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Wednesday, May 3, 2023

FTC Chair Lina Khan says she’s on alert for abusive A.I. use

 The Federal Trade Commission is on alert for the ways that rapidly advancing artificial intelligence could be used to violate antitrust and consumer protection laws it’s charged with enforcing, Chair Lina Khan wrote in a New York Times op-ed on Wednesday.

“Although these tools are novel, they are not exempt from existing rules, and the F.T.C. will vigorously enforce the laws we are charged with administering, even in this new market,” Khan wrote, echoing a theme the agency shared in a joint statement with three other enforcers last week.

In the op-ed, Khan detailed several ways AI might be used to harm consumers or the market that she believes federal enforcers should be looking for. She also compared the current inflection point around AI to the earlier mid-2000s era in tech, when companies like Facebook and Google came to forever change communications, but with substantial implications on data privacy that weren’t fully realized until years later.

“What began as a revolutionary set of technologies ended up concentrating enormous private power over key services and locking in business models that come at extraordinary cost to our privacy and security,” Khan wrote.

But, she said, “The trajectory of the Web 2.0 era was not inevitable — it was instead shaped by a broad range of policy choices. And we now face another moment of choice. As the use of A.I. becomes more widespread, public officials have a responsibility to ensure this hard-learned history doesn’t repeat itself.”

One possible effect enforcers should look out for, according to Khan, is the impact of only a few firms controlling the raw materials needed to deploy AI tools. That’s because that type of control could enable dominant companies to leverage their power to exclude rivals, “picking winners and losers in ways that further entrench their dominance.”

Khan also warned that AI tools used to set prices “can facilitate collusive behavior that unfairly inflates prices — as well as forms of precisely targeted price discrimination.”

“The F.T.C. is well equipped with legal jurisdiction to handle the issues brought to the fore by the rapidly developing A.I. sector, including collusion, monopolization, mergers, price discrimination and unfair methods of competition,” she wrote.

Khan also warned that generative AI “risks turbocharging fraud” by creating authentic-sounding messages. When it comes to scams and deceptive business practices, Khan said the FTC would not only look at “fly-by-night scammers deploying these tools but also at the upstream firms that are enabling them.”

Finally, Khan said that existing laws about improper collection or use of personal data will apply to the massive datasets on which AI tools are trained, and that laws prohibiting discrimination will also apply in cases where AI was used to make decisions.

https://www.cnbc.com/2023/05/03/ftc-chair-lina-khan-says-shes-on-alert-for-abusive-ai-use.html

MiMedx Group Reports Strong First Quarter 2023 Results and Plans for Growth

 As of May 3, 2023, MiMedx Group is a company that specializes in developing and marketing regenerative biomaterials and bioimplants made from human amniotic membrane and other birth tissues. The company’s first-quarter 2023 revenues hit $71.7 million, showing a 22% year-over-year growth rate and surpassing Zacks Small-Cap Research’s estimate. MiMedx Group’s net sales rose by 6.4% from $180M to $191M, while advanced wound care/section 361 net sales increased by 15.9% from $149M to $173M.

In the first half of 2022, MiMedx Group is expanding its portfolio with the launch of two new products. The company also aims to grow existing and new products into existing and new markets, including advanced wound care and surgical recovery. Zacks Small-Cap Research has raised its valuation of MiMedx Group to $12 per share based on increased estimates and applying a 20x 2026 EPS and 15x 2026 EBITDA discounted to present.

Despite the positive financial results, MiMedx Group’s loss from operations was ($3.4) million, which was negatively impacted by higher-than-expected investigation and restatement costs. The company’s net loss for the first quarter of 2023 was ($5.0) million, with a net loss per share of ($0.03).

In conclusion, MiMedx Group is a leading company in the field of regenerative biomaterials and bioimplants. With the launch of two new products and plans to expand into new markets, the company is poised for further growth. Zacks Small-Cap Research has raised its valuation of MiMedx Group, and the company’s first-quarter 2023 revenues have exceeded expectations.

MDXG’s stock rose by 20.53% on May 3, 2023, reaching a high of $5.20 and closing at $4.56. The day’s trading volume was 44,878. MDXG operates in the health technology industry, specifically in medical specialties, with its corporate headquarters located in Marietta, Georgia. MDXG’s next reporting date is August 1, 2023, and the EPS forecast for this quarter is -$0.02. The company’s annual revenue last year was $267.8M, and its annual profit was -$30.2M. The net profit margin for MDXG is -11.27%.

 MiMedx Group Inc (MDXG) had a median target price forecast of 9.75, with a high estimate of 16.00 and a low estimate of 7.00, according to data from CNN Money. This represents a +97.77% increase from the last price of 4.93. The current consensus among 3 polled investment analysts is to buy stock in the company

https://beststocks.com/mimedx-group-reports-strong-first-quarter-202/.

GSK nabs world-first approval for adult RSV vaccine Arexvy

 In landing an FDA approval for its highly anticipated respiratory syncytial virus (RSV) vaccine, GSK has both beat out its market rivals and initiated its next major launch.

Wednesday, the FDA blessed GSK's RSV shot Arexvy for use in adults over 60. It becomes the world's first RSV immunization for adults, beating out a closely watched program from Pfizer and another late-stage candidate from Moderna.

The FDA approved the shot based on phase 3 trial data showing it was 82.6% effective at preventing RSV-related lower respiratory tract disease in adults 60 and older. Protection against severe disease in the trial came in at 94.1%.

That phase 3 trial is ongoing to examine efficacy over three RSV seasons. So far, the shot has turned in "tremendous data," GSK's Leonard Friedland, M.D., vice president and director of scientific affairs and public health for vaccines, said in an interview.

With the approval, GSK is stepping into “the golden age” of vaccine development with “tremendous opportunities," Friedland said. Now, it'll be up to the company to turn its scientific know-how into actual vaccinations.

“And that’s going to be the work of the entire company and the scientific community to make that happen," he said.

RSV is under-recognized and under-diagnosed, so GSK hs already started its awareness efforts. Its campaign, called "Sideline RSV," is led by former basketball star Earvin “Magic” Johnson. Friedland calls Johnson a well-regarded public health figure, particularly in getting out messages to communities of color.

GSK plans to launch its vaccine ahead of the upcoming RSV season. RSV seasons typically peak from December to February.

But the company could soon have competition as Pfizer's rival candidate is up for an FDA decision this month. Moderna's shot has also passed a phase 3 study, but the company has yet to submit its program to regulators.

GSK isn’t concerned about the competition. In fact, having another horse in the race would be “fantastic” as it would provide more options to patients, Friedland explained.

Meanwhile, GSK believes supply won't be an issue as the company has prepared its production teams in anticipation of the approval.

“We’re absolutely confident that our supply will meet demand," Friedland said.

As for pricing, the company is looking to price the shot somewhere between the cost of a high-dose flu shot (around $60) and its shingles vaccine Shingrix (around $185). GSK is also working with insurance companies to ensure the vaccine is available and reimbursable.

In addition, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices is expected to discuss RSV guidance next month.

https://www.fiercepharma.com/pharma/beating-rival-pfizer-gsk-nabs-world-first-approval-adult-rsv-vaccine-arexvy

Why BioCryst Pharmaceuticals Stock Is Soaring

 Shares of BioCryst Pharmaceuticals (BCRX 12.14%) were up by a healthy 14% as of 1:40 p.m. ET Wednesday. The big gain came after the small-cap biotech reported first-quarter earnings ahead of the opening bell. 

Although it missed Wall Street's consensus top-line estimate by $2.6 million for the quarter, investors appear to be more concerned about BioCryst's overall financial health and near-term outlook.

BioCryst said that in Q1, the number of U.S. patients taking its oral hereditary angioedema (HAE) drug Orladeyo rose by 46% year over year. Meanwhile, its research and development expenses plunged by 26% due to the discontinuation of its BCX9930 and BCX9250 programs.

What's more, BioCryst secured $450 million in financing in April via a loan agreement with Pharmakon. Management said the funds will be used in part to pay off a debt to Athyrium, as well as for general corporate purposes.

From the perspective of current shareholders, this loan agreement is arguably a much-preferable way of gaining access to funds than, for example, a dilutive secondary stock offering. BioCryst's stock, after all, is still down by a whopping 43% from its 52-week highs, so this isn't exactly the best time to issue additional shares. 

Is BioCryst's stock still a buy? The good news is that Orladeyo appears to be capturing market share in its indication at a breakneck pace. Even so, BioCryst's story is likely to remain heavily dependent on this drug's commercial performance for years to come. That doesn't mean that the biotech can't be a winning pick for investors, but there are risks associated with such a heavy degree of revenue concentration. BioCryst stock, therefore, is arguably more suitable for those who are comfortable with that level of risk. 

https://www.fool.com/investing/2023/05/03/why-biocryst-pharmaceuticals-stock-is-soaring-toda/

Why Eli Lilly Shares Are Shooting Higher

 Eli Lilly And Co (NYSE: LLY) shares are trading higher in the premarket session Wednesday after it announced positive results of the TRAILBLAZER-ALZ 2 Phase 3 study of donanemab for Alzheimer's disease.

Donanemab met the primary endpoint of change from baseline until 18 months on the integrated Alzheimer's Disease Rating Scale (iADRS), measuring cognition and activities of daily living.

Earlier this year, the FDA issued a complete response letter for the accelerated approval submission of donanemab for early symptomatic Alzheimer's disease due to the limited number of patients with at least 12 months of drug exposure data provided in the submission.

No other deficiencies in the application were noted.

The company said that positive data from the Phase 3 TRAILBLAZER-ALZ 2 trial would form the basis of donanemab's application for traditional approval.

Donanemab treatment slowed clinical decline by 35% compared to placebo and resulted in 40% less decline on the ability to perform activities of daily living.

47% of participants on donanemab showed no decline on CDR-SB, a key measure of disease severity at one year (compared to 29% of participants on placebo).

Participants on donanemab experienced a 39% lower risk of progressing to the next stage of disease compared to placebo.

Donanemab significantly reduced brain amyloid plaque levels as early as six months after initiating treatment. 34% of participants in the intermediate tau population achieved amyloid clearance at six months and 71% at 12 months.

The study also enrolled a smaller number of people with high tau levels at baseline, representing a later stage of disease progression.

In this combined population, donanemab demonstrated meaningful positive results across all clinical endpoints, with CDR-SB and iADRS showing 29% and 22% slowing of decline, respectively.

https://finance.yahoo.com/news/why-eli-lilly-shares-shooting-135657103.html

Improvements in Attention, ADHD Symptoms, and Quality of Life with Akili EndeavorRx Video Therapy

 Attention improved in more than 80 percent of adults with ADHD, and over one-third of participants no longer exhibited an attention deficit following treatment

Improvements in attention were nearly seven times larger than those seen in the pivotal trial that supported EndeavorRx’s FDA authorization for 8-12 year olds with ADHD

Nearly half of adults treated with EndeavorRx met a prespecified threshold for clinically meaningful improvement in their quality of life

Akili, Inc. (Nasdaq: AKLI), a leading digital medicine company, today announced topline results of the STARS-ADHD-Adult clinical trial evaluating the efficacy and safety of EndeavorRx (AKL-T01) in adults with attention-deficit/hyperactivity disorder (ADHD). STARS-ADHD-Adult was designed as a pivotal clinical trial to enable registration with the U.S. Food and Drug Administration (FDA). The trial demonstrated statistically significant improvement in attention functioning after six weeks of treatment, achieving its predefined primary efficacy outcome. Significant improvements were also seen across a range of secondary and exploratory outcomes, including clinical assessments of ADHD-related symptoms and a validated measure of quality of life. EndeavorRx treatment was well-tolerated, with minimal side effects and no serious device-related adverse events reported.

https://finance.yahoo.com/news/adults-adhd-see-significant-improvements-110000284.html

Why Shares of LeMaitre Vascular Are Up

 Shares of LeMaitre Vascular (NASDAQ: LMAT) were up more than 16% as of 1:50 p.m. ET Wednesday after the healthcare company released its first-quarter earnings report on Tuesday. The medical device maker, which specializes in vascular devices, implants, and services, has seen its shares climb more than 40% this year.

The company had three items in the report that helped drive the stock up.

First, it reported quarterly sales of $47.1 million, up 19% year over year, though earnings per share (EPS) were $0.27, down 1% compared to the same period last year. 

The company also released guidance showing it expected second-quarter revenue between $47.1 million and $49.5 million, up 18% year over year at the midpoint, and full-year revenue between $187.1 million and $193.1 million, up 15% at the midpoint. It also gave EPS estimates, saying it expected EPS to be between $0.30 and $0.35 in the second quarter, a 103% increase at the midpoint, and yearly EPS of between $1.14 and $1.27, a rise of 29% at the midpoint.

The company also announced it was raising its quarterly dividend by 12% to $0.14, the 12th consecutive year the company has increased its dividend since it began having one in 2011. The yield on the dividend is around 1.02%.

LeMaitre Chairman and CEO George LeMaitre credited the reopening of hospital business as the COVID-19 pandemic abated and an increase in sales representatives for rising sales. The key for the company will be continuing that upward climb.

The company recently helped itself when it announced that last month that it had agreed to distribute porcine cardiac patches in the U.S. made by Aziyo Biologics. The patches are made to decrease inflammation and stimulate healthy tissue growth. The three-year deal includes an option to buy Aziyo's worldwide patch business in the second and third years of the deal. Last year, Aziyo sold $6.8 million worth of patches in the U.S.

https://www.fool.com/investing/2023/05/03/why-shares-of-lemaitre-vascular-are-up-wednesday/