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Monday, February 13, 2023

Merck target upped by Credit Suisse

 

  • Credit Suisse has raised the price target on Merck & Co Inc  from $120 to $125, with an Outperform rating.
  • The 2023 American College of Cardiology conference is expected to be a significant catalyst for Merck, says the analyst. 
  • The key investor focus will be readouts on March 6 from sotatercept's Phase 3 STELLAR trial for Pulmonary Arterial Hypertension (PAH) and the cholesterol-lowering Phase 2 data from oral PCSK9 (MK-0616).
  • KOL expects a ~25-meter improvement in a six-minute walk distance, which should see sotatercept being slotted as a 4L agent add-on to conventional triplet therapy. 
  • Credit Suisse forecasts a 90% probability of c.$3 billion in peak sales.
  • CS's KOL's expectations for Phase 2 data are for a similar level of lowering low-density lipoprotein cholesterol as injectable PCSK9. Tolerability will be key.
  • The analyst has increased the POS from 30% to 50% and oral PCSK9 peak sales from $1.3 billion to $5 billion. However, a slow build with a turning point based on CVOT data is expected in 2028.

Insiders Use ETFs To Conceal Trading Ahead Of M&A Announcements

 A new study published on the Social Science Research Network (SSRN) reveals that exchange-traded funds (ETFs) are a "new form" of insider trading for those in the 'know' about upcoming merger and acquisition deals. The reason is that the ETF conceals their trading and is harder to track because the fund owns a basket of other stocks. Insiders, who trade on non-public information, are pivoting from single stock bets ahead of announcements because securities agencies can easily flag trading activity. 

The paper is titled "Using ETFs to Conceal Insider Trading" and explains:

Our evidence suggests that some traders in possession of material non-public information about upcoming M&A announcements trade in ETFs that contain the target stock, rather than trading the underlying company shares, thereby concealing their insider trading. 

Researchers described several reasons insiders gravitate toward ETFs:  

  • First, the stock that is the subject of the information may be a constituent of the ETF, so that one can get a direct exposure to the company's share price via the ETF, but in a vehicle that is more subtle than trading the company shares directly, helping reduce scrutiny from law enforcement.

  • Second, ETFs are cost-effective and often more liquid than the underlying company shares, potentially reducing the price impact of insider trades. Both theoretical and empirical evidence shows that insiders trade in highly liquid assets so that they can hide their information and maximize their trading profits.

  • Third, shadow trading in ETFs prior to price-sensitive news allows insiders to benefit from increases in the price of both the source firm and related firms.

Using 13 years of data (2009-21) of all US-listed companies and ETFs, researchers found "significant levels" of transactions known as shadow trading or insider trading. Their results were derived from analyzing sizeable volume increases in the five days before M&A announcements in 3% to 6% of industry ETFs. 

"These ETFs, which are the most likely to be traded by insiders if shadow trading does occur, have significantly higher levels of abnormal trading than various randomized control samples of other ETFs and other trading days. We eliminate M&A events that are preceded by rumors to ensure that the analysis is not picking up general information leakage," Elza Eglite, Dans Staermans, Vinay Patel, and Talis Putnins wrote in the study. The paper is from academics at the Stockholm School of Economics in Riga and the University of Technology, Sydney. 

The amount of insider trading they identified was about $2.75 billion during the researcher's same period or about $212 million per year. 

"Our estimates of the amount of shadow trading in ETFs provide a lower bound given that we only examine shadow trading prior to M&As and not prior to other price-sensitive news announcements," they said. 

This study shows that some insiders conceal their trades in ETFs instead of single stocks. 

https://www.zerohedge.com/markets/study-reveals-insiders-use-etfs-conceal-trading-ahead-ma-announcements

FDA Suggests NRx Bipolar Program Be Enlarged For Chronic Treatment Of Suicidality

 

  • NRx Pharmaceuticals Inc  reported the minutes of a Type B meeting with the FDA's Division of Psychiatry Products held in January.
  • The purpose of the meeting was to discuss the requirements for submitting a marketing application for NRX-101. 
  • FDA noted in written correspondence that the Special Protocol Agreement (SPA), granted in April 2019, remains in effect. 
  • Additionally, the FDA suggested broadening the addressable population of the indication (under the SPA or otherwise) to patients with Severe Bipolar Depression and Recent Acute Suicidality, regardless of how the initial stabilization was accomplished could represent a more straightforward development program. 
  • This broader indication would enable the company to potentially demonstrate the use of NRX-101 to maintain stabilization from suicidality in patients stabilized either with ketamine or with other standard-of-care therapeutic approaches. 
  • This broader indication is not expected to delay the acute care trial expected to be completed in 2023.
  • The FDA further advised the company that as a chronic, or chronic-intermittent treatment, the safety database requirement under ICH guidelines for NRX-101 should be 1,500 patients, with at least 100 treated for one year. The company is evaluating the timing and cost of expanding clinical access to this larger population. 

Mineralys takes on J&J and Astrazeneca

 Is the IPO window inching open again? February has seen two upsized flotations, with the latest to go public, Mineralys, raising $192m. Not only is this the largest IPO of 2023 so far, the sum also rivals the biggest hauls amassed last year. One of those big 2022 floaters was Cincor, a competitor to Mineralys in the burgeoning resistant hypertension space; Cincor, along with its aldosterone synthase inhibitor baxdrostat, was acquired by Astrazeneca this year. Mineralys investors might be hoping for a similar outcome: the group’s lead project, MLS-101, has the same mechanism, and phase 2 data look promising. A mean placebo-adjusted systolic blood pressure reduction of 9.7mmHg at the most effective dose, 50mg once daily, makes MLS-101 look almost as good as baxdrostat did in its successful Brightn study, with the usual caveats about cross-trial comparisons. The picture is complicated, though, by baxdrostat’s failure in Halo in less refractory patients. Another rival is J&J and Idorsia’s aprocitentan, but there have been questions about the effect size seen in phase 3. A recent arrival in the mid-stage pipeline is Novartis’s XXB750; meanwhile, phase 2 data have yet to emerge on Ionis’s IONIS-AGT-LRx, despite being promised last year.

Mid-late stage projects for treatment-resistant hypertension
ProjectCompanyMechanismStatus 
AprocitentanJ&J/IdorsiaEndothelin A & B receptor antagonistPh3 Precision data at AHA 2022; filed in US & EU 
FiribastatQuantum GenomicsAminopeptidase A inhibitorPh3 Fresh failed Oct 2022; extended treatment Refresh terminated
Baxdrostat (CIN-107)Astrazeneca (via Cincor)Aldosterone synthase inhibitorPh2 Brightn succeeded; ph2 Halo failed; ph3 to start 2023 
MLS-101 (MT-4129)Mineralys (licensed from Mitsubishi Tanabe Pharma)Aldosterone synthase inhibitorPh2 Target-HTN toplined positive Nov 2022
IONIS-AGT-LRxIonisAngiotensinogen antisensePh2 Astraas had been due to report H2 2022
ION904IonisAngiotensinogen antisensePh2 ended Jan 2023
Zilebesiran (ALN-AGT01)AlnylamAngiotensinogen RNAi therapeuticPh2 monotherapy Kardia-1 to report mid-2023; ph2 add-on Kardia-2 to report YE 2023
XXB750NovartisNPR1 agonistPh2 ends Feb 2024
Source: Evaluate Pharma & company statements. 

https://www.evaluate.com/vantage/articles/news/deals-snippets/mineralys-takes-jj-and-astrazeneca

US to Sell 26 Million More Barrels From Strategic Oil Reserve

 The Biden administration plans to sell more crude oil from the Strategic Petroleum Reserve, with deliveries estimated to happen between April and June.

The non-emergency sale will amount to 26 million barrels of crude, according to people familiar with the matter, and is part the congressionally mandated sale lawmakers approved years ago for the current fiscal year.

https://www.bloomberg.com/news/articles/2023-02-13/us-to-sell-26-million-more-barrels-from-strategic-crude-reserve