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Thursday, October 6, 2022
Provention, Sanofi to Support Potential U.S. Launch of Teplizumab for Delay in Onset of Type 1 Diabetes
Provention receives $20 million nonrefundable payment granting Sanofi exclusive right of first negotiation to in-license teplizumab globally for T1D
U.S. copromotion agreement leverages Sanofi's in-market infrastructure and established expertise in endocrinology to expand reach, increase awareness and drive T1D screening
Sanofi to invest $35 million at a premium after a potential teplizumab FDA approval
Investor Conference call at 8:30am ET Today
Motus GI Granted a U.S. Patent for Prepless Colonoscopy Methods
Patent provides additional intellectual property protection for methods to enable high-quality colonoscopy with no or minimal prep
Company believes reducing the burden associated with pre-procedural bowel prep may ensure greater compliance to colorectal cancer screening guidelines, particularly in the large outpatient market segment
HeartBeam Broadens Product Portfolio Pipeline with Smartwatch Connectivity
HeartBeam, Inc. (NASDAQ: BEAT), a cardiac technology company that has developed the first and only 3D-vector ECG platform for heart attack detection anytime, anywhere, announced today the expansion of its product portfolio pipeline to serve the growing cardiac device wearable technology market by bringing clinically relevant diagnostic information to patients and clinicians. The product pipeline advancement allows for the addition of arrhythmia detection capabilities to address the multibillion-dollar global market for atrial fibrillation and other arrhythmia monitoring.
https://finance.yahoo.com/news/heartbeam-broadens-product-portfolio-pipeline-123100038.html
AngioDynamics Misses on Quarter; Reaffirms Guidance
Fiscal Year 2023 First Quarter Highlights
Net sales of $81.5 million increased 5.9% compared to the prior-year quarter
Med Tech net sales of $22.8 million increased 29.6%
Med Device net sales of $58.7 million decreased 1.1%
Gross margin of 51.9% declined 20 basis points year over year
GAAP loss per share of $0.33 and adjusted loss per share of $0.06
The Company commenced the Full Market Release of the AlphaVac F18 Mechanical Thrombectomy device
Eli Lilly to start rolling submission for obesity drug approval this year
Eli Lilly and Co said on Thursday it plans to start a rolling submission to the U.S. Food and Drug Administration (FDA) this year to get an approval for its obesity drug tirzepatide.
The data it will submit will include that from two late-stage trials, one of which is expected in April.
The FDA has also granted "Fast Track" designation for the drug to treat obesity or overweight with weight-related comorbidities in adults, under which the regulator expedites the review of medicines to treat serious conditions and fill an unmet medical need.
https://finance.yahoo.com/news/1-eli-lilly-start-rolling-114649301.html
Aldeyra Hits Primary Endpoint in Part 1 of Phase 3 Vitreoretinopathy Trial
ADX-2191 Statistically Superior to Historical Control for Primary Endpoint of Prevention of Retinal Detachment (P=0.024)
Numerical Superiority of ADX-2191 over Routine Surgical Care Achieved for Majority of Secondary, Exploratory, and Safety Endpoints
ADX-2191 Observed to be Well Tolerated with No Safety Concerns Noted
Company Plans to Discuss Completion of Clinical Development in Proliferative Vitreoretinopathy with the U.S. Food and Drug Administration in the First Half of 2023
Company to Host Conference Call at 8:00 a.m. ET Today
Aldeyra will host a conference call to discuss this announcement at 8:00 a.m. ET today, October 6, 2022. The dial-in numbers are (844) 200-6205 for domestic callers and (646) 904-5544 for international callers. The access code is 005042. A live webcast of the conference call will also be available on the "Investors & Media" section of the Aldeyra website at https://ir.aldeyra.com. Presentation slides, which contain material information and should be reviewed in conjunction with this press release, will be available on the investor relations page prior to the start of the conference call and webcast.
After the live webcast, the event will remain archived on the Aldeyra website for 90 days.
https://finance.yahoo.com/news/aldeyra-therapeutics-achieves-primary-endpoint-110000149.html