Sam Goldstein
Healthcare Reporter

FDA decisions, clinical trial readouts, and pharma M&A. PhD in molecular biology before pivoting to science journalism. Can actually read a Phase 3 protocol.new

Latest

Nektar Therapeutics started two Phase III studies for rezpegaldesleukin in moderate-to-severe atopic dermatitis, sending shares up 5.9 percent.

Nektar Therapeutics starts Phase III eczema program as shares gain 5.9%

Nektar Therapeutics initiated two Phase III studies of rezpegaldesleukin for moderate-to-severe atopic dermatitis, with a third study set to begin in September. Shares rose 5.9% on the news. Top-line data is expected in mid-2028.

BridgeBio Pharma announced FDA acceptance of its New Drug Application for encaleret to treat autosomal dominant hypocalcemia type 1, with a PDUFA date of May 8, 2027.

BridgeBio's encaleret gets FDA review with May 2027 PDUFA date

**Key Takeaways:** - FDA accepted BridgeBio's NDA for encaleret in ADH1 with a PDUFA date of May 8, 2027 - The Phase 3 CALIBRATE trial met all primary and key secondary efficacy endpoints - If approved, encaleret would be the first therapy specifically indicated for ADH1

Johnson & Johnson received FDA marketing authorization for its OTTAVA robotic surgical system, clearing the company to compete with Intuitive Surgical in the soft-tissue robotics market.

J&J wins FDA nod for OTTAVA robot, challenging Intuitive's $7B franchise

**Key Takeaways:** - J&J received FDA De Novo authorization for OTTAVA, the first table-integrated soft-tissue surgical robot - The system occupies 30% to 50% less space than traditional robotic systems from Intuitive Surgical - J&J will begin a U.S. commercial launch with select customers, with an investor call set for Aug. 3

Medicare's new GLP-1 pilot program is seeing patients choose injectable obesity drugs over pills, defying industry expectations that older patients would prefer oral versions.

Medicare GLP-1 pilot sees 200 patients choose injections in first week

**Key Takeaways:** - Medicare's GLP-1 pilot saw more than 200 patients approved for injectables in its first week. - Patients are choosing injections over pills despite earlier expectations of a 2-to-1 preference for oral versions. - Injectable drugs showed stronger weight-loss efficacy than oral versions in clinical trials.

Celldex Therapeutics discontinued development of barzolvolimab for prurigo nodularis after the drug failed a Phase 2 study, sending shares down over 7 percent in extended trading.

Celldex drops 7% after barzolvolimab fails Phase 2 prurigo nodularis trial

Celldex Therapeutics shares fell more than 7% in extended trading Tuesday after its experimental drug barzolvolimab failed a Phase 2 study in prurigo nodularis. The company will discontinue the program but remains focused on developing barzolvolimab for other inflammatory conditions, with Phase 3 CSU data expected in September or October 2026.

Gilead Sciences expects an $11.2 billion second-quarter expense from acquiring in-process research and development assets, driving a per-share loss of $7.09.

Gilead Sciences expects $11.2B IPR&D charge to hit Q2 earnings

Gilead Sciences said it expects an $11.2 billion expense in the second quarter of 2026 tied to the acquisition of in-process research and development assets. The charge will push the company to a per-share loss of $7.09, compared with a profit of $2.01 a year earlier.

Acadia Pharmaceuticals announced the FDA granted Fast Track designation to remlifanserin for Alzheimer's disease psychosis, with phase 2 data expected by October 2026.

Acadia wins FDA Fast Track for remlifanserin as phase 2 data nears

**Key Takeaways:** - FDA granted Fast Track designation to remlifanserin for Alzheimer's disease psychosis. - Phase 2 portion of the RADIANT trial is fully enrolled with data due by October. - No FDA-approved therapies currently exist for Alzheimer's disease psychosis.

Eli Lilly outpaces Novo Nordisk in the GLP-1 obesity drug market with $15.8 billion in Q1 2026 revenue and 31.6% projected annual growth.

Eli Lilly leads Novo Nordisk in GLP-1 race with 31.6% revenue growth

**Key Takeaways:** - Eli Lilly's GLP-1 portfolio generated $15.8B in Q1 2026, topping Novo Nordisk's $14.2B - Lilly projects 31.6% revenue growth in 2026 while Novo Nordisk expects a 4.8% decline - Lilly trades at 28.4x forward earnings versus Novo Nordisk's 14.9x, reflecting pipeline confidence

MaxCyte entered a multi-platform technology license partnership with Genentech to support cell therapy development across research, clinical, and manufacturing workflows.

MaxCyte shares slip 5.7% on Genentech cell therapy license deal

MaxCyte licensed its ExPERT GTx cell engineering platform to Genentech for multiple cell therapy programs. The deal covers research through commercial manufacturing workflows. Financial terms of the multi-platform partnership were not disclosed.

Novo Nordisk filed a lawsuit against Eli Lilly on July 21, 2026, alleging misleading advertising for GLP-1 weight-loss drugs Zepbound and Mounjaro.

Novo Nordisk sues Eli Lilly, citing 19% weight loss data in ad dispute

Novo Nordisk sued Eli Lilly on Monday, alleging its GLP-1 drug ads omit data showing Wegovy's higher-dose efficacy of 19% weight loss.

Novartis reported Q2 core operating profit that beat market expectations, driven by strong sales of cancer and multiple sclerosis drugs amid mounting generic competition.

Novartis beats Q2 profit estimates as cancer drugs offset patent losses

**Key Takeaways:** - Novartis Q2 core profit beat estimates on strong drug sales. - Kisqali and Pluvicto drove growth as generic competition mounted. - The company navigates patent cliffs and US drug pricing reforms.

Immix Biopharma shares fell 13% after its chief medical officer was revealed to be a Rhode Island fugitive, triggering securities fraud investigations.

Immix Biopharma drops 13% after fugitive CMO arrest sparks probe

**Key Takeaways:** - Immix Biopharma shares fell as much as 13% on July 20 - CMO "Richard Graydon" was fugitive Ronald Fischer, arrested off New Jersey - Multiple law firms are investigating potential securities law violations

Novo Nordisk received European Union approval for the first oral GLP-1 obesity tablet, expanding its Wegovy product line amid intensifying competition.

Novo Nordisk wins EU nod for oral Wegovy with 17% weight loss

**Key Takeaways:** - EU approved Novo Nordisk's oral Wegovy (semaglutide 25 mg) for weight management. - The pill achieved 17% weight loss in the OASIS 4 trial vs 3% for placebo. - Approval marks the fifth market for oral Wegovy as GLP-1 competition intensifies.

Merck faces a $24 billion annual revenue gap from Keytruda's 2028 patent expiration, driving a restructuring and race for the next standard cancer treatment.

Merck faces $24B Keytruda cliff as successor race heats up

**Key Takeaways:** - Merck faces an estimated $24 billion annual revenue gap when Keytruda's U.S. patent expires in December 2028 - The company split its Human Health division into two units and deployed over $19 billion in acquisitions - A subcutaneous Keytruda formulation and 80-plus Phase 3 studies aim to build $70 billion in pipeline opportunities by the mid-2030s

AbbVie will fund its $10.9 billion acquisition of Apogee Therapeutics with debt, preserving its Dividend King streak and cash reserves.

AbbVie's $10.9B Apogee deal funded with debt, preserving dividend streak

AbbVie will fund its $10.9 billion acquisition of Apogee Therapeutics with debt, preserving cash reserves and the company's dividend program.

Viking Therapeutics initiated a phase 1 clinical trial for VK3019, a dual amylin and calcitonin receptor agonist targeting weight loss beyond the GLP-1 pathway.

Viking Therapeutics starts phase 1 trial for next-gen obesity drug beyond GLP-1

**Viking Therapeutics launched a phase 1 trial for VK3019, a weight-loss drug targeting the amylin pathway — a mechanism distinct from the GLP-1 class dominated by Eli Lilly and Novo Nordisk.**

4DMT announces positive two-year data from PRISM Phase 2b trial of gene therapy 4D-150 in wet AMD patients.

4DMT's gene therapy cuts wet AMD injections 78% in 2-year trial

**Key Takeaways:** - Single dose of 4D-150 cut supplemental injections by 78% over two years - Recently diagnosed patients saw an 87% reduction in treatment burden - No new safety signals emerged with up to four years of follow-up

Viking Therapeutics stock dips after a 19% June rally, while Wall Street maintains a $91 consensus price target on obesity drug candidate VK2735.

Viking Therapeutics dips as Wall Street sees 150% upside on VK2735

**Key Takeaways:** - Wall Street consensus price target of $91 implies 150% upside from current levels - Phase 1 maintenance trial results for obesity drug VK2735 due within six months - Phase 3 data for subcutaneous and oral formulations not expected until 2027-2028

Shanghai Cancer Institute director Liu Yingbin announces AI-assisted diagnosis achieves 92% non-invasive accuracy for gallbladder cancer at World AI Conference 2026.

AI cancer diagnosis hits 92% accuracy in gallbladder cancer breakthrough

**Key Takeaways:** - AI-assisted diagnosis achieves 92% non-invasive detection rate for gallbladder cancer - Shanghai Cancer Institute combines CT scans with liquid biopsy for early detection - Breakthrough presented at WAIC 2026 could reshape oncology screening protocols

uniQure sharpens its gene therapy focus on AMT-130 for Huntington's disease with a Q3 2026 FDA filing target after the agency accepted three-year Phase I/II data for accelerated approval.

uniQure sharpens gene therapy focus as AMT-130 targets 2026 FDA filing

**uniQure is reshaping its gene therapy strategy around a faster regulatory path for AMT-130, its Huntington's disease candidate, while narrowing its operating model to pure research and development.**

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