On Wednesday night, Biogen (BIIB) announced interim results of a phase 1/2 study of tofersen, an antisense oligonucleotide, or ASO, being studied for the potential treatment of amyotrophic lateral sclerosis, or ALS, in adults with a confirmed superoxide dismutase 1 or SOD1, mutation. The data will be presented at the American Academy of Neurology Annual Meeting in Philadelphia. “The interim results of this study, which achieved proof-of-biology and proof-of-concept, support the initiation of a phase 3 clinical trial to confirm the efficacy and safety of tofersen in SOD1-ALS patients and further demonstrate the potential of ASOs to target the genetic driver of disease,” said Michael Ehlers, M.D., Ph.D., executive vice president, research and development at Biogen. “We are committed to bringing a potential breakthrough therapy to patients with ALS and we are expediting our efforts with the aim of addressing this urgent unmet need.” PROGRESSIVE DISEASE: ALS, also called Lou Gehrig’s disease, is a progressive neurodegenerative disease that affects nerve cells in the brain and the spinal cord. People with ALS lose the ability to initiate and control muscle movement, which often leads to total paralysis and death. The average life span after diagnosis is two to five years. Approximately 10% of all ALS cases are genetic and about a fifth of those are caused by SOD1 gene mutations, says the American Academy of Neurology or AAN.”The treatment that we researched in this study, an antisense oligonucleotide called tofersen or BIIB067, works by targeting and reducing protein created by the mutated gene,” said study author Timothy M. Miller, MD, PhD, of Washington University School of Medicine in St. Louis and a member of the American Academy of Neurology. “That mutated protein is toxic and leads to ALS by damaging the nerve cells that control movement. Our research aimed to decrease the production of that protein.” OWNING BIOGEN MAKES SENSE: According to Piper Jaffray analyst Christopher Raymond, owning Biogen shares at these levels “makes a lot of sense.” With valuation and sentiment near all-time lows, the company needs only a few things to go right in order for the stock to start working again, says the analyst. He believes a number of near term catalysts, namely a settlement with Mylan (MYL) over Tecfidera and positive pipeline updates, could “meaningfully change the narrative” on Biogen shares. Raymond kept an Overweight rating on the name with a $280 price target in a note to investors out earlier on Thursday. According to BioSpace, Sanofi (SNY) makes a drug to treat ALS by the name of Rilutek. It was the first drug approved by the FDA to treat ALS, but “it’s no cure for ALS,” though it can slow progression of the disease.
Thursday, May 2, 2019
Piper Jaffray ‘strongly’ encourages buying SeaSpine after Q1 results
Piper Jaffray analyst Matt O’Brien “strongly” encourages investors to buy shares of SeaSpine Holdings following the company’s Q1 results. “We simply cannot find a valid excuse for investors to stay away from the name,” O’Brien writes in a post-earnings research note. He expects more earnings beats as SeaSpine’s new products enter broader market launches. The analyst keeps an Overweight rating on the shares with a $20 price target.
Merck steps up U.S. measles vaccine production with increased demand
Merck & Co said on Wednesday it has increased production of the measles vaccine to meet an uptick in demand in the United States in the midst of the country’s biggest outbreak in 25 years.
Merck, the sole U.S. supplier of measles vaccines, said the increased demand was noticeable, but did not amount to a surge, and has not required a significant increase in distribution across the country.
“Despite what we’ve seen as a huge uptick in the number of cases … the demand side of the equation hasn’t been outstripping our underlying capacity,” Merck Chief Marketing Officer Mike Nally, who also runs the firms Global Human Health business, said in an interview.
The U.S. Centers for Disease Control and Prevention (CDC) reported 704 cases of measles as of April 26, a 1.3 percent increase since the 695 reported last week. The vast majority of cases have occurred in children who have not received the measles-mumps-rubella (MMR) vaccine, and public health officials are working to ensure immunization.
The measles virus is highly contagious and can cause blindness, deafness, brain damage or death. It is currently spreading in outbreaks in many parts of the world.
U.S. officials deemed the disease eliminated in 2000, yet outbreaks still happen as infected travelers expose vulnerable populations to the virus, particularly in communities with many vaccine skeptics.
Adults in the United States who were vaccinated against measles decades ago may also need a new dose of the vaccine depending on when they received the shot and whether they live in an outbreak zone or plan to travel to one, according to public health experts battling the outbreak.
Merck said on Tuesday that U.S. sales of MMR and chickenpox vaccines rose around 10 percent to $343 million in the first quarter.
Nally said much of the increase came from sales to private clinics, which pay more than the government for the vaccines, rather than an increase in volume.
He said there are pockets of demand for the vaccine around areas where there have been cases of measles. The current outbreak has been concentrated in New York City, where officials said more than 390 cases have been recorded since October, mostly among children in Orthodox Jewish communities in Brooklyn.
But Merck has not see a significant uptick of purchases from the CDC, which is a large supplier of the pediatric population through its Vaccines for Children program.
Merck’s Nally said the company believes it will be able to meet that new demand.
“As measles outbreaks have occurred in different parts of the world over the last few decades, we’ve always been able to surge capacity, and we feel confident about our ability to do so in the U.S,” he said.
Piper still cautious on Inovalon after Q1 beat, reiterates Underweight rating
Piper Jaffray analyst Sean Wieland raised his price target for Inovalon to $10 from $8 following the company’s Q1 beat but reiterates an Overweight rating on the shares. Greater add-backs and unbilled receivables drove the beat while the company’s Q2 guidance was below expectations, Wieland tells investors in a post-earnings research note titled “Big Revenue Ramp Makes Us Wary.” He remains remains cautious on Inovalon’s “very steep ramp” in subscription revenue growth.
Subscribe to:
Posts (Atom)