Dj Bristol Myers Squibb Corporate Stock Underperforms Wednesday When Compared To Competitors

Syros Pharmaceuticals Inc revealed on Tuesday that the SELECT-MDS-1 Phase 3 trial of tamibarotene did not meet its primary endpoint of complete response rate.

The trial assessed tamibarotene in combination with azacitidine in newly diagnosed higher-risk myelodysplastic syndrome (HR-MDS) patients with RARA gene overexpression.

Myelodysplastic syndrome is a rare blood cancer that occurs when the DNA in bone marrow stem cells is damaged, preventing them from producing healthy blood cells.

In the first 190 enrolled patients, the complete response rate by intent-to-treat (ITT) in the tamibarotene/azacitidine treatment arm was 23.8% compared to 18.8% in the placebo/azacitidine control arm and was not statistically significant (p-value = 0.2084).

Bristol Myers Squibb & Co markets azacitidine as Vidaza.

In the safety analysis of all enrolled patients (n=245), tamibarotene combined with azacitidine (n=160) appeared to be generally well-tolerated, with an adverse event profile similar to that seen in earlier Syros-sponsored studies.

Syros also reported, as previously disclosed in its filings with the U.S. Securities and Exchange Commission (SEC), the failure of the SELECT-MDS-1 trial to achieve its primary endpoint constitutes an event of default under its secured loan facility with Oxford Finance.

“We are deeply disappointed by this outcome, particularly for the HR-MDS patients who are seeking a new treatment option for this challenging disease,” said Conley Chee, CEO of Syros. “We plan to stop the study, review the clinical data more thoroughly and evaluate the next steps.”

In August, Syros Pharmaceuticals discontinued enrollment in the SELECT-AML-1 Phase 2 trial, which evaluated a triplet regimen of tamibarotene in combination with venetoclax and azacitidine compared to a doublet regimen of venetoclax and azacitidine in newly diagnosed, unfit patients with acute myeloid leukemia (AML) and RARA gene overexpression.

The company said the probability of the SELECT-AML-1 study’s success in demonstrating superiority in the final analysis of 80 randomized patients was considered low.

SYRS Price Action: SYRS stock is down 86.43% at 37 cents at last check Wednesday.

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Prothena Corporation PRTA reported a loss per share of $1.10 per share in the third quarter of 2024, narrower than the Zacks Consensus Estimate of a loss of $1.18.

In the year-ago quarter, the company posted earnings of 38 cents per share, driven by higher revenues.

Third-quarter 2024 revenues totaled $1 million, which missed the Zacks Consensus Estimate of $2 million. PRTA recorded revenues of $85 million in the third quarter of 2023 on the back of collaboration revenues from partner Bristol Myers Squibb BMY.

The company’s shares have lost 52.2% year to date compared with the industry’s decline of 0.9%.

Find the latest EPS estimates and surprises on Zacks Earnings Calendar.

PRTA's Q3 Results in Detail

Research and development (R&D) expenses decreased 12.4% year over year to $50.7 million, primarily due to lower manufacturing expenses.

General and administrative expenses amounted to $16.8 million, up from $16.6 million in the year-ago quarter, primarily due to higher personnel-related expenses.

As of Sept. 30, 2024, Prothena had $520.1 million in cash, cash equivalents and restricted cash, and no debt.

Pipeline Updates from PRTA

Prothena is evaluating PRX012 — a wholly owned investigational next-generation subcutaneous, single-injection once-monthly antibody delivered subcutaneously targeting a key epitope at the N-terminus of amyloid beta (Aβ) — for treating Alzheimer’s Disease (AD).

Initial phase I single ascending dose and multiple ascending dose data support once-monthly subcutaneous administration and ongoing evaluation in MAD cohorts.

PRTA has enrolled approximately 260 patients in the ongoing ASCENT clinical studies on PRX012. Prothena expects to report multiple clinical readouts starting in mid-2025.

PRTA is advancing an early-stage pipeline of programs for several potential neurological indications with BMY.

BMS-986446 (formerly PRX005) is designed to be a best-in-class anti-tau, MTBR-specific antibody for the potential treatment of AD.

Bristol Myers continues to enroll in the ongoing phase II study on BMS-986446 in approximately 475 patients with early AD. The study is expected to be completed in 2027.

BMY is responsible for all development, manufacturing and commercialization of BMS-986446.

PRX019, a potential treatment of neurodegenerative diseases with an undisclosed target, is also being developed in collaboration with BMY. PRTA has initiated a phase I first-in-human clinical trial on PRX019 to evaluate the safety, tolerability, immunogenicity, and pharmacokinetics of single ascending and multiple doses in healthy adults.

Prothena is also developing a dual Aβ-Tau vaccine, PRX123, a potential prevention and treatment for AD. It is a dual-target vaccine targeting key epitopes within the N-terminus of Aβ and MTBR-tau, designed to promote amyloid clearance and block the transmission of pathogenic tau. The FDA cleared an investigational new drug application.

The regulatory body granted Fast Track designation to PRX123 for the treatment of AD. Prothena expects to update plans for the phase I study in 2025.

The company is evaluating prasinezumab, in collaboration with Roche RHHBY, for the treatment of Parkinson’s disease (PD).

A phase II study, PASADENA, is being conducted by Roche in patients with early PD. Data from the study showed that patients taking prasinezumab continued to show reduced motor and functional progression compared with real-world data after four years.

Top-line results from the phase IIb PADOVA study, which has completed enrollment, are expected in the ongoing quarter.

Prothena is also evaluating birtamimab, a wholly-owned potential treatment for AL amyloidosis. PRTA reached a Special Protocol Assessment agreement with the FDA and initiated a confirmatory phase III AFFIRM-AL study of birtamimab in Mayo Stage IV patients with AL amyloidosis. Top-line results from the study are expected in the first half of 2025.

Novo Nordisk NVO acquired Prothena’s clinical-stage antibody, Coramitug (formerly PRX004), a potential first-in-class amyloid depleter antibody for the treatment of ATTR amyloidosis with cardiomyopathy.

NVO is conducting an ongoing phase II study in patients with ATTR cardiomyopathy. The study has completed enrollment of approximately 99 patients and top-line data from the same is expected in the first half of 2025.

PRTA Reiterates 2024 Guidance

The company expects 2024 net cash burn from operating and investing activities to be in the range of $148-$160 million. Prothena expects year-end cash, cash equivalents and restricted cash midpoint to be approximately $468 million. Net loss for 2024 is projected to be in the $120-$135 million range.

PRTA currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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