We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Aura Stock Up as Lead Drug Shows Superior Efficacy in Eye Cancer Study
Read MoreHide Full Article
Shares of Aura Biosciences (AURA - Free Report) gained 7.9% on Sept. 12 after the company announced encouraging data from a phase II study evaluating its lead candidate, bel-sar (AU-011), to treat early-stage choroidal melanoma (CM) in the first-line setting. Bel-sar is a novel investigational agent designed with a dual mechanism of action that includes targeted cytotoxicity and immune activation.
CM is a type of cancer occurring in the choroid, a layer of blood vessels and connective tissue between the sclera (white of the eye) and retina. It is the most common primary intraocular (inside the eye) cancer in adults.
Bel-Sar Leads to Tumor Control & Preserves Visual Acuity
The phase II study results showed that bel-sar achieved an 80% tumor control rate in phase III-eligible patients (8 out of 10) who received the treatment. Among these responders, the tumor stopped growing completely. 90% of the patients preserved their visual acuity. This is particularly important since 80% of these patients had tumors near the fovea or optic disc, areas associated with a high risk of vision loss. This highlights the potential of this new drug class for preserving vision in patients with CM.
Treatment with radiotherapy, which is the current standard of care, results in poor vision outcomes, with up to 87% of patients experiencing visual acuity below 20/200, the threshold for legal blindness in the treated eye. Bel-sar has the potential to be the first treatment to both target the tumor and preserve vision, potentially transforming the treatment approach for patients with CM.
Year to date, shares of AURA have gained 10.5% against the industry’s 0.8% decline.
Image Source: Zacks Investment Research
Aura further states that the investigational bel-sar therapy demonstrated a favorable safety profile and was overall well-tolerated by the CM patient populationregardless of dosage strength. No treatment-related serious adverse events were reported during the phase II study.
Ocular treatment-related adverse events were mostly mild to moderate in severity, which were self-limited, requiring no treatment and resolved in a median of six days.
Aura’s Future Plans for Bel-Sar Treatment in CM Patients
Based on positive phase II results, Aura has already advanced bel-sar to late-stage development. An ongoing global phase III CoMpass study is currently enrolling patients to evaluate the candidate as a first-line treatment for CM patients. Last year, the company received written confirmation from the FDA through a Special Protocol Assessment for the design and planned analysis of its late-stage CM study. This agreement indicates that the regulatory body believes that if the CoMpass study is successful, it will meet the necessary objectives to support Aura’s planned submission for a biologics license application for bel-sar to treat CM.
Apart from the CM indication, AURA is also currently evaluating bel-sar as a monotherapy in an ongoing early-stage study for the treatment of bladder cancer.
In the past 60 days, estimates for Illumina’s 2024 earnings per share have moved up from $1.18 to $3.62. The consensus estimate for 2025 earnings has improved from $2.93 to $4.43. Year to date, shares of ILMN have lost 9.3%.
ILMN’s earnings beat estimates in each of the trailing four quarters, the average surprise being 463.46%.
In the past 60 days, estimates for Krystal Biotech’s 2024 earnings per share have increased from $1.98 to $2.38. The consensus estimate for 2025 earnings has improved from $4.33 to $7.31. Year to date, shares of KRYS have risen 57.7%.
KRYS’ earnings beat estimates in three of the trailing four quarters while missing on the remaining occasion, the average surprise being 45.95%.
In the past 60 days, estimates for Fulcrum Therapeutics’ 2024 loss per share have narrowed from $1.24 to 48 cents. The consensus estimate for 2025 loss per share has narrowed from $1.71 to $1.53. Year to date, shares of FULC have plunged 49%.
FULC’s earnings beat estimates in each of the trailing four quarters, the average surprise being 393.18%.
See More Zacks Research for These Tickers
Normally $25 each - click below to receive one report FREE:
Image: Bigstock
Aura Stock Up as Lead Drug Shows Superior Efficacy in Eye Cancer Study
Shares of Aura Biosciences (AURA - Free Report) gained 7.9% on Sept. 12 after the company announced encouraging data from a phase II study evaluating its lead candidate, bel-sar (AU-011), to treat early-stage choroidal melanoma (CM) in the first-line setting. Bel-sar is a novel investigational agent designed with a dual mechanism of action that includes targeted cytotoxicity and immune activation.
CM is a type of cancer occurring in the choroid, a layer of blood vessels and connective tissue between the sclera (white of the eye) and retina. It is the most common primary intraocular (inside the eye) cancer in adults.
Bel-Sar Leads to Tumor Control & Preserves Visual Acuity
The phase II study results showed that bel-sar achieved an 80% tumor control rate in phase III-eligible patients (8 out of 10) who received the treatment. Among these responders, the tumor stopped growing completely. 90% of the patients preserved their visual acuity. This is particularly important since 80% of these patients had tumors near the fovea or optic disc, areas associated with a high risk of vision loss. This highlights the potential of this new drug class for preserving vision in patients with CM.
Treatment with radiotherapy, which is the current standard of care, results in poor vision outcomes, with up to 87% of patients experiencing visual acuity below 20/200, the threshold for legal blindness in the treated eye. Bel-sar has the potential to be the first treatment to both target the tumor and preserve vision, potentially transforming the treatment approach for patients with CM.
Year to date, shares of AURA have gained 10.5% against the industry’s 0.8% decline.
Image Source: Zacks Investment Research
Aura further states that the investigational bel-sar therapy demonstrated a favorable safety profile and was overall well-tolerated by the CM patient populationregardless of dosage strength. No treatment-related serious adverse events were reported during the phase II study.
Ocular treatment-related adverse events were mostly mild to moderate in severity, which were self-limited, requiring no treatment and resolved in a median of six days.
Aura’s Future Plans for Bel-Sar Treatment in CM Patients
Based on positive phase II results, Aura has already advanced bel-sar to late-stage development. An ongoing global phase III CoMpass study is currently enrolling patients to evaluate the candidate as a first-line treatment for CM patients. Last year, the company received written confirmation from the FDA through a Special Protocol Assessment for the design and planned analysis of its late-stage CM study. This agreement indicates that the regulatory body believes that if the CoMpass study is successful, it will meet the necessary objectives to support Aura’s planned submission for a biologics license application for bel-sar to treat CM.
Apart from the CM indication, AURA is also currently evaluating bel-sar as a monotherapy in an ongoing early-stage study for the treatment of bladder cancer.
Aura Biosciences, Inc. Price and Consensus
Aura Biosciences, Inc. price-consensus-chart | Aura Biosciences, Inc. Quote
Zacks Rank & Stocks to Consider
Aura currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Illumina, Inc. (ILMN - Free Report) , Krystal Biotech, Inc. (KRYS - Free Report) and Fulcrum Therapeutics, Inc. (FULC - Free Report) , each 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 $1.18 to $3.62. The consensus estimate for 2025 earnings has improved from $2.93 to $4.43. Year to date, shares of ILMN have lost 9.3%.
ILMN’s earnings beat estimates in each of the trailing four quarters, the average surprise being 463.46%.
In the past 60 days, estimates for Krystal Biotech’s 2024 earnings per share have increased from $1.98 to $2.38. The consensus estimate for 2025 earnings has improved from $4.33 to $7.31. Year to date, shares of KRYS have risen 57.7%.
KRYS’ earnings beat estimates in three of the trailing four quarters while missing on the remaining occasion, the average surprise being 45.95%.
In the past 60 days, estimates for Fulcrum Therapeutics’ 2024 loss per share have narrowed from $1.24 to 48 cents. The consensus estimate for 2025 loss per share has narrowed from $1.71 to $1.53. Year to date, shares of FULC have plunged 49%.
FULC’s earnings beat estimates in each of the trailing four quarters, the average surprise being 393.18%.