FTSE 100 Closes Week in Green; UK Retail Sales, Business Activity Contract

MT Newswires

UK stocks ended the week on a positive note, with the FTSE 100 index up 1.44% at Friday's close, despite downbeat data on the retail sector and the private sector economy.

Britain's monthly retail sales fell more than expected in October, with the index down 0.7%, compared with the 0.1% rise in September and the consensus estimate of a 0.3% decline. Retailers across different industries suggested that uncertainty around the Budget announcement on Oct. 30 and low consumer sentiment impacted sales, according to the Office for National Statistics.

Meanwhile, UK private sector companies recorded a slight decrease in business activity in November, with the flash composite PMI down to a 13-month low of 49.9 from the previous reading and consensus of 51.8. The manufacturing and services sectors also reached the lowest readings in nine and 13 months, respectively, S&P Global data showed.

"The first survey on the health of the economy after the Budget makes for gloomy reading. Businesses have reported falling output for the first time in just over a year while employment has now been cut for two consecutive months," according to S&P Global Market Intelligence Chief Business Economist Chris Williamson. "The November PMI is indicative of the economy slipping into a modest decline, with GDP dropping at a 0.1% quarterly rate, but the loss of confidence hints at worse to come - including further job losses - unless sentiment revives."

In contrast, the GfK Consumer Confidence Index for the UK improved by three points in November to -18, with all measures up compared with the October data. Analysts expected the figure to stand at -22.

On the corporate front, Games Workshop Group jumped 15.29% after disclosing that its trading since its September update was ahead of expectations. The British miniature wargames maker expects its core revenue, licensing revenue, and pretax profit for the six months to Dec. 1 to be higher than the year-ago figures.

GSK's respiratory syncytial virus vaccine obtained approval in Japan for expanded use in adults aged 50 to 59 years who are at increased risk of severe RSV disease. The vaccine has been approved in the country for adults aged at least 60 since September 2023. The British drugmaker gained 2.44% at Friday's close.

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GSK's RSV Vaccine Approved for Japanese Patients in Their 50s

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GlaxoSmithKline

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Japan Grants Expanded Approval to GSK's RSV Vaccine for Adults

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Weight loss drug makers still have huge upside, and the market overreacted to RFK Jr. named to top health role, BMO says

Business Insider

Shares of obesity drug makers have tumbled since Trump picked RFK Jr. to lead HHS.
Investors are fearful Kennedy's critical stance on the drugs could impact pricing or Medicare coverage.
Yet, BMO says the sell-off was overdone, and argues the role will have limited impact on the drugs.

Shares of pharmaceutical companies that produce popular weight loss drugs have tumbled since president-elect Donald Trump named Robert F. Kennedy Jr. to lead the Department of Health and Human Services, but analysts at BMO Capital Markets said this week that the selloff is overdone.

Since Kennedy's nomination last Thursday, stocks like Wegovy and Ozempic maker Novo Nordisk and Zepbound maker Eli Lilly have lost 3% and 7%, respectively. Other weight loss drug stocks like Amgen and Structure Therapeutics, meanwhile, have fallen 5% and 13%.

The selloffs "reflect more fear than real fundamental downside risk," the analysts argued in a note.

They say Kennedy's role as the top health leader in the US comes with limited ability to actually change policy that would impact the pricing and availability of the drugs. As a result, there is likely little risk to the shares of companies like Eli Lilly and Novo Nordisk.

"The head of HHS is typically a more administrative position," the analysts said.

Kennedy has previously pledged to fight obesity with nutrition instead of GLP-1 drugs. In an interview with Fox News last month, he pointed to a bill that would make Ozempic available to overweight Americans, which would cost $3 trillion per year, he said. He suggested those funds would be better used for other initiatives.

"If we spend about one-fifth of that giving good food, three meals a day to every man, woman, and child in our country, we can solve the obesity and diabetes epidemic overnight for a tiny fraction of the cost," he said.

In reality, though, the health secretary has limited actual authority to influence either GLP-1 drug pricing or the passage of future bills like the Treat and Reduce Obesity Act, which expands Medicare coverage to cover weight loss drugs, the BMO analysts said.

If a public health emergency was declared, the secretary could adjust Medicare reimbursement for some "Part B" drugs, but weight loss drugs fall under "Part D," the analysts say.

"While RFK Jr. appears less optimistic on the use of incretins to curb the obesity crisis, he remains limited in his ability to influence either policy or pricing of obesity medications," the analysts said.

As a result, weight loss drugs still have massive potential, the analysts said, pointing to Novo Nordisk's recent Wegovy launch in China, which has a largely untapped potential market of around 180 million obese adults.

"Importantly, China's national healthcare will not cover Wegovy, and upcoming patent expiration may limit long-term sales in the geography, but we continue to highlight the significant size of patient population and prevalence of cash payment in China may be a tailwind that benefits Novo going forward," the analysts say.

The analysts maintain their $156 price target for Novo Nordisk stock, implying 52% upside from current levels, as well as a price target of $1010 for Eli Lilly, a potential 38% rise.

Kennedy's nomination also sparked a sell-off in health stocks more broadly, particularly among vaccine makers like Moderna, Pfizer, and GSK, as well as a range of European healthcare stocks with exposure to the US market. Kennedy has been a vocal skeptic of vaccines, once calling those that protect against COVID-19 a "crime against humanity."

The sector's losses stand out from much of the rest of the market, which has rallied on the hopes that Trump's deregulatory policies and corporate tax cuts will boost profitability.

Read the original article on Business Insider

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GSK Drug for Rare Disease-Related Itch Meets Goal in Phase III Study

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Mirum Pharmaceuticals

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GSK plc GSK announced positive headline data from the phase III GLISTEN study, which is evaluating its investigational targeted inhibitor of the ileal bile acid transporter (IBAT), linerixibat, for treating adult patients with cholestatic pruritus associated with primary biliary cholangitis (PBC).

The global GLISTEN study met its primary endpoint by showing that treatment with linerixibat led to a statistically significant improvement in monthly itch score as compared with placebo over 24 weeks.

Per management, if successfully developed, linerixibat has the potential to become the first therapy indicated for treating itch associated with PBC globally.

Year to date, shares of GSK have lost 9.7% compared with the industry’s decline of 11.1%.

More on GSK's GLISTEN Study

The preliminary safety data from the ongoing GLISTEN study were similar to those seen in previous studies on linerixibat.

Full data from the GLISTEN study is expected to be presented at a medical conference in the future.

Cholestatic pruritus (relentless itch) is one of the most common symptoms of PBC, a rare autoimmune disease that might lead to liver failure.

Per the press release, by the year 2030, patients diagnosed with PBC will reach 510,000 globally and over 240,000 people will experience relentless itch, for which there is currently no cure.

Other Players in the PBC Market

Given the high unmet medical need, a few other companies are also developing treatments for PBC, as there remains a high unmet medical need.

In August 2024, the FDA granted accelerated approval to Gilead Sciences’ GILD seladelpar for the treatment of PBC, in combination with ursodeoxycholic acid (UDCA), in adults who have had an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA.

The candidate was approved under the brand name Livdelzi.

Seladelpar was added to GILD’s portfolio/pipeline through the acquisition of CymaBay Therapeutics Inc. for $4.3 billion in March 2024. The approval of Livdelzi strengthened GILD’s liver disease portfolio.

Small biotech Mirum Pharmaceuticals MIRM is developing its pipeline candidate, volixibat, also an oral IBAT inhibitor, for the treatment of PBC.

The phase IIb VANTAGE study is currently evaluating MIRM’s volixibat for treating PBC.

In June 2024, Mirum announced positive interim data from the VANTAGE study, which showed that treatment with volixibat led to statistically significant improvement in pruritus as well as meaningful reductions in serum bile acids and also an improvement in fatigue.

GSK's Zacks Rank & Key Pick

GSK currently carries a Zacks Rank #4 (Sell).

A better-ranked stock in the biotech sector is Castle Biosciences, Inc. CSTL, carrying a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

In the past 60 days, estimates for Castle Biosciences’ 2024 loss per share have narrowed from 58 cents to 8 cents. Loss per share estimates for 2025 have narrowed from $2.13 to $1.88 during the same time. Year to date, shares of CSTL have surged 29.3%.

CSTL’s earnings beat estimates in each of the trailing four quarters, the average surprise being 172.72%.

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Mutated Bird Flu Case In California Puts Humans At Increased Risk, So Which Companies Are Developing Vaccines?

Benzinga

A child in Alameda County, California is the latest case of bird flu in the U.S.

According to the Los Angeles Times, the total case count in the U.S. stands at 54. Thirty-one cases are attributed to the dairy industry and 21 to the poultry industry. Two of the case’s causes are unknown.

Companies are racing to develop vaccines, but observers worry that the incoming Trump administration’s selection of vaccine-skeptic Robert F. Kennedy Jr. to lead the Department of Health and Human Services could put a potential treatment in the crosshairs.

Health researchers are exploring the idea that the virus was spread via wild birds. The California child’s genetic sequencing has not been released; it is therefore unclear if it is of wild bird or dairy origins.

Meanwhile, a teenager in Canada who was hospitalized with the bird flu possibly showed signs of mutation, the Guardian reports.

Experts are reportedly concerned that a mutation in the virus would make it easier to spread, making the odds of a widespread outbreak more likely.

Vaccine Efforts: Pfizer Inc and Moderna Inc are currently developing an mRNA bird flu vaccine using similar technology to the companies' COVID-19 vaccines.

The U.S. government has also awarded grants to European pharmaceutical giants GSK plc and Sanofi SA .

Regulatory Question Marks: Kennedy, Donald Trump’s pick to lead the HHS, is widely known as a vaccine-skeptic. While the Kennedy family heir says he will not “take away anybody's vaccines,” his ultimate regulatory intentions are unclear. A bird flu vaccine could face additional hurdles in a Trump administration.

In the past, Kennedy has falsely associated vaccinations with autism in children, a claim that has been thoroughly disproven in the scientific field. A May Lancet study found that vaccines have saved 154 million lives throughout human history. They have effectively treated polio, measles, pertussis, and other diseases.

Kennedy may face a tough confirmation vote in the Republican-controlled Senate given his pro-choice abortion stances. He has, however, found a unique ally in Colorado Governor Jared Polis, a Democrat.

Pfizer, Moderna and other vaccine manufacturers’ stock fell on the news of Kennedy’s selection.

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Incyte Pauses Enrollment in Chronic Spontaneous Urticaria Study

Zacks

Incyte INCY suffered a setback in its ongoing mid-stage study on MRGPRX2 (INCB000262) in chronic spontaneous urticaria (CSU).

Consequently, shares of Incyte were down 9% on Nov. 18 in after-market trading.

Shares of Incyte have risen 5.4% year to date against the industry’s 11.1% decline.

INCY Pauses Enrollment in CSU Study

Incyte announced that it will pause enrollment in the ongoing phase II study of MRGPRX2 in CSU due to certain in vivo preclinical toxicology findings.

The data was also shared with the FDA. The company is now working closely with the FDA to determine the next steps.

Additionally, data from the phase II study evaluating MRGPRX4 in cholestatic pruritus does not support further development.

Meanwhile, enrollment in the other INCB000262 proof-of-concept studies is complete. Data from all studies will help support its future development and guide the potential growth of backup molecules.

INCY’s Heavy Dependence on Jakafi

Incyte’s lead drug, Jakafi, is a JAK1/JAK2 inhibitor approved for the treatment of polycythemia vera in adults who have had an inadequate response to or are intolerant of hydroxyurea; intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF in adults; steroid-refractory acute graft-versus-host disease (GVHD) in adult and pediatric patients 12 years and older; and chronic GVHD after failure of one or two lines of systemic therapy in adult and pediatric patients aged 12 years and older.

Sales in all indications continue to be strong and should maintain momentum.

While the uptake of recently approved drugs has been good and a potential approval of the additional drugs should diversify its portfolio, INCY is heavily dependent on Jakafi for its top-line growth.

Competition has increased for some of Jakafi’s approved indications. The FDA’s approval of GSK plc’s GSK Ojjaara for the treatment of intermediate or high-risk MF, including primary MF or secondary MF (post-polycythemia vera and post-essential thrombocythaemia), in adults with anemia, poses a concern.

Jakafi is also expected to lose patent protection in a few years. Hence, the successful development of new drugs is imperative to INCY.

INCY’s Zacks Rank & Stocks to Consider

Incyte currently carries a Zacks Rank #3 (Hold).

A couple of better-ranked stocks from the biotech sector are Immunocore Holdings plc IMCR and Castle Biosciences, Inc. CSTL, each carrying a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

In the past 60 days, estimates for Immunocore’s 2024 loss per share have narrowed from $1.79 to 94 cents. Loss per share estimates for 2025 have narrowed from $2.35 to $1.57 during the same time frame. Year to date, shares of IMCR have lost 54.6%.

IMCR’s earnings beat estimates in two of the trailing four quarters and missed the same in the other two, the average surprise being 25.57%.

CSTL’s earnings beat estimates in each of the trailing four quarters, the average surprise being 172.72%.

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FTSE 100 Closes Week in Green; UK Retail Sales, Business Activity Contract

GSK's RSV Vaccine Approved for Japanese Patients in Their 50s

Japan Grants Expanded Approval to GSK's RSV Vaccine for Adults

Weight loss drug makers still have huge upside, and the market overreacted to RFK Jr. named to top health role, BMO says

GSK Drug for Rare Disease-Related Itch Meets Goal in Phase III Study

Mutated Bird Flu Case In California Puts Humans At Increased Risk, So Which Companies Are Developing Vaccines?

Incyte Pauses Enrollment in Chronic Spontaneous Urticaria Study

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