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Wednesday, May 14, 2025

Bluebird bio receives higher upfront offer from PE firms Carlyle, SK Capital

 Bluebird bio and Carlyle Group and SK Capital Partners said on Wednesday that the private equity firms have offered $5 per share upfront to takeover the gene therapy maker.

Shareholders may elect to receive either the new offer or the previous offer of $3 per share, with an additional $6.84 contingent upon bluebird achieving certain sales milestones.

https://finance.yahoo.com/news/bluebird-bio-receives-higher-upfront-125148001.html

NeuroPace beats Q1 2025 EPS forecast

 NeuroPace Inc. (NPCE) reported its first-quarter 2025 earnings, surpassing expectations with an EPS of -$0.21 against a forecast of -$0.24. The company also posted a revenue of $22.5 million, exceeding the anticipated $21.85 million. Following the announcement,

Key Takeaways

  • NeuroPace beat EPS expectations by $0.03, indicating improved financial performance.
  • Revenue grew 24% year-over-year, driven by strong RNS system sales.
  • Gross margin improved to 77%, up from 73.6% in the previous year.
  • The stock rose 5.71% in aftermarket trading, reversing a 3.37% decline during regular hours.
  • The company is focusing on expanding its RNS system and discontinuing SEEG product distribution.

Company Performance

NeuroPace demonstrated strong performance in Q1 2025, with significant revenue growth and improved financial metrics. The company’s RNS system sales increased by 26%, contributing to a 24% rise in total revenue compared to the same period last year.

Financial Highlights

  • Revenue: $22.5 million, up 24% YoY
  • Earnings per share: -$0.21, compared to a forecast of -$0.24
  • Gross margin: 77%, an improvement from 73.6% in Q1 2024
  • Net loss: $6.6 million, reduced from $8.9 million in Q1 2024

Earnings vs. Forecast

NeuroPace’s actual EPS of -$0.21 surpassed the forecasted -$0.24, resulting in a positive surprise of $0.03.

https://ng.investing.com/news/transcripts/earnings-call-transcript-neuropace-beats-q1-2025-eps-forecast-stock-rises-93CH-1918596

Kamada earnings matched, revenue topped estimates

 Kamada (NASDAQ: KMDA) reported first quarter EPS of $0.070, in line with the analyst estimate of $0.070. Revenue for the quarter came in at $44M versus the consensus estimate of $41.8M.

Guidance

Kamada sees FY 2025 revenue of $178.000M-$182.000M versus the analyst consensus of $183.300M.

https://www.investing.com/news/earnings/kamada-earnings-matched-revenue-topped-estimates-4044479

Novo Nordisk in $2.2B deal for Septerna's preclinical obesity programs

 Novo Nordisk is making yet another bet on obesity, offering Septerna more than $200 million in upfront and near-term payments for rights to preclinical oral small molecules that hit targets including GLP-1.

Eli Lilly, Novo’s main rival for the obesity market, shared phase 3 data on a small-molecule GLP-1 in April. The readout suggested Lilly’s orforglipron can provide Ozempic-like efficacy in Type 2 diabetes. Lilly is now racing toward phase 3 obesity readouts that could position it to file for approval in weight loss this year. The drugmaker is planning submissions in Type 2 diabetes in 2026.

Septerna’s discovery-stage programs are years behind Lilly, but the biotech has made the case that it has a unique feature that sets its molecules apart from the competition. Now, Septerna has the validation of a deal with Novo that is worth up to $2.2 billion across an upfront payment and milestones.

The biotech’s belief it can come from behind to make a mark on the obesity and diabetes markets rests on the discovery of a binding pocket. Because the pocket has similarity across GLP-1, GIP and glucagon, Septerna believes it can hit multiple incretin receptors using a single small molecule. Septerna’s binding site has 80% to 90% sequence similarity across the three receptors, versus 40% to 60% for rival assets. 

Talking at the J.P. Morgan Healthcare Conference in January, Septerna CEO Jeffrey Finer, M.D., Ph.D., said the company was studying a single-target GIP receptor agonist and a dual-action molecule that hits GIP and glucagon. The biotech had also “started to get some traction” on a triple-action molecule that could activate GLP-1, GIP and glucagon simultaneously.

Septerna has shared (PDF) mouse data on the GIP receptor agonist. Mice lost a little weight after taking the small molecule as a monotherapy, but the combination data are more compelling. Septerna studied a combination of its GIP receptor agonist and semaglutide, the GLP-1 drug in Novo’s Ozempic and Wegovy. Mice on the combination lost 33% of their body weight in 14 days, compared to 24% for semaglutide.

Weight loss on the combination mirrored data on mice that received tirzepatide, the active ingredient in Lilly’s Mounjaro and Zepbound. Whereas semaglutide only hits GLP-1, tirzepatide acts on both GLP-1 and GIP. People lose more weight on tirzepatide than semaglutide, giving Lilly an edge in a booming market. Septerna’s data suggest adding an oral GIP agonist to semaglutide provides tirzepatide-like efficacy. 

Novo and Septerna will initially work on four development programs for small molecules aimed at one or more targets, including GLP-1, GIP and glucagon. The partners will collaborate jointly in the early stages of the programs. Novo will take sole responsibility starting at IND-enabling activities. The agreement gives Septerna an option to take a share of the profits on one program instead of milestones. 

https://www.fiercebiotech.com/biotech/novo-nordisk-inks-22b-deal-septernas-preclinical-obesity-programs

Verve Pipeline Progress and Reports First Quarter 2025 Financial Results

Verve Therapeutics (VERV) reported promising Q1 2025 results and significant progress in its cardiovascular disease pipeline. The company's lead candidate VERVE-102 showed positive initial data from the Heart-2 Phase 1b trial, achieving a mean LDL-C reduction of 53% and maximum reduction of 69% in the 0.6 mg/kg dose cohort. The drug demonstrated a favorable safety profile with no serious adverse events. VERVE-102 received FDA Fast Track designation for hyperlipidemia treatment. The company's second candidate, VERVE-201 targeting ANGPTL3, continues progression in the Pulse-1 Phase 1b trial. Financially, Verve maintains a strong position with $497.1 million in cash and equivalents, providing runway into mid-2027. Q1 2025 saw collaboration revenue of $33.0 million and a net loss of $31.0 million ($0.35 per share).

Downgrades at UnitedHealth after guidance removal

 UnitedHealth Group shares came under renewed pressure after the company unexpectedly withdrew its 2025 earnings guidance and announced a leadership transition, prompting downgrades from Bank of America and Raymond James.

“We are downgrading UNH to Market Perform,” Raymond James wrote, citing the combination of “expected” CEO turnover and the “unexpected” decision to abandon guidance just one month after lowering it..

Andrew Witty is stepping down as CEO, with former chief Stephen Hemsley returning to the role.

The company had already cut its 2025 forecast by 12% in April but pulled the outlook entirely on Monday, as Medicare Advantage (MA) cost trends worsened.

“UNH suspended 2025 guidance… due to MA trend not only getting significantly worse… but now also spreading to more complex patients like duals,” Bank of America said, downgrading the stock to Neutral from Buy.

BofA lowered its price target on UnitedHealth (NYSE:UNH) to $350 from $560, citing both reduced earnings estimates and a lower valuation multiple.

The bank said the company may face “flat/negative MA member growth” in 2026 as it focuses on restoring margins.

Raymond James echoed those concerns, cutting its 2025 EPS estimate to $22 from $26.25 and calling visibility for the rest of 2025 “very low.”

Raymond James analysts also warned that UNH must “pass the Stars test in October” and said muted membership growth is likely in 2026.

Shares of UnitedHealth fell 18% on the day of the announcement and are down 38% year-to-date. “In short, it will be awhile until the smoke clears,” Raymond James wrote.

Both firms pointed to valuation compressions, with BofA noting the stock now trades at about 14x earnings versus its historical 19x multiple.

https://finance.yahoo.com/news/wall-street-analysts-downgrade-unitedhealth-132124129.html

BioCryst FDA Accepts NDA for ORLADEYO for Hereditary Angioedema Aged 2 to 11



The FDA has accepted BioCryst Pharmaceuticals' (BCRX) New Drug Application for ORLADEYO® oral granules to treat hereditary angioedema (HAE) in children aged 2-11 years. The FDA granted Priority Review with a PDUFA target date of September 12, 2025.

The application is based on positive interim data from the APeX-P clinical trial, showing ORLADEYO was well-tolerated with sustained reductions in monthly attack rates. The trial revealed HAE symptoms typically onset at age two, indicating a significant early disease burden. If approved, ORLADEYO would become the first targeted oral prophylactic therapy for HAE patients under 12 years old.

BioCryst has also filed for approval in Europe, with plans for additional submissions in Japan and Canada. ORLADEYO is currently approved for patients 12 years and older in over 30 countries since December 2020.

https://www.stocktitan.net/news/BCRX/bio-cryst-announces-fda-acceptance-of-nda-for-orladeyo-berotralstat-x5u5z7apnuy5.html