Ironwood Pharmaceuticals Inc. is taking over Vectivbio Holding AG for $17 per share in an all-cash deal worth about $1 billion, net of the latter’s available money and debt. Vectivbio brings to Ironwood apraglutide, a next-generation synthetic glucagon-like peptide-2 analog at the phase III stage for short bowel syndrome with intestinal failure. Top-line results are expected by the end of this year. Shares of Vectivbio (NASDAQ:VECT) were trading midday at $16.18, up $4.48, or 38.31%. Ironwood’s stock (NASDAQ:IRWD) was selling for $10, down 47 cents.

Weathering the storm? Rain’s cancer drug misses phase III goal

Rain Oncology Inc.’s only asset failed a phase III study for treating dedifferentiated liposarcoma, casting shadows on the future of the small molecule and the company’s direction. Milademetan, an oral inhibitor of the MDM2-p53 complex that reactivates p53, missed the primary endpoint of progression-free survival (PFS) compared to the standard of care treatment, Yondelis (trabectedin, Johnson & Johnson/Pharmamar SA). The median PFS for milademetan was 3.6 months compared to 2.2 months for trabectedin (p=0.53). CEO Avanish Vellanki said the company is re-evaluating the drug’s future. Rain’s stock (NASDAQ:RAIN) had plummeted a dramatic 87% at midday to about $1.24 a share.

Apnimed moving to phase III with oral therapy for sleep apnea

Apnimed Inc. is gearing up to start phase III testing in the second half of 2023 with AD-109, a once-daily combination of atomoxetine and aroxybutynin aiming to become the first oral therapy to treat obstructive sleep apnea (OSA), following positive results from the phase IIb Mariposa trial. Presented during the OSA Mini Symposium at the ATS 2023 International Conference in Washington over the weekend, the data showed Mariposa met the primary endpoint, as assessed using the Apnea-Hypopnea Index (AH14, 4% desaturation for hypopneas). Both doses of AD-109 achieved a statistically significant reduction of AH14 vs. placebo and improved important symptoms of apnea such as daytime fatigue.

First DME eye drop edges closer to approval as Oculis reports phase III win

With its sights firmly set on being the first company to bring a topical diabetic macular edema (DME) treatment to market, Oculis Holding AG moved a step closer to this potentially game-changing reality as its dexamethasone formulation, OCS-01, turned up a statistically significant improvement in mean BCVA – a measure of visual acuity – at the three-month mark in the phase III Diamond trial.

Pressure mounts for CMS coverage ahead of Leqembi’s full approval date

As the clock ticks toward the full, or traditional, approval date for Biogen Inc./Eisai Co. Inc.’s Alzheimer’s drug, Leqembi (lecanemab), the U.S. Centers for Medicare & Medicaid Services (CMS) is facing increasing pressure to get the structures in place to ensure Medicare beneficiaries have access to the drug as soon as that approval comes. In testifying before a House committee last month, CMS Administrator Chiquita Brooks-LaSure pledged that if Leqembi’s accelerated approval is converted to full approval as expected in early July, CMS will broaden its restrictive coverage of the drug to include beneficiaries enrolled in registries. That promise was met with bipartisan scepticism and criticism as CMS has yet to provide guidance on what those registries must entail. Now a key Democratic senator, Oregon’s Ron Wyden, is adding his voice to the chorus of demands that CMS get its act together before the traditional approval comes.

Hanall’s tanfanercept shows mixed phase III results for dry eye disease

Hanall Biopharma Co. Ltd.’s phase III trial VELOS-3 of tanfanercept did not show effects on the central cornea of the eye or in eye dryness in the treatment of moderate to severe dry eye disease, the primary endpoints. Data from the trial did show improvements in tear production, a secondary endpoint. VELOS-3 is a U.S.-based multicenter, randomized, double-masked, vehicle-controlled study designed to evaluate tanfanercept ophthalmic solution 0.25% for the treatment of adults with moderate to severe dry eye disease.

Sanhome’s alfosbuvir obtains NMPA approval for HCV treatment

Nanjing Sanhome Pharmaceutical Co. Ltd.’s Shengnuodi (alfosbuvir tablets), used as part of a combination treatment for hepatitis C, has been approved by China’s NMPA through a priority review and approval procedure. Shengnuodi is used in combination with daclatasvir to treat chronic hepatitis C virus (HCV) infections of genotypes 1, 2, 3, and 6 in adults that are treatment-naive or interferon-experienced, with or without compensated cirrhosis.

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