On July 16, 2025 MAA Laboratories reported that it has received formal written scientific advice from the Federal Institute for Drugs and Medical Devices (BfArM) in Germany for its Dasatinib Nanoparticle Tablets (Press release, MAA Laboratories, JUL 16, 2025, View Source [SID1234654403]).

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The advice supports MAA’s ongoing development efforts and provides regulatory clarity for advancing the program in the European Union. Importantly, the feedback from BfArM is consistent with guidance previously received from the U.S. Food and Drug Administration (FDA), further validating the Company’s development strategy and the scientific strength of its NanoCont platform.

"We are grateful for BfArM’s constructive guidance," said Dr. Anjani Jha, CEO of MAA Laboratories. "The alignment between U.S. and EU regulators provides strong validation for our regulatory and clinical approach and reinforces our confidence in the potential of our nanoparticle-based therapies."

MAA Laboratories remains committed to delivering differentiated therapies that improve patient outcomes through enhanced drug delivery, tolerability, and systemic performance. The Company looks forward to initiating clinical studies and advancing its broader pipeline across global markets.

On July 16, 2025 Amphista Therapeutics ("the Company" or "Amphista"), a leader in the discovery of next-generation, Targeted Protein Degradation (TPD) medicines, reported the successful achievement of a discovery research milestone under its exclusive research collaboration and licence agreement with Merck (Press release, Amphista Therapeutics, JUL 16, 2025, View Source [SID1234654404]). In conjunction with the milestone achievement, Amphista receives a pre-specified financial payment. The associated target on which the milestone is triggered is currently undisclosed.

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"As we continue to build our portfolio of first- and/or best-in-class Targeted Glues, we are delighted to have reached an important milestone in our collaboration with Merck. The progress we have made together speaks to the effective partnership between scientists from both companies, enabling us to focus on advancing high-quality compounds for further development," said Antony Mattessich, Chief Executive Officer at Amphista. "This achievement reinforces the exceptional capabilities of our Eclipsys platform in the rational design of orally bioavailable protein degraders, bringing us a step closer to improving patient outcomes."

Under the agreement, Amphista is responsible for the discovery and early development of small molecule protein degraders using its Eclipsys platform. Merck is granted a global exclusive license to the resulting degrader molecules and will be responsible for further development and commercialisation activities.

On July 16, 2025 Genmab A/S (Nasdaq: GMAB) reported worldwide net trade sales of DARZALEX (daratumumab), including sales of the subcutaneous (SC) product (daratumumab and hyaluronidase-fihj, sold under the tradename DARZALEX FASPRO in the U.S.), as reported by J&J were USD 3,539 million in the second quarter of 2025 (Press release, Genmab, JUL 16, 2025, View Source [SID1234654407]). Net trade sales were USD 2,017 million in the U.S. and USD 1,521 million in the rest of the world. Genmab receives royalties on the worldwide net sales of DARZALEX, both the intravenous and SC products, under the exclusive worldwide license to J&J to develop, manufacture and commercialize daratumumab.

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On July 16, 2025 Johnson & Johnson (NYSE: JNJ) reported results for second-quarter 2025 (Press release, Johnson & Johnson, JUL 16, 2025, View Source [SID1234654408]). "Today’s strong results reflect the depth and strength of Johnson & Johnson’s uniquely diversified business operating across both MedTech and Innovative Medicine," said Joaquin Duato, Chairman and Chief Executive Officer, Johnson & Johnson. "Our portfolio and pipeline position us for elevated growth in the second half of the year, with game-changing approvals and submissions anticipated in areas like lung and bladder cancer, major depressive disorder, psoriasis, surgery and cardiovascular, which will extend and improve lives in transformative ways."
Overall financial results
Q2
($ in Millions, except EPS)
2025
2024
% Change
Reported Sales

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$23,743
$22,447
5.8%
Net Earnings
$5,537
$4,686
18.2%
EPS (diluted)
$2.29
$1.93
18.7%

Q2
Non-GAAP* ($ in Millions, except EPS)
2025
2024
% Change
Operational Sales1,2

4.6%
Adjusted Operational Sales1,3

3.0%
Adjusted Net Earnings1,4
$6,699
$6,840
-2.1%
Adjusted EPS (diluted)1,4
$2.77
$2.82
-1.8%
Free Cash Flow6,7
~$6,200
$7,507

Regional sales results
Q2

% Change

($ in Millions)
2025
2024
Reported
Operational1,2
Currency
Adjusted
Operational1,3
U.S.
$13,544
$12,569
7.8%
7.8
–
5.0
International
10,199
9,878
3.2
0.6
2.6
0.4
Worldwide
$23,743
$22,447
5.8%
4.6
1.2
3.0

1Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules
2Excludes the impact of translational currency
3Excludes the net impact of acquisitions and divestitures and translational currency
Note: values may have been rounded

Segment sales results
Q2

% Change

($ in Millions)
2025
2024
Reported
Operational1,2
Currency
Adjusted
Operational1,3
Innovative Medicine
$15,202
$14,490
4.9%
3.8
1.1
2.4
MedTech
8,541
7,957
7.3
6.1
1.2
4.1
Worldwide
$23,743
$22,447
5.8%
4.6
1.2
3.0

1Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules
2Excludes the impact of translational currency
3Excludes the net impact of acquisitions and divestitures and translational currency
Note: values may have been rounded

Second-Quarter 2025 segment commentary:

Operational sales* reflected below excludes the impact of translational currency.

Innovative Medicine

Innovative Medicine worldwide operational sales grew 3.8%*, with net acquisitions and divestitures positively impacting growth by 1.4%. Growth was primarily driven by DARZALEX, CARVYKTI, ERLEADA and RYBREVANT/LAZCLUZE in Oncology, TREMFYA and SIMPONI/SIMPONI ARIA in Immunology, and SPRAVATO in Neuroscience. Growth was partially offset by an approximate (1,170) basis points impact from STELARA in Immunology, and an approximate (130) basis points impact from COVID-19 in Infectious Diseases.

MedTech

MedTech worldwide operational sales grew 6.1%*, with net acquisitions and divestitures positively impacting growth by 2.0%. Growth was primarily driven by electrophysiology products and Abiomed in Cardiovascular, as well as wound closure products in General Surgery.

Full-year 2025 guidance:
Johnson & Johnson does not provide GAAP financial measures on a forward-looking basis because the company is unable to predict with reasonable certainty the ultimate outcome of legal proceedings, unusual gains and losses, acquisition-related expenses, and purchase accounting fair value adjustments without unreasonable effort. These items are uncertain, depend on various factors, and could be material to Johnson & Johnson’s results computed in accordance with GAAP.
($ in Billions, except EPS)
July 2025
April 2025
Adjusted Operational Sales1,2,5
Change vs. Prior Year / Mid-point
3.2% – 3.7% / 3.5%
2.0% – 3.0% / 2.5%
Operational Sales2,5 / Mid-point
Change vs. Prior Year / Mid-point
$92.7B – $93.1B / $92.9B
4.5% – 5.0% / 4.8%
$91.6B – $92.4B / $92.0B
3.3% – 4.3% / 3.8%
Estimated Reported Sales3,5/ Mid-point
Change vs. Prior Year / Mid-point
$93.2B – $93.6B / $93.4B
5.1% – 5.6% / 5.4%
$91.0B – $91.8B / $91.4B
2.6% – 3.6% / 3.1%
Adjusted Operational EPS (Diluted)2,4 / Mid-point
Change vs. Prior Year / Mid-point
$10.63 – $10.73 / $10.68
6.5% – 7.5% / 7.0%
$10.50 – $10.70 / $10.60
5.2% – 7.2% / 6.2%
Adjusted EPS (Diluted)3,4 / Mid-point
Change vs. Prior Year / Mid-point
$10.80 – $10.90 / $10.85
8.2% – 9.2% / 8.7%
$10.50 – $10.70 / $10.60
5.2% – 7.2% / 6.2%

1Non-GAAP financial measure; excludes the net impact of acquisitions and divestitures
2Non-GAAP financial measure; excludes the impact of translational currency
3Calculated using Euro Average Rate: July 2025 = $1.13 and April 2025 = $1.10 (Illustrative purposes only)
4Non-GAAP financial measure; excludes intangible amortization expense and special items
5Excludes COVID-19 Vaccine
Note: percentages may have been rounded
Other modeling considerations will be provided on the webcast
Notable announcements in the quarter:
The information contained in this section should be read together with Johnson & Johnson’s other disclosures filed with the Securities and Exchange Commission, including its Current Reports on Form 8-K, Quarterly Reports on Form 10-Q and Annual Reports on Form 10-K. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. The reader is also encouraged to review all other news releases and information available in the Investor Relations section of the company’s website at News Releases, as well as Innovative Medicine News Center, MedTech News & Events, and www.factsabouttalc.com.
Regulatory
Supplemental new drug application submitted to U.S.
FDA for CAPLYTA (lumateperone) with data
demonstrating significant schizophrenia relapse prevention compared to placebo1
Press Release
DARZALEX (daratumumab) receives the first positive CHMP opinion for patients with high-risk smouldering multiple myeloma
Press Release
IMBRUVICA (ibrutinib) receives positive CHMP opinion for the treatment of patients with previously untreated mantle cell lymphoma (MCL) who would be eligible for autologous stem cell transplant
Press Release
U.S. FDA Oncologic Drugs Advisory Committee votes in favor of the benefit-risk profile of DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) for high-risk smoldering multiple myeloma
Press Release
Johnson & Johnson receives FDA approval for IMAAVY (nipocalimab-aahu), a new FcRn blocker offering long-lasting disease control in the broadest population of people living with generalized myasthenia gravis (gMG)
Press Release

Johnson & Johnson MedTech Announces Completion of First Cases with OTTAVA Robotic Surgical System
Press Release
Data Releases IMAAVY (nipocalimab-aahu) showed greater sustained disease control versus approved FcRn blockers for generalized myasthenia gravis (gMG) at multiple timepoints over 24 weeks in newly published indirect treatment comparison (ITC)
Press Release
Investigational combination of first-in-class bispecifics TALVEY and TECVAYLI shows deep and durable responses in heavily pretreated multiple myeloma patients with extramedullary disease
Press Release
Johnson & Johnson’s dual-targeting CAR T-cell therapy shows encouraging first results in large B-cell lymphoma
Press Release
New results for Johnson & Johnson’s bleximenib demonstrate promising antileukemic activity in combination with venetoclax and azacitidine for acute myeloid leukemia
Press Release
Significant efficacy benefit of IMBRUVICA (ibrutinib) plus venetoclax versus acalabrutinib plus venetoclax in frontline treatment of patients with chronic lymphocytic leukaemia suggested by indirect treatment comparison
Press Release
New data show TREMFYA (guselkumab) is the only IL-23 inhibitor proven to significantly inhibit progression of joint structural damage in active psoriatic arthritis
Press Release
DARZALEX FASPRO (daratumumab and hyaluronidase-fihj)-based regimen shows 95 percent progression-free survival at four years in transplant-eligible, newly diagnosed patients with multiple myeloma who achieved sustained MRD negativity
Press Release
Early results from Johnson & Johnson’s trispecific antibody show promising response in heavily pretreated multiple myeloma patients
Press Release
Single infusion of CARVYKTI (ciltacabtagene autoleucel) delivered lasting treatment-free remissions for at least five years in patients with relapsed or refractory multiple myeloma
Press Release
Johnson & Johnson leads with first PARP inhibitor combo to improve efficacy in patients with HRR-altered mCSPC
Press Release
Johnson & Johnson unveils first-in-human results for pasritamig, showing early anti-tumor activity in prostate cancer
Press Release
Shockwave Medical Study Confirms Benefit of IVL-First Strategy in Real-World Female Patients with Complex Calcified Lesions in Late-Breaking Data Presentation at EuroPCR 2025
Press Release
Icotrokinra results show significant skin clearance in patients with difficult-to-treat scalp and genital psoriasis
Press Release
TREMFYA (guselkumab) delivers sustained clinical and endoscopic remission in ulcerative colitis through two years
Press Release
TREMFYA (guselkumab) positioned to become the first and only IL-23 inhibitor to offer subcutaneous induction in ulcerative colitis as demonstrated in new data through 24 weeks
Press Release
Johnson & Johnson’s TAR-200 monotherapy achieves high disease-free survival of more than 80 percent in BCG-unresponsive, high-risk papillary NMIBC
Press Release
Johnson & Johnson’s TAR-200 monotherapy demonstrates highest complete response rate with sustained clinical benefits in patients with certain types of bladder cancer
Press Release

Johnson & Johnson MedTech Presents 3-Month Data from Omny-IRE Clinical Trial at 2025 Heart Rhythm Society Annual Meeting
Press Release

Product Launch
Johnson & Johnson Launches First and Only Daily Disposable Multifocal Toric Contact Lens – ACUVUE OASYS MAX 1-Day MULTIFOCAL for ASTIGMATISM
Press Release
Johnson & Johnson Launches VOLT Wrist and Proximal Humerus Plating Systems in the U.S.
Press Release
Johnson & Johnson Launches New TECNIS Odyssey Next-Generation Intraocular Lens in Europe, the Middle East, and Canada Offering Cataract Patients Precise Vision at Every Distance in Any Lighting
Press Release
Johnson & Johnson Launches KINCISE 2 System, the Only Automated Surgical Impactor Approved for Knee and Hip Revision Procedures
Press Release
Johnson & Johnson MedTech Launches SOUNDSTAR CRYSTAL in the US, Redefining Image Clarity in 2D Intracardiac Imaging
Press Release

Other
Johnson & Johnson Elects Daniel Pinto, President, JPMorganChase to its Board of Directors
Press Release

Webcast information:
Johnson & Johnson will conduct a conference call with investors to discuss this earnings release today at 8:30 a.m., Eastern Time. A simultaneous webcast of the call for investors and other interested parties may be accessed by visiting the Johnson & Johnson website. A replay and podcast will be available approximately two hours after the live webcast in the Investor Relations section of the company’s website at events-and-presentations.

On July 16, 2025 BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW, BCTXZ) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, reported the closing of its best-efforts public offering of 12,000,000 units (Press release, BriaCell Therapeutics, JUL 16, 2025, View Source [SID1234655033]). Each unit consists of one common share (or one pre-funded warrant ("Pre-Funded Warrant") in lieu thereof) and one warrant (the "Warrants"). Each unit was sold to the public at a price of $1.25 per unit (inclusive of the Pre-Funded Warrant exercise price) for gross proceeds of $15 million, before deducting placement agent fees and offering expenses. Each Pre-Funded Warrant is exercisable to purchase one common share at an exercise price of $0.001 until such time as the Pre-Funded Warrant is exercised in full and each Warrant is immediately exercisable, and entitles the holder thereof to purchase one common share at an exercise price of $1.50 per share for a period of five years from the date of issuance. The common shares (or Pre-Funded Warrants) and Warrants were purchased together in the offering but were issued separately.

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No Canadian prospectus has been or will be filed in a province or territory of Canada to qualify the securities in connection with the offering. The Company is relying upon the exemption set forth in Section 602.1 of the TSX Company Manual, which provides that the TSX will not apply its standards to certain transactions involving eligible interlisted issuers on a recognized exchange, such as Nasdaq.

The Company intends to use the net proceeds from the offering for working capital requirements, general corporate purposes, and the advancement of business objectives.

ThinkEquity acted as the sole placement agent for the offering.

A registration statement on Form S-1 (File No. 333-288562) relating to the securities was filed with the Securities and Exchange Commission ("SEC") and became effective on July 15, 2025. This offering was made only by means of a prospectus. Copies of the final prospectus may be obtained from ThinkEquity, 17 State Street, 41 st Floor, New York, New York 10004. The final prospectus has been filed with the SEC and is available on the SEC’s website located at View Source .

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.