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Orchestra BioMed Holdings, Inc.

OBIOFDA catalysts, PDUFA dates & pipeline intelligence
$5.68
▼ -0.06 · -0.96%

Financials

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52W LOW $2.7852W HIGH $6.50
Volume
15.86 K
Value Traded
730.82 K
Short % Float
5.73%
-3.7%Week
+5.14%1 Month
+43.61%3 Month
+38.74%6 Month
-60%5 Year
-64.42%All Time

Cash Data

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  • SEC Filing

Key Stats

Market Cap
341.10 M
EPS (TTM)
-0.98
P/E Ratio
-
Ent. Value
249.14 M
Total Shares
60.11 M
Float Shares
41.39 M
Insiders
31.14%
Institutions
46.10%

Upcoming Catalysts

FDA decisions, readouts and PDUFA dates · scored by probability of approval

Catalyst Drug / Treatment Stage Prob. of Approval Description Drug Type Therapeutic Area Source
PDUFA
2026
Example Drug
Treatment for example condition requiring FDA review
Phase 3Small MoleculeOncology-
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Every FDA decision, readout and PDUFA date, with drug type, therapeutic area and a PoA score you can trade on.
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PoA blends historical approval base rates, trial design score and FDA review track record.

OBIO Catalyst Timeline

Dated clinical, regulatory and corporate events for Orchestra BioMed Holdings, Inc.

Catalyst Timeline

Dated clinical, regulatory & corporate events for Orchestra BioMed Holdings, Inc.

1Total events
0Upcoming
0Tier-1 (high impact)
2026 to 2026Coverage

Event history 1

▲Quarterly UpdateCorporate
Joined Russell 3000 and Russell 2000 Indexes
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Every PDUFA date, readout, approval and corporate move, tiered by market impact and updated daily.
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Past FDA Catalysts and PDUFA Decisions

How OBIO actually traded into and out of each decision

Date Drug Catalyst Stage Reaction Event Move % Best Trade %
-Example Drug Phase 3 data readout Phase 3
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Reaction: 30 trading days around the event · Event Move: close to close on decision day · Best Trade: peak run-up from entry 10 days before the decision

Drug Pipeline Intelligence

No drug pipeline

Orchestra BioMed Holdings, Inc. is a medical device company. The clinical trials it takes part in test other companies' drugs, so it has no drug pipeline of its own to score.

Clinical Trial Results

Readouts, endpoints and source filings for every OBIO program

Drug Name Indication Phase Date Trial Results SummaryTitleSource
AVIM Therapy
Breakthrough
Hypertensive Heart Disease2026-04-2313.2 mmHg; 97%; 125.2 mmHg; 89%; 58%Read MoreOrchestra BioMed to Present AVIM Therapy Clinical and Mechanistic Data at HRS 2026Read More
Scroll for more · summaries link to the source press release
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Inside Trades

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Monthly insider buys and sells against the stock price, with the insider sentiment reading.
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InsiderSideSharesPriceValueDate
Sherman DarrenDirector, Officer (See Remarks)Sell -15,000 1,119,402 held$6.36 10/01/2026
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Hedge Fund 13F Activity

Fund % of Portfolio Current MV Shares Owned Activity
RTW INVESTMENTS, LP 0.4 % 41.23 M 9.56 M 15.05% ( 1.25 M)
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Every 13F position with quarter over quarter share flow and average entry price.
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Shares held by hedge funds each quarter, and who bought or sold.

OBIO Institutional Ownership Trends

Options Data

Option Volume

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Call OI
Put OI
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OI 30-day avg
Today vs avg
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Option Chain Statistics

ExpiryCall VolPut VolVol P/CCall OIPut OIOI P/CIV CallIV Call OI-WtdIV Call Vol-WtdIV PutIV Put OI-WtdIV Put Vol-Wtd
2026-10-16
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Per-expiry call and put volume, open interest, put-call ratios and implied volatility.
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Real-Time Option Chain

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LastVolOILastVolOI
No data available
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Live calls and puts by strike: last price, volume and open interest for every expiry.
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Calls vs Puts by Expiry

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Competitive positioning

How OBIO ranks across every disease it competes in

Competitive Position is a premium feature
See how OBIO ranks against every competitor across each disease it develops in: phase, best drug, trials and likelihood of approval.
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OBIO News

OBIO
Oct 1, 2026
OBIOPhases

Orchestra BioMed Exceeds Full Enrollment Target in the BACKBEAT Global Pivotal Trial of AVIM Therapy

Orchestra BioMed has exceeded its enrollment target in the BACKBEAT Trial, enrolling 330 patients for the evaluation of AVIM Therapy in managing uncontrolled hypertension. The trial aims to provide data supporting future marketing applications to the FDA and other regulatory bodies. Results are expected to be presented at a major cardiovascular conference in Q2 2027.

Read more →
OBIO
Sep 16, 2026
OBIOConferences/Events

Orchestra BioMed Announces AVIM Therapy to Be Featured in Two Sessions at HRX Live 2026

Orchestra BioMed announced that its investigational AVIM Therapy will be featured in two sessions at HRX Live 2026. The sessions will focus on its collaboration with Medtronic to develop AVIM Therapy for uncontrolled hypertension. Clinical evidence suggests AVIM Therapy can significantly reduce blood pressure in patients indicated for cardiac pacemakers. The BACKBEAT Trial is nearing completion, showcasing the therapy's potential impact.

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OBIO
Sep 15, 2026
OBIOGeneral

Orchestra BioMed Receives $6.1 Million Milestone Payment from Acquisition of Vivasure by Haemonetics

Orchestra BioMed has received a $6.1 million milestone payment following the acquisition of Vivasure Medical by Haemonetics. This payment adds to the $5 million received earlier in the year, totaling approximately $11 million. The company is also eligible for up to $10 million in additional proceeds based on future revenue milestones, enhancing its capital for pivotal programs.

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OBIO
Sep 2, 2026
OBIOGeneral

Orchestra BioMed Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

Orchestra BioMed has announced the granting of stock options to seven new employees under its 2025 New Hire Inducement Plan, in compliance with Nasdaq Listing Rule 5635(c)(4). The company focuses on high-impact biomedical technologies, with its lead products, AVIM Therapy and Virtue SAB, currently in pivotal clinical trials and addressing significant market needs.

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OBIO
Aug 27, 2026
OBIOConferences/Events

Orchestra BioMed to Participate in the H.C. Wainwright 28th Annual Global Investment Conference

Orchestra BioMed Holdings, Inc. will present at the H.C. Wainwright 28th Annual Global Investment Conference on September 16, 2026. CEO David Hochman will lead the presentation and host one-on-one meetings with investors. The company is known for its innovative therapies, including AVIM Therapy and Virtue SAB, both undergoing pivotal clinical trials.

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OBIO
Aug 20, 2026
OBIOConferences/Events

Orchestra BioMed to Participate in the Wells Fargo 21st Annual Healthcare Conference

Orchestra BioMed Holdings, Inc. announced its participation in the Wells Fargo 21st Annual Healthcare Conference, where CEO David Hochman will present and hold one-on-one meetings with investors. The company is focused on high-impact biomedical technologies, including its AVIM Therapy and Virtue SAB, both of which are undergoing pivotal clinical trials. These products target significant health issues and have received FDA Breakthrough Device Designations.

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OBIO
Jun 29, 2026
OBIOGeneral
▲ +12%on this news

Orchestra BioMed Joins Russell 3000® and Russell 2000® Indexes

Orchestra BioMed Holdings, Inc. has announced its inclusion in the Russell 3000 and Russell 2000 indexes following the 2026 reconstitution. This membership is significant as it enhances the company's visibility among investors and aligns it with a broad range of market capitalizations. The company is known for its innovative biomedical technologies, including therapies for hypertension and atherosclerotic artery disease.

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OBIO
Jun 3, 2026
OBIOGeneral

Orchestra BioMed Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) - June 2, 2026

Orchestra BioMed announced the grant of stock options to five new employees as part of its 2025 New Hire Inducement Plan, in compliance with Nasdaq Listing Rule 5635(c)(4). The company is focused on advancing its flagship product candidates, AVIM Therapy and Virtue SAB, which are in pivotal clinical trials and target significant market opportunities in hypertension and atherosclerotic artery disease.

Read more →
OBIO
May 19, 2026
OBIOConferences/Events

Orchestra BioMed to Participate in the Jefferies Global Healthcare Conference

Orchestra BioMed Holdings, Inc. announced its participation in the Jefferies Global Healthcare Conference. CEO David Hochman will engage in a fireside chat and hold one-on-one meetings with investors. The event highlights the company's innovative therapies, including AVIM Therapy and Virtue SAB, both of which have received FDA Breakthrough Device Designations.

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OBIO
May 12, 2026
OBIOFDA Updates

Orchestra BioMed Reports First Quarter 2026 Financial Results and Highlights Recent Business Updates

Orchestra BioMed reported its Q1 2026 financial results, highlighting advancements in its BACKBEAT Trial and AVIM Therapy. The company aims to complete enrollment by Q3 2026 and plans a late-breaking presentation at a major cardiology conference in Q2 2027. The FDA granted a second Breakthrough Device Designation for AVIM Therapy, enhancing its market potential. Despite a net loss increase, the company maintains a strong cash runway through Q4 2027.

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OBIO
May 12, 2026
OBIOPhases

Orchestra BioMed Targeting BACKBEAT Trial Enrollment Completion By End of Q3 2026 and Data Presentation in Q2 2027

Orchestra BioMed aims to complete enrollment for the BACKBEAT Trial by Q3 2026, evaluating AVIM Therapy for hypertension in pacemaker patients. The company plans to present primary endpoint results at a major cardiology conference in Q2 2027. Medtronic will seek FDA approval for AVIM Therapy following successful data analysis.

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OBIO
May 6, 2026
OBIOGeneral

Orchestra BioMed Receives $15 Million Investment from Ligand Under Previously Announced Strategic Financing Agreement

Orchestra BioMed has received a $15 million investment from Ligand Pharmaceuticals, completing a scheduled tranche under a royalty-based financing agreement. This investment brings the total capital from Ligand to $40 million, aimed at supporting pivotal trials for its AVIM Therapy and Virtue SAB. The funding reflects confidence in the potential of these therapies to address significant unmet medical needs in cardiovascular health.

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OBIO
May 6, 2026
OBIOFDA Updates

Orchestra BioMed Receives $20 Million Payment from Medtronic Under Previously Announced Financing Agreement

Orchestra BioMed has received a $20 million payment from Medtronic as part of a strategic financing agreement. This funding will support the BACKBEAT Trial, which evaluates Atrioventricular Interval Modulation Therapy for patients with uncontrolled hypertension. The investment reflects Medtronic's commitment to advancing this innovative treatment, which has received FDA Breakthrough Device Designation.

Read more →
OBIO
Apr 30, 2026
OBIOFDA Updates
▲ +5%on this news

FDA Grants Orchestra BioMed Additional Breakthrough Device Designation for AVIM Therapy

Orchestra BioMed has received a second Breakthrough Device Designation from the FDA for its Atrioventricular Interval Modulation (AVIM) Therapy, targeting patients with uncontrolled hypertension. This designation covers a broad patient population and supports favorable reimbursement pathways. The therapy is being evaluated in the BACKBEAT Trial, conducted in collaboration with Medtronic, aiming to improve patient outcomes in hypertension management.

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OBIO
Apr 23, 2026
OBIOConferences/Events

Orchestra BioMed to Present AVIM Therapy Clinical and Mechanistic Data at HRS 2026

Orchestra BioMed announced that it will present new clinical and mechanistic data on its AVIM Therapy at the HRS 2026 Annual Meeting. The data from the MODERATO II trial showcase significant reductions in office systolic blood pressure among patients. AVIM Therapy showed an immediate average reduction of 13.2 mmHg, with 97% of patients achieving significant blood pressure reductions. The company is also actively enrolling patients for the BACKBEAT Global Pivotal Trial to further evaluate AVIM Therapy's efficacy.

Read more →
OBIO
Mar 12, 2026
OBIOGeneral

Orchestra BioMed Reports Full Year 2025 Financial Results and Provides Fourth Quarter Business Update

Orchestra BioMed reported a strong financial performance for 2025, with revenues soaring to $33.5 million, driven by strategic partnerships and agreements. The company is well-positioned for future growth with a cash position of $106.5 million and ongoing pivotal trials for its AVIM Therapy and Virtue SAB programs. CEO David Hochman highlighted the successful enrollment in these trials and the positive impact of recent transactions with Medtronic and Terumo.

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OBIO
Mar 3, 2026
OBIOConferences/Events

Orchestra BioMed Announces Presentations Highlighting AVIM Therapy Potential Impact on Hypertensive Heart Disease and Heart Failure at THT and CRT

Orchestra BioMed announced presentations at THT and CRT 2026, showcasing their Atrioventricular Interval Modulation Therapy (AVIM Therapy) for hypertensive heart disease and heart failure. Presenters highlighted clinical data demonstrating significant reductions in systolic blood pressure and improvements in cardiac function. The therapy is positioned as a novel treatment option for patients with limited alternatives.

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OBIO
Feb 19, 2026
OBIOConferences/Events

Orchestra BioMed to Participate in Upcoming Institutional Investor Conferences

Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO) is set to participate in multiple upcoming institutional investor conferences. The company will engage in live fireside chats and one-on-one meetings at the TD Cowen 46th Annual Health Care Conference and Barclays 28th Annual Global Healthcare Conference. These events will allow Orchestra BioMed to connect with investors and enhance visibility within the industry through live webcasts.

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About Orchestra BioMed Holdings, Inc.

New Hope, PA 86 employees orchestrabiomed.com
Headquarters150 UNION SQUARE DRIVE, NEW HOPE, PA, 18938
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