Here's a roundup of top developments in the biotech space over the last 24 hours:
Stocks In Focus
NuCana Discontinues Biliary Tract Cancer Study Following Futility Analysis
NuCana plc NCNA said it is discontinuing the NuTide:121 study following a pre-planned futility analysis by the study's Independent Data Monitoring Committee. The Phase 3 study evaluated Acelarin plus cisplatin as a first-line treatment of advanced biliary tract cancer.
Although a higher objective response rate was observed in the Acelarin plus cisplatin arm, this did not translate into an overall survival benefit, the company said.
The IDMC concluded that Acelarin plus cisplatin was unlikely to achieve its primary objective of demonstrating at least a 2.2-month improvement in overall survival as compared to the standard of care, gemcitabine plus cisplatin. Acelarin plus cisplatin was generally well tolerated.
The stock was slumping 54.08% to $1.35 in premarket trading.
Ampio Announces Positive Data Form Modified Intent-To-Treat Population In Phase 3 Osteoarthritis Study
Ampio Pharmaceuticals, Inc. AMPE announced positive data from the modified intent-to-treat population in its AP-013 study, a Phase 3 clinical trial of the company's lead candidate, Ampion, in patients suffering from severe osteoarthritis of the knee.
The stock was gaining 7.57% to 54 cents in premarket trading.
Tricida Announces Delay In Kidney Disease Study Due to Ukrainian Crisis
Tricida, Inc. TCDA said about 15% of patients randomized in the VALOR-CKD trial evaluating veverimer in patients with metabolic acidosis and chronic kidney disease are from Ukraine. Given the uncertainty around future participation of Ukrainian subjects in the trial and the potential challenges to collecting and monitoring data from Ukrainian sites, top-line data from the VALOR-CKD trial is now anticipated early in the fourth quarter of 2022 versus its previous guidance of the third quarter of 2022.
Avita Medical AnnouncesAgreement For Its Recell System To Treat Severe Burns
Avita Medical, Inc. RCEL said it was awarded a group purchasing agreement with Premier, Inc., which allows Premier members, at their discretion, to take advantage of special pricing and terms pre-negotiated by Premier for the Recell System for the treatment of adult and pediatric patients that require treatment for severe burns.
The Recell System is a device that enables health care professionals to produce a suspension of Spray-On Skin Cells using a small sample of the patient's own skin for the treatment of acute thermal burns.
Synlogic Names Healthcare Industry Veteran Michael Jensen As CFO
Synlogic, Inc. SYBX announced the appointment of Michael Jensen as chief financial officer.
BeiGene Gets Label Expansion In Canada To Treat Marginal Zone Lymphoma
BeiGene BGNE announced that Brukinsa has been approved by Health Canada for the treatment of adult patients with marginal zone lymphoma, who have received at least one prior anti-CD20-based therapy.
Ascendis Pharma A/S ASND reported an increase in revenues from 6.953 million euros ($7.24 million) in 2020 to $7.78 million euros in 2021. The loss per share narrowed from 8.28 euros to 7 euros.
The stock was moving down 6.09% to $100 in premarket trading.
Singular Genomics Systems, Inc. OMIC reported a fourth-quarter loss of 27 cents per share, narrower than the year-ago loss of 73 cents per share. Analysts had estimated a loss of 31 cents per share.
The stock was slipping 7.84% to $7.17 in premarket trading.
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On The Radar
- Fulcrum Therapeutics, Inc. FULC (before the market open)
- Immunocore Holdings plc IMCR (before the market open)
- Antares Pharma, Inc. ATRS (before the market open)
- Puma Biotechnology, Inc. PBYI (after the market close)
- Profound Medical Corp. PROF (after the market close)
- Oncolytics Biotech Inc. ONCY (after the market close)
- INmune Bio, Inc. INMB (after the market close)
- Evofem Biosciences, Inc. EVFM (after the market close)
- Calyxt, Inc. CLXT (after the market close)
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