Dayforce, Scholar Rock, and More Stocks See Action From Activist Investors
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STUART, Fla., Feb. 1, 2024 /PRNewswire/ — Stuart Therapeutics, Inc. (“Stuart”), a clinical-stage biopharmaceutical company with candidate therapeutics in various phases of clinical development, today announced that it has appointed Jodi Luchs, MD to the position of Chief Medical Officer, and Don Stires to the position of Chief Financial Officer.
With the appointment of Dr. Luchs, Robert Baratta, MD has stepped aside from his current role as Chief Medical Officer but will continue as Stuart’s Executive Chairman of the Board.
“Stuart Therapeutics’ growth, international operations and increase in pipeline opportunities require an expansion of our team and capabilities,” said Eric Schlumpf, President and Chief Executive Officer of Stuart. “Jodi and Don bring significant clinical and industry experience and expertise to our organization, and we are pleased that they will be a part of our future as an organization. Dr. Baratta remains an active part of the company and our culture, and we count on his continued contribution to the development of innovative therapeutics in ophthalmology.”
Jodi Luchs, MD
Dr. Luchs graduated from the University of Pennsylvania and received his M.D. from the Albert Einstein College of Medicine in New York. He completed an internship at the Mount Sinai Medical Center, and his Ophthalmology residency at Long Island Jewish Medical Center. He then completed a fellowship in Cornea/External Disease at the prestigious Wills Eye Hospital in Philadelphia. In 2018, Dr. Luchs Joined Florida Vision Institute in West Palm Beach, Florida.
He has numerous publications on Cornea, External Diseases, and Refractive Surgery to his credit, including 2 books, and lectures nationally, and internationally. He has been the Principal Investigator for over 100 FDA clinical trials, including those which led to the approval of many ophthalmic medications and devices used today.
Dr. Luchs is Board Certified by the American Board of Ophthalmology, and a Fellow of the American Academy of Ophthalmology, the American College of Surgeons, and the American Society of Cataract and refractive Surgery (ASCRS). He is also a member of the Castroviejo Corneal Society, the International Society of Refractive Surgery, the Refractive Surgery Alliance, and a founding member of both the American-European Congress of Ophthalmic Surgery (AECOS) and the Society of Cornea, External Disease and Refractive Surgeons (CEDARS).
In 2017, Dr. Luchs became the Chief Science Advisor for InFocus Capital Partners, a private venture capital firm dedicated to investing in companies developing promising new Ophthalmic medications and devices.
Donald H. Stires, Jr.
Donald (Don) Stires graduated from Lehigh University with a Civil Engineering degree and has an MBA from Columbia University. He has over 40 years of management experience with global medical device, pharmaceutical, and consumer products companies as well as small company start-ups. He has extensive finance and accounting management experience from his background with the Johnson & Johnson Family of Companies, including Ethicon, Johnson & Johnson Interventional Systems, and Cordis, Inc.
Don’s broad background includes key roles in finance and accounting, including controller and CFO, along with general management roles including CEO of an early-stage medical diagnostic technology company.
About Stuart Therapeutics
Stuart Therapeutics, founded in 2017 and based in Stuart, Florida, is the leader in the development of ECM-targeting therapeutics for disease treatment. Its platform technology, PolyCol™, is a portfolio of synthesized collagen mimetic peptides designed to specifically bind to and repair disease- or injury-damaged helical collagen structures. This activity results in both a repair of collagen structures and a restoration of homeostatic cell signaling, with positive effects on cell growth and proliferation and reduction in inflammation. These effects occur rapidly in treated tissues, as demonstrated by the results of extensive research conducted by Stuart Therapeutics in a variety of anterior and posterior segment ophthalmic disease indications, including glaucoma, retinal diseases, dry eye disease and myopia. For more information, visit www.stuarttherapeutics.
Stuart Therapeutics
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Updated Dec 27, 2023, 7:34 am EST / Original Dec 27, 2023, 4:26 am EST
Stock futures traded slightly lower Wednesday after the S&P 500 finished higher Tuesday and just 0.45% below its record close of 4,796.56 hit Jan. 3, 2022. The broad market index has risen 24% this year and has gained 4.5% this month as traders bet the Federal Reserve will begin cutting interest rates as soon as March.
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Bristol Myers Squibb will acquire radiopharmaceutical therapeutics company RayzeBio for $62.50 a share in cash.
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View OptionsTwo weeks ago, bluebird bio secured Food and Drug Administration approval for its gene therapy for sickle cell disease, a significant milestone for the roughly 100,000 people in the U.S. who suffer from the condition.
Dec 19, 2023, 4:31 am EST
Stock futures traded flat Tuesday, a day after the S&P 500 finished up 0.5% and moved closer to its all-time. The broad market index stands just 1.2% below its record of 4,796.56 reached in early January 2022.
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Stock futures pointed higher Friday as Wall Street returned for a shortened trading session following the Thanksgiving holiday. Retailers will be in focus on Black Friday, which marks the unofficial start to the Christmas shopping season.
Ardelyx Inc.
ARDX,
on Tuesday won its long fight for U.S. regulatory approval of a treatment designed to help patients with chronic kidney disease.
The biopharma company said late Tuesday that the U.S. Food and Drug Administration approved tenapanor, marketed under the brand name Xphozah, for control of serum phosphorus in patients with chronic kidney disease on dialysis. A high level of phosphorus in the blood is often a sign of kidney damage and can lead to weak bones, joint pain, cardiovascular problems and other issues.
The approval concludes an extraordinary comeback for Xphozah. Ardelyx’s application for approval of the treatment was previously rejected by the FDA in July 2021, when the agency said the drug’s effect was “small and of unclear clinical significance.” To preserve cash, Ardelyx a few months later said it would cut its workforce by 65%, but it also pursued multiple appeals of the agency’s decision. An FDA advisory committee voted last November that the benefits of Xphozah outweigh its risks. The agency late last year ultimately granted Ardelyx’s appeal, and the company resubmitted its Xphozah application to the FDA in April.
More than 550,000 people in the U.S. have chronic kidney disease and are on maintenance dialysis. The vast majority of them have high phosphorus levels, also called hyperphosphatemia, according to Ardelyx.
High phosphorus levels “must be taken care of in these patients, and the current therapies are mostly insufficient in doing so,” Ardelyx CEO Mike Raab told MarketWatch.
Chronic kidney disease patients with high phosphorus levels have traditionally been treated with phosphate binders that can soak up phosphorus from food during digestion, but that approach can require patients to swallow a large number of pills. The Xphozah treatment requires two pills a day, “each the size of a Tic Tac,” Raab said.
The FDA approved Xphozah as add-on therapy in patients who can’t tolerate or have an inadequate response to phosphate binders, Ardelyx said in a release.
Xphozah, which will be Ardelyx’s second U.S. product launch, should be available sometime in November, Raab said.
Ardelyx will present updated data on Xphozah for hyperphosphatemia at an American Society of Nephrology meeting in early November, the company said in a release Monday.
Ardelyx shares jumped in late September after Japanese regulators approved tenapanor for hyperphosphatemia in adults with chronic kidney disease on dialysis.
Ardelyx shares fell 0.6% on Tuesday and have gained 21% in the year to date, while the S&P 500
SPX
has gained 13.9%.
Updated Oct. 17, 2023 2:47 am ET
Lonza Group warned that its profitability will take a hit next year from losing revenue from an agreement with Moderna and the risk of a smaller business with Kodiak Sciences.
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Pfizer Stock Gains After Earnings Beat. Revenue and Outlook Aren’t So Good.

By Anthony O. Goriainoff
AstraZeneca said Thursday that its and MSD’s Lynparza cancer treatment had been approved in the U.S. for the treatment of metastatic castration-resistant prostate cancer, or mCRPC.
The Anglo-Swedish pharma giant said Lynparza, in combination with abiraterone and prednisone, reduced the risk of disease progression or…
A flurry of announcements relating to COVID vaccines dominated headlines on the pandemic on Monday, with Moderna telling investors it expects to generate some $5 billion in sales in 2023.
That’s down from $18.4 billion in sales in 2022. The company plans to boost spending on research and development to $4.5 billion this year, up from $3.3 billion in 2022.
Moderna
MRNA,
provided the update in advance of the company’s presentation at the annual J.P. Morgan Healthcare Conference in San Francisco.
Separately, CureVac
CVAC,
said preliminary data from its early stage trial for its COVID and seasonal flu shots had positive results to advance to the next stage of clinical testing.
CureVac is developing the shots with GlaxoSmithKline
GSK,
GSK,
CureVac said the shot was well tolerated, and that neutralizing antibodies were beginning at the lowest tested dose for younger adults. The seasonal flu shot was also well tolerated with an increase in antibodies compared to those from a flu vaccine comparator in younger adults, CureVac said.
Ocugen announced positive results in a trial of its COVID vaccine Covaxin, which uses the same vero cell manufacturing platform that has been used in the production of polio vaccines for decades. The Phase 2/3 trial involved 491 U.S. adult participants who received two doses of Covaxin or placebo 28 days apart.
“Covaxin, an inactivated virus vaccine adjuvanted with TLR7/8 agonist, has been demonstrated in clinical trials to generate a broader immune response against the whole virus covering important antigens such as S-protein, RBD, and N-protein; whereas currently approved vaccines in the U.S. target only S-protein antigen,” the company said in a statement.
Chief Executive Dr. Shankar Musnuri said the company is hoping the vaccine will offer an option for those who are still hesitant to take an mRNA vaccine, which uses newer technology.
U.S. cases were lower on Sunday, according to a New York Times tracker. The seven-day average of new cases stood at 67,246, down 1% from two weeks ago.
The daily average for hospitalizations was up 18% at 47,500., the highest level since last March. The average for deaths was 509, up 19% from two weeks ago.
Hospitalizations are becoming concerning, according to the Times trackers, with the Northeast seeing the highest per capita rates, along with the Southeast.
Coronavirus Update: MarketWatch’s daily roundup has been curating and reporting all the latest developments every weekday since the coronavirus pandemic began
Other COVID-19 news you should know about:
• China has suspended or closed the social-media accounts of more than 1,000 critics of the government’s COVID response, as the country rolls back harsh anti-virus restrictions and gears up for the coming Lunar New Year holiday, the Associated Press reported. The popular Sina Weibo social media platform said it had addressed 12,854 violations including attacks on experts, scholars and medical workers and issued temporary or permanent bans on 1,120 accounts. The ruling Communist Party had largely relied on the medical community to justify its tough lockdowns, quarantine measures and mass testing, almost all of which it abruptly abandoned last month, leading to a surge in new cases that have stretched medical resources to their limits. The party allows no direct criticism and imposes strict limits on free speech.
• Pfizer’s
PFE,
antiviral Paxlovid has not been included in the Chinese government’s national reimbursement list that would have allowed patients to get it at a cheaper price throughout the country, saying it was too expensive, the AP reported separately. Although it is supposed to be prescribed by medical professionals, that hasn’t stopped people from scrambling to purchase it on their own through any means at their disposal—including buying generic Indian versions of the drug through the internet, according to local media reports.
• The union representing a group of nurses at a New York City hospital reached a tentative contract agreement with its management, but close to 9,000 nurses at several other major hospitals were still preparing to go on strike, the AP reported. The New York State Nurses Association and BronxCare Health System said Saturday that a tentative agreement had been reached; the union said it included pay raises every year of its three-year term as well as staffing increases. Another hospital, Flushing Hospital Medical Center, got to a tentative agreement with nurses on Friday evening.
Here’s what the numbers say:
The global tally of confirmed cases of COVID-19 topped 664.3 million on Monday, while the death toll rose above 6.7 million, according to data aggregated by Johns Hopkins University.
The U.S. leads the world with 101.2 million cases and 1,096,523 fatalities.
The Centers for Disease Control and Prevention’s tracker shows that 229.3 million people living in the U.S., equal to 69.1% of the total population, are fully vaccinated, meaning they have had their primary shots.
So far, just 48.2 million Americans, equal to 15.4% of the overall population, have had the updated COVID booster that targets both the original virus and the omicron variants.
Danish biotechnology companies Novozymes AS
NZYM.B,
and Chr. Hansen Holding AS
CHR,
said Monday they have agreed to merge, creating a biological solutions provider with combined annual revenue of around 3.5 billion euros ($3.69 billion).
The companies, which produce products such as enzymes, probiotics and biopharmaceutical ingredients, said the combination between two strategically complementary businesses will drive efficiencies while unlocking potential within biosolutions and providing additional growth opportunities.
“Novozymes and Chr. Hansen share the strong conviction that our combined scale, know-how, commercial strengths, and innovation excellence will drive value for our shareholders, customers and society at large,” said Novozymes Chief Executive Ester Baiget.
The deal will see Chr. Hansen shareholders receive 1.5326 new B-shares in Novozymes for each Chr. Hansen share, reflecting an implied premium of 49% to Chr. Hansen’s closing share price on Friday and valuing each Chr. Hansen share at 660.55 Danish kroner ($93.53) a share.
Novo Holdings AS, the largest shareholder in both Novozymes and Chr. Hansen, will support the proposed merger and exchange its 22% stake in Chr. Hansen at an exchange ratio of 1.0227 new B-shares in Novozymes.
The companies said they see annual revenue synergies of EUR200 million within four years after completion of the deal.
Write to Dominic Chopping at dominic.chopping@wsj.com
A fresh analysis of data on the immune response generated by the bivalent COVID-19 booster showed strong results against the newer omicron sublineages, Pfizer and German partner BioNTech said Friday.
The bivalent booster targets the BA.4 and BA.5 omicron variants as well as the original virus, and it also appears to be effective against the sublineages dubbed BA.4.6, BA.2.75.2, BQ.1.1 and XBB.1.
The data, which have been posted on the preprint server bioRxiv, show that the booster induces a greater increase in neutralizing-antibody titers than the companies’ original COVID vaccine.
“Based on these findings, the Omicron BA.4/BA.5-adapted bivalent booster may help to provide improved protection against COVID-19 due to Omicron BA.4 and BA.5 sublineages as well as new sublineages that continue to increase in prevalence,” the companies said in a joint statement.
Specifically, one month after a booster dose of the bivalent COVID-19 vaccine, neutralizing-antibody titers against the sublineages increased 3.2-fold to 4.8-fold compared with the original COVID vaccine.
Neutralizing-antibody titers against BA.4.6, BA.2.75.2, BQ.1.1 and XBB.1 increased 4.8-fold to 11.1-fold from prebooster levels following a booster dose of the bivalent vaccine.
The companies
PFE,
BNTX,
said BA.5 is still the most prevalent sublineage in the U.S., accounting for nearly 30% of cases at time of publication, while the emerging BA.1.1 sublineage accounts for nearly 25% of cases and is spreading globally.
But data released by the Centers for Disease Control and Prevention later Friday showed BQ.1 and BQ.1.1 now account for a combined 49.7% of new cases in the week through Nov. 19, while BA.5 accounted for just 24%.64.8%
In the New York region, BQ.1 and BQ.1.1 accounted for 64.8% of new cases, while BA.5 accounted for 14.0%.
The bivalent booster has been granted emergency-use authorization by the U.S. Food and Drug Administration for people ages 5 and older and has also been allowed in the European Union for that group.
The news comes as U.S. COVID cases have been rising again, although the daily average edged lower on Thursday to 39,562, according to a New York Times tracker, down 1% from two weeks ago.
Cases are rising in roughly half the states and falling in the rest, but there are wide discrepancies between individual states. In Nebraska, cases are up 540% from two weeks ago, the tracker shows, followed by Arizona, where they are up 110%; California, where they have climbed 53%; and Colorado, where they are up 50%.
Meanwhile, Kentucky is seeing a 54% decline in cases from two weeks ago, and Michigan cases are down 48%.
The daily U.S. average for hospitalizations is up 2% to 27,818, while the daily average for deaths is down 4% to 325.
Coronavirus Update: MarketWatch’s daily roundup has been curating and reporting all the latest developments every weekday since the coronavirus pandemic began
Other COVID-19 news you should know about:
• China’s southern manufacturing hub of Guangzhou is planning to build quarantine facilities for nearly 250,000 people to fight surging COVID outbreaks, even as the national government tries to reduce the impact of zero-COVID controls that have confined millions of people to their homes, the Associated Press reported. Guangzhou, a city of 13 million and the biggest of a series of hotspots across China with outbreaks since early October, reported 9,680 new cases in the past 24 hours. That was about 40% of the 23,276 cases reported nationwide.
• Racial disparities in COVID cases and deaths have widened and narrowed over the course of the pandemic, but age-adjusted data still show that Black, Hispanic and American Indian/Alaska Native people have been at higher risk for cases, hospitalizations and deaths, according to a new report from the Kaiser Family Foundation. “While disparities in COVID-19 vaccinations have narrowed over time and have been reversed for Hispanic people, they persist for Black people,” the report found. The pattern is also evident in uptake of the new bivalent booster, with Black and Hispanic people about half as likely as white people to have had one. Black people are also less likely to have access to antivirals, antibody treatments and other therapies.
• The Indian Health Service announced Thursday that all tribal members covered by the federal agency will be offered a vaccine at every appointment when appropriate under a new vaccine strategy, the AP reported. Throughout the pandemic, American Indians and Alaska Natives have had some of the highest COVID vaccination rates across the country. But Indigenous people are especially vulnerable to vaccine-preventable illness, and IHS officials recently noted that fewer patients have been getting vaccines for COVID-19. Monkeypox is now an additional health concern.
• Novavax
NVAX,
said its COVID vaccine has received expanded authorization in Canada as a booster for adults aged 18 and older who had it as their primary shot. The protein-based vaccine has already been approved as a booster in the U.S., European Union and U.K., among other countries, Novavax said.
Here’s what the numbers say:
The global tally of confirmed cases of COVID-19 topped 637.1 million on Friday, while the death toll rose above 6.61 million, according to data aggregated by Johns Hopkins University.
The U.S. leads the world with 98.3 million cases and 1,076,683 fatalities.
The Centers for Disease Control and Prevention’s tracker shows that 228.2 million people living in the U.S., equal to 68.7% of the total population, are fully vaccinated, meaning they have had their primary shots.
So far, just 35.3 million Americans have had the updated COVID booster that targets the original virus and the omicron variants, equal to 11.3% of the overall population.
First the good news: Pfizer Inc. and Germany-based partner BioNTech SE said updated trial data for their omicron BA.4/BA.5-adapted bivalent booster showed a “substantially higher” immune response in adults than the original COVID-19 vaccine.
The companies said the Phase 2/3 clinical-trial data, collected one month after the boosters were given, also demonstrated that safety and tolerability profiles were similar to those of the original vaccine.
The news sent Pfizer’s stock
PFE,
rallying 1.7% and BioNTech’s U.S.-listed shares
BNTX,
22UA,
surging 7.2% in morning trading.
“As we head into the holiday season, we hope these updated data will encourage people to seek out a COVID-19 bivalent booster as soon as they are eligible in order to maintain high levels of protection against the widely circulating Omicron BA.4 and BA.5 sublineages,” said Pfizer Chief Executive Albert Bourla.
Only 8.4% of eligible Americans have received updated COVID booster shots, while 68.5% of the total population have completed the original primary series of vaccinations, according to the latest data from the Centers for Disease Control and Prevention.
The bivalent booster has been authorized for emergency use in the U.S. by the Food and Drug Administration for people age 5 and older and has also been granted marketing authorization in the European Union for those age 12 and older.
In another piece of good news, Pfizer and BioNTech shares were also lifted by a report in The Wall Street Journal that the Chinese government has agreed to approve the companies’ COVID-19 vaccines for foreign residents in China and has also held talks to approve those vaccines for the broader population.
Meanwhile, Bloomberg reported that China was working on a plan to end the practice of penalizing airlines that bring COVID-infected people into the country.
Both reports boost hopes that China is slowly moving toward ending its zero-COVID policy, which has crimped China’s economy and acted as a drag on global growth.
Now for the bad news.
The seven-day average of new COVID cases topped 40,000 for the first time in a month and hospitalizations have also ticked higher, with more than half of U.S. states showing increases over the past two weeks.
According to a New York Times tracker, the daily average of new cases rose to 40,101 on Thursday from 38,208 on Wednesday, and was up 6% from 14 days ago.
Nevada has seen a 96% jump in daily cases, followed by Tennessee with a 69% increase and Louisiana with a 68% rise, leading the 28 states that saw cases increase over the past two weeks.
Still, daily cases were less than one-third of the summer high of more than 130,000 reached during the surge of the BA.5 variant, the data show.
Coronavirus Update: MarketWatch’s daily roundup has been curating and reporting all the latest developments every weekday since the coronavirus pandemic began
The daily average of COVID-related hospitalizations rose 2% to 27,252, while the number of people with COVID in intensive-care units (ICUs) fell 2% to 3,110.
The daily average of COVID-related deaths fell 6% to a four-month low of 339.
On a global basis, the total number of COVID cases has increased to 631.91 million, while deaths have reached 6,598,197, according to data provided by Johns Hopkins University. The U.S. has seen a total of 97.69 million cases and 1,072,245 deaths.
Pfizer Inc.
PFE,
said Thursday that it plans to sell the COVID-19 shot it developed with BioNTech SE
BNTX,
for $110 to $130 per dose once the U.S. market for COVID-19 shots becomes commercial, likely in the first quarter of next year.
Pfizer and BioNTech are currently paid $30.50 per vaccine dose by the U.S. government, which contracted with the companies (as well as other vaccine makers like Moderna Inc.
MRNA,
and Novavax Inc.
NVAX,
) and then made the COVID-19 shots available at no cost to people in the U.S. during the public-health emergency.
The emergency declaration in the U.S. isn’t expected to be renewed next year, which will lead to the formation of an official commercial market for COVID-19 vaccines, tests and treatments. That said, this change doesn’t mean most Americans will be on the hook to pay for their shots in 2023 and beyond.
A recent Kaiser Family Foundation analysis said most people with private insurance won’t be expected to pay anything out of pocket for the vaccines, though the costs may eventually be baked into the price of health-insurance premiums, as is done with flu shots. People with Medicare will have their shots covered by Medicare Part B, while those with Medicaid should also have coverage of COVID-19 vaccines. It’s the uninsured who may find it difficult to find free vaccines and boosters in the future.
Wall Street analysts cheered the news, saying Pfizer’s pricing plan came in above expectations. It also bodes well for Moderna’s stock. SVB Securities upgraded the company to market perform from underperform, though the company has not yet announced its pricing plans for its COVID-19 shots.
“Presuming that MRNA prices as a rational duopolist, this substantially improves the company’s ability to meet 2023 revenue guidance,” SVB analyst Mani Foroohar told investors.