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 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. UTHR and had worked with Amgen, Inc. 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
Jazz Pharmaceuticals, Inc. JAZZ said the U.S. Food and Drug Administration has granted orphan drug exclusivity for Xywav oral solution in the treatment of idiopathic hypersomnia in adults, making it the second ODE for the medication following the exclusivity granted in the treatment of cataplexy or excessive daytime sleepiness in patients 7 years of age and older with narcolepsy.
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. 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. 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
Allena Pharmaceuticals, Inc. ALNA said its ALLN-346, an orally administered enzyme in development for the treatment of hyperuricemia and gout in the setting of advanced chronic kidney disease, demonstrated a statistically significant reduction in serum uric acid and a well-tolerated safety profile in first cohort of patients with hyperuricemia and chronic kidney disease in the Phase 2a Study 201.
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 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. 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
AVROBIO, Inc. AVRO announced that it is shifting its portfolio priorities to focus on lysosomal disorder pipeline and extending its cash runway into the first quarter of 2024. The company is deprioritizing its Fabry disease program due to several factors, including new clinical data showing variable engraftment patterns from the five most recently dosed Phase 2 FAB-GT patients which would significantly extend the program's development timeline, as well as an increasingly challenging market and regulatory environment for Fabry disease.
Click here to access Benzinga's FDA Calendar.
Offerings
Intra-Cellular Therapies, Inc. 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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