Search This Blog

Friday, October 7, 2022

Merck' Ridgeback Update on Molnupiravir Covid Benefits

 

  • A preliminary analysis of the University of Oxford’s open label, prospective real-world evidence study, PANORAMIC, conducted in the UK in highly-vaccinated adults mostly <65 years of age, showed no evidence of a difference between LAGEVRIO added to usual care compared to usual care alone for the reduction of hospitalizations and deaths through Day 28 (primary endpoint was not met); the incidence of hospitalizations and death through Day 28 was very low overall (0.8% in both groups).

  • The main secondary endpoint (time to first self-reported recovery) in the PANORAMIC study was 6 days shorter with the LAGEVRIO group compared to the usual care group; in addition, the use of LAGEVRIO also was associated with earlier recovery across a wide range of other symptom measures, as compared to the usual care group.

  • An analysis of real-world data from a separate observational, retrospective study conducted by investigators in Israel (known as the Clalit study) showed that in a cohort of non-hospitalized, high-risk patients, LAGEVRIO reduced hospitalizations and mortality due to COVID-19 in patients 65 years and above; no evidence of benefit was found in younger adults ages 40 to 64 years.

  • Results from a separate, non-clinical 6-month carcinogenicity study in mice demonstrated that LAGEVRIO was not carcinogenic.

Microbot Strengthens Robotic Portfolio with Acquisition of FDA-Cleared Devices

 Integration with the LIBERTY® Robotic System & One & Done™ Technology May Enable Future Acceleration of Robotic Adoption; Represents an Additional Growth Opportunity by Accessing the $500 Million Chronic Total Occlusion (CTO) Market1 through the Expansion of Robotic Ecosystem for Endovascular Procedures

 Microbot Medical Inc. (Nasdaq: MBOT) announced today, as a continuation of its recent regulatory and future commercialization activities, together with its strategic mission to enable accessibility to multiple endovascular procedures globally, that it has acquired the assets of privately-held Nitiloop Ltd. The acquisition includes the NovaCross™ family of Microcatheters (NovaCross CTO, NovaCross Xtreme and NovaCross BTK), a U.S. Food and Drug Administration (FDA) cleared family of medical devices intended to facilitate the intraluminal placement of conventional and steerable guidewires beyond stenotic lesions, including chronic total occlusions (CTO), prior to PTCA or stent intervention.

The NovaCross™ Microcatheter family, as a standalone device or when potentially integrated with the Company’s One & Done™ technology, is expected to create a collection of procedure related kits that are customized for the LIBERTY® Robotic System. The LIBERTY Robotic System is the first-ever disposable endovascular robotic system with remote operation capabilities and small footprint designed to reduce the requirement of capital investment and Cath Lab space. The Company expects this integration to help revolutionize and standardize the way endovascular procedures are conducted, while eliminating barriers to access and increasing the adoption rate of robotics in the endovascular space.

https://finance.yahoo.com/news/microbot-medical-strengthens-liberty-robotic-123600604.html

Abbott, Dexcom to benefit from proposed CMS decision on CGMs

 Analysts see a new proposed local coverage determination (LCD) from CMS as a potential boost for Dexcom (Nasdaq:DXCM) and Abbott (NYSE:ABT).

The Centers for Medicare and Medicaid Services (CMS) yesterday published the LCD modifying coverage criteria for continuous glucose monitors (CGMs). The modification includes people with diabetes who receive insulin treatment or have a history of problematic hypoglycemia.

Abbott and Dexcom both develop market-leading CGMs. The Dexcom G7 recently launched outside the U.S. and the company hopes for FDA clearance early next year. Meanwhile, Abbott recently announced positive data backing its FreeStyle Libre 2 system.

https://www.massdevice.com/abbott-dexcom-cms-decision-cgm-diabetes/

Horizon cuts guidance on milestone-related expense

 Horizon Therapeutics plc (Nasdaq: HZNP) announced today that it will release its third-quarter 2022 financial results on Wednesday, Nov. 2, 2022. Following the announcement, Horizon’s management will host a live webcast at 8 a.m. Eastern Time to review the Company’s financial and operating results.

The live webcast may be accessed at http://ir.horizontherapeutics.com. Please connect to the Company’s website at least 15 minutes prior to the live webcast to ensure adequate time for any software download that may be needed to access the webcast. A replay will be available approximately two hours after the live webcast.

https://finance.yahoo.com/news/horizon-therapeutics-plc-release-third-120000411.html

Oramed: Unit Has Positive Preliminary Phase 1 Data for its Oral Covid-19 Vaccine

 

  • Primary and secondary endpoints of safety and immunogenicity met

  • Oral vaccine elicited a potentially protective IgG response with significant seroconversion from baseline

  • Trial shows proof of concept for oral delivery of vaccines using Oravax technology

CVS reported to be in exclusive talks to buy Cano Health

https://finance.yahoo.com/video/cvs-reported-exclusive-talks-buy-135946137.html

Nektar and Puretech make strange bedfellows

 If you are wondering what the logic is behind merging an inhaled drug delivery specialist that turned to oncology with a holding company that has a portfolio of disparate healthcare assets you are probably not alone. This morning’s market reaction suggests that investors, too, are puzzled by Nektar’s preliminary approach, confirmed today, to Puretech Health.

However, the companies do have things in common: they have decidedly mixed track records, have been punished heavily by the markets, and also boast healthy cash balances relative to their shrunken market caps. Merging them could give much-needed scale, backed by over $1bn of cash in the bank, as well as allowing some of their less promising holdings to be jettisoned.

But there must surely be fears that Puretech investors will be lowballed – at a $900m market cap their company is worth around half of what it was 18 months ago – and that a deal will mostly comprise stock. Perhaps this explains the market’s reaction to news that Puretech had “exchanged indicative, non-binding proposals with Nektar regarding a possible ... offer for share capital of Puretech”. Puretech shares had climbed 15% yesterday as rumours of a possible takeover spread, but this morning those gains were erased.

Fall from grace

Nektar is smaller than Puretech, capitalised at just over $600m, with its mid-year cash balance accounting for almost the entirety of this. And Nektar’s own shares have had an even more spectacular fall from grace, off 75% year to date, largely because of the blow-up of bempegaldesleukin. They are trading an astonishing 97% below their 2018 peak.

If Nektar has masterminded the approach to Puretech it has certainly not done so from a position of strength.

Mizuho analysts suggest a more prosaic reason for tying the companies up: Puretech’s president is Bharat Chowiria, and he had once served as chairman and chief business officer of Nektar. Still, back then Nektar was focusing on inhaled insulin, and had yet to turn to oncology, the strategy that yielded bempegaldesleukin.

On a purely technical level a merger would result in an entity with pro forma cash of $1.1bn, and would allow each business to be streamlined further. Nektar has already been restructured, cutting 70% of its workforce in the wake of bempegaldesleukn’s discontinuation, and its Nasdaq listing could give Puretech more liquidity than it currently enjoys in the US.

But bringing a deal about would not be easy, even if you ignore the valuation problems. Puretech has set up portfolio companies in which it retains stakes of varying sizes, as well as having an R&D pipeline of its own, and it has not been plain sailing for this somewhat complex business. The sellside regularly touts Karuna as indicating the strength of Puretech’s model, but this is just one resounding success among various duds and mediocrities.

It is hard to see Puretech jumping at the chance of adding Nektar to the stable; but, now that Nektar’s cover has been blown, maybe a better buyer for Puretech will emerge.

Puretech's selected successes and failures
EntityEquity stakeFocusComment
Success…
Karuna4.3%*Schizophrenia project KarXTPivotal trial succeeded, filing due mid-2023; stock 14x above IPO price
…not so much…
Akili14.7%Video game for therapeutic useWent public via Spac, now off 75%
Gelesis23.4%Anti-obesity deviceWent public via Spac, now off 90%
Vor8.3%Cell therapyTrading 80% below IPO price
Vedanta40.5%MicrobiomePrivate; recently cut 20% of staff
RestorbioWas ~25%Failed in respiratory tract infectionReverse merged with Adicet
…and too soon to tell
LYT-100NA**Deuterated pirfenodone for idiopathic pulmonary fibrosisTopline data from registration-enabling study due by end 2023
Follica75.9%Regenerative medicinePrivate; FOL-004 said to be "ph3 ready" for alopecia
Sonde42.7%Voice-based tech Private
Entrega73.8%Drug delivery businessPrivate; preclinical
Note: *stake now thought to be ~3.5% after Puretech sold shares after the phase 3 success; **in-house R&D project, all others are/were Puretech subsidiary companies. Source: Puretech.

https://www.evaluate.com/vantage/articles/news/deals/nektar-and-puretech-make-strange-bedfellows