OBIO

Orchestra BioMed targeting enrollment completion of BACKBEAT Global Pivotal Trial (“BACKBEAT Trial”) by the end of Q3 2026 Medtronic (NYSE: MDT) and Orchestra BioMed intend to pursue late-breaking clinical trial presentation at major cardiology conference in Q2 2027 and subsequent marketing application submission to FDA and global regulatory agencies, assuming primary endpoints are met FDA granted a second Breakthrough Device Designation (“BDD”) for AVIM Therapy specific to patients with uncontrolled hypertension despite the use of anti-hypertensive medications, and an indication for a pacemaker Virtue Trial sites progressing with site activation and patient enrollment acceleration continuing throughout 2026 Cash runway projected into Q4 2027 and through achievement of key upcoming clinical and regulatory milestones NEW HOPE, Pa., May 12, 2026 (GLOBE NEWSWIRE) -- Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO, “Orchestra BioMed” or the “Company”), a biomedical company accelerating high-impact technologies to patients through risk-reward sharing partnerships, today announced financial results for the first quarter ended March 31, 2026, and provided a business update highlighting momentum across the Company’s pivotal-stage programs for Atrioventricular Interval Modulation (“AVIM”) Therapy and Virtue® Sirolimus AngioInfusion™ Balloon (“Virtue SAB”) supported by the Company’s strong balance sheet. David Hochman, Chairman and Chief Executive Officer of Orchestra BioMed stated, “We continued to make meaningful advancements across our late-stage cardiovascular pipeline during the first quarter. Along with the achievement of recently announced important regulatory, clinical and financing milestones, we are pleased to provide clarity on the expected timeline for the BACKBEAT Trial highlighting objectives for enrollment completion, late-breaking clinical trial presentation, and plans for potential regulatory submissions by our strategic collaborator Medtronic. With increasingly strong momentum continuing in the BACKBEAT Trial and the AVIM Therapy program, and great progress for the Virtue Trial and Virtue SAB, our team is excited about the significant value inflection points that lie ahead for Orchestra BioMed.” Q1 2026 and Recent Business Highlights: Provided overall update on the BACKBEAT Trial timeline, targeting enrollment completion by the end of the third quarter...

Codexis (CDXS) came out with quarterly earnings of $0.11 per share, beating the Zacks Consensus Estimate of $0.01 per share. This compares to a loss of $0.13 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +2,100.00%. A quarter ago, it was expected that this producer of custom industrial enzymes would post a loss of $0.15 per share when it actually produced a loss of $0.22, delivering a surprise of -46.67%. Over the last four quarters, the company has surpassed consensus EPS estimates two times. Codexis, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $38.92 million for the quarter ended December 2025, surpassing the Zacks Consensus Estimate by 1.61%. This compares to year-ago revenues of $21.46 million. The company has topped consensus revenue estimates two times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Codexis shares have lost about 23.9% since the beginning of the year versus the S&P 500's decline of 0.9%. While Codexis has underperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Codexis was mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future. You can see the complete list of today's Zac...

Orchestra BioMed Holdings, Inc. (OBIO) came out with quarterly earnings of $0.26 per share, beating the Zacks Consensus Estimate of a loss of $0.38 per share. This compares to a loss of $0.43 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +168.87%. A quarter ago, it was expected that this company would post a loss of $0.38 per share when it actually produced a loss of $0.4, delivering a surprise of -5.26%. Over the last four quarters, the company has surpassed consensus EPS estimates two times. Orchestra BioMed Holdings, Inc., which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $30.92 million for the quarter ended December 2025, surpassing the Zacks Consensus Estimate by 3,813.54%. This compares to year-ago revenues of $0.25 million. The company has topped consensus revenue estimates four times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Orchestra BioMed Holdings, Inc. shares have added about 10.8% since the beginning of the year versus the S&P 500's decline of 1%. While Orchestra BioMed Holdings, Inc. has outperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Orchestra BioMed Holdings, Inc. was mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to...

$106.5 million cash position as of December 31, 2025 to be further enhanced by $35 million expected from Medtronic and Ligand in Q2 2026 from previously announced transactions, as well as Haemonetics’ Vivasure acquisition proceeds $33.5 million in 2025 non-recurring revenue primarily driven by impact of new Virtue SAB agreement with Terumo that was announced in October 2025 Strong balance sheet supports focused execution of pivotal trials for both AVIM Therapy and Virtue SAB programs NEW HOPE, Pa., March 12, 2026 (GLOBE NEWSWIRE) -- Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO) (“Orchestra BioMed” or the “Company”), a biomedical company accelerating high-impact technologies to patients through strategic partnerships with market-leading global medical device companies, today reported its full year 2025 financial results and provided a fourth quarter business update. David Hochman, Chairman and Chief Executive Officer of Orchestra BioMed stated, “We are very proud of our significant clinical, strategic and financing accomplishments in 2025. We are now in an excellent financial and operational position to achieve upcoming value-driving milestones for both of our pivotal stage programs. In the second half of 2025, we leveraged our partnership-driven business model to substantially strengthen our financial position with nearly $150 million in new capital and capital commitments, including strategic transactions with Medtronic, Ligand and Terumo. With a strong balance sheet in place, we are fully focused on driving pivotal trial execution for both AVIM Therapy and Virtue SAB, high impact therapies designed to address major unmet needs in large, established global procedure markets.” Hochman continued, “As we enter 2026 with two pivotal trials underway, we remain focused on disciplined execution and long-term value creation for patients, clinicians and shareholders. We are encouraged by the accelerated pace of enrollment in the BACKBEAT global pivotal study following protocol amendments implemented in the fourth quarter and we plan to provide a substantive update in our next quarterly report. We are also pleased with the early progress of the Virtue Trial, which we initiated during the fourth quarter of 2025. We expect to provide additional updates on this trial, which is randomizing coronary in-stent restenosis patients to treatment with Virtue SAB versus the AGE...

Secured $147.6 million in proceeds and committed capital following completion of strategic transactions and concurrent public and private equity offerings, led by $71.6 million in committed capital from Medtronic and Ligand, as well as $30 million from Terumo Initiated patient enrollments in the Virtue Trial evaluating Virtue® Sirolimus AngioInfusion™ Balloon (“Virtue SAB”) trial versus commercially available paclitaxel-coated balloon Demonstrated partnership-driven business model execution with expanded strategic collaboration with Medtronic and new right of first refusal agreement with Terumo NEW HOPE, Pa., Nov. 10, 2025 (GLOBE NEWSWIRE) -- Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO, “Orchestra BioMed” or the “Company”), a biomedical company accelerating high-impact technologies to patients through risk-reward sharing partnerships, today announced financial results for the third quarter ended September 30, 2025, and provided a business update highlighting recent financial and regulatory milestones. Q3 2025 and Recent Business Highlights: Completed multiple strategic transactions and concurrent public and private equity offerings totaling $147.6 million in gross proceeds to support continued advancement of the Company’s pivotal trial-stage Atrioventricular Interval Modulation Therapy (“AVIM Therapy”) and Virtue SAB clinical programs. Gross proceeds are comprised of: $55 million received or to be received by May 1, 2026, subject to certain conditions, in strategic investments from Ligand Pharmaceuticals Incorporated (Nasdaq: LGND, “Ligand”) and Medtronic, plc (NYSE: MDT, “Medtronic”) $62.6 million received from a $46 million oversubscribed, underwritten public offering of common stock and prefunded warrants and $11.6 million and $5 million received from private placements of common stock to Medtronic and Ligand, respectively $30 million received from Terumo Corporation, including a $10 million payment in exchange for granting Terumo a right of first refusal (“ROFR”) and a $20 million purchase of non-voting preferred stock, convertible into common stock at a minimum of $12 per share (the “Preferred Stock”) Extended cash runway into Q4 2027, supporting potentially significant value-creating catalysts, including: BACKBEAT study enrollment completion in mid-2026 Follow up for the BACKBEAT study primary endpoint data Completion of enrollment of the Virtue Tria...

This article first appeared on GuruFocus. Orchestra BioMed Holdings Inc (NASDAQ:OBIO) is set to release its Q3 2025 earnings on Nov 12, 2025. The consensus estimate for Q3 2025 revenue is $0.76 million, and the earnings are expected to come in at -$0.42 per share. The full year 2025's revenue is expected to be $3.40 million and the earnings are expected to be -$1.78 per share. More detailed estimate data can be found on the Forecast page. Warning! GuruFocus has detected 5 Warning Signs with OBIO. Is OBIO fairly valued? Test your thesis with our free DCF calculator. Revenue estimates for Orchestra BioMed Holdings Inc (NASDAQ:OBIO) have increased from $3.12 million to $3.40 million for the full year 2025 and from $3.47 million to $3.77 million for 2026 over the past 90 days. Earnings estimates have improved from -$1.99 per share to -$1.78 per share for the full year 2025 and from -$1.75 per share to -$1.54 per share for 2026 over the past 90 days. In the previous quarter of 2025-06-30, Orchestra BioMed Holdings Inc's (NASDAQ:OBIO) actual revenue was $0.84 million, which beat analysts' revenue expectations of $0.70 million by 20.11%. Orchestra BioMed Holdings Inc's (NASDAQ:OBIO) actual earnings were -$0.50 per share, which beat analysts' earnings expectations of -$0.51 per share by 0.99%. After releasing the results, Orchestra BioMed Holdings Inc (NASDAQ:OBIO) was up by 7.94% in one day. Based on the one-year price targets offered by 6 analysts, the average target price for Orchestra BioMed Holdings Inc (NASDAQ:OBIO) is $13.50 with a high estimate of $20.00 and a low estimate of $10.00. The average target implies an upside of 257.62% from the current price of $3.78. Based on GuruFocus estimates, the estimated GF Value for Orchestra BioMed Holdings Inc (NASDAQ:OBIO) in one year is $6.76, suggesting an upside of 79.07% from the current price of $3.78. Based on the consensus recommendation from 7 brokerage firms, Orchestra BioMed Holdings Inc's (NASDAQ:OBIO) average brokerage recommendation is currently 2.0, indicating an "Outperform" status. The rating scale ranges from 1 to 5, where 1 signifies Strong Buy, and 5 denotes Sell.

Orchestra BioMed Holdings, Inc. (OBIO) is expected to deliver a year-over-year increase in earnings on lower revenues when it reports results for the quarter ended September 2025. This widely-known consensus outlook gives a good sense of the company's earnings picture, but how the actual results compare to these estimates is a powerful factor that could impact its near-term stock price. The earnings report might help the stock move higher if these key numbers are better than expectations. On the other hand, if they miss, the stock may move lower. While management's discussion of business conditions on the earnings call will mostly determine the sustainability of the immediate price change and future earnings expectations, it's worth having a handicapping insight into the odds of a positive EPS surprise. This company is expected to post quarterly loss of $0.38 per share in its upcoming report, which represents a year-over-year change of +7.3%. Revenues are expected to be $0.75 million, down 24.2% from the year-ago quarter. The consensus EPS estimate for the quarter has been revised 17.71% higher over the last 30 days to the current level. This is essentially a reflection of how the covering analysts have collectively reassessed their initial estimates over this period. Investors should keep in mind that an aggregate change may not always reflect the direction of estimate revisions by each of the covering analysts. Price, Consensus and EPS Surprise Estimate revisions ahead of a company's earnings release offer clues to the business conditions for the period whose results are coming out. Our proprietary surprise prediction model -- the Zacks Earnings ESP (Expected Surprise Prediction) -- has this insight at its core. The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate for the quarter; the Most Accurate Estimate is a more recent version of the Zacks Consensus EPS estimate. The idea here is that analysts revising their estimates right before an earnings release have the latest information, which could potentially be more accurate than what they and others contributing to the consensus had predicted earlier. Thus, a positive or negative Earnings ESP reading theoretically indicates the likely deviation of the actual earnings from the consensus estimate. However, the model's predictive power is significant for positive ESP read...

Secured over $111 million in proceeds and committed capital following completion of strategic transactions and concurrent public and private equity offerings, led by over $71 million in committed capital from Medtronic and Ligand Achieved multiple FDA regulatory milestones: Breakthrough Device Designation for AVIM therapy; approval for expanded BACKBEAT study enrollment criteria, and IDE approval for a U.S. pivotal Virtue SAB trial versus commercially available paclitaxel-coated balloon NEW HOPE, Pa., Aug. 12, 2025 (GLOBE NEWSWIRE) -- Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO, “Orchestra BioMed” or the “Company”), a biomedical company accelerating high-impact technologies to patients through risk-reward sharing partnerships, today announced financial results for the second quarter ended June 30, 2025, and provided a business update highlighting recent financial and regulatory milestones. Q2 2025 and Recent Business Highlights: Completed multiple strategic transactions and concurrent public and private equity offerings totaling an expected $111.2 million in gross proceeds to support continued advancement of the Company’s late-stage atrioventricular interval modulation (“AVIM”) therapy and Virtue Sirolimus AngioInfusion Balloon (“SAB”) clinical programs. Gross proceeds are comprised of: $55 million received or to be received by May 1, 2026, subject to certain conditions, from royalty-based, non-dilutive investments from Ligand Pharmaceuticals Incorporated (Nasdaq: LGND, “Ligand”) and Medtronic, plc (NYSE: MDT, “Medtronic”) Ligand committed $35 million in exchange for a tiered revenue interest in Orchestra BioMed’s future royalties from AVIM therapy and Virtue SAB Medtronic committed $20 million in exchange for a secured subordinated promissory note convertible to capped prepaid revenue share $56.2 million received from a $40 million underwritten public offering of common stock and prefunded warrants and $11.2 million and $5 million received from private placements of common stock to Medtronic and Ligand, respectively Proceeds expected to extend cash runway into the second half of 2027, supporting potentially significant value-creating catalysts, including: BACKBEAT study enrollment completion in mid-2026 BACKBEAT study primary endpoint data Substantial enrollment of the Virtue Trial Medtronic and Orchestra BioMed expanded strategic collaboration to provide...

FDA Breakthrough Device Designation Awarded to AVIM Therapy FDA IDE Approved for Virtue SAB U.S. Pivotal Trial for Launch NEW HOPE, Pa., May 12, 2025 (GLOBE NEWSWIRE) -- Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO, “Orchestra BioMed” or the “Company”), a biomedical company accelerating high-impact technologies to patients through risk-reward sharing partnerships, today announced financial results for the first quarter ended March 31, 2025, and provided a business update highlighting continued regulatory momentum, disciplined operational execution, and a strengthening clinical development pipeline. Q1 2025 Highlights: U.S. Food and Drug Administration (“FDA”) Breakthrough Device Designation (“BDD”) granted for atrioventricular interval modulation (“AVIM”) therapy in patients with uncontrolled hypertension and increased cardiovascular risk, with or without an indication for a pacemaker, marking a major regulatory validation of the therapy's potential to improve hypertensive heart disease outcomes. FDA BDD enables prioritized regulatory interactions and strengthens potential access to add-on reimbursement. BACKBEAT Global Pivotal Study execution continuing to progress in strategic collaboration with Medtronic (NYSE: MDT). New Clinical Data presented demonstrating the favorable impact of AVIM therapy on cardiac function in patients with diastolic dysfunction, a key contributor to the development of heart failure, as late breaker at THT 2025. Intellectual Property Expansion continues with AVIM therapy patent estate reaching 137 issued patents worldwide, with recent additions bolstering coverage for both hypertension and heart failure indications. FDA Investigational Device Exemption (“IDE”) Approval received for the Virtue® Sirolimus AngioInfusion Balloon (“SAB”) U.S. pivotal trial, a randomized head-to-head study comparing Virtue SAB with the commercially available AGENTTM DCB paclitaxel-coated balloon (the “Virtue Trial”). Trial initiation is currently targeted for the second half of 2025. Orchestra BioMed is sponsoring and in full operational control of the Virtue Trial; mediation with Terumo of certain other contractual terms is progressing. Key Chief Executive Officer (“CEO”) Commentary: David Hochman, Chairman and CEO of Orchestra BioMed, stated: “We continued to make meaningful progress during the first quarter with significant inflection points for both...

The market expects Orchestra BioMed Holdings, Inc. (OBIO) to deliver a year-over-year decline in earnings on lower revenues when it reports results for the quarter ended March 2025. This widely-known consensus outlook is important in assessing the company's earnings picture, but a powerful factor that might influence its near-term stock price is how the actual results compare to these estimates. The earnings report might help the stock move higher if these key numbers are better than expectations. On the other hand, if they miss, the stock may move lower. While management's discussion of business conditions on the earnings call will mostly determine the sustainability of the immediate price change and future earnings expectations, it's worth having a handicapping insight into the odds of a positive EPS surprise. This company is expected to post quarterly loss of $0.46 per share in its upcoming report, which represents a year-over-year change of -21.1%. Revenues are expected to be $0.39 million, down 37.1% from the year-ago quarter. The consensus EPS estimate for the quarter has been revised 1.03% lower over the last 30 days to the current level. This is essentially a reflection of how the covering analysts have collectively reassessed their initial estimates over this period. Investors should keep in mind that the direction of estimate revisions by each of the covering analysts may not always get reflected in the aggregate change. Estimate revisions ahead of a company's earnings release offer clues to the business conditions for the period whose results are coming out. Our proprietary surprise prediction model -- the Zacks Earnings ESP (Expected Surprise Prediction) -- has this insight at its core. The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate for the quarter; the Most Accurate Estimate is a more recent version of the Zacks Consensus EPS estimate. The idea here is that analysts revising their estimates right before an earnings release have the latest information, which could potentially be more accurate than what they and others contributing to the consensus had predicted earlier. Thus, a positive or negative Earnings ESP reading theoretically indicates the likely deviation of the actual earnings from the consensus estimate. However, the model's predictive power is significant for positive ESP readings only. A pos...

NEW HOPE, Pa., March 31, 2025 (GLOBE NEWSWIRE) -- Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO, “Orchestra BioMed” or the “Company”), a biomedical innovation company accelerating high-impact technologies to patients through risk-reward sharing partnerships, today reported its full year 2024 financial results and provided a fourth quarter business update. "We remain highly focused on execution of the BACKBEAT global pivotal study, which we believe has the potential to deliver landmark results that can establish AVIM therapy as a new standard of care for the treatment of uncontrolled hypertension in patients already indicated for a pacemaker. We also believe it can lay the foundation for expanding use of AVIM-enabled devices to manage blood pressure and improve cardiovascular function for hypertensive patients with high cardiovascular risk,” commented David Hochman, Chairman, Chief Executive Officer and Founder of Orchestra BioMed. “As we age, our arteries naturally lose elasticity and become stiffer, a process that increases the risk of cardiovascular problems and is linked to changes in blood pressure and heart function. One of the characteristics of this process is the development of diastolic dysfunction, a condition where the heart's ventricles cannot relax and fill with blood properly during the diastolic phase of the cardiac cycle. Our late-breaking data in patients with diastolic dysfunction recently presented at THT showed AVIM therapy’s ability to significantly improve ventricular relaxation and passive filling, highlighting its potential to drive better clinical outcomes through blood pressure reduction, as well as improvement of cardiac function." “In parallel, we are encouraged by the progress of our Virtue SAB program as we actively prepare to initiate a U.S. coronary pivotal study with an updated trial design, currently under FDA review. The study is expected to randomize patients with coronary in-stent restenosis to treatment with Virtue SAB or Boston Scientific’s AGENT drug-coated balloon. We believe this design will optimally highlight the potential advantages of Virtue SAB’s proprietary design advantages which enables protected delivery of extended focal-release sirolimus without the need for a balloon coating,” continued Mr. Hochman. “With regard to our strategic partnership, we and Terumo are moving our negotiations into a formal mediatio...