Oncology precision medicine platform Caris ups range to $19 to $20 ahead of $459M IPO

 Caris Life Sciences, which offers an AI-powered molecular diagnostics platform focused on oncology, raised the proposed deal size for its upcoming IPO on Monday.

The Irving, TX-based company now plans to raise $459 million by offering 23.5 million shares at a price range of $19 to $20. It had previously filed to offer the same number of shares at a range of $16 to $18. Insiders intend to purchase $75 million worth of shares in the offering (16% of the deal). At the midpoint of the revised range, Caris Life Sciences will raise 15% more in proceeds than previously anticipated.

The company is developing and commercializing a platform meant to incorporate next-generation sequencing, artificial intelligence, and machine learning technologies to develop precision medicine diagnostic solutions meant to treat cancer. Caris Life Sciences states that its platform is based off of a data set with more than 6.5 million tests, run on over 849,000 cases, and has generated measurements of over 38 billion molecular markers. Its current commercial product portfolio is focused on oncology and consists of MI Profile, a tissue-based molecular profiling solution that has generated the majority of its revenue to date, and Caris Assure, a blood-based molecular profiling solution that was broadly launched in the first quarter of 2024 for therapy selection.

Caris Life Sciences was founded in 2008 and booked $452 million in revenue for the 12 months ended March 31, 2025. It plans to list on the Nasdaq under the symbol CAI. BofA Securities, J.P. Morgan, Goldman Sachs, Citi, TD Cowen, Evercore ISI, and Guggenheim Securities are the joint bookrunners on the deal. It is expected to price during the week of June 16, 2025.

Relevant Profile: CAI

https://www.renaissancecapital.com/IPO-Center/News/111554/Oncology-precision-medicine-platform-Caris-Life-Sciences-raises-range-to-$1

Truist starts on diabetes device makers, sees glucose monitor, insulin pump growth

 Truist Securities launched coverage on four diabetes technology companies, saying there is a long-term growth potential for continuous glucose monitors (CGM) and insulin pumps amid rising adoption in both type 1 and type 2 diabetes patients.

The firm started Dexcom (NASDAQ:DXCM), Insulet (NASDAQ:PODD), and Beta Bionics with Buy ratings, while initiating Tandem Diabetes Care (NASDAQ:TNDM) at Hold.

Truist already covers Medtronic’s diabetes business, which it rates “Hold.”

Truist said the diabetes device sector is positioned for double-digit growth over the next several years, driven by expanding use in underpenetrated global markets and a shift toward more patient-centric care.

Survey feedback from physicians suggested stronger adoption of pumps and CGMs in type 2 diabetes, particularly among patients using insulin.

Among the large-cap names, the firm favored Dexcom and Insulet, citing strong profitability and leadership in the growing CGM and patch pump segments.

While Truist said that Insulet’s recent CEO change may introduce some near-term uncertainty, it said the company’s growth trajectory remains intact.

Dexcom, which has faced concerns following mid-2024 execution missteps and rising competition from Abbott’s Libre system, still offers a favorable risk-reward, Truist said, pointing to a lower relative valuation and catalysts such as guideline updates and expanding reimbursement for type 2 diabetes.

In the small-cap space, Truist preferred Beta Bionics over Tandem.

It noted both firms face challenges in the slower-growing durable pump market but said Beta Bionics’ iLet system has a potential ease-of-use advantage and a head start in transitioning to more profitable pharmacy distribution channels.

Regarding potential volatility in shares of both Beta Bionics and Tandem, Truist said the broader diabetes device market remains one of the most attractive growth areas in medtech, supported by technology innovation, evolving reimbursement, and increased patient engagement.

https://finance.yahoo.com/news/truist-starts-diabetes-device-makers-142143828.html

Makary Considers More Cuts at FDA

 

According to an internal email, the agency may be in for more consolidation in areas including human resources, communications, travel and acquisitions.

FDA Commissioner Marty Makary is considering further consolidations at the agency—though without affecting groups that conduct inspections and review applications, according to a Friday report from Endpoints News.

In an email sent last Wednesday to FDA employees, Makary suggested that the agency will put human resources, acquisitions, travel, disclosures, communications, facilities, budget and IT operations under a “unified approach.” The goal, according to the email, is to “eliminate duplicative services, increase cross-communications across the FDA and deliver more consistent, efficient and responsive support” for its review teams.

It remains unclear if this move will mean additional layoffs and, if so, how many employees will be affected.

The impending changes, which haven’t been finalized yet, come as the FDA in recent months has struggled to deliver timely decisions on drug applications. Most recently, the regulator on Friday told KalVista Pharmaceuticals that it would not be able to release a verdict in time for its PDUFA target for the company’s oral drug candidate for hereditary angioedema.

According to the biotech’s release, the delay is due to “heavy workload and limited resources” at the FDA. The decision is now expected “within approximately four weeks,” the FDA told KalVista.

The FDA has already missed target decision dates for Novavax’s next-generation COVID-19 vaccine, GSK’s chronic obstructive pulmonary disease expansion for Nucala and Stealth BioTherapeutics’ Barth Syndrome treatment.

In March, Health and Human Services Secretary Robert F. Kennedy Jr. enacted a massive overhaul of the department, including 10,000 layoffs across its various units. The FDA took a heavy blow, losing around 3,500 staff, though Kennedy’s office has insisted that fired employees were not directly involved in product reviews.

https://www.biospace.com/fda/makary-considers-more-cuts-at-fda-amid-continued-delays

Sage’s Story Comes to ‘Good End’ With Up To $795M Acquisition by Supernus

 

Stifel analysts said the deal “feels like an unremarkable outcome for a company that was once one of the hottest stories in CNS.” Supernus’ offer beats Biogen’s unsolicited bid of about $7.22 per share, which arrived with a thud in late January.

Sage Therapeutics has agreed to be acquired by Supernus Pharmaceuticals for up to $795 million, marking a “good end” to the biotech’s story, according to analysts. The deal comes about five months after Sage balked at an unsolicited offer from its Zurzuvae development partner Biogen, which was valued at about $470 million.

The companies announced the acquisition Monday morning. Supernus is offering $8.50 per share in cash, or $561 million, at closing. The deal also includes a non-tradable contingent value right (CVR) of $3.50 per share, or $234 million, payable upon certain sales and commercial milestones. That brings the deal, which is expected to close in the third quarter, up to $12 per share in cash or $795 million.

Stifel analysts wrote in a note to investors that the deal “feels like an unremarkable outcome for a company that was once one of the hottest stories in [central nervous system disorders].” Nevertheless, it is a “good end” for the company, which had been facing myriad challenges including a lack of strategic control over lead asset Zurzuvae, the analysts said. The postpartum depression drug was developed with Biogen and received a limited label upon approval in August 2023.

Sage’s shares rose 36% in premarket trading Monday morning to $9.17. The stock has fallen 41% over the past year after hitting a price of over $90 in 2021.

Supernus’ offer beats Biogen’s unsolicited bid of about $7.22 per share, which arrived with a thud in late January. Sage immediately recoiled at the idea, suing Biogen to stop it. Stifel had assumed that Biogen would return with a “sweetened offer,” but that never happened.

Either way, Stifel did not voice much hope for Sage continuing on its own. “As we see it, for Sage to create value as an independent company, it would’ve required either a substantial acceleration in the PPD launch, or a surprise to the upside from the pipeline—the latter being a higher risk strategy, and a ‘show me story for the street, that would’ve burned significant capital,” the analysts wrote.

The deal does not put much weight in Sage’s pipeline, Stifel added. Supernus noted the potential of Zurzuvae to boost growth and diversify its portfolio. The drug, for postpartum depression, brought in $36.1 million in 2024 and has already taken home $13.8 million for the first quarter. The company also has three approved CNS medicines, Qelbree, ONAPGO and Gocovri, plus five other products.

Supernus and partner Biogen will have to significantly grow Zurzuvae sales for shareholders to see any benefit from the CVR. They will receive $1 of the CVR if Zurzuvae reaches $250 million in a calendar year between now and 2027; $1 if it reaches $300 million between now and the end of 2028; and $1 if sales reach $375 million between now and the end of 2030. Another 50 cents per share will be allocated if Zurzuvae is approved in Japan for major depressive disorder and achieves an initial commercial sale there.

The FDA declined to grant an indication for MDD, instead keeping the label narrowed to PPD.

Sage CEO Barry Greene said in the company’s announcement that the deal concludes a strategic review conducted by the board of directors and he is “confident this deal maximizes value for shareholders.”

https://www.biospace.com/business/sages-story-comes-to-good-end-with-up-to-795m-acquisition-by-supurnus

Roche, Prothena Push Parkinson’s Drug to Phase III Despite Mid-Stage Fail

 

Analysts at Jefferies give Roche and Prothena’s Phase III study just a 25% to 40% probability of success.

Roche and Prothena are forging ahead to late-stage studies for their investigational Parkinson’s disease antibody prasinezumab even though it missed the bar in a mid-stage trial late last year.

In a note to investors on Monday morning, analysts at Jefferies said that while this decision could be an incremental positive for Prothena, the payout will “take patience.” Given the prior failure, the analysts aren’t optimistic about the prospects of this new late-stage trial, giving it a 25% to 40% probability of success.

Prothena’s shares rose 7.3% as the markets opened Monday, trading at $5.40 versus $5.08 at market close on Friday.

“A primary debate here is whether the antibody approach is potent enough to ‘slow the spread’ of an intra-cellular protein,” Jefferies explained. In this case, the analysts questioned whether prasinezumab, a monoclonal antibody that works outside the cell, can efficiently engage and arrest its target alpha-synuclein, a small protein that causes progressive neuron death in Parkinson’s.

The news comes after the Ireland-based biotech announced last week that it was letting go of 91 employees from its California site. The layoffs, which will take effect Aug. 1, follow a Phase III AL amyloidosis stumble in May.

In its press announcement on Monday, Roche focused on what Chief Medical Officer Levi Garraway called “efficacy signals” for prasinezumab in the mid-stage trial. In particular, the pharma maintained that Phase IIb data point to a potential clinical benefit of the investigational antibody when used on top of symptomatic treatment in the disease’s early stages.

Roche also homed in on “positive trends” in motor progression at two years, as well as biomarker evidence to support the effect of prasinezumab on Parkinson’s disease biology.

“We would note Roche continues to refine and enrich the studies to try and find the best patient population,” the Jefferies analysts wrote on Monday, adding that “by changing things each time – this also modifies risk.” The failed Phase IIb study, for instance, was conducted on a patient group that had been modified from the Phase IIa trial, yet the pharma still “got mixed results,” as per Jefferies.

Roche and Prothena have yet to disclose details regarding the timeline and design of the Phase III program.

In December 2024, the partners announced that prasinezumab fell short of its primary efficacy endpoint in the Phase IIb PADOVA study, unable to significantly improve motor progression in patients with Parkinson’s disease. However, they argued that the magnitude of effect at the time—16% with a p-value of 0.0657—showed “potential clinical effect.”

Roche bought into the potential of Prothena’s prasinezumab in December 2013 in a $600 million deal, including a $45 million upfront payment.

https://www.biospace.com/drug-development/roche-prothena-push-parkinsons-drug-to-phase-iii-despite-mid-stage-fail

3 More States Diverge From CDC On COVID-19 Vaccine Recommendations

 by Zachary Stieber via The Epoch Times,

Officials from three states said on June 12 that pregnant women should still be able to receive COVID-19 vaccines, diverging from updated guidance from the Centers for Disease Control and Prevention.

Health officials with California, Oregon, and Washington state said in a joint statement that they “continue to recommend all individuals age 6 months and older should have access and the choice to receive currently authorized COVID-19 vaccines, with an emphasis on protecting higher risk individuals, such as infants and toddlers, pregnant individuals, and others with risks for serious disease.”

The CDC in May updated its immunization schedule for adults, removing a COVID-19 vaccine recommendation for pregnant women. Insurers typically only cover vaccines that are on immunization schedules, according to the American Academy of Family Physicians and other organizations.

The CDC also removed a recommendation for healthy children to receive a COVID-19 vaccine, although the childhood immunization schedule states that “where the parent presents with a desire for their child to be vaccinated, children 6 months and older may receive COVID-19 vaccination, informed by the clinical judgment of a healthcare provider and personal preference and circumstances.”

Officials have for several years been directing vaccine manufacturers to update their formulations on an annual basis. The CDC had been advising people to receive a shot each year, regardless of prior vaccination and infection.

Health Secretary Robert F. Kennedy Jr. said the changes were made because there is no clinical data to support a “repeat booster strategy.”

Wisconsin officials soon after said they were keeping in place COVID-19 vaccine recommendations for all individuals aged 6 months and older. Kirsten Johnson, Wisconsin’s health secretary, said that the current version of the vaccine “continues to be an important tool in preventing severe illness and death.” The Wisconsin Department of Health and Human Services has not responded to requests for citations.

“Under the leadership of Secretary Kennedy, HHS is restoring the doctor-patient relationship. If a parent desires their healthy child to be vaccinated, their decision should be based on informed consent through the clinical judgement of their healthcare provider,” a spokesperson for the U.S. Department of Health and Human Services (HHS) told The Epoch Times in an email.

“Secretary Kennedy has been clear: rebuilding trust in public health starts with transparency, medical autonomy, and access to unbiased information. Americans deserve to make health decisions based on their individual circumstances—not under pressure from politicized institutions or rigid, one-size-fits-all mandates.”

In the new statement, California, Oregon, and Washington state officials said that they “are committed to continuing to work with medical experts, professional organizations, and public health partners to ensure our recommendations reflect the best available science and safeguard the health of all of our residents.”

The officials noted that some medical groups, including the American College of Obstetricians and Gynecologists, recently expressed concern over the CDC’s removal of the COVID-19 vaccine recommendation for pregnant women.

“The COVID-19 vaccine is safe during pregnancy, and vaccination can protect our patients and their infants after birth,” Dr. Steven Fleischman, president of the college, said in a statement.

The U.S. Food and Drug Administration, which clears vaccines, says in package inserts for the three available COVID-19 vaccines that available data on the shots administered to pregnant women “are insufficient to inform vaccine-associated risks in pregnancy.” Known side effects of the vaccines include heart inflammation and severe allergic shock.

Apart from differing over the updated advice for pregnant women, the state officials said they are advising people to follow the CDC immunization schedules.

https://www.zerohedge.com/covid-19/three-more-states-diverge-cdc-covid-19-vaccine-recommendations

Wave Of USAF Tankers Depart America Amid Escalating Israel-Iran Conflict

 Israel's ongoing military campaign, Operation Rising Lion, has conducted coordinated precision strikes against Iran's nuclear infrastructure, crude oil export terminals, and high-value IRGC (Islamic Revolutionary Guard Corps) targets since late last week. The scope and sequencing of these strikes—outlined in a Wall Street Journal op-ed in October 2024—suggest objectives that go well beyond deterrence, aiming instead to pave the way for regime change in Tehran. 

Speaking Sunday, President Trump emphasized that the U.S. "is not involved" in Israel's strikes on Iran—adding, however, that "it's possible we could get involved."

"We're not involved in it. It's possible we could get involved. But we are not at this moment involved," Trump told ABC News' Rachel Scott. 

The president also took to Truth Social, positioning himself as mediator and de-escalator-in-chief, stating: "Iran and Israel should make a deal, and will make a deal."

Even though President Trump is intent on avoiding a direct confrontation with Iran, any IRGC shift from striking Israel to targeting U.S. interests or personnel in the Middle East would likely escalate the conflict and sharply increase the odds of American intervention.

Overnight, several aviation tracking websites, including Flightradar24 and Air Live, reported that dozens of U.S. Air Force tankers took off from the U.S. and headed towards Europe.

Destinations are unknown for some, but the Boeing KC-46A and KC-135 aerial refueling tankers are critical aviation assets that extend the operational reach, endurance, and flexibility of fighter jets. 

However... 

The repositioning of USAF aerial refueling tankers strongly indicates that Western military planners are bracing for a sustained or broadening conflict—measured in weeks, not days. If that's the case, market overservers should take note: JPMorgan warns Brent crude futures could surge into triple-digit territory if the conflict deepens. 

https://www.zerohedge.com/military/wave-usaf-tankers-depart-america-and-deploy-east-amid-escalating-israel-iran-conflict