Here's a roundup of top developments in the biotech space over the last 24 hours.
Scaling The Peaks
(Biotech stocks hitting 52-week highs on June 26)
- Odonate Therapeutics Inc (NASDAQ: ODT)
Down In The Dumps
(Biotech stocks hitting 52-week lows on June 26)
- Acorda Therapeutics Inc (NASDAQ: ACOR)
- Aerie Pharmaceuticals Inc (NASDAQ: AERI)
- Arcus Biosciences Inc (NYSE: RCUS)(presented its mid-year clinical update Tuesday after the close)
- Atara Biotherapeutics Inc (NASDAQ: ATRA)
- Axcella Health Inc (NASDAQ: AXLA)
- Bicycle Therapeutics PLC (NASDAQ: BCYC)(IPOed on May 23)
- BioNano Genomics Inc (NASDAQ: BNGO)
- Biopharmx Corp (NYSE: BPMX)
- Caladrius Biosciences Inc (NASDAQ: CLBS)
- CELLECT BIOTECH/S ADR (NASDAQ: APOP)
- CELYAD SA/ADR (NASDAQ: CYAD)
- DelMar Pharmaceuticals Inc (NASDAQ: DMPI)(announced an extension in the subscription period for its rights offering to July 12)
- Enochian Biosciences Inc (NASDAQ: ENOB)
- GENFIT S A/ADR (NASDAQ: GNFT)
- Hookipa Pharma Inc (NASDAQ: HOOK)
- Kaleido Biosciences Inc (NASDAQ: KLDO)
- Kezar Life Sciences Inc (NASDAQ: KZR)
- Nuvectra Corp(NASDAQ: NVTR)
- Puma Biotechnology Inc (NASDAQ: PBYI)
- Solid Biosciences Inc (NASDAQ: SLDB)
- Spring Bank Pharmaceuticals Inc (NASDAQ: SBPH)
- Surface Oncology Inc (NASDAQ: SURF)
- Tetraphase Pharmaceuticals Inc (NASDAQ: TTPH)
- Unum Therapeutics Inc (NASDAQ: UMRX)
Stocks In Focus Verrica's Wart Treatment Aces Mid-stage Trial
Verrica Pharmaceuticals Inc (NASDAQ: VRCA) announced positive top-line results from a Phase 2 study dubbed COVE-1 of its VP-102 for the treatment of verruca vulgaris or common warts. The study met the primary endpoint of complete clearance of all treatable warts at Day 84 and the secondary endpoint of the percentage reduction of warts.
The investigational asset was also found to be safe and well-tolerated, with no serious adverse events reported.
Verrica said it intends to request an End-of-Phase 2 meeting with the FDA for the indication.
The stock rallied 14.98% to $10.90 in after-hours trading.
Aclaris's Hair Loss Drug Flunks Mid-stage Trial
Aclaris Therapeutics Inc (NASDAQ: ACRS) said its Phase 2 clinical trial of ATI-502, an investigational topical Janus Kinase 1/ 3 inhibitor in patients with alopecia areata did not achieve statistical superiority at the primary or secondary endpoints due to high rates of disease resolution in vehicle-treated patients.
Alopecia areata is medical condition in which the hair of a person falls in round patches.
The stock slumped 32.58% to $3 in after-hours trading.
FDA Accepts For Review Sanofi's Meningococcal Meningitis Vaccine
Sanofi SA (NASDAQ: SNY) said the FDA has accepted for review the BLA for its MenQuadfi Meningococcal Polysaccharide Tetanus Toxoid Conjugate Vaccine candidate to help prevent meningococcal meningitis. The PDUFA date has been set for April 25, 2020.
CDC Committee Recommends Expanded Use Of Merck's HPV Vaccine
Merck & Co., Inc. (NYSE: MRK) said the U.S. Centers for Disease Control and Prevention, or CDC's Advisory Committee On Immunization Practices, or AICP, voted to recommend HPV vaccination with its Gardasil 9 based on shared clinical decision making for individuals 27 through 45 years of age who are not adequately vaccinated. The AICP has also voted to expand routine and catch-up recommendations for males through 26 years of age who are not adequately vaccinated, the company added.
Aridis Lung Infection Drug Gets Orphan Drug Designation
Aridis Pharmaceuticals Inc (NASDAQ: ARDS) said the FDA has granted orphan drug designation to AR-501, its inhaled formulation of gallium citrate for the treatment of lung infection in patients with cystic fibrosis.
On The Radar IPOs
Adaptive Biotechnologies, which translates the scale and precision of people's adaptive immune systems into products to help diagnose, treat and monitor disease, priced its upsized IPO of 15 million shares at $20, within the estimated price range of $19-$22. The shares will be listed on the the NYSE under the ticker symbol ADPT.
BridgeBio Pharma priced its upsized offering of 20.50 million shares at $17, above the estimated price range of $14-$16. The biotech, which focuses on therapies for genetic diseases and cancers, will list its shares on the Nasdaq under the ticker symbol BBIO.
Morphic Holding priced its upsized offering of 6 million shares at $15, the middle of the estimated price range of $14-$16. The biotech that develops small-molecule integrin inhibitors for chronic diseases will list its shares on the Nasdaq under the ticker symbol MORF.
See more from Benzinga
- The Daily Biotech Pulse: Decision Day For Regeneron-Sanofi, Vermillion Offering, PDL BioPharma CFO to Depart
- The Daily Biotech Pulse: Genfit NASH Drug In China, Conatus Explores Sale, Gilead Stitches Up Immuno-Oncology Partnership
- FDA Type A Meetings: What You Need To Know
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