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Zacks News
Better Therapeutics' (BTTX) CBT Gains FDA's Breakthrough Status
by Zacks Equity Research
Better Therapeutics' (BTTX) novel CBT platform attains the FDA's breakthrough device designation to improve patient care in the treatment of liver and metabolic diseases.
Alnylam (ALNY) Receives CRL for the Label Expansion of Onpattro
by Zacks Equity Research
Alnylam's (ALNY) label expansion-seeking application for Onpattro, to treat transthyretin-mediated amyloidosis with cardiomyopathy, gets the FDA's CRL on the grounds of insufficient data. The stock falls 5%.
Jasper (JSPR) Up on FDA Nod to Begin Early-Stage Urticaria Study
by Zacks Equity Research
Jasper (JSPR) announces the FDA clearance to begin the clinical study of briquilimab for chronic spontaneous urticaria. The stock of the company rises 16%.
Lineage (LCTX) Up 10% on Upbeat Data From Eye Disease Study
by Zacks Equity Research
Lineage (LCTX) rises 10% on positive imaging analyses results from the phase I/IIa study of OpRegen in patients with geographic atrophy secondary to age-related macular degeneration.
Orchard (ORTX) Up 97% on $478M Acquisition Deal With Kyowa Kirin
by Zacks Equity Research
Orchard (ORTX) is set to be acquired by Kyowa Kirin for a consideration of $17 per American Depositary Share, which amounts to a total transaction value of approximately $478 million. Shares rise 97%.
Nuvalent (NUVL) Soars 36% on Upbeat Initial NSCLC Study Data
by Zacks Equity Research
Nuvalent (NUVL) surges 36% on encouraging preliminary results from the phase I dose-escalation portion of its early-mid-stage development program for NVL-655 to treat advanced ALK-positive NSCLC.
Sanofi (SNY) Signs Deal to Co-Develop Teva's IBD Candidate
by Zacks Equity Research
Sanofi (SNY) and Teva enter into a collaboration deal to co-develop and co-commercialize the latter's inflammatory bowel disease candidate, TEV'574.
Kezar (KZR) Falls 10% on Strategic Update, Reduces Workforce
by Zacks Equity Research
Kezar (KZR) falls 10% on the decision to channel resources to one clinical candidate as part of its reprioritization efforts and slash the workforce by 41%.
Kinnate Biopharma (KNTE) Falls 40% in a Month: Here's Why
by Zacks Equity Research
Kinnate Biopharma (KNTE) plunges 40% in a month for the decision to streamline its pipeline to one clinical candidate as part of its reprioritization efforts and slash workforce by 70%.
Crinetics (CRNX) Stock Surges 70% in a Month: Here's Why
by Zacks Equity Research
Crinetics (CRNX) surges 69.6% in a month due to encouraging results from its late-stage study, paltusotine, in patients with acromegaly who were switching from current standard-of-care treatment.
Novo Nordisk (NVO), Valo Ink Deal to Develop Heart Disease Drugs
by Zacks Equity Research
Novo Nordisk (NVO) collaborates with Valo Health to discover and develop novel treatments for cardiometabolic diseases using Valo's proprietary drug development platform.
Moleculin (MBRX) Posts Update From Lung Cancer Study, Stock Up
by Zacks Equity Research
Moleculin (MBRX) completes enrollment in the phase II portion of the development program for its lead candidate, Annamycin, to treat soft tissue sarcoma lung metastases. The stock rises 10%.
Aquestive (AQST) Up on Reaffirming Anaphylm Development Pathway
by Zacks Equity Research
Aquestive (AQST) stock rises 11.8% as the company intends to begin a pivotal pharmacokinetic study of Anaphylm as an oral epinephrine product candidate in the fourth quarter of 2023.
Atara (ATRA) Up 11% on Regulatory Update From Blood Cancer Study
by Zacks Equity Research
Atara (ATRA) rises 11% on an update regarding the regulatory pathway for the company's lead product candidate, tab-cel, in the treatment of a rare, deadly and hematologic malignancy.
Gilead's (GILD) Veklury Gets CHMP Nod in Damaged Liver Patients
by Zacks Equity Research
Gilead's (GILD) Veklury gets a positive CHMP opinion, recommending the use of the drug to treat people with COVID-19 with mild to severe hepatic impairment.
Orchard's (ORTX) Rare Neuro Drug Gets FDA Priority Tag, Stock Up
by Zacks Equity Research
Orchard's (ORTX) regulatory filing for OTL-200, in the treatment of pediatric patients suffering from metachromatic leukodystrophy, gets FDA acceptance under Priority Review. The stock rises 16%.
Merck (MRK) Gets CHMP Nod for Keytruda in Adjuvant Lung Cancer
by Zacks Equity Research
Merck's (MRK) Keytruda gets a positive CHMP opinion, recommending the approval of the drug for the adjuvant treatment of adults with non-small cell lung cancer, who are at high risk of recurrence, in the EU.
Alnylam's (ALNY) Onpattro sNDA Gets FDA Advisory Committee Nod
by Zacks Equity Research
Alnylam (ALNY) receives a positive opinion from the FDA's advisory committee regarding the label expansion of patisiran to treat the cardiomyopathy of transthyretin-mediated amyloidosis.
Aquestive's (AQST) Libervant Accepted for FDA Review, Stock Up
by Zacks Equity Research
Aquestive (AQST) announces FDA acceptance of a regulatory application seeking approval for Libervant to treat pediatric patients with frequent seizure activity. The stock rises 4.7% in response.
Bicycle (BCYC) to Begin Pivotal Bladder Cancer Study, Stock Up
by Zacks Equity Research
Bicycle (BCYC) aligns with the FDA on the design of a mid-late-stage registrational study for its bladder cancer drug, BT8009, with the potential to support its accelerated approval. The stock rises 9%.
Codexis (CDXS) Transfers Leasing Rights to Vaxcyte, Stock Up
by Zacks Equity Research
Codexis (CDXS) transfers the leasing rights of its San Carlos, CA location to Vaxcyte to focus on technology development, inducing cost savings, to extend its cash runway to mid-2026. The stock rises 7%.
Alnylam's (ALNY) Zilebesiran Meets Goals in Mid-Stage Study
by Zacks Equity Research
Alnylam's (ALNY) mid-stage study of zilebesiran in the treatment of hypertension in patients at high cardiovascular risk meets primary and key secondary endpoints.
Journey Medical (DERM) & Maruho Ink Deal for Qbrexza Asia Rights
by Zacks Equity Research
Journey Medical (DERM) enters into a second licensing agreement with Maruho to develop and commercialize Qbrexza to treat hyperhidrosis in certain Asian countries. The stock surges 18.4%.
Centessa (CNTA) Surges 72% in the Past 3 Months: Here's Why
by Zacks Equity Research
Centessa (CNTA) shares rise significantly in the past three months due to the encouraging progress in the development of its lead pipeline candidate, SerpinPC, which is currently in mid-late-stage studies.
Here's Why You Should Add Pacira (PCRX) Stock to Your Portfolio
by Zacks Equity Research
Pacira (PCRX) is witnessing strong growth on the back of its lead product, Exparel. Potential label expansion is set to boost sales in future quarters.