Roivant's lung hypertension drug hits Phase 2 goals

Roivant announced on Tuesday that its drug candidate mosliciguat met all primary and secondary goals in a Phase 2 trial for pulmonary hypertension associated with interstitial lung disease (PH-ILD). The treatment reduced pulmonary vascular resistance, a measure of blood flow difficulty in the lungs, by 56%. Roivant called this the highest reduction ever reported in a randomized pulmonary hypertension trial and has already started a Phase 3 study.

Leerink Partners analyst David Risinger described the results as "exceptional." In a note cited by Biopharma Dive, he wrote that development plans for mosliciguat in other conditions could yield a drug with over $10 billion in annual sales. Following the news, Roivant's stock price increased by 20%.

AstraZeneca's Etcamah wins FDA approval

AstraZeneca has secured an accelerated U.S. Approval for its breast cancer pill, Etcamah. The Food and Drug Administration granted the clearance on Friday for first-line treatment of HR-positive, HER2-negative breast cancer where an ESR1 mutation is detected using an FDA-authorized test. This marks a first-of-its-kind treatment approach tied to that specific mutation.

The approval came after a setback in April, when an FDA advisory committee voted against the therapy, finding the supporting evidence inconclusive. The agency subsequently delayed its decision. According to Biopharma Dive, physicians consulted by Leerink Partners noted that AstraZeneca's study did not clearly prove the benefits of this strategy compared to treating patients after their disease progresses. Analyst Andrew Berens wrote that this issue "could impact the commercial opportunity." He added that a larger payoff for Etcamah could come if another ongoing first-line study is successful.

Bristol Myers Squibb's novel CAR-T therapy

Bristol Myers Squibb announced positive mid-stage trial results on Tuesday for a new cell therapy, arlocabtagene autoleucel (arlo-cel). The therapy is a CAR-T treatment directed at the GPRC5D protein, which is overexpressed on diseased cells in multiple myeloma. The company stated that arlo-cel demonstrated a statistically significant and clinically meaningful response rate in patients whose multiple myeloma had progressed after at least four prior lines of therapy. Those prior treatments included drugs targeting BCMA, a more established myeloma target.

Pharvaris and Inhibrx report trial updates

Pharvaris reported that its once-daily pill, deucrictibant, reduced the rate of swelling attacks by 83% in a Phase 3 study for hereditary angioedema (HAE). The company claims this is the first Phase 3 study to evaluate a preventive therapy against all three forms of HAE. Pharvaris plans to seek regulatory approval for the therapy in the first half of 2027, where it would compete with other oral and injectable treatments.

Inhibrx Biosciences announced that a combination of its immunotherapy, INBRX-106, and Merck's Keytruda outperformed Keytruda alone in a mid-stage head and neck cancer trial. The company reported a response rate of roughly 48% for the combination in recurrent head and neck squamous cell carcinoma, compared to about 27% for Keytruda alone. After six months, around 72% of patients on the combination were progression-free, versus nearly 43% in the control group. Stifel analyst Dara Azar wrote that the results "exceeded expectations." Inhibrx is expanding the trial to include 50 more patients with HPV-positive tumors, a subgroup where the drug's effects appear strongest. Despite the positive data, Inhibrx's shares fell by approximately 7%.