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).
PYX-201 achieved a confirmed 50% ORR by RECIST 1.1, including one Complete Response and 100% Disease Control Rate in six heavily pretreated HNSCC patients. The positive data supports PYXS’ plans to launch monotherapy expansion studies in the first quarter of 2025.
Pyxis also announced that it has entered into a clinical trial collaboration agreement with Merck.
Per the terms of the deal, Pyxis Oncology will sponsor a study of PYX-201 in combination with Merck’s anti-PD-1 therapy, Keytruda (pembrolizumab), in patients with first-line and second-line HNSCC, HR+/HER2 breast cancer, and triple-negative breast cancer and sarcoma. Dosing is expected to begin in the first quarter of 2025.
JAZZ Wins Drug Approval
Jazz Pharmaceuticals plc JAZZ announced that the FDA has granted accelerated approval to Ziihera (zanidatamab-hrii) 50mg/mL for injection for intravenous use to treat adults with previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer (BTC), as detected by an FDA-approved test.
The accelerated approval was granted based on a 52% objective response rate (ORR) and a median duration of response (DOR) of 14.9 months as determined by an independent central review. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
The late-stage HERIZON-BTC-302 confirmatory trial is ongoing to evaluate zanidatamab in combination with standard-of-care therapy versus standard-of-care therapy alone in the first-line setting for patients with HER2-positive BTC.
Zanidatamab is also being evaluated in a number of additional tumor types, including phase III studies in gastroesophageal adenocarcinomas and metastatic breast cancer.
Performance
The Nasdaq Biotechnology Index has declined 5.99% in the past five trading sessions and Moderna’s shares have lost 12.34%. In the past six months, shares of MRNA have lost 73.8%. (See the last biotech stock roundup here: Biotech Stock Roundup: NVAX Q3 Results, SNDX Down on AML Data, RNA Surges on Study Data)
Image Source: Zacks Investment Research
What's Next in Biotech?
Stay tuned for more pipeline updates.
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