Shuttle Pharma: Private Placement of $4.3 M of Senior Secured Convertible Note and Warrants

 Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH), a discovery and development stage specialty pharmaceutical company focused on improving the outcomes of cancer patients treated with radiation therapy (RT) while reducing side effects, announced the issuance of a $4.3 million senior secured convertible note and warrant to an institutional investor. Shuttle Pharmaceuticals will receive initial gross proceeds of $4.0 million. In addition, the four-year warrant to purchase up to approximately 1.018 million shares of Shuttle Pharmaceuticals' common stock at an exercise price of $2.35 per share, upon exercise, would result in additional proceeds of approximately $2.4 million if the warrants are exercised by the investor.

https://finance.yahoo.com/news/shuttle-pharmaceuticals-announces-private-placement-211500732.html

Jasper: New Briquilimab Data Shows Safety, Efficacy In Blood Cancer Patients

 

• Jasper Therapeutics Inc 
  JSPR+25.4%+ Free Alerts
   announced that new data for briquilimab (formerly JSP191) will be presented at the 2023 Tandem Meetings: Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR, taking place next month.
• The studies demonstrate that a regimen of briquilimab plus Flu/TBI leads to successful engraftment of donor blood stem cell without the usual short and long-term toxicities accompanying alternative busulfan-based regimens commonly used in the transplant of donor or gene-corrected cells. 
• The company says that briquilimab can potently synergize with radiation, amplifying its stem cell-depleting effects without increasing off-target toxicity.
• The first abstract demonstrates that briquilimab was safe, well-tolerated, and achieved durable remissions in 8 of 12 first-treated AML patients. 
• All eight patients were relapse-free at one-year follow-up. Six of 9 patients who entered transplant with detectable AML showed long-term eradication of the AML clones at one-year. 
• In a companion abstract, 29 AML and MDS patients treated with briquilimab and Flu/TBI demonstrated lower-than-expected rates of acute and chronic graft-versus-host disease (GVHD). 

https://www.benzinga.com/general/biotech/23/01/30409391/jasper-therapeutics-trade-higher-as-new-briquilimab-data-shows-safety-efficacy-in-blood-cancer-pa

FSD Pharma Announces Share Repurchase Program

 FSD Pharma Inc. (NASDAQ: HUGE) (CSE: HUGE) (FRA: 0K9A) ("FSD Pharma" or the "Company"), a biopharmaceutical company dedicated to building a portfolio of innovative assets and biotech solutions to address ailments affecting millions worldwide, is pleased to announce that its Board of Directors has authorized the repurchase under a normal course issuer bid ("NCIB") of up to 1,925,210 of its Subordinate Class B Voting Shares (the "Subordinate Voting Shares") from time to time over the next 12 months at prevailing market prices in order to allow the Company to use its excess cash reserves to strategically return value to shareholders.

https://finance.yahoo.com/news/fsd-pharma-announces-share-repurchase-133000195.html

EMA seeks to issue guidance on liver damage from Novartis' gene therapy

 The European Medicines Agency (EMA) said on Friday it plans to issue advice for physicians using Novartis AG's Zolgensma, calling on them to monitor patients for any liver injury after treatment.

The statement follows two deaths due to liver failure after treatment with the gene therapy against spinal muscular atrophy, reported by Novartis in August.

Spinal muscular atrophy is a group of rare genetic disorders which affect the nerve cells and cause muscle wasting and weakness.

The advice for healthcare professionals has yet to be approved by further expert panels at EMA, which typically takes a few weeks.

Novartis said it had notified health authorities of the deaths and sent letters to update healthcare providers on liver safety in markets including the United States in August.

In Europe, however, such letters had been the subject of discussions with EMA, but Novartis would soon be cleared to send them in EU member states, it added.

The EMA said that if patients do not respond adequately to treatment with corticosteroids, treating physicians should consult specialists and consider adjusting the corticosteroid regimen.

Infusion drug Zolgensma competes with Roche's oral drug Evrysdi and Biogen's spinal injection Spinraza.

It won conditional EU approval during early 2020 and it costs more than $2 million per patient.

https://finance.yahoo.com/news/1-eu-regulator-asks-liver-132541582.html

AnaptysBio Announces Stock Repurchase Plan

 AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company focused on delivering innovative immunology therapeutics, today announced that its Board of Directors has authorized a Stock Repurchase Plan under which the Company may repurchase up to $50,000,000 of the Company’s outstanding common stock, par value $0.001 per share. With cash, cash equivalents and investments greater than $575 million as of December 31, 2022, notwithstanding the potential full execution of the Stock Repurchase Plan, the company reiterates its previous guidance that it anticipates having approximately 4 years of capital to execute against its non-risk adjusted research and development plan, excluding potential future royalties from its GSK immuno-oncology financial collaboration.

https://finance.yahoo.com/news/anaptysbio-announces-stock-repurchase-plan-140000085.html

Low uptake prompts AstraZeneca to withdraw Lumoxiti from US market

 AstraZeneca (LSE: AZN) is to pull its leukemia antibody-drug conjugate Lumoxiti (moxetumomab pasudotox-tdfk) from the US market later this year.

Poor sales performance of the CD22-directed immunotoxin drug, rather than any issues with safety, has been cited by the Anglo-Swedish pharma major as the reason for the move.

Lumoxiti was approved by the US Food and Drug Administration in 2018 to treat patients with relapsed or refractory hairy cell leukemia who have received at least two prior therapies.

AstraZeneca has suggested that reasons for the poor take-up could be other drugs being available, the complexity of administration for a product that is intravenously administered and also safety monitoring needs for patients, since Lumoxiti’s label came with a boxed warning about capillary leak syndrome and hemolytic uraemic syndrome.

The signs that all was not rosy with Lumoxiti emerged in late 2020 when French biotech Innate Pharma (Euronext: IPH) announced it was handing back US and European Union commercialization rights.

AstraZeneca had initially out-licensed the drug to Innate in October 2018. At that time, hopes were high for sales. Sir Pascal Soriot, chief executive of the Cambridge, UK-based company, said that he thought the treatment could achieve blockbuster status, while analysts suggested a more modest, although still significant, $500 million in peak revenues.

Innate chief executive Mondher Mahjoubi said the firm had “determined that there is low strategic value for us in maintaining Lumoxiti in our portfolio due to lower than anticipated product sales, further compounded by the ongoing COVID-19 pandemic.”

https://www.thepharmaletter.com/article/low-uptake-prompts-astrazeneca-to-withdraw-lumoxiti-from-us-market

Organigram upped to Buy by Stifel

 from Hold

https://finviz.com/quote.ashx?t=OGI&ty=c&ta=1&p=d