On May 7, 2026 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, reported 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).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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."

(Press release, Atara Biotherapeutics, MAY 7, 2026, View Source [SID1234665311])

On May 7, 2026 Ascendis Pharma A/S (Nasdaq: ASND) reported financial results for the first quarter ended March 31, 2026, and provided a business update.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"The FDA approval of YUVIWEL, our third consecutive TransCon product, and the robust patient uptake for YORVIPATH are cementing our position as a leading global biopharma," said Jan Mikkelsen, President and Chief Executive Officer of Ascendis Pharma. "Our strong focus on science and making a meaningful difference for patients will continue to be the fundamental driver for our success."

Select Highlights & Anticipated 2026 Milestones

YORVIPATH
(palopegteriparatide, developed as TransCon PTH)
YORVIPATH revenue for the first quarter of 2026 totaled €197 million, which for the U.S. includes normal seasonality and the temporary impact of additional patients supported by free drug, as well as a one-time impact in Europe Direct related to expanded market access.
In the U.S., more than 1,000 new patient enrollments in the first quarter of 2026.
As of March 31, 2026, more than 6,300 unique patient enrollments by more than 2,700 prescribing healthcare providers since launch in the U.S.
Outside the U.S., continued expansion of commercial launches with full reimbursement. Now available commercially or through named patient programs in 35 countries.
Ongoing label expansion trials through PaTHway60 (adults) and PaTHway Adolescent.

YUVIWEL
(navepegritide, developed as TransCon CNP)
Received U.S. Food & Drug Administration (FDA) accelerated approval, indicated to increase linear growth in children 2 years of age and older with achondroplasia with open epiphyses.
The FDA granted orphan drug exclusivity for YUVIWEL, which will run through February 27, 2033.
As of May 1, 2026, more than 60 unique patient enrollments by more than 35 prescribing healthcare providers since U.S. commercial availability in April 2026.
Marketing Authorisation Application remains under review by the European Medicines Agency, with a decision anticipated in the fourth quarter of 2026.
Label expansion trial in infants with achondroplasia, reACHin, is ongoing with enrollment completion anticipated in the third quarter of 2026.
Phase 3 trial planned to investigate TransCon CNP monotherapy for the treatment of hypochondroplasia in the second half of the year.

SKYTROFA
(lonapegsomatropin, developed as TransCon hGH)
SKYTROFA revenue for the first quarter of 2026 totaled €44 million.
Announced Week 52 data from the Phase 2 New InsiGHTS Trial in Turner syndrome that demonstrated comparable efficacy and safety to daily somatropin.
Ongoing Phase 3 HighLiGHts basket trial across a range of established growth disorders including idiopathic short stature (ISS), SHOX deficiency, Turner syndrome, and small for gestational age (SGA).

TransCon CNP + TransCon hGH Combination Therapy
(navepegritide plus lonapegsomatropin)
Announced Phase 2 COACH Trial Week 52 topline results demonstrating mean annualized growth velocity that exceeded the 97th percentile of average stature children, improvements in body proportionality, and a safety profile consistent with TransCon CNP and TransCon hGH monotherapies.
Announced additional Week 52 results from COACH demonstrating meaningful benefits beyond linear growth, including improvements in spinal canal dimensions and lower limb alignment, along with unprecedented improvements in arm span compared to monotherapy.
Interim Week 78 data from COACH expected in the second quarter of 2026 with Week 104 data expected around year end.

Oncology Program
(onvapegleukin alfa)
In the ongoing Phase 1/2 IL-BELIEVE Trial, TransCon IL-2 β/γ in combination with paclitaxel demonstrated improved median overall survival (OS) up to 10 months from 6-7 months for historical controls, with a generally well-tolerated safety profile in patients with late-stage platinum-resistant ovarian cancer, validating the science behind TransCon IL-2 β/γ.
As further internal oncology development does not align with our strategic focus, we have decided to discontinue internal development of TransCon IL-2 β/γ in Oncology and will explore other ways to maximize the value of this asset.

Key Financial Highlights

Total revenue for the first quarter of 2026 was €247 million, compared to €101 million during the same period in 2025. The year-over-year increase in revenue was primarily attributable to an increase in product revenue from YORVIPATH.
Operating profit for the first quarter of 2026 totaled €25 million, reflecting a margin of 10.1%. On a non-IFRS basis, operating profit was €55 million*, reflecting a margin of 22.4%*.
Net profit for the first quarter of 2026 totaled €629 million, or €9.75 per diluted share, including the recognition of previously unrecognized deferred tax assets of €679 million. On a non-IFRS basis, net profit was €18 million*, or €0.27 per diluted share*.
As of March 31, 2026, Ascendis Pharma had cash and cash equivalents totaling €573 million, which includes the impact of repurchases under the previously announced share repurchase program of €52 million and the net settlement of certain Restricted Stock Units for €8 million, compared to cash and cash equivalents totaling €616 million as of December 31, 2025.
Subsequent to March 31, 2026:
On April 20, 2026, the Company’s ordinary shares commenced trading on The Nasdaq Global Select Market, replacing the prior listing of American Depositary Shares (ADSs).
On May 6, 2026, Ascendis redeemed all $575 million aggregate principal amount of its outstanding 2.25% convertible notes due 2028. Within the redemption period, all holders of the convertible notes surrendered their notes for conversion, whereupon the Company delivered 3,635,813 ordinary shares, together with cash in lieu of any fractional shares. The conversion resulted in the settlement of the current liabilities of convertible notes, comprising borrowings and derivative liabilities totaling €733 million as of March 31, 2026. The carrying amount as of the settlement date will be reclassified to equity in the second quarter of 2026.
Entered into agreement to sell its Rare Pediatric Disease Priority Review Voucher (PRV) to an undisclosed buyer for $187.5 million in cash, before transaction-related expenses. The PRV was awarded by the FDA upon approval of YUVIWEL in February 2026. The transaction is subject to customary closing conditions and is expected to close in the second quarter of 2026.

* See "Non-IFRS Financial Measures" below for definitions of these non-IFRS measures and a reconciliation to the most directly comparable IFRS measures.

First Quarter 2026 Financial Results
Total revenue for the first quarter of 2026 was €247 million, compared to €101 million during the same period in 2025. The year-over-year increase in revenue was primarily attributable to an increase in product revenue from YORVIPATH.

Total Revenue
(In EUR’000s) Three Months Ended
March 31,
2026 2025
Revenue
Commercial products 240,853 96,028
Services and clinical supply 5,110 3,524
Licenses 638 1,402
Total revenue 246,601 100,954

Revenue from Commercial Products
(In EUR’000s) Three Months Ended
March 31,
2026 2025
Revenue from commercial products
YORVIPATH 196,896 44,688
SKYTROFA 43,957 51,340
Total revenue from commercial products 240,853 96,028

Research and development expenses for the first quarter of 2026 were €59 million, compared to €87 million during the same period in 2025. The decrease was driven primarily by the completion of certain clinical trials and development activities within our Endocrinology Rare Disease and Oncology pipeline and the first quarter of 2026 being positively impacted by a reversal of prior period write-downs of pre-launch inventories related to YUVIWEL.

Selling, general, and administrative expenses for the first quarter of 2026 were €145 million, compared to €101 million during the same period in 2025. The increase was primarily due to the impact from commercial expansion, including global launch activities.

Total operating expenses for the first quarter of 2026 were €204 million compared to €188 million during the same period in 2025.

Operating profit for the first quarter of 2026 was €25 million, compared to an operating loss of €104 million during the same period in 2025. The increase was primarily driven by the increase in product revenue.

Net finance expenses for the first quarter of 2026 were €63 million, compared to €16 million during the same period in 2025. The increase was primarily driven by non-cash fair-value remeasurement of derivative liabilities associated with our convertible notes.

Income taxes for the first quarter of 2026 included the recognition of previously unrecognized deferred tax assets of €679 million.

For the first quarter of 2026, Ascendis Pharma reported net profit of €629 million, or €10.20 per share basic and €9.75 per share (diluted), compared to a net loss of €95 million, or €1.58 per share (basic and diluted), for the same period in 2025. Net profit for the first quarter of 2026 included the recognition of previously unrecognized deferred tax assets of €679 million.

Cash flows used in operating activities for the first quarter of 2026 were €8 million compared to €14 million used during the same period in 2025. The change primarily reflects the prior-year period benefiting from the $100 million upfront payment received under our exclusive license agreement with Novo Nordisk, which did not recur in the current period, while the current period reflects improved operating performance offset by working capital build.

As of March 31, 2026, Ascendis Pharma had cash and cash equivalents totaling €573 million, compared to €616 million as of December 31, 2025. As of March 31, 2026, Ascendis Pharma had 62,376,846 ordinary shares outstanding, including 265,251 held by the Company.

Beginning with the first quarter of 2026, Ascendis Pharma is introducing supplemental non-IFRS financial measures that management believes will help investors evaluate the Company’s underlying operating performance from period to period and enhance comparability against peer companies. The non-IFRS measures presented are not a substitute for, and should be considered together with, the comparable IFRS measures. See the table below on page 14 for specific reconciling items.

For the first quarter of 2026, non-IFRS operating profit was €55 million, compared to a non-IFRS operating loss of €79 million for the same period in 2025.

For the first quarter of 2026, non-IFRS net profit was €18 million, or €0.27 earnings per diluted share, compared to a non-IFRS net loss of €73 million, or €1.22 loss per diluted share, for the same period in 2025.

Conference Call and Webcast Information
Ascendis Pharma will host a conference call and webcast today at 8:00 am Eastern Time (ET) to discuss its first quarter 2026 financial results.

Those who would like to participate may access the live webcast here, or register in advance for the teleconference here. The link to the live webcast will also be available on the Investors & News section of the Ascendis Pharma website at View Source A replay of the webcast will be available in this section of the Ascendis Pharma website shortly after the conclusion of the event for 30 days.

(Press release, Ascendis Pharma, MAY 7, 2026, View Source [SID1234665309])

On May 7, 2026 AN2 Therapeutics, Inc. (Nasdaq: ANTX), a biopharmaceutical company advancing novel small molecule therapeutics derived from its boron chemistry platform, reported that Eric Easom, Co-Founder, Chairman, President and CEO will participate in a fireside chat at the 2026 Stifel Virtual Targeted Oncology Forum on May 19, 2026 at 4:00 PM ET, and members of management will be available for 1×1 meetings.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

A webcast can be accessed on the Investors section of the AN2 Therapeutics website at www.an2therapeutics.com. An archived replay will be available for at least 30 days following the presentation.

(Press release, AN2 Therapeutics, MAY 7, 2026, View Source [SID1234665308])

On May 7, 2026 Amgen (NASDAQ:AMGN) reported it will present at the Bank of America Merrill Lynch Global Healthcare Conference at 10:00 a.m. PT on Wednesday, May 13, 2026. Peter Griffith, executive vice president and chief financial officer at Amgen, and Jay Bradner, executive vice president of Research and Development at Amgen, will present at the conference. The webcast will be broadcast over the internet simultaneously and will be available to members of the news media, investors and the general public.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The webcast, as with other selected presentations regarding developments in Amgen’s business given by management at certain investor and medical conferences, can be found on Amgen’s website, www.amgen.com, under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen’s Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.

(Press release, Amgen, MAY 7, 2026, View Source [SID1234665307])

On May 7, 2026 ALX Oncology Holdings Inc. ("ALX Oncology" Nasdaq: ALXO), a clinical-stage biotechnology company advancing a pipeline of novel therapies designed to treat cancer and extend patients’ lives, reported that data from exploratory analyses in the Phase 1b/2 clinical trial evaluating the company’s investigational CD47-inhibitor evorpacept in combination with Jazz Pharmaceuticals’ zanidatamab (ZIIHERA) in patients with heavily pre-treated HER2-positive metastatic breast cancer (mBC) were presented for the first time today in a poster session at the ESMO (Free ESMO Whitepaper) Breast Cancer 2026 congress. The findings show that patients with centrally confirmed HER2-positive (ccHER2-positive) mBC and high CD47 expression experienced a promising, durable response.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Specifically, patients in the trial with ccHER2-positive disease and high CD47 expression (defined as total membrane staining of >20%) had a confirmed objective response rate (cORR) of 100% (n=5/5), while the cORR was 25% (n=1/4) among those with lower CD47 expression (<20%). Those patients whose tumors expressed higher levels of CD47 also had longer median progression-free survival (mPFS): 22.1 months as compared to 3.4 months in the low-CD47 expression group. The median duration of response (mDOR) among patients whose tumors expressed high levels of CD47 was also notable at 20.2 months.

"There is a large and growing population of patients with advanced breast cancer who need novel treatment options once their disease has progressed following treatment with currently available therapies, including trastuzumab deruxtecan," said Funda Meric-Bernstam, M.D., Chair of the Department of Investigational Cancer Therapeutics at The University of Texas MD Anderson Cancer Center, who presented the findings today. "Our data suggest that adding evorpacept to HER2-targeted agents may provide one such option, and we may be able to optimize patient selection for these regimens by using a biomarker-driven approach that incorporates CD47."

The Phase 1b/2 open-label, multi-center clinical trial (NCT05027139) evaluating evorpacept plus zanidatamab included patients with heavily pre-treated HER2-positive mBC (median of five prior HER2-targeted therapies), all of whom had received prior ENHERTU therapy. The primary trial results, presented at the 2024 San Antonio Breast Cancer Symposium (SABCS), demonstrated that the investigational combination generated promising anti-tumor activity and a manageable safety profile.

The exploratory analyses comprised 24 patients, including 10 with ccHER2-positive disease. Seventeen of 24 samples were evaluable for CD47 expression, including samples from nine of the 10 ccHER2-positive patients. Patients received zanidatamab plus evorpacept at dosages of 20 mg/kg (n=3) or 30 mg/kg (n=21). As of the August 1, 2024 data cut-off, key findings from the analyses include:

The cORR among all 24 patients was 33% and the mPFS was 3.6 months.
Patients with ccHER2-positive disease (n=10) had higher response rates, with a cORR of 60% and mPFS of 8.3 months.
All of the patients (n=5/5) with ccHER2-positive disease and high CD47 expression (defined as total membrane staining of >20%) responded (including one complete response and four partial responses), with an mDOR of 20.2 months and mPFS of 22.1 months. In comparison, among the patients with ccHER2-positive disease and low CD47 expression (defined as total membrane staining of <20%), cORR was 25% (n=1/4) and mPFS was 3.4 months.
"The findings from these exploratory analyses provide additional evidence that adding evorpacept to HER2-targeted therapies may generate durable responses in heavily pretreated HER2-positive breast cancers, including in patients in the post-ENHERTU setting," said Barbara Klencke, M.D., Chief Medical Officer at ALX Oncology. "They also further support the use of a biomarker-driven approach to predict treatment response, as we previously observed in the HER2-positive gastric cancer setting. We designed the ongoing ASPEN-09-Breast Phase 2 trial of evorpacept plus trastuzumab and chemotherapy to provide additional insight into this approach and, we hope, move closer to delivering a new therapeutic option for this group of patients."

Q1 2026 Results Conference Call and Webcast Details

ALX Oncology management will host a webcast tomorrow (Friday, May 8), to provide an overview of Q1 2026 financial results. Sara Hurvitz, M.D., will join the call to discuss and provide perspective on the Phase 1b/2 trial data shared at the ESMO (Free ESMO Whitepaper) Breast Cancer congress.

Date & Time: Friday, May 8, 2026, 8:30 a.m. ET
Guest Speaker: Sara Hurvitz, M.D., Professor, Senior Vice President and Director, Clinical Research Division and Smith Family Endowed Chair in Women’s Health at Fred Hutchinson Cancer Center; Professor and Head, Division of Hematology and Oncology, Department of Medicine, University of Washington
Webcast Access: View Source;tp_key=2800839c82
Participant Listening Options by Phone: To access the conference call, please dial 1-877-407-0752 or +1-201-389-0912 and ask to be joined into the ALX Oncology First Quarter 2026 Financial Results Conference Call.

Another option for instant telephone access to the event is to use the Call Me link below:
View Source;passcode=13755276&h=true&info=company&r=true&B=6

A live audio webcast of the call, along with the ALX Oncology corporate presentation, will be available under "Events & Presentations" in the Investor section of the Company’s website, www.alxoncology.com. An archived webcast will be available on the Company’s website after the event.

(Press release, ALX Oncology, MAY 7, 2026, https://ir.alxoncology.com/news-releases/news-release-details/alx-oncologys-evorpacept-combination-zanidatamab-generates [SID1234665301])