All entries for: Biologic

March 23, 2026

Context Therapeutics

Neutral Outlook

Philadelphia, PA
1-50 employees

The effect of the IRA on our business is not yet known.

Disease Area: Oncology
Drug Type: Biologic
March 23, 2026

Pyxis Oncology

Neutral Outlook

Boston, MA
1-50 employees

The IRA also imposes additional rebates for certain Part B and Part D drugs where relevant pricing metrics associated with the products increase faster than inflation. However, it is unclear how the IRA will be effectuated or changed under the new Trump Administration and the degree of impact that the IRA will ultimately have upon our business similarly remains unclear.

Disease Area: Oncology
Drug Type: Biologic
March 23, 2026

Surrozen, Inc

Neutral Outlook

South San Francisco, CA
51-200 employees

There have been amendments to and executive, judicial and congressional challenges to certain aspects of the Affordable Care Act. For example, on August 16, 2022, the Inflation Reduction Act of 2022, or the IRA, was signed into law, which among other things, extends enhanced subsidies for individuals purchasing health insurance coverage in the Affordable Care Act marketplaces through plan year 2025. The IRA also eliminates the “donut hole” under the Medicare Part D program beginning in 2025 by significantly lowering the beneficiary maximum out-of-pocket cost and through a newly established manufacturer discount program.

Disease Area: Other
Drug Type: Biologic
March 23, 2026

Arbutus Biopharma Corp/PA

Negative Outlook

Warminster, PA
51-200 employees

The IRA also created a drug price negotiation program under which the prices for certain Medicare units of certain high Medicare spend drugs and biologicals without generic or biosimilar competition are capped by reference to, among other things, a specified non-federal average manufacturer price starting in 2026. Failure to comply with requirements under the drug price negotiation program is subject to an excise tax and/or a civil monetary penalty. This or any other legislative change could impact the market conditions for our product candidates.

Disease Area: Antiviral, Infectious Diseases
Drug Type: Biologic
March 23, 2026

Avalo Therapeutics

Neutral Outlook

Wayne, PA
1-50 employees

The implementation of the IRA is currently subject to ongoing litigation challenging the constitutionality of the IRA’s Medicare drug price negotiation program. The effects of the IRA on our business and the healthcare industry in general is not yet known.

Disease Area: Chronic Disease, Dermatology, Immune Diseases
Drug Type: Biologic, Small Molecule
March 23, 2026

Sutro Biopharma

Negative Outlook

South San Francisco, CA
201-500 employees

Thus, while it is unclear how the IRA will be implemented, it will likely have a significant impact on the biopharmaceutical industry and the pricing of prescription drug products.

Disease Area: Oncology
Drug Type: Biologic
March 23, 2026

Chemomab Therapeutics

Neutral Outlook

Tel Aviv, Israel
51-200 employees

In August 2022, Congress passed the Inflation Reduction Act of 2022, which includes prescription drug provisions that have significant implications for the pharmaceutical industry and Medicare beneficiaries, including allowing the federal government to negotiate a maximum fair price for certain high-priced single source Medicare drugs that have been on the market for at least 7 years and biologics that have been on the market for at least 11 years, and, imposing penalties and excise tax for manufacturers that fail to comply with the drug price negotiation requirements; requiring inflation rebates for all Medicare Part B and Part D drugs, with limited exceptions, if their drug prices increase faster than inflation; and redesigning Medicare Part D to reduce out-of-pocket prescription drug costs for beneficiaries, among other changes.

Disease Area: Chronic Disease, Immune Diseases, Respiratory Diseases
Drug Type: Biologic
March 23, 2026

Cabaletta Bio

Neutral Outlook

Philadelphia, PA
51-200 employees

The effects of the IRA on our business and the healthcare industry in general is not yet known.

Disease Area: Autoimmune, Immune Diseases
Drug Type: Biologic
March 20, 2026

BiomX

Layoffs

Tel Aviv, Israel
51-200 employees

BiomX laid off a significant portion of its staff in December following the discontinuation of its Phase 2b multi-phage cocktail BX004 for cystic fibrosis, after an external data monitoring committee identified unexpectedly high rates of adverse events.

Disease Area: Respiratory Diseases
Drug Type: Biologic
March 20, 2026

Cellectis S.A.

Negative Outlook

Paris, France
201-500 employees

For example, in August 2022, the United States enacted the Inflation Reduction Act of 2022 (IRA), which includes two policies that are designed to have a direct impact on drug prices. The IRA requires the federal government to negotiate prices for certain high-cost drugs covered under Medicare and requires drug manufacturers to pay rebates to Medicare if they increase prices faster than inflation for drugs used by Medicare beneficiaries. The private sector has also sought to control healthcare costs by limiting coverage or reimbursement or requiring discounts and rebates on products. We are unable to predict what additional legislation, regulations or policies, if any, relating to the healthcare industry or third party coverage and reimbursement may be enacted in the future or what effect such legislation, regulations or policies would have on our business. Any cost containment measures could significantly decrease the available coverage and the price we might establish for our potential products, which would have an adverse effect on our net revenues and operating results.

Disease Area: Hematology, Oncology
Drug Type: Biologic
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