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Friday, March 14, 2025
Regeneron stock dips as court denies Eylea patent stay
Regeneron (NASDAQ:REGN) Pharmaceuticals, Inc. (NASDAQ: REGN) shares fell 1.5% following a U.S. appeals court decision that upheld a previous ruling, effectively denying a stay on sales of biosimilar versions of its drug Eylea. The court found Regeneron’s remaining arguments in the patent case to be "unpersuasive."
The decline came after the court affirmed its earlier decision, which had denied Regeneron’s motion for infringement on the grounds that the company did not demonstrate a likelihood of success in proving that Amgen Inc (NASDAQ:AMGN). had infringed on U.S. Patent 11,084,865, claimed to cover a vial containing Eylea. As a result of the ruling, Amgen, which produces a biosimilar for Eylea, saw its shares increase by as much as 0.5%.
This legal setback for Regeneron comes amid competitive pressures in the biologics market, where biosimilars are increasingly offering alternatives to established products like Eylea. The decision may potentially pave the way for Amgen and other competitors to capture market share with their biosimilar products.
Eylea has been a significant revenue driver for Regeneron, and any potential impact on its sales due to competition from biosimilars is closely watched by investors. The court’s ruling thus represents a notable development for both Regeneron and the broader pharmaceutical industry.
Regeneron’s stock movement today reflects the immediate market response to the legal proceedings, highlighting the importance of patent protection and litigation outcomes in the biotech and pharmaceutical sectors. As the situation evolves, market participants will continue to monitor the implications of this decision for Regeneron’s financial performance and competitive position in the market.
FAA issues permanent restrictions on Washington helicopter traffic after fatal collision
The Federal Aviation Administration said Friday it is imposing permanently restrictions on non-essential helicopter operations around Washington Reagan National Airport and eliminating helicopter and passenger jet mixed traffic.
The FAA is permanently closing one key route and evaluating alternative helicopter routes after the National Transportation Safety Board this week made two urgent safety recommendations following the Jan. 29 mid-air collision of an American Airlines regional jet and an Army helicopter that killed 67 people.
The FAA will also prohibit use of two smaller runways at the airport when helicopters conducting urgent missions are operating near the airport.
Abbott, Reckitt Fall as Judge Grants New Trial on Infant Formula
Abbott Laboratories and Reckitt Benckiser Group Plc shares fell as a judge ordered a new trial after rejecting a verdict that had cleared the companies of liability over claims they hid potential risks of their premature-infant formulas.
Abbott was down 4.2% in early trading in New York while Reckitt fell as much as 5.6% in London. Both were the biggest declines in about eight months.
The declines came after a state judge in St. Louis on Thursday ruled that the plaintiff — the son of Elizabeth Whitfield, on whose behalf she brought the case — had been denied a fair trial, granting a request for a new one. A jury last year rejected claims that formulas made by Abbott and Reckitt’s Mead Johnson unit caused necrotizing enterocolitis in Whitfield’s son.
Reckitt said Thursday’s ruling was “at complete odds with the law and the facts” and that the company would appeal it.
“The jury unanimously found, consistent with the scientific consensus, that Mead Johnson was not liable, and nothing the court has now cited justifies disregarding the jury’s determination,” Reckitt said in a statement, adding: “This is not a finding of liability. Should this ruling stand, the plaintiff is entitled only to a new trial.”
Abbott also said it would appeal and that it expected the jury’s verdict to be reinstated. The verdict was “consistent with the consensus of scientists, governmental regulators and the neonatologists who treat these vulnerable patients in intensive care units every day,” the company said in a statement.
Timothy Cronin, a lawyer for Whitfield, said the ruling “speaks for itself” after “an unfair trial for this little boy.”
https://finance.yahoo.com/news/abbott-reckitt-fall-judge-grants-145716141.html
Sutro puts lead ADC on hold, cuts staff and changes CEO
Antibody-drug conjugate (ADC) specialist Sutro Biopharma has shelved its lead drug for ovarian cancer and turned its attention to a trio of "next-generation" drugs still in preclinical development.
The dramatic decision – which has been accompanied by the laying off of around half its workforce and a change in chief executive – comes after Sutro revealed positive results from a phase 2/3 trial of lead drug luveltamab tazevibulin (luvelta, also known as STRO-002) in platinum-resistant ovarian cancer in December.
Sutro said at the time that the 32% objective response rate (ORR) in the dose-finding stage of the REFRαME-O1 study had set up the second pivotal stage of the trial, and it was hoping to file for accelerated approval of the folate receptor α-targeting ADC in mid-2027.
Just a few months later, luvelta has been "deprioritised" while Sutro looks for a partner to take the programme forward, and it is focusing its efforts on a new crop of ADCs that either use a different chemotherapeutic payload (exatecan) – the drug-killing component of the molecule – or dual payloads.
Jane Chung, president and chief operating officer at Sutro, is replacing Bill Newell as chief executive as the company starts the process of shedding staff and shutting down a GMP-compliant manufacturing facility for luvelta.
In a statement, the company said it is stopping luvelta's clinical development "across all indications." It has also been investigating the drug's activity in other trials involving patients with non-small cell lung cancer (NSCLC), a form of acute myeloid leukaemia (AML), and other solid tumours.
The stripped-down company's new internal pipeline will be headed by STRO-004, an exatecan-bearing ADC target tissue factor (TF), which is expected to enter the clinic in the second half of 2025.
The other two preclinical candidates are STRO-006, an integrin beta-6 ADC due to start trials in 2026, and an as-yet unidentified dual-payload ADC, which is slated to enter the clinic in 2027.
South San Francisco-based Sutro ended last year with almost $317 million in cash, and reckons that the cutbacks will allow that to keep it going into the fourth quarter of 2026. It could also be in line for milestone payments from partnered programmes during that period.
It has collaborations in place with Vaxcyte on a pair of pneumococcal vaccine candidates, with Ipsen on a ROR1-directed ADC for solid tumours and blood cancers, and with Astellas on various undisclosed oncology programmes.
https://pharmaphorum.com/news/sutro-puts-lead-adc-hold-cuts-staff-and-changes-ceo
Altimmune To Test Investigational GLP-1–Based Obesity Drug for Alcohol Use Disorder
The Maryland-based biopharma joins Eli Lilly and Novo Nordisk in trialing a GLP-1 agonist for alcohol- and liver-related conditions.
Altimmune is looking to compete with the bigwigs in obesity, expanding the testing of its GLP-1/glucagon agonist into patients with alcohol-related disorders. During a virtual R&D event hosted Thursday, the company said a Phase II trial of pemvidutide for alcohol use disorder (AUD) will start during the second quarter of this year, while another Phase II trial for alcohol-related liver disease will begin in the third quarter.
“In our view, AUD and [alcohol-related liver disease] are logical extensions for evaluation of pemvidutide’s efficacy, given its mechanisms of action,” William Blair analysts Andy Hsieh and Alexandra Ramsey said in a note to investors early Friday. Shares of the company are up about 4% this morning following the news.
At the R&D event, Altimmune highlighted the link between both alcohol use and obesity in exacerbating damage to the liver. The primary endpoint for the liver disease study will be liver stiffness, a proxy for liver health that’s less invasive than a biopsy, while the primary endpoint for the AUD study will be change in the number of heavy drinking days after 24 weeks of treatment.
Altimmune is now the latest in a suite of obesity drugmakers trying to broaden indications into alcohol use. Eli Lilly has its GLP-1 agonist mazdutide in a Phase II trial for AUD, while Novo Nordisk is testing the effectiveness of semaglutide, an amylin analogue and an FGF21 analogue in alcoholic liver disease. Treatment of liver damage is the trial’s primary endpoint, with alcohol use as a secondary endpoint.
Last summer, Altimmune unveiled data from its Phase II MOMENTUM trial testing pemvidutide in obesity, touting 15.6% weight loss at the drug’s highest dose. The company tried to differentiate that result from other obesity drugs by noting that only about one-fifth of that weight loss was due to loss of lean muscle mass, while the rest was fat loss. Altimmune is also testing pemvidutide in the Phase II IMPACT study in metabolic dysfunction-associated steatohepatitis (MASH).
The company is searching for a partner to help push pemvidutide into Phase III trials, according to the William Blair analysts.
Panicking Democrats Send UMich Inflation Expectations To Highest In 32 Years
UMich inflation expectations exploded even higher in preliminary March data with medium-term views spiking to +3.9% - the highest since 1993...
Source: Bloomberg
There's just one thing... it's all Democrats...
Republicans expect very little inflation over the next five years but Democrats expect a surge to +4.6%...
Source: Bloomberg
Short-term expectations are even more divided with Democrats expecting inflation to explode to 6.5% this year while Republicans expect no inflation...
Source: Bloomberg
Overall, consumer sentiment declined significantly...
Source: Bloomberg
UMich notes:
While current economic conditions were little changed, expectations for the future deteriorated across multiple facets of the economy, including personal finances, labor markets, inflation, business conditions, and stock markets.
Many consumers cited the high level of uncertainty around policy and other economic factors; frequent gyrations in economic policies make it very difficult for consumers to plan for the future, regardless of one’s policy preferences.
But once again, it was all Democrats, who are now convinced that the US outlook has never been worse...
Source: Bloomberg
According to Democrats, this is the apocalypse, folks.
No really, Democrat expectations for the economy have NEVER been lower, including the global financial crisis and COVID. For Democrats, this is the 10th circle of hell.
What's more, Democrats are boycotting spending to prop up Trump's economy, and instead are sitting on cash... which according to them will be worth 6.5% less in one year as a result of runaway inflation.
It appears legacy media propaganda works after all...
Finally, the UMich (inflation expectations) data is dramatically different from all the other inflation surveys - including the New York Fed's...
...which makes us wonder who exactly are UMich surveyors asking these questions to?
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