7 Biotech Stocks Trading At 52-Week Highs - Can The Rally Continue?

Ionis Pharmaceuticals

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(RTTNews) - Patience is a virtue - important in all aspects of life, and especially crucial when it comes to investing. As trading expert Steve Burns once said, "Much of our trading comes down to a battle between our patience and our impulses."

Here are some of the biotech stocks that hit new highs last week. Did you take note when they were first featured on our site, and were you patient enough to hold on?

Aurinia Pharmaceuticals Inc. (AUPH)

Aurinia Pharma has been experiencing solid growth for its flagship product LUPKYNIS since it entered the market in 2021.

Lupkynis is the first FDA-approved oral therapy for the treatment of adult patients with active lupus nephritis. For the full year 2025, the company expects net product sales to range between $250 million and $260 million compared to $216.2 million reported last year.

The company is also developing Aritinercept, a dual inhibitor of B cell-activating factor (BAFF) and a proliferation-inducing ligand (APRIL) for the potential treatment of autoimmune diseases. Aritinercept is anticipated to enter clinical studies in at least two autoimmune diseases in the second half of this year.

When we alerted readers to AUPH on April 19, 2024, it was trading at $4.79. The stock touched a 52-week high of $12.87 last week, representing a gain of 168% in 1.5 years.

Arrowhead Pharmaceuticals Inc. (ARWR)

Arrowhead Pharma is an RNAi therapeutics platform company that is on track for its first commercial launch in 2025. Its lead drug candidate, Plozasiran, proposed for the treatment of familial chylomicronemia syndrome, is under FDA review, with a decision due on November 18, 2025.

Familial chylomicronemia syndrome, or FCS, is a rare genetic disease characterized by extremely high triglyceride levels, typically over 880 mg/dL, in the blood. The risk of pancreatitis is very high in people with this ultra-rare condition.

We alerted readers to ARWR on December 30, 2024, when it was trading at $18.86. The stock touched a 52-week high of $31.13 last week, marking a gain of 65% in less than 9 months.

The company is embroiled in a patent suit with its rival Ionis Pharmaceuticals, whose drug Tryngolza received FDA approval last December for the treatment of FCS.

Beta Bionics Inc. (BBNX)

Beta Bionics, a medical device company developing advanced diabetes management solutions, which reported 54% growth in second-quarter net sales recently, expects net sales for the full year of 2025 to increase 35% to 43% year-over-year.

The company's flagship product is iLet Bionic Pancreas, an insulin delivery system that automatically regulates blood glucose levels in adults and children six years of age and older with Type 1 diabetes (T1D).

Net sales were $23.2 million in the second quarter of 2025, up 54% compared to $15.0 million in the second quarter of 2024.

For the full year of 2025, the company now expects net sales to range between $88 million and $93 million compared to $65.1 million reported last year.

We alerted readers to BBNX on June 2, 2025, when it was at $17.24. The stock hit a 52-week high of $26.66 last week, representing a gain of nearly 55% in less than 4 months.

Kiniksa Pharmaceuticals International plc (KNSA)

Kiniksa Pharma has been witnessing expanding sales of its lead drug Arcalyst, supported by growth among both new and repeat prescribers.

Arcalyst is the first and only FDA-approved therapy for recurrent pericarditis, a painful and debilitating auto-inflammatory cardiovascular disease.

The drug is expected to generate net product revenue of $625 million to $640 million for the full year of 2025, compared to $417.0 million reported in 2024.

We alerted readers to KNSA on April 29, 2025, when it was at $25.53. The stock touched a 52-week high of $37.34 last week, reflecting a gain of 46% in less than four months.

Ionis Pharmaceuticals Inc. (IONS)

Ionis Pharma, which secured FDA approval for its lead drug Tryngolza for familial chylomicronemia syndrome last December, is also exploring the drug in the indication of severe hypertriglyceridemia. A supplemental new drug application is expected to be filed with the FDA by the end of this year.

Tryngolza generated net product sales of $19 million in the second quarter of 2025, its second full quarter on the market, and $26 million in the first half of 2025.

The company secured FDA approval for its second drug, DAWNZERA, as recently as last month for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients 12 years of age and older.

Ionis has filed a patent suit alleging that Arrowhead's drug candidate Plozasiran infringes on Tryngolza. In turn, Arrowhead has filed a Complaint for Declaratory Judgment in the United States District Court for the District of Delaware against Ionis Pharma to declare that Ionis's United States Patent No. 9,593,333 ("the '333 patent") is invalid.

We alerted readers to IONS on July 15, 2025, when it was trading at $42.55. The stock touched a 52-week high of $64.72 last week, reflecting a gain of 52% in less than two months.

Stoke Therapeutics Inc. (STOK)

Stoke Therapeutics, which is developing a potential disease-modifying medicine for Dravet syndrome by the name Zorevunersen, touched a 52-week high of $24.60 last week.

Dravet syndrome is a severe developmental and epileptic encephalopathy (DEE) characterized by severe, recurrent seizures as well as significant cognitive and behavioral impairments.

A global phase III trial of Zorevunersen for the treatment of Dravet syndrome, dubbed EMPEROR, is ongoing, with data anticipated in the second half of 2027. This drug candidate is being developed in collaboration with Biogen Inc. (BIIB).

When we alerted readers to STOK on July 22, 2025, it was trading at $13.50. The 52-week high of $24.60, recorded last week, represents a gain of 82% in less than two months.

Fortress Biotech Inc. (FBIO)

Fortress Biotech is awaiting a regulatory catalyst related to an investigational drug developed by its subsidiary Cyprium Therapeutics.

The investigational drug in focus is CUTX-101, a subcutaneous injectable formulation of copper histidinate, proposed for the treatment of Menkes disease, a rare X-linked recessive pediatric disease. The FDA decision on CUTX-101 is expected on September 30, 2025.

Fortress is focused on acquiring and advancing assets to enhance long-term value for shareholders through product revenue, equity holdings, and dividend and royalty revenue streams. Its subsidiary and partner companies that are pursuing development and/or commercialization of biopharmaceutical products and product candidates are: Journey Medical Corporation (DERM), Mustang Bio Inc. (MBIO), Avenue Therapeutics Inc. (ATXI.OB), Baergic Bio Inc., Cellvation Inc., Cyprium Therapeutics Inc., Helocyte Inc., Oncogenuity Inc., and Urica Therapeutics Inc. Checkpoint Therapeutics Inc., a partner company, was acquired by Sun Pharma in May 2025.

We alerted readers to FBIO on August 29, 2025, when it was at $2.46. The stock touched a 52-week high of $3.97 last week, reflecting a gain of 61% in less than a month.