Here's a roundup of top developments in the biotech space over the last 24 hours:
Stocks In Focus
FDA May Authorize Pfizer-BioNTech's COVID-19 Booster For 5-11 Year Kids Soon: NYT
The FDA is expected to authorize a booster shot of Pfizer Inc (NYSE:PFE)/BioNTech SE's (NASDAQ:BNTX) COVID-19 vaccine for children ages 5 to 11, likely Tuesday, the New York Times reported, citing people familiar with the matter.
It is unclear how much demand there is for the third dose in the age group. According to the U.S. Centers for Disease Control and Prevention, just 28.8% of children ages 5 to 11 are fully vaccinated.
Applied Genetic's Vision Loss Gene Therapy Shows Encouraging Safety, Efficacy At Three Months
Applied Genetic Technologies Corporation (NASDAQ:AGTC) reported three-month interim data from its ongoing Phase 2 Skyline trial of AGTC-501 for X-linked retinitis pigmentosa, an inherited condition causing progressive vision loss in boys and young men.
AGTC-501 is a recombinant AAV viral vector-based gene therapy targeting mutations in the RPGR gene.
There were robust improvements in visual sensitivity, the trial's primary efficacy endpoint, in multiple patients three months after dosing, with a 62.5% response rate in dose group B and a 25% response rate in dose group A.
Gilead Sciences Can Resume Injectable Lenacapavir Trial For HIV Infection
The FDA has lifted the clinical hold placed on Gilead Sciences Inc's (NASDAQ:GILD) Investigational New Drug Application to evaluate injectable lenacapavir for HIV treatment and HIV pre-exposure prophylaxis.
The agency has removed the clinical hold after reviewing Gilead's comprehensive plan and corresponding data on the storage and compatibility of lenacapavir injection with an alternative vial made from aluminosilicate glass.
Ampio's Independent Committee Launches Investigation Related To AP-013 Trial
Ampio Pharmaceuticals Inc's (NYSE:AMPE) independent special Committee of the Ampio Board of Directors has started an internal investigation regarding Ampio's AP-013 trial with the assistance of independent legal counsel.
FDA has communicated to Ampio that it does not consider data from AP-013 to be sufficient to demonstrate efficacy as a second pivotal trial for Ampion.
Click here to access Benzinga's FDA Calendar.
Sernova, Evotec Join Forces To Develop 'Functional Cure' For Diabetes
Sernova Corp and Evotec SE (NASDAQ:EVO) have announced an exclusive global strategic partnership to develop cell therapy treatment for insulin-dependent diabetes.
The companies will leverage their respective technologies and scientific expertise to develop an implantable iPSC-based (induced pluripotent stem cells) beta cell replacement therapy.
The partnership provides Sernova with an exclusive global option to license Evotec's iPSC-based beta cells to treat type 1 and type 2 diabetes.
MannKind Acquires Zealand Pharma's Wearable Insulin Delivery Device
MannKind Corporation (NASDAQ:MNKD) has agreed to acquire Zealand Pharma A/S (NASDAQ:ZEAL) V-Go for $10 million, with additional sales-based milestones plus the cost of certain inventory.
The acquisition of V-Go allows MannKind to expand its portfolio and strengthen its commitment to providing innovative mealtime diabetes solutions.
V-Go is a once-daily, wearable insulin delivery device that helps control blood sugar for everyday lifestyles. It is worn like a patch and eliminates the need for taking multiple daily shots.
MediWound's CEO Transition
MediWound Ltd (NASDAQ:MDWD) has appointed Ofer Gonen as CEO of MediWound, effective June 30, succeeding Sharon Malka, who will join the company's board.
Gonen has been a MediWound board member and the CEO of Clal Biotechnology Industries Ltd, MediWound's largest shareholder, for the last five years.
Ultragenyx In-Licenses Abeona's Gene Therapy For Rare Genetic Metabolism Disorder
Ultragenyx Pharmaceutical Inc (NASDAQ:RARE) has announced an exclusive license agreement for Abeona Therapeutics Inc's (NASDAQ:ABEO) AAV gene therapy ABO-102 (now UX111) for Sanfilippo syndrome type A (MPS IIIA).
Ultragenyx will assume responsibility for the ABO-102 program, and Abeona is eligible to receive tiered royalties of up to 10% on net sales and commercial milestone payments following regulatory approval.
FDA Plans AdComm To Discuss Cytokinetics' Heart Drug Potential
The FDA plans to convene an Advisory Committee meeting for Cytokinetics Incorporated's (NASDAQ:CYTK) omecamtiv mecarbil marketing application.
Omecamtiv mecarbil is an investigational, selective, small molecule cardiac myosin activator for heart failure with reduced ejection fraction.
The FDA has assigned the application a standard review with a PDUFA target action date of November 30.
Clinical Readouts/Presentations
American Society of Gene & Cell Therapy (ASGCT) 25th Annual Meeting
Ultragenyx Pharmaceutical Inc (NASDAQ:RARE): Safety and efficacy data from Phase 1/2 trial of DTX301 in adults with late-onset ornithine transcarbamylase Deficiency A.
RegenXbio Inc (NASDAQ:RGNX) Interim Analysis of Data from the First in Human Study of RGX-111 Gene Therapy for Severe Mucopolysaccharidosis Type I.
Cabaletta Bio Inc (NASDAQ:CABA): Early cohort data from Phase 1 Trial of targeted DSG3-CAART cell therapy in mucosal-dominant pemphigus vulgaris.
American Thoracic Society (ATS) 2022 International Conference
Bellerophon Therapeutics Inc (NASDAQ:BLPH): Phase 2 Trial of INOpulse in Patients with Sarcoidosis Associated Pulmonary Hypertension Requiring Supplemental Oxygen.
Akari Therapeutics Plc (NASDAQ:AKTX): Two posters reporting results from the CORONET and CASCADE studies of nomacopan in COVID-19 pneumonia patients.
BELLUS Health Inc (NASDAQ:BLU): Safety and efficacy of BLU-5937 for a refractory chronic cough from the Phase 2b Soothe Trial.
On The Radar
IPO
OKYO Pharma Limited (NASDAQ:OKYO) priced its IPO of 625,000 ADSs at $4/ADS. Trading will start today.
Stock Split
PolarityTE Inc (NASDAQ:PTE): 1-for-25 reverse stock split.
Earnings
ObsEva SA (NASDAQ:OBSV): Before the market open.
Vascular Biogenics Ltd (NASDAQ:VBLT): Before the market open.
Bio-Path Holdings Inc (NASDAQ:BPTH): Before the market open.
