Why Scholar Rock Stock Gain

 Shares of Scholar Rock Holding (SRRK 23.15%) had jumped by more than 25.8% as of 2:32 p.m. ET on Monday after it disclosed in a financial filing that one of its directors, a venture capital investor named Amir Nashat, had purchased upward of $5.87 million worth of the company's shares on June 22. Nashat also purchased 299,498 of its warrants, which can be exercised at a price of $7.35 through the end of 2025.

NASDAQ: SRRK

Scholar Rock Holding Corporation

Today's Change

(23.15%) $1.38

Current Price

$7.34

 SRRK

KEY DATA POINTS

Market Cap

$308M

Day's Range

$6.33 - $8.05

52wk Range

$4.33 - $44.95

Volume

4,309,236

Avg Vol

1,698,707

P/E (ttm)

The investor is a high-ranking executive at the venture capital group Polaris Partners, which invests in biotechnology businesses like Scholar Rock.

Plus, the shares and warrants are both held by the venture capital firm rather than by Nashat directly, though he does independently own a small number of shares. This means that there is a very good chance the biotech industry experts at Polaris Partners believe that Scholar Rock, which is one of their portfolio companies, is going to do something that makes its share price go way up.

Scholar Rock is currently running a phase 3 clinical trial investigating whether its candidate called apitegromab is safe and effective for treating spinal muscular atrophy (SMA). For a major investor to double down, it's likely that management is seeing something quite favorable in the interim results. 

But Scholar Rock has kept mum so far, and the trial won't be done until June 2024 at the very earliest. Keep an eye out for any releases about how things are going, as they're likely to bode extremely well for the drug's eventual approval.

https://www.fool.com/investing/2022/06/27/why-scholar-rock-stock-flew-high-today/

Kezar: Positive Topline Results from Phase 2 Lupus Trial

 

• 11 of 17 patients (64.7%) achieved an overall renal response of 50% or greater reduction in urine protein to creatinine ratio (UPCR) at 6 months

• 6 of 17 patients (35.2%) achieved a complete renal response, including a UPCR of 0.5 or less at 6 months
  
  

• Zetomipzomib continues to demonstrate a favorable safety and tolerability profile for administration over the 6-month treatment period
  
  

• Improvement seen in exploratory measures of extra-renal disease activity associated with systemic lupus erythematosus (SLE) in patients who completed treatment
  
  

• Company-hosted conference call and webcast to be held today at 4:30 p.m. ET

Kezar Life Sciences will host a webcast and conference call today, June 27, 2022, at 4:30 p.m. ET to discuss topline data from the MISSION Phase 2 clinical trial. To access the audio webcast with slides, please visit the "Events & Presentations" page in the Investors & Media section of the Company’s website at https://ir.kezarlifesciences.com/news-events/events-presentations. The call can also be accessed by dialing +1 (800) 309-0220 (domestic) or +1 (805) 309-0220 (international) with conference ID 6423042#.

https://finance.yahoo.com/news/kezar-life-sciences-announces-positive-200100306.html

CVS, Walmart Limit Purchases of Plan B Pills After Surge in Demand

 Some of the nation’s biggest retailers are rationing over-the-counter emergency contraceptive pills as demand spikes following the Supreme Court ruling overturning a constitutional right to abortion.

CVS Health Corp. CVS 0.02%▲ and Walmart Inc. WMT 0.32%▲ were limiting purchases of the pills, which were in short supply or out of stock Monday morning on major retailer websites. CVS was limiting purchases to three. Walmart had some pills available without limits, but only in cases where they wouldn’t ship until next month. Pills available this week were limited to four or six.

https://www.wsj.com/articles/cvs-walmart-limit-purchases-of-plan-b-pills-after-surge-in-demand-11656358819

Otsuka, Lundbeck Tout Positive Phase III Results for Alzheimer's Drug

 Otsuka Pharmaceutical and Lundbeck announced positive Phase III clinical trial results Monday regarding brexpiprazole (Rexulti) as a treatment for agitation in patients with Alzheimer’s dementia. The companies plan to submit a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration based on the results.

Brexpiprazole is being co-developed by the two companies and is approved for a variety of mental health indications. The therapeutic was originally approved by the FDA for the treatment of schizophrenia and as an adjunctive therapy for major depressive disorder in adults. Earlier this year, an sNDA for brexpiprazole as a treatment for schizophrenia in patients ages 13 to 17 was approved.

In 2018, Otsuka and Lundbeck began a 12-week Phase III trial to investigate the drug’s use in reducing agitation in Alzheimer’s patients, a difficult symptom of the disease. Agitation is reported in about 45% of patients with the disease and is associated with poor caregiver outcomes. Agitation covers a broad spectrum of behaviors including pacing, restlessness, profanity, shouting and shoving or hitting.

The trial population planned to include 330 individuals ages 55 to 90 with probable Alzheimer’s disease. In early 2016, the FDA granted Fast Track Designation for brexpiprazole for the treatment of agitation in patients with Alzheimer’s dementia.

Although full study results are not yet available, the companies have announced that an analysis demonstrated a statistically significant difference in mean changes from baseline to week 12 of the trial in an assessment of agitation, meaning that those taking the drug experienced a reduction in agitation. The companies stated that further prespecified and exploratory analyses of the data set will be conducted to examine other potentials the drug could provide to Alzheimer’s patients.

The drug was well-tolerated, and headaches were the treatment-emergent adverse events that occurred with more than 5% incidence in patients. Otsuka and Lundbeck will submit an sNDA to the FDA based on its results and the results of two earlier trials and plan to publish the findings in a scientific journal.

Brexpiprazole is a small molecule that modulates serotonin-dopamine activity at several receptors. It is a partial agonist at the serotonin 5-HT1A and dopamine D2 receptors and an antagonist of serotonin 5-HT2A and noradrenaline receptors. All three neurotransmitter systems may be involved in the behavioral symptoms seen in patients with Alzheimer’s.

Some researchers have posed that agitation in patients is caused by the erosion and destruction of serotonergic pathways, which leads to an imbalance of the serotonergic-dopaminergic axis. Others have investigated the use of antidepressants in reducing agitation in Alzheimer’s patients.

Brexpiprazole is also being investigated for the treatment of post-traumatic stress disorder (PTSD) by Lundbeck and Otsuka for a reduction in re-experiencing symptoms as well irritability. It is also being studied in pediatric autism for the reduction of irritability symptoms. Additionally, Avanir Pharmaceuticals, a subsidiary of Otsuka, is investigating AVP-786 for the reduction of agitation in Alzheimer’s dementia, a different type of therapy for the symptom.

https://www.biospace.com/article/otsuka-lundbeck-have-positive-phase-iii-results-for-alzheimer-s-drug/

Supreme Court sides with doctors convicted of over-prescribing pain medications

 The Supreme Court on Monday sided with two doctors challenging their convictions on drug distribution charges for over-prescribing opioid medications in a decision that could make it harder for federal prosecutors to prove such cases against licensed physicians.

The court was unanimous in ruling for the two doctors but split 6-3 on narrower legal issues in the decision. The justices stopped short of overturning the convictions, instead sending them back to the lower courts to reexamine the legal challenge in light of Monday’s decision.

Justice Stephen Breyer wrote the decision for the majority, ruling that in cases where someone who is authorized to prescribe medication is being prosecuted under the Controlled Substances Act, prosecutors must prove “beyond a reasonable doubt that the defendant knowingly or intentionally acted in an unauthorized manner.”

“We normally would not view such dispensations as inherently illegitimate; we expect, and indeed usually want, doctors to prescribe the medications that their patients need,” Breyer wrote. “In §841 prosecutions, then, it is the fact that the doctor issued an unauthorized prescription that renders his or her conduct wrongful, not the fact of the dispensation itself. In other words, authorization plays a ‘crucial’ role in separating innocent conduct—and, in the case of doctors, socially beneficial conduct—from wrongful conduct.”

Breyer was joined in the opinion by Chief Justice John Roberts as well as Justices Sonia Sotomayor, Elena Kagan, Neil Gorsuch and Brett Kavanaugh.

Prosecutors alleged that the two doctors — Xiulu Ruan and Shakeel Kahn, who were tried separately — ran lucrative “pill mills,” flooding their patients with prescriptions for fentanyl and other serious pain management medications.

Ruan and Khan were convicted by juries and each received sentences of more than 20 years in prison. They challenged their convictions, arguing that the instructions the juries received risked criminalizing standard medical and prescription practices.

https://thehill.com/regulation/court-battles/3538250-supreme-court-sides-with-doctors-convicted-of-over-prescribing-pain-medications/

Judge blocks Louisiana trigger law banning abortion

 A Louisiana judge blocked enforcement on Monday of statewide abortion ban designed to automatically go into effect when Roe fell.

Two abortion rights groups on Monday filed a challenge to Louisiana’s trigger law, which went into effect following the Supreme Court decision in Dobbs v. Jackson Women’s Health Organization that struck down the federal right to abortion.

The Center for Reproductive Rights and Boies Schiller Flexner LLP requested emergency relief allowing providers in the state to continue providing abortions and patients to access the procedure.

In an email after the judge’s decision Monday, the Center for Reproductive Rights said, “Abortion care will resume in the state and a hearing has been set for July 8th.”

The groups, filing on behalf of organizations such as Hope Medical Group for Women and Medical Students for Choice, asked the court to review the state’s trigger laws and determine what options exist for lifesaving care that requires aborting a pregnancy.

Louisiana Attorney General Jeff Landry tweeted shortly after Friday’s decision that “Louisiana’s trigger law banning #abortion is now in effect.”

Louisiana was among more than a dozen GOP-led states that quickly enacted trigger laws either banning or severely restricting abortion within their borders.

https://thehill.com/policy/healthcare/3538276-abortion-rights-proponents-challenge-louisiana-trigger-laws/

UnitedHealth’s Optum looks to cut down on unnecessary lab testing

 

• Optum is launching a new program to help insurers cut down on “unnecessary lab testing,” a move it says will save insurers $3 billion annually.
• The program is intended to address the lack of oversight as new genetic tests enter the market, said Optum, a division of UnitedHealth Group, parent company to the nation’s largest private insurer.
• The aim is to ensure physicians are guiding patients to tests that are clinically proven, avoiding unnecessary tests that can lead to incorrect results and unnecessary follow-up interventions, Optum said.

The move comes on the heels of a New York Times investigation that showed prenatal testing results are frequently wrong.

The newspaper analyzed results from five screening tests and found they were inaccurate between 81% and 93% of the time, leaving some expectant mothers to panic about the health of their unborn child, which resulted in more testing.

In April, the Food and Drug Administration warned the public about prenatal tests that screen for genetic abnormalities.

Even though the tests are widely used, they “have not been reviewed by the FDA and may be making claims about their performance and use that are not based on sound science,” Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said in an April statement.

The increased use of these tests and lack of oversight is where Optum sees an opportunity.

“Testing is expanding so rapidly that most clinicians do not have the bandwidth to stay up-to-date on which ones are the highest quality,” Jill Hagenkord, chief medical officer of Optum Genomics, said in a statement.

Optum says roughly 13 billion clinical lab tests are performed each year and 30% are unnecessary.

Laboratory operators could be challenged as Optum aims to crack down on testing.

Clinical laboratory chain Quest Diagnostics said that it’s committed to appropriate use of laboratory tests.

“We provide several solutions to help health plans and providers optimize laboratory test utilization, engage members in preventive care, and reduce costly out-of-network utilization,” Quest said in a statement to Healthcare Dive.

https://www.healthcaredive.com/news/unitedhealth-optum-cut-down-unnecessary-lab-testing/626080/