FX.co ★ These Biotech Stocks Hit New Highs, Did You Reap The Rewards?

Every investor aims for substantial returns from their stocks, while acknowledging that trading involves a balance of wins and losses. However, a few do manage to strike it big.

Below is a selection of stocks featured on our website that achieved new 52-week high levels this week. This list isn't exhaustive; other stocks may have also reached this milestone.

**Protagonist Therapeutics Inc. (PTGX)**

Protagonist is a clinical-stage biopharmaceutical company with several assets possessing billion-dollar market potential. The company has a global license and collaboration agreement with Takeda for the investigational drug Rusfertide, which is under development for polycythemia vera and other blood disorders. A phase III trial, dubbed VERIFY, is currently evaluating Rusfertide for polycythemia vera, and top-line data for the study’s 32-week primary efficacy endpoint is expected by the end of Q1 2025.

Additionally, JNJ-2113 (formerly known as PN-235) is being developed in partnership with Janssen Biotech Inc. JNJ-2113 is in phase III trials for moderate-to-severe plaque psoriasis and in a phase IIb trial for moderately to severely active ulcerative colitis.

PTGX was featured on our site on March 7, 2023, trading around $16.97. The stock closed at $34.02 yesterday, marking a remarkable 100% gain from our initial recommendation.

**Calliditas Therapeutics AB (publ) (CALT)**

Calliditas, a Sweden-based commercial-stage biopharma company, is focused on developing novel treatments for orphan indications with significant unmet medical needs. Its lead drug, Nefecon, marketed as Tarpeyo, aims to reduce proteinuria in adults with primary immunoglobulin A nephropathy. The drug received accelerated approval from the FDA in December 2021 and full approval in December 2023.

Tarpeyo is also marketed in the EEA, Switzerland, and the UK under the brand name Kinpeygo. In the EU, Kinpeygo received conditional marketing authorization in July 2022, with full approval anticipated in August of this year.

For the first quarter ending March 31, 2024, Tarpeyo's net sales reached $26.8 million, up from $17.8 million in the year-ago quarter. Preliminary net sales for Q2 2024 are estimated at $25.5 million, compared to $25 million in Q2 2023.

CALT was featured on our site on March 13, 2023, trading around $22.60. The stock closed at $41.41 yesterday, indicating an 83% gain from our published price.

**Stoke Therapeutics Inc. (STOK)**

Stoke Therapeutics, a clinical-stage biotechnology company, is focused on RNA-based medicines. Its lead drug, STK-001, is in clinical trials for treating Dravet syndrome, a severe and progressive genetic epilepsy. The company plans to meet with regulatory agencies to discuss a randomized, controlled registrational study for STK-001, with updates expected in the second half of 2024.

STOK was highlighted on our site on April 14, 2023, when it was trading around $8.77. The stock closed yesterday at $15.21, reflecting a 73% increase from our featured price.

**Halozyme Therapeutics Inc. (HALO)**

Halozyme, a biopharmaceutical company, licenses its ENHANZE drug delivery technology to global pharma and biotech companies including Roche, Takeda, Pfizer, AbbVie, Eli Lilly, Bristol-Myers Squibb, Alexion, argenx, Horizon Therapeutics, ViiV Healthcare, and Chugai Pharmaceutical.

The company markets specialty products such as the adjuvant Hylenex, testosterone replacement therapies such as XYOSTED and TLANDO, and NOCDURNA for treating nocturia due to nocturnal polyuria. The company also generates revenue through ENHANZE collaborations and sales or royalties from approved products.

For full-year 2024, Halozyme anticipates revenue of $935 million to $1,015 million, a growth of 13% to 22% over 2023, mainly driven by increases in royalty and collaboration revenue, and growth in product sales from XYOSTED.

HALO was featured on our site on July 13, 2023, trading around $37.55. The stock closed at $51.44 yesterday, resulting in a 37% gain from our published price.

**PepGen Inc. (PEPG)**PepGen: Advancing Neuromuscular Therapies

PepGen is a clinical-stage biotechnology company focusing on therapeutics for severe neuromuscular and neurological disorders. Its flagship candidate, PGN-EDO51, is in phase II trials for Duchenne Muscular Dystrophy, while PGN-EDODM1 is undergoing a phase I trial for Myotonic Dystrophy 1. The company anticipates releasing preliminary data from the phase I PGN-EDODM1 trial (FREEDOM-DM1) in the latter half of 2024. We spotlighted PepGen on October 12, 2023, when the stock was priced around $5.23. It recently closed at $17.34, a remarkable 231% increase.

Agios Pharmaceuticals Inc. (AGIO): Pioneering Rare Disease Therapies

Agios Pharmaceuticals is a commercial-stage company renowned for developing treatments for rare diseases. Its lead product, Mitapivat (branded as Pyrukynd), is approved for treating hemolytic anemia in adults with pyruvate kinase deficiency in the U.S., EU, and Great Britain. Recently, Agios announced that its phase III study of Mitapivat in transfusion-dependent alpha- or beta-thalassemia (ENERGIZE-T) achieved its primary endpoint of a transfusion reduction response. Featured on our site on November 3, 2023, when AGIO traded around $21.20, the stock closed at $47.80, yielding a 125% gain.

Vertex Pharmaceuticals Inc. (VRTX): Global Biotechnology Leader

Vertex Pharmaceuticals is a global biotechnology firm with approved treatments for cystic fibrosis, sickle cell disease, and transfusion-dependent beta thalassemia. For 2024, Vertex projects total product revenue between $10.55 billion and $10.75 billion, up from $9.87 billion in 2023. VRTX was highlighted on January 3, 2024, at $412.43 and recently closed at $485.53, registering a 17% increase.

ADMA Biologics Inc. (ADMA): Advancing Plasma-Derived Therapies

ADMA Biologics is a commercial biopharmaceutical company that develops specialty plasma-derived products for infective disease prevention and treatment in immune-compromised patients. The company has recently upgraded its revenue guidance for 2024 and 2025, expecting over $355 million in 2024, up from prior guidance of $330 million, with revenue in 2023 totaling $258 million. For 2025, projections exceed $410 million, previously estimated at over $380 million. ADMA was featured on February 15, 2024, at $5.36 and recently closed at $10.58, reflecting a 97% increase.

Insmed Inc. (INSM): Targeting MAC Lung Disease

Insmed is an international biopharmaceutical company with a lead product, Arikayce, indicated for Mycobacterium avium complex (MAC) lung disease in adults lacking alternative treatments. The company forecasts global Arikayce revenue between $340 million and $360 million for 2024, compared to $305.2 million in 2023. Featured on March 25, 2024, at $26.52, INSM closed at $57.17, marking a 115% uptick.

Rezolute Inc. (RZLT): Developing DME Treatments

Rezolute is progressing with RZ402, a drug for diabetic macular edema (DME). Positive topline results from its phase II RZ402 clinical study were reported last month for DME patients either naïve to or with limited anti-VEGF injections. RZLT was spotlighted on April 1, 2024, at $2.68 and recently closed at $5.59, exhibiting a 108% rally.

Arcturus Therapeutics Holdings Inc. (ARCT): Innovating mRNA Medicines

Arcturus, a global mRNA medicine company, is set to launch its Kostaive, a self-amplifying mRNA COVID-19 vaccine, in Japan this year. The vaccine received approval from Japan's Ministry of Health, Labor and Welfare last November. The company is also advancing two mRNA therapeutic candidates: ARCT-032 for cystic fibrosis and ARCT-810 for ornithine transcarbamylase (OTC) deficiency. Interim phase 1b data for ARCT-032 will be presented at the European Cystic Fibrosis Conference today.ARCT was highlighted on our website on April 9, 2024, when its stock was priced at approximately $30.83. As of the close of yesterday's trading, the stock had risen to $42.60, reflecting a 38% increase from our noted price.

**Novavax Inc. (NVAX)**

Novavax is a globally recognized company that is at the forefront of developing protein-based vaccines utilizing its Matrix-M adjuvant. Last month, this COVID-19 vaccine producer entered a licensing agreement with Sanofi valued at $1.2 billion.

For the first quarter ending March 31, 2024, Novavax reported total revenue of $94 million, up from $81 million during the same period in 2023.

Novavax plans to launch its JN.1 protein-based, non-mRNA COVID-19 vaccine this fall.

We initially covered NVAX on May 13, 2024, when it was trading at around $9.69. The stock closed yesterday at $19.56, marking a 101% increase from our initial coverage price.