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Tuesday, July 20, 2021

Why Ardelyx got crushed

 Shares of the small-cap biotech Ardelyx (NASDAQ:ARDX) fell by a whopping 73.2% in pre-market action Tuesday morning. The drugmaker's stock is tanking today in response to a July 13 letter from the U.S. Food and Drug Administration regarding the company's New Drug Application (NDA) for tenapanor as a treatment for controlling serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis.

Per a press release from Ardelyx, the letter reportedly stated that the FDA found deficiencies in the NDA that preclude discussion around the would-be labeling and post-marketing requirements for tenapanor. Most importantly, the FDA said it detected issues with both the size and clinical relevance of the drug's treatment effect. 

The FDA is slated to hand down a final decision on tenapanor's NDA on July 29. However, from the sound of things, the agency doesn't plan on approving the drug during this review cycle. The FDA, in fact, refused to even meet with Ardelyx to discuss the NDA's areas of concern, according to the company. That's a fairly strong sign that a Complete Response Letter (aka a rejection) is probably on the way -- a sentiment that's clearly being echoed by the biotech's shareholders today. 


Is Ardelyx a bad news buy? The FDA questioning tenapanor's efficacy at this extremely late stage of the game is unusual to say the least. That doesn't mean the agency's take is wrong, however. The fact of the matter is that investors need a lot more info to make a solid decision on the biotech's value proposition following this unexpected turn of events. In other words, it might be wise to simply watch this falling knife from this sidelines for now. 

https://www.fool.com/investing/2021/07/20/why-ardelyx-stock-is-getting-crushed-today/

Why Endo Soared

 Shares of Endo International (NASDAQ:ENDP) were soaring 23.2% higher as of 11:15 a.m. EDT on Tuesday. The big jump came as investors anticipated that the company would reach a settlement with several Tennessee counties involved in an opioid-related lawsuit.


District Attorney General Barry Staubus told Tennessee News Channel 11 (WJHL) that Endo has extended an offer to settle the case. Jury selection was scheduled to begin in a few days. Officials in Greene, Sullivan, and Washington counties are expected to hold public meetings tomorrow to review the settlement offer. 

No financial details of the settlement have been announced. Endo hasn't issued a public statement on the matter at the time of this writing. However, the company stated on July 15 that it was "exploring all of its legal options" in the case.

Investors are clearly optimistic, though, about the prospects of Endo avoiding a trial based on today's big gain for the pharmaceutical stock. The company is the only defendant in the litigation that hasn't filed for bankruptcy. 


Even if Endo reaches a settlement with the Tennessee counties, the company's legal battles related to its opioid drugs are far from over. New York Attorney General Letitia James said today that three major drug distributors settled with the state of New York and two large counties in the state. However, a trial is still scheduled with Endo and two other drugmakers. 

https://www.fool.com/investing/2021/07/20/why-endo-stock-is-soaring-today/

Some who got J&J vaccines seek boosters as delta variant spreads, despite CDC guidance

 Earlier this year, Erkin Peksoz wanted a COVID-19 vaccine so badly that he drove 640 miles round trip from Chicago to Quincy to get a Johnson & Johnson shot.

Peksoz was happy with that decision — until recently, when the more contagious delta variant of the virus emerged. Now, he’d like to get a shot of a Moderna or Pfizer vaccine, in hopes of increasing his protection.

“Until delta, I was not worried at all,” said Peksoz, a consumer data consultant. “I feel like I’m half-vaccinated now.”

In clinical trials before the delta variant began to spread, the Johnson & Johnson vaccine was found to be 66 percent effective at preventing COVID-19, while Pfizer and Moderna were 95 percent and 94 percent, respectively, although all three were found to be highly effective at preventing hospitalization and death from the illness.

The Centers for Disease Control and Prevention and most experts are not recommending that people who received Johnson & Johnson vaccines, or any other vaccine, get booster shots. Still, a number of individuals who got Johnson & Johnson shots are starting to wonder if a booster might be a good idea, given the rapid spread of the delta variant, a handful of experts who’ve publicly recommended it and what they’re seeing in other countries.

It’s become a topic of discussion on social media, and patients are asking their doctors for advice. Some  have already gone to local pharmacies and gotten Moderna and Pfizer vaccines, even though they previously received Johnson & Johnson shots.

“We’re well aware of this going on,” said Dr. Mia Taormina, chair of the department of infectious disease at DuPage Medical Group. “What’s happening here is people are not being forthcoming. They’ve received Johnson & Johnson, they’re worried, and they’re just showing up at CVS and Walgreens and not even disclosing they received the Johnson & Johnson (vaccine).”

Both CVS Health and Walgreens say they follow CDC guidance, but neither answered questions about whether they have any way of knowing if a person seeking a vaccine has already been vaccinated. Illinois’ largest health insurer, Blue Cross and Blue Shield of Illinois, said it isn’t aware of any claims for vaccines being denied because the second dose of a vaccine came from a different manufacturer than the first.

Doctors say there are good reasons for people to follow CDC guidance and not seek out boosters for Johnson & Johnson vaccines now.

“If you’re under 65, and you’re otherwise healthy, in all probability you’ve developed protective antibodies,” Taormina said.

Also, it’s unknown whether getting a Pfizer or Moderna vaccine, on top of Johnson & Johnson, might cause problems, said Dr. Michael Angarone, an associate professor in the department of medicine and division of infectious diseases at Northwestern University Feinberg School of Medicine.

“We know that vaccines are not without side effects,” Angarone said. He worries that for people who have autoimmune diseases, extra doses of vaccine could trigger flare-ups of those illnesses. “I think when we don’t know the benefit, and we know there’s potential risk, in my mind, that is a risk I don’t think we want to put people under.”

The focus should be on inoculating people who have not yet been vaccinated at all, not giving booster shots to those who’ve already rolled up their sleeves, he said. The makers of all three vaccines say they offer protection against the delta variant though Pfizer has said it plans to ask the U.S. to authorize a booster.

Still, in recent weeks, several prominent health experts made headlines for publicly encouraging people who received Johnson & Johnson to get Moderna and Pfizer shots.

Dr. Vin Gupta, a faculty member at the Institute for Health Metrics and Evaluation at the University of Washington and an NBC News analyst, tweeted late last month that people who got Johnson & Johnson should get a Moderna or Pfizer shot as a booster. “Most I know who got J&J are doing it and are telling others the same — since two seems better than 1 (regarding) delta,” he tweeted.

Dr. Angela Rasmussen, a virologist at the Vaccine and Infectious Disease Organization at the University of Saskatchewan, also tweeted last month that she got a Pfizer vaccine to “top off the J&J vaccine I received in April.”

“I think I did the right thing to make sure I am as protected as possible from the delta variant and thus am protecting others who only have one shot,” she tweeted. “Sometimes public health requires making tough decisions without a complete data set to support it.”

Many people have also been looking at what other countries are doing with booster shots.

Canada’s National Advisory Committee on Immunization last month said that a first dose of the AstraZeneca vaccine should be followed up with a dose of Pfizer or Moderna, partly to elicit a better immune response. Germany has made a similar recommendation.

Though the AstraZeneca vaccine is not the same as the Johnson & Johnson vaccine, they rely on similar technology.

And even among experts who don’t recommend the general public get a booster shot, some are recommending boosters for select patients.

Taormina, with DuPage Medical Group, said in the last couple of months she’s recommended Pfizer or Moderna shots to about half a dozen patients who had already gotten the Johnson & Johnson vaccine but are immunosuppressed and didn’t develop antibodies after getting it.

Doctors and health experts are hopeful more data in coming months will help show who, if anyone, needs boosters.

Some people, however, don’t want to wait, now that the delta variant is spreading. The delta variant now comprises more than half of new COVID-19 cases in the U.S., though Illinois had only 288 known cases due to delta as of Wednesday.

Peksoz, who is in his 40s, has already lost one close friend to COVID-19. Though Peksoz is healthy, the illness’s unpredictable nature makes him nervous. “I’ve seen very unhealthy friends have it and not even know it, and healthy friends who are in the hospital for 10 days,” he said.

Though Peksoz wants a shot of Pfizer or Moderna, he said he won’t likely get one at the moment. He doesn’t want to be dishonest about the fact that he already got a Johnson & Johnson vaccine, which he would potentially have to do to get another shot.

“I just don’t want to lie,” Peksoz said. “It’s a very upsetting situation where we have a surplus of vaccines, and a third of the country doesn’t even want vaccinations, and people who want to have better protection can’t get it.”

https://bangordailynews.com/2021/07/19/news/nation/some-who-got-johnson-johnson-vaccines-are-seeking-booster-shots-as-delta-variant-spreads-despite-cdc-guidance/

Albireo gets FDA OK for liver disease med

– Only once-daily drug indicated for the treatment of pruritus in PFIC –

– Commercial launch of Bylvay immediate; available for prescription in the coming days –

– Rare Pediatric Disease Priority Review Voucher issued to Albireo by the FDA –

– Company to host investor conference call on July 21 at 8:30 a.m. ET –

Albireo Pharma, Inc. (Nasdaq: ALBO), a rare liver disease company developing novel bile acid modulators, today announced U.S. Food & Drug Administration (FDA) approval of Bylvay (odevixibat), the first drug approved for the treatment of pruritus in all subtypes of progressive familial intrahepatic cholestasis (PFIC). Bylvay is a potent, non-systemic ileal bile acid transport inhibitor (IBATi), which does not require refrigeration and is easily administered as a once-daily capsule or opened and sprinkled onto soft foods. Albireo is launching Bylvay immediately to accelerate availability for the patients and families impacted by PFIC.

Conference Call
Albireo will host a conference call and webcast tomorrow, July 21, 2021 at 8:30 a.m. ET. To access the live conference call by phone, dial 877-407-0792 (domestic) or 201-689-8263 (international), and provide the access code 13720443. Live audio webcast will be accessible from the Albireo Media & Investors page ir.albireopharma.com/. To ensure a timely connection to the webcast, it is recommended that participants register at least 15 minutes prior to the scheduled start time. An archived version of the webcast will be available for replay on the Events & Presentations section of the Albireo Media & Investors page for three months following the event.

https://finance.yahoo.com/news/albireo-announces-fda-approval-bylvay-200000206.html

Delta variant now accounts for 83% of all sequenced Covid cases in U.S.: CDC

 The delta variant first identified in India is now estimated to make up 83% of all sequenced Covid-19 cases in the U.S., the director of the Centers for Disease Control and Prevention said Tuesday.

“This is a dramatic increase from up from 50%, the week of July 3,” CDC Director Dr. Rochelle Walensky said during a Senate hearing.

The surge in delta cases is leading to more deaths. Covid fatalities have risen by nearly 48% over the past week to an average of 239 per day, she said.

“Each death is tragic and even more heartbreaking when we know that the majority of these deaths could be prevented with a simple, safe, available vaccine,” she said.

Walensky said nearly two-thirds of the counties in the U.S. have vaccinated less than 40% of their residents, “allowing for the emergence and rapid spread of the highly transmissible delta variant.”

The variant is even more contagious than the alpha variant, which was first identified in the U.K. and was estimated by public health officials there to be between 43% and 90% more transmissible than the original Covid-19 strain. Discovered in October, delta has since spread to more than 100 countries, according to World Health Organization data.

“The reason it’s so formidable is the fact that it has the capability of transmitting efficiently from human to human in an extraordinary manner, well beyond any of the other variants that we’ve experienced, up to now,” Dr. Anthony Fauci, the White House’s chief medical advisor, said during the hearing.

https://www.cnbc.com/2021/07/20/delta-variant-now-accounts-for-83percent-of-all-sequenced-covid-cases-in-the-us-cdc-director-walensky-says.html

Immunome Antibody Cocktail (IMM-BCP-01) Neutralizes the SARS-CoV-2 Delta Variant in Pre-clinical Test

 IMM-BCP-01 already shown to neutralize all other CDC variants of concern in pre-clinical testing

IND submission planned for this quarter

https://finance.yahoo.com/news/immunome-antibody-cocktail-imm-bcp-110000804.html

NeuroMetrix Gets FDA Breakthrough Device Tag for Fibromyalgia Treatment with Wearable Neurostimulation Tech

 NeuroMetrix, Inc. (Nasdaq: NURO) today announced that its Quell® device has received Breakthrough Designation from the U.S. Food and Drug Administration (FDA) for treating the symptoms of fibromyalgia in adults.

Fibromyalgia is a common form of chronic pain that is also accompanied by fatigue, sleep, cognitive and mood disturbances. It affects an estimated 2 to 6 percent of the U.S. population (5 to 15 million people) and is most often diagnosed between the ages of 30 and 50. The cause of fibromyalgia remains unclear, but scientific studies point to abnormalities in the way the brain processes normal sensations and pain. Although several drugs are FDA approved for managing fibromyalgia pain, there is an unmet need for safe and effective non-pharmacological treatments.

Quell is an advanced, non-invasive, nerve stimulation device that is covered by 18 U.S. utility patents. It is the only wearable neurostimulator that is enabled by a custom designed microchip that provides flexible, precise, high-power nerve stimulation in a form factor the size of a credit card. Quell utilizes position and motion sensing to automatically adjust stimulation for an optimal patient experience both day and night. The device supports Bluetooth® low energy (BLE) to communicate with the Quell app, which is available for iOS and Android mobile devices.

https://finance.yahoo.com/news/neurometrix-receives-fda-breakthrough-device-130000711.html