Healthcare Business

Major Biotech, Pharma and FDA Catalysts Coming in October

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

The long and short of the matter is that updates within this industry, as well as U.S. Food and Drug Administration (FDA) rulings, can make or break these companies.

24/7 Wall St. has collected several catalysts that are coming up on the calendar in October and added some color, along with the trading range and price target. Note that, due to many outside and internal factors, there are no assurances that the dates will remain static. Some date changes are positive developments, and some can be disasters if a company is not 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.

Mylan N.V. (NASDAQ: MYL) and Biocon are scheduled to have their PDUFA review date on October 9, for MYL-1401H, a proposed biosimilar to Neulasta (pegfilgrastim). This drug is used to reduce the duration of neutropenia (low count of neutrophils, a type of white blood cell) and the incidence of fever associated with neutropenia in adult patients treated with chemotherapy in certain types of cancer.

Johnson & Johnson (NYSE: JNJ) is expected to have a couple PDUFA dates lined up in mid-October. The firm is looking to gain approval for Stelara (ustekinumab) for the treatment of adolescents with moderate to severe plaque psoriasis, and Simponi Aria (golimumab) for the treatment of adults living with active psoriatic arthritis and the treatment of adults living with active ankylosing spondylitis as well.

Alexion Pharmaceuticals Inc. (NASDAQ: ALXN) has a PDUFA date set for October 23 to extend the indication for Soliris (eculizumab) as a potential treatment for patients with refractory generalized myasthenia gravis who are anti-acetylcholine receptor antibody positive.

Looking ahead to next week, there are results expected from Catabasis Pharmaceuticals Inc. (NASDAQ: CATB) MoveDMD trial for the treatment of Duchene muscular dystrophy (DMD) on October 4. The company is presenting at the International Congress of World Muscle Society in France.

Sarepta Therapeutics Inc. (NASDAQ: SRPT) also will be presenting data from its DMD trials at the World Muscle Society as well, and one of its posters will feature combo data with Catabasis.

In the past, both of these companies have seen incredible volatility in response to their DMD trials.

It worth pointing out that October will also see ID Week 2017 play out between the fourth and the eighth in San Diego. Basically this is a huge annual meeting for companies who deal with infectious diseases to share their research and updates. There are a few names that stood out in terms of the presenters at the conference that could generate more upside after the fact.

Although Achaogen Inc. (NASDAQ: AKAO), Cidara Therapeutics Inc. (NASDAQ: CDTX), Nabriva Therapeutics PLC (NASDAQ: NBRV) and Paratek Pharmaceuticals Inc. (NASDAQ: PRTK) may not be household names, these are some of the firms that stand to gain the most from ID Week.

Here are some quick highlights of what Wedbush thinks of these companies:

Achaogen is presenting five posters on lead program plazomicin, including three with clinical data from the EPIC and CARE studies, and two posters with preclinical data demonstrating the utility of plazomicin against resistant bacteria isolates… Although both studies had small numbers of patients, we believe the data for plazomicin, which was sufficient to support Breakthrough Therapy Designation for plazomicin in BSI CRE infections, represents a more compelling case for use in CRE infections; however, we look forward to additional data at ID Week from TANGO II for more insight.

Cidara is presenting three posters on lead program CD101, which is currently in a Ph 2 study STRIVE that is evaluating two dosing regimens vs. caspofungin in 90 patients with candidemia and invasive candidiasis… Cidara has previously presented data demonstrating high target attainment probability vs. C. auris and recently announced a Part B extension to their STRIVE study targeting clinical sites that have reported C. auris infections, which could faciliate accelerated approval for CD101.

Nabriva is presenting three posters on lefamulin, which recently demonstrated non-inferiority to moxifloxacin in Phase 3 study LEAP-1 in community-acquired bacterial pneumonia (CABP) patients. We expect additional data from the LEAP-1 study at European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) in 2018. Topline data from Phase 3 all-oral study LEAP-2 is expected in the first quarter of 2018.

Paratek is presenting clinical data from the Phase 3 OPTIC study of omadacycline in CABP, as well as additional clinical and preclinical data in an additional eight posters. We note PRTK is hosting an Investor Day in New York City on October 17th, in which the clinical development program and pre-commercialization activities for omadacycline will be discussed.