5 FDA Covid-19 decisions in July could make or break stocks

For the most part, biotech and pharmaceutical companies are involved in the lengthy process of getting their drug candidates to market through clinical trials. In the age of COVID, some are seeing a more expedited process, but the risk/reward of these stocks remains great.

In terms of risk, biopharma stocks could be cratered should a study come back negative or a candidate not be approved. At the same time, if a drug is approved or passes a clinical trial, there can be massive upside. Even winning a simple approval from the U.S. Food and Drug Administration (FDA) can be big.

This year especially has been a wild ride for the health care sector. In fact, the iShares Nasdaq Biotechnology ETF (NASDAQ: IBB) has outperformed the S&P 500 and Dow Jones industrial average with a gain of 14%, leaving both indexes in the dust. Positive trials, approvals and namely COVID speculation has fuelled these gains, and with any luck, companies within this sector will continue on this course.

Here, 24/7 Wall St. has included a calendar of a few of the biggest clinical trial and FDA updates to watch for in July of 2020.

Note that these dates may be subject to change due to various outside and internal factors, or some of these dates may have changed already. Some date changes are positive developments, while others can be disasters if a company is deeply financed.

Novavax Inc. (NASDAQ: NVAX) previously enrolled patients in its Phase 1/2 clinical trial of its coronavirus candidate, NVX-CoV2373, back in May. The company expects to report preliminary immunogenicity and safety results from the Phase 1 portion of the trial in July.

The Phase 1/2 clinical trial is being conducted in two parts. The Phase 1 portion is a randomized, observer-blinded, placebo-controlled trial designed to evaluate the immunogenicity and safety of NVX-CoV2373. The trial is enrolling roughly 130 healthy participants between 18 to 59 years. The protocol’s two-dose trial regimen assesses two dose sizes (5 and 25 micrograms).

The Phase 2 portion is expected to be conducted in multiple countries and would assess immunity, safety and COVID-19 disease reduction in a broader age range. This Phase 1/2 approach allows for rapid advancement of NVXCoV2373

during the pandemic. The trial is being supported by the recently announced funding arrangement with the Coalition for Epidemic Preparedness Innovations (CEPI).

Gritstone Oncology Inc. (NASDAQ: GRTS) recently announced that its management team will host an investor teleconference and webcast on July 13 to present data from its ongoing Phase 1 studies of its immunotherapy product candidates GRANITE and SLATE. Phase 2 study plans also will be discussed at that time.

The company previously reported early immunogenicity, safety and efficacy data from its Phase 1 study evaluating GRANITE for the treatment of patients with advanced solid tumors, including microsatellite stable colorectal cancer (MSS-CRC), gastroesophageal cancer, metastatic non-small cell lung cancer (NSCLC) and bladder cancer.

Gritstone also reported the same data types from a Phase 1 study evaluating SLATE for the treatment of patients with metastatic NSCLC, pancreatic ductal adenocarcinoma and MSS-CRC, as well as in patients with other solid tumor types who have relevant mutation/human leukocyte antigen combinations.

Again the company will present additional data on these studies on July 13, as well as what it has in store for the rest of 2020.

Sanofi (NASDAQ: SNY) and Regeneron Pharmaceuticals Inc. (NASDAQ: REGN) announced in April preliminary results from the Phase 2 portion of its ongoing Phase 2/3 trial evaluating Kevzara in hospitalized patients with “severe” or “critical” respiratory illness caused by COVID-19.

The ongoing Phase 3 portion of the trial was supposed to report results in June, but a missed timeline will push these results into July. Note that this trial discontinued for lower doses of Kevzara. The treatment was not beneficial for patients with less-advanced disease prompting the companies to stop testing the medicine in that group, but it showed real promise for treating the sickest coronavirus patients.

The drug, Kevzara, inhibits a pathway that is thought to contribute to the lung inflammation in patients with the most severe forms of COVID-19.

AstraZeneca PLC (NYSE: AZN) has Phase 1 data due out for its COVID-19 vaccine, AZD1222, in July. Human trials of the vaccine are currently underway, with the firm already reaching agreements to supply around 2 billion doses across the world.

While this is going on, the company has a Phase 3 study underway with results expected in August or September. This phase in the trial is usually the final phase in the clinical development of a vaccine, and it is when the vaccine is given to thousands of people to be tested for efficacy and safety.

Note that AZD1222 is based on a weakened version of the common cold that causes infections in chimpanzees. It also contains the genetic material of the spike protein of SARSCoV-2, the strain of coronavirus that causes the COVID-19. (24/7 Wall St.com)