Powell Kills March 50bps Rate Hike, But Leaves Door Open For Later In 2022

 Rest in Peace 50bps March rate hike.

Moments ago, Fed Chair Powell said that he is "inclined to support a 25 basis point rate hike" in March, which immediately killed any market expectation of a 1+ rate hike in two weeks.

However, in the very next sentence, Powell said that if inflation stays hot, he could move more than 25 basis points at upcoming meetings, which in turn pushed the full year rate hike expectations sharply higher, from 5.2 to 5.6.

Of course, this is not the end of this story, and should oil continue to surge - and it will - unleashing inflationary shockwaves and crippling global growth, expect this hawkish consensus to once again unwind... but not yet, because as noted earlier, the VaR shock in the STIR space is now in full-blown reverse mode, with Dec 2022 ED futs collapsing and undoing their entire Tuesday move...

... even though absolutely nothing has changed in the past 24 hours. More remarkably, looking at the Eurodollar strip, today is shaping up as an even bigger hawkish "surprise" reversal than the July 2013 taper tantrum.

Finally, what all of this means is that bond market volatility is exploding, and assuring that the Fed will have to be on its toes as any geopolitical news can spark a liquidation or short-covering frenzy in a bond market where there is now also virtually no liquidity.

https://www.zerohedge.com/markets/powell-kills-march-50bps-rate-hike-leave-door-open-later-2022

US FDA approval tracker: February

 The last day of February brought FDA joy for Johnson & Johnson, Legend Biotech and CTI Biopharma but anguish for Gilead and Amryt. The latter's epidermolysis bullosa therapy, Oleogel-S10, was knocked back with the FDA requesting additional confirmatory evidence of efficacy, and it is not yet known whether Amryt will need to run another trial. Meanwhile, Gilead’s lenacapavir was turned down owing to vial compatibility issues; the drug had been filed in heavily treatment-experienced individuals with multi-drug resistant HIV-1 infection. In December ten clinical studies, including Purpose-1 and 2 in pre-exposure prophylaxis, were put on hold due vial concerns. The long-acting HIV-1 capsid inhibitor is seen as an important pipeline asset for Gilead and was expected to be one of the biggest launches of 2022, but approval this year now looks very uncertain. J&J and Legend's Car-T agent, newly approved for multiple myeloma, is also slated as one of this year's biggest launches. The developers believe that last month's green light is only the beginning for Carvykti, and expect peak sales to reach at least $5bn, assuming success is achieved in earlier lines of therapy.   

Notable first-time US approval decisions in February
Project	Company	Indication(s)	2026e sales by indication (SBI) ($m)	Outcome
Carvykti (ciltacabtagene autoleucel/cilta-cel)	Johnson & Johnson/ Legend Biotech	3L+ multiple myeloma	1,692	Approved
Lenacapavir	Gilead	Multi-drug resistant HIV in heavily treatment experienced patients	877	CRL (vial compatibility issues)
177Lu-PSMA-617	Novartis	Radioligand therapy for mCRPC	851	Pending, expected H1
Enjaymo (sutimlimab)	Sanofi	Haemolysis in adults with cold agglutinin disease	440	Approved
Vonjo (Enpaxiq/pacritinib)	CTI Biopharma	Myelofibrosis patients with severe thrombocytopenia	368	Approved
Priorix	GSK	MMR vaccine	364	Pending
Pyrukynd (mitapivat)	Agios	PK deficiency	287	Approved
Oleogel-S10 (Filsuvez)	Amryt	Junctional and dystrophic epidermolysis bullosa	269	CRL (additional confirmatory evidence needed)
Bardoxolone	Reata	Alport syndrome	-	CRL (provide evidence of effectiveness)
GC5107 (immune globulin intravenous, 10% liquid)	GC Pharma	Primary humoral immunodeficiency	-	CRL (pre-license inspection)
d-amphetamine transdermal system (ATS)	Noven/ Hisamitsu	ADHD	-	Pending
Annik (penpulimab)	Akeso/Sino	3rd-line nasopharyngeal carcinoma	-	Pending, expected H1
Terlipressin	Mallinckrodt	Hepatorenal syndrome	-	Second CRL (manufacturing facility inspection)
Zynquista (sotagliflozin)	Lexicon	Heart failure in adults with type 2 diabetes	-	NDA filing withdrawn due to technical issue, resbumission targeted for Q2
Source: Evaluate Pharma & company releases.

 

Advisory committee meetings in February
Project	Company	Indication	2026e SBI ($m)	Outcome
Comirnaty	Pfizer/Biontech	Amend the EUA for administration to children 6 months through 4 years of age	7,668	Postponed, waiting for three-dose data (expected in April)
Tyvyt (sintilimab) + pemetrexed + platinum chemotherapy	Lilly/ Innovent	1L stage IIIB, IIIC, or Stage IV non-squamous NSCLC	-	14-1 against, Pdufa March 22
IV tramadol	Avenue	Acute pain	-	14-8 against
Source: Evaluate Pharma, FDA ad com calendar company releases.

 

Supplementary and other notable approval decisions in February
Product	Company	Indication (clinical trial)	Outcome
Generic Restasis (cyclosporine)	Viatris	Increase tear production in patients with dry eye	Approved (first FDA generic)
Solosec	Lupin Pharma	Treatment of bacterial vaginosis and trichomoniasis  in patients aged 12  and older	Approved
Jardiance	Eli Lilly/Boehringer Ingelheim	Heart failure regardless of left ventricular ejection fraction (Emperor-Preserved)	Approved
Generic Farxiga (dapagliflozin)	Zydus	Type 2 diabetes	Final approval
Ruzurgi	Jacobus Pharmaceutical	Paediatric patients with Lambert-Eaton myasthenic syndrome	Revoked, as approval violated Catalyst's exclusivity for Firdapse
Kymriah	Novartis	r/r FL after two prior lines of treatment (Ph2 Elara)	Pending
Lynparza	Astrazeneca	Adjuvant BRCA-mutated Her2-negative breast cancer (OlympiA)	Pending, expected Q1
Fasenra	Astrazeneca	Nasal polyps	Pending, expected H1
Olumiant	Lilly	Atopic dermatitis (Breeze-AD programme)	Pending
Rinvoq	Abbvie	Psoriatic arthritis, ankylosing spondylitis and ulcerative colitis	UC decision expected March, Q2 for ankylosing spondylitis and Q4 for non-radiographic axial SpA
Source: Evaluate Pharma & company releases.

 

FDA issued EUAs to treat Covid-19
Project	Company	Setting
Bebtelovimab (LY-CoV1404)	Eli Lilly	For certain non-hospitalised patients with mild-to-moderate Covid-19 at high risk of progression to severe disease
Source: Evaluate Pharma & company releases.  https://www.evaluate.com/vantage/articles/insights/nme-approvals-snippets/us-fda-approval-tracker-february

White House unveils plan for next phase of COVID-19 fight

 The White House on Wednesday unveiled a plan for fighting COVID-19 in its new phase, with the virus moving from a crisis to a lower-level risk that does not dominate daily life.  

The plan comes as the omicron wave has declined and many are eager to turn the page on the pandemic. President Biden in his State of the Union on Tuesday night said COVID-19 “no longer need control our lives” in this “new moment.” 

The 96-page plan will require new funding from Congress, the White House said, though there are not specific dollar amounts for each item. Ahead of a March 11 deadline for funding the government, the White House recently informally outlined the need for $30 billion focused on domestic needs and $5 billion for global vaccinations.  

To fully execute on this plan requires Congress doing its part to invest in tools that work,” the document states. “This plan lays out the roadmap to help us fight COVID-19 in the future as we move America from crisis to a time when COVID-19 does not disrupt our daily lives and is something we prevent, protect against, and treat."

The risk of a new variant that upends progress remains a threat, and the plan calls for increased surveillance and data collection aimed at monitoring for new variants.  

The National COVID-19 Preparedness Plan is organized around four main areas: protect against and treat COVID-19, prepare for new variants, prevent shutdowns and vaccinate the world.  

It calls for scaling up vaccine production to be able to produce an additional 1 billion vaccine doses per year.  

A new “test to treat” program, announced by Biden on Tuesday night, will allow people to get treatments on the spot at a pharmacy if they test positive, with the first sites launching this month.  

After shortages of tests plagued the country around Christmas amid the omicron wave, the plan calls for continued investments in improving testing supply.  

A new website will give people information about the virus risk level in their area, as well as nearby resources like where to get a free mask or vaccine.  

“The Administration will work with Congress to reinstate tax credits to help small- and mid-size businesses provide paid sick and family leave to deal with COVID-related absences,” the plan says, as part of an effort to bring workers back in-person, including the federal workforce.  

The global vaccination effort, where advocates have for months been pushing for greater urgency and action, will focus in part on helping get shots in arms abroad after the doses themselves are delivered. But like other elements of the plan, the plan notes this effort would require more funding from Congress.  

https://thehill.com/policy/healthcare/596501-white-house-unveils-plan-for-next-phase-of-covid-19-fight

ChromaDex: Peer-Reviewed Study Shows Promising Effect of Nicotinamide Riboside (NR) in Parkinson’s

 ChromaDex Corp. (NASDAQ:CDXC) today announced promising findings from a first-of-its-kind clinical study, as reported in the peer-reviewed journal Cell Metabolism by a team of scientists led by Prof. Charalampos Tzoulis, Haukeland University Hospital and University of Bergen, in Norway. The clinical trial was part of the ChromaDex External Research Program (CERP™) and investigated the company’s proprietary Niagen® ingredient (patented nicotinamide riboside, or "NR") in patients with Parkinson’s disease (PD). Results of the phase I clinical trial showed that NR supplementation significantly increased cerebral nicotinamide adenine dinucleotide (NAD) levels, and resulted in altered cerebral energy metabolism and decreased levels of inflammatory cytokines in patients with PD. This clinical study is a milestone in NR and PD research and builds upon previous preclinical studies exploring the positive impact of NR on neurodegenerative diseases.

https://finance.yahoo.com/news/chromadex-shares-findings-first-ever-113300969.html

Harpoon Receives FDA Fast Track Designation for Multiple Myeloma Med

 Harpoon Therapeutics, Inc. (NASDAQ: HARP), a clinical-stage immunotherapy company developing novel T cell engagers, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to HPN217, a BCMA-targeting TriTAC®, for the treatment of patients with relapsed, refractory multiple myeloma (RRMM) who have received at least four lines of therapy. A Phase 1/2 clinical trial is currently ongoing for HPN217 in the RRMM patient population.

https://finance.yahoo.com/news/harpoon-therapeutics-receives-fda-fast-123000483.html

Endo cut to Underweight from Equal Weight by Barclays

 Target to $2 from $5

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

Intercept:: Now sees NASH data in Q3

 Worldwide Ocaliva® net sales of $92.4 million and $363.5 million for the fourth quarter and full year 2021, representing 11% and 16% growth over the prior year

Company provides 2022 Ocaliva net sales guidance of $375 million to $405 million and non-GAAP adjusted operating expense guidance of $360 million to $390 million

Data package from REGENERATE Phase 3 study in fibrosis due to NASH being generated; targeting potential pre-submission meeting with FDA in 1H 2022

Topline results from REVERSE Phase 3 study in compensated cirrhosis due to NASH now expected in Q3

Company to host conference call today at 8:30 a.m. ET

“In 2021, our team was focused on continuing to grow our foundational PBC business; executing on our clinical and regulatory goals in PBC and NASH; and advancing our pipeline while also taking important steps to significantly strengthen our financial position,” said Jerry Durso, President and Chief Executive Officer of Intercept. “Our team delivered strong double-digit revenue growth for Ocaliva, despite the challenges associated with the pandemic and the U.S. label update. Looking ahead, we continue to see long-term potential for Ocaliva given the number of patients with PBC who are eligible for second-line therapy.”

“We also made important progress in generating what will ultimately be the largest data set in the NASH field,” Durso continued. “We remain focused on delivering the new data package from our Phase 3 REGENERATE study, and if we believe these data support accelerated approval, we will continue to target a potential pre-submission meeting with FDA in the first half of this year. We also look forward to communicating topline results from the Phase 3 REVERSE study, the only active late-stage study in compensated cirrhosis due to NASH, a disease with no approved therapies. Given the magnitude and complexity of these analyses, we now expect to deliver these data in the third quarter of this year. Taken together, REGENERATE and REVERSE continue to represent the most robust, active clinical development program to date in NASH and include more than 3,300 patients across both studies.”

2022 Financial Guidance

We are announcing 2022 Ocaliva net sales guidance of $375 million to $405 million. In addition, we are announcing 2022 non-GAAP adjusted operating expense guidance of $360 million to $390 million. See “Non-GAAP Financial Measures” below. A quantitative reconciliation of projected non-GAAP adjusted operating expenses to total operating expenses is not available without unreasonable effort primarily due to our inability to predict with reasonable certainty the amount of future stock-based compensation expense.

Conference Call on March 2, 2022 at 8:30 a.m. ET

We are hosting our fourth quarter and full year 2021 financial results conference call and webcast on March 2, 2022 at 8:30 a.m. ET. The conference call will be available on the investor page of our website at http://ir.interceptpharma.com or by calling (855) 232-3919 (toll-free) with passcode 3258502. A replay of the call will be available on our website shortly following the completion of the call and will be available for two weeks.

https://finance.yahoo.com/news/intercept-pharmaceuticals-reports-fourth-quarter-120000739.html