Tonix Gets IND Clearance for Depression Treatment

 TNX-601 ER, Tianeptine Hemioxalate, is an Extended-Release Tablet for Once-a-Day Dosing

Phase 2 Clinical Trial of TNX-601 ER Expected to Start First Quarter 2023

https://finance.yahoo.com/news/tonix-pharmaceuticals-announces-ind-clearance-110000875.html

Calithera Receives FDA Fast Track Designation for Treatment of Squamous Lung Cancer

 Enrollment ongoing in Phase 2 study evaluating sapanisertib, a dual mTORC1/2 inhibitor, in patients with squamous non-small cell lung cancer harboring a NRF2 mutation

https://finance.yahoo.com/news/calithera-receives-fda-fast-track-110000872.html

Clene misses in ALS trial

 

• The primary endpoint of adjusted ALSFRS-R and secondary endpoints of CAFS and SVC were not met at 24 weeks
  

• Prespecified exploratory analyses of the secondary survival endpoint for the 30 mg dose demonstrated a >90% reduction in risk of death or risk of death/permanently assisted ventilation at 24 weeks

• Survival signal consistent with prior results from the Phase 2 RESCUE-ALS trial

• Clene will continue the open-label extension of CNM-Au8 in the Healey ALS Platform Trial and is in discussions with the Healey & AMG ALS Center to design and offer an Expanded Access Protocol (EAP) of CNM-Au8 30mg for eligible participants of closed regimens and others

• Clene is pursuing multiple paths, including ongoing discussions with potential strategic partners, in its goal of marketing authorization

• Clene to host investor call and webcast at 8:30 am EDT today

Clene will host a conference call and webcast at 8:30 am EDT to discuss the Healey ALS Platform trial topline results for CNM-Au8. Members of Clene’s executive team will lead the discussion.

Time and Date: 8:30 a.m. EDT on Oct. 3, 2022
Investors: 1 (888) 660-6179 (toll-free) or 1 (929) 203-1946 (toll)
Conference ID: 5318408
Press *1 to ask or withdraw a question, or *0 for operator assistance.

To access the live webcast, please register online at this link. Participants are requested to register at a minimum 15 minutes before the start of the call. A replay of the call will be available two hours after the call and archived on the same web page for six months. A live audio webcast of the call will be available on the Investors section of the Company’s website Events page. An archived webcast will be available on the Company’s website approximately two hours after the event.

https://finance.yahoo.com/news/clene-reports-topline-results-demonstrating-120000314.html

Clovis: Phase 3 Trial of Rubraca Achieves Primary Endpoint

 

• TRITON3 study evaluating Rubraca monotherapy versus chemotherapy or second-line androgen deprivation therapy in patients with metastatic castration-resistant prostate cancer (mCRPC) with mutations in BRCA or ATM achieved the primary endpoint of improved radiographic progression-free survival (rPFS) by independent radiology review (IRR)

– Median rPFS of 11.2 months for Rubraca vs 6.4 months for control group in the BRCA subgroup
– Median rPFS of 10.2 months for Rubraca vs 6.4 months for control group in the ITT population (inclusive of all patients with a BRCA or ATM mutation enrolled in TRITON3)

• Safety profile of Rubraca observed in TRITON3 was consistent with Rubraca labelling

• TRITON3 is the confirmatory study for Rubraca’s current US accelerated approval in mCRPC and will also serve as the basis of a supplemental New Drug Application (sNDA) for US label expansion to be submitted during Q1 2023

• TRITON3 data have been submitted for presentation at the Prostate Cancer Foundation Annual Scientific Retreat later this month and will also be submitted for presentation at a 2023 medical meeting

https://finance.yahoo.com/news/triton3-phase-3-trial-rubraca-110000094.html

PDS Bio: Successful End-of-Phase 2 Meeting, Preps for Registrational Trial

 PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of targeted immunotherapies for cancer and infectious disease, today announced that it has successfully completed an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) for PDS0101 in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) for the treatment of unresectable, recurrent/metastatic human papilloma virus (HPV) 16-positive head and neck squamous cell carcinoma (HNSCC).

https://finance.yahoo.com/news/pds-biotech-announces-successful-end-120000206.html

Omeros in Royalty Monetization Transaction with DRI Healthcare Trust

 - Omeros receives $125 million in gross proceeds in sale of a portion of projected royalties receivable on net sales of OMIDRIA –

https://finance.yahoo.com/news/omeros-corporation-announces-royalty-monetization-111000654.html

Alnylam Reinforces Patisiran Data In Stiff Heart Disorder Before Heading For FDA Approval

 

• Alnylam Pharmaceuticals Inc 
  ALNY+ Free Alerts
   announced results from exploratory endpoints and additional analyses from the APOLLO-B Phase 3 study of patisiran for transthyretin-mediated (ATTR) amyloidosis with cardiomyopathy. 
• The RNAi drug maintained “generally consistent” benefits in efficacy and quality of life across several prespecified subgroups at month 12, Alnylam announced.
• It also revealed more detail on a key miss, a composite secondary endpoint including all-cause mortality. The researchers noted the numbers trended toward a benefit for patisiran, with 10 all-cause deaths in the placebo group versus four in the treatment group.
• Alnylam also presented a handful of echocardiographic parameters or analyses on heart images produced by sound waves.
• Patisiran showed a statistically significant benefit over placebo, including longitudinal strain (p=0.0324) and LV mass (p=0.0402). The p-value for LV end-diastolic volume came in slightly above 0.05, and no significant differences were seen in the mean or relative LV wall thickness and cardiac output.
• The company said it plans on submitting a supplemental marketing application in ATTR amyloidosis with cardiomyopathy based on the APOLLO-B data by the end of the year.

https://www.benzinga.com/general/biotech/22/10/29113266/alnylam-reinforces-patisiran-data-in-stiff-heart-disorder-before-heading-for-fda-approval