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Friday, January 5, 2024

TG Therapeutics to Participate in the 42nd Annual J.P. Morgan

 TG Therapeutics, Inc. (NASDAQ: TGTX), today announced that Michael S. Weiss, the Company’s Chairman and Chief Executive Officer, will present at the 42nd Annual J.P. Morgan Healthcare Conference. The presentation is scheduled to take place on Tuesday, January 9, 2024, at 4:30 PM PT.

A live webcast of this presentation will be available on the Events page, located within the Investors & Media section, of the Company’s website at http://ir.tgtherapeutics.com/events. A replay of the webcast will be available on TG’s website following the event.

https://www.globenewswire.com/news-release/2024/01/05/2804584/8790/en/TG-Therapeutics-to-Participate-in-the-42nd-Annual-J-P-Morgan-Healthcare-Conference.html

AP Frames LGBTQ School Shooter As A Victim

 by Steve Watson via Modernity.news,

The Associated Press published an article Thursday claiming that the latest school shooter was a victim of bullying.

China's Shadow-Banking Giant Files For Bankruptcy

 One of China's "secretive" shadow-banking giants filed for bankruptcy on Friday due to its inability to repay tens of billions of dollars in debt, a warning sign contagion from the downturn in the real estate industry continues to spread and raises questions if the property crisis in the world's second-largest economy will accelerate into the new year. 

2023 has seen China's Shadow Banking system mostly acting as a liquidity-suck (red bars) while corporate bond issuance has barely offset the withdrawals.

Theravance Phase 4 COPD trial disappoints

Theravance Biopharma, Inc. (NASDAQ: TBPH) today announced results from the Phase 4 PIFR-2 study of YUPELRI® (revefenacin) inhalation solution, the only once-daily, nebulized long-acting muscarinic antagonist (LAMA) approved in the U.S. for maintenance treatment of COPD.

The PIFR-2 study aimed to demonstrate greater improvement in lung function for YUPELRI delivered via standard jet nebulizer compared to Spiriva® (tiotropium) delivered via a dry powder inhaler (Spiriva® HandiHaler®) in adults with severe to very severe COPD and suboptimal peak inspiratory flow rate (PIFR).

  • The study did not show a statistically significant difference between YUPELRI and Spiriva HandiHaler on the primary endpoint, change from baseline in trough forced expiratory volume in one second (FEV1) at Day 85.
  • Similar lung function improvement was demonstrated in both arms of the study.
  • YUPELRI demonstrated safety and tolerability consistent with its profile in previous clinical studies.

Aurinia Prelims

 Preliminary unaudited total net revenue for the fourth quarter and full year 2023 of approximately $45 million and $176 million

Preliminary unaudited net product revenue for the fourth quarter and full year 2023 of approximately $42 million and $159 million

Approximately $351 million of cash, cash equivalents, restricted cash and investments as of December 31, 2023 (unaudited)

Net product revenue guidance for 2024 in the range of $200 -$220 million; targeting to be cash flow positive in the second half of 2024

https://www.businesswire.com/news/home/20240105424869/en/

Sana OKd on Application B-cell Malignancies Therapy

 Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on changing the possible for patients through engineered cells, today announced the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application to initiate a study of SC262 in patients with relapsed or refractory B-cell malignancies, initially in patients who have received prior CD19-directed CAR T therapy.

Engineered CAR T cell therapies for B-cell malignancies use binders to target proteins expressed on the surface of B cells. One such protein, CD19, has been the target of all approved autologous CAR T therapies for B-cell lymphoma and B-cell acute lymphoblastic leukemia to date. Unfortunately, incomplete responses or relapses occur in approximately 60% of CD19 CAR T-treated patients. CD22, which is also a B-cell surface protein, has emerged as an alternative to address failure to achieve durable complete responses with CD19-directed CAR T therapy. SC262 expresses the same CAR, including the same CD22 binder, used in CD22-directed CAR T therapies tested in multiple academic clinical trials. To date, these trials have shown durable complete responses in a substantial number of patients in the relapse setting following treatment with a CD19-directed CAR T therapy.

https://finance.yahoo.com/news/sana-biotechnology-announces-fda-clearance-140000664.html

Allogene to cut 22% of its workforce

 Allogene Therapeutics said on Friday it will cut 22% of its workforce, as the gene editing company shifts focus to developing its blood cancer therapy.

The announcement comes shortly after the company, which had 361 employees as of February 2023, had said it will no longer focus on two of its studies testing blood cancer therapy Cema-Cel.

Shares of the California-based company fell over 20% in premarket trading.

Allogene added that trial activities were underway for a new study for the same class of therapy and will focus on developing it as a first-line treatment for patients with a type of blood cancer.

Analysts at TD Cowen said the move was "surprising yet thoughtful", while Truist noted it enables the company to "achieve a much more commercially attractive outcome".

B. Riley Securities said ending the two studies would introduce potential delays in bringing the cell therapy to market.

Allogene estimates it will incur charges of about $5.0 million to $5.5 million associated with the layoffs.

The reduction in workforce is expected to be completed by the end of January 2024.

https://finance.yahoo.com/news/1-allogene-cut-22-workforce-132538678.html