r/Biotechplays

Biotech catalyst and short-pressure watchlist for next week
▲ 6 r/Biotechplays+1 crossposts

Biotech catalyst and short-pressure watchlist for next week

Sharing a biotech-only watchlist I put together for weekend research.

This is not meant to be a buy list. I was looking for biotech names where multiple factors overlap, including short interest, borrow pressure, low float, days to cover, liquidity, and upcoming catalyst context.

The highest pressure name from the scan was SONN, due to active volume, low float, elevated short float, and high borrow cost.

Other names that stood out from the pressure side:

ELTX — high borrow pressure / low float
SLS — short pressure with Phase 3 data readout context
VERA — PDUFA decision context
RGNX — Phase 3 readout context
ALT — elevated short interest and DTC
CMPX — catalyst context plus short pressure

For catalyst tracking, I also flagged CHRS, AVBP, OLMA, INO, IMUX, and ZNTL based on upcoming event timing and historical reaction data.

Biotech can be brutal, especially around clinical data and FDA events, so I treat this as a research list first. The goal is to identify names worth deeper DD, not to blindly chase tickers.

I built the graphic from my scanner data. The tool is at scstonkemporium.com, but I’m mainly posting this here because I figured a biotech-specific version would be more useful to this sub than the broader watchlists.

Watchlist only. Not financial advice.

▲ 8 r/Biotechplays+3 crossposts

Due Diligence: DRTS and the Abscopal Effect (the HOLY GRAIL of ONCOLOGY)

I'll give you the bullets and, if this is interesting, you can get into the deep dive below.

Bullets...

  • Alpha Darts have been tested in conjunction with Keytruda (Pembrolizumab)
  • What? Keytruda is Merck's $32B/year immunotherapy drug.
  • When? Results will be announced on Tuesday, July 21st, 2026 at the AHNS cancer conference in Boston
  • Who cares? Every oncologist, every solid tumor cancer patient and every DRTS investor
  • Why? We may see the first fully documented Abscopal Effect
  • What's that? Abscopal Effect is where treating one tumor causes tumors throughout the body to shrink - even though they were never directly treated.
  • How? Keytruda can't "see" cold tumors. Cold tumors are its achilles heel. Once Alpha DaRTs "light them up" the tumor turns hot and Keytruda allows your immune system to destroy tumors all over the body.
  • Which? All solid tumors.
  • All? Yes. Skin, Breast, Lung, Colorectal, Pancreas, Prostate, Ovarian, Cervical, Head, Oral, Liver, Bladder, Vulvar, etc.
  • Wait... Which doesn't it treat? The liquid cancers: Leukemia, Lymphoma, Multiple Myeloma
  • OMG! I know, right?

Deep dive due diligence

Still here? Ok. Stay with me because what you'll read below might make you very wealthy. At minimum, you'll be more interesting at parties.

First, what is Keytruda? Keytruda is an immunotherapy. It's a PD-1 inhibitor and it's on pace to be the best selling (revenue) drug of all time.

Your body has killer T-cells that have a receptor on their surface called PD-1. It's like an "off-switch" to prevent it from destroying everything in a healthy body. PD-L1 is a camouflage shield that cancer uses to "trick" the killer T-cells into passing by the cancer.

When a T-cell approaches a cancer cell to inspect it, the cancer cell pushes the shield (PD-L1) into the T-cell's off-switch (PD-1). By plugging into that receptor, the cancer cell slams the brakes and the T-cell goes to sleep and the cancer continues to grow undetected.

Keytruda is an antibody engineered to fit perfectly on the PD-1 receptor of the immune cell. When a patient receives Keytruda, the drug floods the system and physically caps the PD-1 receptors with the result that the cancer can no longer flip the off-switch. The body's immune system (T-cells) recognize the cancer as hostile and destroy it.

Sounds amazing! It is. But Keytruda has a weakness called "cold tumors."

For Keytruda to be effective, it has to have two things:

  1. Killer T-cells must already be inside or surrounding the tumor

  2. Those T-cells must be actively trying to fight the cancer but are suppressed (shut off) by the tumor's defense shield.

Cold tumors have no T-cells inside the microenvironment to begin with. Keytruda's job is to "cut the brakes" so that the killer T-Cells don't stop fighting. No T-cells to cut brakes, no reaction to cold tumors.

Alpha Darts can target cold tumors. Using CT and MRI, we (humans) can see the tumors. Both hot and cold tumors will show up and appear as physical, abnormal masses of tissue. You won't be able to tell if the tumor is hot or cold because you can't see if it's crawling with fighting T-cells (hot) or if it's been deserted by the immune system (cold.)

Via advanced imaging (Immuno-PET) a hot tumor will glow brightly because it's packed with T-cells. A cold tumor will remain dim because there are no T-cells for the tracker to stick to.

Identifying and targeting the cold tumor is the key to unlock...

T H E H O L Y G R A I L

A cold tumor is completely invisible to the immune system. There are no T-cells there so drugs like Keytruda are completely useless.

By inserting Alpha DaRT directly into a cold tumor, the localized high LET radiation physically shatters the cancer cells. This forced destruction acts like a giant biological flare gun. It forces the tumor to spill its hidden internal proteins (antigens) directly into the tissue microenvironment.

This "wakes up" the immune system and rushes killer T-cells to the site and effectively turns the cold tumors hot. Once those T-cells are trained on the newly exposed cancer "fingerprints", they can travel through the bloodstream to hunt down other metastatic tumors elsewhere in the body. Keytruda ensures they never hit the brakes.

This is called the Abscopal Effect and it is a major paradigm shift in oncology.

Alpha DaRT's superpower here is its ability to "light up" a cold tumor, creating the exact environment that Keytruda needs to step in, jam the immune brakes open and unleash a full-body abscopal effect.

Historical note: We've seen some evidence of abscopal effect with Alpha Tau in the past. If you remember, we saw an instance during the Pancreatic presentation.

Personal note: My concern with this upcoming event is that we're dealing with elderly head & neck cancer cases. Elderly people already have a diminished immunity system and the recurring head and neck won't help. This Abscopal Effect won't wipe out tumors systemically unless there are T-cells to do battle. And the truth is that this combination therapy wasn't designed to test for Abscopal Effect but there is good news: It was set up with Best Overall Response Rate (ORR) as its primary objective.

RESULTS SO FAR...

The amazing news is that it worked, at least in early efforts.

ORR means the total percentage of patients whose cancer meaningfully shrank or disappeared.

ORR for Keytruda: 19%

ORR for Keytruda + Alpha DaRT: 75% (!)

Complete Response (CR) means all target cancer lesions have completely disappeared.

Complete Response Rate for Keytruda: 5%

Complete Response Rate for Keytruda + Alpha DaRT: 37.5% (!!)

If these numbers hold up in the presentation, this is a massive performance improvement to the biggest selling immune drug on Earth.

How this could play out...

Remember, Alpha DaRTs are a device and not a drug. Sorry to keep stressing that but it's important. With a device, you run a 30-50 person safety/feasibility trial and then you run a 300 person efficacy "pivot" trial.

If you are safe (trial 1) and more effective than the standard of care (trial 2) you get a gold star on your forehead and the FDA calls you certified.

The challenge is that the FDA won't approve Alpha DaRT + Keytruda. That's not how the FDA works. What they'll do is clear the path for Alpha DaRT + Keytruda in head and neck cancers to be approved.

Then, Alpha DaRT + Keytruda in the next solid tumor and the next solid tumor and the next solid tumor.

And each time, Alpha DaRT + Keytruda will be looking not just for ORR and Complete Response rates but they'll be looking for Abscopal effects.

Which cancers tend to be "cold?"

These will be names you recognize from recent, impressive results:

PDAC Pancreatic cancer - This is the quintessential cold tumor. Up to 70% of the tumor mass isn't actually cancer cells, it's a dense, scarring physical wall (desmoplastic stroma) made of collagen and hyaluronic acid (needed AI for that one.)

Glioblastoma (aggressive brain cancer) - GBM populates an environment heavily dominated by immunosuppressive cells rather than T-Cells. Keytruda has struggled here.

Ovarian cancer - some go hot but most are in "cold deserts."

Prostate cancer - Low mutational burden so it looks like normal healthy tissue. Once it becomes resistant to hormone therapy (castration-resistant prostate cancer) it metastasizes to the bone and is incredibly difficult to treat.

Colorectal cancer - 95% of metastatic colorectal cancers are "Microstaellite-Stable (MSS), meaning they have few mutations and are entirely cold. Keytruda is great with the 5% hot tumors here.

Oncology researchers are desperate for bridging technologies like Alpha DaRT. If a local treatment can shatter the dense stromal walls of PanC or force a low-mutation prostate tumor to spill internal antigens, it will act as a mechanical override - forcing these highly fatal "cold fortresses" to turn hot.

COSTS...

Reimbursement: If you have a choice of reimbursing a drug you know (Keytruda) and an outpatient targeted radiation treatment like Alpha DaRT or you could reimburse for Car-T, TIL Therapy or TCR-T therapy plus a required hospital stay, as an insurance provider, you're going with Keytruda every day. Here's why.

Keytruda: $10k to $15k per dose (given every 3 to 6 weeks) A full year costs $150k to $185k.

CAR-T therapy: MFG cost: $375k Total cost (plus hospital) $1M

TIL Therapy: MFG cost: $515k Total cost + hospital: $1M

TCR-T Therapy: MFG cost: $400k Total cost + hospital $1M

The reason these therapies are expensive is because scientists must physically harvest your cells, ship them to a multi-million dollar lab, re-engineer or cultivate them over several weeks and ship them back. This is a one-patient, one batch process. Then, patients must undergo intense chemotherapy to clear out their existing immune system to make room for the new engineered cells. The therapies can trigger life-threatening immune overreactions and patients routinely require days or weeks in ICU to manage the dangerous side effects while the cells adapt.

Compare that to popping a pill and undergoing a biopsy like outpatient procedure.

Not only the insurance guy but the oncologist and the patient will all want Keytruda + DaRTs.

CLOSING...

Still reading? Thank you for allowing me to share a double Ted talk. The abscopal effect, if it shows up consistently in conjunction with Keytruda means that we've won a battle. Oncologists have a new weapon, patients have new hope, and we have invested in a multi-billion dollar global platform across all solid tumors and we were there back when it was at a paltry $1B market cap back in mid-2026.

reddit.com
u/Emotional-Breath-838 — 4 days ago
▲ 4 r/Biotechplays+1 crossposts

Unicycive Therapeutics Receives Complete Response Letter from FDA Regarding Resubmitted Oxylanthanum Carbonate (OLC) New Drug Application (NDA)

>The CRL is based on the same third-party manufacturing deficiencies that were identified in the previous CRL issued in June 2025. Unicycive understands that the FDA has not yet conducted its inspection of that third-party manufacturing vendor as part of the review process of the resubmitted NDA. The NDA for OLC had been resubmitted based on Unicycive’s belief of continued progress by the original third-party manufacturing vendor in resolving FDA-cited deficiencies and demonstrating inspection readiness. Unicycive previously discussed these milestones during a Type A meeting with the FDA in September 2025, which was held to obtain feedback and alignment on resolving the deficiencies identified in the Company’s CRL related to the compliance status of the vendor. The FDA did not express any concerns about the third-party manufacturer’s progress and no additional issues were raised by the FDA at the Type A meeting.

https://ir.unicycive.com/news/detail/123/unicycive-therapeutics-receives-complete-response-letter

It's been a while since I've seen the Agency issue a CRL due to a lack of a facility inspection. Not since the Covid era, when travel restrictions impacted a lot of inspections. I would love to see the CRL, to see if there is any hint as to why the 3rd party facility wasn't inspected. But unfortunately, the FDA hasn't published any CRLs since Makary left. The most recent CRL on the FDA website is Abbvie's April 22nd CRL.

ir.unicycive.com
u/TwongStocks — 6 days ago
▲ 6 r/Biotechplays+1 crossposts

Daily Watchlist - Wednesday June 1st

Today was a **record setting day for alerts at the Stonk Emporium**.

We had **$JEM hit a staggering +1,099.0% from alert to HOD**, **$CELZ hit +482.6%**, and **$LGCL hit +187.7%**.

The alert stack was on fire across **borrow spikes, after-hours expansion, runners, HOD pressure, short-pressure setups, and momentum scans**.

Join us for more alerts, scanners, and daily watchlists:

**Website:** https://www.scstonkemporium.com
**Discord:** https://discord.gg/fGmHHgNzxQ

u/Adventurous-Shoe-903 — 5 days ago
▲ 9 r/Biotechplays+1 crossposts

Daily Watchlist - June 30th

Today’s board was led by $UPC at $12.18 (+311.49%), $TNMG at $1.0100 (+106.97%), $DCOY at $9.59 (+73.79%), $SDOT at $35.85 (+67.13%), and $DGNX at $1.4000 (+58.51%) — all flagged as Daily Top Gainers.

The new Cockpit Trade Center is built to turn market chaos into a cleaner trading command center: daily watchlists, live scanners, biotech catalysts, earnings, trade ideas, smart-money flow, social heat, and momentum confirmation all in one place.

Check it out:
https://www.scstonkemporium.com
Join the Discord: https://discord.gg/fGmHHgNzxQ

u/Adventurous-Shoe-903 — 6 days ago
▲ 24 r/Biotechplays+7 crossposts

$DRTS - Alpha Tau Successfully Treats First Recurrent Glioblastoma Patient Outside of the United States with Alpha DaRT® at Hadassah University Medical Center in Israel (NASDAQ: DRTS)

Alpha Tau Successfully Treats First Recurrent Glioblastoma Patient Outside of the United States with Alpha DaRT® at Hadassah University Medical Center in Israel

- First glioblastoma patient ever treated with Alpha DaRT® outside of the United States, and the first in Israel - performed at Hadassah University Medical Center in Jerusalem, one of the world's premier academic neurosurgical institutions -

- The procedure marks the first international clinical application of Alpha DaRT's brain-specific proprietary delivery system -

- Glioblastoma is the most common and aggressive primary brain cancer, with approximately 160,000 new cases diagnosed globally each year; with recurrence occurring in virtually all patients, typically within 6-9 months, for which there is no established standard of care -

- The patient was treated under the ALL clinical protocol, Alpha Tau's broad-access study at Hadassah University Medical Center open to patients with solid tumors in any location of the body amenable to Alpha DaRT source delivery -

JERUSALEM, June 23, 2026 (GLOBE NEWSWIRE) — Alpha Tau Medical Ltd. (Nasdaq: DRTS, DRTSW) ("Alpha Tau"), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT®, today announced the successful treatment with Alpha DaRT of the first glioblastoma patient in Israel, and the first ever outside of the United States, performed at Hadassah University Medical Center in Jerusalem. The procedure was carried out by a multidisciplinary team led by Prof. Yigal Shoshan, Professor of Neurosurgery at Hadassah University Medical Center. Using the Company's proprietary brain applicator under real-time stereotactic neuro-navigation, Alpha DaRT sources were precisely delivered to the recurrent tumor through a single, minimally-invasive burr hole entry point into the brain. The procedure was completed safely and without unexpected complications.

Glioblastoma (GBM) is the most common and most lethal primary brain tumor in adults, with approximately 160,000 new cases diagnosed globally each year. Following standard first-line treatment, typically consisting of a combination of surgery, radiation, and chemotherapy, recurrence is virtually inevitable, occurring in nearly all GBM patients within 6 to 9 months of initial treatment. It is at this stage that the disease becomes most unforgiving: median overall survival from the time of recurrence is only an additional 6 to 9 months, there is no standard of care, and the majority of patients are ineligible for repeat surgical resection — leaving them with severely limited therapeutic options. It is precisely this population, facing progression with nowhere left to turn, that Alpha DaRT aims to reach.

Uzi Sofer, CEO of Alpha Tau, stated: "Today's announcement marks a significant milestone for Alpha Tau's glioblastoma program: the first-ever treatment of a GBM patient outside of the United States, delivered at an institution as scientifically rigorous and globally respected as Hadassah. Israel is the birthplace of Alpha DaRT, and bringing this technology to Israeli brain tumor patients — patients who today have so few options — is a moment of deep pride and significance for our entire team."

Prof. Yigal Shoshan, Professor of Neurosurgery at Hadassah University Medical Center, stated: "I am proud that this first Israeli case has advanced the field not just by a geography, but by a genuine technical step forward. My involvement in Alpha DaRT for brain tumors began in the laboratory, through our preclinical study, in which we demonstrated that stereotactic implantation of Alpha DaRT sources in the swine brain was both safe and technically feasible. That work laid the scientific and procedural groundwork for today's clinical milestone. The procedure was completed successfully, without unexpected complications, and represents an important proof of concept for how the flexibility of Alpha DaRT's delivery system can be adapted to the complexity of individual brain tumor anatomy. The patient — male, 77 years old, with recurrent glioblastoma following surgery and radiation therapy — tolerated the procedure well."

Dr. Robert Den, CMO of Alpha Tau, commented: "Treating a patient with glioblastoma who has no remaining standard of care — under a protocol designed precisely to reach that population — is exactly what this program is built for. The treatment of the first patient in Israel adds to the momentum of our multicenter US Recurrent GBM REGAIN trial, which is continuing to recruit patients swiftly following the fantastic interim results last month and the FDA clearance to proceed to full enrollment with the addition of two new leading U.S. academic centers. Together, these milestones are building a genuine clinical foundation for Alpha DaRT in one of oncology's most challenging and underserved diseases. We look forward with genuine anticipation to learning from Prof. Shoshan and his team as this work progresses, and above all, we look forward to following this patient's progress."

About Alpha Tau Medical Ltd.

Founded in 2016, Alpha Tau is an Israeli oncology therapeutics company focused on the research, development, and potential commercialization of the Alpha DaRT for the treatment of solid tumors. The technology was initially developed by Prof. Itzhak Kelson and Prof. Yona Keisari from Tel Aviv University.

About Alpha DaRT®

Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) is designed to enable highly potent and conformal alpha-irradiation of solid tumors by intratumoral delivery of radium-224 impregnated sources. When the radium decays, its short-lived daughters are released from the sources and disperse while emitting high-energy alpha particles with the goal of destroying the tumor. Since the alpha-emitting atoms diffuse only a short distance, Alpha DaRT aims to primarily affect the tumor and to spare healthy tissue surrounding it. For intracranial use, Alpha DaRT sources are delivered via a specialized stereotactic delivery system that interfaces with standard real-time neuronavigation platforms, enabling precise, image-guided source placement through minimally invasive burr-hole access without requiring open craniotomy.

About the ALL Protocol

The ALL protocol is a broad-access clinical trial conducted at Hadassah University Medical Center in Jerusalem, Israel. The protocol is open to patients with a wide range of solid tumor types to which Alpha DaRT sources can be delivered, who do not qualify for participation in other existing Alpha Tau clinical trials or who have no remaining standard treatment alternatives according to the treating physician. To date, patients have been treated under the ALL protocol across multiple indications, including pancreatic cancer, recurrent glioblastoma, rectal cancer, liver cancer, oral cavity cancer, and skin cancer.

Forward-Looking Statements

This press release includes "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. When used herein, words including "anticipate," "being," "will," "plan," "may," "continue," and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, including with respect to clinical trials, the ALL clinical protocol and the safety, feasibility, and efficacy of Alpha DaRT for the treatment of glioblastoma, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon Alpha Tau's current expectations and various assumptions. Alpha Tau believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. Alpha Tau may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important factors, including, without limitation: (i) Alpha Tau's ability to receive regulatory approval for its Alpha DaRT technology or any future products or product candidates; (ii) Alpha Tau's limited operating history; (iii) Alpha Tau's incurrence of significant losses to date; (iv) Alpha Tau's need for additional funding and ability to raise capital when needed; (v) Alpha Tau's limited experience in medical device discovery and development; (vi) Alpha Tau's dependence on the success and commercialization of the Alpha DaRT technology; (vii) the failure of preliminary data from Alpha Tau's clinical studies to predict final study results; (viii) failure of Alpha Tau's early clinical studies or preclinical studies to predict future clinical studies; (ix) Alpha Tau's ability to enroll patients in its clinical trials; (x) undesirable side effects caused by Alpha Tau's Alpha DaRT technology or any future products or product candidates; (xi) Alpha Tau's exposure to patent infringement lawsuits; (xii) Alpha Tau's ability to comply with the extensive regulations applicable to it; (xiii) the ability to meet Nasdaq's listing standards; (xiv) costs related to being a public company; (xv) changes in applicable laws or regulations; and the other important factors discussed under the caption "Risk Factors" in Alpha Tau's annual report filed on form 20-F with the SEC on March 9, 2026, and other filings that Alpha Tau may make with the United States Securities and Exchange Commission. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While Alpha Tau may elect to update such forward-looking statements at some point in the future, except as required by law, it disclaims any obligation to do so, even if subsequent events cause its views to change. These forward-looking statements should not be relied upon as representing Alpha Tau's views as of any date subsequent to the date of this press release.

Investor Relations Contact:
IR@alphatau.com

https://www.globenewswire.com/news-release/2026/06/23/3315968/0/en/Alpha-Tau-Successfully-Treats-First-Recurrent-Glioblastoma-Patient-Outside-of-the-United-States-with-Alpha-DaRT-at-Hadassah-University-Medical-Center-in-Israel.html

u/MarketNewsFlow — 13 days ago
▲ 13 r/Biotechplays+10 crossposts

$ENTX - Entera Bio Receives Positive FDA Feedback on 12-Month Registrational Phase 3 Study for EB613 - the First Oral Anabolic Tablet in Development for Postmenopausal Women with Osteoporosis (NASDAQ: ENTX)

The planned Phase 3 trial in approximately 750 postmenopausal women with osteoporosis, with a primary endpoint of total hip bone mineral density (BMD) at Month 12, would support Entera’s plan to submit a New Drug Application (NDA) for EB613

Entera expects to submit its NDA for EB613 based on 12-month data, with an open-label extension study to follow patients through 24 months to supplement EB613’s safety, durability of effect and sequence data

Phase 3 initiation is planned for late 2026 with topline data anticipated in the second half of 2028

TEL AVIV, June 22, 2026 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX) (“Entera” or the “Company”), a leader in the development of oral peptides, today announced that it has received positive feedback from the U.S. Food and Drug Administration (FDA) on its Phase 3 registrational protocol for EB613 (oral PTH(1-34), teriparatide), the first oral anabolic (bone-building) tablet in development for the treatment of osteoporosis. The FDA feedback is in response to a Clinical Amendment submitted by Entera to its Investigational New Drug (IND) application, as announced in March 2026.

The FDA accepted Entera’s plan to conduct a single, randomized, double-blind, placebo-controlled, Phase 3 trial in approximately 750 postmenopausal women with osteoporosis, with a primary endpoint of percent change from baseline in total hip BMD at Month 12 to support a potential New Drug Application (NDA) submission for EB613 for the treatment of women with post-menopausal osteoporosis. The proposed NDA package will also include Entera’s scientific bridge analysis with Forteo® (teriparatide SC injection, Eli Lilly) under the 505(b)(2) pathway, and a transiliac crest bone biopsy sub-study in a subset of patients.

The FDA also agreed with Entera’s proposal to continue following the randomized patients out to 24 months in an open-label extension study under a separate protocol. Entera will plan to submit data through up to 18 months as part of the 120-day safety update to its NDA. Additionally, Entera will submit the complete 2-year data upon completion of the open-label extension study to characterize further the durability of the treatment effect, safety, and sequence data for EB613 followed by a standard anti-resorptive therapy for 12 months.

The registrational study is powered to demonstrate EB613’s clinical effectiveness with projected increases in total hip BMD that are comparable to reported outcomes for Forteo® at 12 months, changes associated with a 60% to 80% relative reduction in vertebral fracture risk.

Entera completed a placebo-controlled, 6-month, Phase 2 study of EB613 in 161 postmenopausal women. The study met its primary (PD/bone turnover biomarker) and secondary (BMD) endpoints, with statistically significant increases in BMD at the lumbar spine, total hip, and femoral neck (JBMR 2024). The increase in total hip BMD in this study was comparable to what has been reported for Forteo® at 6-months. Most recently, at ENDO 2026, comparative Phase 1 data presented as a Late-Breaking Oral Presentation demonstrated that the single tablet of EB613 achieved a pharmacokinetic and pharmacodynamic profile comparable to both the multi-tablet EB613 evaluated in the Phase 2 study and Forteo®.

The Company plans to initiate the registrational Phase 3 study in late 2026, with topline results anticipated in the second half of 2028.

"We are grateful to the FDA for their support of our program.  Entera has a clear and optimized registrational path with the aim of getting EB613 to women with osteoporosis,” said Miranda Toledano, Chief Executive Officer of Entera. "Our goal with EB613 is to democratize anabolic treatment and enable millions of women and men to protect their bones and potentially prevent the catastrophic consequences of fracture. In a silent and asymptomatic disease, access and ease of administration matter."

About EB613

Substantial evidence supports the efficacy of anabolic therapies over bisphosphonates for lowering fracture risk in osteoporosis patients at high risk. However, all available anabolic therapies are administered by subcutaneous (SC) injection and used in a minority of eligible patients. Entera’s EB613 program (oral PTH(1-34), teriparatide) is being developed as the first oral, once-daily anabolic tablet treatment for osteoporosis. Entera completed a Phase 2, 6-month, 161-patient, placebo-controlled study that met all biomarker and BMD endpoints without significant safety concerns in women with postmenopausal osteoporosis or low BMD (JBMR 2024). EB613 produced rapid dose-proportional increases in biochemical markers of bone formation, reductions in markers of bone resorption, and increases in lumbar spine, total hip, and femoral neck BMD. The effects of EB613 on trabecular and cortical bone using 3D-DXA showed increases with EB613 compared to placebo on a variety of indices, including integral volumetric BMD and trabecular volumetric BMD, cortical thickness, and cortical surface BMD. Mechanistically, the findings suggest that bone strengthening and fracture resistance may occur rapidly with EB613. Furthermore, the data are consistent with that of published subcutaneous teriparatide at the 6-month time point.

About Osteoporosis

Osteoporosis is a chronic, progressive disorder in which bone resorption exceeds formation, resulting in decreased bone strength and increased susceptibility to fracture. Osteoporosis is a major and growing public health issue, responsible for over 2 million fractures annually in the US. After age 50, one in three women and one in five men will suffer an osteoporosis-related fracture in their remaining lifetime. Osteoporotic fractures lead to chronic pain, decreased quality of life, and increased disability, and contribute to premature death. Studies show that up to 20-24% of hip fracture patients die within one year of the fracture. The total medical cost of osteoporotic fractures is projected to increase from $57 billion in 2018 to $95 billion by 2040, largely related to the aging population. Postmenopausal women are at higher risk of developing osteoporosis-related fractures, particularly in the hip, spine, and wrist. The mechanism for low BMD in postmenopausal women is primary estrogen deficiency, which leads to accelerated bone loss, especially in the first 5-10 years after menopause. Forteo^(®) (Eli Lilly) was first approved by FDA in 2002 for the treatment of postmenopausal women with osteoporosis and subsequently for treatment of men with primary or hypogonadal osteoporosis at high risk of fracture, and for osteoporosis associated with sustained systemic glucocorticoid therapy.

About Entera 

Entera is a clinical stage company focused on developing oral peptide and protein replacement therapies for significant unmet medical needs where an oral tablet form holds the potential to transform the standard of care. The Company leverages a disruptive and proprietary technology platform (N-Tab^(®)) and its pipeline of first-in-class oral peptide programs. The Company’s most advanced product candidate, EB613 (oral PTH(1-34)), is being developed as the first oral, osteoanabolic (bone building) once-daily tablet for osteoporosis. A placebo-controlled, dose-ranging Phase 2 study of EB613 tablets (n = 161) met primary (PD/bone turnover biomarker) and secondary endpoints (BMD). Entera is also developing the first oral Long Acting PTH(1-34) tablet as a replacement therapy for patients with hypoparathyroidism (EB612), the first oral oxyntomodulin, a dual targeted GLP1/glucagon peptide tablet for the treatment of obesity and metabolic syndromes; and the first oral GLP-2 tablet as an injection-free alternative for patients suffering from rare malabsorption conditions such as short bowel syndrome in collaboration with OPKO Health, Inc. For more information on Entera, visit www.enterabio.com or follow us on LinkedInTwitter, and Facebook.

Cautionary Statement Regarding Forward Looking Statements

Various statements in this press release are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements (other than statements of historical facts) in this press release regarding our prospects, plans, financial position, business strategy, clinical development activities, collaboration arrangements and expected financial and operational results are forward-looking statements. Words such as, but not limited to, “anticipate,” “believe,” “can,” “could,” “expect,” “estimate,” “design,” “goal,” “intend,” “may,” “might,” “objective,” “plan,” “predict,” “project,” “target,” “likely,” “should,” “will,” and “would,” or the negative of these terms and similar expressions or words, identify forward-looking statements. Forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. Forward-looking statements should not be read as a guarantee of future performance or results and may not be accurate indications of when such performance or results will be achieved. Important factors that could cause actual results to differ materially from those reflected in Entera’s forward-looking statements include, among others: changes in the interpretation of clinical data; results of our clinical trials; the FDA’s interpretation and review of our results from and analysis of our clinical trials; unexpected changes in our ongoing and planned preclinical development and clinical trials, the timing of and our ability to make regulatory filings and obtain and maintain regulatory approvals for our product candidates; the potential disruption and delay of manufacturing supply chains; loss of available workforce resources, either by Entera or its collaboration and laboratory partners; impacts to research and development or clinical activities that Entera may be contractually obligated to provide; overall regulatory timelines; the size and growth of the potential markets for our product candidates; the scope, progress and costs of developing Entera’s product candidates; Entera’s reliance on third parties to conduct its clinical trials; Entera’s ability to establish and maintain development and commercialization collaborations; Entera’s operation as a development stage company with limited operating history; Entera’s competitive position with respect to other products on the market or in development for the treatment of osteoporosis, hypoparathyroidism, short bowel syndrome, obesity, metabolic conditions and other disease categories it pursues; Entera’s ability to continue as a going concern absent access to sources of liquidity; Entera’s ability to obtain and maintain regulatory approval for any of its product candidates; Entera’s ability to comply with Nasdaq’s minimum listing standards and other matters related to compliance with the requirements of being a public company in the United States; Entera’s intellectual property position and its ability to protect its intellectual property; and other factors that are described in the “Cautionary Statement Regarding Forward-Looking Statements,” “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Entera’s most recent Annual Report on Form 10-K filed with the SEC, as well as Entera’s subsequently filed Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. There can be no assurance that the actual results or developments anticipated by Entera will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Entera. Therefore, no assurance can be given that the outcomes stated or implied in such forward-looking statements and estimates will be achieved. Entera cautions investors not to rely on the forward-looking statements Entera makes in this press release. The information in this press release is provided only as of the date of this press release, and Entera undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except to the extent required by law.

https://www.globenewswire.com/news-release/2026/06/22/3315282/0/en/Entera-Bio-Receives-Positive-FDA-Feedback-on-12-Month-Registrational-Phase-3-Study-for-EB613-the-First-Oral-Anabolic-Tablet-in-Development-for-Postmenopausal-Women-with-Osteoporosi.html

u/MarketNewsFlow — 14 days ago