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Here's a roundup of top developments in the biotech space over the last 24 hours.
(Biotech Stocks Hitting 52-week Highs Sept. 2)
(Biotech Stocks Hitting 52-week Lows Sept. 2)
Mallinckrodt plc (OTC: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.
Related Link: Rani Therapeutics, RxSight: 2 Bullish Health Care Stock Picks From BofA
Cassava Sciences, Inc. (NASDAQ: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 plc (NASDAQ: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 Biotechnology Ltd. (NASDAQ: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 Therapeutics, Inc. (NASDAQ: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. (NASDAQ: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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