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Wednesday, March 1, 2023

Guggenheim: Opportunities For Chinook To Thrive In Emerging Renal Markets

 

  • Guggenheim starts coverage on Chinook Therapeutics Inc  with a Buy rating and a $43 price target, being 'bullish' on the immunoglobulin A nephropathy (IgAN) market.
  • The analyst is "bullish" on the increased interest, investment, and innovation in the immunoglobulin A nephropathy, or IgAN, market and believes Chinook is "well-positioned to benefit from these trends." 
  • Atrasentan and BION-1301 have each shown "impressive early data," writes the analyst, while their benefits still need to be demonstrated in pivotal trials.
  • Rival drug Filspari from Travere Therapeutics Inc  is paving an exciting path for endothelin receptor antagonists (ERAs) in IgAN and FSGS, but the analyst believes atrasentan's more extensive safety database may allow for it to have a less restrictive REMS program.
  • Guggenheim projects both drugs to make it to the market and hold >$1 billion annual peak sales potential by 2030, anticipating a 2025 atrasentan launch, with a 75% probability of success in IgAN and a 45% odds of success in focal segmental glomerulosclerosis (FSGS).

House GOP probes intermediaries in prescription drug prices

 Rep. James Comer (R-Ky.), chairman of the House Committee on Oversight and Accountability, announced Wednesday that he is launching an investigation into pharmacy benefit managers (PBM) and actions that increase health care costs for patients.

“Pharmacy Benefit Managers’ anticompetitive tactics are driving up health care costs for Americans and harming patient care,” Comer said in a statement. “Federal agencies administering health care programs for seniors, active-duty military, and federal employees rely on PBMs as middlemen to set drug prices, which opens the door to government waste at the expense of American taxpayers.”

Comer called for enhanced transparency in the PBM industry in order to better ascertain the impact it has on the pharmaceutical market and health care programs run by the federal government.

The chairman requested that the Office of Personnel Management, Centers for Medicare and Medicaid Services and the Defense Health Agency provide documents and communication to determine how PBMs impact those programs.

PBMs are third-party companies that operate between pharmaceutical manufacturers and insurance providers. These companies negotiate drug spending with manufacturers and play a large part in how much medications cost for insurers.

PBMs generate profits through administrative fees and spread pricing, when insurers and health plan customers are charged more for prescriptions than what a pharmacy is reimbursed for and the companies keep the difference.

The majority of the PBM industry is dominated by only a few companies, which Comer noted in his announcement. He has requested that three major PBMs — Express Scripts, CVS Caremark and OptumRx — provide documents and communications relating to their practices.

PBMs have regularly been criticized for lacking transparency, particularly when it comes to rebates they receive from drug manufacturers. Drug makers provide rebates to PBMs to ensure their medications are included on the list of drugs that insurance companies will cover.

These rebates may help lower the cost that customers pay at the pharmacy, but this does not always occur and does not directly affect the price of the drug itself. In his letters to the PBMs, Comer demanded to know all the rebates and fees the companies had received over the years.

The Pharmaceutical Care Management Association (PCMA), a national group that represents PBMs, sought to bring attention to other drug cost-lowering measure in response to Comer’s announcement.

“Pharmacy benefit companies have a proven track record of reducing prescription drug costs in federal programs, ultimately for patients and taxpayers,” PCMA CEO J.C. Scott said in a statement. “While we appreciate — and share — the Committee’s concern around drug pricing and existing gaps in affordability, we strongly urge members of the committee and Congress to stay focused on real solutions that are proven to reduce prescription drug costs.”

“Increasing competition in the prescription drug market is the most effective way to lower costs — and is achievable if lawmakers hold big drug companies accountable for common and egregious abuses of the drug patent system, which block competition and keep drug prices high, and of their pricing power, which is the root cause of high drug prices,” added Scott.

Other organizations expressed their support of Comer’s investigation.

David Mitchell, founder of the Patients For Affordable Drugs NOW organization, praised Comer’s announcement, writing, “We have consistently supported investigations into the practices of secret PBMs to ensure they are serving patients first and foremost to produce lower prices and better health.”

https://thehill.com/policy/healthcare/3879512-house-republicans-open-investigation-into-role-of-intermediaries-in-prescription-drug-prices/

Florida lawmaker’s bill would get rid of the Democratic Party

 Florida Democrats took on tremendous losses last election cycle, and now a Republican state lawmaker wants to eliminate the party entirely with a bill filed Tuesday.

“The Ultimate Cancel Act” (SB 1248), sponsored by state Sen. Blaise Ingoglia (R-Spring Hill), would cancel the filings of any political party that supported slavery during the Civil War.

“The Democrat party adopted pro-slavery stances in their party platforms and this bill says that if you have done that in the past, then the Secretary of State shall de-certify and get rid of the party,” Ingoglia said. 

If the controversial bill were approved, voters registered with any “canceled” party would become non-party-affiliated voters.

“It would be interesting to find out if those voters who are now de-certified choose to go back to the party now that they know that they were the party that was advocating for the issue of slavery,” Ingoglia said.

Any “canceled” party could register again, but the name of the organization must be substantially different from the name of any other party that was previously registered with the department.

The proposal is drawing widespread criticism from Democrats.

“Shame on the Republican Party for initiating legislation of this magnitude. This is what a dictator does,” newly elected Florida Democratic Party chair Nikki Fried said. 

 “It’s a complete and absolute abuse, and it’s unconstitutional. This bill will go nowhere. It is meritless. It deserves zero airtime and frankly, it’s a distraction from the Republicans’ failed policies,” House Minority Leader Fentrice Driskell said.

When asked if he thought the bill would get any traction in the upcoming session, Ingoglia said, “I guess we’re gonna see, aren’t we?”

Ingoglia said he has not spoken to the governor or legislative leaders about the bill.

“Florida Democrats are lucky I’m not asking them to return all the political contributions that they got in years past for their Jefferson Jackson dinners since they want to cancel everything. They were raising money based upon two people that, by their own admission, should have been canceled,” Ingoglia said.

On Wednesday, the Florida Democratic Party issued the following statement:

“Presenting a bill that would disenfranchise 5 million voters is both unconstitutional and unserious. Under Ron DeSantis, Senator Ingoglia is using his office to push bills that are nothing more than publicity stunts instead of focusing on the issues that matter most to Floridians, such as reforming property insurance, addressing housing affordability and combating climate change.

“The sooner DeSantis and his puppets in the legislature learn that Florida is a Democratic Republic and not a Banana Republic, the better it will be for all Floridians.”

The governor’s office declined to comment on the legislation. Legislative leaders in the House and Senate have yet to express interest in taking up the bill during the upcoming session. If this were to become law, it would take effect in July 2023.

Incidentally, the Republican and Democratic parties didn’t always hold the stances they do today. According to Britannica, the Republican Party organized in 1792 and was “the direct antecedent of the present Democratic Party.”

Essentially, the parties switched platforms over time. According to Livescience, between the 1860s and 1936,” the (Democratic) party of small government became the party of big government, and the (Republican) party of big government became rhetorically committed to curbing federal power.”

https://thehill.com/homenews/state-watch/3879164-florida-lawmakers-bill-would-get-rid-of-the-democratic-party/

BeyondSpring starts Phase 2 for Combo for Lung Cancer

 BeyondSpring Inc. (NASDAQ: BYSI) (“BeyondSpring” or the “Company”), a clinical-stage global biopharmaceutical company focused on developing innovative cancer therapies, today announced that the first patient has been enrolled in BeyondSpring’s Phase 2 investigator-initiated trial with lead asset, Plinabulin, in combination with Merck’s anti-PD-1 therapy Keytruda® (pembrolizumab) and Docetaxel for previously treated patients with metastatic non-small cell lung cancer (NSCLC) and progressive disease after immunotherapy (anti-PD-1 / PD-L1 inhibitor) alone or in combination with platinum-doublet chemotherapy.

Most patients experience disease progression after immune checkpoint inhibitor-based (ICI) treatment regimens. BeyondSpring’s triple-combination therapy has the potential to improve ICI resistance and provide a new treatment option for metastatic NSCLC patients previously treated with an immunotherapy. The study1 is actively recruiting at Peking Union Medical College Hospital in Beijing, China, with Dr. Mengzhao Wang, Chief of the Department of Respiratory and Critical Care Medicine, as principal investigator. Patients will receive the following doses during each three-week cycle (via IV infusions)2:

  • Plinabulin at 30 mg / m2 on Days 1 and 8

  • Keytruda at 200 mg on Day 1

  • Docetaxel at 75 mg / m² on Day 1

 

Oragenics in Agreement with Inspirevax to Develop Intranasal Covid Vaccine Candidate

 Licensing milestones provides opportunity to expand vaccine program

 

Oragenics, Inc. (NYSE American: OGEN) (“Oragenics” or the “Company”), a biotech company dedicated to fighting infectious diseases including COVID-19, today announced that the Company has entered into an exclusive global license agreement with Inspirevax Inc. for its novel intranasal mucosal adjuvant, BDX301, for the development of NT-CoV2-1, Oragenics’ lead intranasal COVID-19 vaccine candidate.

Under the exclusive licensing agreement, Oragenics will pursue the development of NT-CoV2-1 with Inspirevax’s novel BDX301 intranasal mucosal adjuvant. The companies will form a Joint Development Committee (JDC) comprising representatives of both companies to oversee the development efforts collaboratively. Oragenics will make clinical, regulatory and commercial milestone payments, as well as tiered royalty payments. Additionally, the agreement provides a certain period of time for the companies to expand their collaboration to pursue the development of additional intranasal vaccine candidates using Inspirevax’s adjuvants.

https://www.biospace.com/article/releases/oragenics-enters-into-an-exclusive-global-license-agreement-with-inspirevax-to-develop-intranasal-covid-vaccine-candidate-/

Tyra Expands Development of TYRA-300, an Oral FGFR3 Selective Agent, into Achondroplasia

  In preclinical models, TYRA-300 demonstrated significant increases in growth and bone length-

-Phase 2 clinical study for pediatric achondroplasia planned to be initiated in 2024-
-Conference call and webcast today, March 1st, at 8:00 am ET-
TYRA will host a conference call and webcast today, March 1, 2023 at 8:00 a.m. ET. The conference call can be accessed by dialing 1-646-968-2525 for domestic callers and 1-888-596-4144 for international callers. Please provide the operator with the passcode 7533836 to join the conference call. The conference call will also be available via webcast under the "For Investors" section of TYRA's website at www.tyra.bio. An archive of the teleconference and webcast will also be made available on TYRA's website following the call.

CCP government 'intentionally released' COVID-19 'all over the world,' Chinese virologist says

 A Chinese virologist who sounded the alarm in early 2020 about where the coronavirus came from said Monday the U.S. has reached a "milestone achievement" after a classified intelligence report from the Energy Department reportedly found the virus most likely originated in a Chinese lab. 

Dr. Li Meng Yan told "Tucker Carlson Tonight" in September 2020 that the Chinese government intentionally manufactured and released the COVID-19 virus, leading to nationwide shutdowns and deaths. 

Host Tucker Carlson asked Yan on Monday if she still believes the virus was intentionally released nearly three years after the pandemic started. 

"Of course, it was not an accident," she responded. 

"Maybe for people who don't have this kind of biosafety lab 3 or 4 experience on coronavirus, maybe it's easy for them to accept the accident lab leak. However, I'm a scientist, working in [a] research lab using coronavirus. And I can tell you, based on the print protocol and also the other surveillance system, it would be impossible for the lab leak [to] accidentally happen in such [a] lab and cause the Wuhan outbreak and also the pandemic," Yan said. 

"So definitely now we just reached the first step. It was from China's lab, and we need to pursue the truth of origin, and we need to keep going on."

Carlson suggested the Chinese government unleashed COVID to destroy Western economies and elevate their own position globally. 

Yan said based on the evidence she has seen and the source she has spoken to, the virus was "intentionally brought out of this strict lab and released in the community."

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"However, I don't think the outbreak in Wuhan was intentional. I would say it was because [the] CCP government and the military scientists underestimated the transmissibility," she added. "That's why finally it got out of control and the cost [was] a local outbreak. However, we should know that [the] CCP government intentionally let it go all over the world to kill millions of people all over the world later."

Yan was a respected doctor who specialized in virology and immunology at the Hong Kong School of Public Health before fleeing in April 2020 after she began looking into the growing number of cases coming out of mainland China that involved human-to-human transmission. 

Residents wait in line for their routine COVID-19 test at a coronavirus testing site in Beijing, Dec. 7, 2022.

Residents wait in line for their routine COVID-19 test at a coronavirus testing site in Beijing, Dec. 7, 2022. (AP Photo/Andy Wong)

She said she reported her findings to her supervisor on Jan. 16, but that's when he allegedly told her "to keep silent, and be careful."

"As he warned me before, 'Don't touch the red line,'" Yan said referring to the government. "We will get in trouble, and we'll be disappeared." 

https://www.foxnews.com/media/ccp-government-intentionally-released-covid-19-over-world-chinese-virologist