$15 M IPO: Inflammatory Disease Biotech Curanex Launches on Nasdaq with Botanical Focus

Curanex Pharmaceuticals (NASDAQ:CURX), a developmental stage pharmaceutical company focused on botanical drugs for inflammatory diseases, has successfully completed its Initial Public Offering (IPO). The company raised $15 million in gross proceeds through the offering of 3,750,000 shares at $4.00 per share.

Trading of CURX shares commenced on the Nasdaq Capital Market on August 26, 2025. The underwriters, led by Dominari Securities LLC, have a 45-day option to purchase up to 562,500 additional shares at the public offering price, less underwriting discounts and expenses.

https://www.stocktitan.net/news/CURX/curanex-pharmaceuticals-inc-announces-closing-of-its-initial-public-pu072jo6qwxe.html

After Short Stint as a Private Company, BBOT Leaves SPAC Process Ready To Execute

 

After spinning out of BridgeBio in May 2024, BBOT had an eye on another round of fundraising in 2025. A SPAC quickly emerged as the best option.

BBOT—known legally as BridgeBio Oncology Therapeutics—has barely been an independent company for a year and has already made the jump to the public markets via a special purpose acquisition company deal. Too soon, you might be wondering? Only if you don’t realize that CEO Eli Wallace and his team have been working away at BBOT for years.

The company’s origins go back to 2019, when Wallace was recruited to run the oncology research unit of BridgeBio by that company’s CEO Neil Kumar and University of California, San Francisco Professor Frank McCormick, a leader in RAS-mutated cancer. While Wallace reported to Kumar, he operated the unit as a “semi-autonomous biotech.”

Eli Wallace

Courtesy BBOT

Meanwhile, BridgeBio was doing its own thing, moving acoramidis (now approved as Attruby) toward regulatory approval and running other late-stage programs. Finally, the executives decided it was time for BBOT to launch from the nest to allow BridgeBio to focus its resources on commercialization efforts and the non-cancer assets.

To do so, BBOT needed some new investors that were more focused on oncology to effectively support the unit’s pipeline. The companies split in May 2024, with BridgeBio remaining as a major stakeholder and Kumar and McCormick as members of the board. BBOT wasofficially born.

The split allowed BBOT to raise $200 million in capital to support the clinical programs.

“It wasn’t like we were really a series A–type company,” Wallace said of the fundraising. Having existed for four years prior to the spinout, “we were a much more mature biotech.”

What followed was a summer of execution. Initial patients were dosed in June 2024 in the Phase I ONKORAS-101 trial that is testing BBO-8520 KRASG12C non-small cell lung cancer. Then, in October, patients received doses in the Phase I BREAKER-101 trial testing BBO-10203 in solid tumors.

Wallace said BBOT always had plans to raise more capital in 2025 and had been keeping an open mind as to what form that took. He said the company considered a traditional crossover round or a regular IPO. But then Cormorant Asset Management’s Bihua Chen, who had been involved in the spinout, came forward with an idea: a SPAC. Cormorant was sponsoring Helix Acquisition Corp. II, the second blank check company of the Helix family after the successful launch of MoonLake Immunotherapeutics.

“It just became a very attractive way to get the capital that we needed,” Wallace said.

The deal was announced in February, with proceeds expected to be $450 million after Helix’s trust holdings and a private investment in public equity (PIPE) financing. Over the next six months, the deal churned through the regulatory process and Wallace said BBOT was insulated from the market volatility happening around it with a guaranteed valuation.

“With everything that happened probably starting in March in the public market, I think in retrospect, it was absolutely the right decision,” Wallace said of the SPAC.

On August 11, the de-SPAC was officially complete. BBOT began trading the next day. The team will ring the bell at Nasdaq next month. Cormorant’s Chen has even joined BBOT’s board, which is not typical after a de-SPAC. That made the SPAC path all the more clear for BBOT, Wallace said.

“We can’t do the control experiment to see if IPO would have been better for us. Maybe those strengths of the company would have carried us through,” Wallace said. “I guess we’ll never know.”

With the process complete, Wallace and the team head back to a place they know: executing on the clinical program. The company’s three clinical programs have readouts spaced out over the next 9 to 18 months.

“This capital gives us the ability to be data driven and to move all three towards proof of concept and then really make a data-driven decision on the best path forward. It could be all three. It could be two. We’ll just have to see how it plays out,” Wallace said. “I feel very fortunate. I have a very strong team and a very strong set of investors, and so we’ll just keep doing what we do.”

https://www.biospace.com/business/after-short-stint-as-a-private-company-bbot-leaves-spac-process-ready-to-execute

Novartis Doubles Down on Argo Pact With Fresh $5.2B Commitment

 

Novartis and Argo Biopharma go back to January 2024, when the pharma first bet up to $4.165 billion across two RNAi agreements targeting cardiovascular diseases.

Novartis and Shanghai-based Argo Biopharmaceutical are deepening their relationship with a new multibillion-dollar agreement that will see the partners work on multiple siRNA assets for cardiovascular targets.

Under the terms of the deal, announced Wednesday, Novartis will front Argo $160 million and commit up to $5.2 billion in milestone and option payments. Argo, meanwhile, will additionally be entitled to tiered royalties. Novartis and Argo first linked up in January 2024 with two license and collaboration agreements for investigational cardiovascular RNAi therapies. Those initial deals totaled $185 million upfront plus up to $4.165 billion in milestones.

Wednesday’s new agreement covers “multiple” cardiovascular candidates from Argo’s pipeline, though the companies did not specify how many assets they will work on together.

Argo brings to the table its siRNA drug discovery engine, which aims to produce more stable, long-acting siRNA molecules, according to its website.

These long-acting siRNA therapies “represent an important paradigm shift in prevention and treatment of cardiovascular diseases,” Shaun Coughlin, global head of Cardiovascular and Metabolism at Novartis Biomedical Research, said in the companies’ announcement. The Argo agreements, he added, strengthen “our efforts to advance potential new therapies that address unmet medical needs.”

Novartis’ $5.2 billion-plus bet with Argo is the third—and heftiest—deal the pharma has signed in just over a week. On Aug. 26, Novartis put $772 million on the line in a collaboration with BioArctic, gaining access to its BrainTransporter platform to advance therapies for neurodegenerative diseases that can cross the blood-brain barrier. Then, on Tuesday, the pharma joined up with Arrowhead Pharmaceuticals to develop an RNAi therapy for Parkinson’s disease, paying $200 million upfront and pledging up to $2 billion in milestones.

Novartis has been busy in dealmaking this year. In June, for instance, the company signed a $750-million-per-target agreement with Flagship Pioneering’s ProFound Therapeutics for protein therapies for cardiovascular diseases.

And in April, the company paid $800 million upfront and bet up to $1.7 billion to acquire Regulus Therapeutics, gaining ownership of the oligonucleotide farabursen, being developed for autosomal dominant polycystic kidney disease. A few months earlier, in February, Novartis dropped $3.1 billion to buy the privately held Anthos Therapeutics, gaining ownership of the anticoagulant antibody abelacimab.

https://www.biospace.com/business/novartis-spending-spree-continues-with-5-2b-argo-sirna-pact

''All Wrapper, No Gift’: FDA Releases New Rare Disease Approval Framework'

 

While the new framework signals continued flexibility at the FDA regarding rare disease approvals, some analysts and advocates question what tangible impacts the new guidelines will have.

The FDA’s Centers for Biologics Evaluation and Research and Center for Drug Evaluation and Research on Wednesday unveiled a new framework meant to streamline the approval of therapies for ultra-rare diseases. Some analysts and rare disease advocates, however, seem unimpressed by the program.

Paul Kim, advisor at the National Organization for Rare Disorders, put it bluntly when he wrote in a LinkedIn post on Wednesday that the framework, called the Rare Disease Evidence Principles (RDEP), “is all wrapper and no gift.” The RDEP, he continued, “is merely a restatement of current Agency practice.”

According to the FDA’s announcement, RDEP will allow companies to file for approval under an investigational new drug (IND) application using only a single-arm trial—but only for diseases that affect a “very small, rare disease population . . . generally less than 1,000 persons in the United States.”

The RDEP only applies to treatments for conditions linked to a known genetic defect, as well as those characterized by progressive functional deterioration leading to disability or death “in a relatively short period of time.” The target diseases should also not have “adequate” alternative therapies, according to the FDA.

In their applications companies will also have to provide supporting data, such as evidence of a treatment effect on the disease’s pathophysiology and findings from relevant non-clinical models, among others.

Writing to investors on Wednesday, analysts at William Blair said “it remains unclear what tangible impact the framework will have on the development process and approval timeline, given several gene therapies in development are already utilizing single-arm trials for registration.” The restriction on patient population, the analysts continued, means that “most therapies in development won’t be eligible to apply.”

Jefferies analysts had a more positive view of the RDEP, particularly because it signals a more “favorable” regulatory environment at the FDA regarding rare diseases. With the RDEP, they wrote on Wednesday, “the FDA continues to follow through on its commitment to streamline rare disease drug approvals.”

FDA Commissioner Marty Makary made such a commitment in April, in an appearance on The Megyn Kelly Show when he said that he is considering a new regulatory pathway for rare diseases based on a molecule’s “plausible mechanism.” If a drug “makes sense physiologically,” he said, then the FDA could consider approval “on a conditional basis . . . even though we don’t have a randomized controlled trial because it’s not feasible.”

But experts at the time seemed skeptical. In an interview with BioSpace in May, Daniel Kracov, partner and chair of the Global Life Sciences Industry Practice at Arnold & Porter, said that the FDA will need legislation to enact such changes to its rare disease review pathways. More importantly, Kracov insisted that streamlined pathways should not come at the expense of quality controls.

“There has to be a meaningful standard for the approval of products in order for payers to be willing to pay for those products,” he said. Basing approvals on a drug’s plausible mechanism, he added, is “about as low a standard as you could possibly get.”

https://www.biospace.com/fda/all-wrapper-no-gift-fda-releases-new-rare-disease-approval-framework

Bone Biologics expects to complete enrollment in NB1 clinical trial

 Bone Biologics Corporation (NASDAQ:BBLG), a micro-cap biotechnology company with a market capitalization of $3.72 million, announced Thursday it expects to complete enrollment in its first-in-human clinical trial for its NB1 bone graft product by the end of 2025, according to a letter to stockholders from President and CEO Jeffrey Frelick.

The multicenter study, which began last year in Australia, is evaluating the safety and preliminary effectiveness of NB1 in patients with degenerative disc disease undergoing transforaminal lumbar interbody fusion. The trial is comparing two concentrations of NB1 against autograft control in up to 30 subjects.

NB1 combines the recombinant human protein NELL-1 with demineralized bone matrix and is being developed for spinal fusion applications. The company reports that recent stability studies have extended the product’s shelf life to 18 months from the previous 12 months.

Frelick outlined several anticipated milestones for the coming year, including adding more hospital sites in Australia, further extending shelf life to 24 months, developing an enhanced potency assay, and providing an interim update once all patients reach six-month follow-up.

The company completed a public offering on June 30, raising $5 million in gross proceeds, which it expects will fund operations into the second quarter of 2026. 

Bone Biologics is positioning NB1 as a potential alternative for spinal fusion procedures, particularly for patients with difficult-to-heal bones. The company believes the product may offer improved safety and fusion rates compared to existing options. While trading near its 52-week low of $2.03,

In other recent news, Bone Biologics Corporation has announced a 1-for-6 reverse stock split, which will take effect at the start of trading on June 10, 2025. This move was approved by stockholders during the annual meeting on May 30, 2025. The reverse stock split will consolidate every six shares of issued and outstanding common stock into one share. The company’s board of directors authorized the split within a range of 1-for-2.5 to 1-for-10, ultimately deciding on the 1-for-6 ratio. Bone Biologics will continue trading under the same symbol, BBLG, on Nasdaq, but will have a new CUSIP number, 098070600. The par value per share will remain unchanged at $0.001. Additionally, adjustments will be made to the per-share exercise prices and the number of shares issuable under all outstanding warrants and equity awards to reflect the reverse stock split. These developments are part of Bone Biologics’ recent activities.

https://www.investing.com/news/company-news/bone-biologics-expects-to-complete-enrollment-in-nb1-clinical-trial-93CH-4224002

Sanofi phase 3 eczema win falls short of analyst expectations

 A phase 3 trial of Sanofi’s eczema prospect amlitelimab has hit its primary and key secondary endpoints. Yet, with the data falling short of analyst expectations, shares in the company opened down 9% in Paris. 

The trial tested amlitelimab, an anti-OX40L antibody that Sanofi has predicted could generate peak sales in excess of $5 billion. Based on phase 2 results, TD Cowen analysts said in a note to investors earlier this week that their base case phase 3 readout was a 45% to 50% rate of EASI-75 and a 35% to 40% rate of IGA0/1 after 24 weeks of monthly dosing.

Thursday, Sanofi reported EASI-75 of 35.9% and 46%, depending on which patients were included. The drugmaker also reported validated investigator global assessment scale for atopic dermatitis (vIGA-AD) 0/1 of 21.1% and 26.5%, again depending on which patients were included. 

EASI-75 looks at the proportion of patients reaching a 75% or greater improvement in the eczema area and severity index total score. Sanofi used the vIGA-AD to look at the proportion of patients with clear or almost clear skin.

The results were statistically significant compared to placebo, achieving the co-primary endpoints of the trial. However, the response rates fell into TD Cowen analysts’ bear case scenario. In that scenario, the analysts predicted Sanofi’s stock would slump below 80 euros ($93). Investors sent the stock down to 78.36 euros in early morning trading in Paris.

Meanwhile on the Nasdaq, Sanofi was down more than 7% when trading opened Wednesday morning. 

In a note to clients posted Wednesday morning, analysts at Jefferies said that Sanofi's drug "doesn't replicate [phase 2] efficacy and looks soft compared to other biologics. However, the drug clearly works at dosing every 12 weeks with efficacy improving over time and is safe. Middle of the pack on efficacy with best convenience should still be a drug."

Analysts at Leerink said in its breakdown of the data that: "Despite the underwhelming efficacy, it is possible that amlitelimab could find a role in [second line] settings, particularly given the novel mechanism of action and convenience of Q12W dosing. But the atopic dermatitis landscape is set to become increasingly crowded over the next several years, likely with novel drugs with better efficacy than amlitelimab." 

Cross-trial comparisons are complicated by the lack of equivalent 24-week data on Eli Lilly’s Ebglyss and Sanofi and Regeneron’s Dupixent. The phase 3 Dupixent program delivered (PDF) EASI-75 rates of 44% to 69% after 16 weeks across three studies. 

Amgen has also struggled to convince analysts that its OX40 drug candidate rocatinlimab can compete, despite the company racking up phase 3 wins. After seeing phase 3 data, TD Cowen analysts wrote that the antibody “showed good efficacy and better than expected tolerability, although unlikely to unseat Dupixent and will likely face stiff competition from [Sanofi’s] amlitelimab.”

The extent to which amlitelimab is a threat to rocatinlimab—and vice versa—will become clearer across a series of data drops. Amgen is scheduled to publish data from two phase 3 trials by the end of the year. Sanofi expects to share results from the four other phase 3 trials in its Oceana clinical development program through 2026. 

TD Cowen analysts said the readouts are “mission critical” for Sanofi. Amlitelimab is important to Sanofi “not only because of its peak sales potential, but perhaps, more importantly, for sentiment around [its] R&D efforts,” the analysts said.

Sentiment soured in May when Sanofi reported the failure of a phase 3 trial of its Regeneron-partnered IL-33 drug candidate itepekimab in chronic obstructive pulmonary disease. In recent months, Sanofi has also reported the failure of phase 2 trials of an oral TNF inhibitor in psoriasis and amlitelimab in asthma. 

https://www.fiercebiotech.com/biotech/rash-selling-sanofi-shares-slump-phase-3-eczema-win-fails-soothe-market-fears

FDA extends review period for Agios’ thalassemia drug

 The U.S. Food and Drug Administration has extended its review timeline for Agios Pharmaceuticals’ (NASDAQ:AGIO) supplemental New Drug Application for PYRUKYND by three months, the company announced Thursday.

The new Prescription Drug User Fee Act goal date for the oral pyruvate kinase activator has been moved from September 7 to December 7, 2025. The extension follows Agios’ submission of a proposed Risk Evaluation and Mitigation Strategy to address potential hepatocellular injury risk. 

The FDA classified this submission as a major amendment to the application, necessitating additional review time. Agios emphasized that the extension was not prompted by new safety or efficacy data.

"We remain confident in the favorable benefit-risk profile of PYRUKYND in thalassemia," said Brian Goff, Chief Executive Officer at Agios.

The application seeks approval for PYRUKYND to treat adult patients with both non-transfusion-dependent and transfusion-dependent alpha- or beta-thalassemia, a rare inherited blood disorder affecting approximately 6,000 adult patients in the U.S.

The submission is supported by data from two Phase 3 clinical trials - ENERGIZE and ENERGIZE-T - which evaluated the drug’s efficacy and safety in adults with thalassemia. The ENERGIZE trial focused on non-transfusion-dependent patients, while ENERGIZE-T studied transfusion-dependent individuals.

PYRUKYND is currently approved for treating hemolytic anemia in adults with pyruvate kinase deficiency, according to the company’s press release statement. 

In other recent news, Agios Pharmaceuticals reported its Q2 2025 earnings, revealing a larger-than-expected loss per share, with an EPS of -$1.93, missing the forecast of -$1.81. However, the company achieved a notable revenue beat, with revenue surging to $12.5 million, surpassing expectations of $9.54 million. In response to safety concerns regarding its drug mitapivat, TD Cowen reiterated its Buy rating on Agios Pharmaceuticals, dismissing any link between the drug and reported adverse events. BofA Securities also maintained a Buy rating on the stock while raising its price target to $52 from $50. This adjustment followed the company’s clarification after reports of patient deaths appeared in the FDA’s adverse events reporting system. Additionally, Agios Pharmaceuticals addressed an analyst report concerning safety data for PYRUKYND, its treatment for hemolytic anemia. The report involved four patient cases, with three previously reported to the FDA as part of routine pharmacovigilance. These recent developments highlight the company’s ongoing efforts to manage safety concerns and meet financial expectations.

https://www.investing.com/news/company-news/fda-extends-review-period-for-agios-thalassemia-drug-93CH-4224010