Here's a roundup of top developments in the biotech space over the last 24 hours:
Stocks In Focus
Liquidia Appoints Pharma Industry Veteran Roger Jeffs As CEO
Liquidia Corporation (NASDAQ:LQDA) announced the appointment of Dr. Roger Jeffs as chief executive officer effective Jan. 3 and said he will continue as a director on the board. He succeeds Damian deGoa, who will remain a director of the company and will provide transition support through Jan. 31.
Jeffs was previously co-CEO at United Therapeutics, Inc. (NASDAQ:UTHR) and had worked with Amgen, Inc. (NASDAQ:AMGN) as well.
The stock was jumping 13.23% at $5.82 in premarket trading.
Jazz Pharma's Xywav Gets Orphan Drug Exclusivity For Treating Idiopathic Hypersomnia
As Jazz was the first sponsor to obtain FDA approval for idiopathic hypersomnia, Xywav will have seven-year market exclusivity for this indication from its FDA approval on Aug. 12, 2021.
Aravive's Chairman-Led Venture Invests $10M In The Biotech
Aravive, Inc. (NASDAQ:ARAV) said its chairman, Fred Eshelman, through his Eshelman Ventures, LLC, agreed to purchase a pre-funded warrant to purchase 4.55 million shares of the company's common stock at a price of $2.20 per share, which was the consolidated closing bid price of the company's common stock on the Nasdaq on Dec. 31, 2021.
The investment strengthens the company's balance sheet by approximately $10 million, enhancing the company's financial flexibility and liquidity ahead of multiple anticipated clinical milestones throughout 2022 for each of the company's clinical programs. The investment is expected to close on Wednesday.
The stock was advancing 8.98% to $2.67 in premarket trading.
Viridian Submits Regulatory Application To Commence Thyroid Eye Disease Drug Study
Viridian Therapeutics, Inc. (NASDAQ:VRDN) announced the submission of an investigational new drug application to the FDA for VRDN-002, a humanized monoclonal antibody that incorporates half-life extension technology and is designed to support administration as a convenient, low-volume, subcutaneous injection for the treatment of thyroid eye disease.
Viridian said it submitted the IND for VRDN-002 in December 2021.
Related Link: The Week Ahead In Biotech (Jan 2-Jan. 8): Stray Clinical Readouts In Focus In Slow News Week
Allena Announces Positive Midstage Readout For ALLN-346 In Treating Excessive Levels Of Uric Acid In Blood
The company also said it has initiated a process to explore a range of strategic and financing alternatives to maximize shareholder value. Potential strategic alternatives that may be evaluated include partnerships for either or both of the its development candidates, a sale of one or both of the development candidates, a sale or merger or securing additional financing to enable further development of the programs.
The stock was jumping 51.38% to 98 cents in premarket trading.
Spectrum Pharma Gets $20M Equity Investment From Hanmi
Spectrum Pharmaceuticals (NASDAQ:SPPI) announced a $20-million equity investment by Hanmi Pharmaceutical along with revisions to the licensing agreements for ROLONTIS and poziotinib. Under the terms of the strategic investment, Hanmi entered into a $20-million equity purchase agreement that will be priced at $1.60 per share.
Amendments to the licensing agreements for both ROLONTIS and poziotinib will result in the conversion of the upfront milestone payments for both products to deferred royalties. In addition, the royalty obligation for ROLONTIS will be changed to mid-single digits as a percent of sales for a specified period.
Spectrum shares were up 2.52% to $1.63 per share in premarket trading.
Plus Therapeutics Meets 2 Key Milestones For Manufacturing Lead Investigational Therapeutic
Plus Therapeutics, Inc. (NASDAQ:PSTV) announced it has met two significant milestones as it progresses toward cGMP manufacture of Rhenium-186 NanoLiposome.
The company said it has entered into a master services agreement with IsoTherapeutics for the development, manufacture and supply of current cGMP grade Rhenium-186 isotope for the investigational radiotherapeutic. Additionally, the company has completed the technology transfer of analytical test methods with Piramal Pharma Solutions for the drug product intermediate.
The stock was jumping 25.69% to $1.37 in premarket trading.
Avrobio To Deprioritize Fabry Disease Program, Focus On Lysosomal Disorder Pipeline
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Offerings
Intra-Cellular Therapies, Inc. (NASDAQ:ITCI) announced that it has commenced an underwritten public offering of $400 million in shares of its common stock. All of the shares in the offering will be sold by Intra-Cellular Therapies.
The stock was down 8.29% at $47.71 in after-hours trading.
Related Link: Attention Biotech Investors: Mark Your Calendar For January PDUFA Dates
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