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Thursday, April 7, 2022

Rite Aid shares tank on Deutsche Bank downgrade

 Rite Aid shares plunged on Thursday after Deutsche Bank downgraded the pharmacy retail chain and cut the stock's price target ahead of the release of its quarterly results next week.

TickerSecurityLastChangeChange %
RADRITE AID CORP.6.64-1.80-21.36%

The big bank downgraded Rite Aid from "hold" to "sell" and cut its price target to $1 per share from $16. Shares fell more than 20% to $6.61 on Thursday.

According to Deutsche Bank analyst George Hill, Rite Aid's guidance for fiscal year 2023 will be investors' key focus. The company previously indicated it could generate well over $430 million in earnings before interest, taxes, depreciation and amortization (EBITDA).

Hill notes that the company needs to generate about $400 million to $450 million in annual adjusted EBITDA to continue as an operating company, including $190 million to $200 million in cash annually to cover its debt service costs, plus another $200 million to $250 million to cover its store maintenance capital expenditure requirement.

"At a number below $400mm, the equity arguably has no value as the company is not in a position to generate real returns to shareholders," he wrote in a note to clients Thursday. "Unfortunately, we believe Covid has hastened the decline of the retail pharmacy segment and we see the potential for a dramatic negative inflection point for RAD shares as this preliminary F2023 outlook seems to be unattainable."

Deutsche Bank warned that Rite Aid faces operational challenges on multiple fronts, including rising labor costs, higher retail shrink and continued reimbursement pressure.

"We are also increasingly concerned with 340B derived earnings as we expect more manufacturers will decide to pull back providing discounts to 340B contact pharmacies going forward,"  Hill continued. "Rite Aid could also have some exposure to opioid litigation and related penalties/settlements, as the prosecution of these cases has now moved on from the drug wholesalers and downstream to the retail pharmacies, with CVS announcing a near half-billion dollar settlement with the state of Florida last week."

The firm estimates that Rite Aid's adjusted EBITDA for 2023 will come in at $377 million.

https://www.foxbusiness.com/markets/rite-aid-stock-tanks-on-deutsche-bank-downgrade

Aptinyx discovers the perils of the data dredge

 Investors, alarmed by the failure of Aptinyx’s NYX-2925 in diabetic peripheral neuropathy, have sent the group’s stock down 48% so far today. But their surprise is itself somewhat surprising. The phase 2b study always looked like a big risk since an earlier phase 2a trial of the NMDA modulator failed; it was a post-hoc analysis of this that spurred Aptinyx to push on. Now ’2925 has failed to beat placebo on change from baseline in average daily pain on the numeric rating scale after 12 weeks of treatment, and the project appears to be toast in this indication. But Aptinyx still believes that the agent might have a chance in fibromyalgia, according to Leerink analysts, who write that because fibromyalgia is primarily driven by abnormal pain processing in the brain NYX-2925 might have a stronger rationale here than in neuropathy. A phase 2b trial of ’2925 is due to read out in the summer. The group also has two other NMDA modulators in trials due to report by the end of next year; it says it will “manage [its] existing balance sheet” to enable it to get to the finish line of these trials. 

Looking shaky: Aptinyx's NMDA modulators
ProjectIndicationTiming
NYX-2925Diabetic peripheral neuropathyPh2b failed Apr 2022, after ph2 failure in 2019 
FibromyalgiaPh2b data due Q3 2022
NYX-458Cognitive impairmentPh2 data due late 2022/Q1 2023
NYX-783Post-traumatic stress disorderPh2/3 data due H2 2023, previous ph2 trial failed
Source: Evaluate Pharma & clinicaltrials.gov.

https://www.evaluate.com/vantage/articles/news/trial-results-snippets/aptinyx-discovers-perils-data-dredge

Whitmer asks state Supreme Court to decide whether abortion is constitutional

 Michigan Gov. Gretchen Whitmer (D) announced on Thursday that she is requesting that the state’s Supreme Court make a decision on the constitutionality of abortion.

According to Whitmer’s office, she is using a power she has as governor known as an “executive message” to request that Michigan’s Supreme Court take the question of whether the procedure is constitutional out of the state’s trial courts and make its own decision. 

“If Roe is overturned, abortion could become illegal in Michigan in nearly any circumstance—including in cases of rape and incest—and deprive Michigan women of the ability to make critical health care decisions for themselves,” Whitmer, who is up for reelection this year, said in a statement to reporters on Thursday.

“This is no longer theoretical: it is reality. That’s why I am filing a lawsuit and using my executive authority to urge the Michigan Supreme Court to immediately resolve whether Michigan’s state constitution protects the right to abortion.”

Whitmer’s office notes that the move marks a departure from various GOP-led states moving to restrict access to the procedure at a rapid pace. 

Texas, Arizona, Kentucky and Idaho have moved to restrict abortion access in their states. On Tuesday, the Oklahoma Legislature gave the green light to a bill that would make performing an abortion a felony, punishable by up to 10 years in prison. The only exception to the proposed legislation is if the life of the mother is in danger. 

Additionally, the U.S. Supreme Court is slated to rule on Dobbs v. Jackson Women’s Health Organization, which centers on the constitutionality of a Mississippi law that bans abortion after 15 weeks of pregnancy. 

If the high court, which has a 6-3 conservative majority, rules in favor of Mississippi, it could result in states chipping away at abortion rights. 

In Michigan, a 1931 law criminalizing abortion, except when the life of the mother is at risk, is still on the books. However, the 1973 landmark abortion case Roe v. Wade blocks the 1931 law and legalizes abortion in the state. 

Whitmer and her allies warn that if Roe v. Wade is rolled back or overturned, the 1931 law criminalizing abortion will go back into effect. 

“If the U.S. Supreme Court refuses to protect the constitutional right to an abortion, the Michigan Supreme Court should step in,” Whitmer said. “We must trust women—our family, neighbors, and friends—to make decisions that are best for them about their bodies and lives.”

https://thehill.com/news/state-watch/3261365-whitmer-asks-state-supreme-court-to-decide-whether-abortion-is-constitutional/

Tenn. Senate passes bill to allow over-the-counter sales of ivermectin

 A local lawmaker has co-sponsored a bill that would allow ivermectin to be sold over the counter in Tennessee without a prescription. On Wednesday, the bill co-sponsored by Sen. Rusty Crowe (R-Johnson City) was passed by the state Senate.

Senate Bill 2188 was introduced by Sen. Frank Niceley (R-Strawberry Plains) on Jan. 31. Crowe became one of the bill’s co-sponsors as it made its way past committees in the Senate. It passed in the Senate with a vote of 23-6.

The bill would authorize “ivermectin suitable for human use” to be sold or bought as an over-the-counter medication in Tennessee without a prescription. Pharmacists and other licensed healthcare providers would not be required to provide a consultation prior to the sale either.

“Sales will be pursuant to each pharmacist’s physician collaborative agreement, and to procedures that will be developed by the Tennessee Board of Pharmacy,” a release from the Senate Republican Caucus states in reference to the bill’s passage in the Senate.

The release states that under the bill, any pharmacist or prescriber who acts in good faith would be immune to disciplinary actions or civil liability related to the sale of ivermectin.

“Ivermectin is one of the many therapeutic options like vaccines, monoclonal antibodies, and anti-virals that have proven to be effective in the treatment of COVID-19,” Crowe stated in the release. “This bill will provide for a safe and effective way for patients to quickly access ivermectin over the counter and under the supervision of their pharmacists and the physician with whom the pharmacists have their collaborative agreement.”

The Food and Drug Administration (FDA) has advised against using ivermectin as a treatment for COVID-19. According to the FDA, ivermectin tablets have been approved “at very specific doses” for the treatment of some parasitic worms, as well as a topical formula for lice and certain skin conditions. However, the FDA reports that data does not suggest ivermectin is effective against COVID-19, with trials related to using it as a treatment remain ongoing.

The FDA has warned that taking large doses of ivermectin is, in fact, dangerous. Further, the FDA warns anyone from taking medication intended for animals as the products differ.

In a March 30 article, ABC News reported on a study published by the New England Journal of Medicine. That study found that ivermectin did not reduce the risk of being hospitalized with COVID-19.

The study was based on 1,300 patients, some of whom were given ivermectin and others a placebo. Ultimately, the study concluded that there was no difference in hospitalization risk found between the two groups.

In the release from the Senate Republican Caucus, both Crowe and Niceley stated that ivermectin is effective.

“Ivermectin is cheap, safe, and effective,” Niceley said. “This bill lets the pharmacist prescribe the correct dose for a patient’s condition, and takes into consideration the patient’s preexisting conditions and the medications they are currently taking. I sincerely hope that this bill can be helpful to the people that we all represent.”

The House version of the bill has been placed on the regular calendar for consideration on Thursday

https://thehill.com/news/state-watch/3261642-tennessee-senate-passes-bill-to-allow-over-the-counter-sales-of-ivermectin/

Vulnerable Senate Democrats undercut Biden on Title 42

 Moderate Democrats are undercutting the Biden administration’s months of careful messaging on Title 42 that cast its retention of the Trump-era policy as a public health necessity rather than a border management tool. 

The Centers for Disease Control and Prevention (CDC) announced Friday it would on May 23 rescind the order that blocks migrants from seeking asylum in the U.S. as the country learns to mitigate the effects of the coronavirus pandemic.

But rather than view it as a public health victory, some moderate Democrats see a huge political liability, leaving them furious that the White House ended policy ahead of a tough midterm election.

In the days since the decision, Democratic Senate moderates have warned of chaos at the border, echoing talking points previously pushed largely by the GOP.

Sen. Joe Manchin (D-W.Va.) called it a “frightening decision.” Sen. Mark Kelly (D-Ariz.) called it “wrong.” And Sen. Maggie Hassan (D-N.H.) said the Biden administration “does not appear to be ready” for the surge in migration that could result. Kelly and Hassan both face difficult reelection battles in November.

For advocates who have long argued the policy was an illegal and inhumane holdover, moderate Democrats are finally saying the quiet part out loud.

“A lot of the pushback on Title 42 shows it has nothing to do with public health and is viewed purely as a migration deterrent policy, which is completely illegal. So a lot of those statements prove our point: that this policy had nothing to do with public health and everything to do with evading U.S. refugee law,” Kennji Kizuka with Human Rights First said.

The friendly fire is in many ways a result of the Biden administration’s failure to define the Trump-era policy for itself, at once decrying it as a bad immigration tool and defending it as a public health necessity.

Few observers believed either the Trump or Biden administrations’ insistence on the public health reasoning, but the growing debate over Title 42 gave the policy notoriety that is now being exploited by Republicans as a political cudgel.

It’s forced vulnerable Democrats up for reelection this year to break from colleagues who have spent months furious with the Biden administration for keeping the policy in place.

“I am concerned that there is not a sufficient plan in place to address the steep increase in border crossings that could result from this reported decision,” Hassan said even before the move was formally announced. 

“This preemptive repeal threatens border security at a time when the administration should be focused on strengthening it.”

Others have likewise talked about the policy almost exclusively in migration terms.

“I think this is not the right time, and we have not seen a detailed plan from the administration. We need assurances that we have security at the border and that we protect communities on this side of the border,” Sen. Raphael Warnock (D-Ga.), who is also in a tight race, said. “I think this is the wrong time, and I haven’t seen a plan that gives me comfort.”

And Sen. Catherine Cortez Masto (D-Nev.) blasted the decision despite previously signing on to letters pushing to rescind the Trump-era policy.

“This is the wrong way to do this and it will leave the administration unprepared for a surge at the border,” she said in a statement this week.

“We should be working to fix our immigration system by investing in border security and treating immigrant families with dignity. Instead, the administration is acting without a detailed plan.”

Cortez Masto joined a letter written just a few months into the Trump administration’s use of Title 42 that referred to it as the “CDC asylum ban” and warned it was “designed to further an ongoing agenda to exclude asylum seekers.”

In announcing why she signed on to the letter Cortez Masto, said former President Trump had “dismantled the United States’ asylum system” and called for the policy’s reversal.

While most observers expected Democratic senators like Manchin and Sen. Kyrsten Sinema (Ariz.) to oppose the termination of Title 42, many were surprised to see the likes of Cortez Masto and Warnock jump on the border security bandwagon.

Immigration advocates have spent the last year blasting the Biden administration over its continued use of Title 42, warning the policy could be a factor in depressing the turnout of immigration-conscious voters in November.

The issue could play a crucial role among Hispanic voters in states like Arizona, Nevada or Georgia, where the Latino vote could tip the scales in close Senate elections.

“Just about any Democrat in America today needs Latinos to vote for them to win an election, and Latinos are following the Title 42 stuff pretty closely,” said Kristian Ramos, a Democratic strategist and founder of Autonomy Strategies.

“They care about immigration. They care about making sure that our country is honoring our tradition of always helping those who needed help. And they’re watching, they’re listening and they’re seeing who’s on their side and who isn’t,” added Ramos.

And the Biden administration’s repeated claims that Title 42 is a public health provision have fallen on deaf ears, meaning senators opposing its termination will essentially be arguing in favor of blocking the right to asylum.

“Most people commenting on Title 42 have abandoned the pretense that it’s about public health and not immigration, and we have to remember that the CDC doesn’t have the authority to set our immigration law,” said Aaron Reichlin-Melnick, policy counsel with the American Immigration Counsel.

“And those calling for keeping Title 42 in place as an immigration deterrent don’t care about Title 42 because of public health, but want to keep it in place because there are too many people that want asylum.”

Sen. Jon Tester (D-Mont.) was one of the few to nod to the pandemic while expressing concern over the effect on the border.

“Ending Title 42 is expected to cause a significant increase of migration to the United States and put more pressure on an already broken system. These problems do not only affect the southern border, but put more strain on those working to secure the northern border as well,” he wrote in a letter to the Department of Homeland Security (DHS) asking how it plans to address staffing shortages and ensure that too many personnel are not diverted from the northern border.

“Title 42 is an emergency order and should not stay in effect indefinitely, especially as we continue making headway in combating the COVID-19 pandemic. But we should not end this policy without ample preparation,” Tester added.

Calls for the administration to prepare for an upcoming surge at the border are most likely attempts at a preemptive remedy assuming a migratory uptick does materialize, whether spurred by the termination of Title 42 or not.

DHS, while acknowledging higher border apprehension numbers are likely, has tried to shift focus toward expansion of asylum processing and better border management, regardless of immigration numbers.

But vulnerable Democrats are unlikely to stop Republican attacks by targeting the administration’s termination of Title 42.

“Republicans are always going to be embracing fear and demagoguery on this issue. Democrats should expect that. Democrats need to stand up for what they believe in or the convictions many of them are stated in the past that they stand for. We have to show we care about and where our values are,” Ramos said.

And Republicans vowed to strike at vulnerable Democrats despite their criticism of Biden’s move.

“It’s too little too late for Democrats trying to change course with empty rhetoric. Vulnerable Democrats are trying to distance themselves from Biden’s failure that they enabled, but voters know they are in lockstep with Biden’s agenda,” said Republican National Committee spokeswoman Nicole Morales.

Regardless of Title 42, border management will remain a challenge for the Biden administration and beyond, border and migration experts said.

“There are no silver bullets, no buttons that can be pushed, no wands that can be waved. You cannot solve this problem overnight, and we need to have a conversation with the American public about that,” Reichlin-Melnick said.

https://thehill.com/latino/3261056-vulnerable-senate-democrats-undercut-biden-on-title-42/

Tonix starts next stage of Phase 3 for fibromyalgia management med

 Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced that the first participant was enrolled in the Phase 3 RESILIENT study of TNX-102 SL1 (cyclobenzaprine HCl sublingual tablets) 5.6 mg for the management of fibromyalgia.

RESILIENT is the Company’s potentially pivotal Phase 3 study of TNX-102 SL, a proprietary sublingual tablet formulation of cyclobenzaprine HCl taken daily at bedtime for the management of fibromyalgia. An interim analysis by an Independent Data Monitoring Committee of the first 50% of enrolled patients for a potential sample size readjustment or early stop for futility is expected in the first quarter of 2023.

TNX-102 SL is in mid-Phase 3 development for the management of fibromyalgia. In December 2020, Tonix reported positive results from the first Phase 3 study (RELIEF) of TNX-102 SL 5.6 mg for the management of fibromyalgia (primary endpoint, p=0.010). Several secondary measures in RELIEF highlighted the broad effects of TNX-102 SL across several cardinal symptoms of fibromyalgia beyond pain. In March 2022, Tonix reported results of a subsequent Phase 3 study (RALLY) in which TNX-102 SL did not achieve statistical significance on the primary endpoint (p=0.115). Relative to the previous positive Phase 3 study (RELIEF), RALLY had an unexpected increase in study participant adverse event-related discontinuations in both the drug and placebo groups.

https://finance.yahoo.com/news/tonix-pharmaceuticals-initiates-enrollment-resilient-110000355.html

FDA 'Urges' Transition to Throw-Away Duodenoscopes

 In an updated safety communication, the FDA urged healthcare providers to complete the transition from fixed endcap duodenoscopes to "innovative" designs, including fully disposable duodenoscopes and those with single-use components.

Duodenoscopes are used in more than 500,000 endoscopic retrograde cholangiopancreatography procedures each year in the U.S. Newer duodenoscope models can reduce the risk of patient infection compared with older fixed endcap models, which are no longer marketed in the U.S., but continue to be used by healthcare facilities.

In 2015, the FDA ordered manufacturers of reusable duodenoscopes to conduct postmarket surveillance studies to determine contamination rates due to features that made them difficult to clean. Final results from these studies found that up to 6.6% of samples tested positive for organisms of high concern after reprocessing.

Postmarket surveillance studies were again ordered in 2019 to determine if the new disposable endcap designs reduced contamination. Interim results for one model showed that only 0.5% tested positive for high-concern organisms.

"Given the cleaning concerns and contamination data with fixed endcap duodenoscopes and the increasing availability of duodenoscope models that facilitate or eliminate the need for reprocessing, hospitals and endoscopy facilities should complete transition to innovative duodenoscope designs that include disposable components such as disposable endcaps, or to fully disposable duodenoscopes," the FDA noted.

"Emerging data ... suggests that the best solution to reducing the risk of disease transmission by duodenoscopes is through innovative device designs that make reprocessing easier, more effective, or unnecessary," they added.

Transition programs were developed by duodenoscope manufacturers after the Olympus TJF-180V duodenoscope was recalled due to adhesive deterioration, which may increase the risk of contamination.

Pentax is also withdrawing two devices (ED-3490TK and ED34-i10T), while Fujifilm withdrew its fixed endcap duodenoscope (ED-530XT).

The FDA has currently cleared seven fully disposable duodenoscopes or models with disposable components.

The agency recommends that healthcare providers implement periodic maintenance and routine inspection schedules, per the manufacturers' instructions. In addition, reprocessing instructions should be "meticulously" followed, and a quality control program for monitoring sampling and microbiological culturing should be developed.

Furthermore, supplemental sterilization in accordance with device labeling should be considered.

https://www.medpagetoday.com/gastroenterology/generalgastroenterology/98089