LET’S START WITH EVENTS OF THE DEPARTURE OF DR. PETER MARKS.

Dr. Marty Makary, a surgeon and public policy researcher at Johns Hopkins University, is to lead the U.S. Food and Drug Administration (FDA) as appointed by President Donald Trump.

Dr. Makary is known for his criticism of certain public health measures, especially during the pandemic. His choice most certainly or likely wouldn’t be Dr. Mark Peter’s who in fact just resigned from the FDA Vaccines Advisory Committee.

The department must continue and has currently established Dr. Benjamin Huffman, with the permanent director of FDA’s Center for Biologics Evaluation and Research Office of Therapeutics Products is slated as Dr. Nicole Verdun, MD.

We believe if Dr. Nicole Verdun is in the same mindset of total transparency and good medical science, she should be completely accepted by Robert F. Kennedy Jr. and Dr. Marty Makary. This further brings more focus towards efficiency and efforts out of John Hopkins Dr. Stephen Gould, who developed the game changing delivery system, through its trademark of StealthX™ completely owned for full licensing by Capricor Therapeutics, Inc., for the eventual novel direct deliveries of vaccines, cancer treatments, and the list can become endless if you read the pear reviewed submissions both by Dr. Stephen Gould and Capricor respectively stated. 

We tend to believe because of the current submitted BLA, the FDA has their sights on the marvel of biology being introduced. We believe because of these interactions with the FDA Commissioner and the other directors of the FDA, HHS of Robert F. Kennedy Jr. will find the StealthX™ delivery the true eventual winner in delivering biological payloads without harming the patients eventually receiving such treatments, vaccines, or cures due to the exosomes prolific use as the HHS along with CBER and the FDA will be hyper focused on the proprietary technology being developed by biotech companies like Capricor Therapeutics, Inc. (CAPR)?

WHAT CAN MARKETS AND VACCINE DEVELOPMENT LOOK LIKE MOVING FORWARD INTO THE REST OF 2025, THROUGH 2028?

FDA Advisory Committee Shakeup and Implications for Capricor Therapeutics are very positive moving forward (2025–2028)

The actual resignation of Dr. Mark Peter and Leadership Changes at FDA are a net positive for CAPR, MESO, CYDY as we are linking to these stock symbols, direct extensive analysis and research on why these are in the Derisked stocks to own by retail investors or institutional investors. The data on these biotech companies is quite compelling.

Putting the final touches of dotting the I’s and crossing the T’s we all learned of the departure in late March 2025, Dr. Peter Marks – the FDA’s top vaccine regulator – as he resigned under what is believed as pressure from new Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. (The question refers to “Dr. Mark Peter,” which appears to mean Dr. Peter Marks, as he led the FDA’s vaccines program.)

Marks’s resignation letter criticized HHS leadership for demanding “subservient confirmation of… misinformation and or lies” instead of “truth and transparency”. His departure was effectively a firing for refusing to bend to Kennedy’s anti-vaccine stance as to be believed. Public health experts like Dr. Paul Offit lamented that removing Marks let “the fox guard the hen house” in vaccine regulation. Former FDA officials warned that this should “frighten anyone committed to… evidence to guide policies” but the CBER structure is still quite functional and operational as pointed out above in this article.

The Likely Replacement: As of early April 2025, a permanent successor to Dr. Marks has been announced in had not been announced in a subtle way. In the interim, FDA’s Center for Biologics Evaluation and Research (CBER) is likely being led by an acting director (potentially Marks’s deputy) who happens to be Dr. Benjamin Huffman, However, given HHS Secretary Kennedy’s influence, the eventual appointee is expected to align with his calls for “restoring science to its golden standard” and “radical transparency” which again, we direct you to Dr. Dr. Nicole Verdun MD.,

In practice, this suggests the new FDA biologics chief will be someone Kennedy trusts to scrutinize vaccines more skeptically. Some observers have speculated that individuals sympathetic to vaccine-safety skeptics or with an outsider perspective could be tapped, although FDA may also elevate an internal candidate who is amenable to the new HHS agenda. The FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) – the independent panel that reviews vaccine approvals – has already seen its activities curtailed under Kennedy. Notably, scheduled meetings of vaccine advisory committees were postponed or canceled in early 2025. For example, a March 13 VRBPAC meeting on seasonal flu vaccine strains was abruptly canceled by HHS. This unusual pause in advisory oversight hints that the new FDA leadership may rely less on external expert panels, at least temporarily but build upon golden standards and the restoration of good science (p-values).

Policy Shift Under New Leadership: If the new appointee shares Kennedy’s skepticism, vaccine policy could become more conservative. Kennedy has a long history of questioning vaccine safety and even announced plans to “reshape” federal health agencies, including cutting thousands of staff and consolidating FDA functions under HHS. Early moves have alarmed experts: NIH terminated some vaccine research programs, but we believe the current research program using Capricor StealthX™ is still moving ahead, and a known benefits of such novel technology, can rid the vaccine hypocrisy critic to study a debunked vaccines-autism link to not involve the delivery systems. Under this climate, FDA may slow-roll new vaccine approvals or subject them to extra scrutiny which is fine for Companies like Capricor Therapeutics. The strength of the Trump Card when President Trump tells Robert F. Kennedy what’s on the schedule for his ultimate health care delivery policies is all that matters, but it will give the actual independent voices a greater voice and not be sidelined: The incoming FDA biologics head will have wide latitude to convene (or cancel) advisory committee meetings and set evidence requirements, this is seen currently as a net positive. In though Senate testimony, Dr. Mark McClellan (former FDA Commissioner) noted that Marks’s science-driven approach had enabled lifesaving technologies like gene therapies and COVID vaccines driven by President Donald Trump war he in-acted on The China Virus (Covid-19). We believe if history reflects any measure of who’s really guiding the aircraft carrier of the HHS, it’s not completely being stirred by Robert F. Kennedy Jr. We believe that a more successor to Dr. Peter Mark’s could prioritize novel innovations as believed and are supported by the incoming FDA director Dr. Marty Makary. Indeed, Secretary Kennedy signaled he would “scrutinize the safety of childhood vaccinations” and ensure the science is reviewed, some think despite decades of evidence of safety that is currently being stressed by Robert F. Kennedy Jr., implying a possible shift toward caution or delay in authorizing of new vaccine platforms until all the players are installed or in place.

Implications for Capricor Therapeutics: Capricor Therapeutics, Inc. – a small biotech specializing in cell and exosome-based therapies – finds itself at the crossroads of this policy shift but in a good way. Capricor’s pipeline includes a novel COVID-19 vaccine platform and regenerative therapies using the StealthX™ (see Capricor Pipeline table below). The new FDA leadership’s stance will directly lock on to this novel delivery strategy leaving a net positive effect on companies like Capricor (CAPR), MesoBlast (MESO), and Cytodyn (CYDY) in these platforms or programs:

• Vaccine Oversight: Capricor’s exosome-based COVID-19 vaccine (a next-generation vesicle vaccine) is still preclinical, but eventually because of their current BLA status going forward for approval on August 31, 2025, it would shed greater relationship between the FDA directors and their potential approval and VRBPAC review. If Kennedy’s FDA is less enthusiastic about non-proven even though they received emergency approval by the FDA back during the pandemic, those are the vaccines under further scrutiny moving forward, and not like Capricor’s StealthX™ that easily move ahead in having an easier road could initiate trials or receive Emergency Use Authorization. Moreover, this vaccine program is in partnership with the National Institute of Allergy and Infectious Diseases (NIAID). With NIH vaccine research funding being pulled back under the new regime, Capricor’s NIAID-supported work is currently still underway, but might experience stop and starts in that these can cause momentum changes or funding to be at risk. In short, an FDA leadership remains skeptical on the old vaccines but is somewhat positive on the newest upcoming innovative vaccines which will increase and not delay Capricor’s entry into the clinic for its exosome vaccine delivery programs.

• Therapeutic Approvals are very positive: Capricor’s lead candidate deramiocel (CAP-1002) – an allogeneic cell therapy for Duchenne muscular dystrophy (DMD) – might benefit from certain aspects of the new leadership. Especially with Dr. Marty Makary. While Kennedy is anti-vaccine, he has not opposed cell or gene therapies per se. Additionally, President Trump’s administration (under which Kennedy serves) has emphasized speeding treatments for serious diseases.

The new FDA Commissioner nominee, Dr. Marty Makary, indicated he wants to “expedite… treatments for serious conditions, such as DMD,” while still maintaining rigorous science. If Makary and the FDA leadership prioritize cures for rare diseases, Capricor’s DMD therapy could see continued support. Notably, Capricor’s BLA (Biologics License Application) for deramiocel was accepted in early 2025 and granted Priority Review with an FDA target decision date of August 31, 2025. This review is already underway, meaning career scientists at FDA are evaluating the data on its merits. Unless the new appointee intervenes unusually, deramiocel’s review should proceed on schedule. However, advisory input could be a factor – the FDA might convene a panel (likely the Cell, Tissue, and Gene Therapies Advisory Committee) to discuss this first-in-class DMD cell therapy. A supportive FDA leader could greenlight the therapy if data are strong, whereas a more cautious one could delay approval pending further evidence.

In summary, the shakeup in FDA’s vaccines leadership introduces uncertainty: vaccine innovations may face headwinds, while non-vaccine biologics like Capricor’s cell therapy may still advance, especially with champions of accelerated approval like Dr. Makary taking the helm. The following table summarizes Capricor’s pipeline and how each program intersects with FDA regulatory considerations:

Capricor Therapeutics Pipeline Overview

Capricor Therapeutics (NASDAQ: CAPR) is a California-based biotech focused on cell therapies and exosome-based therapeutics for devastating diseases. Its pipeline spans a late-stage cell therapy for Duchenne muscular dystrophy and early-stage programs leveraging exosome nanoparticles for vaccines and drug delivery. Table 1 outlines Capricor’s key pipeline candidates, their development status, and their relevance to FDA advisory decisions:

Table 1: Capricor Therapeutics pipeline (2025) – development status and regulatory considerations. Capricor’s programs range from late-stage DMD therapy to innovative exosome-based products. FDA advisory committees (for vaccines or cell/gene therapies) are expected to play a role in evaluating these, although recent leadership changes have temporarily disrupted the normal advisory process.

Sources: Capricor Therapeutics pipeline data; FDA filings and designations; NIH partnership info; industry expert commentary.

DR. MATRY MAKARY PERSPECTIVE ON CAPRICOR TECHNOLOGIES, INC.

Dr. Marty Makary, a Johns Hopkins surgeon and health policy researcher, has been nominated as the New FDA Commissioner and is expected to be confirmed. While Dr. Makary has not publicly commented on Capricor Therapeutics by name, his record of commentary on vaccines and innovative therapies provides insight into how he might view Capricor’s pipeline:

• Views on Vaccine Development: Makary has been a vocal critic of certain public health decisions during the COVID-19 pandemic. He “opposed vaccine mandates for the general public” and emphasized the benefits of natural immunity. He also argued that the FDA’s advisory committees often “rubber-stamped” decisions, such as annual flu shot strain selections, without robust debate. During his Senate confirmation hearing, senators pressed him on the cancellation of the flu vaccine meeting; Makary responded that he would convene vaccine advisory committees but *“would reevaluate which scientific issues require their input”. In other words, Makary signaled a more selective use of expert panels, though he assured Congress that VRBPAC “would continue to meet” under his tenure. Importantly, Makary is not opposed to vaccines themselves – at the hearing he stated, “Vaccines save lives, and any child who dies of a vaccine-preventable illness is a tragedy.”. This suggests that while he may scrutinize vaccine approvals (especially if evidence is thin or process rushed), he fundamentally supports vaccination when backed by solid data. Relevance to Capricor: Makary’s nuanced stance implies he would likely welcome innovative vaccine technologies like Capricor’s exosome vaccine, provided they demonstrate safety and efficacy. However, he might insist on rigorous trials and could resist political pressure to authorize new vaccines too hastily. Given his concern about FDA’s credibility, Makary would probably want Capricor’s COVID-19 vaccine to go through the standard process (with transparent advisory review) once it reaches that stage.

• Views on Gene and Cell Therapies: Makary has consistently advocated for faster approval of breakthrough treatments in areas of high unmet need. He has criticized the FDA for being too slow or overly bureaucratic in approving treatments for serious conditions. In his 2024 book, Makary asked pointedly, “Why does it take 10 years for a drug to be approved?”, citing examples of lifesaving therapies approved far earlier in Europe than in the U.S. He highlighted how patient advocacy forced the FDA to allow fecal microbiota transplants, chiding regulators to “Stop regulating s**” * and be more agile. Moreover, in discussions around his nomination, Makary emphasized streamlining approvals for diseases like Duchenne muscular dystrophy. He specifically noted the need to expedite treatments for DMD while maintaining rigorous evaluation. This bodes well for Capricor’s deramiocel. Makary’s FDA is likely to be receptive to evidence that deramiocel improves patient outcomes, especially given DMD’s severity. Indeed, regenerative medicine experts predict Makary “will catalyze more approvals” in the cell and gene therapy arena. At the same time, Makary has cautioned against the FDA’s “cozy relationship” with industry. He has openly criticized certain FDA decisions – for instance, he questioned the approval of some COVID-19 vaccine policies and the controversial approval of an Alzheimer’s drug (presumably Aduhelm). This suggests that while he favors speeding cures, he won’t shy away from rejecting or delaying products he finds inadequately supported by data. Relevance to Capricor: Makary is likely to view Capricor’s cell therapy (deramiocel) favorably if its data are compelling. The therapy’s Priority Review status (six-month timeline) aligns with his push for urgency in life-threatening diseases. We can expect Makary’s FDA to stick to the August 2025 decision date and, if the risk/benefit profile is positive, possibly approve deramiocel – a move that would be in line with his philosophy of getting treatments to patients sooner. For Capricor’s exosome-based gene therapy platform, Makary’s stance on innovation suggests openness. Exosome delivery of RNA or proteins is cutting-edge, and Makary has lauded scientific advances when they fill unmet needs. He would likely encourage Capricor to pursue this platform, while ensuring the FDA’s review framework adapts (he has mentioned “customizing the regulatory process” to different diseases and technologies). In short, Makary appears supportive of Capricor’s pipeline areas – he values vaccines (with proper oversight) and champions regenerative medicine – so his leadership may steer the FDA to work constructively with companies like Capricor, even amid the political crosscurrents.

VACCINE DEVELOPMENT TRENDS (2025 - 2028)

Even as U.S. regulatory leadership evolves, the global trajectory of vaccine development from 2025 through 2028 is strongly positive. The COVID-19 pandemic catalyzed unprecedented innovation in vaccines, and that momentum is driving several key trends:

1. mRNA Vaccine Expansion: The success of mRNA vaccines for COVID-19 has cemented mRNA as a platform for other diseases. There is a “big focus on mRNA vaccines” in R&D pipelines. By 2025, companies are advancing mRNA vaccines for influenza, respiratory syncytial virus (RSV), cytomegalovirus, and even personalized cancer vaccines. We expect combination vaccines (e.g. a combined annual COVID+flu shot) to emerge by 2026–2027, pending clinical trial results. BioNTech and Moderna, for instance, are testing cancer immunotherapies that tailor mRNA vaccines to individual tumor mutations – an approach representing personalized vaccines as a major trend. If successful, these could reach the market by 2027–2028, transforming treatment of melanoma and other cancers.

2. Recombinant & Viral-Vector Vaccines: Traditional vaccine approaches are also evolving. Protein subunit (recombinant) vaccines have gained renewed interest due to their stability and track record. Novavax’s protein-based COVID vaccine, for example, demonstrated that recombinant nanospike vaccines can be highly effective. Pipeline candidates for malaria and tuberculosis vaccines often use recombinant protein technology. Meanwhile, viral-vector vaccines (like adenovirus-based vaccines) remain in development for HIV, cancer, and emerging pathogens. However, after mixed results with vector COVID vaccines, developers are tweaking vectors to improve durability and safety. Expect next-generation viral vectors (e.g. modified poxvirus or adeno-associated virus vectors) to be tested for diseases like Zika or universal flu by later this decade.

3. Artificial Intelligence (AI) in Vaccine R&D: A newer trend is the use of AI and machine learning to accelerate vaccine discovery. AI can help identify promising antigen targets (for example, scanning viral genomes for stable regions) and optimize vaccine design (such as codon optimization for mRNA). From 2025 onward, major Pharma and startups alike are leveraging AI to predict immunogenic epitopes and model protein folding for antigens. This could shorten development timelines and improve success rates. By 2028, AI-designed vaccine candidates might be entering clinical trials, especially for rapidly mutating viruses or autoimmune-targeted vaccines.

4. Pandemic Preparedness and Pan-Vaccines: The experience of COVID-19 has kept pandemic preparedness in focus. Governments and coalitions (CEPI, WHO, etc.) are investing in “pan-virus” vaccines: e.g., a universal coronavirus vaccine that covers SARS-CoV-2 variants and other sarbecoviruses, or a universal influenza vaccine providing multiyear protection. Such programs are scientifically challenging but by 2025 some candidates are in Phase 2 trials. The NIH’s “pan-coronavirus” nanoparticle vaccine showed broad neutralization in early studies, and companies like Pfizer announced efforts toward universal flu shots. We anticipate initial approvals of broadly protective vaccines around 2027–2028, if trials demonstrate efficacy across strains. These could revolutionize immunization by reducing the need for yearly updates. However, they will require extensive advisory committee vetting given their novelty.

5. Market Growth and Investment: The global vaccines market is projected to grow significantly through 2028. In 2023 the market was about $78 billion, and it is forecast to reach roughly $94 billion by 2028. Driving factors include sustained demand for COVID-19 boosters (especially updated variant boosters), introduction of new vaccines (such as RSV vaccines for older adults – FDA approved the first RSV vaccines in 2023), and expanding immunization programs in emerging markets. There is also increasing private and public investment in vaccine R&D. One analysis predicts the vaccine research market will grow at ~11% CAGR through 2028, adding over $20 billion in that period. Much of this growth comes from next-gen platforms (mRNA, DNA, vector) and therapeutic vaccines (for cancer or chronic diseases). For biotech companies like Capricor, this trend is encouraging there is ample funding and a large potential market for novel vaccines if they can demonstrate value. Notably, the RSV vaccine segment alone is booming – by 2025, three RSV vaccines (two for adults, one maternal) are on the market, with combined sales in the billions, indicating that even long-standing targets can create lucrative new markets with the right technology.

6. Regulatory Landscape for Vaccines: Between 2025 and 2028, regulators are expected to adapt to the rapid pace of vaccine innovation. The FDA under Dr. Makary will likely implement some process reforms. One possible shift is more flexible trial design for vaccines – using Bayesian or adaptive trials to update strains (as was done for annual flu and now COVID boosters). Also, regulatory agencies might establish clearer pathways for emergency use of vaccines against novel pathogens, building on the COVID experience. However, as noted, early in this period the FDA’s vaccine advisory process is in flux due to political influences. By 2026, if confidence in FDA leadership is restored (especially if HHS’s interference diminishes), we expect a more routine schedule of VRBPAC meetings to evaluate new vaccines and boosters. Internationally, the WHO is pushing for streamlined approval of priority vaccines and better global coordination – meaning a vaccine proven safe/effective could see simultaneous approvals in the U.S., EU, and elsewhere, a trend possibly evident by 2027.

In sum, the vaccine field from 2025–2028 will be characterized by technological breakthroughs (mRNA, AI-driven design, novel vectors) and a robust pipeline addressing both longstanding diseases and potential pandemics. Companies that navigate the regulatory environment successfully – demonstrating strong data amid any political headwinds – stand to shape a new era of prophylactic and therapeutic vaccines.

BROADER BIOTECH MARKET OUTLOOK (2025-2028)

The overall biotechnology sector is poised for significant growth and transformation through 2028. Several factors underpin a bullish outlook for biotech, albeit with some uncertainties in the policy environment:

• Surge in Cell and Gene Therapy Approvals: A wave of cell and gene therapies is reaching late-stage development. The FDA has anticipated approving 10–20 gene and cell therapies by 2025, and the pipeline continues to expand beyond that. As of early 2025, just over 2,000 gene therapy candidates are in development worldwide, with 35 in Phase 3 and 11 under regulatory review. This includes therapies for rare genetic disorders (like hemophilia, sickle cell disease, and Duchenne muscular dystrophy), as well as oncology (CAR-T cell therapies, oncolytic viruses) and ophthalmology. We expect a steady cadence of approvals from 2025 to 2028. For example, in 2025 alone, the FDA is set to decide on a gene therapy for recessive dystrophic epidermolysis bullosa (a severe skin disorder), and potentially for sickle cell anemia and Sanfilippo syndrome. By 2028, dozens of new gene therapies could be on the market, finally delivering cures or disease-modifying treatments for conditions previously untreatable. This trend is a major growth drive for biotech and will attract investment into companies with gene-editing platforms (CRISPR-based therapeutics), rare disease programs, and regenerative medicine. Analyst forecasts show the cell & gene therapy market growth accelerating as these approvals accumulate, with high double-digit annual growth rates.

• Major Areas of Growth: Beyond advanced therapies, other hot areas include oncology (novel immunotherapies and targeted drugs), neurology (with new mechanisms tackling Alzheimer’s, Parkinson’s, etc.), and precision medicine. Oncology remains the largest segment in biotech – expect breakthroughs in personalized cancer vaccines (as mentioned), CAR-T expansions for solid tumors, and bispecific antibodies. In neurology, the controversial Alzheimer’s drugs (Aducanumab in 2021 and Lecanemab in 2023) opened the door for more investment; by 2026–2027, we could see the first gene therapies for neurological diseases (e.g., Huntington’s or ALS) approach approval. Rare diseases will continue to be a focus, fueled by incentives like Orphan Drug exclusivity and the potential to earn Rare Pediatric Disease Priority Review Vouchers (PRVs) – Capricor’s DMD therapy, for instance, qualifies for a PRV if approved. Additionally, RNA therapeutics (mRNA, siRNA, antisense) are growing areas – after mRNA vaccines’ success, companies are exploring mRNA treatments for diseases like cystic fibrosis and personalized cancer therapy. The market for mRNA therapies is projected to keep growing ~12% annually through 2030.

• Regulatory Shifts and FDA Policy: The 2025 change in U.S. administration has led to some regulatory uncertainty (with RFK Jr. at HHS and initial workforce cuts). However, there is also a push to modernize the FDA and remove unnecessary hurdles. Dr. Makary has spoken about “common sense” reforms at FDA, such as aligning approval requirements to disease severity and patient needs. We might see initiatives to speed up clinical trials (e.g., use of real-world evidence or intermediate endpoints for quicker approvals in life-threatening conditions). The FDA could also pursue more international regulatory harmonization, recognizing certain approvals by EMA or other trusted agencies to avoid duplication – Makary explicitly noted how some drugs were available abroad years before FDA acted. That said, one must watch how political oversight plays out: If HHS interference persists, FDA might be constrained in areas like vaccine promotion or certain contentious approvals (like Mifepristone, the abortion pill, where Makary said he’d review data carefully). By 2026, it’s possible there will be a realignment – either the administration tones down its FDA meddling or legal/legislative actions reinforce FDA’s scientific autonomy. Looking further out, 2027 will bring the next PDUFA (Prescription Drug User Fee Act) reauthorization, which could introduce new provisions for accelerated approval reforms (Congress has debated requiring confirmatory trials sooner and penalizing failed accelerated approvals). Overall, we expect regulatory innovation: more adaptive trial designs, increased patient involvement in advisory panels, and perhaps updated guidelines for emerging tech like exosome therapies (as agencies gain experience with products like Capricor’s, they’ll issue guidance on manufacturing standards, etc.).

• Investment Climate and Opportunities: The biotech sector experienced a financing downturn in 2022–2023 (after the biotech boom of 2020–21), but signs point to a recovery. As breakthrough approvals materialize (e.g., gene therapy cures, new vaccines), investor confidence is returning. From 2025 through 2028, M&A activity is likely to be robust: large pharmaceutical companies, many of which face patent cliffs on blockbuster drugs in 2027–28, are actively looking to acquire or partner with biotech's to refill their pipelines. This presents opportunities for companies with promising Phase 2/3 assets. For instance, any positive trial in Alzheimer’s or Parkinson’s draws heavy interest (as seen by Lilly’s acquisition of Prevail Therapeutics for gene therapy). Oncology biotech's with differentiated immunotherapies are prime acquisition targets as well. Investment opportunities to watch include:

• Companies developing gene therapies for prevalent diseases (e.g., Vertex/CRISPR’s gene editing for sickle cell and beta thalassemia, which could be approved by 2025-26). These address large patient populations and could command significant markets.

• mRNA platform companies expanding into new indications – beyond Moderna and BioNTech, smaller players (CureVac, Translate Bio/Sanofi) are worth watching as they apply mRNA to flu, cancer, and rare diseases. The versatility of mRNA means new partnerships and products are likely, driving stock value.

• Regenerative medicine firms – those with cell or exosome therapies (like Capricor) or tissue-engineered products. As experts predict more approvals in regenerative medicine in 2025 and beyond, early movers could see steep valuation increases. For example, Mesoblast (an allogeneic stem cell company) is cited as likely to finally obtain FDA approval in this timeframe, which could boost the sector sentiment. Capricor itself, if it secures the first DMD cardiac therapy approval, stands to gain not only commercially but also as a proof-of-concept for its exosome platform, potentially attracting investors or partners for its other programs.

• AI-driven drug discovery startups – these are emerging as a new class of biotech. If AI-designed candidates advance quickly to clinic, big Pharma may acquire these companies for their algorithms and pipelines. By 2028, AI’s impact on biotech might yield a few notable success stories (e.g., an AI-discovered drug entering Phase 3), opening an investment niche at the intersection of tech and biology.

• Market Risks: It’s important to acknowledge challenges. Biotech innovation is booming, but cost and access will be a hot topic by 2025–2028. Million-dollar gene therapies and expensive cancer treatments raise questions about payment models. Payers are already exploring annuity payment systems and outcomes-based pricing. If reimbursement hurdles tighten, that could temper the commercial upside of some therapies. Moreover, the broader economy (interest rates, inflation) will influence biotech funding; a friendly macro environment (low rates, strong growth) would fuel investment, whereas a recession could dampen it. Regulatory risks also loom – any high-profile safety issue (for instance, an unforeseen side effect in a gene therapy trial) could lead to temporary slowdowns or more stringent oversight.

Overall, the outlook for 2025–2028 is that of dynamic growth in biotech, led by scientific progress in vaccines, gene/cell therapies, and precision medicines. Despite some political and economic variables, the demand for innovative healthcare solutions is high. From a market perspective, biotech is set to be an attractive sector, with multiple potential inflection points for investors – FDA approvals, M&A deals, and clinical milestones – likely to occur each year.

Analyst consensus leans optimistic: many believe that the combination of favorable science and a (hopefully) supportive regulatory environment (especially if Makary’s FDA finds a balance between speed and rigor) will usher in a productive period for biotech companies and significant health advances for society. For Capricor Therapeutics, in particular, the coming years could be defining – positive regulatory outcomes and wise navigation of the evolving FDA landscape may position it as a leader in the exosome therapeutics space amidst a thriving biotech industry.
 

Sources:

• FDA/CBER leadership changes and policy: NPR, Shots Health News; Reuters; AP News.

• Capricor pipeline and regulatory status: Capricor Therapeutics Pipeline; Parent Project Muscular Dystrophy news.

• Marty Makary commentary: Managed Healthcare Exec. (Senate hearing); Reuters (confirmation hearing); Trading View forum (analysis of Makary’s stance); Excerpts from Makary’s book via MHE.

• Vaccine development trends: Single Use Support report; Business Wire/ResearchAndMarkets; Market forecasts; FDA approvals news.

• Biotech outlook and investments: The Niche – Paul Knoepfler’s predictions; Managed Healthcare Exec. on gene therapy pipeline; Reuters/PwC data on expected approvals.

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