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Tuesday, December 9, 2025

'Absolutely Ignore Them': Med societies, health departments, insurers still support HBV birth vax

 A CDC vaccine advisory panel's decision to stop recommending universal hepatitis B vaccination for newborns has sparked a split between federal advisors and the medical societies that guide clinical care.

After the recently revamped Advisory Committee on Immunization Practices (ACIP) voted to weaken its hepatitis B vaccine birth-dose recommendations, leaders of organizations including the American Academy of Pediatrics (AAP) and multiple state and local health departments indicated that they do not plan to follow the revised guidance and instead will continue advocating for the vaccine at birth.

"If the political appointees running our health agencies and communities are going to ignore data and evidence, we must absolutely ignore them going forward," said Michael T. Osterholm, PhD, MPH, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, which hosts the Vaccine Integrity Project.

AAP will team with other experts and organizations to publish independent vaccine recommendations, said Aaron Milstone, MD, a pediatric infectious disease expert at Johns Hopkins University School of Medicine in Baltimore.

"Medical experts and many parents have lost confidence in the decisions of the current ACIP committee," he said. "Parents and pediatricians look to public health leaders, like the CDC, for clear guidance. That was not the outcome of last week's chaotic ACIP meeting."

The committee voted Dec. 5 to end its longstanding recommendation for universal hepatitis B vaccination at birth, breaking with more than three decades of public health policy. The panel adopted a shared clinical decision-making model for infants born to mothers who test negative for the virus' surface antigen. For families opting to delay the birth dose, the panel suggested administering the first dose at 2 months.

Earlier this year, HHS Secretary Robert F. Kennedy Jr., a longtime vaccine critic, dismissed all 17 members of the previous ACIP panel and replaced them with a smaller group that includes some vaccine skeptics. ACIP's recommendations historically have shaped national vaccination policy, clinical guidance, and insurance coverage.

"In the past, we've had a consistent message. We've had a uniform process," said Ronald G. Nahass, MD, MHCM, president of the Infectious Diseases Society of America. "Because the ACIP is not following the evidence, not following the science, and not collaborating, we now have an effort across the country to offset that confusion and chaos. We are here to advocate for a unified approach."

Some states have formed "health alliances" to develop public policies independent of ACIP's guidance. Medical society leaders emphasized that clinicians and patients in areas not covered by such alliances may take cues from the guidance those organizations promote.

"We rely on good evidence-based recommendations to make our decisions, and when there is an absence of it, we have to turn to trusted sources," said Jason Goldman, MD, president of the American College of Physicians. "When Secretary Kennedy's vaccine committee cannot be trusted, we have to go to trusted sources. So physicians throughout the country should be turning to the various medical specialty societies ... and follow the guidelines, the science, and the evidence to make those best recommendations."

Insurance coverage is another concern, with most private insurers required under the Affordable Care Act to cover ACIP-recommended vaccines at no cost. Two major insurance groups told MedPage Today that they will continue to recommend coverage of all vaccines recommended by ACIP earlier this year through 2026 with no cost-sharing. The Blue Cross Blue Shield Association said its companies will provide coverage for all immunizations recommended as of Jan. 1, 2025. AHIP (formerly America's Health Insurance Plans) said its health plans will continue to cover all vaccinations recommended as of Sept. 1.

Goldman pointed out that Kennedy, whose office also oversees CMS, could use his authority to enforce compliance with his hand-picked ACIP's recommendations, potentially affecting reimbursement or vaccine labeling.

"Their decisions have real-world consequences on how it is reimbursed, how physicians can stock vaccines," Goldman said. "There are so many ways the secretary can cause damage."

Public health leaders acknowledge that a solution is not yet in place but remain committed to addressing the situation.

"I don't want anybody to walk away from this ... feeling like we've got this thing solved. We don't," Osterholm said. "I think it's important you see we're working on it. We understand it. We get it. And I think that's the really important message right now to get out. We will try to help every practicing clinician in any community, whether they're in a red state or a blue state, try to deal with this very challenging situation."

https://www.medpagetoday.com/pediatrics/vaccines/118917

Pfizer in pact with China’s Fosun Pharma for oral GLP-1 drugs

 Chinese drugmaker Fosun Pharma (SFOSF) on Tuesday announced a global licensing agreement with Pfizer (PFE) to hand the U.S. pharma giant exclusive rights to its oral GLP-1 drugs in a deal worth up to $2B.

As part of the deal, Fosun (SFOSF) subsidiary Chongqing Yao Pharmaceutical is expected to issue an exclusive worldwide license for its oral small-molecule glucagon-like peptide-1 receptor (GLP-1R) agonists, including its clinical-stage therapy YP05002.

In exchange, Pfizer (PFE) will make an upfront payment of $150M to Yao Pharma as well as potential milestone payments worth up to $1.935B and tiered royalties on product sales, Fosun Pharma (SFOSF) said in a statement.

The drugs targeted in the deal have been developed by Yao Pharma for conditions including chronic weight management, type 2 diabetes, and metabolic dysfunction-associated steatohepatitis. New York-based Pfizer (PFE) is expected to take over the future development of YP05002 after Yao Pharma completes its ongoing Phase 1 clinical trial in Australia.

The deal comes weeks after the New York-based company completed its $10B acquisition of GLP-1 drug developer Metsera following a bitter bidding war with obesity drugmaker Novo Nordisk (NVOin November.

https://www.msn.com/en-us/money/companies/pfizer-in-pact-with-china-s-fosun-pharma-for-oral-glp-1-drugs/ar-AA1S17vE

Vor Bio spikes as J.P. Morgan starts at Overweight on lead asset

 Vor Biopharma (VOR) rose ~17% on Tuesday after J.P. Morgan initiated its coverage with an Overweight recommendation and a Dec. 2026 price target of $43, citing a potential blockbuster status for the biotech’s lead asset, telitacicept.

Analyst Anupam Rama argued that telitacicept, marketed in China by Vor’s (VOR) partner RemeGen (REGMF) for autoimmune diseases such as myasthenia gravis, has been “highly derisked” for multiple indications.

With global late-stage studies for the drug underway, including for MG and primary Sjögren’s disease ((pSD)), Rama noted that telitacicept for each of the indications targeted by Vor Bio (VOR) could generate blockbuster peak sales in the U.S. alone.

The analyst noted that there is a sizable valuation disconnect between VOR shares and telitacicept’s probability-adjusted value in MG and pSD.

“As the known late-stage data from China in both indications are better appreciated and there is progress in the global studies, we see the potential for VOR shares to grind higher,” he added.

https://www.msn.com/en-us/money/companies/vor-bio-spikes-as-jp-morgan-starts-at-overweight-on-lead-asset/ar-AA1S1mCj

Citius Oncology added to the Russell Microcap Index

 

  • Citius Oncology (CTOR) has been added to the Russell Microcap Index.
  • Inclusion becomes effective at the market open on December 22, 2025.
  • The addition is part of the 2025 Russell indexes reconstitution.

Sarepta a new outperform at Wedbush as selloff overdone

 Wedbush has initiated Sarepta Therapeutics (SRPT) at outperform saying that a selloff that began earlier this year following the deaths of two boys who were taking one of its Duchenne muscular dystrophy gene therapies is overdone.  

The firm has a $32 price target (~46% upside based on Dec. 8 close). 

Analyst Yun Zhong said that he sees further upside coming given the US FDA's potential re-approval of Elevidys (delandistrogene moxeparvovec), the drug involved in the deaths, in non-ambulatory patients in early 2027. The treatment, currently, can only be used in ambulatory patients.

The drug now has a Boxed Warning on the risk of fatal acute liver failure. Zhong noted that Sarepta has received clearance to begin a study to evaluate the addition of sirolimus as part of an immunosuppression regimen to Elevidys therapy by the end of the year, with primary endpoint data collection expected in H2 2026. He added that another study showed no acute liver injury when sirolimus was added on a prophylactic basis to Elevidys. 

"Importantly, a KOL that we talked to sees Elevidys' profile as still favorable for non-ambulatory patients, although the criteria for eligibility needs to be defined with specific parameters," he wrote.

Zhong added that he expects the company's other Duchenne drugs to continue to perform well. "We project continued patient uptake based on a high compliance rate that SRPT has reported, comprehensive real world data supporting clinical benefit, and favorable KOL feedback."

https://www.msn.com/en-us/money/savingandinvesting/sarepta-a-new-outperform-at-wedbush-as-selloff-overdone/ar-AA1S1mCk

Ligand Pharma sets 2026 outlook as Citi starts at Buy on valuation

 As Ligand Pharma (LGND) held its Investor Day in New York City on Tuesday, Citi initiated its coverage with a Buy recommendation and a target price of $270, noting that the biotech’s valuation remains underappreciated despite its YTD rally.

Florida-based Ligand (LGND) has added more than 70% this year, which Citi analyst Yigal Nochomovitz attributed to the company’s recent profitability gains driven by its long-term investments in drugs such as Filspari, which it develops with Travere Therapeutics (TVTX).

“However, we believe current levels are still underappreciating LGND’s valuation as upcoming catalysts for partnered programs,” expected by the end of 2025 or 2026, including a potential label expansion for Filspari “could further rerate the stock,” Nochomovitz added.

Meanwhile, ahead of the investor day event, Ligand (LGND) unveiled its 2026 guidance, indicating $245M - $285M in total revenue and $8.00 - $9.00 of core adjusted earnings per diluted share compared to $259.2M and $4.69 in the consensus, respectively.

The company continues to expect its 2025 total core revenue and core adjusted earnings per diluted share to reach $225M - $235M and $7.40 - $7.65, respectively, and projects at least a 23% compound annual growth rate from long-term royalty receipts.

https://www.msn.com/en-us/money/topstocks/ligand-pharma-sets-2026-outlook-as-citi-starts-at-buy-on-valuation/ar-AA1S1y1O

STAAR Surgical jumps after Alcon raises offer to $30.75/share in cash

 STAAR Surgical (STAA) soared 10% after Alcon (ALC) increased its offer for STAAR to $30.75/share in cash. 

The purchase price increase represents an additional ~$150 million in equity value for stockholders, according to a statement on Tuesday. Alcon increased its offer to $30.75 from its original purchase price of $28 in August.

Alcon (ALC) intends to finance the transaction through the issuance of short- and long-term credit facilities. 

Alcon (ALC) expects the transaction to be accretive to earnings in year two. It is expected to close early next year. Alcon urged STAAR (STAAA) shareholders to vote in favor of the transaction in advance of the Dec. 19 vote on the deal.

The increased deal price comes after proxy advisers and shareholders had come out against the original transaction, recommending that STAAR (NASDAQ:STAA) shareholders reject the deal. Several large holders, including Broadwood Partners, STAAR Surgical's biggest holder with a ~30.2% stake, have come out against the deal, publicly saying they plan to vote against it.

Broadwood Partners said it still plans to vote against the revised deal, the investor said in a statement on Tuesday.

"We believe STAAR has a bright future as an independent company," Broadwood said in the statement. "In fact, if the Company achieves management’s own projections, STAAR will be one of the most profitable medical technology companies in the world. Based on this fact, we believe the Company is worth substantially more than $30.75 per share."

https://www.msn.com/en-us/money/companies/staar-surgical-jumps-after-alcon-raises-offer-to-30-75-share-in-cash/ar-AA1S0IeI