Struggling German conglomerate Bayer, which trimmed its workforce by 3,200 positions in the first half of the year, has announced additional layoffs this week as it continues to address financial and operational hurdles. Meanwhile, Aadi Bioscience's plans to expand the use of its key drug met a major obstacle due to unsatisfactory results from a phase II solid tumor trial. On the regulatory front, the FDA has approved updated COVID-19 vaccines targeting the KP.2 strain for enhanced protection this fall. Additionally, Johnson & Johnson has made a notable acquisition in its MedTech cardiovascular portfolio, a significant step in its growth strategy.
Let's delve into the specifics.
Layoffs
Aadi Bioscience Inc. (AADI) announced on Wednesday that it is reducing its Research & Development workforce by 80% following its decision to halt the registration-intended PRECISION1 trial. This phase II study of Fyarro (nab-sirolimus) targeted patients with solid tumors featuring TSC1 or TSC2 inactivating alterations. An Independent Data Monitoring Committee analysis revealed that the study was unlikely to achieve the efficacy required for accelerated approval, the key objective of the trial. The company projects extending its cash runway at least into the second half of 2026. Fyarro, its marketed drug, was approved in the U.S. in 2021 for treating malignant perivascular epithelioid cell tumor (PEComa).
AADI's stock closed Friday at $1.58, an increase of 1.94%.
German pharmaceutical and biotech giant Bayer (BAYRY.OB) is set to cut approximately 150 of its 1,000 full-time positions, primarily within its Consumer Health division in Basel, Switzerland, as reported by NZZ on Tuesday. Facing significant financial strain, Bayer reduced its workforce by 3,200 in the first half of this year as part of its restructuring efforts. As of June 30, 2024, the company's net financial debt stood at €36.76 billion.
BAYRY.OB's stock closed Friday at $7.81, up 0.26%.
FDA Approvals and Rejections
The FDA gave the green light to Pfizer Inc. (PFE) and BioNTech SE's (BNTX) updated COVID-19 vaccine on Thursday, targeting the KP.2 strain of the JN.1 lineage for individuals aged 12 and older. According to the CDC, the JN.1 variant of SARS-CoV-2, the virus causing COVID-19, accounted for about 62% of all circulating variants earlier this year. The Omicron KP.2-adapted 2024-2025 Formula COVID-19 vaccine was also granted emergency use authorization for individuals aged six months to 11 years the same day. Moderna Inc.’s (MRNA) updated COVID-19 vaccine targeting the KP.2 variant also received FDA approval for individuals 12 years and older.
Pfizer's stock closed Friday at $28.90, an increase of 0.42%.
Regeneron Pharmaceuticals Inc. (REGN) announced on Tuesday that the FDA declined to approve its investigational drug Linvoseltamab for treating relapsed/refractory multiple myeloma that has progressed after at least three prior therapies. The decision was tied to issues discovered during a pre-approval inspection at a third-party fill/finish manufacturer for another company's product candidate. The third-party manufacturer has since informed Regeneron that it believes the issues have been resolved, with an FDA reinspection expected in the coming months.
Regeneron's stock closed Friday at $1,199.12, up 0.96%.
Johnson & Johnson’s (JNJ) combination of RYBREVANT and LAZCLUZE received FDA approval on Tuesday for the first-line chemotherapy-free treatment of locally advanced or metastatic EGFR-mutated non-small-cell lung cancer. The drug, in combination with chemotherapy, received FDA approval for first-line treatment of patients with non-small-cell lung cancer with EGFR Exon 20 insertion mutations earlier this year, in March.
JNJ's stock closed Friday at $164.13, up 1.10%.
Liquidia Corp. (LQDA) announced on Monday that the FDA granted tentative approval to Yutrepia inhalation powder for treating adults with pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease. On the same day, the FDA also granted a three-year new clinical investigation exclusivity (NCI exclusivity) to United Therapeutics Corp.'s (UTHR) marketed drug Tyvaso DPI, indicated for the same conditions. The two companies are embroiled in a long-standing patent dispute, with United Therapeutics alleging that Liquidia's Yutrepia infringes on Tyvaso’s patent.
LQDA's stock closed Friday at $9.97, up 3.53%.
Deal or No Deal
Johnson & Johnson (JNJ) announced its agreement on Tuesday to acquire Israel-based V-Wave, a privately-held company that offers innovative heart failure treatment options. The deal includes an upfront payment of $600 million, with potential additional payments of up to $1.1 billion contingent on achieving regulatory and commercial milestones. V-Wave will become part of Johnson & Johnson MedTech, and the transaction is anticipated to close by the end of 2024. Notably, in April 2024, Johnson & Johnson acquired Shockwave Medical Inc., a Nasdaq-listed cardiovascular medical device firm, for approximately $13.1 billion.
Johnson & Johnson’s stock (JNJ) closed Friday's trading at $164.13, marking a 1.10% increase.
Dr. Reddy's Laboratories (RDY) and its CRDMO division, Aurigene Pharmaceutical Services Limited, announced a partnership on Tuesday with Kainomyx Inc., a US-based company, to jointly develop an affordable anti-malarial drug. This collaboration aims to leverage Kainomyx's expertise in novel drug discovery, Aurigene's integrated drug discovery and development capabilities, and Dr. Reddy's experience in product commercialization across low and middle-income countries, as well as in the US and Europe.
Dr. Reddy’s stock (RDY) closed Friday's trading at $82.16, down 0.54%.
Clinical Trials - Breakthroughs and Setbacks
Jazz Pharmaceuticals plc (JAZZ) disclosed on Friday that results from a phase III trial in Japan were disappointing. The trial evaluated the safety and efficacy of a cannabidiol oral solution as an adjunctive treatment for seizures related to Lennox-Gastaut syndrome (LGS), Dravet syndrome (DS), or tuberous sclerosis complex (TSC) in Japanese pediatric patients. Despite the setback, the company will continue data collection and plans to engage with Japanese regulatory authorities regarding a potential new drug application. The cannabidiol oral solution is marketed as Epidiolex for treating seizures related to LGS, DS, or TSC in patients aged one year and older. In the European Union, it is known as Epidyolex and is approved for adjunctive use alongside clobazam for treating seizures related to LGS and DS in patients aged two years and older, and for treating seizures related to TSC. Epidiolex/Epidyolex generated $247.1 million in net product sales during the second quarter of 2024, reflecting a 22% increase from the same period in 2023.
Jazz Pharmaceuticals’ stock (JAZZ) closed Friday's trading at $113.87, down 0.59%.
Sutro Biopharma Inc. (STRO) announced on Thursday the initiation of REFRaME-L1, a global phase II study of the investigational drug Luvelta for patients with non-small cell lung cancer expressing Folate Receptor-a (FRa). Initial data from this study is expected in the first half of 2025.
Sutro Biopharma’s stock (STRO) closed Friday's trading at $5.01, up 10.11%.
Nykode Therapeutics ASA (VACBF.PK) revealed on Wednesday its decision to discontinue a phase II trial of its therapeutic cancer vaccine candidate VB10.16, targeting second-line HPV16-positive cervical cancer. The trial, known as VB-C-04, was part of a strategic repositioning for VB10.16. The company will now focus on locally advanced cervical cancer and recurrent metastatic head and neck cancer, anticipating a development cost reduction for VB10.16 by over $25 million, thus extending its cash runway.
Nykode Therapeutics’ stock (VACBF.PK) closed Friday's trading at $0.95, down 24%.
Palatin Technologies Inc. (PTN) announced on Thursday that it has commenced dosing the first subjects in its phase II trial, referred to as BMT-801. This trial evaluates Bremelanotide co-administered with Tirzepatide for the treatment of obesity and aims to enroll 60 patients, with enrollment expected to conclude this quarter. Topline results are anticipated in the first quarter of 2025.
Palatin Technologies’ stock (PTN) closed Friday's trading at $1.54, up 4.05%.
