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PRVB Awaits FDA's Decision, BCAB Soars On Clinical Trial Updates, CYTK Braces For Busy Months

earnings nov04 lt

The following are some of the companies belonging to the healthcare sector that reported quarterly financial results on Thursday.

Agios Pharmaceuticals, Inc.'s (AGIO) flagship product PYRUKYND has generated product sales of $3.5 million in the third quarter ended Sep.30, 2022.

PYRUKYND, which is the company's first marketed drug, was approved by the FDA on February 17, 2022, for the treatment of hemolytic anemia in adults with pyruvate kinase deficiency. The European Medicines Agency's decision on the drug is expected by the end of this year.

PYRUKYND is also being studied in phase III trials in not regularly transfused and regularly transfused adults with thalassemia, ENERGIZE and ENERGIZE-T, respectively.

A phase II/III trial of PYRUKYND in adults with sickle cell disease, dubbed RISE UP, is also underway.

Net loss for the third quarter of 2022 narrowed to $81.7 million, or $1.49 per share from $88.7 million, or $1.56 per share in the third quarter of 2021 and was well above analysts' estimates of a loss of $1.76 per share.

On September 30, 2022, cash, cash equivalents, and marketable securities totaled $1.026 billion.

AGIO has traded in a range of $16.75 to $50.98 in the last 52 weeks. The stock closed Thursday's trading at $26.36, down 5.25%.

BioAtla, Inc. (BCAB) has provided updates related to its clinical programs Mecbotamab vedotin, Ozuriftamab vedotin, and CAB-CTLA-4

Mecbotamab vedotin is under a phase II trial in patients with AXL-positive Non-Small Cell Lung Carcinoma and AXL-positive Soft Tissue and Primary Bone Sarcomas

Ozuriftamab vedotin is under a phase II trial in patients with ROR2-positive NSCLC, ROR2-positive Melanoma, and ROR2-positive SCCHN pl write the abbreviation

CAB-CTLA-4 is under a phase 1/2 dose-escalation trial across multiple solid tumor types responsive to CTLA-4.

The company revealed that in the part 1, phase II Mecbotamab vedotin trial in NSCLC, involving 14 efficacy-evaluable patients, the interim results continue to show antitumor activity.

Full interim data set of approximately 20 efficacy evaluable patients from the Mecbotamab vedotin trial are anticipated by year-end

Discussions with the FDA regarding the potentially registrational part 2 of the phase II Mecbotamab vedotin study in AXL-positive NSCLC patients are expected to occur in the first half of 2023

The company intends to share interim data from the phase II Trial of Ozuriftamab Vedotin in patients with ROR2-positive NSCLC, in the beginning of 2023.

The net loss in the quarter that ended on Sep. 30, 2022, grew to $25.8 million from $22.9 million in the same quarter in 2021.

The company ended the third quarter of 2022 with $178.1 million in cash and cash equivalents.

BCAB has traded in a range of $2.01 to $31.26 in the last 52 weeks. The stock closed Thursday's trading at $6.36, down 1.40%.

Cytokinetics, Incorporated (CYTK) has a regulatory catalyst to watch next month.

The FDA Advisory Committee will review Omecamtiv Eecarbil, a cardiac muscle activator, for the treatment of heart failure with reduced ejection fraction (HFrEF), on December 13, 2022.

The revenue declined to $2.5 million in Q3 2022, from $5.4 million in Q3 2021.

In the third quarter of 2022, the net loss widened to $142.3 million or $1.52 per basic and diluted share from $76 million or $0.95 per basic and diluted share in Q3 2021. Analysts polled by Thomson Reuters expected a loss of $1.57 per basic and diluted share.

Anticipated Events:

In 1H 2023, the company expects results from Cohort 4 of phase II REDWOOD-HCM trial of CK-3773274 in patients with Hypertrophic Cardiomyopathy (HCM)

In 1H 2023, the company expects data from the second interim analysis of the phase III COURAGE-ALS trial of Reldesemtiv in patients with Amyotrophic Lateral Sclerosis (ALS).

Cytokinetics expects results from the phase III SEQUOIA-HCM trial of CK-3773274 in patients with Obstructive Hypertrophic Cardiomyopathy (oHCM), in 2H 2023.

The company ended Q3 2022 with $1.075 billion in cash reserve.

CYTK has traded in a range of $29.26 to $55.8 in the last 52 weeks. The stock closed Thursday's trading at $39.75, down 5.06%.


Organon & Co. (OGN), which reported a 4% decline in third-quarter revenue, has narrowed its revenue range outlook for the year.

Net revenue declined to $1.537 billion in Q3 2022 from $1.6 billion in Q3 2021.

On a GAAP basis, net income for the third quarter of 2022 declined to $227 million, or $0.89 per share, from last year's $323 million, or $1.27 per share.

On a non-GAAP basis, the net income fell to $337 million or $1.32 per share in Q3 2022 from $401 million or $1.58 per share in Q3 2021. Wall Street analysts expected a profit of $1.09 per share.

Organon's Board of Directors announced a quarterly dividend of $0.28 per issued and outstanding share of the company's common stock.

The company narrowed the revenue guidance range for full-year 2022 to $6.1 billion to $6.2 billion from its prior forecast range of $6.1 billion to $6.3 billion as a result of foreign currency headwinds.

On Sep.30, 2022, Organon's cash and cash equivalents totaled $499 million, and debts of $2.27 billion.

OGN has traded in a range of $22.88 to $39.48 in the last 52 weeks. The stock closed Thursday's trading at $25.88, down 0.19%.


Provention Bio, Inc. (PRVB), which reported a wider loss for the third quarter Sep.30, 2022, has a couple of events to watch in the coming months..

Net loss widened to $28.6 million in the quarter that ended Sep. 30, 2022, from $27.02 million in Q3 2021.

The company entered a co-promotion agreement with Sanofi (SNY) for the potential launch of Provention's lead investigational drug candidate, Teplizumab.

Teplizumab is currently under FDA review, for the delay of clinical type 1 diabetes (T1D) in at-risk individuals, with the PDUFA action date of November 17, 2022.

In the second half of 2023, the company expects to report topline data from the Phase III PROTECT trial evaluating Teplizumab in patients with newly diagnosed, insulin-dependent T1D.

By the end of 2023, the Company expects topline results from the PROACTIVE Phase 2b study of Ordesekimab in adults with non-responsive celiac disease.

In the second half of 2024, the company expects to report the topline result of the PREVAIL-2 Phase 2a trial evaluating PRV-3279 in patients with Systemic Lupus Erythematosus (SLE).

Provention ended the third quarter of 2022 with $186.5 million of cash, cash equivalents, and marketable securities.

PRB has traded in a range of $1.09 to $2.33 in the last 52 weeks. The stock closed Thursday's trading at $8.41, up 26.09%.

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