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Zacks News
Does KALA BIO (KALA) Have the Potential to Rally 152.83% as Wall Street Analysts Expect?
by Zacks Equity Research
The mean of analysts' price targets for KALA BIO (KALA) points to a 152.8% upside in the stock. While this highly sought-after metric has not proven reasonably effective, strong agreement among analysts in raising earnings estimates does indicate an upside in the stock.
KALA BIO (KALA) Reports Q3 Loss, Misses Revenue Estimates
by Zacks Equity Research
KALA BIO (KALA) delivered earnings and revenue surprises of -58.60% and 100%, respectively, for the quarter ended September 2023. Do the numbers hold clues to what lies ahead for the stock?
Dermata (DRMA) Gains on Positive FDA Response for Acne Candidate
by Zacks Equity Research
Dermata (DRMA) gains on positive FDA response for the further development of DMT310 for treating severe to moderate acne.
VYNE Gains on Preclinical Data for IPF Candidate
by Zacks Equity Research
VYNE gains on positive preclinical data evaluating VYN201 for treating idiopathic pulmonary fibrosis.
Madrigal (MDGL) Gains on NASH Treatment's Breakthrough Therapy Tag
by Zacks Equity Research
Madrigal Pharmaceuticals (MDGL) gains on receiving Breakthrough Therapy designation from the FDA for resmetirom.
Gamida Cell (GMDA) Surges on FDA Approval for Omisirge
by Zacks Equity Research
Gamida Cell's (GMDA) shares surge as it receives FDA approval for Omisirge, an allogeneic cell therapy for blood cancer patients.
Humanigen (HGEN) Surges on Lenzilumab Study Data for Leukemia
by Zacks Equity Research
Humanigen's (HGEN) shares surge after presenting promising early results of its Precision Approach to Chronic Myelomonocytic Leukemia study of lenzilumab in chronic myelomonocytic leukemia.
Alvotech (ALVO) Declines on CRL for Humira's Biosimilar Candidate
by Zacks Equity Research
Alvotech's shares decline as it receives a complete response letter for biosimilar candidate, AVT02, treating autoimmune disorders.
Regulus (RGLS) Surges on Enrollment Completion for RGLS8429
by Zacks Equity Research
Regulus (RGLS) surges as it completes enrollment in the first cohort to evaluate RGLS8429 for kidney disease.
Panbela (PBLA) Enrolls First Patient for Type 1 Diabetes Drug
by Zacks Equity Research
Panbela (PBLA) surges as it enrolls the first patient in the mid-stage clinical study to evaluate CPP-1X-T (Eflornithine tablets) for treating recent-onset type 1 diabetes.
Biotech Stock Roundup: MRNA Provides Update, KALA, IFRX Surge on Regulatory News
by Zacks Equity Research
Regulatory and pipeline updates from Moderna (MRNA) and KALA are the key highlights for the biotech sector.
KALA Up on Fast Track Designation to Lead Ocular Candidate
by Zacks Equity Research
KALA gets Fast Track Designation from the FDA for lead candidate KPI-012 to treat persistent corneal epithelial defects.
Humacyte (HUMA) Completes Enrollment in HAV Technology Study
by Zacks Equity Research
Humacyte (HUMA) surges as it completes patient enrollment in a late-stage clinical study on the human acellular vessel product for vascular access in hemodialysis patients.
Panbela (PBLA) Regains Flynpovi Rights to Treat FAP
by Zacks Equity Research
Panbela (PBLA) shares surge as it regains rights to develop and commercialize Flynpovi for the familial adenomatous polyposis treatment.
Apellis (APLS) Stock Up 50% in Three Months: Here's Why?
by Zacks Equity Research
Apellis (APLS) stock rises 50% in the past three months owing to the approval of Syfovre (pegcetacoplan injection) in February. An encouraging uptake in its first marketed product, Empaveli, also contributed to the surge.
Immunic's (IMUX) Ulcerative Colitis Study Shows Positive Data
by Zacks Equity Research
Immunic (IMUX) reports positive results from the maintenance phase of the phase II study evaluating its lead candidate, vidofludimus calcium, to treat patients with ulcerative colitis.
Palisade (PALI) Enrolls First Patient in LB1148 Study in China
by Zacks Equity Research
Palisade's (PALI) development partner, Newsoara, enrolls first patient in the late-stage clinical study of LB1148 to improve postoperative GI function for patients in China.
Kala Pharmaceuticals (KALA) Dips More Than Broader Markets: What You Should Know
by Zacks Equity Research
Kala Pharmaceuticals (KALA) closed the most recent trading day at $13.71, moving -1.37% from the previous trading session.
InflaRx (IFRX) Stock Up on FDA's EUA for COVID-19 Treatment
by Zacks Equity Research
InflaRx (IFRX) shares gain as it receives emergency-use authorization from the FDA for Gohibic (vilobelimab) to treat COVID-19 in terminally-ill patients.
CRISPR (CRSP) & Vertex Complete BLA Submission for Exa-Cel
by Zacks Equity Research
CRISPR (CRSP) and Vertex complete BLA submissions to the FDA for exa-cel for treating sickle cell disease and transfusion-dependent beta-thalassemia.
Kodiak (KOD) Treats First Patient in Diabetic Macular Edema Study
by Zacks Equity Research
Kodiak (KOD) has its first patient in the early-stage study of KSI-501 for treating retinal diseases.
Kala Pharmaceuticals (KALA) Stock Sinks As Market Gains: What You Should Know
by Zacks Equity Research
In the latest trading session, Kala Pharmaceuticals (KALA) closed at $14.60, marking a -1.48% move from the previous day.
Emergent's (EBS) Narcan Gets OTC Status for Opioid Overdose
by Zacks Equity Research
Following the FDA approval, Emergent's (EBS) Narcan nasal spray becomes the first OTC product approved for emergency treatment of opioid overdose. This product will be made available by late summer of this year.
Viking (VKTX) Announces Clinical Data for Metabolic Disorders
by Zacks Equity Research
Viking (VKTX) announces positive clinical data, evaluating VK2735 to treat metabolic disorders. It is also initiating an early-stage extension study on the same.
Amicus (FOLD) Gets Pompe Disease Treatment Approval in Europe
by Zacks Equity Research
Amicus (FOLD) receives approval from the European Commission to treat the adult late-onset Pompe disease with Pombiliti (cipaglucosidase alfa).