Major Biopharma Catalysts on September’s FDA Calendar

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Biotech and pharmaceutical companies generally are involved in the lengthy process of getting their drug candidates to market through clinical trials. The amount of risk involved ranges from fair to great, should a study come back negative or a candidate not be approved. Conversely, if a drug is approved or passes a clinical trial, there can be massive upside.

In simpler terms, these updates within the industry have the potential to make or break biopharma companies.

Here, 24/7 Wall St. has included a calendar of some of the biggest companies expecting clinical trial and U.S. Food and Drug Administration (FDA) updates in September.

It’s worth mentioning that these dates may be subject to change due to various internal and outside factors. Some of these changes are positive developments and some can be disasters if a company is deeply financed.

As a side note about the Prescription Drug User Fee Act (PDUFA): a Priority Review designation is granted to medicines that the FDA determines have the potential to provide significant improvements in the treatment, prevention or diagnosis of a disease.

Pfizer Inc. (NYSE: PFE) announced in April that the FDA had accepted the company’s New Drug Application (NDA) and granted priority review for dacomitinib, a pan-human epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR-activating mutations. Expect to see the PDUFA date in September.

GlaxoSmithKline PLC (NYSE: GSK) announced in July that the Pulmonary Allergy Drugs Advisory Committee of the FDA had voted (three for, 16 against) that the basis of data presented for mepolizumab was not adequate to support approval. Mepolizumab in this case was used as an add-on treatment to inhaled corticosteroid-based maintenance treatment for the reduction of exacerbations in patients with chronic obstructive pulmonary disease. Look for a PDUFA date in early September.

Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) announced earlier this summer that the FDA extended the goal date of its Biologics License Application (BLA) for fremanezumab, an investigational therapy for the preventive treatment of migraine. The PDUFA date is set for September 16.

Incyte Corp. (NASDAQ: INCY) is presenting Phase 2 data from its study on ruxolitinib in atopic dermatitis. The data are being presented between September 12 and 16 at the European Academy of Dermatology and Venereology.

Loxo Oncology Inc. (Nasdaq: LOXO) is presenting data at the International Association for the Study of Lung Cancer (IASLC) 19th World Conference on Lung Cancer being held September 23 to 26. Specifically, the company is presenting data on LOXO-292 patients with RET fusion NSCLC as part of its ongoing Phase 1/2 clinical trial.

This past week, Novocure Ltd. (NASDAQ: NVCR) announced final results from its STELLAR Phase 2 registration trial in mesothelioma, demonstrating a significant extension in median overall survival among patients treated with Tumor Treating Fields plus standard of care chemotherapy compared to historical control data of patients who received standard of care chemotherapy alone. The final data will be presented at the IASLC on September 25.

Spectrum Pharmaceuticals Inc. (NASDAQ: SPPI) is another company presenting data at the IASLC. In this case the company is announcing new interim poziotinib data from the MD Anderson Phase 2 NSCLC study. The oral session for this presentation will be on September 24.

Insmed Inc. (NASDAQ: INSM) previously announced that the FDA’s Antimicrobial Drugs Advisory Committee voted 12 to two in favor of the safety and effectiveness of ALIS (amikacin liposome inhalation suspension) for adults with nontuberculous mycobacterial lung disease caused by Mycobacterium avium complex who have limited or no treatment options. Expect a PDUFA date on September 28.