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Tandem and Heron Lead Local Life Science Stock Gains

On average, stocks of public life sciences companies in San Diego gained 12 percent during the second quarter, lifted in large part by a diabetes pump maker.

The San Diego Business Journal tallied the performance of 34 stocks during the second quarter — April 2 to July 2 — and Tandem Diabetes Care stuck out with an eye-popping 336 percent increase.

Other notable stories include Heron Therapeutics, which topped the mid- to large-cap category, along with Acadia Pharmaceuticals stumbling upon media reports of a regulatory reexamination.

Here’s a rundown of notable stock happenings:

Going Gangbusters

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Tandem Diabetes Care

Market cap: $1.15 billion

Stock symbol and exchange: TNDM on Nasdaq

Quarter-over-quarter change: +336%

A mere year ago competitors whispered of Tandem’s potential demise. No more.

Capping off a momentous quarter, in June the company won U.S. Food and Drug Administration approval for an automated insulin technology that lowers the frequency and duration of low blood sugar.

This technology, called Basal-IQ, will be available free of charge on Tandem’s touchscreen insulin pumps via a remote software update.

Basal-IQ’s algorithm, which looks 30 minutes into the future at glucose levels, suspends insulin delivery when predicting low blood sugar levels. Insulin delivery resumes once glucose rises.

Tandem pumps integrate with diabetes technology from another San Diego company: Dexcom, which itself had a nice quarter with a 32 percent increase in its shares.

Tandem has more going in its favor. Customers who bought the company’s first pumps four years ago — meaning their four-year warranty recently expired — are coming back. So yes, repeat business.

Also worth mentioning: Last fall, Johnson & Johnson pulled the plug on a division specializing in insulin pumps, and some customers looking for another pump went with Tandem. And the company’s pipeline looks promising, according to analysts.

Heron Therapeutics

Market cap: $2.78 billion

Stock symbol and exchange: HRTX on Nasdaq

Quarter-over-quarter change: +46%

Heron received good news in June. Its postoperative pain anesthetic — touted as a way to cut down on opioids — hit clinical targets in two additional surgical areas.

Just a few months earlier, Heron reported that the drug, HTX-011, showed efficacy in final-stage clinical trials. HTX-011 lessened pain and reduced opioid use 72 hours after surgery.

Around 80 percent of patients undergoing surgery are prescribed opioids to help manage post-operative pain, a gateway to addiction, for both patients and others in the home with access to leftover pills.

In the second half of this year, Heron plans to submit an application asking the FDA for approval to sell the painkiller.

The company in June reported that HTX-011 secured an FDA breakthrough therapy status, which should speed up review.

“That is very telling in terms of what the political environment is, that they’re (the FDA) really seeking something that’s really going to reduce opioid usage,” said Liisa Bayko, managing director and senior research analyst at JMP Securities, in June.

Anticipating regulatory approval, Heron is also looking toward commercialization, intending to launch the drug in the U.S. solo. This makes Heron a rarity among regional biotechs, which often partner with big pharma for late-stage trials and hitting the market.

The company also has drugs on the market for managing nausea and vomiting brought on by chemotherapy, another reason for recent success.

Troubling

Times

Acadia

Pharmaceuticals

Market cap: $2.05 billion

Stock symbol

and exchange: ACAD on Nasdaq

Quarter-over-quarter

change: -20%

Early in the quarter, Acadia shareholders were spooked after media reports of the FDA reexamining Acadia’s drug to treat hallucinations and delusions brought on by Parkinson’s disease.

The FDA approved the drug, Nuplazid, in 2016. What specifically prompted the new review isn’t clear, only that the agency identifies “potential signals of serious/new safety information” by looking at adverse event data.

The adverse event reports, which are reviewed by the FDA, do not mean that a medication has been proven to cause the harm and are typically not the result of official investigations. The FDA uses the reports to gauge potential issues with a drug.

In addition, the FDA is not recommending patients stop taking the drug during the evaluation period.

Acadia did receive positive news late in the quarter: Regulatory approval of two new Nuplazid dosing formulations.

“While we see these approvals as not entirely unexpected and incremental

to the overall commercial trajectory,

we do believe this somewhat

(but not completely) de-risks the FDA review,” said J.P. Morgan analyst Cory Kasimov in a June 29 research note. “On that, we note that ACAD has yet to be notified of review

completion.”

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