Biotech Stocks Facing FDA Decision In July 2024

(RTTNews) - As we flip the calendar to July, it's time to take a look at the biotech stocks awaiting FDA decision.

Arcutis Biotherapeutics, Inc. (ARQT)

The FDA decision on Arcutis Biotherapeutics' Roflumilast cream 0.15% is expected on July 7, 2024.

Roflumilast cream 0.15% is proposed for the treatment of mild to moderate atopic dermatitis in adults and children down to age 6.

Atopic dermatitis, the most prevalent form of eczema, impacts a significant portion of the U.S. population, with roughly 9.6 million children and 16.5 million adults affected. This skin condition typically manifests as an inflamed, pruritic rash, commonly appearing on the face, upper and lower limbs. In severe cases, the rash can spread to cover 50% or more of the body's surface area.

Roflumilast cream 0.3% is already approved for topical treatment of plaque psoriasis, including intertriginous areas, in patients 6 years of age and older.

ARQT closed Thursday's (June 27, 2024) trading at $9.42, up 1.40%.

Orexo AB's (publ.) (ORXOY.OB)

Swedish pharmaceutical company Orexo AB's nasal rescue medication OX124 is under FDA review, with a decision anticipated on July 15, 2024.

OX124, based on the company's drug delivery platform, amorphOX, is designed to reverse the effects of the most powerful synthetic opioids, such as fentanyl.

Synthetic opioids are said to account for 91 percent of all fatal opioid overdoses.

If approved, the company expects the US launch of OX124 to be initiated late 2024.

ORXOY.OB closed Thursday's trading at $2.15, up 7.50%.

Phathom Pharmaceuticals Inc. (PHAT)

The FDA decision on Phathom Pharma's Voquezna, proposed as a daily treatment of heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (GERD) in adults, is expected on July 19, 2024.

Non-Erosive GERD, the most common form of gastroesophageal reflux disease, affects an estimated 38 million adults in the U.S. This condition involves reflux symptoms without visible damage to the esophageal lining. About 15 million of these individuals receive diagnosis and prescription treatment yearly. The symptoms, which can significantly impact quality of life, may include intermittent heartburn (particularly at night), regurgitation, difficulty swallowing, and chest discomfort.

Voquezna tablets contain the active ingredient vonoprazan, an oral small molecule potassium-competitive acid blocker (PCAB). The drug was approved in the U.S. last November for the treatment of adults with Erosive Esophagitis, also known as Erosive GERD, and the relief of heartburn associated with Erosive GERD.

PHAT closed Thursday's trading at $10.40, up 1.76%.

AstraZeneca PLC (AZN)

On July 25, 2024, a panel of outside experts will meet to advise the FDA on the expanded use of AstraZeneca's drug Imfinzi.

The company has sought approval for Imfinzi in combination with chemotherapy as neoadjuvant treatment, followed by Imfinzi as monotherapy after surgery, for the treatment of adult patients with resectable non-small cell lung cancer.

In the indication of non-small cell lung cancer, Imfinzi is approved for unresectable stage III non-small cell lung cancer, and as a 1st-line treatment for adult patients with extensive-stage small cell lung cancer in combination with standard-of-care (SoC) chemotherapies, etoposide plus either carboplatin or cisplatin (platinum-etoposide).

In addition, the drug is approved for small cell lung cancer, biliary tract tumor, hepatocellular carcinoma, and endometrial cancer.

Imfinzi generated global sales of $1.11 billion in the first quarter of 2024, compared to $900 million in the year-ago quarter.

AZN closed Thursday's trading at $78.18, down 1.14%.

Alpha Cognition Inc. (ACOG.CN) (ACOGF.OB)

The FDA decision on Alpha Cognition's ALPHA-1062, proposed for the treatment of mild-to-moderate Alzheimer's disease, is expected on July 27, 2024.

ALPHA-1062 is being reviewed under the 505(b)(2) regulatory pathway.

ACOGF.OB closed Thursday's trading at $0.49, down 5.77%.

Xspray Pharma AB (publ) (XSPRAY.ST)

The FDA is expected to announce its decision on Xspray Pharma's resubmitted New Drug Application for Dasynoc on July 31, 2024.

Dasynoc, the company's innovative protein kinase inhibitor product candidate, is proposed for the treatment of chronic myeloid leukemia.

This is Dasynoc's second go-around with the FDA. In July 2023, the U.S. regulatory agency had declined to approve Dasynoc, citing the need for additional details regarding the drug's appropriate dosage and information about the third-party manufacturing site producing the drug.

Chronic myeloid leukemia is a type of blood cancer where the body produces malignant white blood cells.

XSPRAY.ST closed Thursday's trading at SEK 78.80, down 1.87%.