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Monday, April 4, 2022

Bayer Gets Positive Results in Atrial Fibrillation Drug Trial

 Bayer AG said late Sunday that it got positive results from a Phase 2b trial studying asundexian, a drug meant to prevent bleeding in patients with atrial fibrillation--an irregular and often very rapid heart rhythm (arrhythmia) that can lead to blood clots in the heart--who are also at risk of stroke.

The drug could have the potential to prevent thromboembolic events without increasing the risk of bleeding in patients, according to Bayer.

The company said that the trial evaluated asundexian with another drug, called apixaban. Asundexian hasn't yet been approved for use in any country, Bayer said.

https://www.marketscreener.com/quote/stock/BAYER-AG-436063/news/Bayer-Gets-Positive-Results-in-Atrial-Fibrillation-Drug-Trial-39954726/

FDA advisers to discuss additional COVID vaccine shots, booster design

 The U.S. Food and Drug Administration's expert advisers will discuss the timing of additional COVID-19 vaccine boosters and the people eligible for the extra shots in a meeting later this week, the health agency said on Monday.

The independent advisers will also discuss at the April 6 meeting the FDA's role in how future versions of COVID vaccines are created to help fight new variants.

It could be similar to the current process of selecting the composition of the seasonal flu shot, where regulators pick the strain to use for the coming year's vaccines, FDA staff said in briefing documents ahead of the meeting.

"Implicit in all of this is the notion that we will need further boosters down the road," said Dr. William Schaffner, infectious disease expert at Vanderbilt University Medical Center in Nashville, Tennessee.

U.S. health officials in late March authorized a second booster dose of the Moderna and Pfizer vaccines for people aged 50 and older, citing data showing waning immunity and the risks posed by Omicron variants of the virus.

Roughly 45% of the fully vaccinated in the United States have received a booster dose, according to federal data.

"The greatest concern many of us have is the acceptability of continuing boosters," Schaffner said.

The FDA's staff said on Monday that new variants are often more infectious, transmissible and distinct from earlier virus strains.

"The accumulating data suggest that the composition of vaccines may need to be updated at some point to ensure the high level of efficacy demonstrated in the early vaccine clinical trials," FDA staff said in briefing documents ahead of the April 6 meeting.

https://www.marketscreener.com/quote/stock/MODERNA-INC-47437573/news/U-S-FDA-advisers-to-discuss-additional-COVID-vaccine-shots-booster-design-39958783/

Swift resolution emerges to China's non-compliance

 Just when several Chinese biotechs are scrambling to regain long-term compliance with tightened-up US audit regulations a solution to the problem has appeared on the horizon. China’s Securities Regulatory Commission has proposed removing its requirement that local businesses be inspected on-site by Chinese auditors, deeming this rule outdated. This issue was very relevant for Chinese companies with US listings, and a conflict arose when the US SEC stipulated that any US-listed business had to be audited by a US accounting firm. Last month the SEC published its first list of non-compliant companies, threatening their delisting if the non-US auditor situation persisted to 2023, and last week Casi Pharmaceuticals, a US biotech with a significant subsidiary in Beijing, was added to this. In the meantime Beigene and I-Mab have already changed auditors, and the latter is moving to list additionally in Hong Kong, meaning that it could continue trading in the theoretical event of its US listing being cancelled. Last month Loncar Investments’ chief executive, Brad Loncar, said the fact matters came to a head like this could actually spur a resolution. This view looks now to be playing out.

Selected US-listed biotechs with China operations
CompanyOn SEC's non-compliance list?Statement
Zai LabYes (conclusive list)Working to engage independent auditor that satisfies PCAOB requirements
HutchmedYes (conclusive list)Shares trade in UK & Hong Kong, ADSs on Nasdaq; maintaining dialogue with China regulator
BeigeneYes (conclusive list)Changed auditor from Ernst & Young Hua Ming (China) to Ernst & Young (US)
Casi PharmaceuticalsYes (provisional list)Evaluating control changes to meet HFCAA requirements
AdageneNoEvaluating control changes to meet HFCAA requirements
I-MabNoHas engaged PCAOB-compliant auditor; shares trade on Nasdaq; Hong Kong listing is being pursued
LianbioNoSays principal auditor is located in New York, and inspected by PCAOB
PCAOB=Public Company Accounting Oversight Board; HFCAA=Holding Foreign Companies Accountable Act. Source: stock exchange & company information.

https://www.evaluate.com/vantage/articles/news/policy-and-regulation-snippets/swift-resolution-emerges-chinas-non-compliance

US FDA approval tracker: March

 March proved to be a busy month at the FDA, with success for Novartis’s second radioligand product and the ushering in of three first-in-class drugs: Marinus’s Ztalmy, CTI Biopharma’s Vonjo, and Bristol Myers Squibb's Opdualag. The final product on the list is a combination of Opdivo and relatlimab, the first Lag3 inhibitor to pass the regulator. Bristol might be hoping that relatlimab’s reduced toxicity will allow it in time to swap out Yervoy in combination treatments. Meanwhile, approval of Novartis’s Pluvicto in patients with metastatic castration-resistant prostate cancer after androgen receptor blockade plus chemo looks to have provided some justification of the Swiss group’s $2.1bn acquisition of Endocyte in 2018. On the other side of the coin, those facing disappointment last month included Akebia, and Lilly and its Chinese partner Innovent. Akebia fell foul of FDA concerns around thromboembolic events and toxicity, which have hit others in the HIF-PH inhibitor space, while Lilly/Innovent’s chances of approval for the PD-1 antibody Tyvyt were doomed after a 14-1 advisory committee vote against.

Notable first-time US approval decisions in March
ProjectCompanyIndication(s) 2026e sales by indication ($m)Outcome
Pluvicto
(177Lu-PSMA-617)
NovartisRadioligand therapy for mCRPC851Approved
U2 combination
(Ukoniq + ublituximab) 
TG TherapeuticsChronic lymphocytic leukaemia and small lymphocytic lymphoma691Adcom Apr 22, Pdufa extended to Jun 25
VadadustatAkebia/
Vifor/
Otsuka
Anaemia due to CKD in adult patients on/not on dialysisCRL (toxicity concerns, new pivotal study required)
Opdualag (relatlimab + Opdivo)Bristol Myers Squibb1L melanoma437Approved
Ztalmy (ganaxolone)MarinusSeizures associated with CDKL5 deficiency disorder (rare form of genetic epilepsy)384*Approved
Vonjo
(pacritinib)
CTI BiopharmaMyelofibrosis469Approved
Tyvyt
(sintilimab)
Lilly/
Innovent
1L nonsquamous NSCLCCRL (mutliregional study required, non-inferiority design against SoC)
Source: Evaluate Pharma & company releases. *SBI as general epilepsy.

 

Advisory committee meetings in March
ProjectCompanyIndicationPeak sales (non-risk adjusted, $m)Outcome
AMX0035 (sodium phenylbutyrate + taurursodiol)AmylyxALS1,8206-4 against approval 
Source: broker reports (pre adcom) & FDA adcom calendar.

 

Supplementary and other notable approval decisions in March
ProductCompanyIndication (clinical trial)Outcome
CabenuvaGlaxo/ Viiv/ J&JTreatment of HIV-1 in virologically suppressed adolescents who are 12 years of age or older and weigh at least 35kg (Mocha)Approved
Adlarity
(donepezil  transdermal system)
CoriumDementia due to mild, moderate, or severe Alzheimer's diseaseApproved
FinteplaZogenix/ UCBSeizures associated with Lennox-Gastaut SyndromeApproved
ReblozylBristol/ Merck & CoAnaemia in adults with non-transfusion-dependent beta-thalassemia (ph2 Beyond)Delayed to Jun 27 (information request)
KeytrudaMerck2nd-line MSI-H/dMMR endometrial cancer (Keynote-158, cohorts D & K)Approved
TlandoLipocine/
Antares
Oral testosterone replacement therapyApproved (final approval, received tentative decision in December)
LynparzaAstrazenecaAdjuvant BRCA-mutated Her2 -ve breast cancer (OlympiA)Approved
Ozempic (2.0mg)Novo NordiskType 2 diabetes (Sustain Forte)Approved
FasenraAstrazenecaInadequately controlled chronic rhinosinusitis with nasal polyps (Ostro)CRL (additional data requested)
RinvoqAbbvieAnkylosing spondylitis and ulcerative colitis Approved in UC
Opdivo + chemoBristolNeoadjuvant stage IB-IIIA NSCLC all-comers (Checkmate-816)Approved (~4 months early)
Releuko
(filgrastim biosimilar)
Kashiv/
Amneal
Treatment and prevention of febrile neutropeniaApproved (third filgrastim biosim approved by the FDA)
Source: Evaluate Pharma & company releases.

 

US EUAs to treat Covid-19
ProjectCompanySettingOutcome
CovaxinOcugen/ Bharat
Biotech
Prevent Covid-19 in individuals aged 2-18 years oldDeclined
Spikevax
(mRNA-1273)
ModernaSecond booster dose in adults aged 50 and older, and ≥18 if immunocompromisedApproved
ComirnatyPfizerSecond booster dose in adults aged 50 and older, and ≥12 if immunocompromised

https://www.evaluate.com/vantage/articles/news/snippets/us-fda-approval-tracker-march-1

Estimates for LianBio (NASDAQ:LIAN) Decreased at Jefferies

 LianBio (NASDAQ:LIAN - Get Rating) - Analysts at Jefferies Financial Group lowered their Q1 2022 earnings per share (EPS) estimates for LianBio in a note issued to investors on Wednesday, March 30th. Jefferies Financial Group analyst M. Yee now expects that the company will earn ($0.22) per share for the quarter, down from their previous estimate of ($0.20). Jefferies Financial Group also issued estimates for LianBio's Q2 2022 earnings at ($0.25) EPS, Q3 2022 earnings at ($0.28) EPS, Q4 2022 earnings at ($0.32) EPS, FY2022 earnings at ($1.07) EPS, Q1 2023 earnings at ($0.34) EPS, Q2 2023 earnings at ($0.37) EPS, Q3 2023 earnings at ($0.36) EPS, Q4 2023 earnings at ($0.37) EPS and FY2023 earnings at ($1.44) EPS.

https://www.marketbeat.com/instant-alerts/nasdaq-lian-analyst-earnings-estimates-2022-04/

Ardelyx Announces US Launch of IBSRELA

 

  • IBSRELA®(tenapanor) is the First and Only NHE3 Inhibitor FDA Approved for the Treatment of IBS-C in Adults

  • First Novel Mechanism Therapy to Treat IBS-C in a Decade

Quest cut to Neutral from Buy by Citi

 Target to $140 from $175

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