12 Biotech Stocks Hit New Highs; Did You Make The Most Of It?

(RTTNews) - Following are some biotech stocks that touched new highs yesterday. Were you able to profit from them?

1. Cabaletta Bio Inc. (CABA)

Cabaletta is a clinical-stage biotechnology company focused on the discovery and development of engineered T cell therapies for autoimmune diseases.

The company's drug candidates can be classified into 2 categories - Chimeric Antigen Receptor T cell for Autoimmunity (CARTA) candidate and Chimeric AutoAntibody Receptor T (CAART) cell therapy product candidate.

The lead CARTA candidate is CABA-201, being developed as a potential treatment for a broad range of autoimmune diseases in indications such as systemic lupus erythematosus, rheumatoid arthritis, myositis and systemic sclerosis, among others where B cells contribute to disease pathogenesis.

The CAART cell therapy product candidates include DSG3-CAART, MuSK-CAART, PLA2R-CAART, and DSG3/1-CAART.

What next?

The company anticipates submitting an Investigational New Drug Application to the FDA for CABA-201 in the first half of 2023.

The lead CAART cell therapy candidate is DSG3-CAART, under a phase I trial in mucosal pemphigus vulgaris, a blistering skin disease, dubbed DesCAARTes. The company expects releasing 1 month safety & persistence data from the DesCAARTes trial in the first half of this year.

CABA was trading around $7.38 when it was profiled in our site on Dec.21, 2022. Yesterday, the stock hit a 52-week high of $11.59 during intraday trading, implying a gain of 57% in nearly a month.

2. Sanara MedTech Inc. (SMTI)

Sanara is a medical technology company developing and commercializing transformative technologies to improve clinical outcomes and reduce healthcare expenditures in the surgical and chronic wound and skin care markets.

In the third quarter ended Sep.30, 2022, the results of which were reported recently, net loss had narrowed as revenue soared over 120%.

We had profiled SMTI on Aug.17, 2022, when it was trading around $28.00. The stock touched a 52-week high of $49.50 in intraday trading yesterday, reflecting a gain of nearly 77% in 5 months.

3. Amicus Therapeutics Inc. (FOLD)

Amicus is a biotechnology company developing medicines for people living with rare metabolic diseases.

The company's flagship product is Galafold, which is indicated for the treatment of adults with a confirmed diagnosis of Fabry disease and an amenable galactosidase alpha gene variant based on in vitro assay data.

Approved in the European Union in May 2016 and in the U.S. in August 2018, Galafold has been witnessing continued momentum across geographies.

What next?

The company is scheduled to report full-year 2022 financial results next month.

For full-year 2022, the company expects revenue of $329 million, up from $306 million reported in 2021.

FOLD was profiled in our site on Jan.24, 2022, when it was trading around $8.83, and again on Aug.7, 2022, when it was trading around $12.18. The stock touched a 52-week high of $13.62 in intraday trading yesterday, and that marks a gain of 54% in a year.

4. Supernus Pharmaceuticals Inc. (SUPN)

Supernus Pharma is a revenue-generating biopharmaceutical company developing and commercializing products for the treatment of central nervous system diseases.

Upcoming event:

The company is scheduled to report fourth-quarter and full-year 2022 financial results next month.

For full-year 2022, the company foresees total revenue range of $650 million to $680 million. The total revenue was $579.8 million in 2021.

SUPN was trading around $35.18 when it was profiled in our site on Sep.2, 2022. Yesterday, the stock hit a 52-week high of $41.19 during intraday trading, implying a gain of 17% in less than 5 months.

5. Poseida Therapeutics Inc. (PSTX)

Poseida is a clinical-stage cell and gene therapy company advancing a new class of treatments for patients with cancer and rare diseases.

The company's gene therapies in active clinical testing include P-MUC1C-ALLO1 and P-BCMA-ALLO1.

P-MUC1C-ALLO1 is an allogeneic CAR-T product candidate in phase I development for multiple solid tumor indications. P-BCMA-ALLO1 is an allogeneic CAR-T product candidate, partnered with Roche, targeting B-cell maturation antigen (BCMA) for the treatment of relapsed/refractory multiple myeloma, also in phase I development.

Early data from the trials, presented last month, showed that P-MUC1C-ALLO1 and P-BCMA-ALLO1 were well tolerated, with no dose-limiting toxicities (DLTs), cytokine release syndrome (CRS), graft vs host disease (GVHD) or immune effector cell-associated neurotoxicity syndrome (ICANS), according to the company.

We profiled PSTX in our site on Aug.3, 2022, when it was trading around $3.70. The stock touched a 52-week high of $7.42 in intraday trading yesterday, reflecting a gain of 100% in 5.5 months.

6.BioXcel Therapeutics Inc. (BTAI)

BioXcel is a commercial-stage biopharmaceutical company whose lead product is IGALMI, a proprietary, sublingual film formulation of dexmedetomidine, approved for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults.

Approved by the FDA last April, IGALMI, previously known as BXCL501, has been getting positive market response and is well-positioned for growth in 2023, according to the company.

The company is also developing BXCL701, an investigational, oral innate immune activator for the treatment of aggressive forms of prostate cancer and advanced solid tumors.

Last week, the company announced promising top-line data from its phase II trial of BXCL701 in combination with KEYTRUDA in small cell neuroendocrine metastatic castration-resistant prostate cancer (SCNC) patients.

What next?

BXCL501 is also being studied in a pivotal phase III program for the acute treatment of agitation in patients with Alzheimer's disease, dubbed TRANQUILITY. This program includes two trials named TRANQUILITY II and TRANQUILITY III. Topline data from the two trials are expected in the first half of this year.

Another phase III trial evaluating at-home use of BXCL501 for agitation associated with bipolar I or II disorder or schizophrenia, dubbed SERENITY III, is underway, with topline data anticipated in the first half of 2023.

We had profiled BTAI on July 11, 2022, when it was trading around $16.07. The stock touched a 52-week high of $29.50 in intraday trading yesterday, reflecting a gain of 83% in 6 months.

7. Viridian Therapeutics Inc. (VRDN)

Viridian is a biopharmaceutical company developing medicines for serious and rare diseases.

The company is developing two drugs for thyroid eye disease namely VRDN-001 and VRDN-002.

A phase III trial evaluating the efficacy and safety of the VRDN-001 in patients with active thyroid eye disease, dubbed THRIVE, is underway. Results from this trial are expected in 2024.

VRDN-001 is also being evaluated in a phase II proof-of-concept trial in patients with chronic thyroid eye disease. Initial results from this study are expected in the first half of 2023.

VRDN-002, designed to support administration as a convenient, low-volume, subcutaneous (SC) injection for the treatment of thyroid eye disease, is under a phase I trial. Topline data from this study are expected in the second half of 2023.

We had profiled VRDN initially on July 7, 2022, when it was trading around $11.08, and again on Nov.30, 2022, when it was trading around $26.93. Yesterday's intraday high price of $38.03 reflects a gain of 243% in 6.5 months and 41% in less than 2 months.

8. TransMedics Group Inc. (TMDX)

TransMedics has developed technologies to preserve organ quality and assess organ viability prior to transplant for patients with end-stage lung, heart, and liver failure.

For the third quarter of 2022, net revenue was $25.7 million, a 378% increase compared to $5.4 million in the year-ago period.

What next?

The company is slated to report fourth quarter and full year 2022 financial results next month.

For full year 2022, revenue is expected to be in the range of $80 million to $85 million. Revenue was $30.3 million in the full year 2021.

TMDX was trading around $21.13 when we profiled it on Apr.28, 2022, and around $25.40 when we alerted our subscribers again on May 4, 2022. The stock touched an all-time high of $65.47 in intraday trading yesterday, reflecting a gain of over 200% in 9 months.

9. Celldex Therapeutics Inc. (CLDX)

Celldex is a clinical stage biotechnology company developing antibody-based therapeutics.

The company's lead drug candidate is Barzolvolimab, being evaluated in inflammatory diseases, such as chronic urticaria.

Last month, the company announced encouraging data from its phase 1b clinical trial of Barzolvolimab in patients with antihistamine refractory chronic inducible urticarias.

To know more about the company's pipeline, please refer to our report titled "Celldex - On Track".

CLDX was trading around $37.54 when it was profiled in our site on Nov.11, 2022. The stock touched a 52-week high of $48.40 in intraday trading yesterday, representing a gain of nearly 28% in a little over 2 months.

10. Takeda Pharmaceutical Co. Limited (TAK)

Takeda is a global, R&D-driven biopharmaceutical company headquartered in Japan.

The financial results for the first half of fiscal year 2022 (period ended September 30, 2022) were encouraging and based on the first half results, the company has boosted its outlook for full fiscal year.

We profiled TAK in our site on Feb.3, 2022, when it was trading around $14.63. The stock touched a 52-week high of $16.27 in intraday trading yesterday, reflecting a gain of 11% in 11.5 months.

11. Treace Medical Concepts Inc. (TMCI)

Treace Medical is a commercial-stage medical technology company focused on the surgical management of bunion deformities and related midfoot correction.

Last week, the company announced preliminary unaudited results for fourth quarter and full year 2022.

For the fourth quarter, the company now expects revenue to be in the range of $49.1 million to $49.6 million, representing 47% to 48% growth over the year-ago quarter.

Revenue for full-year 2022 is now expected to be in the range of $141.2 million to $141.7 million, representing 50% growth over 2021.

We had profiled TMCI in our site on Jul.28, 2022, when it was trading around $16.90. The stock touched a 52-week high of $26.50 in intraday trading yesterday, which represents a gain of nearly 56% in a little less than 6 months.

12. Encompass Health Corporation (EHC)

Encompass Health owns and operates rehabilitation hospitals in the United States.

The company is scheduled to report results for its fourth quarter ended Dec. 31, 2022, after the market closes on Feb. 7, 2023.

EHC was trading around $51.23 when we had profiled it on Oct.27, 2022. Yesterday's 52-week high of $62.11 during intraday trading reflects a gain of 21% in 3 months.