Search This Blog

Thursday, August 10, 2023

Jazz ups guidance after Q2

 Strong execution delivered second quarter 2023 total revenues of $957 million –

– Commercial excellence drove continued adoption of low-sodium Xywav®; net product sales increased 39% year-over-year –
– Continued growth of Epidiolex®; net product sales increased 15% 2Q23 year-over-year –
– Strong demand for Rylaze® drove 39% increase in net product sales year-over-year –
– Oncology portfolio expected to reach ~$1 billion in net product sales this year –
– Zanidatamab leads a diversified pipeline with near-term catalysts positioned to deliver as many as four late-stage data readouts by the end of 2024 –

CorMedix's DefenCath Aims to Tackle Catheter-Related Blood Stream Infections: RBC

 RBC Capital Markets initiated coverage on CorMedix Inc 

 with an Outperform rating and a price target of $6.

CorMedix's antimicrobial asset, DefenCath, can transition the company's execution story with the potential to capture an attractive hemodialysis market.

Despite previous CRLs, DefenCath's data remains robust. The Phase 3 LOCK-IT-100 study in patients undergoing hemodialysis therapy for ESRD demonstrated strong safety and efficacy in preventing CRBSIs. The Phase III LOCK-IT-100 trial results, which analyzed data from 795 out of 806 patients, are promising. 

The analyst Gregory Renza is impressed with CRMD's robust launch and reimbursement plans for inpatient and outpatient contexts, aiming for a peak potential of $600 million in the U.S. by the 2030s. 

Furthermore, potential expansion into pediatric hemodialysis, oncology, and total parenteral nutrition may provide enduring avenues for growth.

The analyst writes that though the November 15 FDA decision date comes with binary risk and historical PDUFA-stage share volatility, DefenCath's resubmission has improved its positioning and is more likely than not to be approved.

Should DefenCath be approved, the analyst sees an upside in sequence through CRMD's launch and DefenCath's market formation.

https://www.benzinga.com/analyst-ratings/analyst-color/23/08/33715655/cormedixs-defencath-aims-to-tackle-catheter-related-blood-stream-infections-analyst

Treasury's $23 billion auction of 30-year bonds comes in 'soft'

Thursday afternoon's sale of $23 billion in 30-year Treasury bonds came in "soft" and produced a modest selloff in the longest-dated maturities, according to BMO Capital Markets rates strategist Ben Jeffery. The auction was the final test this week of how well demand for U.S. government debt would hold up following increased worries that emerged last week about the fiscal outlook. Wednesday's $38 billion auction of 10-year notes was described as "good" to "fair," and Tuesday's sale of $42 billion in 3-year notes was seen as strong. Treasury yields were mixed after Thursday's auction results.

https://www.morningstar.com/news/marketwatch/20230810477/treasurys-23-billion-auction-of-30-year-bonds-comes-in-soft

Fauci, Collins Bagged 58 Royalty Payments Amid $325 Million Collected By NIH

 The two longtime directors of the National Institutes of Health and its National Institute of Allergy and Infectious Diseases, Francis Collins and Anthony Fauci received 58 royalty payments from companies to license and deploy their products using taxpayer dollars, according to a new release from OpenTheBooks.

On Wednesday, the organization published more than 1500 pages of unredacted records revealing which companies were involved, and which NIH scientists were paid for inventions. The release came after a Freedom of Information Act (FOIA) battle with the NIH, reports Just the News.

The 56,000 transactions add up to more than $325 million, according to OpenTheBooks, though the individual amounts for each payment and corresponding license are not listed in the records.

Fauci received 37 payments from three companies between 2010-2021: 15 from Santa Cruz Biotechnology, which creates products for medical research including antibodies and made the fifth-most payments in the royalty database; 14 from Ancell Corp., which produces immunology tolls; and eight from Chiron Corp., acquired by Novartis in 2006. -JTN

According to the report, Novartis has received some $17 million in NIH contract payments and $15 million in NIH grants since the acquisition of Chiron. In 2004, Fauci's NIAID had a contract with the company to develop an avian influenza vaccine.

Collins, meanwhile, who stepped down as NIH director at the end of 2021 before serving as President Joe Biden's COVID-19 czar, received 21 payments from four companies between 2010 and 2018. Twelve of them came from GeneDX, which received $5 million in federal contract payments - mostly from NIH - since 2008.

Quest Diagnostics' Specialty Laboratories, a biological testing company, made four payments to Collins. He received four more from Ionis Pharmaceuticals, originally named ISIS, which develops RNA-targeted therapeutics. The last entity to pay Collins was the Progeria Research Foundation - a nonprofit which does research for congenital disorders.

According to OpenTheBooks, obtaining the full names and license numbers for each payment - which the NIH had originally redacted until a court forced them to unredact - was crucial for "scrutinizing these records for potential conflicts of interest or public health risks."

As Just the News further notes, Fauci has already admitted to receiving more than $45,000 in royalties nearly two decades ago when he was also NIAID director, for an experimental AIDS treatment funded by the NIH.

https://www.zerohedge.com/political/fauci-collins-bagged-58-royalty-payments-amid-325-million-collected-nih

Salarius to Explore Strategic Alternatives

  Salarius Pharmaceuticals, Inc. (Nasdaq: SLRX), a clinical-stage biopharmaceutical company using protein inhibition and protein degradation to develop cancer therapies for patients in need of new treatment options, today announced plans to explore strategic alternatives and implement measures to extend its resources.

“The second quarter and recent weeks were highlighted by significant advancements in both of our development programs, but after a review of each program’s future funding needs and the current financial markets, the Board of Directors has made the difficult decision to limit further drug development while we explore strategic alternatives for both Salarius and continued development of our drugs. This was an exceptionally difficult decision in light of the promising early seclidemstat Ewing sarcoma clinical data, seclidemstat hematological clinical data and the recent U.S. Food and Drug Administration (FDA) clearance to begin the SP-3164 Phase 1 trial," said David Arthur, president and chief executive officer of Salarius Pharmaceuticals.

The Company has retained Canaccord Genuity, LLC to lead a comprehensive review of strategic alternatives focusing on maximizing shareholder value including, but not limited to, an acquisition, merger, reverse merger, divestiture of assets, licensing or other strategic transactions involving the Company. However, there is no set timetable for this process and there can be no assurance that this process will result in the Company pursuing a transaction or that any transaction, if pursued, will be completed on attractive terms. If the Company is unable to complete a transaction, it may be necessary to seek other alternatives for restructuring and resolving its liabilities, including an orderly wind-down of operations. Salarius does not expect to disclose developments with respect to this process unless and until the evaluation of strategic alternatives has been completed or the Board of Directors has concluded that disclosure is appropriate or legally required.

Sonendo down after missing Q2 estimates

Piper Sandler downgrades to 'neutral'

https://seekingalpha.com/news/4001019-sonedo-down-after-missing-q2-estimates-piper-sandler-downgrades-to-neutral

Vera Therapeutics Q2 update

 

  • Presented positive 36-week results from the Phase 2b ORIGIN clinical trial of atacicept in IgAN as a late breaking clinical trial at the 60th ERA Congress

  • Initiated Phase 3 ORIGIN 3 clinical trial of atacicept in June for the treatment of IgAN

  • Strong balance sheet expected to fund operations to early 2026