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.

Latest

Eli Lilly announced that its latest weight loss drug, retatrutide, has shown in recent clinical trials to be a stronger treatment for diabetes and weight loss than its predecessors (Zepbound) and competitors (Wegovy).

Eli Lilly's new drug shows 3-way action in weight loss race

**Key Takeaways:** * Eli Lilly's retatrutide, a novel triple-agonist, shows potentially superior weight loss and diabetes control in Phase 3 trials compared to existing single and dual-agonist drugs. * The drug targets three separate hormones (GLP-1, GIP, and glucagon) to regulate appetite and metabolism, a first for the market. * While not yet launched, retatrutide could solidify Lilly's lead over Novo Nordisk in a weight-loss drug market projected to exceed $100 billion.

ImmunityBio announced an exclusive U.S. agreement with Japan BCG Laboratory for the Tokyo-172 strain of BCG to address the ongoing bladder cancer drug shortage.

ImmunityBio Tackles 10-Year Cancer Drug Shortage With New Japan Deal

**Key Takeaways:** * ImmunityBio (IBRX) signed an exclusive U.S. agreement with Japan BCG Laboratory to supply the Tokyo-172 strain of Bacillus Calmette-Guérin (BCG). * The deal aims to address a more than decade-long shortage of BCG, the standard of care for high-grade non-muscle invasive bladder cancer (NMIBC). * A Phase III trial showed the Tokyo strain was non-inferior to the current TICE BCG, with a 5-year high-grade recurrence-free survival rate of 64 percent.

Denali Therapeutics says the commercial launch of its first drug, AVLAYAH, is ahead of expectations following its accelerated approval for Hunter syndrome.

Denali says 1st drug launch ahead of plan after approval

**Key Takeaways:** * Denali Therapeutics says the early launch of its first drug, AVLAYAH, is "ahead of expectations" after its March 24 accelerated approval for Hunter syndrome. * The company reports strong physician engagement and smooth reimbursement, with the first commercial patients already starting the therapy. * AVLAYAH, which treats neurologic and systemic symptoms, is seen as a potential $1 billion opportunity combined with another pipeline candidate.

Dr. Reddy's Laboratories announced on May 16, 2026, that it has launched its generic Semaglutide injection in Canada for the treatment of type 2 diabetes.

Dr Reddy's Launches 2 mg Generic Semaglutide Pen in Canada, a G7 First

**Key Takeaways** * Dr. Reddy's launches generic Semaglutide injection in Canada for type 2 diabetes. * Canada is the first G7 country to grant market authorization for the generic drug. * The launch introduces price competition for Novo Nordisk's brand-name version.

Regeneron Pharmaceuticals announced its Phase 3 trial for a first-line metastatic melanoma treatment, combining fianlimab and cemiplimab, did not meet its primary endpoint for progression-free survival.

Regeneron Melanoma Drug Fails Phase 3 Trial With p-Value of 0.0627

**Key Takeaways:** * Regeneron’s fianlimab/cemiplimab combo failed to meet its primary endpoint in a Phase 3 melanoma trial. * The high-dose combination showed a median progression-free survival of 11.5 months versus 6.4 months for pembrolizumab. * The result was not statistically significant, with a p-value of 0.0627, narrowly missing the threshold.

On May 15, 2026, the U.S. Food and Drug Administration granted clearance to United Therapeutics to proceed with a clinical study of its UHeart™, a genetically modified pig heart for xenotransplantation.

United Therapeutics to trial pig hearts in humans after FDA clearance

**Key Takeaways:** * FDA clears Investigational New Drug application for UHeart™ xenotransplantation. * The EXPRESS study will initially enroll up to two patients with end-stage heart failure. * The UHeart™ is derived from a pig with 10 genetic modifications to improve compatibility.

Candel Therapeutics announced that its prostate cancer drug, aglatimagene besadenovec, demonstrated a 39% reduction in disease recurrence risk in a phase 3 trial.

Candel Drug Cuts Prostate Cancer Recurrence Risk by 39% in Phase 3 Data

**Key Takeaways** * CAN-2409 showed a 39% improvement in disease-free survival vs. placebo * Time to metastasis was reduced by 90% in intermediate-risk patients * Company plans to file for FDA approval in the fourth quarter of 2026

Kissei Pharmaceutical reported that twenty people in Japan died after taking a rare immune-disease drug from Amgen, leading Kissei to halt new prescriptions and U.S. drug regulators to request Amgen voluntarily withdraw the drug.

Amgen Stock Drops Over 2% After 20 Deaths Tied to Tavneos Drug

Amgen's stock fell after its Japanese partner, Kissei Pharmaceutical, reported 20 deaths among patients taking the rare-disease drug Tavneos. Kissei has halted new prescriptions for the drug in Japan following the report, which also cited at least 22 cases of serious liver injury.

On May 15, 2026, West Pharmaceutical Services announced that its global manufacturing and logistics operations were recovering from a cyberattack that occurred earlier in May 2026.

West Pharma stock up 1% as production ramps after cyberattack

**Key Takeaways:** * West Pharmaceutical Services announced its operations are recovering from a May 4 cyberattack that disrupted global manufacturing and led to data exfiltration. * The company's stock (WST) rose over 1% on the news, recovering a portion of the 7% loss it suffered since the attack was disclosed. * All high-value product sites are fully operational, and production is ramping up across all locations, though the full financial impact has not yet been disclosed.

On May 15, 2026, the U.S. Food and Drug Administration (FDA) approved Genentech's (a Roche Group member) drug Tecentriq for adjuvant treatment of muscle-invasive bladder cancer (MIBC) in patients with circulating tumor DNA molecular residual disease (ctDNA MRD), as identified by Natera's Signatera test.

Genentech wins first FDA approval for ctDNA-guided cancer therapy

**Key Takeaways:** * Genentech, a Roche unit, received FDA approval for Tecentriq as an adjuvant therapy for muscle-invasive bladder cancer (MIBC) after surgery. * The approval is the first of its kind, using Natera’s Signatera test to detect circulating tumor DNA (ctDNA) and guide treatment decisions. * In the Phase III IMvigor011 trial, the treatment cut the risk of death by 41% in ctDNA-positive patients compared to a placebo.

Moleculin Biotech announced a 40% composite complete remission rate in its pivotal AML trial for Annamycin but revealed its cash would only fund operations into Q3 2026.

Moleculin reports 40% remission rate in AML trial but cash runs short

**Key Takeaways** * Moleculin’s Annamycin shows a 40% blinded composite complete remission rate in a pivotal AML trial, more than double the 18% historical rate for the current standard of care. * The company ended Q1 2026 with $10.3 million in cash, which is only expected to fund operations into Q3 2026, creating significant financing risk. * Key upcoming catalysts include the first 45-subject data unblinding in Q2 2026 and full Part A enrollment of 90 subjects in Q3 2026.

Sensei Biotherapeutics reported a $170.2 million Q1 net loss driven by acquisition costs, but a concurrent $200 million capital raise provides a multi-year runway for its new lead cancer therapy, PIKTOR.

Sensei Bio pivots to PI3K, ends Q1 with $203M after Faeth deal

**Key Takeaways** * Reports a Q1 net loss of $170.2 million, driven by a $133 million one-time charge from its acquisition of Faeth Therapeutics. * Ends the quarter with $202.8 million in cash, strengthened by a $200 million private placement completed in February. * PIKTOR, a PI3K/AKT/mTOR pathway inhibitor, is now the lead asset with topline Phase 2 endometrial cancer data due in 2H 2026.

Protara Therapeutics announced positive 12-month data from its Phase 2 trial of TARA-002, showing a 55% complete response rate in a form of bladder cancer.

Protara Posts 55% 12-Month Bladder Cancer Response Rate

**Key Takeaways** * TARA-002 shows a 55% complete response rate at 12 months in BCG-Naïve NMIBC. * No Grade 3 or higher treatment-related adverse events were reported in the trial. * The company plans to start the pivotal ADVANCED-3 trial in the second half of 2026.

Alpha Cognition (NASDAQ: ACOG) reported a 40% sequential revenue growth for the first quarter of 2026, attributing the increase to the commercial adoption of its Alzheimer's treatment, ZUNVEYL.

Alpha Cognition reports 40% revenue growth on Zunveyl adoption

**Key Takeaways** * Reported Q1 2026 net revenue of $3.5 million, a 40% sequential increase driven by its Alzheimer’s drug Zunveyl. * Zunveyl bottles dispensed grew 23% quarter-over-quarter to 6,054, with active prescribers rising 23% to 1,060. * Company expects top-line data from its BEACON real-world study in early Q3 2026, ahead of its prior schedule.

Esperion Therapeutics, following a $1.1 billion acquisition agreement with Archimed, announced it will present new positive data from a pediatric Phase 2 study and adult outcomes trial for its bempedoic acid franchise.

Esperion to Detail New Bempedoic Acid Data After $1.1B Buyout

**Key Takeaways:** * Following its $1.1 billion acquisition agreement with Archimed, Esperion will present new data on its cholesterol-lowering bempedoic acid at the EAS Congress 2026. * A Phase 2 study showed bempedoic acid reduced LDL-C in children with HeFH, supporting a move to Phase 3 trials and potentially opening a new pediatric market. * The acquisition deal includes a $3.16 per share cash payment and up to $100 million in future sales milestones for bempedoic acid and the recently acquired drug Enbumyst.

Senti Biosciences secured up to $40 million in financing and received positive FDA feedback to advance its SENTI-202 cell therapy into a pivotal trial for acute myeloid leukemia.

Senti Bio Secures $40 Million, Advances Cancer Therapy to Pivotal Trial

**Key Takeaways:** * Senti Bio received positive FDA feedback to start a single-arm pivotal trial for its SENTI-202 cancer therapy in patients with relapsed/refractory acute myeloid leukemia. * The company identified a "Donor X" profile that boosted composite complete remission rates to 50% from 12.5% in a 22-patient Phase 1 study. * A new financing deal provides up to $40 million, extending the company's cash runway as it prepares for the later-stage trial.

AIM ImmunoTech highlighted positive interim data from two studies for its lead pancreatic cancer drug, Ampligen, with further results expected in June 2026.

AIM ImmunoTech Highlights 2 Sources of Positive Pancreatic Cancer Data

**Key Takeaways** * AIM ImmunoTech showcased positive data for its lead drug, Ampligen, in treating late-stage pancreatic cancer during a virtual investor event. * The data comes from a completed Named Patient Program and an ongoing Phase 2 trial in collaboration with AstraZeneca. * The company expects to report further milestones for the Phase 2 DURIPANC study in June 2026, including the completion of enrollment.

The American Urological Association strengthened its recommendation for PROCEPT BioRobotics' Aquablation therapy, a key validation that supports the company's rapid revenue growth.

PROCEPT Eyes 40 Million Patient Market as AUA Lifts Aquablation

**Key Takeaways:** * The American Urological Association (AUA) issued a strengthened recommendation for PROCEPT BioRobotics’ Aquablation therapy, validating it as a primary surgical option for a wider range of patients with benign prostatic hyperplasia (BPH). * The endorsement supports PROCEPT’s rapid growth, which saw Q1 2026 revenue climb 20% to $83.1 million and U.S. procedure volume jump 30% even as the company invests heavily in commercialization. * This key clinical validation, following a similar upgrade in Europe, provides a crucial tailwind for the company as it aims for positive adjusted EBITDA by the fourth quarter of 2026.

Celcuity is expanding its Phase 3 VIKTORIA-2 trial of gedatolisib to include endocrine-sensitive patients as a first-line treatment for HR+/HER2- advanced breast cancer.

Celcuity Expands Gedatolisib Trial to 90,000 Patients in First-Line Breast Cancer

**Celcuity is broadening the pivotal Phase 3 trial for its cancer drug gedatolisib, aiming to capture a larger share of the first-line treatment market for the most common type of advanced breast cancer.**

On May 14, 2026, Cabaletta Bio presented 6-to-9-month clinical data for its product rese-cel from the RESET-PV study at the ASGCT 2026 Annual Meeting and also reported its first-quarter 2026 financial results.

Cabaletta posts 50% response rate in PC-free CAR-T study

**Key Takeaways:** * A single low-dose infusion of rese-cel without preconditioning produced a 6-month drug-free response in 50% of patients with pemphigus vulgaris. * The company reported a net loss of $43.5 million for Q1 2026, with a cash runway projected into mid-2027. * Initial data confirmed consistent manufacturing of rese-cel using the automated Cellares Cell Shuttle platform, a key step for scalable production.

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