On July 28, 2026 Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) ("Corbus" or the "Company") a clinical-stage company focusing on developing new therapies in oncology and obesity, reported that the U.S. Food and Drug Administration (FDA) has cleared the start of the Company’s registrational study ("TEMPO-1") of CRB-701, a next-generation Nectin-4 targeted antibody drug conjugate (ADC), in second-line (2L) oropharyngeal squamous cell carcinoma (OPSCC).

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TEMPO-1 is a randomized controlled study (n=250) designed to evaluate the efficacy and safety of CRB-701 compared with investigator’s choice of capecitabine, cetuximab or docetaxel. The study’s primary endpoint is objective response rate (ORR), which is intended to support a potential accelerated approval; overall survival (OS) is intended to support potential conversion to full approval.

The incidence and prevalence of OPSCC continue to rise in the U.S. largely driven by HPV infection. The disease primarily affects men in their 50s and 60s who have little or no history of smoking or heavy alcohol use. Each year approximately 14,000 OPSCC patients are estimated to be eligible for 2L treatment and approximately 7,000 patients are estimated to succumb to the disease in the United States alone.

The FDA’s decision to allow the registrational study to proceed was supported by results from Corbus’ ongoing Phase 1/2 clinical study of CRB-701, presented at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. In an analysis of patients with 2L+ OPSCC treated at the 3.6 mg/kg dose, CRB-701 achieved a confirmed ORR of 42.9%, with a median duration of response (DoR) of 6.3 months and a median progression-free survival (PFS) of 5.6 months (ongoing).

"The data presented at ASCO (Free ASCO Whitepaper) provided important insight into the potential clinical path for CRB-701 in 2L oropharyngeal cancer, a distinct tumor-type that is on the rise due to HPV infections," said Yuval Cohen, Ph.D., Chief Executive Officer of Corbus. "Unfortunately, current treatment options have shown limited efficacy underscoring the need for additional therapeutic options. OPSCC represents a significant commercial opportunity."

About CRB-701
CRB-701 (SYS6002) is a next-generation antibody drug conjugate targeting Nectin-4, that contains a site-specific, cleavable linker and a homogenous drug antibody ratio of 2, using monomethyl auristatin E (MMAE) as the payload. Nectin-4 is a clinically validated, tumor-associated antigen in urothelial cancer and highly expressed in other tumor types such as cervical and head and neck squamous cell carcinoma (HNSCC). The FDA has granted two Fast Track designations to CRB-701 in HNSCC and cervical cancer.

(Press release, Corbus Pharmaceuticals, JUL 28, 2026, View Source [SID1234669456])

On July 28, 2026 Alkermes plc (Nasdaq: ALKS) reported financial results for the second quarter of 2026.

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"The second quarter was marked by strong commercial performance and meaningful progress across our pipeline as we continued to execute on our strategic priorities. Our commercial portfolio consists of differentiated products that are positioned to generate substantial revenue and cash flow for years to come. At the same time, our orexin 2 receptor agonist portfolio represents a potentially transformational growth opportunity for Alkermes and positions us at the forefront of one of the most exciting new therapeutic categories in neuroscience," said Richard Pops, Chairman and Chief Executive Officer of Alkermes. "As I prepare to transition the Chief Executive Officer role, I do so with tremendous pride in what this organization has achieved and great optimism for its future. Blair and the leadership team are well positioned to build on this momentum and lead Alkermes through its next phase of growth, innovation and value creation, and I look forward to supporting them in my continuing role as Chairman."

"As we move into the second half of the year, we have clear priorities and a sharp focus on execution. With our first ADHD data for ALKS 7290 expected in the coming months and topline results from our alixorexton phase 2 idiopathic hypersomnia study expected toward year-end, we are generating significant new datasets that may open new opportunities for our orexin 2 receptor portfolio," said Blair Jackson, Chief Operating Officer of Alkermes. "With a talented team, a strong financial foundation and exciting opportunities ahead in sleep medicine and across our neuroscience portfolio, I am honored to step into the CEO role and continue building on the strong foundation for growth that Richard and the entire organization have established."

Key Financial Highlights

Revenues

Three Months Ended

June 30,

Six Months Ended

June 30,

(In millions)

2026

2025

2026

2025

Total Revenues

$

496.0

$

390.7

$

888.9

$

697.2

Total Proprietary Net Sales

$

411.7

$

307.2

$

749.8

$

551.7

VIVITROL

$

124.5

$

121.7

$

236.9

$

222.7

ARISTADAi

$

96.7

$

101.3

$

190.5

$

174.8

LYBALVI

$

94.0

$

84.3

$

186.3

$

154.3

LUMRYZ

$

96.6

$

—

$

136.1

$

—

Profitability

Three Months Ended

June 30,

Six Months Ended

June 30,

(In millions)

2026

2025

2026

2025

GAAP Net (Loss) Income

$

0.5

$

87.1

$

(66.0)

$

109.6

EBITDA

$

49.0

$

101.6

$

18.8

$

124.3

Adjusted EBITDA

$

139.2

$

126.5

$

219.5

$

172.1

1

Revenue Highlights

Proprietary Product Revenues

•
LYBALVI revenues for the quarter were $94.0 million. Revenues and total prescriptions grew 12% and 18%, respectively, compared to the second quarter of 2025.
•
ARISTADAi revenues for the quarter were $96.7 million. During the quarter, the company recorded ARISTADA revenue of approximately $4 million related to gross-to-net favorability, primarily driven by favorable patient mix.
•
VIVITROL revenues for the quarter were $124.5 million. During the quarter, the company recorded VIVITROL revenue of approximately $4 million related to gross-to-net favorability, primarily driven by favorable patient mix.
•
LUMRYZ revenues for the quarter were $96.6 million, which included approximately $7 million of inventory benefit due to timing of shipments.
Manufacturing & Royalty Revenues

•
VUMERITY manufacturing and royalty revenues for the quarter were $30.6 million.
•
Royalty revenue from XEPLION, INVEGA TRINZA/TREVICTA and INVEGA HAFYERA/BYANNLI for the quarter were $27.5 million.
•
Manufacturing revenue from RISPERDAL CONSTA for the quarter was $20.9 million.

Key Operating Expenses

Three Months Ended

June 30,

(In millions)

2026

GAAP

2026

Transaction Adjustments

2026

Non-GAAP

Adjusted

2025

GAAP

Cost of Goods Sold

$

98.1

$

31.0

$

67.1

$

49.5

R&D Expense

$

112.9

$

0.1

$

112.8

$

77.4

SG&A Expense

$

217.6

$

1.3

$

216.3

$

170.8

Six Months Ended

June 30,

(In millions)

2026

GAAP

2026

Transaction Adjustments(1)

2026

Non-GAAP

Adjusted

2025

GAAP

Cost of Goods Sold

$

159.7

$

43.8

$

115.9

$

98.7

R&D Expense

$

216.3

$

8.2

$

208.1

$

149.2

SG&A Expense

$

482.2

$

56.6

$

425.6

$

342.6

(1)
Includes $20.2 million of share-based compensation expense related to the acceleration of vesting of equity awards for former Avadel Pharmaceuticals plc (Avadel) employees which vested in full upon the closing of the transaction.
•
During the quarter, the company recorded a change in the fair value of contingent consideration of $26.4 million, related to the CVR milestone associated with the acquisition of Avadel, which was deemed more likely to be achieved following the recently announced positive topline results of the phase 3 study of LUMRYZ in idiopathic hypersomnia.

Balance Sheet

•
At June 30, 2026, the company recorded cash, cash equivalents and total investments of $691.6 million, compared to $538.2 million at March 31, 2026.

2

Financial Expectations for 2026

All line items are according to GAAP, except as otherwise noted.

(In millions)

Previous 2026 Expectations

(provided May 5, 2026)

Updated 2026 Expectations

(provided July 28, 2026)

Total Revenues

$1,730 – $1,840

$1,730 – $1,840

VIVITROL Net Sales

$460 – $480

$460 – $480

LYBALVI Net Sales

$380 – $400

$380 – $400

ARISTADAi Net Sales

$365 – $385

$365 – $385

LUMRYZ Net Sales a

$315 – $335

$315 – $335

Cost of Goods Sold b

$320 – $340

$320 – $340

R&D Expenses

$445 – $485

$445 – $485

SG&A Expenses

$890 – $930

$890 – $930

Amortization of Intangible Assets c

$75 – $85

$75 – $85

Change in the Fair Value of Contingent Consideration d

—

~$25

Net Interest Expense

$75 – $85

$75 – $85

Net Tax Benefit

~$0

~$0

GAAP Net Loss e

($70) – ($90)

($95) – ($115)

EBITDA f

$105 – $135

$75 – $95

Adjusted EBITDA f

$370 – $410

$370 – $410

a

The acquisition of Avadel closed on Feb. 12, 2026. LUMRYZ Net Sales expectations represents the period of Feb. 12, 2026 – Dec. 31, 2026.

b

In connection with the acquisition of Avadel, the company will record approximately $125 million of LUMRYZ inventory fair value step-up; the company expects that approximately $105 million of this amount will be expensed in 2026 as this inventory is sold.

c

In connection with the acquisition of Avadel, the company expects to record approximately $1.8 billion of intellectual property related to LUMRYZ, which will be amortized over an expected life of 14 years.

d

In connection with the positive topline results of the LUMRYZ phase 3 study in idiopathic hypersomnia, the company recorded an increase of $26.4 million in the fair value of contingent consideration related to the Avadel acquisition contingent value right (CVR) milestone.

e

Expected 2026 weighted average basic share count of approximately 169.1 million shares outstanding and a weighted average diluted share count of approximately 172.8 million shares outstanding.

f

Non-GAAP measure.

Conference Call

Alkermes will host a conference call and webcast presentation with accompanying slides at 8:00 a.m. ET (1:00 p.m. BST) on Tuesday, July 28, 2026, to discuss these financial results and expectations and provide an update on the company. The webcast may be accessed on the Investors section of Alkermes’ website at www.alkermes.com. The conference call may be accessed by dialing +1 877 407 2988 for U.S. callers and +1 201 389 0923 for international callers. In addition, a replay of the conference call may be accessed by visiting Alkermes’ website.

(Press release, Alkermes, JUL 28, 2026, View Source [SID1234669455])

On July 27, 2026 VERAXA Biotech AG (NASDAQ: VRXA; "VERAXA" or the "Company"), an emerging leader in designing novel cancer therapies, reported the advancement of bispecific ADC (bsADC) program VXA-222, following successful achievement of a key technical milestone in its alliance with OmniAb, Inc. (NASDAQ: OABI, "OmniAb"). The program is moving into its next collaboration phase with OmniAb’s discovery work successfully concluded. VXA-222 utilizes an "AND-gate" logic to address two different target antigens present on solid tumors with one molecule. Established in May 2025, the alliance and joint discovery collaboration brought together OmniAb’s cutting-edge suite of transgenic antibody discovery solutions and screening technologies with VERAXA’s proprietary antibody drug conjugate (ADC) linker technology and conjugation expertise to support next-generation therapeutic discovery.

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"We are pleased to announce this important achievement and the advancement of this program from our alliance with OmniAb for the development of a novel AND-gated bsADC utilizing our conjugation and linker technology," commented Christoph Erkel, Ph.D., Chief Scientific Officer of VERAXA. "This successful partnership has united two highly complementary technologies to establish a new therapeutic candidate in VXA-222, representing a powerful opportunity for a best-in-class bispecific ADC to address solid tumor indications with high unmet medical need. We look forward to advancing this program and acknowledge OmniAb’s partnership and contributions in delivering a diverse set of highly promising antibodies."

Under the terms of the May 2025 agreement, VERAXA initiated a novel bsADC program addressing two attractive target molecules in cancer medicine. The Company utilized OmniAb’s suite of transgenic antibody discovery solutions, including OmniClic, a common light-chain transgenic chicken developed to facilitate the generation of bispecific antibodies, to source high-quality human antibody leads, which are naturally optimized through in vivo affinity maturation. VERAXA will subsequently establish the bsADC lead candidate by applying its proprietary linker technology and conjugation routine and will be responsible for in vitro and in vivo validation. VERAXA holds exclusive rights to develop and commercialize products incorporating the OmniAb-derived antibodies under the collaboration, with OmniAb entitled to a share of specified revenue generated from those products.

"We’re delighted to see this bispecific ADC program cross this important threshold," said Bill Harriman, Ph.D., Senior Vice President of Discovery Partnership Management and Technology Development and Operations at OmniAb. "Continuation of the discovery phase at VERAXA underscores the productive collaboration and alliance between our scientific and business teams, and highlights the complementary strengths of OmniAb’s technologies and VERAXA’s expertise in ADC conjugation and development. We look forward to seeing our partners at VERAXA advance this exciting program."

(Press release, Veraxa Biotech, JUL 27, 2026, View Source [SID1234669450])

On July 27, 2026 Calidi Biotherapeutics, Inc. (NYSE American: CLDI) ("Calidi" or the "Company"), a clinical-stage biotechnology company pioneering the development of systemically delivered, targeted genetic medicines, reported on July 23, 2026, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Drug Discovery and Development (AACR D3) Conference in Boston, MA. The Company presented new data on its CLD-401 program that it expects to enter the clinic in the first quarter of 2027 and its in situ T-cell engager (TCE) program.

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"The data presented last week at the conference shows the advances we have made in both our CLD-401 program that we expect will be entering the clinic soon and our in situ TCE program including a new TCE targeting the EpCam receptor," said Calidi Chief Executive Officer Eric Poma, PhD. "The data highlights the unique ability of the RedTail platform to deliver genetic medicines to distal tumor sites to drive efficacy."

(Press release, Calidi Biotherapeutics, JUL 27, 2026, View Source [SID1234669449])

On July 27, 2026 ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, reported Lumara Bio as a dedicated oncology therapeutics division that combines ITM’s existing pipeline and the internal teams supporting its development and commercialization.

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Lumara Bio will operate as a defined division within ITM to focus key resources toward commercial readiness for its most advanced drug candidate, 177Lu-edotreotide (ITM-11), which is currently under review by the U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) goal date of August 28, 2026, alongside its broader early- and late-stage drug development activities.

"As we approach ITM-11’s PDUFA date, creating the Lumara Bio division enables us to focus our internal efforts and create a structure around the teams responsible for a potential commercial launch," said Dr. Andrew Cavey, chief executive officer of ITM. "In addition, Lumara Bio reflects the evolution of the two pillars of ITM’s business and builds on our deep expertise in isotope manufacturing and supply as well as our proven track record in radiopharmaceutical development. Lumara Bio is uniquely positioned to address the growing need for radiopharmaceutical innovation by accelerating progress across our targeted radiopharmaceutical pipeline and expanding our portfolio."

Beyond 177Lu-edotreotide, Lumara Bio will advance ITM’s diverse pipeline of targeted radiopharmaceutical candidates spanning multiple cancer types, treatment approaches, and proprietary isotope platforms, with the goal of bringing innovative radiopharmaceutical therapies to more patients. The division builds on ITM’s scientific foundation and isotope expertise, as well as its radiopharmaceutical development and strategic scientific collaborations. Lumara Bio will leverage ITM’s isotope manufacturing and supply services to support its pipeline and potential commercial launch activities.

177Lu-edotreotide is currently under regulatory review by the U.S. Food and Drug Administration and is not approved by any regulatory authority for any use.

(Press release, ITM Isotopen Technologien Munchen, JUL 27, 2026, View Source [SID1234669448])