Potential Takeover In Works for Cardiovascular Treatment Focused Cytokinetics

 Cytokinetics Inc CYTK, a late-stage biotech company focused on cardiovascular treatments, is reportedly exploring potential takeover options as it has garnered interest from at least one major pharmaceutical company in recent months.

While the company has not disclosed any specifics, it is currently assessing its next course of action.

Citing sources, the Bloomberg report suggests that potential suitors may wait until Cytokinetics releases data from an upcoming Phase 3 trial before formally pursuing any acquisition. 

In August, the company said it completed enrollment in the SEQUOIA-HCM Phase 3 trial of aficamten in obstructive hypertrophic cardiomyopathy, with topline results on track by the end of 2023.

If approved, Aficamten could become the company's inaugural commercial product.

The Betaville blog had previously mentioned market rumors surrounding Cytokinetics' acquisition prospects, adding to the growing speculation in the industry.

In March, Cytokinetics discontinued the COURAGE-ALS study of reldesemtiv in all patients.

The Data Monitoring Committee reviewed unblinded data from COURAGE-ALS and recommended discontinuing the clinical trial due to futility, as it found no evidence of effect in patients treated with reldesemtiv relative to placebo on the primary endpoint of change from baseline to 24 weeks in ALSFRS-R or in key secondary endpoints. 

https://www.benzinga.com/general/biotech/23/11/35540001/potential-takeover-in-works-for-cardiovascular-treatment-focused-cytokinetics

Hyperinsulinemia acts via acinar insulin receptors to initiate pancreatic cancer

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Summary

The rising pancreatic cancer incidence due to obesity and type 2 diabetes is closely tied to hyperinsulinemia, an independent cancer risk factor. Previous studies demonstrated reducing insulin production suppressed pancreatic intraepithelial neoplasia (PanIN) pre-cancerous lesions in Kras-mutant mice. However, the pathophysiological and molecular mechanisms remained unknown, and in particular it was unclear whether hyperinsulinemia affected PanIN precursor cells directly or indirectly. Here, we demonstrate that insulin receptors (Insr) in KrasG12D-expressing pancreatic acinar cells are dispensable for glucose homeostasis but necessary for hyperinsulinemia-driven PanIN formation in the context of diet-induced hyperinsulinemia and obesity. Mechanistically, this was attributed to amplified digestive enzyme protein translation, triggering of local inflammation, and PanIN metaplasia in vivo. In vitro, insulin dose-dependently increased acinar-to-ductal metaplasia formation in a trypsin- and Insr-dependent manner. Collectively, our data shed light on the mechanisms connecting obesity-driven hyperinsulinemia and pancreatic cancer development.

https://www.sciencedirect.com/science/article/abs/pii/S1550413123003728

Regenxbio started at Buy by Stifel

 Target $35

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

enGene (Nasdaq: ENGN) Launched as Publicly Traded Genetic Medicines Company

 Business combination transaction completed with Forbion European Acquisition Corp.

Clinical stage biotechnology company with EG-70 lead program in pivotal clinical study targeting BCG-unresponsive non-muscle invasive bladder cancer (NMIBC)

$138M in gross proceeds from transaction to support advancement of EG-70 clinical program, which is currently enrolling patients, and continued pipeline expansion in additional therapeutic areas

https://www.prnewswire.com/news-releases/engene-nasdaq-engn-launched-as-publicly-traded-genetic-medicines-company-301973481.html

Silence: Positive Topline Results from Phase 1 Study in Cardiovascular Disease

 Silence Therapeutics plc, Nasdaq: SLN (“Silence” or the “Company”), an experienced and innovative biotechnology company committed to transforming people’s lives by silencing diseases through precision engineered medicines, today announced positive topline results from the multiple dose component of the APOLLO phase 1 study of zerlasiran (formerly SLN360) in 36 adults with baseline lipoprotein(a), or Lp(a), levels at or over 150 nmol/L and stable atherosclerotic cardiovascular disease (ASCVD). Zerlasiran is a siRNA (short interfering RNA) designed to lower the body’s production of Lp(a), a key genetic risk factor for cardiovascular disease affecting approximately 20% of the world’s population.

https://www.businesswire.com/news/home/20231101637440/en/

Israel Rushes Warships To Red Sea After Yemeni Houthis Launch Ballistic Missile & Drones

 Israel has rushed warships to the Red Sea, where US naval assets are also patrolling, after Yemen's Houthis declared "war" earlier this week. The Houthis had also reportedly launched a ballistic missile at Israel, and released a video showing the launch. In total the Houthis are believed to have attempted three drone and missile attacks on Israel. One of the initial projectiles days ago had been intercepted by a US warship off Yemen, and another was stopped as follows: 

The Israeli military on Tuesday used its Arrow missile defence system for the first time to intercept an "aerial threat" over the Red Sea, believed to have been a ballistic missile.

According to newly released Israeli military images, Sa’ar-class corvettes are now patrolling near Eilat port in the Red Sea.

They will be monitoring skies over the Red Sea and around Israel after the Yemeni rebel group widely seen as backed by Iran has vowed to "help the Palestinians to victory."

While apart from Gaza, Israel has been most focused on the Hezbollah threat on the northern border - having engaged in daily exchanges of fire with the militant group in southern Lebanon - the Yemeni action raises the specter of the situation spiraling into a broader regional war.

Sporadic fire along the occupied Golan Heights, and Israel's attacks south of Damascus, also raises the possibility of the Gaza war spilling into Syria. 

According to fresh reporting in The New York Times, the Houthis are already escalating their attacks on faraway Israel:

Yemen’s Houthi militia claimed an attempted attack on southern Israel on Tuesday, saying it had launched a “large batch” of ballistic and cruise missiles as well as drones toward Israeli targets.

The Iran-backed militia carried out the attempted assault in response to what it called “brutal Israeli-American aggression” in Gaza, the Houthi military spokesman, Yahya Sarea, said on the social media platform X. Mr. Sarea said the attack was the third operation conducted by the Houthis “in support of our persecuted brothers in Palestine,” and threatened further missile and drone assaults.

The Houthis have been locked in a war with Saudi Arabia (and allies UAE & the US) since 2015. In 2014 the Shia rebel group overran the Yemeni capital of Sanaa, sparking the Saudi-UAE intervention to uphold the pro-Saudi government. Many tens of thousands have been killed over the last half-decade of fighting, with the country also on the brink of starvation. 

Disagreement persists among analysts over whether the Houthis possess missiles that could effectively reach Israel.

The US and Israel have long accused Tehran of shipping weapons to the Houthis. It's believed that their surprisingly sophisticated missile arsenal comes from the Iranians, and these have been used to attack Saudi Arabia several times, including strikes on Saudi Aramco oil facilities.

https://www.zerohedge.com/geopolitical/israel-rushes-warships-red-sea-after-yemeni-houthis-launch-ballistic-missile-drones 

Earnings Due For Stealth GLP-1 Weight-Loss Drug Play McKesson, Rivals

 Amid the excitement over GLP-1 weight-loss drugs, a few of the unheralded beneficiaries are set to report earnings starting Wednesday afternoon. The Medical-Wholesale Drug/Supplies group, which is led by McKesson (MCK), is by far the stock market's top-rated medical group, ranked No. 16 among 197 industry groups by IBD.

McKesson is part of the flagship IBD 50 list of leading growth stocks. IBD Stock Checkup shows that the group's three titans — McKesson, Cencora (COR) and Cardinal Health (CAH) — all have excellent 98 IBD Composite Ratings, a single rating for both technical and fundamental factors, out of a possible 99. All three are part of the S&P 500.

On Oct. 17, Citi hiked its price target for buy-rated MCK stock to 525 from 490, highlighting potential upside to fiscal second-quarter estimates, principally due to GLP-1 usage.

Citi also noted positive trends for the group as a whole, including double-digit growth in branded drugs, normalizing medical utilization patterns and a better pricing environment for generic drugs.

Argus analyst David Toung raised his MCK stock target to 480 from 450 on Oct. 9, keeping a buy rating. He described McKesson as "riding the tailwinds" from surging demand for GLP-1 weight-loss drugs, as well as higher utilization of specialty and oncology drugs.

McKesson reports Wednesday after the close, Cencora, which recently changed its name from AmerisourceBergen, reports early Thursday. Cardinal Health reports Friday morning.

Also of note: Weight-loss drug leaders Novo Nordisk (NVO) and Eli Lilly (LLY) report early Thursday.

McKesson Earnings

Estimates: Analysts expect McKesson earnings per share to rise 1.5% to $6.16. Sales are expected to grow 8% to $76 billion.

Results: Check back late Wednesday.

Cencora Earnings

Estimates: Cencora earnings per share are seen rising 8% to $2.81 as revenue expands 8% to $66,3 billion

Results: Check back early Thursday.

Cardinal Health Earnings

Estimates: Fiscal Q1 EPS is seen rising 17% to $1.40 on 10% revenue growth to $54.8 billion.

Results: Check back early Friday.

https://www.investors.com/news/mckesson-earnings-stealth-glp-1-weight-loss-drug-play-mckesson-rivals/