FX.co ★ Biotech Stocks Facing FDA Decision In July 2024

As we turn the calendar to July, it's time to assess the biotech stocks awaiting FDA decisions.

### Arcutis Biotherapeutics, Inc. (ARQT)

The FDA decision on Arcutis Biotherapeutics' Roflumilast cream 0.15% is anticipated on July 7, 2024. This cream is proposed for treating mild to moderate atopic dermatitis in adults and children as young as six. Atopic dermatitis, a prevalent form of eczema, affects a significant portion of the U.S. population, impacting roughly 9.6 million children and 16.5 million adults. This skin condition typically presents as an inflamed, pruritic rash, often found on the face and limbs. In more severe cases, the rash can cover more than 50% of the body's surface area. Roflumilast cream 0.3% is already approved for treating plaque psoriasis, including intertriginous areas, in patients aged six and older. ARQT closed Thursday's (June 27, 2024) trading at $9.42, up 1.40%.

### Orexo AB (publ.) (ORXOY.OB)

Swedish pharmaceutical firm Orexo AB's nasal rescue medication, OX124, is under FDA review, with a decision expected on July 15, 2024. Developed using the company's drug delivery platform, amorphOX, OX124 aims to counteract the effects of powerful synthetic opioids, such as fentanyl. Synthetic opioids account for 91% of all fatal opioid overdoses. If approved, Orexo plans to launch OX124 in the U.S. in late 2024. ORXOY.OB closed Thursday's trading at $2.15, up 7.50%.

### Phathom Pharmaceuticals Inc. (PHAT)

The FDA is expected to rule on Phathom Pharma's Voquezna, intended as a daily treatment for heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (GERD) in adults, on July 19, 2024. Non-erosive GERD, the most common form of this condition, affects an estimated 38 million adults in the U.S. Symptoms, which can significantly impact the quality of life, include intermittent heartburn (particularly at night), regurgitation, difficulty swallowing, and chest discomfort. Voquezna contains the active ingredient vonoprazan, a potassium-competitive acid blocker (PCAB). The drug was approved in the U.S. last November for treating Erosive Esophagitis and relieving 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 convene to advise the FDA on the expanded use of AstraZeneca's drug Imfinzi. The company seeks approval for Imfinzi in combination with chemotherapy as neoadjuvant treatment, followed by monotherapy post-surgery, for adult patients with resectable non-small cell lung cancer. Imfinzi is already approved for unresectable stage III non-small cell lung cancer and as a first-line treatment for extensive-stage small cell lung cancer in combination with standard-of-care chemotherapies, etoposide plus either carboplatin or cisplatin (platinum-etoposide). Additionally, it is approved for small cell lung cancer, biliary tract tumors, hepatocellular carcinoma, and endometrial cancer. Imfinzi generated global sales of $1.11 billion in Q1 2024, compared to $900 million in the same quarter last year. 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, intended for treating 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 slated to announce its decision on Xspray Pharma's resubmitted New Drug Application for Dasynoc on July 31, 2024. Dasynoc, an innovative protein kinase inhibitor, is proposed for treating chronic myeloid leukemia (CML). The drug had previously been declined by the FDA in July 2023, due to the need for additional information regarding its appropriate dosage and details about the third-party manufacturing site. Chronic myeloid leukemia is a blood cancer where the body produces malignant white blood cells. XSPRAY.ST closed Thursday's trading at SEK 78.80, down 1.87%.

This upcoming month is critical for these biotech companies, as FDA decisions will significantly impact their market performance and future developments.