The focus shifts back to regualr pipleine updates in the biotech sector with the end of the third-quarter earnings season. Among these, Sage Therapeutics, Inc. SAGE  and Incyte INCY were in focus this week as investors were disappointed with study failures.

Recap of the Week’s Most Important Stories:

SAGE Suffers Setback

Sage Therapeutics  announced disppointing top-line results from the mid-stage study on dalzanemdor (SAGE-718). The phase II DIMENSION Study was a 12-week, double-blind, placebo-controlled study to evaluate the effects of dalzanemdor in participants with cognitive impairment (CI) associated with Huntington’s Disease (“HD”). A total of 189 participants were randomized.

However, the study did not demonstrate a statistically significant difference from baseline in participants treated with dalzanemdor versus placebo on the Symbol Digit Modalities Test (“SDMT”), a measure of cognitive function, at day 84, the primary endpoint.

In addition, analyses of secondary endpoints did not demonstrate statistically significant or clinically meaningful differences in participants treated with dalzanemdor compared to placebo. Consequently, SAGE does not plan further development of dalzanemdor.

SAGE will also discontinue the ongoing PURVIEW Study, an open-label safety study of dalzanemdor in participants with HD.

Earlier, LIGHTWAVE study to evaluate the effects of dalzanemdor in participants with mild cognitive impairment or mild dementia due to Alzheimer’s Disease (“AD”) also failed to meet its primary endpoint. SAGE then decided to stop the development of the candidate in AD.

Sage Therapeutics currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Incyte Pauses Enrollment in CSU Study

Incyte suffered a setback in its ongoing mid-stage study on MRGPRX2 (INCB000262) in chronic spontaneous urticaria (CSU).

Incyte announced that it would pause enrollment in the ongoing phase II study of MRGPRX2 in CSU due to certain in vivo preclinical toxicology findings. The data was also shared with the FDA. The company is now working closely with the FDA to determine the next steps.

Additionally, data from the phase II study evaluating MRGPRX4 in cholestatic pruritus does not support further development.

Meanwhile, enrollment in the other INCB000262 proof-of-concept studies is complete. Data from these studies should help support INCY’s future development and guide the potential growth of backup molecules.

Shares of INCY plunged on this setback.

Pyxis Reports Phase I Data

Pyxis Oncology, Inc. PYXS announced positive preliminary data from the ongoing phase I clinical dose escalation study evaluating PYX-201 in multiple types of solid tumors. Significant clinical responses were observed in patients with head and neck squamous cell carcinoma (HNSCC).