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Shares of Ascendis Pharma ASND rose 17% on Monday after it reported top-line results from the pivotal ApproaCH study that evaluated investigational once-weekly administered TransCon CNP in children aged two to 11 years with achondroplasia, the most common form of dwarfism.
ASND Drug Shows AGV Benefit in Achondroplasia Patients
The ApproaCH study met its primary endpoint of annualized growth velocity (AGV) at 52 weeks — children treated with TransCon CNP achieved a mean AGV of 5.89 cm/year compared with 4.41 cm/year in the placebo group.
Management also provided sub-group analyses of this data by age groups — children aged two to less than five years and another group aged five to 11 years. Patients in the first group who received TransCon CNP achieved a mean AGV of 6.07 cm/year compared with 5.06 cm/year in placebo. Those who received the drug in the second age group achieved a mean AGV of 5.79 cm/year compared with 4.02 cm/year on placebo.
Per Ascendis, treatment with the drug also demonstrated statistically significant improvement in other secondary endpoints, including height Z-score and changing from baseline AGV.
But Why Did BioMarin Stock Dip on TransCon CNP Data
There is only one drug approved to treat achondroplasia in the United States and Europe — Voxzogo — which is marketed by BioMarin BMRN. Since its launch in 2021, BMRN has been experiencing a rapid uptake for Voxzogo driven by strong prescription demand. The drug added nearly $337 million to BioMarin’s topline in the first half of 2024, up 67% year over year.
While it is difficult to compare the results of two different clinical studies directly, investors were likely impressed with the once-weekly dosing advantage of TransCon CNP over Voxzogo, which requires daily dosing. This major factor was not only responsible for Ascendis’ share price soaring but also sent BioMarin stock down nearly 18% after the results were announced.
Ascendis’ shares have moved up 10.8% in the year compared with the industry’s 1.0% growth.
Ascendis’ Future Plans for the Drug
Based on the ApproaCH study results, management intends to submit a regulatory filing seeking approval for TransCon CNP in achondroplasia with the FDA during first-quarter 2025. It also plans to submit a similar filing with the EMA by third-quarter 2025.
ASND’s Zacks Ranks
Ascendis currently carries a Zacks Rank #3 (Hold).
Ascendis Pharma A/S Price
Ascendis Pharma A/S price | Ascendis Pharma A/S Quote
Our Key Picks in the Biotech Sector
Some better-ranked stocks in the overall healthcare sector are Bioventus BVS and Illumina ILMN. Each stock presently sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Bioventus’ 2024 earnings per share (EPS) have risen from 27 cents to 40 cents. Estimates for 2025 have increased from 43 cents to 45 cents during the same period. Year to date, shares of Bioventus have surged 109.9%.
BVS’ earnings beat estimates in three of the last four quarters and missed the mark on one occasion. Bioventus delivered a four-quarter average earnings surprise of 102.86%.
In the past 60 days, estimates for Illumina’s 2024 EPS have risen from $1.84 to $3.62. Estimates for 2025 have increased from $3.22 to $4.43 during the same period. Year to date, Illumina’s shares have lost 7.0%.
Earnings of Illumina beat estimates in each of the last four quarters. Illumina delivered a four-quarter average earnings surprise of 463.46%.
Zacks Investment Research
NORTHAMPTON, MA / ACCESSWIRE / September 17, 2024 / IlluminaThe quality control stability scientist embraces family, sports, work, and her leadership role in Illumina's iLatinx employee resource group
Originally published on Illumina News Center
Karina Katalina Moreno has taken a circuitous route to her American dream. She grew up in Monterrey, Mexico, about 140 miles (225 km) south of Laredo, Texas, and got her degree in biotech engineering at Tecnológico de Monterrey. Following a brief stop in Barcelona, Spain, she earned her master of science degree at the University of Edinburgh.
Family brought Moreno back to Monterrey. Her mother was diagnosed with lung cancer, and she moved in to help care for her parents and three siblings. She worked as a science teacher at a local high school and helped her mom get to and from treatment.
"After my mom passed away, I thought, okay, this is life, I knew it was coming," she says. "She was diagnosed with stage three lung cancer, and the doctors told us she wouldn't have a lot of time. She was a real fighter, and stayed with us for three more years. But 13 days after my mom died, my dad passed from COVID. At that point I felt lost. My life changed so much in two weeks that I didn't know what I was going to do with my life."
Coming to Illumina Moreno had worked in pharma and cosmetics but always wanted to pursue a career in biotech. In 2023, a friend encouraged her to apply at Illumina and, after a rigorous interview process, she was hired as a quality control stability scientist. In this role, she focuses on measuring reagent stability, which has already paid big dividends in extended expiration dates.
She's been with Illumina for about a year and a half, but Moreno is already making her mark. She is well known in Building 6, at Illumina's San Diego campus, for her seemingly endless supply of Mexican candy-it's part of her ongoing mission to share her culture.
iLatinx Moreno is the treasurer of iLatinx, a growing employee resource group (ERG) at Illumina. The group has more than a hundred active members and hosts many events that focus on building community: attending San Diego Padres and Wave games, celebrating Hispanic Heritage Month, and working with the Make-a-Wish Foundation and the Clearity Foundation.
The group has also committed to mentoring young women. For the past two summers, iLatinx has partnered with the Women at Illumina Network ERG to sponsor Girls Who Lead days at the company.
"We have around 60 girls who come to Illumina and go to the lab with us," Moreno says, "but we try to involve them in other activities, as well, because not everyone works in the lab. Some people handle money or are in charge of production. We want to show them all their options."
The iLatinx group has big plans for this year's Hispanic Heritage Month, which runs from September 15 to October 15: a career panel, salsa classes, a mariachi band, and lots of treats. They highlight different countries each year: Last time it was Mexico and Peru; this year will be Colombia and Venezuela, among others.
"People like to learn about the different cultures at Illumina, and we try to find people from those places who can share their flags, food, and local customs," Moreno says. "We want everyone to know they don't have to be Latino to be part of this community. They only need to like the food, music, and culture."
Her safe space An avid athlete, Moreno has been active in team handball since she was young and now plays on teams in San Diego and Baja California. At Illumina, she participates in flag football, basketball, and softball. When she's not working or playing, she often visits her family in Monterrey. But looking at the life she's built, she is incredibly grateful to have found a home in San Diego and Illumina.
"Everybody is really open [at Illumina], and that makes me feel great," says Moreno. "I have this accent and nobody cares, and I can wear a flower shirt, which is typical in Mexico, or sing in Spanish, and nobody is going to say anything. For me, it's a really safe space."
Karina Katalina Moreno at the Paris Olympics, summer 2024. | Photo courtesy of Moreno.
View additional multimedia and more ESG storytelling from Illumina on 3blmedia.com.
Contact Info: Spokesperson: Illumina Website: https://www.3blmedia.com/profiles/illumina Email: info@3blmedia.com
SOURCE: Illumina
View the original press release on accesswire.comEuropean equities traded in the US as American depositary receipts were trending modestly lower late Tuesday morning, declining 0.16% to 1,445.76 on the S&P Europe Select ADR Index.
From continental Europe, the gainers were led by biopharmaceutical company Genfit and pharmaceutical company Ascendis Pharma , which rose 6.8% and 5.7% respectively. They were followed by internet advertising firm Criteo and biotech firm BioNTech , which increased 2.3% and 0.5% respectively.
The decliners from continental Europe were led by furniture maker Natuzzi and medical device maker EDAP TMS , which fell 6.7% and 3.3% respectively. They were followed by biotech firm Evaxion Biotech and biopharmaceutical company DBV Technologies , which lost 2.8% and 1.5% respectively.
From the UK and Ireland, the gainers were led by biopharmaceutical companies Biodexa Pharmaceuticals and Akari Therapeutics , which were up 2% and 3.6% respectively. They were followed by pharmaceutical company Silence Therapeutics and insurance company Prudential , which increased 3.4% and 1.3% respectively.
The decliners from the UK and Ireland were led by biopharmaceutical company NuCana , which tumbled 31.4%, followed by tobacco company British American Tobacco , which was down 2.7%. Pharmaceutical company GSK and medical device maker Smith & Nephew dropped 1.7% and 1.2% respectively.
Shares of NuCana plc NCNA skyrocketed 150.8% on Monday after the announcement of encouraging final data from the mid-stage study of its investigational candidate, NUC-7738, in combination with Merck’s MRK blockbuster oncology drug, Keytruda (pembrolizumab), to treat metastatic melanoma. The melanoma patient population included those who were refractory to or had relapsed on prior PD-1 inhibitor therapy.
The results were presented at the ESMO Congress held on Sept. 14, 2024, in Spain.
NCNA Combo Therapy Shows Superior Efficacy in Melanoma Study
Per the data readout from the phase II NuTide:701 study, out of the 12 patients treated with the NUC-7738/Meck’s Keytruda combo regimen, nine (75%) achieved disease control, including two patients who achieved partial responses.
A patient who had previously undergone two rounds of PD-1 inhibitor therapy and experienced disease progression within two months after treatment with Bristol Myers’ BMY Yervoy (ipilimumab) and Opdivo (nivolumab), achieved a 55% reduction in tumor size. Additionally, seven out of the 12 patients had a progression-free survival exceeding five months, which is unusually long for this group. Per NuCana, the median progression-free survival duration with the standard-of-care treatment for PD-1 inhibitor refractory and resistant melanoma patients is 2-3 months.
In the NuTide:701 study, the combination of NUC-7738 and Meck’s Keytruda also demonstrated a favorable safety profile.
NUC-7738 is a novel anti-cancer agent that disrupts RNA polyadenylation. Its unique mechanism of action allows the candidate to sensitize PD-1-resistant tumors to rechallenge with PD-1 inhibitors. Per the company, the data presented from tumor biopsies obtained before and after NUC-7738-based treatment demonstrated increases in genes related to antigen presentation and T-cell activation, which supports the hypothesis.
Year to date, shares of NuCana have lost 13.9% against the industry’s 0.5% growth.
Bristol Myer’s immunotherapy drug, Opdivo, in combination with Yervoy, is indicated for the treatment of adult and pediatric patients of 12 years and older with unresectable or metastatic melanoma. Both drugs are individually approved for the melanoma indication. Bristol Myer is also currently conducting studies to further expand the combo’s label. Bristol Myer’s Opdivo is approved both as a monotherapy and in combination with Yervoy to treat several other cancer indications in many countries, including the United States and the EU.
Like Bristol Myers’ Opdivo, Merck’s Keytruda is also an anti-PD-1 therapy. It is currently marketed as the standard of care in the frontline treatment of metastatic non-small cell lung cancer patients. Merck’s Keytruda is approved for several types of cancer, accounting alone for 47% of the company’s pharmaceutical sales in 2023. Keytruda is continuously growing and expanding into new indications and markets globally, bolstering Merck’s position in the oncology market.
NuCana’s Future Plans for NUC-7738 Clinical Development
Based on additional data on NUC-7738 obtained in other tumor types, NuCana believes that the unique mechanism of action of the candidate is not restricted to melanoma and that NUC-7738 could potentially sensitize other PD-1 inhibitor-resistant tumor types.
The company expects to share further development plans for NUC-7738 soon.
NuCana PLC Sponsored ADR Price and Consensus
NuCana PLC Sponsored ADR price-consensus-chart | NuCana PLC Sponsored ADR Quote
NuCana’s Other Pipeline Developmental Programs
Apart from NUC-7738, NuCana’s clinical pipeline has another investigational candidate, NUC-3373, which is currently being evaluated in combination with other agents in three separate early to mid-stage studies to treat colorectal cancer, lung cancer and advanced solid tumors.
Data readouts from all three studies are expected by the end of 2024.
Zacks Rank & Stock to Consider
NuCana currently carries a Zacks Rank #3 (Hold).
A better-ranked stock in the biotech sector is Illumina, Inc. ILMN, sporting 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 Illumina’s 2024 earnings per share have moved up from $1.84 to $3.62. The consensus estimate for 2025 earnings has improved from $3.22 to $4.43. Year to date, shares of ILMN have lost 7%.
ILMN’s earnings beat estimates in each of the trailing four quarters, the average surprise being 463.46%.
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