US Market News
4週前
Atara Biotherapeutics Announces First Quarter 2026 Financial Results and Operational ProgressMay 12, 2026 4:05 PM
Business Wire Productive meeting held with the FDA; planning for tabelecleucel BLA resubmission Operating efficiencies and ATM proceeds extend cash runway into mid-2027 Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, today reported financial results for the first quarter 2026 and business updates. Tabelecleucel (tab-cel® or Ebvallo™) for Post-Transplant Lymphoproliferative Disease (PTLD) As previously communicated, Pierre Fabre Pharmaceuticals (PFP), with Atara’s support, had a productive meeting with the FDA and discussed a potential path forward to resubmitting the tab-cel Biologics License Application (BLA). The FDA agreed that a single arm study using an appropriate historical control applicable to the trial population, conducted in a pre-specified manner, could serve as an adequate and well controlled study and provide safety and efficacy data in support of a marketing application of tab-cel for the proposed indication. PFP has indicated they intend to submit an updated dataset with additional patients and longer follow-up from the pivotal Phase 3 single arm ALLELE study as well as supportive data, as a part of the resubmission plan being defined with the FDA. Atara anticipates providing a further regulatory update in the third quarter. First Quarter 2026 Financial Results Cash, cash equivalents and short-term investments as of March 31, 2026 totaled $8.4 million, as compared to $8.5 million as of December 31, 2025. Net cash used in operating activities was $3.1 million for the first quarter 2026, as compared to $28.1 million in the same period in 2025. Total revenues were $0.5 million for the first quarter 2026, as compared to $98.1 million for the same period in 2025. The prior-year period reflects a one-time acceleration of revenue recognized upon the transfer of tab-cel manufacturing responsibilities to Pierre Fabre Laboratories on March 31, 2025. In the current period, commercialization revenue relates solely to ongoing regulatory activities Total costs and operating expenses include non-cash stock-based compensation, depreciation and amortization expenses of $0.8 million for the first quarter 2026, as compared to $6.0 million for the same period in 2025. Research and development expenses were $0.2 million for the first quarter 2026, as compared to $27.4 million for the same period in 2025. Research and development expenses also include $0.3 million of non-cash stock-based compensation expenses for the first quarter 2026, as compared to $1.6 million for the same period in 2025. General and administrative expenses were $3.6 million for the first quarter 2026, as compared to $11.5 million for the same period in 2025. General and administrative expenses include $0.5 million of non-cash stock-based compensation expenses for the first quarter 2026, as compared to $2.6 million for the same period in 2025. Atara reported a net loss of $4.1 million, or ($0.29) basic and diluted loss per share, for the first quarter 2026, as compared to net income of $38.0 million, or $3.53 basic earnings per share and $3.50 diluted earnings per share, for the same period in 2025. 2026 Outlook and Cash Runway: Operating expenses are expected to decline significantly year-over-year, reflecting the full-year benefit of cost-reduction initiatives implemented in 2025. Atara expects its cash, cash equivalents, and short-term investments as of March 31, 2026, combined with $4.8 million of ATM proceeds after quarter end and operating efficiencies achieved in 2025, will be sufficient to fund planned operations into mid-2027. About Atara Biotherapeutics, Inc. Atara is harnessing the natural power of the immune system to develop off-the-shelf cell therapies for difficult-to-treat cancers and autoimmune conditions that can be rapidly delivered to patients from inventory. With cutting-edge science and differentiated approach, Atara is the first company in the world to receive regulatory approval of an allogeneic T-cell immunotherapy. Our advanced and versatile T-cell platform does not require T-cell receptor or HLA gene editing and forms the basis of a diverse portfolio of investigational therapies that target EBV, the root cause of certain diseases. Atara is headquartered in Southern California. For more information, visit atarabio.com and follow @Atarabio on X and LinkedIn. Forward-Looking Statements This press release contains or may imply "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. For example, forward-looking statements include statements regarding: (1) the development, timing and progress of tab-cel, including the timing of PFP’s resubmission, the potential characteristics and benefits of tab-cel, and the results of, and prospects for bringing tab-cel to U.S. patients with EBV+ PTLD, the global partnership with Pierre Fabre Medicament involving tab-cel, and the potential financial benefits to Atara as a result of the global partnership with Pierre Fabre Medicament, including the receipt, timing and amount of any payments to be received by Atara thereunder; and (2) Atara’s cash runway, receipt of potential milestone payments, and estimated reduction in operating expenses, including Atara’s ability to fund its planned operations into mid-2027. Because such statements deal with future events and are based on Atara’s current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of Atara could differ materially from those described in or implied by the statements in this press release. These forward-looking statements are subject to risks and uncertainties, including, without limitation, risks and uncertainties associated with the costly and time-consuming pharmaceutical product development process and the uncertainty of clinical success; risks related to FDA’s review of tab-cel, including the risk that a resubmission of the tab-cel BLA may not address the deficiencies identified in the Complete Response Letter received on January 9, 2026 or other issues that may be raised by the FDA on review; the fact that PFP, and not Atara, holds the tab-cel BLA and controls the timing, content and strategy of any resubmission and related FDA interactions, and Atara's ability to influence the resubmission process is limited; our ability to access capital, and the sufficiency of Atara’s cash resources and access to additional capital on favorable terms or at all; and other risks and uncertainties affecting Atara, including those discussed in Atara’s filings with the Securities and Exchange Commission, including in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Atara’s most recently filed periodic reports on Form 10-K and Form 10-Q and subsequent filings and in the documents incorporated by reference therein. Except as otherwise required by law, Atara disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date hereof, whether as a result of new information, future events or circumstances or otherwise. Financials ATARA BIOTHERAPEUTICS, INC. Condensed Consolidated Balance Sheets (Unaudited) (In thousands) March 31, December 31, 2026 2025 Assets Current assets: Cash and cash equivalents $ 8,360 $ 8,482 Accounts receivable — 1,253 Other current assets 3,813 2,477 Total current assets 12,173 12,212 Property and equipment, net 55 73 Operating lease assets 6,879 7,064 Other assets 890 886 Total assets $ 19,997 $ 20,235 Liabilities and stockholders’ equity (deficit) Current liabilities: Accounts payable $ 637 $ 127 Accrued compensation 629 1,271 Accrued research and development expenses 41 82 Deferred revenue 684 716 Liability related to the sale of future revenues – current portion 715 9,750 Other current liabilities 2,939 2,976 Total current liabilities 5,645 14,922 Operating lease liabilities – long-term 9,076 9,347 Liability related to the sale of future revenues – long-term 40,759 32,673 Other long-term liabilities 1,829 1,795 Total liabilities 57,309 58,737 Commitments and contingencies (Note 9) Stockholders’ equity (deficit): Common stock—$0.0001 par value, 500,000 shares authorized as of March 31, 2026 and December 31, 2025; 8,512 and 7,324 shares issued and outstanding as of March 31, 2026 and December 31, 2025, respectively 1 1 Additional paid-in capital 1,988,697 1,983,361 Accumulated other comprehensive income (loss) — 1 Accumulated deficit (2,026,010 ) (2,021,865 ) Total stockholders’ equity (deficit) (37,312 ) (38,502 ) Total liabilities and stockholders’ equity (deficit) $ 19,997 $ 20,235 ATARA BIOTHERAPEUTICS, INC. Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) (In thousands, except per share amounts) Three Months Ended March 31, 2026 2025 Commercialization revenue $ 516 $ 98,149 Costs and operating expenses: Cost of commercialization revenue 124 20,439 Research and development expenses 164 27,433 General and administrative expenses 3,597 11,475 Total costs and operating expenses 3,885 59,347 Income (loss) from operations (3,369 ) 38,802 Other income (expense), net: Interest income 54 236 Interest expense (830 ) (1,017 ) Other income (expense), net — (11 ) Total other income (expense), net (776 ) (792 ) Income (loss) before provision for (benefit from) income taxes (4,145 ) 38,010 Provision for (benefit from) income taxes — — Net income (loss) $ (4,145 ) $ 38,010 Other comprehensive gain (loss): Unrealized gain (loss) on available-for-sale securities (1 ) (8 ) Comprehensive income (loss) $ (4,146 ) $ 38,002 Basic (loss) earnings per common share $ (0.29 ) $ 3.53 Diluted (loss) earnings per common share $ (0.29 ) $ 3.50 Basic and diluted weighted-average shares outstanding 14,081 10,764 Diluted weighted-average shares outstanding 14,081 10,851 View source version on businesswire.com: https://www.businesswire.com/news/home/20260512257848/en/ Investor and Media Relations
Amber Daugherty
Sr. Director, Strategy and Operations
adaugherty@atarabio.com Original: Atara Biotherapeutics Announces First Quarter 2026 Financial Results and Operational Progress
US Market News
4週前
Atara Biotherapeutics Provides Regulatory Update on TabelecleucelMay 7, 2026 8:05 AM
Business Wire Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, today provided an update following the recent Type A meeting with the U.S. Food and Drug Administration (FDA) to discuss the Complete Response Letter (CRL) to the Biologics License Application (BLA) for tabelecleucel (tab-cel) held by our partner Pierre Fabre Pharmaceuticals, Inc. (PFP). PFP, with Atara’s support, had a productive meeting with the FDA and discussed a potential path forward to resubmitting the tab-cel BLA. The FDA agreed that a single arm study using an appropriate historical control applicable to the trial population, conducted in a pre-specified manner, could serve as an adequate and well controlled study and provide safety and efficacy data in support of a future marketing application of tab-cel for the proposed indication. PFP has indicated they intend to submit an updated dataset with additional patients and longer follow up from the pivotal Phase 3 single arm ALLELE study of tabelecleucel in adults and children two years of age and older with R/R EBV+ PTLD following solid organ transplant or hematopoietic cell transplant as well as supportive data, as a part of the resubmission plan being defined with the FDA. “We are grateful to the agency for engaging in a collaborative conversation with our partners, Pierre Fabre, and us. We appreciate the FDA’s continued engagement with PFP and Atara, and we believe the Type A Meeting provided helpful alignment on the regulatory framework to resubmit,” said Cokey Nguyen, President and Chief Executive Officer of Atara. “We will continue to support Pierre Fabre as it prepares the resubmission and anticipate providing a further regulatory update in the third quarter.” About Atara Biotherapeutics, Inc. Atara is harnessing the natural power of the immune system to develop off-the-shelf cell therapies for difficult-to-treat cancers and autoimmune conditions that can be rapidly delivered to patients from inventory. With cutting-edge science and differentiated approach, Atara is the first company in the world to receive regulatory approval of an allogeneic T-cell immunotherapy. Our advanced and versatile T-cell platform does not require T-cell receptor or HLA gene editing and forms the basis of a diverse portfolio of investigational therapies that target EBV, the root cause of certain diseases. Atara is headquartered in Southern California. For more information, visit atarabio.com and follow @Atarabio on X and LinkedIn. Forward-Looking Statements This press release contains or may imply "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. For example, forward-looking statements include statements regarding: (1) the development, timing and progress of tab-cel, including the timing of PFP’s resubmission of the tab-cel BLA, the potential characteristics and benefits of tab-cel; and (2) the prospect of bringing tab-cel to U.S. patients with EBV+ PTLD. Because such statements deal with future events and are based on Atara’s current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of Atara could differ materially from those described in or implied by the statements in this press release. These forward-looking statements are subject to risks and uncertainties, including, without limitation, risks and uncertainties associated with the costly and time-consuming pharmaceutical product development process and the uncertainty of clinical success; risks related to FDA’s review of tab-cel, including the risk that a resubmission of the tab-cel BLA may not address the deficiencies identified in the CRL or other issues that may be raised by the FDA on review; the fact that PFP, and not Atara, holds the tab-cel BLA and controls the timing, content and strategy of any resubmission and related FDA interactions, and Atara's ability to influence the resubmission process is limited; our ability to access capital, and the sufficiency of Atara’s cash resources and access to additional capital on favorable terms or at all; and other risks and uncertainties affecting Atara, including those discussed in Atara’s filings with the Securities and Exchange Commission, including in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Atara’s most recently filed periodic reports on Form 10-K and Form 10-Q and subsequent filings and in the documents incorporated by reference therein. Except as otherwise required by law, Atara disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date hereof, whether as a result of new information, future events or circumstances or otherwise. View source version on businesswire.com: https://www.businesswire.com/news/home/20260507608246/en/ Investor and Media Relations
Amber Daugherty
Sr. Director, Strategy and Operations
adaugherty@atarabio.com Original: Atara Biotherapeutics Provides Regulatory Update on Tabelecleucel
US Market News
3月前
Atara Biotherapeutics Announces Fourth Quarter and Full Year 2025 Financial Results and Operational ProgressMarch 16, 2026 4:05 PM
Business Wire
Atara delivers significant operational efficiencies and extends cash runway through year-end 2026
A Type A meeting has been scheduled between Pierre Fabre Pharmaceuticals and the FDA
Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, today reported financial results for the fourth quarter and full year 2025 and business updates.
“We continue to focus on streamlining our costs and liabilities, allowing us to be a nimbler, fit for purpose organization,” said Cokey Nguyen Ph.D., President and Chief Executive Officer of Atara. “With the adjustments we have made we are able to focus on supporting our partner, Pierre Fabre Pharmaceuticals, as they work towards addressing the concerns in the latest Complete Response Letter with the agency. We strongly believe that tabelecleucel can bring substantial benefit to post-transplant lymphoproliferative disease patients and we are committed to supporting Pierre Fabre Pharmaceuticals as they get this life-saving drug to the finish line in the U.S.”
Tabelecleucel (tab-cel® or Ebvallo™) for Post-Transplant Lymphoproliferative Disease (PTLD)
A Type A meeting with the U.S. Food and Drug Administration (FDA) has been scheduled for our partner Pierre Fabre Pharmaceuticals to discuss the issues raised by the FDA in the Complete Response Letter received in January 2026. We anticipate providing a regulatory update in the second quarter.
Corporate Updates
As previously communicated, Atara entered into an amendment (Amendment) to the Purchase and Sale Agreement dated as of December 20, 2022 with a fund managed by HealthCare Royalty (“HCRx”). Under the terms of the Amendment, HCRx agreed to amend the due date of the one-time $9.0 million cash payment associated with the achievement of a certain milestone from June 30, 2026 to January 1, 2028 in exchange for the issuance of a warrant to purchase up to 400,000 shares of Atara common stock.
Financial Update:
Fourth Quarter and Full Year 2025 Financial Results:
Cash, cash equivalents and short-term investments as of December 31, 2025 totaled $8.5 million, as compared to $42.5 million as of December 31, 2024.
Net cash used in operating activities was $5.7 million and $50.9 million for the fourth quarter and fiscal year 2025, as compared to $24.5 million and $68.7 million for the same periods in 2024.
Atara reported a net loss of ($3.4) million, or ($0.25) per share, and a net income of $32.7 million, or $2.61 per share, for the fourth quarter and fiscal year 2025, respectively, as compared to a net loss of ($12.7) million, or ($1.19) per share, and ($85.4) million, or ($11.41) per share, for the same periods in 2024.
Commercialization revenues were $120.8 million in 2025 as compared to $128.9 million in 2024.
Total costs and operating expenses include non-cash stock-based compensation, depreciation and amortization expenses of $1.6 million and $11.9 million for the fourth quarter and fiscal year 2025, respectively, as compared to $6.9 million and $32.1 million for the same periods in 2024.
Research and development expenses were ($0.2) million and $37.4 million for the fourth quarter and fiscal year 2025, respectively, compared to $28.7 million and $151.5 million for the same periods in 2024. The 2025 results include a $2.6 million non-cash gain from an ARC facility lease amendment, resulting in a fourth-quarter credit rather than an expense.
Research and development expenses include $0.4 million and $2.9 million of non-cash stock-based compensation expenses for the fourth quarter and fiscal year 2025, respectively, compared to $2.6 million and $13.5 million for the same periods in 2024.
General and administrative expenses were $4.3 million and $26.3 million for the fourth quarter and fiscal year 2025, respectively, as compared to $9.4 million and $39.9 million for the same periods in 2024.
General and administrative expenses include $1.1 million and $6.9 million of non-cash stock-based compensation expenses for the fourth quarter and fiscal year 2025, respectively, compared to $3.3 million and $13.5 million for the same periods in 2024.
2026 Outlook and Cash Runway:
Operating expenses are expected to continue to decline significantly year-over-year as a result of the comprehensive cost-reduction initiatives completed in 2025.
Atara expects that cash, cash equivalents and short-term investments as of December 31, 2025, combined with recent ATM proceeds of $3.0 million and the operating efficiencies realized in 2025, will be sufficient to fund planned operations through year-end 2026.
About Atara Biotherapeutics, Inc.
Atara is harnessing the natural power of the immune system to develop off-the-shelf cell therapies for difficult-to-treat cancers and autoimmune conditions that can be rapidly delivered to patients from inventory. With cutting-edge science and differentiated approach, Atara is the first company in the world to receive regulatory approval of an allogeneic T-cell immunotherapy. Our advanced and versatile T-cell platform does not require T-cell receptor or HLA gene editing and forms the basis of a diverse portfolio of investigational therapies that target EBV, the root cause of certain diseases. Atara is headquartered in Southern California. For more information, visit atarabio.com and follow @Atarabio on X and LinkedIn.
Forward-Looking Statements
This press release contains or may imply "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. For example, forward-looking statements include statements regarding: (1) the development, timing and progress of tab-cel, including the timing and results of the Type A meeting and the potential path forward for the timely accelerated approval of EBVALLO™, the potential characteristics and benefits of tab-cel, and the results of, and prospects for bringing tab-cel to U.S. patients with EBV+ PTLD, the global partnership with Pierre Fabre Medicament involving tab-cel, and the potential financial benefits to Atara as a result of the global partnership with Pierre Fabre Medicament, including the receipt, timing and amount of any payments to be received by Atara thereunder; (2) the timing of the $9.0 million cash payment to HCRx; (3) Atara’s cash runway, receipt of potential milestone payments, and estimated reduction in operating expenses, including Atara’s ability to fund its planned operations to year-end 2026; and (4) Atara’s evaluation of strategic alternatives and ability to consummate one or more strategic transactions. Because such statements deal with future events and are based on Atara’s current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of Atara could differ materially from those described in or implied by the statements in this press release. These forward-looking statements are subject to risks and uncertainties, including, without limitation, risks and uncertainties associated with the costly and time-consuming pharmaceutical product development process and the uncertainty of clinical success; risks related to FDA’s review of the resubmitted BLA for tab-cel; our ability to access capital, and the sufficiency of Atara’s cash resources and access to additional capital on favorable terms or at all; the timing of the strategic review process; whether Atara will pursue any strategic alternatives; in the event Atara pursues a strategic alternative, that the strategic alternative may not be attractive or ultimately consummated; whether any strategic alternative will result in additional value for Atara and its stockholders; whether the process will have an adverse impact on Atara and other risks and uncertainties affecting Atara, including those discussed in Atara’s filings with the Securities and Exchange Commission, including in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of the Company’s most recently filed periodic reports on Form 10-K and Form 10-Q and subsequent filings and in the documents incorporated by reference therein. Except as otherwise required by law, Atara disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date hereof, whether as a result of new information, future events or circumstances or otherwise.
Financials
ATARA BIOTHERAPEUTICS, INC.
Consolidated Balance Sheets
(In thousands, except per share amounts)
December 31,
December 31,
2025
2024
Assets
Current assets:
Cash and cash equivalents
$
8,482
$
25,030
Short-term investments
—
17,466
Restricted cash
—
146
Accounts receivable
1,253
1,482
Inventories
—
10,655
Other current assets
2,477
10,115
Total current assets
12,212
64,894
Property and equipment, net
73
1,294
Operating lease assets
7,064
39,807
Other assets
886
3,103
Total assets
$
20,235
$
109,098
Liabilities and stockholders’ equity (deficit)
Current liabilities:
Accounts payable
$
127
$
4,367
Accrued compensation
1,271
6,589
Accrued research and development expenses
82
7,984
Deferred revenue
716
95,092
Liability related to the sale of future revenues – current portion
9,750
382
Other current liabilities
2,976
20,160
Total current liabilities
14,922
134,574
Operating lease liabilities – long-term
9,347
29,914
Liability related to the sale of future revenues – long-term
32,673
38,624
Other long-term liabilities
1,795
3,269
Total liabilities
58,737
206,381
Commitments and contingencies (Note 9)
Stockholders’ equity (deficit):
Common stock—$0.0001 par value, 500,000 shares authorized as of December 31, 2025 and 2024, respectively; 7,324 and 5,859 shares issued and outstanding as of December 31, 2025 and 2024, respectively
1
1
Additional paid-in capital
1,983,361
1,957,261
Accumulated other comprehensive income
1
8
Accumulated deficit
(2,021,865
)
(2,054,553
)
Total stockholders’ equity (deficit)
(38,502
)
(97,283
)
Total liabilities and stockholders’ equity (deficit)
$
20,235
$
109,098
ATARA BIOTHERAPEUTICS, INC.
Consolidated Statements of Operations and Comprehensive Income (Loss)
(In thousands, except per share amounts)
Years Ended December 31,
2025
2024
Commercialization revenue
$
120,772
$
128,940
Total revenue
120,772
128,940
Costs and operating expenses:
Cost of commercialization revenue
21,212
21,009
Research and development expenses
37,445
151,483
General and administrative expenses
26,253
39,886
Total costs and operating expenses
84,910
212,378
Income (loss) from operations
35,862
(83,438
)
Other income (expense), net:
Interest income
683
2,110
Interest expense
(3,792
)
(4,615
)
Other income (expense), net:
(34
)
528
Total other income (expense), net
(3,143
)
(1,977
)
Income (loss) before provision for (benefit from) income taxes
32,719
(85,415
)
Provision for (benefit from) income taxes
31
(12
)
Net income (loss)
$
32,688
$
(85,403
)
Other comprehensive gain (loss):
Unrealized gain (loss) on available-for-sale securities
(7
)
212
Comprehensive income (loss)
$
32,681
$
(85,191
)
Basis earnings (loss) per common share
$
2.61
$
(11.41
)
Diluted earnings (loss) per common share
$
2.57
$
(11.41
)
Basic weighted-average shares outstanding
12,544
7,488
Diluted weighted-average shares outstanding
12,718
7,488
View source version on businesswire.com: https://www.businesswire.com/news/home/20260316154875/en/
Investor and Media Relations
Amber Daugherty
Sr. Director, Strategy and Operations
adaugherty@atarabio.com
Original: Atara Biotherapeutics Announces Fourth Quarter and Full Year 2025 Financial Results and Operational Progress
US Market News
3月前
Atara Biotherapeutics Provides Regulatory Update on TabelecleucelMarch 12, 2026 8:05 AM
Business Wire
Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, today announced that a Type A meeting with the U.S. Food and Drug Administration (FDA) has been scheduled to discuss the Complete Response Letter (CRL) to the Biologics License Application (BLA) for tabelecleucel (tab-cel) held by our partner Pierre Fabre Pharmaceuticals.
Pierre Fabre Pharmaceuticals, with Atara’s support, will meet with the agency to collaboratively address the points from the CRL and enable a resubmission with the additional efficacy data that has been collected since the original BLA submission.
“We are pleased that the FDA has granted a Type A Meeting to our partner, Pierre Fabre, and hope to gain clarity on a path forward for re-submission of the tab-cel BLA,” said Cokey Nguyen, President and Chief Executive Officer of Atara. “We anticipate providing a regulatory update in the second quarter.”
About Atara Biotherapeutics, Inc.
Atara is harnessing the natural power of the immune system to develop off-the-shelf cell therapies for difficult-to-treat cancers and autoimmune conditions that can be rapidly delivered to patients from inventory. With cutting-edge science and differentiated approach, Atara is the first company in the world to receive regulatory approval of an allogeneic T-cell immunotherapy. Our advanced and versatile T-cell platform does not require T-cell receptor or HLA gene editing and forms the basis of a diverse portfolio of investigational therapies that target EBV, the root cause of certain diseases. Atara is headquartered in Southern California. For more information, visit atarabio.com and follow @Atarabio on X and LinkedIn.
Forward-Looking Statements
This press release contains or may imply "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. For example, forward-looking statements include statements regarding: (1) the development, timing and progress of tab-cel, including the timing of the Type A meeting and PFP’s and Atara’s plans to urgently interact with the FDA to find a path forward for the timely accelerated approval of EBVALLO™, the potential characteristics and benefits of tab-cel; and (2) the prospect of bringing tab-cel to U.S. patients with EBV+ PTLD. Because such statements deal with future events and are based on Atara’s current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of Atara could differ materially from those described in or implied by the statements in this press release. These forward-looking statements are subject to risks and uncertainties, including, without limitation, risks and uncertainties associated with the costly and time-consuming pharmaceutical product development process and the uncertainty of clinical success; risks related to FDA’s review of tab-cel; our ability to access capital, and the sufficiency of Atara’s cash resources and access to additional capital on favorable terms or at all; risks and uncertainties related to Atara’s financial close and year-end audit procedures; the timing of the strategic review process; whether Atara will pursue any strategic alternatives; in the event Atara pursues a strategic alternative, that the strategic alternative may not be attractive or ultimately consummated; whether any strategic alternative will result in additional value for Atara and its stockholders; whether the process will have an adverse impact on Atara and other risks and uncertainties affecting Atara, including those discussed in Atara’s filings with the Securities and Exchange Commission, including in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Atara’s most recently filed periodic reports on Form 10-K and Form 10-Q and subsequent filings and in the documents incorporated by reference therein. Except as otherwise required by law, Atara disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date hereof, whether as a result of new information, future events or circumstances or otherwise.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260312166607/en/
Investor and Media Relations
Amber Daugherty
Sr. Director, Strategy and Operations
adaugherty@atarabio.com
Original: Atara Biotherapeutics Provides Regulatory Update on Tabelecleucel
subslover
2年前
NEWS
Atara Biotherapeutics Announces Closing of Expanded Global Tab-cel® Partnership with Pierre Fabre Laboratories
THOUSAND OAKS, Calif.--(BUSINESS WIRE)-- Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, today announced the closing of the expanded global partnership with Pierre Fabre Laboratories for tabelecleucel (tab-cel® or EBVALLOTM). Building on the earlier partnership announced in October 2021 to commercialize tab-cel in Europe, this transaction provides Pierre Fabre Laboratories with the development, manufacturing, and commercialization rights for tab-cel in the United States and all remaining markets.
“We are pleased to announce the closing of the transaction with Pierre Fabre Laboratories who are committed to expanding the reach of tab-cel to patients in the U.S. and across the globe,” said Pascal Touchon, President and Chief Executive Officer of Atara. “Atara’s priority is to now submit the tab-cel BLA filing package, while initiating our first clinical study with ATA3219, a potential best-in-class allogeneic off-the-shelf CD19 CAR T with unique features.”
With the closing of the transaction, Atara will receive approximately USD 27 million in cash upfront and initial inventory purchase. Under the agreement, Atara has the potential to receive up to a total of USD 640 million and significant double-digit tiered royalties on net sales, including up to USD 100 million in potential regulatory milestones through BLA approval. In addition, Pierre Fabre Laboratories will reimburse Atara for expected tab-cel global development costs through the Biologics License Application (BLA) transfer, and purchase future tab-cel inventory through the manufacturing transfer date.
Substantially all tab-cel manufacturing, clinical, and regulatory activities are planned to transition from Atara to Pierre Fabre Laboratories at the time of BLA transfer.
Atara plans to submit the BLA to the U.S. Food and Drug Administration (FDA) for tab-cel for the treatment of post-transplant lymphoproliferative disease (PTLD) in the second quarter of 2024.
About Atara Biotherapeutics, Inc.
Atara is harnessing the natural power of the immune system to develop off-the-shelf cell therapies for difficult-to-treat cancers and autoimmune conditions, that can be rapidly delivered to patients within days. With cutting-edge science and differentiated approach, Atara is the first company in the world to receive regulatory approval of an allogeneic T-cell immunotherapy. Our advanced and versatile Epstein-Barr virus (EBV) T-cell platform does not require T-cell receptor or HLA gene editing and forms the basis of a diverse portfolio of investigational therapies that target EBV, the root cause of certain diseases, in addition to next-generation AlloCAR-Ts designed for best-in-class opportunities across a broad range of non-EBV-associated liquid and solid tumors. Atara is headquartered in Southern California. For more information, visit atarabio.com and follow @Atarabio on X (formerly known as Twitter) and LinkedIn.
Forward-Looking Statements
This press release contains or may imply "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. For example, forward-looking statements include statements regarding: (1) the development, timing and progress of tab-cel®, including a potential BLA, the potential characteristics and benefits of tab-cel®, and the progress and results of, prospects for, and closing of the expanded global partnership with Pierre Fabre Laboratories involving tab-cel®, and the potential financial benefits to Atara as a result of the expanded global partnership with Pierre Fabre Laboratories; (2) the development, t
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5年前
Atara Biotherapeutics (NASDAQ:ATRA) Upgraded by JPMorgan Chase & Co. to Overweight
Posted by ABMN Staff on May 19th, 2021
Atara Biotherapeutics logoAtara Biotherapeutics (NASDAQ:ATRA) was upgraded by JPMorgan Chase & Co. from a “neutral” rating to an “overweight” rating in a research note issued on Wednesday, Benzinga reports. The brokerage presently has a $29.00 price objective on the biotechnology company’s stock, up from their prior price objective of $23.00. JPMorgan Chase & Co.‘s target price points to a potential upside of 99.59% from the company’s previous close.
Several other research firms have also issued reports on ATRA. HC Wainwright reduced their price target on shares of Atara Biotherapeutics from $32.00 to $31.00 and set a “buy” rating on the stock in a research report on Tuesday, May 11th. Citigroup raised Atara Biotherapeutics from a “neutral” rating to a “buy” rating and set a $27.00 target price on the stock in a report on Tuesday, March 2nd. Finally, William Blair reissued an “outperform” rating on shares of Atara Biotherapeutics in a report on Tuesday, March 2nd. One investment analyst has rated the stock with a sell rating, two have issued a hold rating and eight have issued a buy rating to the company. The company has an average rating of “Buy” and an average target price of $34.33.
Shares of NASDAQ ATRA opened at $14.53 on Wednesday. The business has a fifty day moving average price of $14.06 and a two-hundred day moving average price of $17.83. The stock has a market capitalization of $1.22 billion, a PE ratio of -3.15 and a beta of 2.65. Atara Biotherapeutics has a fifty-two week low of $8.90 and a fifty-two week high of $28.20.
Atara Biotherapeutics (NASDAQ:ATRA) last issued its quarterly earnings results on Monday, May 3rd. The biotechnology company reported ($0.86) EPS for the quarter, topping the Zacks’ consensus estimate of ($0.92) by $0.06. As a group, equities research analysts expect that Atara Biotherapeutics will post -3.89 earnings per share for the current fiscal year.
In other Atara Biotherapeutics news, CFO Utpal Koppikar sold 1,761 shares of the business’s stock in a transaction that occurred on Friday, March 26th. The shares were sold at an average price of $14.58, for a total transaction of $25,675.38. Following the sale, the chief financial officer now directly owns 172,582 shares of the company’s stock, valued at approximately $2,516,245.56. The transaction was disclosed in a legal filing with the Securities & Exchange Commission, which is available at this hyperlink. Also, COO Joe Newell sold 7,000 shares of the company’s stock in a transaction that occurred on Monday, March 15th. The shares were sold at an average price of $17.41, for a total transaction of $121,870.00. Following the completion of the transaction, the chief operating officer now owns 145,219 shares of the company’s stock, valued at $2,528,262.79. The disclosure for this sale can be found here. In the last three months, insiders have sold 14,901 shares of company stock worth $238,537. 4.30% of the stock is currently owned by company insiders.
Several institutional investors have recently modified their holdings of the stock. Signaturefd LLC raised its position in Atara Biotherapeutics by 6,757.1% during the 1st quarter. Signaturefd LLC now owns 2,400 shares of the biotechnology company’s stock worth $34,000 after purchasing an additional 2,365 shares during the last quarter. Penserra Capital Management LLC raised its position in shares of Atara Biotherapeutics by 181.5% during the fourth quarter. Penserra Capital Management LLC now owns 1,785 shares of the biotechnology company’s stock worth $35,000 after acquiring an additional 1,151 shares during the last quarter. Pacer Advisors Inc. lifted its stake in shares of Atara Biotherapeutics by 50.9% in the first quarter. Pacer Advisors Inc. now owns 4,608 shares of the biotechnology company’s stock worth $66,000 after acquiring an additional 1,554 shares during the period. Nisa Investment Advisors LLC increased its position in Atara Biotherapeutics by 589.6% during the 4th quarter. Nisa Investment Advisors LLC now owns 4,620 shares of the biotechnology company’s stock valued at $91,000 after purchasing an additional 3,950 shares during the period. Finally, E Fund Management Co. Ltd. acquired a new position in Atara Biotherapeutics in the first quarter valued at $118,000.
Atara Biotherapeutics Company Profile
Atara Biotherapeutics, Inc, an off-the-shelf T-cell immunotherapy company, develops treatments for patients with cancer, autoimmune, and viral diseases in the United States. It is developing tabelecleucel, a T-cell immunotherapy that is Phase 3 clinical trials for the treatment of epstein-barr virus (EBV) driven post-transplant lymphoproliferative disease, as well as hematologic and solid tumors, including nasopharyngeal carcinoma.