish krone against other monetary units, although the company previously believed that it would achieve an improvement in this parameter in the range of 16-24%.

- Shionogi announced the acquisition of Torii Pharmaceutical, along with Japan Tobacco's pharmaceutical business, including its U.S. subsidiary Akros Pharma. The deal is valued at over 150 billion yen (about $1.1 billion) . As part of its 2030 strategy, Shionogi is focusing on developing drugs for infectious diseases.

Thanks to the acquisition, the company’s product portfolio will be enriched with the products of Torii Pharmaceutical (including skin and kidney diseases) and Japan Tobacco (immunology, inflammation, and disorders of the cardiovascular, renal, muscular and central nervous systems).

Thursday (8.5.2025)

- Takeda said sales and operating profit this year will be "broadly flat" compared with the previous 12-month period, impacted by recent significant sales headwinds related to its generic drug Vyvanse . Last year, profit was 107.9 billion yen, down 25% year-on-year.

The Japanese company expects revenue of 4.5 trillion yen ($31.7 billion), down from nearly 4.6 trillion yen in fiscal 2024. Takeda expects Vyvanse sales to fall about 30% this fiscal year to 241 billion yen, after falling nearly 22% in fiscal 2024 to 351 billion yen.

“ Takeda is currently at an inflection point , with multiple Phase III data readouts expected this fiscal year,” noted Milano Furuta, Takeda’s CFO.

In March, the company said the late-stage VERIFY study of rusfertide in patients with polycythemia vera had met its primary goal of developing marketing applications for the hepcidin mimetic peptide therapeutic. The company expects additional Phase III readouts for the oral orexin agonist in narcolepsy type 1 in the first half of 2025 and for the oral tyrosine kinase 2 (TYK2) inhibitor zasocitinib in the second half of this year.

- Teva plans to reduce its workforce by 8% as part of an effort to cut $700 million in operating costs and reach a goal of a 30% operating profit margin by 2027. That means cutting nearly 3,000 jobs at the company, which now has more than 36,000 employees. The cuts are part of Teva's plan to move from a generics-only business to a full-blooded biopharmaceutical company. The company did not say which Teva plants, scattered around the world, employees should feel unsafe. It only knows that the number of plants will drop from 35 to 30 by 2027.

- Insilico Medicines is making its third attempt at seeking public market capital. To that end, it has filed for an IPO on the Hong Kong Stock Exchange. Two months earlier, the company raised $110 million in a private placement to expand its portfolio of AI-designed medicines (that offering valued the company at more than $1 billion). The company disclosed late last year that ISM001-055, a small molecule, met its primary safety endpoint and key secondary efficacy measures in a Chinese Phase IIa study for idiopathic pulmonary fibrosis.

Insilico has 30 other drug candidates in development, including inflammatory bowel disease, solid tumors, obesity, and pain. The company previously tried unsuccessfully to conduct public offerings in 2023 and 2024.

Friday (9.5.2025)

AstraZeneca announced that the Phase III study of the PD-L1 inhibitor Imfinzi (durvalumab) in patients with high-risk non-muscle-muscle invasive bladder cancer met its primary endpoint of disease-free survival, without negatively impacting the survival benefits observed with Bacillus Calmette-Guérin induction and maintenance therapy.