Here's a roundup of top developments in the biotech space over the last 24 hours.
Scaling The Peaks
(Biotech Stocks Hitting 52-week Highs Sept. 2)
- Abbott Laboratories ABT (announced acquisition of medical device company Walk Vascular)
- Adagio Therapeutics, Inc. ADGI (IPOed Aug. 6)
- Axonics, Inc. AXNX
- Bicycle Therapeutics plc BCYC
- Bio-Rad Laboratories, Inc. BIO
- Bio-Techne Corporation TECH
- Biohaven Pharmaceutical Holding Company Ltd. BHVN
- Catalent, Inc. CTLT
- Celldex Therapeutics, Inc. CLDX
- Cerevel Therapeutics Holdings, Inc. CERE
- Crinetics Pharmaceuticals, Inc. CRNX (announced COO appointment)
- Cryo-Cell International, Inc. CCEL (announced uplisting to Nasdaq on Tuesday)
- DexCom, Inc. DXCM
- Edwards Lifesciences Corporation EW
- Enanta Pharmaceuticals, Inc. ENTA
- Erasca, Inc. ERAS
- Genmab A/S GMAB
- Globus Medical, Inc. GMED
- Intuitive Surgical, Inc. ISRG
- Kezar Life Sciences, Inc. KZR
- Medtronic plc MDT
- Merit Medical Systems, Inc. MMSI
- MiMedx Group, Inc. MDXG
- Monte Rosa Therapeutics, Inc. GLUE
- PDS Biotechnology Corporation PDSB
- PPD, Inc. PPD
- Prothena Corporation plc PRTA
- Quest Diagnostics Incorporated DGX
- Repligen Corporation RGEN
- ShockWave Medical, Inc. SWAV
- Surmodics, Inc. SRDX
- West Pharmaceutical Services, Inc. WST
- Zoetis Inc. ZTS
Down In The Dumps
(Biotech Stocks Hitting 52-week Lows Sept. 2)
- Assembly Biosciences, Inc. ASMB ( announced halting of mid-Phase hepatitis B virus study due to safety concerns)
- Sera Prognostics, Inc. SERA
Stocks In Focus
Mallinckrodt Reaches Agreement With Opioid-related Creditors That Will Pave Way For Amended Plan of Reorganization
Mallinckrodt plc MNKKQ said it has reached an agreement with the official committee of opioid-related creditors and the restructuring support agreement parties to support an amended plan of reorganization, which it will file in the coming days.
The agreement with the OCC follows recently announced agreements to support the amended plan that Mallinckrodt reached with the Official Committee of Unsecured Creditors appointed in its Chapter 11 cases and certain of Mallinckrodt's second lien noteholders.
Cassava Refutes Allegations of Data Manipulation Yet Again, Pledges to Defend Itself Vigorously
Cassava Sciences, Inc. SAVA released a public statement regarding recent allegations made against it.
"The allegations claim our science is improbable, unexpected and unique to Cassava Sciences, and therefore it's all an elaborate fraud," said Remi Barbier, Cassava's President & CEO.
"By these criteria, all drug innovations are fraudulent. We intend to vigorously defend ourselves and our stakeholders against false and misleading allegations."
The stock was down 1.75% at $53.40 in premarket trading.
AstraZeneca, EC End Legal Proceedings Over COVID-19 Vaccine Supply Deal
AstraZeneca plc AZN said it has reached an agreement with the European Commission that ends legal proceedings over the execution of the "Advance Purchase Agreement" for the delivery of the COVID-19 vaccine Vaxzevria.
Under the agreement, AstraZeneca commits to deliver 60 million doses of the vaccine by the end of the third quarter 2021, 75 million by the end of the fourth quarter 2021 and 65 million by the end of the first quarter 2022. Member States will be provided with regular delivery schedules, and capped rebates will apply in the event of any delayed doses, the company added.
Separately, AstraZeneca said its Ultomiris has been approved in the European Union for expanded use to include children and adolescents with paroxysmal nocturnal haemoglobinuria an ultra-rare and severe blood disorder characterized by the destruction of red blood cells that can cause thrombosis and result in organ damage and potentially premature death.
Cellect Says First ApoGraft Transplantation Done In a Leukemia Patient
Cellect Biotechnology Ltd. APOP announced the first ApoGraft transplantation in a Leukemia patient in its clinical trial at Washington University in the U.S.
ApoGraft is a product based on the company's cell selection technology designed to optimize immune therapy, in this application - prevent graft-versus-host disease following bone marrow transplantation.
Following the closing of the previously announced strategic merger transaction between Cellect and Quoin Pharmaceuticals, ApoGraft development will be pursued by EnCellX, the privately held U.S.-based company that is acquiring Cellect's proprietary technology concurrently with such merger.
The stock was up 8.66% at $57.45 in premarket trading.
Aclaris, Praxis Move On Insider Transactions
Aclaris Therapeutics, Inc. ACRS disclosed in a filing with the SEC that Joseph Monahan, its chief scientific officer, sold 1,041 shares of the company at $17.22 apiece. The shares sold was part of the 2,333 restricted stock unit the executive received.
The stock was up 3.35% at $18.19 in premarket trading.
Praxis Precision Medicines, Inc. PRAX said its CFO Timothy Edwin Kelly bought 3,905 shares in the company at $19.48 per share.
The stock was moving up 3.19% to $21.67 in premarket trading.
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