Concentra Spies New Target After Kezar’s Lupus Trial Hold

 

After four patient deaths, Kezar’s lupus trial is officially on hold, sparking investor Kevin Tang’s interest for acquisition.

After four patient deaths paused its lupus study, Kezar Life Sciences is now being courted for buyout by Concentra Biosciences. Kevin Tang, CEO of Concentra’s parent company Tang Capital Management, sent an offer for Concentra to scoop the biotech up for $1.10 a share in cash on Tuesday.

Tang Capital Management, Tang Capital Partners, and Tang himself each own 9.9% Kezar’s shares already.

Kezar hit rocky waters last week when the company announced four patients died in the Phase IIb PALIZADE trial testing the company’s lead candidate, an immunoproteasome inhibitor dubbed zetomipzomib, in patients with active lupus nephritis. According to the company, three of the four deaths demonstrated a “common pattern of symptoms and proximity to dosing.”

Last Monday, Kezar voluntarily paused enrollment and dosing of the mid-stage study, per the recommendations of an independent data monitoring committee. The FDA then issued a formal clinical hold. At this time, the Phase IIa PORTOLA trial of zetomipzomib in autoimmune hepatitis has not been affected. No grade 4 or serious adverse events have been documented in PORTOLA.

While analysts at the time believe the totality of the data for zetomipzomib highlight a favorable safety profile, the trial pause is certainly a setback—one that investor Tang is ready to pounce on.

Kezar’s stock closed trading Tuesday at 74 cents, having not traded over $1 since early spring. Current shareholders would receive a contingent value right of 80% of the proceeds from the out-licensing or sale of any of Kezar’s programs. Tang’s offer of $1.10 per share sent the stock up over 20% Wednesday morning.

“Concentra has funds immediately available to execute this transaction,” Tang’s offer letter said.

Tang specializes in buying out struggling biotech companies, with Concentra having acquired Theseus Pharmaceuticals last year after the company scrapped its lead drug over toxicity issues and laid off 72% of its staff.

More recently, last month Concentra made a bid to buy Singular Genomics, offering $12 a share for the multiomic discovery platform company.

https://www.biospace.com/deals/concentra-spies-new-target-after-kezars-lupus-trial-hold

Harris Attempts To Blame Trump For FEMA Hurricane Relief Failures

 by Steve Watson via Modernity.news,

Kamala Harris reverted to her default position when talking to the cackling hags on The View about FEMA’s disastrous hurricane relief efforts.

She attempted to blame Donald Trump.

“He puts himself before the needs of others. I fear that he really lacks empathy,” Harris said of Trump, also describing his criticism of her as “callousness.”

Trump hasn’t been in office since 2020, yet somehow a woeful federal government response to a hurricane that occurred in 2024 is his fault because he said some mean words.

It’s pathetic.

She repeated the same script on Colbert’s propaganda parade.

While Harris is on The View, Stern and Colbert, Trump is giving out free accommodation to first responders prepping for the massive storm heading toward Florida, yet he’s the selfish one with no empathy according to her.

Harris also claimed that Trump is using the hurricane to play political games, yet she outright lied Monday in claiming that Florida governor Ron DeSantis wouldn’t take her calls.

Let’s also not forget that while Americans were begging for help, Kamala was appearing on a sex podcast, laughing about tampons. 

Her response is always either laugh inanely, talk about her mother, or blame Trump.

*  *  *

https://www.zerohedge.com/political/harris-attempts-blame-trump-fema-hurricane-relief-failures

Biden Holds Phone Call With Netanyahu On Iran Strike Plans After Gallant Trip Blocked

 President Biden and Israeli Prime Minister Benjamin Netanyahu are holding a crucial phone call Wednesday morning focused on Israel's plans to strike back at Iran for the Oct.1st ballistic missile attack, which saw some 200 warheads launched, many of which hit targets on the ground including key airbases.

It marks the first call since Iran's attack, and also the first between the leaders in two months, and comes as Washington has signaled it is deeply worried that a bigger regional war could break out if Israel's retaliation goes too far. The call is scheduled for 10:30ET. NBC is reporting that Vice President Kamala Harris will join the call.

The call comes amid some internal Israeli drama, given the open spat between Netanyahu and his Defense Minister. Netanyahu has forced Gallant to cancel a planned trip to Washington. It was set for Wednesday, and he was to meet with counterparts in the Pentagon about "ongoing Middle East security developments," a Pentagon statement had indicated.

File image: Israeli Defense Ministry

"An Israeli official, who asked not to be identified discussing the decision, cited last-minute objections to the trip by Prime Minister Benjamin Netanyahu," Bloomberg confirms.

"Defense Minister Yoav Gallant, who has sparred with Netanyahu about the conduct of the yearlong war in Gaza and on other fronts, had been due to fly to Washington for talks," the report adds.

And Axios has filled in some further details as follows:

• Netanyahu told Gallant his trip wouldn't be approved he had received a call from Biden and the Israeli security cabinet had approved the attack plans.
• The Biden-Netanyahu call was already scheduled before the flare-up between Netanyahu and Gallant, according to a source familiar with the issue.

As it stands, Biden is opposing both Israeli potential plans to strike nuclear facilities, and also energy sites such as oil and gas depots.

"A Netanyahu aide told Axios that once a decision was made, Netanyahu would want to brief Biden," Axios noted. Is the Wednesday call all about Bibi getting a final go ahead from the White House?

The White House is said to be frustrated over lack of Israeli information-sharing on the planned attack. Times of Israel in fresh coverage specifically cites "growing frustration in Washington over Jerusalem’s unwillingness to share details of its intentions." The US also reportedly learned of the Nasrallah assassination plans only after the fact of his death:

The lack of communication led to a blunt exchange between US Defense Secretary Lloyd Austin and Defense Minister Yoav Gallant when Gallant phoned his counterpart on September 27 to inform him of the strike on Nasrallah after the fact.

“Excuse me, what did you say?” Austin reportedly asked Gallant. In a second phone call that same day, Austin asked his Israeli counterpart if Jerusalem was ready to defend itself on its own, as the US hadn’t had time to deploy its forces to deflect any immediate reprisal, the report said.

Should Israel want to use heavy US-supplied bombs in the attack, it would need to seek Washington's blessing. But a US official has said, "We want to use the call to try and shape the limitations of the Israeli retaliation."

Should conflict spiral across the region, US forces in Iraq and Syria would likely feel the brunt of the retaliation of Iran and its proxies in the region. Iraqi paramilitaries have already vowed to hit US positions hard in the scenario of Israeli escalation. The US is widely seen as supporting Israel hand-and-glove.

Already there's nearly a full-scale war in Lebanon, and Israel has stepped up its strikes against Syria, last week also reportedly coming close to hitting a major Russian airbase on Syria's coast. Bibi certainly looks in a mood to fight, and is likely indeed preparing to hit the Islamic Republic hard.

https://www.zerohedge.com/geopolitical/biden-holds-phone-call-netanyahu-iran-strike-plans-after-gallant-trip-blocked

Helene damaged a factory that makes IV fluids

 The fallout from storm damage to a North Carolina factory that makes critical hospital supplies will be felt broadly and could linger, experts say.

Flooding triggered by Hurricane Helene hit a Baxter International plant in North Cove, North Carolina, that makes much of the country’s supply of sterile intravenous, or IV, fluids. It also makes fluids used by some patients on home kidney dialysis.

Here’s a closer look at the impact.

What happened?

Baxter had to close the factory, which it says is its largest manufacturing facility, employing more than 2,500 people.

The company also started limiting how much supply customers can order, a restriction designed to prevent stockpiling and keep access equal.

Dr. Paul Biddinger of Mass General Brigham said this week that Baxter told the Massachusetts health system it will get about 40% of the supply it normally receives.

Will this affect patient care?

Yes.

Hospitals may start making small changes for now to stretch supplies of IV fluids, which are used to keep patients hydrated and also to deliver medicine.

Mass General Brigham, which includes 12 hospitals, is giving some patients water or Gatorade instead of starting an IV, Biddinger said.

He added that anyone who needs an IV can still get one, and the system’s clinical services are operating normally.

Hospitals may reschedule elective surgeries to conserve IV fluids, said Mike Ganio, who studies drug shortages at the American Society of Health-System Pharmacists. He added that they also may have nurses inject some medicines like antibiotics into patients with a syringe instead of using an IV.

Bigger changes may happen for people who need dialysis solutions made at the plant.

For those patients, Baxter is recommending that care providers review prescriptions to determine whether they can get by with less. The company also says delays to the start of dialysis should be considered.

How are supplies now?

The U.S. Food and Drug Administration, as of Friday, has not declared any new shortages tied to products made at Baxter’s plant.

But experts see vulnerability in the supply chain. Bags of IV solutions take up a lot of space, and it’s expensive for hospitals to keep large stockpiles.

IV solutions also must be kept sterile and don’t have long shelf lives, Biddinger noted.

“Maintaining a large supply of things that expire quickly is actually pretty tricky,” he said.

Smaller hospitals may only have a few days of supply on hand, Ganio noted.

Baxter is looking at using other factories around the world to fill some of the supply gap.

https://finance.yahoo.com/news/helene-damaged-factory-makes-iv-210731242.html

Viking positive phase 1b results in adrenoleukodystrophy trial

 Reductions in Very Long-Chain Fatty Acids and Plasma Lipid Levels Observed After 28 Days of Once Daily Dosing 

VK0214 Shown to be Safe and Well-Tolerated in 28-Day Study

Viking Therapeutics, Inc. (Viking) (NASDAQ: VKTX), a clinical-stage biopharmaceutical company focused on the development of novel therapies for metabolic and endocrine disorders, today announced positive data from the company's Phase 1b clinical trial of VK0214, a novel small molecule agonist of the thyroid hormone receptor beta (TRβ), in patients with X-linked adrenoleukodystrophy (X-ALD).  Results from this study showed VK0214 to be safe and well-tolerated following once-daily dosing over the 28-day study period. In addition, significant reductions were observed in plasma levels of very long-chain fatty acids (VLCFAs) and other lipids, as compared to placebo.

https://www.prnewswire.com/news-releases/viking-therapeutics-announces-results-from-phase-1b-clinical-trial-of-vk0214-in-patients-with-x-ald-302270769.html

Biogen Breamthrough Tag for Treatment of Antibody-Mediated Rejection in Kidney Transplant

 

• Designation is based on data from the clinical development program which demonstrated clinical proof of concept
  
• Felzartamab, an investigational anti-CD38 monoclonal antibody, is a potential first-in-class therapeutic candidate for a range of rare immune-mediated indications with planning underway for Phase 3 development
• FDA Breakthrough Therapy Designation is intended to expedite the development and review of drugs for serious or life-threatening conditions and which have potential to show substantial improvement over existing therapies

https://www.globenewswire.com/news-release/2024/10/09/2960415/0/en/Biogen-Receives-U-S-FDA-Breakthrough-Therapy-Designation-for-Felzartamab-for-the-Treatment-of-Antibody-Mediated-Rejection-in-Kidney-Transplant-Recipients.html

Gerresheimer shares jump as activist investor buys over 5% stake

 Gerresheimer's shares rose as much as 6.8% on Wednesday after a regulatory filing showed activist investor Ricky Chad Sandler had bought a 5.43% stake in German medical packaging maker.

The shares were trading 4.9% higher by 1030 GMT after the stake was disclosed late on Tuesday.

Dialogue between Sandler, the founder of activist investor Eminence Capital, and Gerresheimer's management had been ongoing since June, a spokesperson for the German group said.

"We don't know their agenda," the spokesperson added, but said Gerresheimer did not have an impression that Sandler was looking at an activist agenda.

Eminence was not immediately available for comment.

Gerresheimer in late September cut its annual outlook for the second time this year as it reported preliminary third quarter results, sending its shares tumbling 18% in a single day.

It is scheduled to report full quarterly results on Thursday.

https://uk.finance.yahoo.com/news/gerresheimer-shares-jump-activist-investor-103422617.html