Weekly Buzz: NVS, MRK Win FDA Nod; LLY Snaps Up ATAI; MANE Shines On Hair Loss Data
(RTTNews) – This week, the healthcare sector saw multiple U.S FDA and European Commission approvals, strategic licensing and M&A activity, as well as pivotal clinical trial readouts and regulatory setbacks.
Positive data readouts spanned multiple therapeutic areas, including pulmonary arterial hypertension, weight loss, pattern hair loss and thrombosis.
Let us unpack the specifics.
Regulatory Approvals
FDA Approvals and Rejections
Novartis Wins FDA Approval For Fabhalta In IgA Nephropathy
Novartis AG (NVS) received traditional FDA approval for Fabhalta (iptacopan), the first complement inhibitor for adults with primary IgAN at risk of progression. In the Phase 3 APPLAUSE-IgAN trial, Fabhalta reduced eGFR decline and proteinuria with consistent safety. It was first approved in 2023 for paroxysmal nocturnal hemoglobinuria and in March 2025 for the treatment of adults with C3 glomerulopathy.
NVS closed Friday’s trading (July 17, 2026) at $153.76, up 0.67%.
Merck Secures FDA Approval For LIPFENDRA
Merck & Co., Inc.(MRK) won FDA approval for LIPFENDRA (enlicitide), the first once-daily oral PCSK9 inhibitor for adults with hypercholesterolemia, including HeFH. In the Phase 3 CORALreef trial, the drug cut LDL-C by up to 59% versus placebo, marking a pivotal advance in cholesterol management.
MRK closed Friday’s trading at $127.50, down 0.10%.
Novo Nordisk Wins EU Approval for Wegovy Pill
Novo Nordisk (NVO) gained European Commission authorization for its once-daily oral semaglutide 25 mg Wegovy pill to treat adults with obesity or overweight with at least one comorbidity. The approval was supported by OASIS Phase 3 data showing approximately 17% weight loss versus 3% with placebo, with 1 in 3 patients losing 20% or more of their body weight.
NVO closed Friday’s trading at $50.32, down 2.25%.
Celcuity Wins FDA Approval for REVTORPYK In Breast Cancer
Celcuity Inc. (CELC) secured FDA approval for REVTORPYK (gedatolisib) to treat HR-positive, HER2-negative locally advanced or metastatic breast cancer without a PIK3CA mutation after progression on endocrine therapy. The approval was supported by Phase 3 VIKTORIA-1 trial data that showed significant progression-free survival benefit with both doublet and triplet regimens.
CELC closed Friday’s trading at $88.38, up 0.10%.
Elevar Gets FDA CRL for Liver Cancer Combo
Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Co., Ltd. (028300.KQ), received a complete response letter (CRL) from the FDA for its NDA seeking approval for Rivoceranib plus Camrelizumab as first-line treatment for unresectable or metastatic hepatocellular carcinoma. The decision was tied to deficiencies at a third-party manufacturing site, not the clinical data. Phase 3 CARES-310 showed a median overall survival of 23.8 months, the longest reported to date in first-line HCC, with consistent efficacy and manageable safety.
028300.KQ closed Friday’s trading at KRW 35,300.00, up 1.73%.
Merck Gains FDA Approval for KEYTRUDA+ Padcev Combo
Merck & Co Inc. (MRK) announced FDA approval of KEYTRUDA (pembrolizumab) and KEYTRUDA QLEX (pembrolizumab and berahyaluronidase alfa-pmph), each in combination with Padcev (enfortumab vedotin-ejfv), as a neoadjuvant and adjuvant treatment for adults with muscle-invasive bladder cancer (MIBC). The approvals, based on Phase 3 KEYNOTE-B15 trial results in 808 patients, mark the first PD-1 inhibitor plus ADC regimens authorised for MIBC regardless of cisplatin eligibility, building on the earlier KEYNOTE-905 approval for cisplatin-ineligible patients.
MRK closed Friday’s trading at $127.50, down 0.10%.
Deals
Elutia Signs Agreement To Sell SimpliDerm Business To Cellution For Up To $11 Mln
Elutia Inc. (ELUT) signed a definitive agreement to sell its SimpliDerm human acellular dermal matrix business to Cellution Biologics Inc. for total consideration of up to $11 million.
The divestiture aligns with Elutia’s strategy to focus its resources on NXT-41x, its antibiotic-eluting biomatrix in development for the $1.5 billion U.S. plastic and reconstructive surgery market. The deal is expected to close in the second half of 2026.
ELUT closed Friday’s trade at $0.95.
Eli Lilly and Company (LLY) announced a definitive agreement to acquire AtaiBeckley Inc. (ATAI), a clinical-stage biopharmaceutical company developing innovative therapeutics for mental health conditions, to expand its neuroscience pipeline.
The deal includes AtaiBeckley’s lead program, BPL-003 (mebufotenin benzoate), which, in a Phase 2b study, showed rapid and durable reductions in depressive symptoms, according to the company.
Under the terms of the agreement, Lilly will acquire all outstanding shares of AtaiBeckley for $6.75 per share in cash upon closing, plus up to $2.50 per share in the form of a Contingent Value Right (CVR).
The upfront cash consideration is approximately $2.8 billion, and the CVR represents an additional potential value of approximately $1.0 billion. Transaction closure is expected in the third quarter of 2026.
LLY closed Friday’s trade at $1,179.11, up 0.85%.
Glucotrack and Lokahi Therapeutics Complete Strategic Business Combination
Glucotrack, Inc. (GCTK) announced the completion of its strategic business combination with Lokahi Therapeutics, and the combined organisation integrates Lokahi’s dual-engine model and AI-driven asset sourcing and advancement platform with Glucotrack’s existing technology infrastructure to create a scalable framework.
As per transaction terms, Lokahi Therapeutics becomes the operating and controlling business of the combined company, leveraging Glucotrack’s public market platform to support long-term growth and access to capital.
GCTK closed Friday’s trade at $0.49, down 1.60%.
AstraZeneca Acquires Global Rights To Zegfrovy
AstraZeneca (AZN) has entered into an exclusive license agreement with Dizal Pharmaceutical Co., Ltd for Zegfrovy, an oral irreversible epidermal growth factor receptor inhibitor for patients with lung cancer and will acquire worldwide rights to develop and commercialise Zegfrovy.
As per the transaction terms, AstraZeneca will make an upfront payment to Dizal of $600 million, with additional payments of up to $900 million upon achievement of specific development, regulatory, and sales-related milestones.
AZN closed Friday’s trade at $168.90, down 0.23%.
Matinas BioPharma To Merge With GH Power; Sells LNC Platform And MAT2203 To Azurity Pharmaceuticals
Matinas BioPharma Holdings Inc. (MTNB) announced a strategic business combination with GH Power Inc., focused on advanced clean energy solutions, to form a publicly traded clean energy and green hydrogen company.
In addition, it signed a definitive agreement to sell its lipid nano-crystal (LNC) technology and lead antifungal candidate, MAT2203, to Azurity Pharmaceuticals, which includes $4 million upfront, up to $17.5 million in milestone payments, and future mid-single-digit royalties.
Under the Matinas and GH deal, the combined entity plans to accelerate commercialisation, expand project development across North America and Europe, and leverage public capital markets to support growth.
MTNB closed Friday’s trade at $0.34, down 3.62%.
Clinical Trials – Breakthroughs & Setbacks
Insmed Reports Positive 12-Month Data For Treprostinil Palmitil Inhalation Powder In PAH
Insmed Incorporated (INSM) announced encouraging 12-month results from its ongoing open-label extension study of treprostinil palmitil inhalation powder (TPIP), a once-daily therapy being developed for pulmonary arterial hypertension (PAH).
According to the company, the findings highlight sustained improvements across key efficacy measures and reinforce TPIP’s potential as a next-generation prostanoid treatment. Doses up to 1,280 µg once daily were permitted in the study, with no new safety concerns identified.
INSM closed Friday’s trade at $108.3, up 0.80%.
Fractyl’s Revita Maintains Weight Loss Post GLP-1 Discontinuation
Fractyl Health, Inc. (GUTS) announced positive one-year randomised data from the REMAIN-1 Midpoint Cohort, demonstrating that its Revita duodenal mucosal resurfacing (DMR) system can help maintain weight loss after stopping GLP-1 therapy.
According to the company, a single Revita procedure reduced weight regain by approximately 40% versus sham at one year, and the FDA-mandated co-primary endpoint of responder rate, which is maintaining at least 5% total body weight loss at one year, was achieved by 73% of Revita patients in the Midpoint Cohort, rising to 91% in those with complete ablation.
GUTS closed Friday’s trade at $0.81, down 5.19%.
Veradermics Reports Positive Phase 2 Results For VDPHL01 In Women With Pattern Hair Loss
Veradermics, Incorporated (MANE) reported positive topline results from its Phase 2 study of VDPHL01, an extended-release oral minoxidil formulation, in women with mild-to-moderate pattern hair loss.
The company said VDPHL01 was generally well tolerated, produced clinically meaningful hair growth, with participants experiencing increases in non-vellus terminal hair counts after six months of treatment. Women receiving a 4.5 mg once-daily dose recorded an average increase of 22.7 hairs per square centimetre, while those receiving the same dose twice daily saw an increase of 23.3 hairs per square centimetre.
MANE closed Friday’s trade at $111.32, up 5.19%.
Biogen’s Phase 2 CELIA Study Shows Tau Reduction and Cognitive Benefit In Early Alzheimer’s
Biogen Inc. (BIIB) presented new data from its Phase 2 CELIA study of Diranersen, an investigational antisense oligonucleotide therapy targeting tau, at the Alzheimer’s Association International Conference (AAIC) 2026, highlighting meaningful clinical outcomes and strong biomarker responses in patients with early Alzheimer’s disease.
The 60 mg dose showed the strongest response, slowing cognitive decline by 42% on ADAS-Cog13, 50% on MMSE, and 26% on CDR-SB compared to placebo.
BIIB closed Friday’s trade at $205.99, down 1.40%.
Cadrenal Presents Positive Phase 2 Data For CAD-1005 In Treating Thrombosis
Cadrenal Therapeutics (CVKD), a late-stage biopharmaceutical company, announced late-breaking data from the Phase 2 study for CAD-1005, a selective 12-lipoxygenase (12LOX) inhibitor for the treatment of Heparin-Induced Thrombocytopenia.
According to the company, the Phase 2 study for CAD-1005 showed improved efficacy, with treated patients experiencing more than a 25% reduction in new or worsening thrombotic events compared with the placebo arm, alongside no new safety signals.
CVKD closed Friday’s trade at $2.16, down 7.30%.
GSK Decides Not To Progress Development Of Camlipixant In Refractory Chronic Cough
GSK plc (GSK, GSK.L) issued an update on the CALM-1 and CALM-2 phase III clinical trials, which assessed the efficacy and safety of two doses of camlipixant in adults with refractory chronic cough.
In the aggregate data, the limited efficacy demonstrated is unlikely to transform patient care, said GSK. Although CALM-1 met its primary endpoint, CALM-2 did not reach statistical significance for the same primary endpoint at 50mg twice daily at week 24.
GSK closed Friday’s trade at $51.76, down 1.91%.
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